WO2024086307A1 - Produits alimentaires formulés - Google Patents

Produits alimentaires formulés Download PDF

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Publication number
WO2024086307A1
WO2024086307A1 PCT/US2023/035547 US2023035547W WO2024086307A1 WO 2024086307 A1 WO2024086307 A1 WO 2024086307A1 US 2023035547 W US2023035547 W US 2023035547W WO 2024086307 A1 WO2024086307 A1 WO 2024086307A1
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WO
WIPO (PCT)
Prior art keywords
preparation
component
food
acid
payload
Prior art date
Application number
PCT/US2023/035547
Other languages
English (en)
Inventor
Aaron C. Anselmo
Anant S. BALIJEPALLI
Emily E. BONACQUISTI
Andrew D. CHRISTENSON
Joshua K. DEGENNARO
Seo Yeon Kim
Kevin M. LUO
James D. SIEVERT
Andrea Stamp
Ana Jaklenec
Catherine B. Reynolds
Robert S. Langer
Sarah Grace ADZEMA
Christina Lynn MAKRIS
Original Assignee
Vitakey Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vitakey Inc. filed Critical Vitakey Inc.
Publication of WO2024086307A1 publication Critical patent/WO2024086307A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P10/00—Shaping or working of foodstuffs characterised by the products
    • A23P10/30—Encapsulation of particles, e.g. foodstuff additives

Definitions

  • TECHNICAL FIELD The present disclosure is generally related to food and/or beverage compositions (e.g., formulated meals, formulated foods, formulated beverages, formulated supplements, and/or their nutritional constituents, etc.; e.g., formulated ingestibles) and technologies (e.g., methods of preparation, use, etc.) relating thereto.
  • BACKGROUND The health benefits of formulated foods, formulated beverages, formulated supplements, and their nutritional constituents to mammals such as humans have been studied for several decades.
  • a food and/or beverage composition e.g., formulated ingestibles
  • a food and/or beverage composition can be included in a supplement, a food, a supplemented (i.e., fortified) food product, a beverage, a supplemented (i.e., fortified) beverage product, a powder, or a supplemented (i.e., fortified) powder product intended to confer health benefits.
  • Popular food and/or beverage compositions include protein shakes, dry powders (e.g., baby formula, protein powder, drink mixes, coffee grinds), Meal Ready-to-Eat (MRE), Meal Ready-to-Drink (RTD), electrolyte beverages, sports beverages, hard seltzers (alcoholic seltzers), dry foods (e.g., rice, pasta), water, medical foods (e.g., Ready-to-drink low phenylalanine medical food), supplements, beer, wine, soda, coffee, fermented foods and beverages (e.g., yogurt, beer, etc.); for example, MREs, Gatorade, Truly, Ensure, PKU Sphere Liquid, etc.
  • MRE Meal Ready-to-Eat
  • RTD Meal Ready-to-Drink
  • electrolyte beverages sports beverages, hard seltzers (alcoholic seltzers)
  • dry foods e.g., rice, pasta
  • medical foods e.g., Ready-to-drink
  • the present disclosure provides technologies (e.g., food and/or beverage compositions, such as formulated ingestibles) that involve utilizing energy sources (e.g., macronutrients) such as carbohydrates, fats, ketones and proteins to confer health benefits and provide energy (e.g., calories, Joules) acquisition.
  • energy sources e.g., macronutrients
  • carbohydrates, fats, ketones and proteins e.g., carbohydrates, fats, ketones and proteins
  • the present disclosure provides technologies (e.g., food and/or beverage compositions such as formulated ingestibles) in which nutrients (e.g., antioxidants, electrolytes, flavonoids, micronutrients, minerals, polyphenols, prebiotics, vitamins, etc.) are provided as a preparation that is compatible, for example, with an ingestible item or material such as a supplement, and/or a food or nutrient source, and/or a beverage, consumed by a human or an animal (e.g., a domesticated animal such as a chicken, a cow, a dog, etc.).
  • nutrients e.g., antioxidants, electrolytes, flavonoids, micronutrients, minerals, polyphenols, prebiotics, vitamins, etc.
  • a preparation that is compatible, for example, with an ingestible item or material such as a supplement, and/or a food or nutrient source, and/or a beverage, consumed by a human or an animal (e.g., a domesticated
  • the present disclosure provides technologies (e.g., and/or food and/or beverage compositions, such as (e.g., formulated ingestibles) in which one or more nutrients (e.g., macronutrients and/or micronutrients), which in some embodiments may be or comprise one or more amino acids, polypeptides (e.g., peptides or proteins), elements, lipids (e.g., fats, fatty acids, short-chain fatty acids, etc.), saccharides (e.g., a mono- or poly-saccharide, such as sugars, carbohydrates, etc., which may in some embodiments be or comprise dietary fiber such as prebiotic fiber), minerals (e.g., electrolytes, salts, etc.), carotenoids, ketone bodies, polyphenols (e.g., flavonoids), vitamins, probiotics (bacteria, yeast, etc.), postbiotics (e.g., short- chain fatty acids, lactic acid,
  • nutrients e.g.
  • a preparation that is compatible, for example, with an ingestible item or material such as a Page 2 of 315 11645787v1 Docket No.: 2017299-0086 supplement, and/or a food or nutrient, and/or a beverage, consumed by a human or an animal (e.g., a chicken, a cow, a dog, etc.).
  • an ingestible item or material such as a Page 2 of 315 11645787v1 Docket No.: 2017299-0086 supplement, and/or a food or nutrient, and/or a beverage, consumed by a human or an animal (e.g., a chicken, a cow, a dog, etc.).
  • provided food and/or beverage compositions achieve one or more advantages for macronutrients/calorie sources/energy sources (e.g., proteins, carbohydrates, fats) such as stability, extended shelf-life, controlled residence time, controlled absorption, controlling the spatial distribution in the gastrointestinal tract, controlled coverage of the surface area in the gastrointestinal tract, controlled release, sustained release, increased absorption after ingestion, increased bioavailability, controlled satiety, decreased gastrointestinal discomfort and compatibility with other materials.
  • macronutrients/calorie sources/energy sources e.g., proteins, carbohydrates, fats
  • food and/or beverage compositions (e.g., formulated ingestibles) provided herein may comprise, for example, one or more antioxidants, macronutrients, micronutrients, polyphenols, fatty acids, ketones, minerals, electrolytes, prebiotics, probiotics, vitamins, or combinations thereof.
  • provided food and/or beverage compositions are characterized by one or more of the following advantages: (i) improved absorption and/or bioavailability of payloads, (ii) improved shelf-life and resistance to degradation at decreased temperatures (e.g., -80°C, -20°C, and/or 4°C), elevated temperatures (e.g., 22°C, 25°C, 30°C, 35°C, and/or 40°C), in food and/or food products, in beverages and/or beverage products, in supplements, in dry powders, in the presence of high relative humidity (e.g., up to 100%) or moisture, or a combination thereof; (iii) prolonged residence time or transit time in the gastrointestinal tract or gastrointestinal tract compartments, (iv) controlled release or sustained release of payload components in the gastrointestinal tract, (v) controlled spatial distribution of payloads in and/or on the gastrointestinal tract, (vi) controlled concentration of payloads in the following advantages: (i) improved absorption and/or bioavailability of payloads, (i
  • food and/or beverage compositions may be used to confer health benefits in a human or animal.
  • food and/or beverage compositions e.g., formulated ingestibles
  • nutrients e.g., macronutrients, micronutrients, flavonoids, etc.
  • bioavailability nutrients e.g., macronutrients, micronutrients, flavonoids, etc.
  • controlling satiety enhancing and/or controlling energy acquisition, and/or supporting bowel movements, etc.
  • food and/or beverage compositions confer health benefits, may do so by prolonging or extending the Page 4 of 315 11645787v1 Docket No.: 2017299-0086 absorption time of nutrients, prolonging or extending the gastrointestinal residence time of nutrients, controlling the surface area or volume that nutrients have access to in the gastrointestinal tract, controlling the rate at which the payloads release from the food and/or beverage compositions (e.g., formulated ingestibles), increasing the absorption or bioavailability of nutrients, controlling payload spatial interactions within the host (e.g., controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, controlled residence time of nutrients in the gastrointestinal tract), and/or concentration of nutrients in the gastrointestinal tract, or controlling interactions between payload and gastrointestinal environments.
  • absorption time of nutrients e.g., prolonging or extending the gastrointestinal residence time of nutrients
  • controlling the surface area or volume that nutrients have access to in the gastrointestinal tract controlling
  • these approaches may be useful in conferring health benefits (e.g., controlled satiety, controlled fullness, controlled feeling of fullness, improved distribution of energy/nutrients over time, increased overall energy acquisition, increased overall nutrient acquisition, increased bioavailability, reduced frequency of meal intake, etc.).
  • provided food and/or beverage compositions e.g., formulated ingestibles
  • Controlling food and/or beverage (e.g., formulated ingestibles) absorption time in the gastrointestinal tract may be beneficial to organisms (e.g., animals, e.g., humans) due to various mechanisms (e.g., controlled absorption time of nutrients in the stomach and/or intestines, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, increased energy acquisition, controlled energy acquisition, increased nutrient acquisition, controlled nutrient acquisition, reduced frequency of meal intake, etc.).
  • organisms e.g., animals, e.g., humans
  • various mechanisms e.g., controlled absorption time of nutrients in the stomach and/or intestines, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, increased energy acquisition, controlled energy acquisition, increased nutrient acquisition, controlled nutrient acquisition, reduced frequency of meal intake, etc
  • provided food and/or beverage compositions may be used to accelerate, prolong, and/or extend the residence time of nutrients.
  • Controlling food and/or beverage (e.g., formulated ingestibles) residence time in the gastrointestinal tract may be beneficial to organisms (e.g., animals, e.g., humans) due to various mechanisms (e.g., controlled absorption time of nutrients in the stomach and/or intestines, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration Page 5 of 315 11645787v1 Docket No.: 2017299-0086 of nutrients in the mucus, increased energy acquisition, increased nutrient acquisition, reduced frequency of meal intake, etc.).
  • provided food and/or beverage compositions may be used to control the surface area or volume that nutrients have access to in the gastrointestinal tract.
  • Controlling food and/or beverage compositions’ e.g., formulated ingestibles’
  • spatial interactions with host-tissues in the gastrointestinal tract may be beneficial to organisms (e.g., animals, e.g., humans) due to various mechanisms (e.g., controlled satiety, controlled fullness, controlled feeling of fullness, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, controlled residence time of nutrients in the gastrointestinal tract, etc.).
  • provided food and/or beverage compositions may be used to control the rate of release of nutrients and/or payloads.
  • Controlling nutrient and/or payload release rate from food and/or beverage compositions may be beneficial to organisms (e.g., animals, e.g., humans) due to various mechanisms (e.g., controlled absorption time of nutrients in the stomach and/or intestines, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, increased energy acquisition, increased nutrient acquisition, increased bioavailability of energy sources or nutrients, reduced frequency of meal intake, etc.).
  • provided food and/or beverage compositions may be used to increase the bioavailability of nutrients.
  • Increased bioavailability of nutrients may be beneficial to organisms (e.g., animals, e.g., humans) due to various mechanisms (e.g., increased energy acquisition, increased nutrient acquisition, reduced frequency of meal intake, etc.).
  • provided food and/or beverage compositions may be used to increase the concentration of nutrients and/or payloads in various sections and areas in the gastrointestinal tract (e.g., stomach, small intestines, large intestines, epithelial surface, mucus, lumen, etc.).
  • Controlling concentration of nutrients and/or payloads in the gastrointestinal tract may be beneficial to organisms (e.g., animals, e.g., humans) due to various mechanisms (e.g., increased energy acquisition, increased nutrient acquisition, reduced frequency of meal intake, etc.).
  • the present disclosure provides an insight that one challenge in using food and/or beverage compositions (e.g., formulated ingestibles) may be achieving nutrient and/or payload stability after host ingestion due to nutrient and/or payload sensitivity (e.g., chemical degradation) in various physiological conditions (e.g., stomach, stomach acids, low pH, bile salts, bile, etc.), which may (i) reduce nutrient and/or payload amount, (ii) reduce benefits outlined above (e.g., reduced bioavailability, reduced energy acquisition, reduced nutrient acquisition, etc.), or both (i) and (ii).
  • nutrient and/or payload sensitivity e.g., chemical degradation
  • physiological conditions e.g., stomach, stomach acids, low pH, bile salts, bile, etc.
  • benefits outlined above e.g., reduced bioavailability, reduced energy acquisition, reduced nutrient acquisition, etc.
  • the present disclosure further provides an insight that a challenge in using food and/or beverage compositions (e.g., formulated ingestibles) may be achieving sufficient control over nutrient and/or payload release, absorption, residence time, gastrointestinal concentration, absorption time, and/or bioavailability, etc. within the host organism after ingestion, which may (i) reduce nutrient and/or payload amount, (ii) reduce control over nutrient and/or payload absorption, (iii) reduce benefits outlined above (e.g., reduced bioavailability, reduced energy acquisition, reduced nutrient acquisition, etc.), or (i), (ii), and/or (iii) and combinations thereof.
  • a challenge in using food and/or beverage compositions e.g., formulated ingestibles
  • the present disclosure further provides an insight that a challenge in using food and/or beverage compositions (e.g., formulated ingestibles) may be achieving sufficient nutrient and/or payload dose in various supplement, food and/or beverage formats (e.g., a sufficient number of nutrients to confer health benefits in a host) in conditions that these products are often stored in (e.g., high water activity, high humidity, high moisture, high temperatures, high oxygen, etc.), which may (i) reduce nutrient and/or payload amount, (ii) reduce control over nutrient and/or payload absorption, (iii) reduce benefits outlined above (e.g., reduced bioavailability, reduced energy acquisition, reduced nutrient acquisition, etc.), or (i), (ii), and/or (iii) and combinations thereof.
  • a challenge in using food and/or beverage compositions e.g., formulated ingestibles
  • a food and/or beverage composition e.g., formulated ingestibles
  • a food and/or beverage composition will face multiple challenges in series and/or in parallel that reduce nutrient and/or payload stability and reduce control over nutrient and/or payload release, spatial interactions with host-tissues, bioavailability, absorption, residence time, etc.
  • the present disclosure provides technologies that address these challenges, e.g., that can preserve and maintain these features (individually and/or in combination) throughout the lifetime of a food and/or beverage composition (e.g., formulated ingestibles).
  • a food and/or beverage composition e.g., formulated ingestibles.
  • the present disclosure appreciates that preserving nutrient and/or payload stability in food and/or beverage compositions (e.g., formulated ingestibles) can be important at least because many of the beneficial functions provided by nutrients require their stability (e.g., energy acquisition, etc.).
  • possibilities include the food and/or beverage itself (e.g., a particular unit or portion of a composition is exposed to and/or in contact with other units or portions of the composition), one or more particular constituents of the food and/or beverage composition, shelf-storage conditions, manufacturing conditions, the environmental conditions after the food and/or beverage is unsealed/opened, physiological environment within a host that ingests the composition, etc.
  • the food and/or beverage itself e.g., a particular unit or portion of a composition is exposed to and/or in contact with other units or portions of the composition
  • one or more particular constituents of the food and/or beverage composition e.g., shelf-storage conditions, manufacturing conditions, the environmental conditions after the food and/or beverage is unsealed/opened, physiological environment within a host that ingests the composition, etc.
  • compositions that are or include a food and/or beverage compositions may further include one or more, promoters Page 8 of 315 11645787v1 Docket No.: 2017299-0086 that increase metabolite secretion and/or improve microbiome colonization and/or improve microbiome survival.
  • controlling the spatiotemporal concentrations of nutrients and/or payloads may impact certain food and/or beverage composition (e.g., formulated ingestibles) functions (e.g., extending payload absorption time, extending payload retention time, controlling payload spatial interactions within the host, controlling payload release rate, increasing or decreasing payload absorption, increasing or decreasing payload concentrations within the host, etc.) that confer desired or intended health benefits (e.g., controlled satiety, controlled fullness, controlled feeling of fullness, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, controlled residence time of nutrients in the gastrointestinal tract, controlled absorption time of nutrients in the stomach and/or intestine, increased energy acquisition, increased nutrient acquisition, increase bioavailability, reduced frequency of meal intake, etc.); thus, in some embodiments, provided food and/or beverage compositions may comprise one or more constituents that ensure control over nutritive nutrients and/or payloads
  • nutrient and/or payload stability can impact certain food and/or beverage composition (e.g., formulated ingestibles) functions (e.g., extending payload absorption time, extending payload retention time, controlling payload spatial interactions within the host, controlling payload release rate, increasing or decreasing payload absorption, increasing or decreasing payload concentrations within the host, etc.) that confer desired or intended health benefits (e.g., controlled satiety, controlled fullness, controlled feeling of fullness, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, controlled residence time of nutrients in the gastrointestinal tract, controlled absorption time of nutrients in the stomach and/or intestine, increased energy acquisition, increased nutrient acquisition, increase bioavailability, reduced frequency of meal intake, etc.); thus, in some embodiments, provided food and/or beverage compositions may Page 9 of 315 11645787v1 Docket No.: 20172
  • the present disclosure provides an insight that including sufficient amounts of provided food and/or beverage composition(s) (e.g., formulated ingestibles) in consumer products, or otherwise delivering them to a host, can have beneficial impacts including, for example, (e.g., extending payload absorption time, extending payload retention time, controlling payload spatial interactions within the host, controlling payload release rate, increasing or decreasing payload absorption, increasing or decreasing payload concentrations within the host, etc.), some or all of which may confer health benefits.
  • beneficial impacts including, for example, (e.g., extending payload absorption time, extending payload retention time, controlling payload spatial interactions within the host, controlling payload release rate, increasing or decreasing payload absorption, increasing or decreasing payload concentrations within the host, etc.), some or all of which may confer health benefits.
  • attributes of certain provided technologies food and/or beverage compositions e.g., formulated ingestibles
  • specifically performance e.g., controlled release, controlled absorption, controlled residence time, controlled concentration
  • important benefits e.g., controlled satiety, controlled fullness, controlled feeling of fullness, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, controlled residence time of nutrients in the gastrointestinal tract, controlled absorption time of nutrients in the stomach and/or intestine, increased energy acquisition, increased nutrient acquisition, increase bioavailability, reduced frequency of meal intake, etc.
  • the present disclosure provides food and/or beverage compositions (e.g., formulated ingestibles) that are or comprise a particle preparation, wherein particles of the particle preparation comprise (i) an encapsulant component; and (ii) a payload component, wherein the encapsulant component comprises a protein, carbohydrate, fat, or other nutrient that is compatible with supplement, food, beverage, and/or physiological fluid/environments (e.g., stomach acids, stomach, intestines, etc.); and the payload component comprises nutrient and wherein the preparation achieves one or more of: (i) protection (maintenance/preservation of nutrient stability) of the payload in supplements, foods, beverages, and/or physiological fluids/environment (e.g., stomach acids, stomach, intestines, etc.), and/or processing/manufacturing environments (e.g., high pressure pasteurization, high temperature pasteurization, etc.); (ii) one or more delivery functions (e.g.,
  • the composition and/or the particle preparation is characterized in that the payload component shows increased stability (e.g., is protected against one or more of degradation, oxidation, pressure, other physical and/or chemical changes) when exposed to one or more environmental conditions such as, for example, heat, acid, protons, pasteurization, shear, high pressure, salt, light, water, oxidation, antimicrobial peptides, elevated temperatures, and/or in the context of a complex material.
  • the compositions and/or the particle preparation is characterized in that it enables controlled release of the payload component in the host’s gastrointestinal tract (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the compositions and/or the particle preparation is characterized in that it enables sustained release of the payload component in the host’s gastrointestinal tract (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the compositions and/or the particle preparation is characterized in that it retention time of the payload component in the host’s gastrointestinal tract is controlled (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the compositions and/or the particle preparation is characterized in that payload absorption in the host’s gastrointestinal tract is controlled (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the compositions and/or the particle preparation is characterized in that payload spatiotemporal association within the host’s gastrointestinal tract is controlled (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the compositions and/or Page 11 of 315 11645787v1 Docket No.: 2017299-0086 the particle preparation is characterized in that it controls the payload concentration in the host’s gastrointestinal tract (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the present disclosure provides human and/or animal consumable compositions (e.g., supplement products, food products, powder products, beverage products, liquid products, etc.) comprising disclosed food and/or beverage compositions (e.g., formulated ingestibles), at least one nutrient, or a combination thereof.
  • food and/or beverage compositions further comprise at least one nutraceutical.
  • nutrient components for example, nutrient payloads
  • nutraceuticals comprise one or more nutraceuticals.
  • humans may be a prenatal human, infant, toddler, child, teenager, adolescent, young adult, adult, geriatric, medical patient, athlete, student, etc.
  • animals may be an agricultural animal (e.g., a horse, a cow, a camel, a goat, a sheep, a fish, a crab, etc.), a pet (e.g., a dog, a cat, a fish, a duck, etc.), and/or a wild animal (e.g., a raccoon, a deer, a moose, a bear, a whale, an ant, a bee, a wasp, etc.).
  • provided compositions are edible (i.e., consumable by eating).
  • an edible composition may be a powder or slurry that is mixed with food (e.g., a freshly prepared meal, a pre-prepared meal, etc.) prior to consumption.
  • provided compositions are drinkable (i.e., amenable to consumption by drinking).
  • a drinkable composition may be a powder or slurry that is mixed with a beverage (e.g., water, a protein shake, etc.) prior to consumption.
  • the present disclosure provides methods for preparing a nutrient and/or nutraceutical payload component.
  • a provided methods may comprise steps of: (i) formulation (e.g., encapsulation, association, and/or complexation with materials); (ii) post-formulation processing (e.g., drying, characterization, additions of excipients, etc.); (iii) storage (e.g., bagging in aluminum sachets, addition of nitrogen or vacuum environments, etc.); (iv) combination with or as supplements and/or foods and/or beverages; (v) methods to ingestions (e.g., swallowing as a capsule, addition to other existing food and/or beverages); or (vi) a combination of (i), (ii), (iii), (iv), and (v).
  • formulation e.g., encapsulation, association, and/or complexation with materials
  • post-formulation processing e.g., drying, characterization, additions of excipients, etc.
  • storage e.g., bagging in aluminum sachets, addition of nitrogen or vacuum environments, etc.
  • the disclosure provides food and/or beverage compositions (e.g., formulated ingestibles) and/or nutrient payloads, which may in some embodiments have been prepared by a method described herein.
  • food and/or beverage compositions e.g., formulated ingestibles
  • nutrient payloads which may in some embodiments have been prepared by a method described herein.
  • the present disclosure provides food and/or beverage compositions (e.g., formulated ingestibles) comprising a carrier component and a payload component, wherein the payload component is associated with (e.g., encapsulated in, adhered to, dispersed in) the carrier component; and wherein the payload component comprises: (i) a nutrient component; (ii) a nutrient that the payload utilizes for functional performance (e.g., extending payload absorption time, extending payload retention time, controlling payload spatial interactions within the host, controlling payload release rate, increasing or decreasing payload absorption, increasing or decreasing payload concentrations within the host, etc.) within the host; (iii) a component that modulates the environment (e.g., food matrix, liquid environment, physiological fluid, tissue/organ such as stomach, etc.) to preserve or maintain nutrient stability and/or delivery functions; (iv) one or more other payload component(s), or (iv) a combination of (
  • provided food and/or beverage compositions are or comprise particles (e.g., microparticles) that include a matrix component (e.g., a polymer component) and a payload component (e.g., nutrients, macronutrients, micronutrients, proteins, carbohydrates, fats, vitamins, minerals, ketones, polyphenols, etc.).
  • a matrix component e.g., a polymer component
  • a payload component e.g., nutrients, macronutrients, micronutrients, proteins, carbohydrates, fats, vitamins, minerals, ketones, polyphenols, etc.
  • a matrix component is or comprises a hydrophobic component.
  • a hydrophobic component is or comprises a sugar, a polysaccharide, a carbohydrate, an oil, a fat, a wax, a protein, or a combination thereof.
  • a matrix component comprises a salt (e.g., calcium carbonate).
  • a matrix component comprises a surfactant (e.g., sodium dodecyl sulfate).
  • a matrix component comprises a polymer (e.g., polyvinyl alcohol).
  • one or more layers of payload components are present.
  • a matrix component is or comprises a hydrophilic component.
  • a hydrophilic component is or comprises a sugar, a Page 13 of 315 11645787v1 Docket No.: 2017299-0086 polysaccharide, a carbohydrate, an oil, a fat, a wax, a protein, or a combination thereof.
  • a matrix component comprises a salt (e.g., sodium chloride).
  • a matrix component comprises a surfactant (e.g., sodium dodecyl sulfate).
  • one or more layers of payload components are present.
  • a matrix component is or comprises a amphiphilic component.
  • a amphiphilic component is or comprises a sugar, a polysaccharide, a carbohydrate, an oil, a fat, a wax, a protein, or a combination thereof.
  • a matrix component comprises a salt (e.g., sodium chloride).
  • a matrix component comprises a surfactant (e.g., sodium dodecyl sulfate).
  • one or more layers of payload components are present.
  • a matrix component comprises a biocompatible material.
  • a biocompatible material is or comprises a sugar, a polysaccharide, a carbohydrate, an oil, a fat, a wax, a lipid, a protein, an amino acid, a peptide, or a combination thereof.
  • a matrix component comprises a salt (e.g., calcium carbonate).
  • a matrix component comprises a surfactant (e.g., sodium dodecyl sulfate).
  • a matrix component further comprises one or more nutrient (e.g., antioxidants, flavonoids, polyphenols, vitamins, minerals, micronutrients, prebiotics, electrolytes) payloads.
  • the present disclosure provides technologies for making and/or characterizing matrix components comprising encapsulants described herein, and/or compositions that include them.
  • the disclosed processes and methodologies to generate matrices include extrusion, granulation, extrusion-based methods, melt processing, shear-based granulation methods, lyophilization, atomization, prilling, spray chilling, and/or spray congealing methods.
  • the carrier component comprises at least one carbohydrate, at least one polymer, and/or at least one lipid.
  • disclosed nutrient components comprise a nutrient selected from the group consisting of: a naturally-occurring nutrient, and a nutrient prepared by any method described herein; a commercially-available nutrient, and a nutrient prepared by any Page 14 of 315 11645787v1 Docket No.: 2017299-0086 method described herein; a commercially-available nutrient preparation (e.g., freeze-dried, or already-formulated nutrients), and a nutrient prepared by any method described herein.
  • a nutrient selected from the group consisting of: a naturally-occurring nutrient, and a nutrient prepared by any method described herein; a commercially-available nutrient, and a nutrient prepared by any Page 14 of 315 11645787v1 Docket No.: 2017299-0086 method described herein; a commercially-available nutrient preparation (e.g., freeze-dried, or already-formulated nutrients), and a nutrient prepared by
  • disclosed nutrient components comprise a commercially-available nutrient powder that includes a carrier or matrix component that is then further encapsulated in a carrier, as described herein.
  • an inner carrier containing the nutrient is itself encapsulated in one or more outer encapsulant layers or carriers.
  • the present embodiments are directed to a method of promoting health or longevity in a human, the method comprising: providing an effective amount of the any preparation as described herein.
  • a provided composition may be or comprise one or more particles; typically, a population of particles (e.g., a particle preparation).
  • a particle or population thereof is characterized by its diameter (e.g., average diameter).
  • a particle “diameter” i.e., a particle size
  • food and/or beverage compositions are or comprise particles with a distribution of particle diameters (e.g., D[3,2], D[4,3], etc.).
  • food and/or beverage compositions are or comprise particles with a distribution of particle diameters (e.g., D[3,2], D[4,3], etc.) of up to about 1 nm, up to about 100 nm, up to about 500 nm, up to about 1 ⁇ m, up to about 10 ⁇ m, up to about 100 ⁇ m, up to about 500 ⁇ m, up to about 1 mm, up to about 1 mm, up to about 10 mm, or up to about 50 mm.
  • particle diameters e.g., D[3,2], D[4,3], etc.
  • food and/or beverage compositions may include particle preparations that include particles with one or more of a variety of shapes or forms, for example, having a cross-section shape of a circle, an oval, a triangle, a square, a hexagon, or an irregular shape.
  • food and/or beverage compositions e.g., formulated ingestibles
  • comprise particles e.g., nanoparticles, microparticles), wherein a significant percentage (e.g., a majority) of particles have a common shape.
  • food and/or beverage compositions are or comprise particles of various such shapes in combination.
  • food and/or beverage compositions may include individual constituents that self-assemble into particle preparations upon exposure to a specific environment (e.g., food matrix, beverage matrix, physiological fluid, stomach acids, bile salts, temperature, etc.).
  • Food and/or beverage compositions e.g., formulated ingestibles
  • Food and/or beverage compositions that self-assemble into particle preparations upon introduction into specific environments include any shape or form, for example, having a cross-section shape of a circle, an oval, a triangle, a square, a hexagon, or an irregular shape.
  • food and/or beverage compositions comprise particles (e.g., nanoparticles, microparticles), wherein a majority of particles have a common shape.
  • food and/or beverage compositions e.g., formulated ingestibles
  • provided food and/or beverage compositions are characterized by having a layered structure, e.g., wherein adjacent layers have different chemical structures.
  • provided food and/or beverage compositions are characterized by having multiple polymer components, wherein the food and/or beverage compositions (e.g., formulated ingestibles) may be additionally encapsulated with a separate polymer component.
  • the compositions (e.g., formulated ingestibles) provided by the present disclosure include a first layer that is or comprises a nutrient and/or a second nutrient and a second layer that is or comprises a different nutrient and/or the same nutrient.
  • a nutrient material may be or comprise proteins and/or carbohydrates; in some embodiments, the protein may be encapsulated within the carbohydrate; in some embodiments, the carbohydrate may be encapsulated within the protein; in some embodiments, the carbohydrate may be encapsulated within the same or a distinct carbohydrate. In some embodiments, the carbohydrate may be encapsulated within a mixture of protein and carbohydrates. In some embodiments, the layers are reversed.
  • the composition and/or the preparation is characterized in that the payload component shows increased stability (e.g., is protected against Page 16 of 315 11645787v1 Docket No.: 2017299-0086 one or more of degradation, oxidation, pressure, other physical and/or chemical changes) when exposed to one or more environmental conditions such as, for example, heat, acid, protons, pasteurization, shear, high pressure, salt, light, water, oxidation, antimicrobial peptides, elevated temperatures, and/or in the context of a complex material.
  • the payload component shows increased stability (e.g., is protected against Page 16 of 315 11645787v1 Docket No.: 2017299-0086 one or more of degradation, oxidation, pressure, other physical and/or chemical changes) when exposed to one or more environmental conditions such as, for example, heat, acid, protons, pasteurization, shear, high pressure, salt, light, water, oxidation, antimicrobial peptides, elevated temperatures, and/or in the context
  • Food and/or beverage compositions comprising enhanced stability provides benefits over existing comparable products, among other things because enhanced stability will extend shelf-life.
  • the present disclosure provides technologies for manufacturing provided food and/or beverage compositions (e.g., formulated ingestibles) that increase payload stability during and/or following manufacturing (thereby minimizing payload losses in food and/or beverage products).
  • the present disclosure provides technologies for manufacturing provided food and/or beverage compositions (e.g., formulated ingestibles) that increase shelf-life following manufacturing (thereby minimizing payload losses in food and/or beverage products).
  • the present disclosure provides technologies for manufacturing provided food and/or beverage compositions (e.g., formulated ingestibles) that increase shelf-life time following manufacturing (thereby minimizing payload losses in food and/or beverage products).
  • the compositions and/or the particle preparation is characterized in that it enables controlled release of the payload component in a host’s gastrointestinal tract (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • Food and/or beverage compositions (e.g., formulated ingestibles) comprising controlled release of payloads have benefits over existing products, among other things because controlled payload release will provide methods to improve or extend nutrient absorption.
  • the present disclosure provides technologies for manufacturing provided food and/or beverage compositions (e.g., formulated ingestibles) that Page 17 of 315 11645787v1 Docket No.: 2017299-0086 provide controlled release of payloads following manufacturing (thereby ensuring that products containing compositions can provide controlled delivery of nutrients).
  • the compositions and/or the particle preparation is characterized in that it enables sustained release of the payload component in the host’s gastrointestinal tract (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the present disclosure provides technologies for manufacturing provided food and/or beverage compositions (e.g., formulated ingestibles) that provide sustained release of payloads following manufacturing (thereby ensuring that products containing compositions can provide sustained delivery of nutrients).
  • the compositions and/or the particle preparation is characterized in that it enables extended retention time of the payload component in the host’s gastrointestinal tract is (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the present disclosure provides technologies for manufacturing provided food and/or beverage compositions (e.g., formulated ingestibles) that provide extended retention time of payloads following manufacturing (thereby ensuring that products containing compositions can provide sustained delivery of nutrients).
  • the compositions and/or the particle preparation is characterized in that payload absorption in the host’s gastrointestinal tract is controlled (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the present disclosure provides technologies for manufacturing provided food and/or beverage compositions (e.g., formulated ingestibles) that provide controlled absorption of payloads following manufacturing (thereby ensuring that products containing compositions can control nutrient absorption).
  • the compositions and/or the particle preparation is characterized in that payload spatiotemporal association within the host’s gastrointestinal tract is controlled (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • Food and/or beverage compositions comprising controlled payload spatial association within the host’s gastrointestinal tract have benefits over Page 18 of 315 11645787v1 Docket No.: 2017299-0086 existing products, among other things because controlled payload spatial association within the host’s gastrointestinal tract will provide methods to improve or extend satiety.
  • the present disclosure provides technologies for manufacturing provided food and/or beverage compositions (e.g., formulated ingestibles) that provide controlled payload spatial association within the host’s gastrointestinal tract following manufacturing (thereby ensuring that products containing compositions can control satiety).
  • the compositions and/or the particle preparation is characterized in that it controls the payload concentration in the host’s gastrointestinal tract (e.g., esophagus, stomach, small intestine, large intestine, etc.).
  • the present disclosure provides technologies for manufacturing provided food and/or beverage compositions (e.g., formulated ingestibles) that provide controlled payload concentration within the host’s gastrointestinal tract following manufacturing (thereby ensuring that products containing compositions can control nutrient acquisition and/or energy acquisition from foods and/or beverages).
  • the present disclosure provides food and/or beverage compositions (e.g., formulated ingestibles) with resistance (e.g., mitigation of nutrient degradation) to stomach acids, simulated gastric fluids, proton-rich liquids, or low-pH (e.g., less than a pH of 3) fluids and/or liquids and/or beverages.
  • the present disclosed food and/or beverage compositions e.g., formulated ingestibles
  • the present disclosure provides food and/or beverage compositions (e.g., formulated ingestibles) with resistance (e.g., mitigation of nutrient degradation) to intestinal fluids, bile salts, bile, or neutral-pH (e.g., greater than pH of 5 but lower than pH of 9) fluids and/or liquids and/or beverages.
  • food and/or beverage compositions e.g., formulated ingestibles
  • resistance e.g., mitigation of nutrient degradation
  • intestinal fluids e.g., bile salts, bile, or neutral-pH (e.g., greater than pH of 5 but lower than pH of 9) fluids and/or liquids and/or beverages.
  • neutral-pH e.g., greater than pH of 5 but lower than pH of 9
  • the present disclosed food and/or beverage compositions may provide benefits over existing products, among other things because neutral solutions lead to nutrient degradation or impair nutrient absorption after ingestion, and/or upon contact with the intestines and/or Page 19 of 315 11645787v1 Docket No.: 2017299-0086 intestinal fluids and/or upon contact with beverages.
  • the present disclosure provides technologies with a variety of advantages.
  • the present disclosure provides food and/or beverage compositions (e.g., formulated ingestibles) for stability in supplements, foods and/or beverages at elevated temperatures, water activities, humidity and/or moisture.
  • the present disclosure provides particular insight that identifies the source of a limitation associated with certain current food and/or beverage compositions (e.g., formulated ingestibles) in that food and/or beverage compositions do not provide control over: 1) extending payload absorption time; 2) extending payload retention time; 3) controlling payload spatial interactions within the host; 4) payload release rate; 5) increasing or decreasing payload absorption; 6) increasing or decreasing payload concentrations within the host, which lead to limitations in being able to create and implement food and/or beverage products capable of controlling: 1) satiety; 2) fullness; 3) feeling of fullness; 4) concentration of nutrients in the stomach and/or intestines; 5) concentration of nutrients at the epithelial surface; 6) concentration of nutrients in the mucus; 7) residence time of nutrients in the gastrointestinal tract; 8) absorption time of nutrients in the
  • a bile-responsive, pH-responsive, and/or microbiome-responsive encapsulating component can facilitate location-specific release of the nutrients into the stomach and/or small and/or large intestines by leveraging the physiological or environmental differences in stomach and intestinal fluids, tissues and/or organs.
  • a temperature-responsive encapsulant is more readily processed at lower temperatures (e.g., glass transition temperature) through addition of payloads or plasticizers.
  • payloads alone can lower the glass transition temperature of temperature-responsive polymers.
  • a provided food and/or beverage composition (e.g., formulated ingestibles) provides increased shelf-life in beverages at 4°C, 18°C, 25°C, 30°C, 35°C.
  • a provided food and/or beverage composition (e.g., formulated ingestibles) provides increased shelf-life in dry powders at -20°C, 4°C, 18°C, 25°C, 30°C, 35°C.
  • a provided food and/or beverage composition (e.g., formulated ingestibles) provides increased shelf-life in food matrices at -20°C, 4°C, 18°C, 25°C, 30°C, 35°C.
  • a provided food and/or beverage composition (e.g., formulated ingestibles) provides increased shelf-life prior to incorporation into any matrix at -20°C, 4°C, 18°C, 25°C, 30°C, 35°C.
  • a provided food and/or beverage composition e.g., formulated ingestibles
  • a provided food and/or beverage compositions may be or is effective at protecting payload components (e.g., nutrient payload component) and/or encapsulant components (e.g., a nutrient encapsulant) against a physical change, a chemical change, or both (e.g., degradation, oxidation, hydrolysis, isomerization, fragmentation, or a combination thereof).
  • payload components e.g., nutrient payload component
  • encapsulant components e.g., a nutrient encapsulant
  • a provided food and/or beverage compositions may be or remain stable, e.g., to store for a particular period of time under particular conditions.
  • 99% of a payload and/or encapsulant component present in a provided composition at a particular point in time remains present, and/or one or more size characteristics (e.g., average diameter and/or one or more features of size distribution of a particle composition) remains stable throughout a period of time during which the composition is maintained under particular conditions.
  • a payload component present in a provided composition may remain stable in a dry powder form for a period of time.
  • a payload component present in a provided composition may remain stable for a period of time when dispersed within solid food (at chilled, room temperature, and/or elevated temperatures).
  • a payload component present in a provided composition may remain stable for a period of time when dispersed within a beverage (at chilled, room temperature, and/or elevated temperatures). In some embodiments, a payload component present in a provided composition may remain stable for a period of time when dispersed within an acidic solution (for example, at a pH ⁇ 3). [0093] In some embodiments, the period of time is at least 2, 3, 4, 5, 6, 7,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 weeks or more, and/or at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months or more, and/or at least about 1, 2, 3, 4, 5 years or more. [0094] In some such embodiments, the particular conditions comprise ambient temperature.
  • the particular conditions comprise elevated (above ambient) temperature.
  • the particular conditions comprise aqueous conditions (e.g., aqueous liquid conditions).
  • the period of time is at least two months and the particular conditions comprise ambient temperature.
  • stability comprises mitigation, limitation, or prevention of chemical degradation of nutrient payloads and/or nutrient encapsulants.
  • stability comprises maintenance of delivery functions (e.g., extending payload absorption time, extending payload retention time, controlling payload spatial interactions within the host, payload release rate, increasing or decreasing payload absorption, increasing or decreasing payload concentrations within the host, etc.) of provided Page 22 of 315 11645787v1 Docket No.: 2017299-0086 food and/or beverage compositions (e.g., formulated ingestibles) and/or nutrient payloads and/or nutrient encapsulants.
  • delivery functions e.g., extending payload absorption time, extending payload retention time, controlling payload spatial interactions within the host, payload release rate, increasing or decreasing payload absorption, increasing or decreasing payload concentrations within the host, etc.
  • stability comprises maintenance of conferred health benefits (e.g., controlled satiety, controlled fullness, controlled feeling of fullness, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, controlled residence time of nutrients in the gastrointestinal tract, controlled absorption time of nutrients in the stomach and/or intestine, increased energy acquisition, increased nutrient acquisition, increase bioavailability, reduced frequency of meal intake, etc.) for food and/or beverage compositions (e.g., formulated ingestibles) and/or nutrient payloads and/or nutrient encapsulants.
  • conferred health benefits e.g., controlled satiety, controlled fullness, controlled feeling of fullness, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, controlled residence time of nutrients in the gastrointestinal tract, controlled absorption time of nutrients in the stomach and/or intestine, increased
  • food and/or beverage compositions e.g., formulated ingestibles
  • a food and/or beverage composition may further comprise an excipient component (e.g., an anti-caking component, an anti-clumping component, a plasticizer, an anti-agglomerating component, and/or an anti- aggregating component [e.g., any of an excipient comprising microcrystalline cellulose, starches, calcium carbonate, etc.], wherein an excipient component is at least about 99 wt%, at least about 90 wt%, at least about 85 wt%, at least about 80 wt%, at least about 75 wt%, at least about 70 wt%, at least about 65 wt%, at least about 60 wt%, at least about 55 wt%, at least about 50 wt%, at least about 45 wt%, at least about 40 wt%, at least about 35 wt%, at least about 30 wt%, at least about 25 wt%, a food and/or beverage composition (e.g., formulated ingestibles
  • the disclosed food and/or beverage composition may be particularly useful for stabilizing nutrient payloads and/or encapsulant payloads, and maintaining delivery functions (e.g., extending payload absorption time, extending payload retention time, controlling payload spatial interactions within the host, payload release rate, Page 23 of 315 11645787v1 Docket No.: 2017299-0086 increasing or decreasing payload absorption, increasing or decreasing payload concentrations within the host, etc.), and enabling the associated health benefits (e.g., controlled satiety, controlled fullness, controlled feeling of fullness, controlled concentration of nutrients in the stomach and/or intestines, controlled concentration of nutrients at the epithelial surface, controlled concentration of nutrients in the mucus, controlled residence time of nutrients in the gastrointestinal tract, controlled absorption time of nutrients in the stomach and/or intestine, increased energy acquisition, increased nutrient acquisition, increase bioavailability, reduced frequency of meal intake, etc.) in consumable
  • delivery functions e.g., extending payload absorption time
  • the present disclosure provides consumable compositions (e.g., a food product, a beverage product, an animal-consumable product, dry powders, a supplement, etc.)
  • consumable compositions e.g., a food product, a beverage product, an animal-consumable product, dry powders, a supplement, etc.
  • provided food and/or beverage composition e.g., formulated ingestibles
  • provided consumable compositions are or may be useful for improving health or longevity in humans and/or animals.
  • consumable compositions comprising food and/or beverage composition e.g., formulated ingestibles
  • an edible composition may be a protein bar, a cereal, a protein powder, a milk powder, a salad dressing, a nutritional supplement, a baby formula, a smoothie, a yogurt, an ice cream, a sachet, a spice, a food additive, a candy, a sprinkle packet, a pet food, an agricultural seed, a dry powder, and/or a fertilizer.
  • consumable compositions comprising food and/or beverage composition (e.g., formulated ingestibles) are drinkable.
  • a drinkable composition may be a sports drink, beer, wine, tea, coffee, milk, juice, water, yogurt, soda, carbonated water, or a liquid pharmaceutical formulation.
  • FIG.1 shows, in a non-limiting example, a schematic of exemplary core-shell preparations which may comprise carrier components, payload components, food components, excipient components, matrix preparations, core components, shell components, and combinations thereof. Additionally, or alternatively, exemplary core-shell preparations may comprise a particle comprising at least one carrier component, at least one payload component, at least one core component, at least one shell component, at least one food component, at least one excipient component, at least one matrix component, at least one matrix preparation, or a combination thereof.
  • FIG.2 shows, in a non-limiting example, a schematic of exemplary core-shell preparations with multiple layers which may comprise carrier components, payload components, food components, excipient components, matrix preparations, core components, shell components, and combinations thereof.
  • exemplary multi-layer core-shell preparations may comprise a particle comprising at least one core-shell preparation, at least one carrier component, at least one payload component, at least one core component, at least one shell component, at least one food component, at least one excipient component, at least one matrix component, at least one matrix preparation, or a combination thereof.
  • FIG.3 shows, in a non-limiting example, a schematic of exemplary matrix preparations which may comprise carrier components, payload components, food components, excipient components, core-shell preparations, matrix components, solute components, and combinations thereof. Additionally, or alternatively, exemplary matrix preparations may Page 25 of 315 11645787v1 Docket No.: 2017299-0086 comprise a particle comprising at least one carrier component, at least one payload component, at least one food component, at least one excipient component, at least one core-shell preparation, at least one matrix component, at least one solute component, and combinations thereof.
  • FIGs.4A and 4B show, in a non-limiting example, brightfield micrographs of exemplary encapsulated macronutrient compositions comprising a core component (e.g., sucrose) and a shell component (e.g., zein).
  • FIGs.5A and 5B show, in a non-limiting example, photographs of exemplary encapsulated micronutrient compositions comprising a solute component (e.g., riboflavin) and matrix component (e.g., gelatin).
  • FIGs.6A and 6B show, in a non-limiting example, photographs of exemplary encapsulated micronutrient compositions, further characterized as a matrix preparation.
  • a solute component comprising a payload component (e.g., whey protein isolate) and a matrix component (e.g., gelatin) are prepared and further coated with a shell component (e.g., cellulose acetate phthalate).
  • a payload component e.g., whey protein isolate
  • a matrix component e.g., gelatin
  • a shell component e.g., cellulose acetate phthalate
  • a matrix preparation comprising a payload component (e.g., whey protein isolate) and matrix component (e.g., gelatin) are further coated with a shell component (e.g., cellulose acetate phthalate), with a secondary shell component applied (e.g., Zein).
  • a payload component e.g., whey protein isolate
  • matrix component e.g., gelatin
  • a shell component e.g., cellulose acetate phthalate
  • a secondary shell component applied e.g., Zein
  • FIG.8 shows, in a non-limiting example, a schematic of a method used to apply a coating to a food and/or beverage composition, referred to herein as “coating”.
  • FIG.9 shows, in a non-limiting example, a schematic of a method used to create a matrix food and/or beverage composition, referred to herein as “matrix”.
  • FIG.10 shows, in a non-limiting example, a schematic of a method used to characterize dissolution and/or release of food and/or beverage composition, referred to herein as “dissolution” and/or “release”.
  • FIGs.11A-11D present, in a non-limiting example, 4 theoretical release profiles (concentration of food component vs incubation period) of one or more food component(s) from one or more food and/or beverage composition(s).
  • FIG.12 presents, in a non-limiting example, a plot of glucose release (mg/dL or mg/dL/min) over time, indicating release of glucose payload from food and/or beverage compositions (e.g., with exemplary food and/or beverage compositions (core-shell preparation encapsulating sucrose coated with 10% zein)).
  • FIGs.13A and 13B present, in a non-limiting example, a plot of glucose release (mg/dL or mg/dL/min) over time, indicating release of glucose payload from food and/or beverage compositions (e.g., with exemplary food and/or beverage compositions (core-shell preparation encapsulating sucrose coated with 10% zein, 2.5% glyceryl monostearate, 1% propylene glycol)) at 37°C for 60 minutes.
  • exemplary food and/or beverage compositions core-shell preparation encapsulating sucrose coated with 10% zein, 2.5% glyceryl monostearate, 1% propylene glycol
  • FIGs.14A and 14B present, in a non-limiting example, a plot of whey protein isolate release (mg/dL or mg/dL/min) over time, indicating release of whey payload from food and/or beverage compositions (e.g., with exemplary food and/or beverage compositions (core- shell preparation encapsulating whey protein isolate within a matrix of gelatin, further coated with 15% (w/v) cellulose acetate phthalate in acetone) at 20 °C for 90 minutes.
  • FIGs.15A and 15B show, in a non-limiting example that food and/or beverage compositions demonstrate low ( ⁇ 0.20) water activity and low moisture content at 25°C.
  • FIGs.16A-16D illustrate, in a non-limiting example, brightfield micrographs of food and/or beverage compositions (e.g., alginate/whey beads, gelatin/whey beads, and/or sucrose/amylose beads) blended homogeneously with commercially available food product (e.g., MRE, Ensure), imparting minimal change to visible appearance (e.g., color and texture).
  • FIGs.17A-17D illustrate, in a non-limiting example, brightfield micrographs of the stability of food and/or beverage compositions (e.g., alginate/whey beads, gelatin/whey beads, and/or sucrose/amylose beads) when blended homogenously with water.
  • FIG.18 shows, in a non-limiting example, that food and/or beverage compositions (e.g., with exemplary food and/or beverage compositions (core-shell preparation encapsulating whey protein isolate within a matrix of gelatin, further coated with 15% (w/v) cellulose acetate phthalate in acetone) demonstrate triggered release functionality.
  • FIGs.19A-19D present, in a non-limiting example, that matrix preparation(s) and selection of matrix component(s) influences release of one or more food component(s).
  • FIG.19A-19D present, in a non-limiting example, that matrix preparation(s) and selection of matrix component(s) influences release of one or more food component(s).
  • FIG.19A illustrates release of 10% (w/v) whey protein isolate from 5% (w/v) agarose matrix preparation(s) comprising 2% (w/v) sodium carboxymethylcellulose (white squares), 1% (w/v) tween-60 (grey squares), and 2% (w/v) poly(acrylic acid) (black squares).
  • FIG.19B illustrates a comparison of modeled first-order release rate of 10% (w/v) whey protein isolate from 5% (w/v) agarose matrix preparation(s) comprising 2% (w/v) sodium carboxymethylcellulose (white), 1% (w/v) tween-60 (grey), and 2% (w/v) poly(acrylic acid) (black).
  • FIG.19C illustrates release of either unformulated whey (open circle) or 5% (w/w) or 10% (w/w) whey protein isolate from formulation(s) comprising: 5% (w/v) agarose and 1% (w/v) hydroxypropyl methylcellulose (black squares), 80% (w/w) hydrogenated soy oil and 15% (w/w) soy lecithin (black circles), 75% (w/w) candelilla wax and 15% (w/w) Gelucire 50/13 (black triangles), and 70% (w/w) 27- Stearine, 12.5% (w/w) ⁇ -sitosterol, and 12.5% (w/w) ⁇ -oryzanol (black diamonds).
  • Fig.19D illustrates a comparison of modeled first-order release rate of either unformulated whey (black) or 5% (w/w) or 10% (w/w) whey protein isolate from formulation(s) comprising: 5% (w/v) agarose and 1% (w/v) hydroxypropyl methylcellulose (dark grey), 80% (w/w) hydrogenated soy oil and 15% (w/w) soy lecithin (medium grey), 75% (w/w) candelilla wax and 15% (w/w) Gelucire 50/13 (light grey), and 70% (w/w) 27-Stearine, 12.5% (w/w) ⁇ -sitosterol, and 12.5% (w/w) ⁇ -oryzanol (white).
  • FIG.20 shows, in a non-limiting example, a schematic of exemplary core-shell preparations which may comprise carrier components, payload components, food components, excipient components, matrix preparations, core components, shell components, and combinations thereof. Additionally, or alternatively, exemplary core-shell preparations may comprise a particle comprising at least one carrier component, at least one payload component, at least one core component, at least one shell component, at least one food component, at least one Page 28 of 315 11645787v1 Docket No.: 2017299-0086 excipient component, at least one matrix component, at least one matrix preparation, or a combination thereof.
  • FIG.21 shows, in a non-limiting example, a schematic of exemplary core-shell preparations with multiple layers which may comprise carrier components, payload components, food components, excipient components, matrix preparations, core components, shell components, and combinations thereof.
  • exemplary multi-layer core-shell preparations may comprise a particle comprising at least one core-shell preparation, at least one carrier component, at least one payload component, at least one core component, at least one shell component, at least one food component, at least one excipient component, at least one matrix component, at least one matrix preparation, or a combination thereof.
  • FIG.22 shows, in a non-limiting example, a schematic of exemplary matrix preparations which may comprise carrier components, payload components, food components, excipient components, core-shell preparations, matrix components, solute components, and combinations thereof. Additionally, or alternatively, exemplary matrix preparations may comprise a particle comprising at least one carrier component, at least one payload component, at least one food component, at least one excipient component, at least one core-shell preparation, at least one matrix component, at least one solute component, and combinations thereof.
  • FIG.23 shows, in a non-limiting example, a comparison of unformulated carbohydrate powder and food composition(s) comprising carbohydrate(s) as component(s) of matrix composition(s) and/or core-shell preparation(s).
  • A Unformulated glucose
  • B sucrose- amylose matrix preparation(s) encapsulated in Zein
  • C 60% (w/v) glucose encapsulated in 2% (w/v) pectin
  • D 1% (w/v) inulin encapsulated in 2% (w/v) agarose
  • E 10% (w/v) calcium caseinate and 1% (w/v) inulin encapsulated in 2% (w/v) sodium alginate.
  • FIG.24 shows, in a non-limiting example, a comparison of unformulated protein and food composition(s) comprising protein(s) as component(s) of matrix composition(s) and/or core-shell preparation(s).
  • WPI Unformulated whey protein isolate
  • B 20% (w/v) whey protein isolate encapsulated in 80% (w/v) beeswax
  • C whey protein (5% w/v) encapsulated in 80% (w/v) fully hydrogenated soy oil and Tween 80 (15% w/v);
  • D whey protein (10% w/v) encapsulated in 3% (w/v) agarose and 1% (w/v) chitosan.
  • FIG.25 shows, in a non-limiting example, a comparison of unformulated lipid and food composition(s) comprising lipid(s) as component(s) of matrix composition(s) and/or core-shell preparation(s).
  • FIG.26 illustrates, in a non-limiting example, several exemplary release profiles of carbohydrate(s) encapsulated within one or more food composition(s) in phosphate buffered saline, pH 7.4, 37 oC.
  • Food composition(s) characterized as matrix preparation(s) are colored light grey, while those characterized as core-shell preparations wherein the core component(s) are further characterized as matrix preparation(s) are colored dark grey.
  • A Release of glucose from food composition(s) over time; each line represents an average of 3 dissolution experiments for a distinct food composition (e.g., distinct component(s) and concentration(s)) comprising glucose.
  • FIG.27 illustrates, in a non-limiting example, several exemplary release profiles of protein(s) encapsulated within one or more food composition(s) in phosphate buffered saline, pH 7.4, 37 oC.
  • Food composition(s) characterized as matrix preparation(s) are colored light grey, while those characterized as core-shell preparations wherein the core component(s) are further characterized as matrix preparation(s) are colored dark grey.
  • FIG.28 illustrates, in a non-limiting example, several exemplary release profiles of lipid(s) encapsulated within one or more food composition(s) in phosphate buffered saline, pH 7.4, 37 oC.
  • Food composition(s) characterized as matrix preparation(s) are colored light grey.
  • A Release of oleic acid from food composition(s) over time; each line represents an average of 3 dissolution experiments for a distinct food composition (e.g., distinct component(s) and concentration(s)) comprising oleic acid.
  • B First order release rates modeled from oleic acid Page 30 of 315 11645787v1 Docket No.: 2017299-0086 release of distinct food composition(s) sorted from fastest release (top) to slowest release (bottom).
  • FIG.29 illustrates, in a non-limiting example, a comparison of unformulated flavonoid (e.g., polyphenol) and formulated flavonoid (e.g., polyphenol) in food composition(s) as components of matrix preparation(s) and/or core-shell preparation(s), as well as release profile(s) of encapsulated flavonoid(s).
  • A Unformulated cyanidin chloride powder.
  • B Matrix preparation comprising glucose.
  • C core-shell preparation wherein core component(s) comprise glucose and shell component(s) comprise cyanidin chloride.
  • D Release of cyanidin chloride from core-shell preparation in phosphate buffered saline, pH 7.4, 37 oC.
  • FIG.30 illustrates, in a non-limiting example, a comparison of unformulated carbohydrate and formulated carbohydrate in food composition(s) as components of matrix preparation(s) and/or core-shell preparation(s), as well as release profile(s) of encapsulated carbohydrate(s).
  • A Unformulated inulin powder.
  • B Matrix preparation comprising inulin.
  • C Release of inulin from matrix preparation in phosphate buffered saline, pH 7.4, 37 oC.
  • FIG.31 shows, in a non-limiting example, cross-sectional micrographs of food composition(s).
  • FIG.32 shows, in a non-limiting example, a schematic of a method used to create a core-shell food and/or beverage composition, referred to herein as “core-shell”.
  • FIG.33 shows, in a non-limiting example, that core-shell preparation(s) control the release of one or more food component(s).
  • A Micrograph depicting uncoated sucrose- containing matrix preparation(s);
  • B Zein-coated sucrose-containing matrix preparations.
  • FIG.34 shows, in a non-limiting example, a schematic of a method used to create a matrix food and/or beverage composition, referred to herein as “matrix”.
  • FIG.35 shows, in a non-limiting example, that matrix preparation(s) control the release of one or more food component(s).
  • A Photograph and release profile(s) in 10 mM phosphate buffered saline, pH 7.4 of unformulated whey protein isolate
  • B Photograph and release profile(s) in 10 mM phosphate buffered saline, pH 7.4 of 10% (w/v) whey protein isolate, 65% (w/v) oleic acid encapsulated in ethyl cellulose (25% w/v);
  • C Photograph and release profile(s) in 10 mM phosphate buffered saline, pH 7.4 of 10% (w/v) whey protein isolate, 1.9% (w/v) chitosan encapsulated in genipin (0.1% w/v)’
  • D Photograph and release profile(s) in 10 mM phosphate buffered saline, pH 7.4 of 10% (w/v) whey protein isolate encapsulated 3% (w/v) agarose and 1% (w/v) chitosan.
  • FIG.36 shows, in a non-limiting example, that, in some instances, core-shell preparation(s) comprise encapsulated matrix preparation(s).
  • A 10% (w/v) whey protein isolate, 65% (w/v) oleic acid encapsulated in 10% (w/v) carnauba wax and 15% (w/v) ethyl cellulose, further encapsulated in a shell component comprising cellulose acetate phthalate;
  • B 60% (w/v) Page 32 of 315 11645787v1 Docket No.: 2017299-0086 glucose encapsulated in 2% (w/v) pectin, further encapsulated in a shell component comprising cellulose acetate phthalate.
  • FIG.37 shows, in a non-limiting example, a schematic of a method used to characterize dissolution and/or release of food and/or beverage composition, referred to herein as “dissolution” and/or “release”.
  • FIG.38 shows, in a non-limiting example, exemplary release environment(s).
  • FIG.39 shows, in a non-limiting example, food composition(s) comprising pH- responsive shell component(s).
  • A Release of 5% (w/v) whey protein isolate encapsulated in 80% (w/v) fully hydrogenated soybean oil and 15% (w/v) Kolliphor P188 with cellulose acetate phthalate coating in simulated intestinal fluid (hollow circle) vs Eudragit E PO coating in simulated intestinal fluid (filled square);
  • FIG.40 presents, in a non-limiting example, 4 theoretical release profiles (concentration of food component vs incubation period) of one or more food component(s) from one or more food and/or beverage composition(s).
  • FIG.41 presents, in a non-limiting example, that choice of food component(s) influences release of one or more food component(s). Release of whey protein isolate from 5% (w/v) agarose matrix preparation(s) comprising sodium carboxymethylcellulose (2% w/v) (white squares), tween-60 (1% w/v) (grey), and poly(acrylic acid) (2% w/v) (black squares).
  • FIG.42 presents, in a non-limiting example, that concentration of food component(s) influences release of one or more food component(s). Release of whey protein isolate from formulations comprising varying amounts of candelilla wax and gelucire 50/13 (w/v): 75%/15%, (white circle), 85%/5% (gray circle), and 80%/15% (black circle). [0149] FIG.43 presents, in a non-limiting example, that matrix component(s) influence release of one or more food component(s).
  • FIG.44 shows, in a non-limiting example that food and/or beverage compositions demonstrate low ( ⁇ 0.20) water activity and low moisture content at 25°C.
  • FIG.45 illustrates, in a non-limiting example, brightfield micrographs of food and/or beverage compositions (e.g., alginate/whey beads, gelatin/whey beads, and/or sucrose/amylose beads) blended homogeneously with commercially available food product (e.g., MRE, Ensure, water), imparting minimal change and/or discernable change to visible appearance (e.g., color and texture).
  • FIG.46 shows, in a non-limiting example, exemplary multi-layer core-shell particle preparation(s) controlling the release of protein payload(s).
  • FIG.46A illustrates a photograph of multi-layer core-shell particle preparation(s) comprising 50% (w/w) casein, 27% (w/w) starch, 9% (w/w) lactose, 4% (w/w) inulin, 5% (w/w) hypromellose, and 5% (w/w) ethyl cellulose produced through a wet granulation, extrusion, and spheronization process, followed by fluid bed coating to a total coating weight gain of 10% (w/w). Particles exhibit a 14-mesh size.
  • FIG.46B illustrates exemplary release of casein from exemplary multi-layer core-shell particle preparation(s) over 4 hours in 10 mM phosphate buffered saline, pH 7.4 with no shell (black circles), inner shell of Hypromellose and outer shell of ethyl cellulose (dark grey diamonds), or inner shell of ethyl cellulose and outer shell of hypromellose (light grey squares).
  • Data are an average percent release with respect to loaded protein concentration (e.g., initial loading within exemplary multi-layer core-shell particles) of 3 replicates +/- standard deviation.
  • FIG.47 shows, in a non-limiting example, exemplary pH-responsive matrix particle preparation(s) controlling the release of protein payload(s).
  • FIG.47A illustrates a micrograph of pH-responsive matrix particle preparation(s) comprising 61% (w/w) sodium alginate and 29% (w/w) calcium caseinate produced through a spray drying process utilizing an ultrasonic nozzle. Particles size analysis yields an average particle diameter (e.g., Dv50) of 19.2 ⁇ m.
  • FIG.47B illustrates exemplary release of casein from exemplary pH-responsive matrix particle preparation(s) over 4 hours in either simulated intestinal fluid, pH 6.8 (black circles) or simulated gastric fluid, pH 1 (grey squares). Data are an average percent release with respect to loaded protein concentration (e.g., initial loading within exemplary matrix particles) of 3 replicates +/- standard deviation.
  • FIG.48 shows, in a non-limiting example, exemplary bile salt-resistive matrix particle preparation(s) controlling the release of fatty acid payload(s).
  • FIG.48A illustrates a micrograph of bile salt-resistive matrix particle preparation(s) comprising 30% (w/w) 27- Stearine, 30% (w/w) CITREM, and 40% (w/w) linoleic acid produced through a hot melt homogenization process.
  • Particles size analysis yields an average particle diameter (e.g., Dv50) of 149 ⁇ m.
  • FIG.48B illustrates exemplary release of unformulated linoleic acid (black circles) or formulated linoleic acid (e.g., 30% (w/w) 27-Stearine, 30% (w/w) CITREM, 40% (w/w) linoleic acid) (grey squares) from exemplary bile salt-resistive matrix particle preparation(s) over 4 hours in simulated intestinal fluid, pH 6.8 with 0.2% (w/v) sodium taurocholate.
  • Data are an average percent release with respect to loaded protein concentration (e.g., initial loading within exemplary matrix particles) of 3 replicates +/- standard deviation.
  • FIG.49 shows, in a non-limiting example, exemplary pH-responsive core-shell particle preparation(s) controlling the release of carbohydrate payload(s).
  • FIG.49A illustrates a micrograph of pH-responsive core-shell particle preparation(s) comprising 50% (w/w) casein, 27% (w/w) starch, 9% (w/w) lactose, 4% (w/w) glucose, 5% (w/w) hypromellose acetate succinate, and 5% (w/w) sodium alginate produced through a wet granulation, extrusion, and spheronization process, followed by fluid bed coating to a total coating weight gain of 10% (w/w). Particles exhibit a 14-mesh size.
  • FIG.49B illustrates exemplary release of glucose from exemplary pH-responsive core-shell particle preparation(s) over 3 hours in either simulated intestinal fluid, pH 6.8 (black circles) or simulated gastric fluid, pH 1 (grey squares). Data are an Page 35 of 315 11645787v1 Docket No.: 2017299-0086 average percent release with respect to loaded protein concentration (e.g., initial loading within exemplary multi-layer core-shell particles) of 3 replicates +/- standard deviation.
  • FIG.50 shows, in a non-limiting example, exemplary pH-responsive core-shell particle preparation(s) controlling the release of protein payload(s).
  • FIG.51 shows, in a non-limiting example, controlling one or more properties of particle preparation(s) by selecting method(s) of manufacture and incorporation thereof into commercial food and/or beverage products.
  • FIG.51A Macroscopic matrix preparation comprising a protein payload dispersed within a lipid matrix.
  • FIG.51B Macroscopic granulated and spheronized particle preparation(s) comprising protein payload dispersed within a carbohydrate matrix.
  • FIG.51C Microscopy of coarsely milled protein-containing particle preparation(s) with associated particle size histogram (FIG.51F) and median particle diameter Dv 50.
  • FIG.51D Microscopy of finely milled protein-containing particle preparation(s) with associated particle size histogram (FIG.51G) and median particle diameter Dv 50 .
  • FIG.51E Microscopy of spray dried protein-containing particle preparation(s) with associated particle size histogram (FIG.51H) and median particle diameter Dv 50.
  • FIG.51I commercial food and/or beverage powder with incorporation of spheronized protein-containing particle preparation
  • FIG. 51J uniform integration of finely milled protein-containing particle preparation into commercial food and/or beverage powder.
  • FIG.51G poor incorporation of particle preparation into aqueous suspension;
  • FIG.51L additional matrix component(s) leading to better incorporation;
  • FIG.51H uniform incorporation of improved particle preparation(s) into enteral nutrition (Nutren®, Nestlé).
  • FIGs.52A-52D show, in a non-limiting example, micrographs of particles (e.g., microparticles) of formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.53A and 53B show theoretical data plots of apparent viscosity (FIG.53A) and apparent tack for formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.53C-53F show, in a non-limiting example, micrographs of particles (e.g., microparticles) of formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.54A-54C show, in a non-limiting example, photographs of food products including disclosed formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.55A and 55B show, in a non-limiting example, photographs of food products including disclosed formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.56A and 56B show, in a non-limiting example, photographs of food products including disclosed formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.57A-57F show, in a non-limiting example, a plot of particle size distribution (FIG.57A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.58A-58F show, in a non-limiting example, a plot of particle size distribution (FIG.58A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.59A-59F show, in a non-limiting example, a plot of particle size distribution (FIG.59A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.60A-60F show, in a non-limiting example, a plot of particle size distribution (FIG.60A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.61A-61F show, in a non-limiting example, a plot of particle size distribution (FIG.61A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.62A-62E show, in a non-limiting example, a plot of particle size distribution (FIG.62A), a micrograph of particles (e.g., microparticles) of a formulation (FIG. 62B), and a photographs of food products (FIGs.62C and 62D) and water (FIG.62F) including formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.63A-63F show, in a non-limiting example, a plot of particle size distribution (FIG.63A), a micrograph of particles (e.g., microparticles) of a formulation (FIG. 63B), a photograph of a bulk amount of a formulation (FIG.63C), and a photographs of food products (FIG.63D and 63E) and water (FIG.63F) including formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.64A-64F show, in a non-limiting example, a plot of particle size distribution (FIG.64A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.65A-65F show, in a non-limiting example, a plot of particle size distribution (FIG.65A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.66A-66F show, in a non-limiting example, a plot of particle size distribution (FIG.66A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.67A-67F show, in a non-limiting example, a plot of particle size distribution (FIG.67A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.68A-68F show, in a non-limiting example, a plot of particle size distribution (FIG.68A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.69A-69F show, in a non-limiting example, a plot of particle size distribution (FIG.69A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.70A-70F show, in a non-limiting example, a plot of particle size distribution (FIG.70A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.71A-71E show, in a non-limiting example, a plot of particle size distribution (FIG.71A), photograph of a bulk amount of a formulation (FIG.71B), photographs of food products (FIGs.71C and 71D) and water (FIG.71E) including formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.72A-72E show, in a non-limiting example, a plot of particle size distribution (FIG.72A), a micrograph of particles (e.g., microparticles) of a formulation (FIG. 72B), and a photographs of food products (FIG.72C and 72D) and water (FIG.72E) including formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.73A-73C show, in a non-limiting example, a plot of particle size distribution (FIG.73A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.74A-74F show, in a non-limiting example, a plot of particle size distribution (FIG.74A), a micrograph of particles (e.g., microparticles) of a formulation (FIG. 74B), a photograph of a bulk amount of a formulation (FIG.74C), and a photographs of food products (FIG.74D and 74E) and water (FIG.74F) including formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.75A-75B show, in a non-limiting example, a plot of particle size distribution (FIG.75A), and a micrograph of a particles (e.g., a microparticle) of a formulation (FIG.75B), according to illustrative embodiments of the present disclosure.
  • FIGs.76A-76C show, in a non-limiting example, a plot of particle size distribution (FIG.76A), a micrograph of particles (e.g., microparticles) of a formulation (FIG. 76B) and a photograph of a bulk amount of a formulation (FIG.76C), according to illustrative embodiments of the present disclosure.
  • FIGs.77A-77F show, in a non-limiting example, a plot of particle size distribution (FIG.77A), a micrograph of particles (e.g., microparticles) of a formulation (FIG. 77B), a photograph of a bulk amount of a formulation (FIG.77C), and a photographs of food products (FIG.77D and 77E) and water (FIG.77F) including formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.78A-78F show, in a non-limiting example, a plot of particle size distribution (FIG.78A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.79A-79F show, in a non-limiting example, a plot of particle size distribution (FIG.79A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.80A-80F show, in a non-limiting example, a plot of particle size distribution (FIG.80A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.81A-81F show, in a non-limiting example, a plot of particle size distribution (FIG.81A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIGs.82A-82F show, in a non-limiting example, a plot of particle size distribution (FIG.82A), a micrograph of particles (e.g., microparticles) of a formulation (FIG.
  • FIG.83A shows, in a non-limiting example, data plots of bicinchoninic assays to determine protein concentration, according to illustrative embodiments of the present disclosure.
  • FIG.83B shows, in a non-limiting example, a data plot of a Pierce TM 660 assay to determine protein concentration, according to illustrative embodiments of the present disclosure.
  • FIG.84 shows, in a non-limiting example, a data plot of a glucose oxidase amplex red assay quantifying glucose, according to illustrative embodiments of the present disclosure.
  • FIGs.85A and 85B show, in a non-limiting example, data plots of dinitrosalicylic assays quantifying glucose, according to illustrative embodiments of the present disclosure.
  • FIGs.86A-86C show, in a non-limiting example, data plots of a non-esterified fatty acid Wako (HR-2) assay to determine fatty acid concentration, according to illustrative embodiments of the present disclosure.
  • FIGs.87A-87C show, in a non-limiting example, data plots of a fluorometric FITC inulin assay (FIG.87A) and dinitrosalicylic (DNS) assays (FIGs.87B and 87C) to quantify inulin, according to illustrative embodiments of the present disclosure.
  • FIS dinitrosalicylic
  • FIGs.88A-88D show, in a non-limiting example, data plots of standard colorimetric assays to quantify concentrations of flavonoids, according to illustrative embodiments of the present disclosure.
  • FIGS.88E-88H show, in a non-limiting example, data plots of ferric antioxidant status detection kits to quantify concentration of flavonoids, according to illustrative embodiments of the present disclosure.
  • FIGs.89A-90D show, in a non-limiting example, data plots of release curve measurements of formulations, according to illustrative embodiments of the present disclosure.
  • FIGs 91A-91K show, in a non-limiting example, plots of particle size distribution of formulations (FIGs.91A-91F), release curve measurements of formulations, photographs of a bulk amount of formulations (FIGs.91H-91J), and a micrograph of particles of formulations (FIG.91K), according to illustrative embodiments of the present disclosure.
  • FIGs.92A-92D show, in a non-limiting example, gelation of formulations (FIG. 92A) and plots of melting temperature v. component mass fraction of formulations (FIGs.92B- 92D), according to illustrative embodiments of the present disclosure.
  • FIGs.93A-93F show, in a non-limiting example, release curve measurements of formulations (FIGs.93A-93C) and micrographs of particles of formulations (FIGs.93D-93F), according to illustrative embodiments of the present disclosure.
  • FIGs.94A-95B show, in a non-limiting example, release curve measurements of formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.96A-96E show, in a non-limiting example, photographs of a bulk amount of formulations (FIGs.96A-96D) and release curve measurements of formulations (FIG.96E), according to illustrative embodiments of the present disclosure.
  • FIGs.97A-97D show, in a non-limiting example, photographs of formulations incorporated into food compositions, according to illustrative embodiments of the present disclosure.
  • FIGs.98A-98F show, in a non-limiting example, photographs of a bulk amount of formulations, according to illustrative embodiments of the present disclosure.
  • FIGs.99A-99H show, in a non-limiting example, a method of manufacturing formulations (FIG.99A and FIG.99E), micrographs of formulations (FIG.99B and FIG.99F), photographs of a bulk amount of formulations (FIG.99C and FIG.99G), and plots of particle size distributions of formulation (FIG.99D and FIG.99H), according to illustrative embodiments of the present disclosure.
  • FIGs.100A-100D show, in a non-limiting example, release curve measurements (FIGs.100A and 100B), a schematic of a particle of formulations (FIG.100C), and a photograph of a bulk amount of a formulation (FIG.100D), according to illustrative embodiments of the present disclosure.
  • FIGs.100E-100K show, in a non-limiting example, release curve measurements (FIGs.100E and 100F), schematics of a particle of formulations (FIG.100G and FIG.100I), and photographs of a bulk amount of formulations (FIG.100J and FIG.100K), according to illustrative embodiments of the present disclosure.
  • FIGs.101A-100I show, in a non-limiting example, release curve measurements (FIGs.101A and 101B), plots of particle size distribution of formulations (FIGs.101C and 101D) a schematic of a particle of formulations (FIG.101E), photographs of a bulk amount of formulations (FIG.101F and FIG.101H), and micrographs of particles of formulations (FIGs. 101G and101I), according to illustrative embodiments of the present disclosure.
  • FIGs.102A-102H show, in a non-limiting example, a plot of particle size distribution of particles of a formulation (FIG.102A), micrographs of particles of formulations Page 43 of 315 11645787v1 Docket No.: 2017299-0086 (FIG.102B-102F), plots of release curve measurements of formulations (FIGs.102C-102G, and 102H), according to illustrative embodiments of the present disclosure.
  • FIGS.102A-103G show, in a non-limiting example, plots of TEER measurements (FIGs.103A, 103D, and 103G), permeability (FIGs.103B and 103E), and Peff (FIGs.103C and 103F), according to illustrative embodiments of the present disclosure.
  • FIGs.104A-104D show, in a non-limiting example, release curve measurement plots of formulations, according to illustrative embodiments of the present disclosure. DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS [0213] Section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described. A.
  • Ambient refers to a typical indoor (e.g., climate-controlled) temperature, usually within a range of about 18° C to about 32° C, and/or typical indoor (e.g., climate-controlled) humidity, usually within a range of about 30% to 50%.
  • ambient temperature is within a range of about 20° C to about 30° C.
  • ambient temperature is 25 ⁇ 5° C.
  • ambient temperature is approximately 21° C.
  • ambient temperature is 18° C.
  • ambient temperature is 19° C.
  • ambient temperature is 20° C.
  • ambient temperature is 21° C.
  • ambient temperature is 22° C.
  • ambient temperature is 23° C. In some embodiments, ambient temperature is 24° C. In some embodiments, ambient temperature is 25° C. In some embodiments, ambient temperature is 26° C. In some embodiments, ambient temperature is 27° C. In some embodiments, ambient temperature is 28° C. In some embodiments, ambient temperature is 29° C. In some embodiments, ambient temperature is 30° C. In some embodiments, ambient may be used to describe outdoor conditions, and may include temperatures ranging from about 15° C to about 40° C, or from about 25° C to about 40° C. In some embodiments, ambient humidity is within a range of about 35% to about 45%. In some embodiments, ambient humidity is 35%. In some embodiments, ambient humidity is 36%.
  • ambient humidity is 37%. In some embodiments, ambient humidity is 38%. In some embodiments, ambient humidity is 39%. In some embodiments, ambient humidity is 40%. In some embodiments, ambient humidity is 41%. In some embodiments, ambient humidity is 42%. In some embodiments, ambient humidity is 43%. In some embodiments, ambient humidity is 44%. In some embodiments, ambient humidity is 45%. Page 45 of 315 11645787v1 Docket No.: 2017299-0086 [0221] Beverage: As used herein, the term “beverage” is used to refer to a potable liquid (e.g., that can be ingested, swallowed, drunk, or consumed by a person or animal without material risk to the person or animal).
  • a potable liquid e.g., that can be ingested, swallowed, drunk, or consumed by a person or animal without material risk to the person or animal.
  • beverage can be or comprise beer, juice, milk, a sports drink, tea, water, soda, yogurt, etc.
  • a “beverage” may be or comprise a pharmaceutical formulation in liquid form.
  • Biocompatible As used herein, the term “biocompatible” is used to describe a characteristic of not causing significant detectable harm to living tissue when placed in contact therewith e.g., in vivo. In certain embodiments, materials are “biocompatible” if they are not significantly toxic to cells, e.g., when contacted therewith in a relevant amount and/or under relevant conditions such as over a relevant period of time.
  • materials are “biocompatible” if their addition to cells in vitro results in less than or equal to 20% cell death, and/or their administration in vivo does not induce significant inflammation or other adverse effects.
  • Comparable refers to two or more agents, entities, situations, sets of conditions, etc., that may not be identical to one another but that are sufficiently similar to permit comparison therebetween so that one skilled in the art will appreciate that conclusions may reasonably be drawn based on differences or similarities observed.
  • comparable sets of conditions, circumstances, individuals, or populations are characterized by a plurality of substantially identical features and one or a small number of varied features.
  • a chemical compound is degraded typically means that the chemical structure of the chemical Page 46 of 315 11645787v1 Docket No.: 2017299-0086 compound has changed (e.g., a chemical bond is broken).
  • Common mechanisms of degradation include, for example, oxidation, hydrolysis, isomerization, fragmentation, or a combination thereof.
  • Delivery is used to refer to the carrying and/or deposition and/or moving of nutrients (e.g., macronutrients, micronutrients, ketones, flavanols, prebiotics, etc.) and/or encapsulants to particular location (e.g., into and/or throughout the body).
  • delivery may refer to payload delivery to the epithelial cells in the gastrointestinal tract.
  • delivery may refer to payload delivery to into the blood stream (e.g., systemic absorption).
  • delivery may refer to ingestion at the point of consumption for a shelf-stable food composition containing a nutrient payload.
  • Diameter As used herein, the term “diameter” is used to refer to the longest distance from one end of a particle to another end of the particle. Those skilled in the art will appreciate that a variety of techniques are available for use in characterizing particle diameters (i.e., particle sizes).
  • size of particles can be measured by a Coulter Counter.
  • size of particles e.g., diameter of particles
  • a population of particles is characterized by an average size (e.g., D[3,2], D[4,3], etc.) and/or by particular characteristics of size distribution (e.g., absence of particles above or below particular sizes [e.g., Dv10, Dv20, Dv30, Dv40, Dv50, Dv60, Dv70, Dv80, Dv90, Dv99, etc.], a unimodal, bimodal, or multimodal distribution, etc.).
  • Dispersity is used to refer to the breadth of particle size distribution relative to the average particle size.
  • size of particles e.g., diameter of particles
  • size of particles can be measured by a Coulter Counter.
  • size of particles e.g., diameter of particles
  • Malvern Mastersizer e.g., Malvern Mastersizer
  • the population of particles is characterized by, for example, an average size (e.g., Dv50) and, for example, a corresponding standard deviation.
  • the dispersity of a population of particles refers to double (e.g., 2-fold) the ratio of standard deviation (e.g., ⁇ ) to average particle diameter (e.g., Dv50).
  • Page 47 of 315 11645787v1 Docket No.: 2017299-0086 [0228]
  • Encapsulant is used to refer to anything that is used to encapsulate a payload.
  • a payload component e.g., a nutrient component
  • an encapsulant e.g., polymer component, food component, material component, etc.
  • Encapsulated As used herein, the term “encapsulated” is used to refer to a characteristic of being physically associated with, and in some embodiments partly or wholly covered or coated. For example, in many embodiments of the present disclosure, a payload component (e.g., a microbe component and/or a nutrient component) is described as being encapsulated by a polymer component.
  • a payload component e.g., a microbe component and/or a nutrient component
  • Food As used herein, the term “food” is used to refer to an edible solid (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal).
  • food can be or comprise agricultural seed, baby formula, bread, candy, capsule, cake, cereal, chip, cookie, dry powder, fertilizer, food additive, ice cream, kefir, nutrition supplement, packaged food, pet feed, pet food, protein bar, protein powder, sachet, salad dressing, smoothie, spice, sprinkle packet, tablet, yogurt, etc.
  • a “food” may be or comprise a pharmaceutical formulation in solid form.
  • a “food” may generally refer to a food and/or beverage product.
  • a “food” may generally refer to an edible object that is intended to confer a benefit (e.g., health, energy, nutrition, performance, well-being) on one or more animal(s).
  • Food Compositions As used herein, the term “food compositions” is used to refer to an edible solid (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) or an ingestible liquid (e.g., that can be ingested, swallowed, drank, or consumed by a person or animal without material risk to the person or animal) that provides health benefits resulting from controlled release, absorption, spatial access, concentration, and/or residence time of nutrients.
  • food compositions can be or comprise agricultural seed, dry powders, supplements, solid foods, beverages and/or drinks, etc.
  • a “food composition” may be or comprise a pharmaceutical formulation in solid form. In some embodiments, a “food composition” may be or comprise a pharmaceutical formulation in liquid form. In some embodiments, a “food composition” may generally refer to a food and/or beverage product. In some embodiments, a “food composition” Page 48 of 315 11645787v1 Docket No.: 2017299-0086 may generally refer to an edible object that is intended to confer a benefit (e.g., health, energy, nutrition, performance, well-being) on one or more animal(s).
  • a benefit e.g., health, energy, nutrition, performance, well-being
  • Examplary food compositions include protein shakes, dry powders (e.g., baby formula, protein powder, drink mixes, coffee grinds), Meal Ready-to-Eat (MRE), Meal Ready-to-Drink (RTD), electrolyte beverages, sports beverages, hard seltzers (alcoholic seltzers), dry foods (e.g., rice, pasta), water, medical foods (e.g., Ready-to-drink low phenylalanine medical food), supplements, beer, wine, soda, coffee, fermented foods and beverages (e.g., yogurt, beer, etc.); for example, MREs, Gatorade, Truly, Ensure, PKU Sphere Liquid, etc.
  • MRE Meal Ready-to-Eat
  • RTD Meal Ready-to-Drink
  • electrolyte beverages sports beverages
  • hard seltzers alcoholic seltzers
  • dry foods e.g., rice, pasta
  • medical foods e.g., Ready-to-drink low
  • Food and Beverage Compositions As used herein, the term “food and beverage compositions” is used to refer to an edible solid (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) or an ingestible liquid (e.g., that can be ingested, swallowed, drank, or consumed by a person or animal without material risk to the person or animal) that provides health benefits resulting from controlled release, absorption, spatial access, concentration, and/or residence time of nutrients.
  • food and beverage compositions can be or comprise agricultural seed, dry powders, supplements, solid foods, beverages and/or drinks, etc.
  • a “food and beverage composition” may be or comprise a pharmaceutical formulation in solid form. In some embodiments, a “food and beverage composition” may be or comprise a pharmaceutical formulation in liquid form. In some embodiments, a “food and beverage composition” may generally refer to a food and/or beverage product. In some embodiments, a “food and beverage composition” may generally refer to an edible object that is intended to confer a benefit (e.g., health, energy, nutrition, performance, well-being) on one or more animal(s).
  • a benefit e.g., health, energy, nutrition, performance, well-being
  • Example food and beverage compositions include protein shakes, dry powders (e.g., baby formula, protein powder, drink mixes, coffee grinds), Meal Ready-to-Eat (MRE), Meal Ready-to-Drink (RTD), electrolyte beverages, sports beverages, hard seltzers (alcoholic seltzers), dry foods (e.g., rice, pasta), water, medical foods (e.g., Ready-to-drink low phenylalanine medical food), supplements, beer, wine, soda, coffee, fermented foods and beverages (e.g., yogurt, beer, etc.); for example, MREs, Gatorade, Truly, Ensure, PKU Sphere Liquid, etc.
  • MRE Meal Ready-to-Eat
  • RTD Meal Ready-to-Drink
  • electrolyte beverages sports beverages
  • hard seltzers alcoholic seltzers
  • dry foods e.g., rice, pasta
  • medical foods e.g., Ready-to-drink low
  • Formulated Beverages As used herein, the term “formulated beverages” is used to refer to an ingestible liquid (e.g., that can be ingested, swallowed, drank, or consumed by a Page 49 of 315 11645787v1 Docket No.: 2017299-0086 person or animal without material risk to the person or animal) that provides health benefits resulting from controlled release, absorption, spatial access, concentration, and/or residence time of nutrients.
  • an ingestible liquid e.g., that can be ingested, swallowed, drank, or consumed by a Page 49 of 315 11645787v1 Docket No.: 2017299-0086 person or animal without material risk to the person or animal
  • Formulated Foods examples include protein shakes, coffee, Meal Ready-to-Drink (RTD), electrolyte beverages, sports beverages, hard seltzers (alcoholic seltzers), water, medical foods (e.g., Ready- to-drink low phenylalanine medical food), supplements, beer, wine, soda, fermented foods and beverages (e.g., yogurt, beer, etc.); [0234] Formulated Foods: As used herein, the term “formulated foods” is used to refer to an edible solid (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) that provides health benefits resulting from controlled release, absorption, spatial access, concentration, and/or residence time of nutrients.
  • an edible solid e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal
  • Formulated Ingestibles examples include dry powders (e.g., baby formula, protein powder, drink mixes), Meal Ready- to-Eat (MRE), yogurt, cheese, freshly prepared meals, frozen meals, etc.
  • formulated ingestibles is used to refer to an edible dosage form (e.g., that can be ingested, drank, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) such as a pill, capsule, tablet, etc. that provides health benefits resulting from controlled release, absorption, spatial access, concentration, and/or residence time of nutrients.
  • Formulated Meals As used herein, the term “formulated meals” is used to refer to a solid meal (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) such as microwavable meals, freshly prepared meals, frozen meals, MREs, etc., that provides health benefits resulting from controlled release, absorption, spatial access, concentration, and/or residence time of nutrients.
  • Formulated Supplements As used herein, the term “formulated supplements” is used to refer to an edible dosage form (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) such as a pill, capsule, tablet, etc. that provides health benefits resulting from controlled release, absorption, spatial access, concentration, and/or residence time of nutrients.
  • Hard Seltzers As used herein, the term “hard seltzer” is used to refer to an ingestible liquid that contains alcohol and carbonated water.
  • HLB As used herein, the term “HLB” is used to refer to the hydrophilic lipophilic balance that is an inherent property of, for example, a nonionic surfactant. In some instances, the HLB value of a given non-ionic surfactant is obtained from a commonly accessible tabular source. In some embodiments, non-ionic surfactants characterized as having a low HLB value (e.g., ⁇ 8) are compatible emulsifiers for lipid systems.
  • nonionic surfactants characterized as having a high HLB value are compatible emulsifiers for aqueous systems.
  • non-ionic surfactants characterized as having an intermediate HLB value are compatible emulsifiers with both lipid and aqueous systems.
  • Homogenous As used herein, the term “homogenous” means of substantially uniform structure and/or composition throughout.
  • Hydrophobic As used herein, the term “hydrophobic” is used to refer to the propensity of a material to reject association, chemically and/or physically, with water.
  • a material characterized as being hydrophobic is biologically derived and/or synthetically derived. In some instances, a material characterized as being hydrophobic is a lipid, protein, and/or carbohydrate. In some instances, a material characterized as being hydrophobic is a polymer and/or small molecule. Alternatively, or additionally, in some embodiments, composites, mixtures, blends, or super-structures of several materials are collectively referred to as hydrophobic based on their observed propensity to reject association, chemically and/or physically, with water.
  • incorporación As used herein, the term “incorporation” is used to refer to a characteristic of being physically associated with, and in some embodiments, dispersed within, embedded within, or mixed in a bulk material (e.g., a lipid matrix component).
  • a bulk material e.g., a lipid matrix component.
  • Layer As used herein, the term “layer” typically refers to a material disposed above or below a distinguishable material.
  • a particular entity or preparation (e.g., particle preparation) is described as “layered” if it is prepared via a process in which a first material is laid down and then a second material is applied atop or underneath the first material(e.g., as by dipping or spraying, etc); in some such embodiments, physical or chemical distinctness of layers may be maintained over time, whereas in some such Page 51 of 315 11645787v1 Docket No.: 2017299-0086 embodiments, physical or chemical distinctness of layers may decay over time, at least at layer interface(s).
  • a particular sample or preparation may be described as layered, independent of its mode of preparation, so long as at a particular point in time and/or using a particular mode of assessment, distinct materials can be identified in a layered structure.
  • a “layered” particle may include one or more layers that wholly encapsulate a material below.
  • a “layered” particle may include one or more layers that does not wholly encapsulate a material below.
  • at least one layer of a layered preparation is or comprises a polymer, e.g., a hydrophobic polymer or hydrophilic polymer.
  • each layer of a layered preparation is or comprises a polymer, e.g., a pH responsive polymer or a temperature- responsive polymer.
  • a polymer e.g., a pH responsive polymer or a temperature- responsive polymer.
  • lipid is used to refer to a class of chemical structures characterized as hydrophobic materials. In some instances, a lipid material is derived from a biological source. In other instances, a lipid material is derived from a synthetic source. In some instances, a lipid is comprised of one or more aliphatic alcohols and/or acids linked by glycerol and/or glycol moieties.
  • a lipid is comprised of aliphatic chains, linear conjugated, aromatic, and/or cyclic aliphatic moieties.
  • a lipid refers to a pure chemical entity. In other embodiments, a lipid refers to a mixture of several pure chemical entities.
  • lipids include, but are not limited to: paraffin wax, montan wax, microcrystalline wax, polyethylene wax, petrolatum wax, ozokerite wax, ceresin wax, beeswax, lanolin wax, spermaceti wax, tallow wax, lac wax, chinese insect wax, ambergris wax, soy wax, carnauba wax, candelilla wax, coconut wax, palm kernel wax, rice bran wax, butyric acid, n- butanol, pentanoic acid, n-pentanol, hexanoic acid, n-hexanol, heptanoic acid, n-heptanol, caprylic acid, n-octanol, nonanoic acid, n-nonanol, capric acid, n-decanol, lauric acid, n- dodecanol, myristic acid, n-tetradecanol, palmitic acid,
  • Lyophilized As used herein, the term “lyophilized” is used to refer to the end product of a process by which water is removed from a material via sublimation. In some instances, prior to sublimation of water, the material is cooled to ⁇ -10 oC, ⁇ -20 oC, ⁇ -30 oC, ⁇ - 40oC, ⁇ -50oC, ⁇ -60oC, and/or ⁇ -70 oC.
  • the pressure is lowered to ⁇ 200 torr, ⁇ 150 torr, ⁇ 100 torr, ⁇ 50 torr, ⁇ 10 torr, ⁇ 5 torr, and/or ⁇ 1 torr.
  • Medical Foods As used herein, the term “medical foods” is used to refer to an edible dosage form (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) such as a pill, capsule, tablet, etc. that provides health benefits resulting from controlled release, absorption, spatial access, concentration, and/or residence time of nutrients.
  • Nutraceutical As used herein, the terms “nutraceutical” or “nutraceutical composition” refer to a substance or material that is or comprises a nutraceutical agent (e.g., a nutraceutical).
  • nutraceutical agents such as, for example, agents that are or comprise one or more antioxidants, macronutrients, micronutrients, minerals, prebiotics, probiotics, probiotic powders, probiotic ingredients, probiotic food ingredients, probiotic supplement ingredients, prebiotics, vitamins, or combinations thereof.
  • a nutraceutical is or comprises a carotenoid compound such as alpha ⁇ lipoic acid, astaxanthin, adonixanthin, adonirubin, beta ⁇ carotene, coenzyme Q10, lutein, lycopene, or zeaxanthin.
  • a nutraceutical is or comprises a vitamin such as vitamin D.
  • a nutraceutical agent is a Page 53 of 315 11645787v1 Docket No.: 2017299-0086 natural product, and in certain such embodiments it is a product produced by plants.
  • Many nutraceutical agents are compounds that have been reported or demonstrated to confer a benefit or provide protection against a disease in an animal or a plant.
  • nutraceuticals may be used to improve health, delay the aging process, protect against chronic diseases, increase life expectancy, or support the structure or function of the body of an animal, such as a human, a pet animal, an agricultural animal, or another domesticated animal.
  • the terms “nutraceutical composition,” “food preparation,” “food composition,” “particle preparation,” etc. may all be generally understood to describe compositions, preparations, and/or particles that include one or more food components (for example, encapsulated food component(s)).
  • Nutrient As used herein, the term “nutrient” is used to refer to a nutraceutical, a macronutrient, a carbohydrate, a sugar, a polysaccharide, a dietary fiber, a fat, a fatty acid, a lipid, a short-chain fatty acid, a protein, an amino acid, a peptide, a micronutrient, a vitamin, a mineral, a carotenoid, an element, a ketone body, a prebiotic, a probiotic, a postbiotic, a bacteria, a yeast, a polyphenol, a flavonoid, an antioxidant, an electrolyte, a salt, a circadian rhythm modulator, a supplement, a nootropic, and/or a source of energy.
  • Overfortification As used herein, the term “overfortification” is used to addition of a nutrient in excess of a label claim, due to expected nutrient degradation or loss of stability during manufacturing, processing, and/or shelf-life. This additional amount of nutrient is used to account for losses during manufacturing, processing, and/or shelf-life to still meet the nutrient label claim.
  • Particle As used herein, the term “particle” is used to refer to a discrete physical entity, typically having a size (e.g., a longest cross-section, such as a diameter) within a range.
  • a particle can have a size of about 5-3000 ⁇ m, about 5-2000 ⁇ m, about 5- 1000 ⁇ m, about 5-500 ⁇ m, about 5-50 ⁇ m, about 5-300 ⁇ m, about 5-200 ⁇ m, about 5-100 ⁇ m, about 5-50 ⁇ m, about 5-25 ⁇ m, or about 5-10 ⁇ m.
  • a particle may describe or include animal pellets ranging in size up to 1 mm, 5 mm, 10 mm, 25 mm, and even about 50 mm (about 2 inches) in diameter.
  • a “particle” is not limited to a particular shape or form, for example, having a cross-section shape of a sphere, an oval, a triangle, a square, a hexagon, or an irregular shape.
  • particles can be solid particles.
  • Page 54 of 315 11645787v1 Docket No.: 2017299-0086 particles can be liquid particles.
  • particles can be gel or gel-like particles.
  • particles may have a particle-in-particle structure wherein a layer of one material (e.g., one type of polymer component) encapsulates another material (e.g., another type of polymer component, which may itself encapsulate yet another, or rather may be or comprise a “core” – e.g., a polymer matrix core – of the particle).
  • ppm Parts per million
  • 1 ppm (“parts per million”) is equivalent to 1 milligram per liter (mg/L) or 1 milligram per kilogram (mg/kg).
  • Payload In general, the term “payload”, as used herein, refers to an agent that may be delivered or transported by association with another entity.
  • association may be or include a covalent linkage; in some embodiments such association may be or include non-covalent interaction(s).
  • association may be direct; in some embodiments, association may be indirect.
  • payload is not limited to a particular chemical identity or type; for example, in some embodiments, a payload may be or comprise, for example, an entity of any chemical class including, for example, a nutrient, a lipid, a metal, a nucleic acid, a polypeptide, a saccharide (e.g., a polysaccharide), small molecule, or a combination or complex thereof.
  • a nutrient may include a lipid, a saccharide, a protein, etc.
  • a payload may be or comprise a biological modifier, a detectable agent (e.g., a dye, a fluorophore, a radiolabel, etc.), a detecting agent, a nutrient, a therapeutic agent, etc., or a combination thereof.
  • a payload may be or comprise a cell or organism, or a fraction, extract, or component thereof.
  • a payload may be or comprise a natural product in that it is found in and/or is obtained from nature; alternatively or additionally, in some embodiments, the term may be used to refer to one or more entities that is man-made in that it is designed, engineered, and/or produced through action of the hand of man and/or is not found in nature.
  • a payload may be or comprise an agent in isolated or pure form; in some embodiments, such agent may be in crude form.
  • pH Responsive is used to refer to certain polymer component(s) as described herein, and in particular means that the relevant polymer component is characterized in that one or more aspects of its structure or arrangement is altered when exposed to a change in pH condition (e.g., to a particular pH and/or to a pH change of particular Page 55 of 315 11645787v1 Docket No.: 2017299-0086 magnitude).
  • a polymer component is considered to be “pH-responsive” if, when the relevant polymer component is associated with a payload component in a particle preparation as described herein, the particle preparation releases the payload component under specific pH condition(s).
  • >90% of payload component is released from a particle preparation that includes a pH-responsive polymer component within 15 minutes when the particle preparation is exposed to a particular defined pH condition (e.g., within a range of defined pH values and/or at a specific pH value); in some embodiments, such release results when such contacting occurs at temperatures between 33-40°C, and in aqueous-based buffers of ionic strength ranging from 0.001-0.151 M (e.g., water, simulated gastric fluid, gastric fluid, simulated intestinal fluid, intestinal fluid) with osmolality between 1-615 mOsm/kg.
  • a pH-responsive polymer component is one that degrades when exposed to a particular pH or pH change.
  • a pH- responsive polymer component is one that becomes soluble, or significantly (e.g., (e.g., by at least about 5%) increases its solubility when exposed to a particular pH level, or pH change.
  • a pH-responsive polymer component includes one or more moieties whose protonation state changes at the relevant pH or in response to the relevant pH change.
  • a pH responsive polymer component includes one or more amine moieties that become protonated upon exposure to a relevant pH or pH chance.
  • Polyphenols As used herein, the term “polyphenol” is used to refer to naturally occurring organic compounds, comprising one or multiple aromatic groups with one or more hydroxyl groups or hydroxyl derivatives (e.g., methoxyl, ethoxyl, acetyl, etc.) and/or deriving from the shikimate, phenylpropanoid, and/or polyketide pathways.
  • a polyphenol may be phenolic acids, flavonoids, stilbenes, and lignans, antioxidants, tannins, and/or combinations thereof.
  • Prebiotic As used herein, the term “prebiotic” is used to refer to a nondigestible food ingredient that promotes the growth of beneficial microorganisms in the intestines.
  • Reference As used herein describes a standard or control relative to which a comparison is made. For example, in some embodiments, an agent, animal, individual, population, sample, sequence or value of interest is compared with a reference or control agent, animal, individual, population, sample, sequence or value. In some embodiments, a reference or Page 56 of 315 11645787v1 Docket No.: 2017299-0086 control is tested and/or determined substantially simultaneously with the testing or determination of interest.
  • a reference or control is a historical reference or control, optionally embodied in a tangible medium.
  • a reference or control is determined or characterized under comparable conditions or circumstances to those under assessment. Those skilled in the art will appreciate when sufficient similarities are present to justify reliance on and/or comparison to a particular possible reference or control.
  • Residual solvent refers to a solvent that remains in a material after manufacture or processing of the material. In some embodiments, level of residual solvent is assessed by HPLC, mass spec, NMR, FTIR, and/or gas chromatography.
  • Satiety refers to being full and/or sated; for example, feeling satisfied due to ingestion of a food and/or beverage composition or having a desire removed following ingestion of a food and/or beverage composition.
  • Stable when applied to compositions herein, means that the compositions maintain (e.g., as determined by one or more analytical assessments) one or more aspects of their physical structure and/or performance characteristic(s) (e.g., activity) over a period of time and/or under a designated set of conditions.
  • stable refers to maintenance of a characteristic such as average particle size, maximum and/or minimum particle size, range of particle sizes, and/or distribution of particle sizes (i.e., the percentage of particles above a designated size and/or outside a designated range of sizes) over a period of time and/or under a designated set of conditions.
  • stable often refers to maintenance or preservation of delivery functions (e.g., controlled release, sustained release, controlled residence time, sustained residence time, etc.).
  • Temperature-responsive As used herein, the term “temperature-responsive” is used to refer to certain polymer component(s) as described herein, and in particular means that the relevant polymer component is characterized in that one or more aspects of its structure or Page 57 of 315 11645787v1 Docket No.: 2017299-0086 arrangement is altered when exposed to a change in temperature condition (e.g., to a particular temperature and/or to a temperature change of particular magnitude).
  • a polymer component is considered to be “temperature-responsive” if, when the relevant polymer component is associated with a payload component in a particle preparation as described herein, amorphous regions of the polymer component experience a transition from a rigid state (e.g., glassy state) to a more fluid-like flexible state (e.g., more conducive to flow), at a temperature close to the point of transition from the solid state to rubbery state (e.g., glass transition).
  • a rigid state e.g., glassy state
  • a more fluid-like flexible state e.g., more conducive to flow
  • Water activity As used herein, “water activity” of a material is an indication (e.g., a measurement) of how much free (i.e., available to bind or react) water is present in the material, and is typically determined as the ratio of the vapor pressure of water in a material (p) to the vapor pressure of pure water (p0) at the same temperature. For example, a water activity of 0.80 means the vapor pressure is 80 percent of that of pure water. Water activity typically increases with temperature.
  • Preventive Electrolytic Hygrometers REH
  • Capacitance Hygrometers Capacitance Hygrometers
  • Dew Point Hygrometers sometimes called chilled mirror.
  • compositions e.g., food and/or beverage compositions (e.g., formulated ingestibles)) comprised of food component(s), comprising at least one of a nutrient, a nutraceutical, a macronutrient, a carbohydrate, a sugar, a monosaccharide, a polysaccharide, a dietary fiber, a fat, a fatty acid, a lipid, a protein, an amino acid, a peptide, a micronutrient, a vitamin, a mineral, a polypeptide, a carotenoid, an element, a ketone body, a prebiotic (e.g., a prebiotic fiber), a polyphenol, a flavonoid, an antioxidant, an electrolyte, a salt, a circadian rhythm modulator, a supplement, a nootropic, and/or a source of energy, one or more excipient component(s),
  • a nutrient e.g., a
  • provided food and/or beverage compositions are comprised of food component(s) and/or excipient component(s) Page 58 of 315 11645787v1 Docket No.: 2017299-0086 physically or chemically arranged in a predetermined configuration.
  • provided food and/or beverage compositions are comprised of food component(s) and/or excipient component (s) physically or chemically arranged in an indeterminate configuration.
  • a predetermined physical configuration is a core-shell preparation and/or a matrix preparation and/or a layered preparation.
  • a predetermined chemical configuration is a salt, a linear oligomer, a linear polymer, a star-shaped oligomer, and/or a star-shaped polymer.
  • the configuration of one or more food component(s) establishes the means of controlled release of food component(s) from food composition(s).
  • provided food and/or beverage compositions e.g., formulated ingestibles
  • provided food and/or beverage compositions are comprised, on a dry weight basis, of at least 90% of food component(s), comprising at least one of a carbohydrate, a fat, a protein, a vitamin, a ketone body, and/or an antioxidant.
  • provided food and/or beverage compositions are comprised, on a dry weight basis, of at least 99% of food component(s), comprising at least one of a carbohydrate, a fat, a protein, a vitamin, a ketone body, and/or an antioxidant.
  • one or more food component(s) establishes the means of controlled release of food component(s) from food composition(s).
  • a combination of one or more food component(s) and their configuration establishes the means of controlled release of food component(s) from food composition(s).
  • the present disclosure provides one or more food composition(s) characterized as providing a means of controlled release of one or more food component(s) comprising one or more food component(s) and their arrangement. The present disclosure leverages (e.g., understanding and repurposing) the physical and/or chemical traits of one or more food component(s) to control the interaction of one or more food composition(s) in one or more animal(s).
  • one or more nutrients, nutraceuticals, macronutrients, carbohydrates (e.g., one or more carbohydrate components), proteins (e.g., one or more protein components), fats (e.g., one or more fat components), micronutrients, vitamins, minerals, polyphenols, electrolytes, salts, ketone bodies, prebiotics, polymers, or combinations thereof are used to encapsulate a food component and/or core-shell and/or matrix preparations comprising one or more food composition(s).
  • one or more hydrophobic materials, hydrophilic materials, and/or amphiphilic materials are used to encapsulate a food component and/or core-shell and/or matrix preparations comprising one or more food composition(s).
  • one or more responsive properties of one or more food component(s) enables the means of controlled release of food component(s) from food composition(s).
  • properties of one or more food component(s) advantageous to establishing means of controlled release include, but are not limited to, response to pH, response to temperature, response to water, response to mechanical forces, response to endogenous chemical or enzymatic triggers, response to exogenous chemical or enzymatic triggers, response to osmotic pressure, and/or response to time.
  • one or more interfacial properties of one or more food component(s) enables the means of controlled release of food component(s) from food composition(s).
  • properties of one or more food component(s) advantageous to establishing means of controlled release include, but are not limited to, mucoadhesion, bioadhesion, buoyancy, size, and/or shape.
  • a combination of one or more responsive properties and one or more interfacial properties of one or more food component(s) establishes the means of controlled release of food component(s) from food composition(s).
  • means for reducing daily meal frequency further comprising a means of providing satisfaction and/or satiety, and/or a means of providing a nutritional benefit, further comprising an effective daily dose of one or more food component(s), excipient component(s), and/or food composition(s).
  • a means of providing satisfaction and/or satiety is one or more food component(s), one or more excipient component(s), and/or one or more food composition(s) further characterized by pleasing taste, pleasing texture, controlled release, modulation of physiological satiety response, or combinations thereof.
  • a means of providing nutritional benefit is one or more food component(s), one or more excipient component(s), and/or one or more food composition(s) further characterized by caloric value and/or mass (e.g., grams, lbs/pounds), as enzyme inhibitors, and/or as absorption enhancers.
  • caloric value and/or mass of one or more food component(s), excipient component(s), and/or food composition(s) is sufficient to provide for the nutritional benefit, as described herein, of one or more animal(s).
  • the caloric value one of or more food component(s), excipient component(s), and/or food composition(s) is at least about 250, at least about 500, about 1000, about 1500, about 2500, about 3500, and/or about 4500 calories.
  • the total mass of protein provided by one or more food composition(s) is characterized as at least about 100, at least about 200, about 300, about 400, about 500, about 600, and/or about 700 g.
  • a caloric value and/or mass of macronutrients provided represents the theoretical maximum energy comprised in one or more food component(s), excipient component(s), and/or food composition(s).
  • the caloric value and/or mass of one or more food component(s), excipient component(s), and/or food composition(s) is not necessarily indicative of a nutritional benefit. Accordingly, the present disclosure provides a means of reducing daily meal frequency by providing a means of nutritional benefit comprising an unexpectedly low caloric value and/or mass.
  • the present disclosure provides one or more food composition(s), ingested in one meal, characterized by sufficient satisfaction, satiety, and nutritional benefit for a 24-hour period. Page 61 of 315 11645787v1 Docket No.: 2017299-0086 C.
  • a food composition disclosed herein is comprised of one or more food components, in a predetermined physical and/or chemical configuration. In some embodiments, a food compositions is comprised of one or more food components in an indeterminate physical and/or chemical configuration. In some embodiments, the configuration of a food composition facilitates a controlled release of one or more food component(s). In some embodiments, the selection of one or more food component(s) facilitates a controlled release of one or more food component(s) from a food composition. [0277] In some embodiments, a food composition disclosed herein comprises one food component.
  • a food composition comprises two or more food components. In some embodiments, the arrangement of a food component facilitates the controlled release of one or more food component(s) from a food composition. In some embodiments, the arrangement of two or more food components facilitates the controlled release of one or more food component(s) from a food composition.
  • a food composition disclosed herein comprises one or more food component(s), that provides nutritional benefits when consumed by an animal. (i) Food component(s) providing a nutritional benefit [0279] In some embodiments, a food composition disclosed herein comprises one or more food component(s). In some embodiments, one or more food component(s) provides a nutritional benefit when consumed by an animal.
  • a nutritional benefit is selected from, but not limited to, providing energy (e.g., calories) to an animal; controlling satiety; providing metabolic intermediates (e.g., metabolic support); providing osmotic balance; maintaining an animal’s health; and maintaining an animal’s microbiome health.
  • a food compositioncomprising one or more food component(s) provides one, two, several, or all, of the nutritional benefits selected from: providing energy (e.g., calories) to an animal; controlling satiety; providing metabolic intermediates (e.g., metabolic support); Page 62 of 315 11645787v1 Docket No.: 2017299-0086 providing osmotic balance; maintaining an animal’s health; and maintaining an animal’s microbiome health.
  • a food composition(s) comprising one or more food component(s) controls satiety when consumed by an animal.
  • a food composition comprising one or more food component(s) controls fullness and/or a sensation of fullness experienced by an animal.
  • a food composition comprising one or more food component(s) controls release of one or more nutrients in the stomach and/or intestines of an animal that has consumed the food composition.
  • a food component comprises or consists of one or more nutrients.
  • a food composition comprising one or more food component(s), controls release of one or more nutrients at the gastrointestinal epithelial surface of an animal that has consumed the food composition.
  • a food composition comprising one or more food component(s), controls release of one or more nutrients in the gastrointestinal mucosal layer of an animal that has consumed the food composition. In some embodiments, a food composition comprising one or more food component(s), controls the residence time of one or more released nutrients in the gastrointestinal tract of an animal that has consumed the food composition. In some embodiments, a food composition comprising one or more food component(s), controls absorption time of one or more released nutrients in the stomach and/or intestine of an animal that has consumed the food composition. In some embodiments, a food composition comprising one or more food component(s), provides energy (e.g., calories) to an animal that has consumed the food composition over a sustained period.
  • energy e.g., calories
  • a food composition comprising one or more food component(s), provides one or more nutrients to an animal that has consumed the food composition over a sustained period. In some embodiments, a food composition comprising one or more food component(s), increases bioavailability of one more released nutrient to an animal that has consumed the food composition. In some embodiments, a food composition comprising one or more food component(s), reduces the requirement and/or frequency of a meal intake in an animal that has consumed the food composition.. [0282] In some embodiments a food composition disclosed herein comprising one or more food component(s) maintains the health of an animal that has consumed the food Page 63 of 315 11645787v1 Docket No.: 2017299-0086 composition.
  • maintaining the health an animal that has consumed the food composition includes supporting at least one endogenous enzymatic or metabolic process (e.g., metals, cofactors, vitamins), resisting oxidation (e.g., antioxidants), supporting bone and/or tooth health (e.g., minerals), supporting growth (e.g., amino acids, peptides, proteins), supporting digestive function (e.g., dietary fiber), supporting sensory tissue (e.g., carotenoids), supporting microbiome health (e.g., polyphenols, prebiotics), supporting circadian rhythm, supporting psychological well-being (e.g., lipids), supporting energy requirements (e.g., caloric intake), or a combination thereof.
  • endogenous enzymatic or metabolic process e.g., metals, cofactors, vitamins
  • resisting oxidation e.g., antioxidants
  • supporting bone and/or tooth health e.g., minerals
  • supporting growth e.g., amino acids, peptides, proteins
  • a food composition disclosed herein comprising one or more food component(s) promotes the microbiome health of an animal that has consumed the food composition.
  • promoting microbiome health includes supporting the growth, proliferation, and/or diversity of commensal microbiota of an animal that has consumed the food composition.
  • a food composition disclosed herein comprising one or more food component(s) comprises a probiotic, a probiotic food ingredient, a probiotic composition, a prebiotic, an essential microbial nutrient (e.g., a simple sugar, an amino acid, a fatty acid), or a combination thereof that promotes the microbiome health of an animal that has consumed the food composition.
  • a food composition disclosed herein comprising one or more food component(s) provides energy to an animal that has consumed the food composition.
  • the caloric content can be a surrogate measure for the amount of energy in one or more food component(s).
  • caloric content can be quantified using calorimetry.
  • the caloric content of one or more food component(s) is a measure of the theoretical maximum carbon content available for oxidation (e.g., to metabolically harness via aerobic respiration).
  • a food composition disclosed herein comprises a total caloric content of at least about 500 kcal, at least about 750 kcal, at least about 1000 kcal, at least about 1500 kcal, at least about 2000 kcal, at least about 2500 kcal, at least about 3000 kcal, at least about 4000 kcal, or at least about 5000 kcal.
  • Page 64 of 315 11645787v1 Docket No.: 2017299-0086 [0286]
  • a food composition disclosed herein comprises one or more metabolic intermediate.
  • the metabolic intermediate is a ketone body.
  • metabolic intermediates offer an alternative energy source to traditional food sources (e.g., digestible carbohydrates, fats, and proteins).
  • traditional food sources e.g., digestible carbohydrates, fats, and proteins.
  • consumption of a food composition provides energy while mitigating one or more metabolic responses (e.g., insulin release, drowsiness, fat storage) to consumption of traditional food sources (e.g., digestible carbohydrates, fats, and proteins).
  • a food composition disclosed herein comprising one or more food component(s) promotesosmotic balance in an animal that has consumed the food composition.
  • promoting osmotic balance includes maintaining the content of electrolytes in bodily fluids (e.g., interstitial fluid, luminal fluid, blood, urine, tears, and/or sweat) iof the animal that has consumed the food composition.
  • one or more food component(s) comprises or consists of at one or more dietary salt, one or more monosaccharide, or a combination thereof.
  • a food component disclosed herein exhibits one nutritional benefit in an animal that has consumed the food component.
  • a food component disclosed herein exhibits one or more nutritional benefits in an animal that has consumed the food component.
  • one or more food component(s) comprising the provided food composition(s) provide for the health of one or more animal(s).
  • one or more food component(s) providing for the health of one or more animal(s) is or are characterized as being at least one of: a nutrient, a nutraceutical, a macronutrient, a micronutrient, a polyphenol, a metal, a cofactor, a vitamin, an antioxidant, a mineral, an amino acid, a peptide, a ketone, an electrolyte, a salt, a protein, a carbohydrate, a sugar, a polysaccharide, a fat, a lipid, a fatty acid, a prebiotic, a dietary fiber, a carotenoid, a circadian rhythm modulator, a supplement, a nootropic, and/or a source of energy.
  • one or more food component(s) comprising the provided food composition(s) may comprise a formulated nutrient component (e.g., food ingredient, ingredient, formulated nutrient, encapsulated nutrient).
  • a formulated nutrient component e.g., food ingredient, ingredient, formulated nutrient, encapsulated nutrient.
  • one or more food component(s) characterized as being a metal may be or comprises at least one metal.
  • food component(s) characterized as being a metal can be a combination of metals, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a metal may comprise calcium, chromium, cobalt, copper, iodine, iron, magnesium, manganese, molybdenum, potassium, selenium, sodium, and/or zinc.
  • one or more food component(s) characterized as being a cofactor may be or comprises at least one cofactor.
  • food component(s) characterized as being a cofactor can be a combination of cofactors, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a cofactor may comprise nicotinamide adenine dinucleotide, flavin adenine dinucleotide, adenosine triphosphate, S-adenosylmethionine, Coenzyme Q, glutathione, heme, lipoamide, molybdopterin, and/or tetrahydrobiopterin.
  • one or more food component(s) characterized as being a vitamin may be or comprises at least one vitamin.
  • food component(s) characterized as being a vitamin can be a combination of vitamins, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a vitamin may comprise trans-retinol, trans- ⁇ -carotene, thiamine, riboflavin, niacin, niacinamide, nicotinamide riboside, pantothenic acid, pyridoxine, pyridoxamine, pyridoxal, biotin, folic acid, cyanocobalamin, hydroxocobalamin, methylcobalamin, adenosylcobalamin, ascorbic acid, cholecalciferol, ergocalciferol, tocopherol, tocotrienol, phylloquinone, and/or menaquinone.
  • one or more food component(s) characterized as being an antioxidant may be or comprises at least one antioxidant.
  • food component(s) characterized as being an antioxidant can be a combination of antioxidants, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a polyphenol and/or an antioxidant may comprise tannic acid, ellagitannin, apigenin, luteolin, tangeritin, isorhamnetin, kaempferol, myricetin, quercetin, rutin, eriodictyol, genipin, hesperetin, naringenin, catechin, gallocatechin, epicatechin, epigallocatechin, theaflavin, daidzein, genistein, glycitein, resveratrol, pterostilbene, hydroxytyrosol, cyanidin, delphinidin, malvidin, pelargonidin, peonidin, petunidin, chicoric acid, chlorogenic acid, cinnamic acid, ellagic acid, gallic acid, sinapic acid, rosmarinic acid, salicylic acid, cur
  • one or more food component(s) characterized as being a mineral may be or comprises at least one mineral.
  • food component(s) characterized as being a mineral can be a combination of minerals, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a mineral may comprise iron oxide, calcium chloride, calcium carbonate, and/or calcium hydroxyapatite.
  • one or more food component(s) characterized as being an amino acid may be or comprises at least one amino acid.
  • food component(s) characterized as being an amino acid can be a combination of amino acids, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being an amino acid may comprise alanine, arginine, asparagine, aspartic acid, cysteine, selenocysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, norvaline, norleucine, pipecolic acid, ornithine, homocysteine, homoserine, isovaline, and/or sarcosine.
  • one or more food component(s) characterized as being a branched chain amino acid may be or comprises at least one branched chain amino acid.
  • food component(s) characterized as being a branched chain amino acid can be a combination of branched chain amino acids, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a branched chain amino acid may comprise isoleucine, leucine, and/or valine.
  • one or more food component(s) characterized as being a peptide may be or comprises at least one peptide.
  • food component(s) characterized as being a peptide can be a combination of peptides, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a peptide may comprise aspartame, GLP-1, GLP-2, collagen, sermorelin, tesamorelin, lenomorelin, anamorelin, ipamorelin, macimorelin, ghrelin, tabimorelin, alexamorelin, GHRP-1, GHRP-2, GHRP-3, GHRP-4, GHRP-5, GHRP-6, and/or hexarelin.
  • one or more food component(s) characterized as being a dietary fiber may be or comprises at least one dietary fiber.
  • food component(s) characterized as being a dietary fiber can be a combination of dietary fibers, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a dietary fiber may comprise cellulose, dextrins, amylose, amylopectin, pectin, inulin, lignin, chitin, xanthan gum, sodium alginate, potassium alginate, calcium alginate, ammonium alginate, propylene glycol alginate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, agar, agarose, carrageenan, raffinose, cellulose acetate, methyl cellulose, ethyl cellulose, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate succinate, hydroxypropyl methylcellulose
  • one or more food component(s) characterized as being at least one macronutrient is or comprises at least one carbohydrate, at least one fat, at least one protein, or a combination thereof.
  • a food component(s) characterized as being at least one fatty acid is or comprises at least one of medium-chain triglyceride, docosahexaenoic acid, eicosapentaenoic acid, or combinations thereof.
  • one or more food component(s) characterized as being at least one short chain fatty acid is or comprises acetate, propionate, and butyrate, or a combination thereof.
  • one or more food component(s) characterized as being a carotenoid may be or comprises at least one carotenoid.
  • food component(s) characterized as being a carotenoid can be a combination of carotenoids, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a carotenoid may comprise alpha-lipoic acid, lycopene, ⁇ -carotene, lutein, zeaxanthin, adonixxanthin, adonirubin, meso-zeaxanthin, astaxanthin, capsanthin, citroxanthin, echinenone, astacein, bixin, crocetin, and/or peridin.
  • one or more food component(s) characterized as being a circadian rhythm modulator may be or comprises at least one circadian rhythm modulator.
  • food component(s) characterized as being a circadian rhythm modulator can be a combination of circadian rhythm modulators, each of which may or may not individually provide for the health of one or more animal(s).
  • one or more food component(s) characterized as being a circadian rhythm modulator may comprise melatonin, methylcobalamin, adrafinil, cathine, cathinone, dextroamphetamine, ephedrine, epinephrine, armodafinil, modafinil, phenylethylamine, synephrine, theanine, 5-hydroxytryptophan, caffeine, theobromine, and/or taurine.
  • one or more food component(s) comprising the provided food composition(s) provide energy.
  • one or more food component(s) providing energy is or are characterized as being at least one of: a carbohydrate, a protein, a fat, and/or a ketone body.
  • one or more food component(s) characterized as being a carbohydrate may be or comprises at least one carbohydrate.
  • food component(s) characterized as being a carbohydrate can be a combination of carbohydrates, each of which may or may not individually provide energy.
  • one or more food component(s) characterized as being a carbohydrate may comprise glucose, fructose, mannitol, allulose, sorbitol, xylitol, erythritol, lactitol, galactose, sucrose, maltodextrin, isomaltulose, glycogen, chitosan, guar gum, pullulan, cellulose, dextrins, amylose, amylopectin, pectin, inulin, lignin, chitin, xanthan gum, sodium alginate, potassium alginate, calcium alginate, ammonium alginate, propylene glycol alginate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate,
  • one or more food component(s) characterized as being a protein may be or comprises at least one protein.
  • food component(s) characterized as being a protein can be a combination of proteins, each of which may or may not individually provide energy.
  • one or more food component(s) characterized as being a protein may comprise pea protein isolate, whey protein isolate, oat protein isolate, soy protein isolate, wheat protein isolate, egg protein isolate, casein, bovine serum albumin, ovalbumin, ⁇ -lactalbumin, ⁇ -lactoglobulin, collagen, glutanin, gliadin, kefirin, avenin, zein, silk, gelatin, hordein, and/or legumin.
  • one or more food component(s) characterized as being a fat may be or comprises at least one fat.
  • food component(s) characterized as Page 70 of 315 11645787v1 Docket No.: 2017299-0086 being a fat can be a combination of fats, each of which may or may not individually provide energy.
  • one or more food component(s) characterized as being a fat may comprise paraffin wax, montan wax, microcrystalline wax, polyethylene wax, petrolatum wax, ozokerite wax, ceresin wax, beeswax, lanolin wax, spermaceti wax, tallow wax, lac wax, chinese insect wax, ambergris wax, soy wax, carnauba wax, candelilla wax, coconut wax, palm kernel wax, rice bran wax, butyric acid, n-butanol, pentanoic acid, n-pentanol, hexanoic acid, n-hexanol, heptanoic acid, n-heptanol, caprylic acid
  • one or more food component(s) characterized as being a polyunsaturated fatty acid may be or comprises at least one polyunsaturated fatty acid.
  • food component(s) characterized as being a polyunsaturated fatty acid can be a combination of polyunsaturated fatty acids, each of which may or may not individually provide energy.
  • one or more food component(s) characterized as being a polyunsaturated fatty acid may comprise at least one of medium-chain triglyceride, docosahexaenoic acid, eicosapentaenoic acid, arachidonic acid, linoleic acid, linolenic acid, oleic acid, parinaric acid, rumenic acid, or combinations thereof.
  • Page 71 of 315 11645787v1 Docket No.: 2017299-0086 As provided herein, one or more food component(s) characterized as being a ketone body may be or comprises at least one ketone body.
  • food component(s) characterized as being a ketone body can be a combination of ketone bodies, each of which may or may not individually provide energy.
  • one or more food component(s) characterized as being a ketone body may comprise acetoacetate, R- ⁇ -hydroxybutyl R- ⁇ -hydroxybutyrate, ⁇ - hydroxybutyrate, R-3-hydroxybutyl R-3-hydroxybutyrate monoester, and/or 1,3-butanediol.
  • Food component(s) providing for microbiome health In certain embodiments, one or more food component(s) comprising the provided food composition(s) provide for microbiome health.
  • one or more food component(s) providing for microbiome health is or are characterized as being at least one of: a probiotic, a probiotic food ingredient, a probiotic composition, a prebiotic, a polyphenol, and/or essential microbial nutrients (e.g., simple sugar, amino acid, fatty acid, iron).
  • one or more food component(s) characterized as being a probiotic, a probiotic food ingredient, and/or a probiotic composition may be or comprises at least one probiotic, a probiotic food ingredient, and/or a probiotic composition.
  • food component(s) characterized as being a probiotic, a probiotic food ingredient, and/or a probiotic composition can be a combination of probiotic, a probiotic food ingredient, and/or a probiotic composition (e.g., probiotic compositions), each of which may or may not individually provide for microbiome health.
  • one or more food component(s) characterized as being a probiotic, a probiotic food ingredient, and/or a probiotic composition may be essentially comprised of Bacillus coagulans, Bacillus licheniformis, Bacillus subtilis, Bifidobacterium angulatum, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium Bifidobacterium longum, Enterococcus faecium, Enterococcus faecalis, Lactobacillus acidophilus, Lactobacillus amylovorus, Lactobacillus alimentarius, Lactobacillus bulgaricus, Lactobacillus casei subsp.
  • one or more food component(s) characterized as being a prebiotic may be or comprises at least one prebiotic.
  • food component(s) characterized as being a prebiotic can be a combination of prebiotics, each of which may or may not individually provide for microbiome health.
  • one or more food component(s) characterized as being a prebiotic may comprise galactooligosaccharides, inulin, fructan, ⁇ -glucan, xylan, and/or pectin.
  • one or more food component(s) characterized as being a postbiotic may be or comprises at least one postbiotic.
  • food component(s) characterized as being a postbiotic can be a combination of postbiotic, each of which may or may not individually provide for microbiome health.
  • one or more food component(s) characterized as being a postbiotic may comprise lactic acid, butyrate, propionate, and/or acetate.
  • Food component(s) providing osmotic balance [0334] In certain embodiments, one or more food component(s) comprising the provided food composition(s) provide osmotic balance.
  • one or more food component(s) providing osmotic balance is or are characterized as being at least one of a salt and/or monosaccharide.
  • one or more food component(s) characterized as being a salt may be or comprises at least one salt.
  • food component(s) characterized as Page 73 of 315 11645787v1 Docket No.: 2017299-0086 being a salt can be a combination of salts, each of which may or may not individually provide osmotic balance.
  • one or more food component(s) characterized as being a salt may comprise sodium chloride, potassium chloride, sodium fluoride, potassium fluoride, sodium iodide, potassium iodide, calcium chloride, and/or calcium carbonate.
  • Excipient components [0337] In certain embodiments, one or more component(s) comprising one or more food composition(s) may be further characterized as an excipient component. [0338] In some embodiments, an excipient component utilized in accordance with the present disclosure is or comprises components that are not one or more food component(s) as described herein.
  • an excipient component is or comprises at least one anti- caking (e.g., anti-agglomerating, anti-clumping, anti-aggregating) component, surfactant component, plasticizing component, acid scavenger (e.g., buffering agent), moisture scavenger, water scavenger, oxygen scavenger, a desiccant, a polymer, a preservative, a colorant, a flavoring, an antioxidant, a humectant, a solvent, or a combination thereof.
  • anti- caking e.g., anti-agglomerating, anti-clumping, anti-aggregating
  • surfactant component e.g., plasticizing component
  • acid scavenger e.g., buffering agent
  • moisture scavenger e.g., water scavenger
  • oxygen scavenger e.g., oxygen scavenger
  • desiccant e.g., a polymer,
  • an excipient component imparts a benefit (e.g., reduced caking, increased stability, increased solubility, improved physical properties, improved taste, improved longevity, increased biocompatibility) on one or more food composition(s).
  • a benefit e.g., reduced caking, increased stability, increased solubility, improved physical properties, improved taste, improved longevity, increased biocompatibility
  • an excipient component imparts a change to the environment within the food composition (e.g., pH change, color change, oxygen concentration change, water concentration change).
  • an excipient component imparts a change (e.g., pH change, oxygen concentration change, flavor change, water concentration change) to the local environment (e.g., stomach, food matrix, beverage) where the food composition resides at a point in time.
  • an excipient component increases and/or decreases the solubility of one or more food component(s) in one or more food composition(s) upon mixing in one or more dissolution solvent(s).
  • Excipient components exhibiting one or more of anti-caking (e.g., anti- agglomerating, anti-clumping, anti-aggregating), surfactant, plasticizing, acid scavenger (e.g., Page 74 of 315 11645787v1 Docket No.: 2017299-0086 buffering agent), moisture scavenger, water scavenger, desiccant, polymer, preservative, colorant, flavoring, antioxidant, humectant, and/or solvent properties may be comprised of substance(s) identified by one or more governing bodies as safe (e.g., generally regarded as safe and/or food additives).
  • excipient component(s) are or may be selected from those excipient(s) recognized as Generally Regarded as Safe (i.e., GRAS) by the U.S. Food and Drug Administration. In some instances, those skilled in the art will appreciate that excipient component(s) are or may be selected from those excipient(s) recognized in 21 C.F.R.184. In some instances, those skilled in the art will appreciate that excipient component(s) are or may be selected from those excipient(s) recognized in GB2760-2014 by the National Health and Family Planning Commission of the People’s Republic of China. [0341] In some cases, an excipient component is or comprises a single excipient species.
  • an excipient component can comprise multiple excipients and combinations thereof.
  • excipients are added to one or more food composition(s) during a manufacturing process.
  • one or more shell component(s), core component(s), matrix component(s), and/or solute component(s) further comprise an excipient component.
  • excipients are added to one or more food composition(s) prior to consumption.
  • an excipient component is at least about 10 wt%, at least about 5 wt%, at least about 1 wt%, at least about 0.8 wt%, at least about 0.5 wt%, and/or at least about 0.1 wt% of one or more food composition(s).
  • an excipient component can lower water activity of food and/or beverage compositions (e.g., formulated ingestibles).
  • an excipient component can lower moisture content of food and/or beverage compositions (e.g., formulated ingestibles).
  • an excipient component can lower residual solvent content of food and/or beverage compositions (e.g., formulated ingestibles). Page 75 of 315 11645787v1 Docket No.: 2017299-0086 [0347] In some cases, an excipient component can reduce the friability of food and/or beverage compositions (e.g., formulated ingestibles). [0348] In some cases, an excipient component can improve the flowability of food and/or beverage compositions (e.g., formulated ingestibles). [0349] In some cases, an excipient component can reduce clumping upon storage of food and/or beverage compositions (e.g., formulated ingestibles).
  • an excipient component can improve the solubility of one or more food component(s) comprising one or more food composition(s). [0351] In some cases, an excipient component can improve the mixing of one or more food component(s) with one or more dissolution solvent(s). [0352] In some cases, an excipient component can improve the mixing of one or more food component(s) with one or more food products(s). [0353] In some cases, an excipient component can improve the mixing of one or more food component(s) with one or more beverage products(s). [0354] In some cases, an excipient component can improve the mixing of one or more food component(s) with one or more supplement products(s).
  • an excipient component can improve the mixing of one or more food component(s) with other food component(s).
  • an excipient component can either raise or lower the elastic modulus of food and/or beverage compositions (e.g., formulated ingestibles). In some cases, this may enable or facilitate methods of formulating or manufacturing food and/or beverage compositions (e.g., formulated ingestibles).
  • an excipient component can either raise or lower the crystallinity of food and/or beverage compositions (e.g., formulated ingestibles).
  • an excipient component can either alter and/or maintain the pH of a food composition.
  • excipient components used as a means of maintaining pH are additionally used as a means of gas generation.
  • generation of gas within one or more food composition(s) may reduce the density of a food composition and introduce buoyancy leading to increased residence time in one or more gastrointestinal compartments.
  • an excipient component can either react with environmental molecular oxygen or introduce molecular oxygen towards one or more food composition(s).
  • an excipient component is essential to triggered release, as described herein, for one or more food component(s) from one or more food and/or beverage compositions (e.g., formulated ingestibles).
  • an excipient component can alter pH within the microenvironment (e.g., stomach, food matrix, beverage) where the food composition resides.
  • an excipient component affects response of the food composition to heat.
  • an excipient component affects response of the food composition to shear.
  • an excipient component affects response of the food composition to elevated pressure.
  • an excipient component prevents fouling (e.g., microbial growth) of one or more food and/or beverage compositions (e.g., formulated ingestibles) over a period of at least 4 weeks, at least 12 weeks, at least 6 months, at least 1 year, at least 2 years, at least 5 years, and/or at least 10 years.
  • an excipient component improves the taste and/or fragrance of one or more food composition(s).
  • an excipient component maintains the water activity of one or more food composition(s).
  • an excipient component provides a visually pleasing appearance to one or more food composition(s).
  • an excipient component can affect the stability of one or more food composition(s) towards light, heat, pressure, shear, enzymes, bacteria, and/or one or more dissolution solvent(s) as described herein.
  • Food component(s) providing a means for controlled release of food component(s) [0370]
  • one or more food composition(s) are comprised of one or more food component(s).
  • one or more food component(s) are characterized as material(s) providing a means of controlled release.
  • release of one or more food component(s) from one or more food composition(s) is characterized by physical and/or chemical dissociation. In some cases, release of one or more food component(s) from one or more food composition(s) is characterized by the amount of one or more food component(s) released from one or more food composition(s) in the presence of one or more dissolution solvent(s) (e.g., dissolution). In some cases, release of one or more food component(s) from one or more food composition(s) is characterized by the rate of one or more food component(s) released from one or more food composition(s) in the presence of one or more dissolution solvent(s) (e.g., release rate).
  • the release of one or more food component(s) from one or more food composition(s) is characterized by a combination of amount of dissolution and/or release rate (e.g., release profile).
  • amount of dissolution and/or release rate e.g., release profile
  • one or more food component(s) may be essentially characterized by solubility.
  • one or more food component(s) may be characterized as slightly soluble, partially soluble, and/or completely soluble in one or more dissolution solvent(s).
  • solubility of one or more food component(s) may be achieved by physical and/or chemical dispersal of one more food component(s) within one or more dissolution solvent(s).
  • dispersal e.g., dissolution
  • dissolution solvent(s) relevant to a useful (e.g., to provide a health benefit) application of one or more technologies may be further characterized as release.
  • solubility characteristic(s) of one more food component(s) is or are important factor(s) determining their gastrointestinal absorption.
  • solubility characteristic(s) of one more food component(s) is or are important factor(s) determining their nutritional content.
  • a means of controlling the solubility characteristic(s) of one or more food component(s) is of particular benefit (e.g., to improve the health or performance of an animal) through influence of the gastrointestinal absorption and/or nutritional content of one or more food component(s).
  • a means of controlling the release of one or more food component(s) may be characterized as a means of controlling the solubilization of one or more food component(s) (e.g., release modifier).
  • means of controlling the release of one or more food component(s) from one or more food composition(s) are provided.
  • one or more food component(s) provides a means of controlling the release of one or more food component(s) from one or more food composition(s).
  • a means of controlling the release of one or more food component(s) from one or more food composition(s) may be characterized by at least one of: (i) controlling access of one or more dissolution solvent(s) to one or more food component(s) (e.g., core-shell preparation) and/or (ii) diffusivity of one or more food component(s) (e.g., matrix preparation), [0375]
  • a means of controlling the release of one or more food component(s) from one or more food composition(s) characterized as core-shell and/or matrix preparations is further characterized as controlling the chemical properties and/or chemical structure of one or more food component(s), modulators of gastrointestinal residence time, and/or trigger-responsive materials.
  • one or more means of controlling release of one or more food component(s) from one or more food composition(s), as provided herein provide a benefit (e.g., for the improvement of health, performance, satiety, taste, and/or energy) of one or more animals.
  • core-shell preparations e.g., food and/or beverage compositions (e.g., formulated ingestibles)
  • core-shell preparations as a means of controlling the Page 79 of 315 11645787v1 Docket No.: 2017299-0086 release of one or more food component(s) from one or more food composition(s).
  • one or more food composition(s) are or comprise core-shell preparations.
  • core-shell preparations may comprise a core component (e.g., interior component) and/or a shell component (e.g., coating, exterior component), each of which are essentially comprised of one or more food component(s), as described herein.
  • a core component is comprised of one or more food component(s) and/or one or more excipient component(s).
  • a shell component is comprised of one or more food component(s) and/or one or more excipient component(s).
  • an exemplary core-shell preparation may comprise a formulation comprising at least one food component and/or one excipient component arranged as a core component and at least one food component and/or one excipient component arranged as a shell component.
  • the at least one food component and/or one excipient component comprising a core component are additionally the at least one food component and/or one excipient component comprising a shell component.
  • the at least one food component and/or one excipient component comprising a core component are different from the at least one food component and/or one excipient comprising a shell component.
  • an exemplary core-shell preparation 100 may comprise a core component 120 comprising at least one food component and/or at least one excipient component.
  • an exemplary core-shell preparation 100 may comprise a shell component 110 comprising at least one food component and/or at least one excipient component.
  • the at least one food component and/or at least one excipient component comprising exemplary core component 120 is different from the at least one food component and/or at least one excipient component comprising exemplary shell component 110.
  • the at least one food component and/or at least one excipient component comprising exemplary core component 120 is the same as the at least one food component and/or at least one excipient component comprising exemplary shell component 110.
  • Page 80 of 315 11645787v1 Docket No.: 2017299-0086 [0381]
  • the exemplary core component 120 is comprised of a single food component and/or excipient component.
  • the exemplary core component 120 is comprised of several food components and/or excipient components.
  • the exemplary shell component 110 is comprised of a single food component and/or excipient component.
  • the exemplary shell component 110 is comprised of several food components and/or excipient components.
  • At least one food component and/or excipient component 120 may be described as being dispersed within (e.g., embedded within) at least one shell component 110.
  • at least one shell component 110 may be described as encapsulating at least one core component 120, comprising at least one food component and/or excipient component.
  • one or more core component(s) and/or a shell component(s) may be further characterized as a matrix preparation.
  • one or more core component(s) and/or shell component(s) comprise a matrix preparation.
  • an exemplary core-shell preparation may comprise a formulation comprising multiple layers of at least one food component and/or one excipient component arranged as a core component and at least one food component and/or one excipient component arranged as at least one shell component.
  • an exemplary core-shell preparation 200 may comprise a core component 210 comprising at least one food component and/or excipient component, at least one shell component 220 comprising at least one food component and/or excipient component 225 and/or a second shell component 230 comprising at least one food component and/or excipient component 225.
  • At least one core-shell composition 220, 210 may be described as being dispersed within (e.g., embedded within) at least one shell component 230.
  • at least one shell component 230 may be described as encapsulating at least one core-shell preparation and/or matrix preparation 210 and 220.
  • At least one payload or core component 210, at least one excipient or food component 225, at least one shell component (for example, an inner shell component) 220, or a combination thereof may be described as being dispersed within (e.g., encapsulated in) at least one carrier or shell component 230 (for example, an outer shell component 230).
  • one or more core-shell preparation(s) are encapsulated in a range of 1-15, 1-10, 1-8, 1-6, 1-4, and/or 1-2 distinct shell component(s).
  • one or more core component(s) may be characterized as a core-shell preparation.
  • a core-shell preparation is further encapsulated in 1 shell component. In other embodiments, a core-shell preparation is encapsulated in 2 layered shell components. [0391] In certain embodiments, a core-shell preparation is encapsulated in a range of 1- 15, 1-10, 1-8, 1-6, 1-4, and/or 1-2 shell component(s) that are homogeneously blended. In certain embodiments, the core-shell preparations are encapsulated in a range of 1-15, 1-10, 1-8, 1-6, 1-4, and/or 1-2 shell components that are subsequently encapsulated in a range of 1-15, 1-10, 1-8, 1- 6, 1-4, and/or 1-2 shell components.
  • one or more food component(s) comprising a shell component and/or a core component is characterized as being a liquid. In some embodiments, one or more food component(s) comprising a shell component and/or a core component is characterized as being a solid.
  • provided core-shell preparations may be characterized as a particle (e.g., particle preparation), an emulsion, a suspension, a powder, a bar, a gel, a capsule, a tablet, a fiber, an extrudate, a hard candy, a chip, and/or a mesh.
  • one or more core-shell preparation(s) comprising one or more food composition(s) may be further characterized as an emulsion.
  • one or more emulsion(s) present in one or more food composition(s) comprise one or more shell component(s), one or more core component(s), or both shell component(s) and core component(s) characterized by low solubility (e.g., miscibility) in water.
  • one or more emulsion(s) present in one or more food composition(s) comprise one or more shell component(s), one or more core component(s), or both shell component(s) and core component(s) of amphiphilic nature.
  • one or more core-shell preparation(s) further characterized as an emulsion may be described as having one or more core component(s) of low solubility (e.g., miscibility) in water and one or more shell component(s) of amphiphilic nature.
  • one or more core-shell preparation(s) further characterized as an emulsion may be described as having one or more core component(s) of high solubility (e.g., miscibility) in water and one or more shell component(s) of amphiphilic nature.
  • one or more emulsion(s) are prepared prior to consumption by one or more animal(s).
  • one or more emulsion(s) form spontaneously upon addition to one or more dissolution solvent(s).
  • one or more emulsion(s) form spontaneously upon exposure to one or more triggers.
  • one or more emulsion(s) form spontaneously in response to cross-linkers, pH, bile salts, surfactants, reducing and/or oxidizing agents, osmotic pressure, proteases, amylases, lipases, bacteria, yeast, transglutaminases, thrombin, temperature, time, and/or mechanical forces.
  • core-shell preparations e.g., food and/or beverage compositions
  • one or more shell component(s) controls the release profile of one or more core component(s).
  • one or more core component(s) controls the release profile of one or more shell component(s). In certain embodiments, control of the release of one more core component(s) is achieved by one or more shell component(s) providing a physical barrier to a dissolution solvent, controlling the diffusivity of one or more core component(s), controlling the chemical properties of one or more core component(s), controlling residence time of one or more core component(s) in the dissolution medium, and/or responsiveness to one or more triggers, as described herein.
  • control of the release of one more shell component(s) is achieved by one or more core component(s) controlling the diffusivity of one or more shell component(s), controlling the chemical properties of one or more shell component(s), controlling residence time Page 83 of 315 11645787v1 Docket No.: 2017299-0086 of one or more shell component(s) in the dissolution medium, and/or responsiveness to one or more triggers, as described herein.
  • one or more shell component(s) provides a physical barrier between a dissolution solvent and one or more core component(s).
  • one or more shell component(s) may be characterized as insoluble in aqueous media (e.g., water, phosphate buffered saline solution, simulated intestinal fluid, simulated gastric fluid, simulated tear fluid, simulated urine, HEPES buffered saline solution, Dulbecco’s Modified Eagle Medium, Hank’s balanced salt solution, biological intestinal fluid, biological gastric fluid, plasma, saliva, urine, feces, sweat, tear fluid, and/or Kreb’s buffer).
  • aqueous media e.g., water, phosphate buffered saline solution, simulated intestinal fluid, simulated gastric fluid, simulated tear fluid, simulated urine, HEPES buffered saline solution, Dulbecco’s Modified Eagle Medium, Hank’s balanced salt solution, biological intestinal fluid, biological gastric fluid, plasma, saliva, urine, feces, sweat, tear fluid, and/or Kreb’s buffer.
  • one or more shell component(s) may be characterized
  • one or more shell component(s) characterized by insolubility, slow, and/or zero-order solubilization in aqueous media prevent access of such aqueous media to one or more core component(s), thus preventing dissolution (e.g., release) of one or more core component(s).
  • one or more shell component(s) controls the chemical properties of one or more core component(s).
  • one or more core component(s) controls the chemical properties of one or more shell component(s).
  • one or more shell component(s) may be ionically and/or covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer and/or a crystal) and/or one or more core component(s).
  • one or more core component(s) may be ionically and/or covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer and/or a crystal) and/or one or more shell component(s).
  • ionic and/or covalent bonding of one or more core component(s) with itself and/or one or more shell component(s) may reduce its solubility, increase hydrophobicity, and/or increase molecular weight of the core component, thereby reducing diffusivity and release.
  • ionic and/or covalent bonding of one or more shell component(s) with itself and/or one or more core component(s) may reduce its solubility, increase hydrophobicity, and/or increase molecular weight of the shell component, thereby reducing diffusivity and release.
  • one or more shell component(s) performs a chemical reaction on one or more core Page 84 of 315 11645787v1 Docket No.: 2017299-0086 component(s) to change its molecular weight and/or introduce a new chemical functionality.
  • one or more core component(s) performs a chemical reaction on one or more shell component(s) to change its molecular weight and/or introduce a new chemical functionality.
  • one or more component(s) performing chemical reactions to reduce the molecular weight of a core component or a shell component may increase the release of one or more component(s) from a core-shell preparation.
  • one or more shell component(s) controls the chemical properties of one or more core component(s).
  • one or more core component(s) controls the chemical properties of one or more shell component(s).
  • one or more shell component(s) may be non-covalently bonded (e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.) to itself (e.g., a polymer and/or a crystal) and/or one or more core component(s).
  • one or more core component(s) may be non-covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer and/or a crystal) and/or one or more shell component(s).
  • itself e.g., a polymer and/or a crystal
  • shell component(s) e.g., a polymer and/or a crystal
  • non- covalent bonding of one or more core component(s) with itself and/or one or more shell component(s) may reduce its solubility, increase hydrophobicity, and/or increase molecular weight of the core component, thereby reducing diffusivity and release.
  • non-covalent bonding of one or more shell component(s) with itself and/or one or more core component(s) may reduce its solubility, increase hydrophobicity, and/or increase molecular weight of the shell component, thereby reducing diffusivity and release.
  • one or more shell component(s) performs a chemical reaction on one or more core component(s) to change its molecular weight and/or introduce a new chemical functionality.
  • one or more core component(s) performs a chemical reaction on one or more shell component(s) to change its molecular weight and/or introduce a new chemical functionality.
  • one or more component(s) performing chemical reactions to reduce the molecular weight of a core component or a shell component may increase the release of one or more component(s) from a core-shell preparation.
  • Page 85 of 315 11645787v1 Docket No.: 2017299-0086 [0399]
  • one or more shell component(s) controls the residence time of one or more core component(s) in a biological compartment.
  • one or more core-shell preparation(s) e.g., food and/or beverage compositions
  • one or more core-shell preparation(s) are characterized by lack of retention in a biological compartment.
  • one or more shell component(s) is or are characterized as being mucoadhesive (e.g., affinity and/or adhesion to one or more mucosal interfaces through interaction with the mucus, glycocalyx, extracellular matrix, cell membrane proteins, and/or cell membranes).
  • one or more shell component(s) is or are characterized as being mucopenetrative (e.g., lack of interaction with the mucus, glycocalyx, extracellular matrix, cell membrane proteins, and/or cell membranes).
  • mucoadhesive component(s) are further characterized as pH-responsive carbohydrates, as described herein.
  • pH-responsive carbohydrates are carbohydrate materials that are characterized by their water solubility at a predetermined pH.
  • pH-responsive carbohydrates are characterized by their water solubility at low pH (e.g., pH ⁇ about 5, pH ⁇ about 4, pH ⁇ about 3, pH ⁇ about 2, pH ⁇ about 1).
  • pH-responsive carbohydrates exhibit low water solubility at low pH and higher water solubility at moderate (e.g., pH of about 5.5, about 6, about 6.5, about 7, about 7.5, about 8) to high (e.g., pH >8, pH > 9, pH > 10, pH > 11, pH > 12) pH. In other embodiments, pH-responsive carbohydrates exhibit higher water solubility at low pH and lower water solubility at moderate to high pH.
  • pH-responsive carbohydrate component(s) may comprise sodium alginate, potassium alginate, calcium alginate, magnesium alginate, zinc alginate, sodium pectinate, potassium pectinate, calcium pectinate, zinc pectinate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, magnesium hyaluronate, zinc hyaluronate, cellulose acetate succinate, cellulose acetate butyrate, cellulose acetate phthalate, hydroxypropyl methylcellulose acetate succinate, heparin sodium, sodium carboxymethylcellulose, chitosan, and/or combinations thereof.
  • mucoadhesive component(s) are considered mucoadhesive carbohydrates.
  • mucoadhesive carbohydrates are carbohydrate materials that are characterized by their ability to interact with the mucosal interface (e.g., mucus, mucins, glycocalyx, proteoglycans, cell membrane, phospholipids).
  • mucoadhesive carbohydrates may utilize a combination of hydrogen bonding, charge-charge interaction, and hydrophobic effect to prolong residence time of formulations (e.g., particle preparations) on a mucosal surface.
  • mucoadhesive carbohydrate component(s) may comprise sodium alginate, potassium alginate, calcium alginate, magnesium alginate, zinc alginate, sodium pectinate, potassium pectinate, calcium pectinate, zinc pectinate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, magnesium hyaluronate, zinc hyaluronate, sodium carboxymethylcellulose, chitosan, and/or combinations thereof.
  • mucoadhesive component(s) are considered mucoadhesive proteins.
  • mucoadhesive proteins are protein materials that are characterized by their ability to interact with the mucosal interface (e.g., mucus, mucins, glycocalyx, proteoglycans, cell membrane, phospholipids).
  • mucoadhesive proteins may utilize a combination of hydrogen bonding, charge-charge interaction, and hydrophobic effect to prolong residence time of formulations (e.g., particle preparations) on a mucosal surface.
  • mucoadhesive protein component(s) may comprise Lycopersicon esculentum agglutinin, wheat germ agglutinin, urtica dioica agglutinin, and/or combinations thereof.
  • mucoadhesive component(s) are considered catechols.
  • mucoadhesive catechols are polyphenol (e.g., as described herein) that are characterized by their ability to interact with the mucosal interface (e.g., mucus, mucins, glycocalyx, proteoglycans, cell membrane, phospholipids).
  • mucoadhesive catechols may utilize a combination of hydrogen bonding, ⁇ - stacking, chemical cross-linking, and hydrophobic effect to prolong residence time of formulations (e.g., particle preparations) on a mucosal surface.
  • mucoadhesive catechols may comprise L- dopamine, poly(L-dopamine), hydroxytyrosol, catechol, caffeic acid, vanillin, veratraldehyde, eugenol, tannic acid, syringaldehyde, and/or protocatechuic aldehyde.
  • mucoadhesive component(s) are further characterized as charged polymers (e.g., polymers exhibiting charge depending on pH of one or more dissolution solvent(s)).
  • a charged polymer may be an anionic mucoadhesive polymer component (e.g., polymers exhibiting a negative charge depending on pH of one or more dissolution solvent(s)).
  • a charged polymer may be cationic mucoadhesive polymer component (e.g., polymers exhibiting a positive charge depending on pH of one or more dissolution solvent(s)).
  • charged polymers facilitate interaction with the mucosal interface (e.g., mucus, mucins, glycocalyx, proteoglycans, cell membrane, phospholipids) thereby enabling greater retention time of one or more core-shell preparation(s).
  • anionic mucoadhesive polymer component(s) may comprise poly(acrylic acid), poly(methacrylic acid), and/or poly(glycerol citrate)
  • cationic mucoadhesive polymer component(s) may comprise poly(ethyleneimine), trimethylchitosan, and/or poly(L-arginine).
  • mucopenetrative component(s) are characterized by lack of interaction with the mucus, glycocalyx, extracellular matrix, cell membrane proteins, and/or cell membranes.
  • one or more shell component(s) comprising a mucopenetrative component is contemplated to increase the diffusion of one or more core-shell preparation(s) at a mucosal interface.
  • mucopenetrative component(s) may comprise poly(ethylene glycol), poly(propylene glycol), poly(vinyl alcohol), and/or poly(ethylene oxide-co-propylene oxide).
  • one or more shell component(s) controls the release of one or more core component(s) by responding to a trigger.
  • one or more core component(s) controls the release of one or more shell component(s) by responding to a trigger.
  • a trigger is characterized as a chemical trigger, enzymatic Page 88 of 315 11645787v1 Docket No.: 2017299-0086 trigger, and/or a physical trigger.
  • a chemical trigger may be further characterized as a cross-linker, pH, bile salts, reducing and/or oxidizing agents, and/or osmotic pressure.
  • an enzymatic trigger may be further characterized as exposure to proteases, amylases, lipases, bacteria, transglutaminases, and/or thrombin.
  • a physical trigger may be further characterized as temperature, time, and/or mechanical forces.
  • one or more trigger(s) may act to alter the physical and/or chemical properties of one or more core component(s) and/or one or more shell component(s). It is further contemplated that alteration of one or more physical properties (e.g., increasing porosity, reducing molecular weight) acts to increase the release rate of one or more food component(s). It is further contemplated that alteration of one or more chemical properties (e.g., increasing charge, increasing polarity) acts to increase the release rate of one or more food component(s).
  • Matrix preparations e.g., food and/or beverage compositions (e.g., formulated ingestibles)) as a means of controlling the release of one or more food component(s) from one or more food composition(s).
  • one or more food composition(s) are or comprise matrix preparations.
  • matrix preparations may comprise a solute component and/or a matrix component, each of which are essentially comprised of one or more food component(s), as described herein.
  • a solute component is comprised of one or more food component(s) and/or one or more excipient component(s).
  • a matrix component is comprised of one or more food component(s) and/or one or more excipient component(s).
  • an exemplary matrix preparation may comprise a formulation comprising at least one food component and/or one excipient component arranged as a solute component and at least one food component and/or one excipient component arranged as a matrix component.
  • the at least one food component and/or one excipient component comprising a solute component are additionally the at least one food component and/or one excipient component comprising a matrix component.
  • the at least one food component and/or one excipient component comprising a solute component are different from Page 89 of 315 11645787v1 Docket No.: 2017299-0086 the at least one food component and/or one excipient comprising a matrix component.
  • one or more solute component(s) are distributed homogeneously within a matrix preparation (e.g., food composition).
  • one or more solute component(s) are distributed heterogeneously within a matrix preparation (e.g., food composition).
  • an exemplary matrix preparation 300 may comprise one or more solute components 320 and/or 330 further comprising one or more food component(s) and/or excipient component(s).
  • an exemplary matrix preparation 300 may comprise one or more matrix components 340 further comprising one or more food component(s) and/or excipient component(s).
  • the matrix components 340 hold the food component and/or excipient components in place at a pre-defined spatial distribution.
  • the both the matrix component 340 and the solute 320 or excipient components 330 are comprised of food components.
  • the matrix preparation in some embodiments, may also include an outer shell 310.
  • At least one food component 320 and/or an at least one excipient component 330 may be described as being dispersed within (e.g., embedded within) at least one matrix component 340.
  • at least one matrix component 340 may be described as encapsulating (i) at least one food component 320, and/or at least one excipient component 330.
  • at least one food component 320, at least one excipient component 330, at least one matrix component 340, or a combination thereof may be described as being dispersed within (e.g., encapsulated in) at least one matrix preparation 300 (for example, radially contained within an outer shell 310).
  • At least one food component 320, at least one excipient component 330, at least one matrix component 340, or a combination thereof comprising one or more matrix preparations 300 may be described as being dispersed within (e.g., encapsulated or embedded within) a shell component 310, as a core-shell preparation.
  • Page 90 of 315 11645787v1 Docket No.: 2017299-0086 [0420]
  • one or more solute component(s) and/or matrix component(s) may be further characterized as a core-shell preparation.
  • one or more solute component(s) and/or matrix component(s) comprise a core-shell preparation.
  • one or more food component(s) comprising a matrix component and/or a solute component is characterized as being a liquid. In some embodiments, one or more food component(s) comprising a matrix component and/or a solute component is characterized as being a solid.
  • provided matrix preparations may be characterized as a particle (e.g., particle preparation), a bar, a gel, a capsule, a tablet, a fiber, an extrudate, a hard candy, a chip, and/or a mesh.
  • matrix preparations e.g., food and/or beverage compositions (e.g., formulated ingestibles)
  • matrix preparations are characterized as a means of controlling the release of one or more food component(s).
  • one or more matrix component(s) controls the release profile of one or more solute component(s).
  • one or more solute component(s) controls the release profile of one or more matrix component(s).
  • control of the release of one more solute component(s) is achieved by one or more matrix component(s) providing a physical barrier to a dissolution solvent, controlling the diffusivity of one or more solute component(s), controlling the chemical properties of one or more solute component(s), controlling residence time of one or more solute component(s) in the dissolution medium, and/or responsiveness to one or more triggers, as described herein.
  • control of the release of one more matrix component(s) is achieved by one or more solute component(s) controlling the chemical properties of one or more matrix component(s), and/or responsiveness to one or more triggers, as described herein.
  • one or more matrix component(s) controls the diffusivity of one or more solute component(s).
  • one or more solute component(s) controls the diffusivity of one or more matrix component(s).
  • one or more matrix component(s) and/or one or more solute component(s) may be characterized by at least one of porosity, chain length, and/or electric charge.
  • one or more matrix component(s) characterized by reduced porosity and/or increased chain length and/or complementary charge to one or more solute component(s) reduce free movement (e.g., diffusivity) of one or more solute component(s) by presenting a physical obstruction and/or an electric field, thus preventing dissolution (e.g., release) of one or more solute component(s).
  • one or more solute component(s) characterized by increased chain length and/or complementary charge to one or more matrix component(s) reduce free movement (e.g., diffusivity) of one or more matrix component(s) by presenting a physical obstruction and/or an electric field, thus preventing dissolution (e.g., release) of one or more matrix component(s).
  • one or more matrix component(s) controls the chemical properties of one or more solute component(s).
  • one or more solute component(s) controls the chemical properties of one or more matrix component(s).
  • one or more matrix component(s) may be ionically and/or covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer) and/or one or more solute component(s).
  • one or more solute component(s) may be ionically and/or covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer) and/or one or more matrix component(s).
  • ionic and/or covalent bonding of one or more solute component(s) with itself and/or one or more matrix component(s) may reduce its solubility, increase hydrophobicity, and/or increase molecular weight of the solute component, thereby reducing diffusivity and release.
  • ionic and/or covalent bonding of one or more matrix component(s) with itself and/or one or more solute component(s) may reduce its solubility, increase hydrophobicity, and/or increase molecular weight of the matrix component, thereby reducing diffusivity and release.
  • one or more matrix component(s) performs a chemical reaction on one or more solute component(s) to change its molecular weight and/or introduce a new chemical functionality.
  • one or more solute component(s) performs a chemical reaction on one or more matrix component(s) to change its molecular weight and/or introduce a new chemical functionality.
  • Page 92 of 315 11645787v1 Docket No.: 2017299-0086 contemplated that one or more component(s) performing chemical reactions to reduce the molecular weight of a solute component or a matrix component may increase the release of one or more component(s) from a matrix preparation.
  • one or more matrix component(s) controls the chemical properties of one or more solute component(s).
  • one or more solute component(s) controls the chemical properties of one or more matrix component(s).
  • one or more matrix component(s) may be non-covalently bonded (e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.) to itself (e.g., a polymer) and/or one or more solute component(s).
  • one or more solute component(s) may be non-covalently bonded (e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.) to itself (e.g., a polymer) and/or one or more matrix component(s).
  • non-covalent bonds e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.
  • non-covalent bonds of one or more solute component(s) with itself and/or one or more matrix component(s) may reduce its solubility, increase hydrophobicity, and/or increase molecular weight of the solute component, thereby reducing diffusivity and release.
  • non-covalent bonds e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.
  • one or more matrix component(s) may reduce its solubility, increase hydrophobicity, and/or increase molecular weight of the matrix component, thereby reducing diffusivity and release.
  • one or more matrix component(s) performs a chemical reaction on one or more solute component(s) to change its molecular weight and/or introduce a new chemical functionality.
  • one or more solute component(s) performs a chemical reaction on one or more matrix component(s) to change its molecular weight and/or introduce a new chemical functionality.
  • one or more component(s) performing chemical reactions to reduce the molecular weight of a solute component or a matrix component may increase the release of one or more component(s) from a matrix preparation.
  • one or more matrix component(s) controls the release of one or more solute component(s) by responding to a trigger.
  • a trigger is characterized as a chemical trigger, enzymatic trigger, and/or a physical trigger.
  • a chemical trigger may be further characterized as a cross-linker, pH, bile salts, reducing and/or oxidizing agents, and/or osmotic pressure.
  • an enzymatic trigger may be further characterized as exposure to proteases, amylases, lipases, bacteria, transglutaminases, and/or thrombin.
  • a physical trigger may be further characterized as temperature, time, and/or mechanical forces.
  • one or more trigger(s) may act to alter the physical and/or chemical properties of one or more solute component(s) and/or one or more matrix component(s). It is further contemplated that alteration of one or more physical properties (e.g., increasing porosity, reducing molecular weight) acts to increase the release rate of one or more food component(s). It is further contemplated that alteration of one or more chemical properties (e.g., increasing charge, increasing polarity) acts to increase the release rate of one or more food component(s).
  • the release of one or more food component(s) is characterized by the amount (e.g., concentration) of one or more food component(s) solubilized in one or more dissolution solvent(s) over a predetermined period of time (e.g., incubation period).
  • the present disclosure provides for a means of controlled release of one or more food component(s) (e.g., core-shell preparations and/or matrix preparations).
  • controlled release of one or more food component(s) is control of the amount (e.g., concentration) of one or more food component(s) released over an incubation period (e.g., release rate).
  • the concentration and release rate comprise the release profile of one or more food component(s).
  • control of the release profile of one or more food component(s) provides a benefit (e.g., for the improvement of health, performance, satiety, taste, and/or energy) of one or more animal(s).
  • the release of one or more food component(s) may be held at a constant release rate for at least about 1, about 2, Page 94 of 315 11645787v1 Docket No.: 2017299-0086 about 4, about 6, about 12, about 24, and/or about 48 hours.
  • the release of one or more food component(s) may occur in intervals (e.g., bolus dose) every about 30 minutes, about 1 hour, about 2 hours, about 4 hours, about 6 hours, about 8 hours, about 12 hours, and/or about 24 hours.
  • the release of one or more food component(s) may occur with a release rate that increases after at least about 1, about 2, about 4, about 6, about 12, about 24, and/or about 48 hours.
  • the release of one or more food component(s) may occur with a release rate that decreases after at least about 1, about 2, about 4, about 6, about 12, about 24, and/or about 48 hours.
  • dissolution solvents the release of one or more food component(s) from one or more food composition(s) is characterized by quantification of solubilization in one or more dissolution solvent(s), as provided herein.
  • one or more dissolution solvent(s) may be characterized by their miscibility with water.
  • one or more dissolution solvent(s) may be characterized by their salinity.
  • one or more dissolution solvent(s) may be characterized by their pH.
  • one or more dissolution solvent(s) may be characterized as being a native biological fluid (i.e., a fluid characterized as essential to a living organism).
  • one or more dissolution solvent(s) may be characterized as being a surrogate of a native biological fluid (i.e., a surrogate of a fluid characterized as essential to a living organism).
  • one or more dissolution solvent(s) may be characterized by a combination of at least one of their miscibility with water, pH, and/or salinity, as being a native biological fluid, and/or resembling a native biological fluid.
  • one or more food composition(s) is added to an excess quantity, by weight, of one or more dissolution solvent(s) to characterize solubility.
  • one or more food composition(s) is added to at least about 5 fold, at least about 10 fold, at least about 20 fold, at least about 50 fold, at least about 100 fold, at least about 200 fold, at least about 1000 fold, at least about 5000 fold, and/or at least about 10000 fold, by weight, excess of one or more dissolution solvent(s) to characterize solubility.
  • Page 95 of 315 11645787v1 Docket No.: 2017299-0086 [0433]
  • one or more food composition(s) is added to one or more dissolution solvent(s) at a controlled temperature to characterize solubility.
  • one or more food composition(s) is added to one or more dissolution solvent(s) held at least at about -20 oC, at least at about 0 oC, at least at about 4 oC, at least at about 20 oC, at least at about 37 oC, and/or at least at about 50 oC to characterize solubility.
  • one or more food composition(s) is added to one or more dissolution solvent(s) for a predetermined period of time (e.g., incubation period) to characterize solubility.
  • one or more food composition(s) is added to one or more dissolution solvent(s) for at least about 30 seconds, at least about 1 minute, at least about 5 minutes, and/or at least about 10 minutes to characterize solubility.
  • one or more food composition(s) is added to one or more dissolution solvent(s) for a predetermined period of time (e.g., incubation period) to characterize solubility.
  • one or more food composition(s) is added to one or more dissolution solvent(s) for at least about 10 minutes, at least about 30 minutes, at least about 60 minutes, and/or at least about 120 minutes to characterize solubility.
  • one or more food composition(s) is added to one or more dissolution solvent(s) for a predetermined period of time (e.g., incubation period) to characterize solubility.
  • one or more food composition(s) is added to one or more dissolution solvent(s) for at least about 120 minutes, at least about 6 hours, at least about 12 hours, and/or at least about 24 hours to characterize solubility.
  • one or more food composition(s) is added to one or more dissolution solvent(s) at a particular combination of weight ratio, temperature, and/or period of time, as described herein, to characterize solubility.
  • one or more dissolution solvent(s) is characterized as being miscible with water.
  • one or more dissolution solvent(s) is characterized as being immiscible with water.
  • one or more dissolution solvent(s) characterized as being miscible with water may be water, phosphate buffered saline solution, simulated intestinal fluid, simulated gastric fluid, simulated tear fluid, simulated urine, HEPES buffered saline solution, Dulbecco’s Page 96 of 315 11645787v1 Docket No.: 2017299-0086 Modified Eagle Medium, Hank’s balanced salt solution, Cyrene, Glycofurol, furfural, Kreb’s buffer, acetone, tetrahydrofuran, ethanol, methanol, dimethylformamide, and/or dimethyl sulfoxide.
  • one or more dissolution solvent(s) characterized as being immiscible with water may be n-octanol, n-nonanol, n-decanol, n-dodecanol, n-tetradecanol, n- hexadecanol, n-octadecanol, n-icosanol, fatty alcohol monoglyceride ethers, fatty acid monoglyceride esters, fatty alcohol diglyceride ethers, fatty acid diglyceride esters, fatty alcohol triglyceride ethers, fatty acid triglyceride esters, fatty alcohol glycol monoether, fatty acid glycol monoesters, fatty alcohol glycol diethers, fatty acid glycol diesters, coconut oil, corn oil, cottonseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil,
  • one or more dissolution solvent(s) is characterized by salinity.
  • one or more dissolution solvent(s) characterized by salinity may be water, phosphate buffered saline solution, simulated intestinal fluid, simulated gastric fluid, simulated tear fluid, simulated urine, HEPES buffered saline solution, Dulbecco’s Modified Eagle Medium, Hank’s balanced salt solution, biological intestinal fluid, biological gastric fluid, plasma, saliva, urine, feces, sweat, tear fluid, and/or Kreb’s buffer.
  • one or more dissolution solvent(s) is characterized by pH.
  • one or more dissolution solvent(s) characterized by pH may be water, phosphate buffered saline solution, simulated intestinal fluid, simulated gastric fluid, simulated tear fluid, simulated urine, HEPES buffered saline solution, Dulbecco’s Modified Eagle Medium, Hank’s balanced salt solution, biological intestinal fluid, biological gastric fluid, plasma, saliva, urine, feces, sweat, tear fluid, and/or Kreb’s buffer.
  • one or more dissolution solvent(s) is characterized as being a native biological fluid.
  • one or more dissolution solvent(s) characterized as being a native biological fluid may be water, biological intestinal fluid, biological gastric fluid, plasma, saliva, urine, feces, sweat, oral fluid, cecum fluid, bile, and/or tear fluid.
  • one or more dissolution solvent(s) is characterized as being a surrogate of native biological fluid.
  • one or more dissolution solvent(s) characterized as being a surrogate of native biological fluid may be water, phosphate buffered saline solution, simulated intestinal fluid, simulated gastric fluid, simulated tear fluid, simulated urine, HEPES buffered saline solution, Dulbecco’s Modified Eagle Medium, Hank’s balanced salt solution, and/or Kreb’s buffer. 3.
  • Moisture content [0445]
  • provided food composition(s) is or are characterized by low moisture content.
  • the present disclosure provides technologies for preparing and/or characterizing food and/or beverage compositions (e.g., formulated ingestibles) comprising low moisture content.
  • the present disclosure provides one or more food composition(s) with low moisture content. Disclosed technologies provide benefits over existing products because high moisture content formulations may lead to rapid degradation of food component(s). [0447] In some embodiments, the present disclosure provides one or more food composition(s) with low moisture content. In some instances, provided food and/or beverage compositions (e.g., formulated ingestibles) may have a moisture content of ⁇ 8 wt%, ⁇ 6 wt%, ⁇ 4 wt%, ⁇ 2 wt%, ⁇ 1 wt%, or ⁇ 0.5 wt%.
  • provided food and/or beverage compositions are characterized by resistance or mitigation of water absorption or moisture absorption when exposed to high humidity or moisture content.
  • the present disclosure provides technologies for preventing uptake of water or moisture.
  • the present disclosure provides one or more food composition(s) that resist or mitigate moisture absorption when exposed to high humidities or Page 98 of 315 11645787v1 Docket No.: 2017299-0086 moisture.
  • provided food and/or beverage compositions resist absorption of less than about 0.25%, less than about 0.5%, less than about 1%, and/or less than about 5% (w/w) moisture content, as compared to initial moisture content, after incubation in relative humidities of about 33%, about 53%, and/or about 75%.
  • Water activity [0450] Without wishing to be bound by any particular theory, food component(s) may exhibit poor stability in environments with high water activity. In certain aspects of the present embodiments, a food composition of low water activity exhibits a water activity of ⁇ about 0.4, ⁇ about 0.3, ⁇ about 0.2, and/or ⁇ about 0.1.
  • the disclosed invention provides one or more food composition(s) of water activity ⁇ about 0.4, ⁇ about 0.3, ⁇ about 0.2, and/or ⁇ about 0.1. In certain embodiments, the disclosed invention provides one or more food composition(s) of low water activity. In some embodiments, the present disclosure provides technologies for preparing and/or characterizing food composition(s) comprising low water activity. [0452] In some embodiments, the present disclosure provides one or more food composition(s) with low water activity. Disclosed technologies provide benefits over existing products because high water activity formulations lead to rapid degradation of food component(s). 5.
  • Particle preparations e.g., food and/or beverage compositions, e.g., nutrient particle preparations.
  • food and/or beverage compositions e.g., formulated ingestibles
  • particles are or comprise particles (e.g., particle preparations, e.g., nutrient particle preparations).
  • particles may comprise a payload component (e.g., macronutrients, micronutrients, nutrients, etc.) and/or a carrier component.
  • one or more food composition(s) are or comprise particles (e.g., particle preparations).
  • the present disclosure provides particle preparations in which particles have a particular shape or form, for example, having a cross- section shape of a circle, an oval, a triangle, a square, a hexagon, or an irregular shape.
  • a preparation includes particles of different shapes or forms. In some embodiments, most or substantially all or all particles in a preparation have a common shape.
  • particles in a provided particle preparation may have a distribution of diameters (e.g., Dv(10), Dv(20), Dv(30), Dv(40), Dv(50), Dv(60), Dv(70), Dv(80), Dv(90), Dv(99), etc.).
  • particles in a provided particle preparation may have an average diameter (e.g., D[3,2], D[4,3], etc.). Regardless of the shape of the particle, the “diameter” (i.e., size) of a particle is the longest distance from one end of the particle to another end of the particle.
  • particles in a particle preparation as described and/or utilized herein may have a distribution of diameters (e.g., Dv(10), Dv(20), Dv(30), Dv(40), Dv(50), Dv(60), Dv(70), Dv(80), Dv(90), Dv(99), etc.) of up to about 10000 ⁇ m, up to about 5000 ⁇ m, up to about 2500 ⁇ m, up to about 1250 ⁇ m, up to about 800 ⁇ m, up to about 400 ⁇ m, up to about 200 ⁇ m, up to about 100 ⁇ m, up to about 50 ⁇ m, up to about 40 ⁇ m, up to about 30 ⁇ m, up to about 20 ⁇ m, up to about 10 ⁇ m, or up to about 5 ⁇ m.
  • Dv(10), Dv(20), Dv(30), Dv(40), Dv(50), Dv(60), Dv(70), Dv(80), Dv(90), Dv(99), etc. of
  • a means for controlled release of one or more food component(s) from one or more food composition(s) is provided.
  • the controlled release of one or more food components is characterized by at least one of release profile (e.g., as described herein), total amount (e.g., mass and/or weight) of one or more food component(s) released, total amount of one or more food component(s) released relative to initial loading (e.g., percent release), total amount of energy provided (e.g., calories released), total amount of nutrients provided, and/or location of release in a given incubation period in one or more dissolution solvent(s).
  • a total amount (e.g., mass and/or weight) of one or more food component(s), percent release, calories released, total amount of nutrients provided, and/or location of release is characterized by one or more release profiles (e.g., as described herein).
  • the release of one or more food component(s) is characterized by release over a given time frame.
  • release is characterized over a time period of at least about 10 seconds, at least about 30 seconds, at least about 1 minute, at least about 5 Page 100 of 315 11645787v1 Docket No.: 2017299-0086 minutes, at least about 10 minutes, at least about 30 minutes, at least about 60 minutes, at least about 2 hours, at least about 4 hours, at least about 8 hours, at least about 16 hours, and/or at least about 24 hours.
  • release is characterized over a time period relevant to time periods between one or more meals. For example, in certain embodiments, release is characterized over a time period of at least about 8 hours, at least about 16 hours, and/or at least about 24 hours.
  • release profiles of one or more food component(s) may be characterized (e.g., as described herein) as held at a constant release rate, bolus dose in intervals, with increasing release rate, and/or decreasing release rate for at least about 30 minutes, about 1 hour, about 2 hours, about 4 hours, about 6 hours, about 8 hours, about 12 hours, about 24 hours, and/or about 48 hours.
  • one or more food component(s) comprising one or more food composition(s) exhibit the same release (e.g., release profile).
  • one or more food component(s) comprising one or more food composition(s) exhibit differing release (e.g., release profile).
  • controlled release of one or more food component(s) is characterized by the total amount (e.g., mass and/or weight) of food component(s) provided to one or more animal(s) in a given incubation period in one or more dissolution solvent(s).
  • at least about 0 g, about 50 g, about 125 g, about 250 g, about 500 g, about 1000 g, about 1500 g, and/or about 2000 g of one or more food component(s) are released over an 8 hour period.
  • At least about 125 g, about 250 g, about 500 g, about 750 g, about 1250 g, about 1750 g, and/or about 2250 g of one or more food component(s) are released over a 16 hour period. In certain embodiments, at least about 1000g, about 1500 g, about 2000 g, about 2500 g, and/or about 3000 g of one or more food component(s) are released over a 24 hour period. [0460] In certain embodiments, controlled release of one or more food component(s) is characterized by the percent release in a given incubation period in one or more dissolution solvent(s).
  • At least about 0 %, about 10 %, about 25 %, about 50 %, about 75 %, and/or about 100 % of one or more food component(s) are released over an 8 hour period. In certain embodiments, at least about 0 %, about 10 %, about 25 %, about 50 %, about 75 %, and/or about 100 % of one or more food component(s) are released over a 16 hour period.
  • At least about 0 %, about 10 %, about 25 %, about 50 %, about 75 %, and/or about 100 % of one or more food component(s) are released over a 24 hour period.
  • controlled release of one or more food component(s) is characterized by the total amount of calories released in a given incubation period in one or more dissolution solvent(s).
  • at least about 0, at least about 250, at least about 500, about 1000, about 1500, about 2500, about 3500, and/or about 4500 kcal of one or more food component(s) are released over an 8 hour period.
  • At least about 500, about 1000, about 1500, about 2500, about 3500, and/or about 4500 kcal of one or more food component(s) are released over a 16 hour period. In certain embodiments, at least about 1500, about 2500, about 3500, and/or about 4500 kcal of one or more food component(s) are released over a 24 hour period.
  • controlled release of one or more food component(s) is characterized by the total amount of macronutrients (e.g., carbohydrates, fats, and/or proteins) released in a given incubation period in one or more dissolution solvent(s).
  • the total amount (e.g., weight) of macronutrients released is selected in order to confer a benefit (e.g., for the improvement of health, performance, satiety, taste, and/or energy) to the consumer.
  • the relative amount (e.g. weight) of macronutrients released is selected in order to confer a benefit (e.g., for the improvement of health, performance, satiety, taste, and/or energy) to the consumer.
  • at least about 0, at least about 25, at least about 50, about 100, about 200, about 300, about 400, and/or about 500 g of one or more carbohydrate(s) are released over an 8 hour period.
  • At least about 50, about 100, about 200, about 300, about 400, and/or about 500 g of one or more carbohydrate(s) are released over a 16 hour period. In certain embodiments, at least about 200, about 300, about 400, and/or about 500 g of one or more carbohydrate(s) are released over a 24 hour period. In certain embodiments, at least about 0, at least about 12, at least about 25, about 50, about 100, about 200, about 300, and/or about 400 g of one or more fat(s) are released over an 8 hour period. In certain embodiments, at least about 25, about 50, about 100, about 200, about 300, and/or about 400 g of one or more fat(s) are released over a 16 hour period.
  • At least about 100, about 200, about 300, and/or about 400 g of one or more fat(s) are released over a 24 hour period.
  • at least about 0, at Page 102 of 315 11645787v1 Docket No.: 2017299-0086 least about 100, at least about 200, about 300, about 400, about 500, about 600, and/or about 700 g of one or more protein(s) are released over an 8 hour period.
  • at least about 200, about 300, about 400, about 500, about 600, and/or about 700 g of one or more protein(s) are released over a 16 hour period.
  • At least about 400, about 500, about 600, and/or about 700 g of one or more protein(s) are released over a 24 hour period.
  • the ratio of carbohydrates to fats, by dry weight is between about 3 and about 12.
  • the ratio of proteins to fats, by dry weight is between about 0.5 and about 5.
  • the ratio of carbohydrates to proteins, by dry weight is between about 0.5 and about 10.
  • controlled release of one or more food component(s) is characterized by a targeted gastrointestinal location of release.
  • one or more food component(s) is characterized by release in at least one of the buccal cavity, stomach, duodenum, jejunum, ileum, colon, and/or rectum.
  • one or more food component(s) comprising one or more core component(s) and/or shell component(s) is characterized as controlling release in at least one of the buccal cavity, stomach, duodenum, jejunum, ileum, colon, and/or rectum.
  • one or more food component(s) comprising one or more solute component(s) and/or matrix component(s) is characterized as controlling release in at least one of the buccal cavity, stomach, duodenum, jejunum, ileum, colon, and/or rectum.
  • the at least one food component controlling release in at least one of the buccal cavity, stomach, duodenum, jejunum, ileum, colon, and/or rectum is further characterized as triggered by pH.
  • one or more food component(s) is characterized by release at a pH of at about 1-2, about 2-3, about 3-4, about 4-5, about 5-6, about 6-7, about 7-8, about 8-9, and/or about 9-10.
  • the at least one food component controlling release in at least one of the buccal cavity, stomach, duodenum, jejunum, ileum, colon, and/or rectum is further characterized as enzymatically triggered.
  • one or more food component(s) is characterized by susceptibility to amylases, lipases, proteases, and/or bacteria.
  • the at least one food component controlling release in at least one of the buccal cavity, stomach, duodenum, jejunum, ileum, colon, and/or rectum is further characterized as triggered by physical forces.
  • one or more food component(s) is characterized by release upon application of Page 103 of 315 11645787v1 Docket No.: 2017299-0086 physical pressure and/or shear forces.
  • the at least one food component controlling release in at least one of the buccal cavity, stomach, duodenum, jejunum, ileum, colon, and/or rectum is further characterized as triggered by temperature.
  • one or more food component(s) is characterized by release at a temperature of at least about 20 oC, about 25 oC, about 28 oC, about 30 oC, about 35 oC, about 37 oC, about 40 oC, about 45 oC, and/or about 50 oC.
  • the at least one food component controlling release in at least one of the buccal cavity, stomach, duodenum, jejunum, ileum, colon, and/or rectum is further characterized as triggered by time.
  • one or more food component(s) is characterized by release after an incubation period of at least about 10 minutes, about 30 minutes, about 60 minutes, about 2 hours, about 4 hours, about 8 hours, about 12 hours, about 24 hours, and/or about 36 hours.
  • 7. Incorporation of Food and/or beverage Compositions into Food and/or Beverage Products [0464]
  • the current disclosure provides for the incorporation of one or more food and/or beverage composition(s) into food and/or beverage products.
  • one or more food and/or beverage composition(s) are incorporated into food and/or beverage products in the food and/or beverage manufacturing process. In some cases, one or more food composition(s) are incorporated into food and/or beverage products in the food and/or beverage packaging process. In some cases, one or more food composition(s) are incorporated prior to pasteurization of a food and/or beverage product. In some cases, one or more food composition(s) are incorporated prior to mixing of a food and/or beverage product. In some cases, one or more food composition(s) are incorporated into finished food and/or beverage products. In some cases, one or more food composition(s) are incorporated into food and/or beverage products immediately prior to consumption.
  • incorporation of food and/or beverage composition(s) into food and/or beverage products utilizes size reduction techniques and/or homogenization.
  • size reduction techniques are applied to food composition(s) prior to incorporation.
  • size reduction techniques are applied to food and/or beverage products during incorporation of the food composition(s).
  • size reduction techniques are applied to food Page 104 of 315 11645787v1 Docket No.: 2017299-0086 and/or beverage products after incorporation of the food composition(s).
  • the present disclosure provides for size reduction using, for example, planetary milling, ball milling, burr milling, roller milling, media milling, impact milling, jet milling, high-pressure homogenization, cryo milling, hammer milling, conical milling, hand screening, or granulation/extrusion, extrusion, spray drying, lyophilization/milling, fluid bed agglomeration, spray congealing, high-shear granulation, tableting, pouring, roller compaction, crosslinking, prilling, spinning disc atomization, and/or combinations thereof.
  • homogenization is applied to food and/or beverage composition(s) following incorporation into food and/or beverage products.
  • incorporation of food and/or beverage composition(s) into food and/or beverage products significantly affects the visual appearance, texture, and/or taste of the food and/or beverage products. In other embodiments, incorporation of food composition(s) into food and/or beverage products minimally affects the visual appearance, texture, and/or taste of the food and/or beverage products.
  • disclosed food and/or beverage composition(s) minimally affect visual appearance, texture, and/or taste when incorporated, as provided herein, into a protein beverage (e.g., Ensure). In some instances, disclosed food composition(s) minimally affect visual appearance, texture, and/or taste when incorporated, as provided herein, into dehydrated peanut butter. In some instances, disclosed food composition(s) minimally affect visual appearance, texture, and/or taste when incorporated, as provided herein, into a MRE (i.e., meal ready-to-eat).
  • a protein beverage e.g., Ensure
  • disclosed food composition(s) minimally affect visual appearance, texture, and/or taste when incorporated, as provided herein, into dehydrated peanut butter.
  • disclosed food composition(s) minimally affect visual appearance, texture, and/or taste when incorporated, as provided herein, into a MRE (i.e., meal ready-to-eat).
  • Some aspects of the current disclosure provide methods of promoting health or longevity in an animal, comprising providing an effective amount of food and/or beverage compositions described herein in combination with a consumable composition (e.g., a food product, a beverage product, an animal-consumable product, etc.) to an animal.
  • a consumable composition e.g., a food product, a beverage product, an animal-consumable product, etc.
  • consumable compositions comprise core-shell preparations and/or matrix preparations.
  • an animal is a human, for example, an adult, an elder, a teenager, an adolescent, or an infant.
  • an animal is an agricultural animal, for example, a horse, a cow, a pig, a sheep, a goat, a domesticated bird (e.g., chicken, duck, goose), a non-domesticated (e.g., wild) bird, etc.
  • an animal is a pet animal, for example, a dog, a cat, a rabbit, and/or a fish.
  • consumable compositions e.g., food products, beverage products, animal-consumable compositions
  • consumable compositions comprising food and/or beverage compositions is or comprises a food product.
  • a food product is characterized by high water activity.
  • a food product is or comprises at least one of agricultural seed, baby formula, bread, candy, capsule, cake, cereal, chip, cookie, dry powder, fertilizer, food additive, ice cream, kefir, nutrition supplement, packaged food, pet feed, pet food, protein bar, protein powder, sachet, salad dressing, smoothie, spice, sprinkle packet, tablet, and/or yogurt.
  • consumable compositions comprising food compositions are provided to an animal in a mixture with a food or food ingredient.
  • non-consumable compositions comprising food compositions is or comprises an agricultural product for plant growth or plant nutrient delivery. In some cases, an agricultural product is characterized by high water activity. In some cases, non-consumable compositions comprising food compositions are provided to seeds or plants in a mixture with a seed or fertilizer or plant ingredient.
  • consumable compositions e.g., food products, beverages, animal-consumable compositions
  • consumable compositions comprising food compositions is or comprises a beverage product. In some cases, a beverage product is characterized by high water activity.
  • a beverage product is or comprises at least one of liquid supplement formulation, beer, seltzer, kefir, coffee, juice, liquid pharmaceutical formulation, milk, soda, sports drink (e.g., Gatorade, sports drinks, Vitamin beverage), tea, water, liquor (e.g., vodka, Page 106 of 315 11645787v1 Docket No.: 2017299-0086 whiskey, rum, etc.) and/or wine.
  • the formulation is provided to an animal in a mixture with a beverage or beverage ingredient.
  • the powder-based supplement, food, and/or beverage-mix products are characterized by high water activity.
  • the powder-based supplement, food, and/or beverage-mix products is a pre-workout powder, post-workout powder or pill, pre-workout capsule/pill, baby formula, whey powder, milk powder, protein powder, drink powder mix (e.g., Kool-Aid type mix), or a powder- based supplement, food, or beverage-mix products.
  • whey powder whey powder
  • milk powder protein powder
  • drink powder mix e.g., Kool-Aid type mix
  • the stability of one or more food component(s) may refer to a chemical stability, a physical stability, a stability of function, a stability of benefit, and/or combinations thereof.
  • the present disclosure provides stability of one or more food component(s) via one or more food composition(s) upon standing, upon incorporation into one or more food and/or beverage products, and/or upon mixing with one or more dissolution solvent(s) at a predetermined temperature, a predetermined humidity, and/or a predetermined period of time (e.g., incubation period).
  • a food composition provides for stability of a food component in a liquid (e.g., water, simulated gastric fluid, simulated intestinal fluid), food and/or beverage product(s) (e.g., sachet, yogurt, milk powder, seltzer, alcoholic beverage, vitamin beverage, sprinkle packet, meals ready-to-eat, protein drink) or environment (e.g., elevated humidity, temperature).
  • a liquid e.g., water, simulated gastric fluid, simulated intestinal fluid
  • food and/or beverage product(s) e.g., sachet, yogurt, milk powder, seltzer, alcoholic beverage, vitamin beverage, sprinkle packet, meals ready-to-eat, protein drink
  • environment e.g., elevated humidity, temperature
  • food composition(s) may be or are effective at protecting food component(s) against a physical change, a chemical change, a functional change, a change in benefit or combinations thereof.
  • stability of one or more food component(s) in one or more food composition(s) refers to the percentage of change of a measured stability characteristic (e.g., stability properties) after a period of storage relative to the measured property immediately after formulation.
  • stability of one or more food component(s) is defined as ⁇ about 40%, ⁇ about 30%, ⁇ about 20%, ⁇ about 10%, ⁇ about 5%, ⁇ about 2%, and/or ⁇ about 1% change in one or more measured stability properties.
  • the chemical stability of one or more food component(s) may be determined by a chemical quantity (e.g., mol, g, lbs) of one or more food component(s) relative to initial formulation.
  • the physical stability of one or more food component(s) may be determined by a physical quantity (e.g., diameter, morphology, porosity) of one or more food component(s) relative to initial formulation.
  • the functional stability of one or more food component(s) may be determined by comparison of release profile, as described herein, of one or more food component(s) relative to initial formulation.
  • the stability of benefit of one or more food component(s) may be determined by a comparison of maintenance of health, maintenance of microbiome health, provision of energy, provision of metabolic intermediates, and/or provision of osmotic stability relative to initial formulation.
  • stability of one or more food components(s) in a provided food composition is assessed over a period of time at a particular environmental condition. In some embodiments, stability is assessed after 6 months at ambient temperature.
  • a provided food composition is stable in that percent change of a stability property is minimized after passage of a period of time (e.g., at least about 1, 2, 3, 4, 5, 6, 7, or 8 weeks) under a particular environmental condition (e.g., ambient temperature).
  • a period of time e.g., at least about 1, 2, 3, 4, 5, 6, 7, or 8 weeks
  • stability is a measured change of ⁇ about 40%, ⁇ about 30%, ⁇ about 20%, ⁇ about 10%, ⁇ about 5%, ⁇ about 2%, and/or ⁇ about 1% of a food component over a period of time under the environmental condition.
  • the period of time is up to about 8 weeks and the environmental condition is or comprises ambient temperature.
  • the period of time is up to about 2 weeks and the environmental condition is or comprises presence of water (e.g., in aqueous solution).
  • the period of time is up to about 72 hours and the environmental condition is or comprises exposure to light at elevated temperatures (e.g., about 37°C).
  • a provided food composition is stable in that percent change of a stability property is minimized after passage of a period of time (e.g., at least about 1, 2, 3, 4, 5, 6, 7, or 8 weeks) under a particular environmental condition (e.g., ambient temperature).
  • stability is a measured change of ⁇ about 40%, ⁇ about 30%, ⁇ about 20%, ⁇ about 10%, ⁇ about 5%, ⁇ about 2%, and/or ⁇ about 1% of a food component over a period of time under the environmental condition.
  • the period of time is up to about 36 months and the environmental condition is or comprises ambient temperature.
  • the period of time is up to about 12 months and the environmental condition is or comprises presence of food product (e.g., in a mixture with a food product).
  • the period of time is up to about 1 month and the environmental condition is or comprises exposure to a food product (e.g., in a mixture with yogurt).
  • stability of one or more food component(s) is maintained after storage in a solid food (e.g., bread, rice, baked goods, etc.) at ambient temperatures for time periods between 0-1 week, 0-1 month, 0-1 years, or 1-5 years of storage.
  • a dry powder e.g., supplement powder, milk powder, baby formula, flour, etc.
  • stability of one or more food component(s) is maintained after storage in a liquid beverage (e.g., coffee, drinkable yogurt, protein beverage, water, soda, Gatorade, sports drinks, etc.) at ambient temperatures for time periods between 0-1 week, 0-1 month, 0-1 years, or 1-5 years of storage.
  • a liquid beverage e.g., coffee, drinkable yogurt, protein beverage, water, soda, Gatorade, sports drinks, etc.
  • disclosed food compositions are stable ( ⁇ about 20% change in one or more stability properties) up to 2 weeks, up to 1 month, up to 6 months, up to 1 year, up to 2 years, up to 5 years, etc. in water at ambient temperature.
  • disclosed food compositions are stable ( ⁇ about 20% change in one or more stability properties) up to 2 weeks in yogurt at ambient temperature.
  • disclosed food compositions are stable ( ⁇ about 20% change in one or more stability properties) up to 2 weeks in milk powder at ambient temperature.
  • disclosed food compositions are stable ( ⁇ about 20% change in one or more stability properties) up to 2 weeks in baby formula at ambient temperature.
  • disclosed food compositions are stable ( ⁇ about 20% change in one or more stability properties) up to 2 weeks in milk powder at ambient temperature.
  • disclosed food compositions are stable ( ⁇ about 20% change in one or more stability properties) up to 2 weeks in high dry powders at ambient temperature. [0491] In some embodiments, disclosed food compositions are stable ( ⁇ about 20% change in one or more stability properties) up to 2 weeks in a sachet at ambient temperature. [0492] In some embodiments, disclosed food compositions are stable ( ⁇ about 20% change in one or more stability properties) up to 2 weeks when combined with animal feed (e.g., total meal ration, animal feed pellets, etc.) at ambient temperature. [0493] In some embodiments, food compositions may be effective to protect food component(s) against humidity-induced degradation.
  • food component(s) dispersed in food product(s) is or are stable ( ⁇ about 20% change in one or more stability properties) when exposed to ambient humidity (e.g., 30% relative humidity) at ambient temperatures (e.g., 25 oC) for up to 6 weeks.
  • ambient humidity e.g., 30% relative humidity
  • ambient temperatures e.g., 25 oC
  • food compositions are incorporated into a food and/or beverage product in the presence of humidity (e.g., water, moisture content, water activity). In some instances, food compositions are effective to protect food component(s) against humidity- induced degradation.
  • food component(s) is or are stable ( ⁇ about 20% change in one or more stability properties) when exposed to >15%, >20%, >25%, and/or > 30% relative Page 110 of 315 11645787v1 Docket No.: 2017299-0086 humidity, at >-20 oC and/or >4 oC and/or >25 oC and/or >30 oC and/or >35 oC and/or >37 oC and/or >50 oC, for >1, >2, >3, >4, >6, and/or >8 weeks.
  • stability of the food component ( ⁇ about 20% change in one or more stability properties) is maintained after storage in a freezer (-85C to 0 oC), a refrigerator (1-10 oC), or atmospheric temperature (-10 oC-40 oC) for time periods between 0-1 week, 0-1 month, 0-1 years, or 1-5 years of storage.
  • protection against oxygen, heat, light, and water of a food component is maintained after storage in a freezer (-85 oC to 0 oC), a refrigerator (1-10 oC), or atmospheric temperature (-10 oC-40 oC) for time periods ranging from 0-1 week, 0-1 month, 0-1 year, and/or 1-5 years of storage.
  • the disclosed food compositions provide protection against degradation (e.g., oxidation, hydrolysis, isomerization, fragmentation, lysis, or a combination thereof) of food component(s).
  • the disclosed food compositions comprise core-shell and/or matrix preparations wherein food components are protected from environmental factors (e.g., water, humidity, moisture, water activity, light, heat, and/or acid).
  • provided food compositions disclosed herein are suitable for use in varying consumable compositions (e.g., a food product, a beverage product, an animal- consumable product). It is further contemplated that provided food compositions disclosed herein are suitable for use in consumable compositions of high water activity.
  • disclosed food compositions provide for stability of food component(s) further characterized as core components, shell components, matrix components, solute components, or a combination thereof when used with consumable compositions (e.g., a food product, a beverage product, an animal-consumable product).
  • consumable compositions e.g., a food product, a beverage product, an animal-consumable product.
  • D. Methods of Manufacturing Food Composition(s) [0499] The present disclosure provides a method of manufacturing (e.g., formulating) one or more food composition(s) that comprises, on a dry weight basis, at least about 90%, at least about 95%, and/or at least about 99% of one or more food component(s), as described herein.
  • a means of controlling the release of one or more food component(s) is characterized as being a physical arrangement (e.g., formulation) of one or more food component(s) comprising one more food composition(s).
  • the physical arrangement (e.g., formulation) of one or more food component(s) comprising one or more food composition(s) is further characterized as a core-shell preparation and/or a matrix preparation.
  • one or more core-shell and/or matrix preparations are further characterized as particle preparations.
  • the disclosure provides a method of manufacture for food and/or beverage compositions (e.g., formulated ingestibles) for improving health.
  • one or more matrix preparation(s) are formulated using one or more matrix component(s) and one or more solute component(s).
  • one or more core- shell preparation(s) are formulated using one or more shell component(s) and one or more core component(s).
  • one or more solute component(s) are characterized as a core-shell preparation.
  • one or more core component(s) are characterized as a matrix preparation.
  • the present disclosure provides a method of formulating one or more matrix, solute, core, and/or shell component(s).
  • the present disclosure provides a method of formulating one or more core-shell preparations and/or matrix preparations.
  • food and/or beverage compositions e.g., formulated ingestibles
  • food and/or beverage compositions are characterized as having an average particle diameter of ⁇ 10000 ⁇ m, ⁇ 5000 ⁇ m, ⁇ 1000 ⁇ m, ⁇ 500 ⁇ m, ⁇ 250 ⁇ m, ⁇ 125 ⁇ m, ⁇ 50 ⁇ m, ⁇ 20 ⁇ m, and/or ⁇ 5 ⁇ m.
  • one or more food composition(s) are characterized as having an average particle diameter between about 10 ⁇ m - 200 ⁇ m.
  • one or more food composition(s) are characterized as having an average particle diameter between about 50 ⁇ m - 800 ⁇ m.
  • one or more food composition(s) are characterized as having an average particle diameter in a range from about 90 ⁇ m - 400 ⁇ m.
  • Page 112 of 315 11645787v1 Docket No.: 2017299-0086 (i) Methods of size reduction [0503]
  • one or more core, shell, matrix, solute, core-shell, and/or matrix preparation component(s), as described herein, are reduced to a size (e.g., size reduction) amenable to homogeneous formulation.
  • one or more core, shell, matrix, solute, core-shell, and/or matrix preparation component(s) is reduced to a size (e.g., size reduction) amenable to mitigate any sensory aspects (e.g., texture, grit, taste, etc.).
  • a size reduction amenable to mitigate any sensory aspects (e.g., texture, grit, taste, etc.).
  • one or more core, shell, matrix, solute, core-shell, and/or matrix preparation component(s) undergoing one or more size reduction processes are characterized as a particle preparation, as described herein.
  • one or more core, shell, matrix, solute, core-shell, and/or matrix preparation component(s) characterized as particle preparation(s) are further characterized by particle diameter, morphology, and/or porosity.
  • methods of size reduction of food and/or beverage compositions include, but are not limited to, planetary milling, ball milling, burr milling, roller milling, media milling, impact milling, jet milling, high- pressure homogenization, cryo milling, hammer milling, conical milling, hand screening, or granulation/extrusion, extrusion, spray drying, fluid bed agglomeration, spray congealing, high- shear granulation, tableting, pouring, roller compaction, crosslinking, prilling, spinning disc atomization, and/or combinations thereof.
  • one or more core, shell, matrix, solute, core-shell, and/or matrix preparation component(s), as described herein, are mixed within a homogeneous formulation. In some cases, mixing is between solid food component(s) in liquid food component(s), solid food component(s) in solid food component(s), liquid food component(s) in liquid food component(s), and/or liquid food component(s) in solid food component(s). In some cases, mixing of one or more core, shell, matrix, solute, core-shell, and/or matrix component(s) enables uniformity of sensory aspects (e.g., texture, grit, taste, etc.).
  • mixing of one or more core, shell, matrix, solute, core-shell, and/or matrix component(s) enables a uniform distribution in a formulation.
  • mixed core, shell, matrix, solute, core-shell, and/or matrix preparation component(s) are characterized by concentration as a function of sampling location.
  • Page 113 of 315 11645787v1 Docket No.: 2017299-0086 [0506]
  • methods of mixing of food and/or beverage compositions include, but are not limited to, stir-bar, overhead stirring, ultrasonic mixing, high-shear mixing, and/or combinations thereof.
  • Methods of preparing matrix component(s) and/or matrix preparation(s) are provided.
  • one or more matrix component(s) and/or matrix preparation(s) is characterized as a solid, a gel, a particle, a liquid, or combinations thereof.
  • one or more matrix component(s) and/or matrix preparation(s) is characterized as having partial, high, and/or complete solubility in water (e.g., hydrophilic).
  • one or more matrix component(s) and/or matrix preparation(s) are characterized as having no, low, and/or moderate solubility in water (e.g., hydrophobic). In certain embodiments, one or more matrix component(s) and/or matrix preparation(s) are characterized as being amphiphilic. In certain embodiments, the preparation of one or more matrix component(s) and/or matrix preparation(s) is characterized as solidification, crystallization, self-assembly, gelation, and/or hydration.
  • the preparation of one or more matrix component(s) and/or matrix preparation(s), characterized as solidification, crystallization, self-assembly, gelation, and/or hydration is achieved through heating, in a range of about 20 oC to about 200 oC, mixing of one or more food composition(s), and subsequent cooling in a range of about -40 oC to about 20 oC.
  • the preparation of one or more matrix component(s) and/or matrix preparation(s), characterized as solidification, crystallization, self-assembly, gelation, and/or hydration is achieved through the action of a trigger (e.g., exposure to water, pH, light, physical forces, chemical reaction, enzymatic reaction) as provided herein.
  • a trigger e.g., exposure to water, pH, light, physical forces, chemical reaction, enzymatic reaction
  • the preparation of one or more matrix component(s) and/or matrix preparation(s) further includes size reduction, as provided herein.
  • Methods of preparing shell component(s) and/or core-shell preparation(s) [0510] In some cases, methods of preparation of one or more shell component(s) and/or core-shell preparation(s) are provided.
  • one or more shell component(s) Page 114 of 315 11645787v1 Docket No.: 2017299-0086 and/or core-shell preparation(s) is characterized as a solid, a gel, a particle, a liquid, or combinations thereof.
  • one or more shell component(s) and/or core-shell preparation(s) is characterized as having partial, high, and/or complete solubility in water (e.g., hydrophilic).
  • one or more shell component(s) and/or core-shell preparation(s) are characterized as having no, low, and/or moderate solubility in water (e.g., hydrophobic).
  • one or more shell component(s) and/or core-shell preparation(s) are characterized as being amphiphilic.
  • the preparation of one or more shell component(s) and/or core-shell preparation(s) is further characterized as a coating process and/or layering process.
  • methods of coating and/or layering may be or comprise a single method of coating and/or layering. In some instances, methods of coating and/or layering may be or comprise at least 1, 2, or 3 successive methods of coating and/or layering. In some instances, methods of coating and/or layering may be or comprise several successive methods of coating and/or layering.
  • methods of coating comprise, but are not limited to, spray pan coating, fluidized bed coating, dip coating, roller coating, sputter coating, self-assembly, or combinations thereof.
  • methods of layering comprise, but are not limited to, dip coating, roller coating, layered deposition, vapor deposition, physical arrangement, or combinations thereof.
  • one or more shell component(s) and/or core-shell preparation(s) are prepared by homogenous coating and/or layering of one or more core component(s), solute component(s), and/or matrix preparation(s) with an aqueous solution of one or more shell component(s) and/or core-shell preparation(s).
  • one or more shell component(s) and/or core-shell preparation(s) are prepared by heterogeneous coating and/or layering of one or more core component(s), solute component(s), and/or matrix preparation(s) with an aqueous solution of one or more shell component(s) and/or core-shell preparation(s).
  • one or more shell component(s) and/or core-shell preparation(s) are prepared by homogenous coating and/or layering of one or more core Page 115 of 315 11645787v1 Docket No.: 2017299-0086 component(s), solute component(s), and/or matrix preparation(s) with an organic solution of one or more shell component(s) and/or core-shell preparation(s).
  • one or more shell component(s) and/or core-shell preparation(s) are prepared by heterogeneous coating and/or layering of one or more core component(s), solute component(s), and/or matrix preparation(s) with an organic solution of one or more shell component(s) and/or core-shell preparation(s).
  • a method of coating a food and/or beverage compositions uses or may utilize materials that improve (e.g., protect, or improve the functionality of) the food and/or beverage compositions (e.g., formulated ingestibles).
  • a method of coating a food and/or beverage compositions improves resistance to moisture (e.g., humidity, water, water activity).
  • a method of coating a food and/or beverage compositions improves resistance to acidity (e.g., pH responsive materials).
  • a method of coating a food and/or beverage composition reduces porosity.
  • a method of coating a food and/or beverage compositions reduces agglomeration, aggregation, and/or tackiness.
  • a method of coating a food composition increases gastrointestinal residence time (e.g., mucoadhesive components). In some cases, a method of coating a food composition improves taste and/or fragrance.
  • the preparation of one or more shell component(s) and/or core-shell preparation(s) further includes size reduction, as provided herein.
  • Methods of Drying food composition(s) [0517] In certain embodiments, a method of drying food and/or beverage compositions (e.g., formulated ingestibles) is provided. In some cases, drying of a food and/or beverage compositions (e.g., formulated ingestibles) comprises reduction of moisture content.
  • drying of a food and/or beverage compositions comprises reduction of water activity.
  • the disclosed method of drying certain food and/or beverage compositions improves upon the prior art by further eliminating Page 116 of 315 11645787v1 Docket No.: 2017299-0086 exposure of food components (e.g., micronutrients, macronutrients, etc.) to moisture and/or presence of water.
  • drying of certain food and/or beverage compositions is achieved by the use of chemical drying agents, elevated temperature, vacuum, or combinations thereof.
  • drying of food and/or beverage compositions is achieved by use of drierite, heating, vacuum, molecular sieves, sodium sulfate, magnesium sulfate, calcium carbonate, calcium chloride, or combinations thereof.
  • Method of quantifying amount of food component(s) in one or more food composition(s) [0521]
  • the present disclosure provides methods for the quantification of food component(s) present in one or more disclosed food composition(s) (e.g., loading).
  • quantifying loading is beneficial to understanding the efficiency of the manufacturing process.
  • quantifying loading is beneficial to understanding the relative composition of nutrients in one or more food composition(s).
  • quantifying loading is beneficial to understanding the nutritional content of one or more food composition(s).
  • loading of one or more food composition(s) is quantification of amount of one food component.
  • loading of one or more food composition(s) is quantification of amount of several distinct food components.
  • quantification of one or more food component(s) within one or more food composition(s) is quantification of the concentration (e.g., amount) of one or more food component(s) following complete release (e.g., 100%) from one or more food composition(s).
  • loading of one or more food composition(s) is quantified by subjecting one or more food composition(s) to one or more dissolution solvent(s) and/or trigger(s) to effect complete release.
  • quantification of one or more food component(s) is achieved using at least one of nuclear magnetic resonance, mass spectrometry, liquid Page 117 of 315 11645787v1 Docket No.: 2017299-0086 chromatography, intrinsic colorimetry, intrinsic fluorimetry, enzymatic colorimetry, enzymatic fluorimetry, enzymatic amperometry, and/or antibody-mediated recognition (e.g., ELISA, Western blot).
  • ELISA ELISA
  • Western blot Western blot
  • one or more meal(s) refers to a particular combination of one or more food component(s) ingested by one or more animal(s) in a singular portion at regular intervals (e.g., meal frequency) over a 24-hour period (e.g., daily).
  • a meal is comprised of a particular combination of one or more food component(s) that is ingested by one or more animal(s) and characterized as providing satisfaction and/or satiety (e.g., a pleasurable taste, a pleasurable fragrance, comfort, mitigate hunger).
  • a meal is comprised of a particular combination of one or more food component(s) that is ingested by one or more animal(s) and characterized as providing a nutritional benefit (e.g., maintaining the health of one or more animals, maintaining the microbiome health of one or more animals, provision of caloric content, provision of metabolic intermediates, and/or provision of osmotic stabilizers).
  • a nutritional benefit e.g., maintaining the health of one or more animals, maintaining the microbiome health of one or more animals, provision of caloric content, provision of metabolic intermediates, and/or provision of osmotic stabilizers.
  • a meal is comprised of a particular combination of one or more food component(s) ingested by one or more animal(s), an effective daily dose characterized as providing satisfaction, satiety, and/or a nutritional benefit in a 24-hour period (e.g., daily), In some cases, an effective daily dose of one or more food component(s) is provided with 1 meal in a 24-hour period. In some cases, an effective daily dose of one or more food component(s) is provided with several meals in a 24-hour period.
  • one or more animal(s) are characterized as consuming one or more meals, as provided herein, in regular intervals (e.g., meal frequency) over a 24-hour period (e.g., daily). In some cases, one or more animal(s) consume at least 1, 2, 3, 4, 5, 6, 7, 8, 9, and/or at least 10 meals in a 24-hour period (e.g., daily). Without wishing to be bound by any particular theory, one or more animal(s) generally consume about 2 to about 5 meals daily.
  • the consumption of one or more meals by one or more animals is primarily Page 118 of 315 11645787v1 Docket No.: 2017299-0086 driven by a need for satisfaction and/or satiety and secondarily driven by a need for nutritional benefit.
  • a meal characterized as providing satisfaction and/or satiety is not necessarily characterized as providing a nutritional benefit.
  • a meal characterized as providing a nutritional benefit is not necessarily satisfying and/or satiating.
  • an effective daily dose of one or more food component(s) such as to provide for satisfaction and/or satiety may be an insufficient daily dose of one or more food component(s) such as to provide for nutritional benefit. It is similarly contemplated that an effective daily dose of one or more food component(s) such as to provide for satisfaction and/or satiety may be an excessive daily dose of one or more food component(s) such as to provide for nutritional benefit.
  • an effective daily dose of one or more food component(s) such as to provide for satisfaction and/or satiety may be an excessive daily dose of one or more food component(s) such as to provide for nutritional benefit.
  • one or more food composition(s), as described herein comprise a means of reducing daily meal frequency.
  • one or more food component(s), as described herein comprise a means of providing satisfaction, a means of providing satiety, and/or a means of providing a nutritional benefit.
  • one or more excipient component(s), as described herein comprise a means of providing satisfaction, Page 119 of 315 11645787v1 Docket No.: 2017299-0086 a means of providing satiety, and/or a means of providing a nutritional benefit.
  • the physical arrangement of one or more food component(s) comprise a means of providing satisfaction, a means of providing satiety, and/or a means of providing a nutritional benefit.
  • a means of providing satiety is also a means of providing satisfaction and/or nutritional benefit.
  • a means of providing satisfaction is also a means of providing satiety and/or nutritional benefit.
  • a means of nutritional benefit is also a means of providing satisfaction and/or satiety. 1.
  • one or more means of providing satisfaction and/or satiety provide a means of reducing daily meal frequency.
  • one or more means of providing satisfaction and/or satiety include, but are not limited to, combinations of providing a pleasing taste, providing a pleasing texture, controlling the release profile(s), as provided herein, of one or more food component(s), and/or controlling the physiological response of one or more animal(s).
  • one or more means of providing satisfaction and/or satiety further comprise one or more food component(s), excipient component(s), and/or food composition(s).
  • one or more food component(s), excipient component(s), and/or food composition(s) provide the same means of providing satisfaction and/or satiety. In certain embodiments, one or more food component(s), excipient component(s), and/or food composition(s) provide differing means of providing satisfaction and/or satiety. (i) Means of providing a pleasing taste [0534] In certain embodiments, one or more food component(s), excipient component(s), and/or food composition(s) are characterized by pleasing taste (e.g., taste modifier) as a means of providing satisfaction and/or satiety as a means of reducing daily meal frequency.
  • pleasing taste e.g., taste modifier
  • one or more taste modifier(s) are characterized as providing a sweet, sour, salty, bitter, and/or savory taste.
  • one or more taste Page 120 of 315 11645787v1 Docket No.: 2017299-0086 modifier(s) directly provides a pleasing taste.
  • one or more taste modifier(s) are characterized by modulating the taste of other food component(s).
  • one or more taste modifier(s) include, but are not limited to, glucose, vanillin, acetic acid, chlorogenic acid, cafestol, and/or sodium chloride.
  • one or more taste modifier(s) further include, but are not limited to, substance(s) identified by one or more governing bodies as safe (e.g., generally regarded as safe and/or food additives).
  • substance(s) identified by one or more governing bodies as safe e.g., generally regarded as safe and/or food additives.
  • taste modifier(s) are or may be selected from those substance(s) recognized as Generally Regarded as Safe (i.e., GRAS) by the U.S. Food and Drug Administration.
  • taste modifier(s) are or may be selected from those substance(s) recognized in 21 C.F.R.184.
  • taste modifier(s) are or may be selected from those substance(s) recognized in GB2760-2014 by the National Health and Family Planning Commission of the People’s Republic of China.
  • one or more taste modifier(s) comprise, on a dry weight basis, at least about 0%, about 1%, about 5%, about 10%, about 15%, about 20%, about 25%, about 50%, about 75%, about 90%, about 95%, about 99%, and/or about 100% of one or more means of providing a pleasing taste.
  • one or more taste modifier(s) comprise, on a dry weight basis, at least about 0%, about 1%, about 5%, about 10%, about 15%, about 20%, about 25%, about 50%, about 75%, about 90%, about 95%, about 99%, and/or about 100% of one or more means of providing satisfaction and/or satiety.
  • Means of providing a pleasing texture In certain embodiments, one or more food component(s), excipient component(s), and/or food composition(s) are characterized by pleasing texture (e.g., texture modifier) as a means of providing satisfaction and/or satiety as a means of reducing daily meal frequency.
  • one or more texture modifier(s) are characterized as providing a mechanically, geometrically, or chemically pleasing texture.
  • Page 121 of 315 11645787v1 Docket No.: 2017299-0086 one or more texture modifier(s) directly provides a pleasing texture.
  • one or more texture modifier(s) are characterized by modulating the texture of other food component(s).
  • one or more texture modifier(s) controls mechanical properties to influence hardness, cohesiveness, viscosity, elasticity, brittleness, chewiness, and/or gumminess.
  • one or more texture modifier(s) controls geometric properties to influence particle size and/or morphology.
  • one or more texture modifier(s) controls chemical properties to influence adhesiveness, oiliness, and/or greasiness.
  • one or more texture modifier(s) is further characterized by the geometric properties (e.g., size, morphology) of one or more food compositions.
  • one or more texture modifier(s) is characterized as being a core-shell preparation and/or a matrix preparation.
  • one or more texture modifier(s) is further characterized as a particle preparation, characterized by a morphology and/or particle diameter.
  • one or more texture modifier(s) further include, but are not limited to, substance(s) identified by one or more governing bodies as safe (e.g., generally regarded as safe and/or food additives). In some instances, those skilled in the art will appreciate that texture modifier(s) are or may be selected from those substance(s) recognized as Generally Regarded as Safe (i.e., GRAS) by the U.S. Food and Drug Administration.
  • texture modifier(s) are or may be selected from those substance(s) recognized in 21 C.F.R.184. In some instances, those skilled in the art will appreciate that texture modifier(s) are or may be selected from those substance(s) recognized in GB2760-2014 by the National Health and Family Planning Commission of the People’s Republic of China. [0544] In certain embodiments, the selection of one or more food component(s), excipient component(s), and/or food composition(s) is a means of providing a pleasing texture.
  • one or more texture modifier(s) comprise, on a dry weight basis, at least about 0%, about 1%, about 5%, about 10%, about 15%, about 20%, about 25%, about 50%, about 75%, about 90%, about 95%, about 99%, and/or about 100% of one or more means of providing a pleasing texture.
  • one or more texture modifier(s) comprise, on a dry weight basis, at least about 0%, about 1%, about 5%, about 10%, about 15%, about 20%, about 25%, about 50%, about 75%, about 90%, about 95%, about 99%, and/or about 100% of one or more means of providing satisfaction and/or satiety.
  • Means of controlling release profiles of one or more food component(s) [0546]
  • one or more food component(s), excipient component(s), and/or food composition(s) are characterized by controlling release of one or more food component(s) (e.g., satiety profile) as a means of providing satisfaction and/or satiety as a means of reducing daily meal frequency.
  • one or more satiety profile(s) are characterized by the release profile(s) of one or more food component(s) and/or relative release profile(s) of one or more food component(s). In certain embodiments, one or more release profile(s) of one or more food component(s) is achieved using one or more food composition(s), as provided herein. In certain embodiments, one or more food component(s) comprising one or more food composition(s) exhibits one release profile. In certain embodiments, one or more food component(s) comprising one or more food composition(s) exhibits several release profiles. [0548] In certain embodiments, one or more satiety profile(s) are characterized by the release profile of one or more carbohydrates as described herein.
  • one or more satiety profile(s) are characterized by the release profile of glucose, amylose, allulose, xylitol, and/or cellulose.
  • one or more satiety profile(s) are characterized by the release profile of one or more proteins as described herein.
  • Page 123 of 315 11645787v1 Docket No.: 2017299-0086 one or more satiety profile(s) are characterized by the release profile of whey protein, casein, soy protein, pea protein, corn protein, zein, gliadin, gelatin, and/or collagen.
  • one or more satiety profile(s) are characterized by the release profile of one or more fats as described herein.
  • one or more satiety profile(s) are characterized by the release profile of soybean oil, palm oil, carnauba wax, and/or lecithin.
  • one or more satiety profile(s) provided by one or more food composition(s) are characterized as extending the release of one or more food component(s) relative to unformulated food component(s).
  • extending (e.g., extended) release prolongs the incubation period required for 100% release of one or more food component(s) from one or more food composition(s) in one or more dissolution solvent(s). In certain embodiments, extending (e.g., extended) release prolongs the residence time of one or more food component(s) in one or more food composition(s) in one or more gastrointestinal compartment(s). In certain embodiments, extended release is achieved using a core-shell preparation, and/or a matrix preparation as described herein. [0552] In certain embodiments, means of controlled release of one or more food component(s) from one or more food composition(s), as provided herein, are utilized as means of controlling satiety profile(s).
  • a multilayered core-shell preparation is utilized to elicit sequentially bolus dose of sucrose in 8-hour intervals, such that 15 g of sucrose is released after 8 hours, 30 g of sucrose is released after 16 hours, and 60 g of sucrose is released after 24 hours.
  • a mucoadhesive core- shell preparation extends the jejunal residence time of one or more food composition(s) exhibiting sustained release of sucrose such that 60 g of sucrose is released over a 24-hour period.
  • a combination of release profiles of one or more carbohydrates, proteins, and/or fats comprises one or more satiety profile(s).
  • the release profile(s) of one or more food component(s) are temporally arranged to Page 124 of 315 11645787v1 Docket No.: 2017299-0086 elicit maximum satiety.
  • one or more means of providing satiety may comprise a food composition comprised of carbohydrates, released with constant rate over a 24-hour period, proteins, released in bolus dose in 8-hour intervals, and fats, released in a bolus dose within the first hour post-ingestion.
  • one or more combinations of release profile(s) are temporally arranged to provide satiety for at least about 8 hours, about 10 hours, about 12 hours, about 16 hours, about 20 hours, and/or about 24 hours.
  • a means of controlling release comprise, on a dry weight basis, at least about 0%, about 1%, about 5%, about 10%, about 15%, about 20%, about 25%, about 50%, about 75%, about 90%, about 95%, about 99%, and/or about 100% of one or more means of providing satisfaction and/or satiety.
  • Means of controlling physiological response of one or more food component(s) are characterized as controlling physiological response (e.g., physiological modulator) as a means of providing satisfaction and/or satiety.
  • one or more physiological modulator(s) are characterized by the modulation of an endogenous physiological satiety response.
  • one or more physiological modulator(s) elicits an endogenous physiological satiety response to provide satisfaction and/or satiety.
  • an endogenous physiological satiety response may be characterized by factors including, but not limited to, providing a feeling of fullness, reducing the desire to eat, reduced serum ghrelin, and/or increased serum leptin.
  • physiological modulation of satiety is achieved through physical means.
  • physiological modulation of satiety is achieved through chemical means.
  • physical means of modulating a physiological response to satiety include application of pressure or interaction with a surface area of one or more gastrointestinal compartments.
  • one or more food composition(s) characterized as a core-shell preparation and/or a matrix preparation provides a physical means of modulating a physiological response to satiety.
  • Page 125 of 315 11645787v1 Docket No.: 2017299-0086
  • one or more food composition(s) characterized as a core-shell preparation and/or a matrix preparation provides a physical means of modulating a physiological response to satiety by increasing size, and/or increasing surface area.
  • one or more food composition(s) characterized as a core-shell preparation and/or a matrix preparation increases size by swelling and uptake of one or more dissolution solvent(s), self-assembly in response to a trigger, or combinations thereof.
  • one or more food composition(s) characterized as a core-shell preparation and/or a matrix preparation increases surface area by unfolding (e.g., denaturing) in response to a trigger, increased porosity in response to a trigger, or combinations thereof.
  • chemical means of modulating a physiological response to satiety include selection of food component(s) and/or selection of food component release profile(s).
  • one or more food composition(s) characterized as a core-shell preparation and/or a matrix preparation provides a chemical means of modulating a physiological response to satiety.
  • one or more food component(s) characterized as a chemical modulator of physiological response to satiety include micronutrients, macronutrients, or combinations thereof.
  • a micronutrient is tannic acid, ellagitannin, apigenin, luteolin, tangeritin, isorhamnetin, kaempferol, myricetin, quercetin, genipin, rutin, eriodictyol, hesperetin, naringenin, catechin, gallocatechin, epicatechin, epigallocatechin, theaflavin, daidzein, genistein, glycitein, resveratrol, pterostilbene, hydroxytyrosol, cyanidin, delphinidin, malvidin, pelargonidin, peonidin, petunidin, chicoric acid, chlorogenic acid, cinnamic acid, ellagic acid, gallic acid, sinapic acid, rosmarinic acid, salicylic acid, curcumin, piperine, silymarin, silybin, eugenol
  • a macronutrient is aspartame, GLP-1, GLP- 2, collagen, sermorelin, tesamorelin, lenomorelin, anamorelin, ipamorelin, macimorelin, ghrelin, leptin, tabimorelin, alexamorelin, GHRP-1, GHRP-2, GHRP-3, GHRP-4, GHRP-5, GHRP-6, hexarelin, cellulose, dextrins, amylose, amylopectin, pectin, inulin, lignin, chitin, xanthan gum, sodium alginate, potassium alginate, calcium alginate, ammonium alginate, propylene glycol Page 126 of 315 11645787v1 Docket No.: 2017299-0086 alginate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate,
  • a release profile of one or more micronutrient(s) and/or macronutrient(s) is a chemical means of modulating a physiological response to satiety.
  • the release profile(s) of one or more macronutrients e.g., carbohydrates, proteins, fats
  • the release profile(s) of one or more carbohydrates are characterized as slow, constant release to provide a continuous energy source.
  • the release profile(s) of one or more proteins are characterized as bolus dose in 8 hour intervals to sufficiently stimulate growth hormone secretion.
  • one or more physical and/or chemical means of modulating a physiological response to satiety provide satiety for at least about 8 hours, about 10 hours, about 12 hours, about 16 hours, about 20 hours, and/or about 24 hours.
  • one or more physical and/or chemical means of modulating a physiological response to satiety comprise, on a dry weight basis, at least about 0%, about 1%, about 5%, about 10%, about 15%, about 20%, about 25%, about 50%, about 75%, about 90%, about 95%, about 99%, and/or about 100% of one or more means of providing satisfaction and/or satiety.
  • Means of providing sufficient nutritional benefit [0565] In certain embodiments, one or more means of reducing daily meal frequency is comprised of a means of providing sufficient nutritional benefit, as described herein.
  • a means of providing sufficient nutritional benefit further comprises providing a Page 127 of 315 11645787v1 Docket No.: 2017299-0086 sufficient total amount (e.g., cal, g) of one or more food component(s), a sufficient amount (e.g., cal, g) of one or more macronutrients, a sufficient balance of one or more macronutrients, one or more enzyme inhibitors, and/or one or more absorption enhancers.
  • one or more means of providing sufficient nutritional benefit further comprise one or more food component(s), excipient component(s), and/or food composition(s).
  • one or more food component(s), excipient component(s), and/or food composition(s) provide the same means of providing nutritional benefit. In certain embodiments, one or more food component(s), excipient component(s), and/or food composition(s) provide differing means of providing nutritional benefit. (i) Total amount of food component(s) [0566] In certain embodiments, a means of providing sufficient nutritional benefit is characterized as one or more food component(s), excipient component(s), and/or food composition(s) further characterized by a total amount of food component(s), as provided herein. In certain embodiments, a total amount of food component(s) is total caloric content (e.g., kcal) and/or mass (e.g., g).
  • a total caloric content and/or mass represent the theoretical energy (e.g., a nutritional benefit) provided by one or more meals.
  • effective daily meal consumption is characterized by a sufficient caloric content and/or mass for a nutritional benefit.
  • one or more food component(s), excipient component(s), and/or food composition(s) is characterized by a total mass of at least about 50 g, about 125 g, about 250 g, about 500 g, about 750 g, about 1000 g, about 1250 g about 1500 g, about 1750 g, about 2000 g, about 2500 g, and/or about 3000 g.
  • one or more food component(s), excipient component(s), and/or food composition(s) is characterized by a total caloric content of at least about 250, at least about 500, about 1000, about 1500, about 2500, about 3500, and/or about 4500 kcal.
  • the total caloric content and/or mass of one or more food component(s), excipient component(s), and/or food composition(s) refers to that which is present upon manufacture.
  • the total caloric content and/or mass of one or more Page 128 of 315 11645787v1 Docket No.: 2017299-0086 food component(s), excipient component(s), and/or food composition(s) refers to that which is released over a given period of time in one or more dissolution solvent(s).
  • the total caloric content and/or mass of one or more food component(s), excipient component(s), and/or food composition(s) refers to that which is absorbed by one or more animals.
  • the total caloric content and/or mass of food component(s) comprise, on a dry weight basis, at least about 0%, about 1%, about 5%, about 10%, about 15%, about 20%, about 25%, about 50%, about 75%, about 90%, about 95%, about 99%, and/or about 100% of one or more means of providing a nutritional benefit.
  • a means of providing sufficient nutritional benefit is characterized as one or more food component(s), excipient component(s), and/or food composition(s) further characterized by a total amount and balance of macronutrients, as provided herein.
  • a total amount of macronutrients is mass (e.g., g), and balance is caloric ratio between carbohydrates, fats, proteins, or combinations thereof.
  • a total amount of macronutrients and their ratio represent support of growth and maintenance (e.g., a nutritional benefit) provided by one or more meals.
  • one or more food component(s), excipient component(s), and/or food composition(s) is characterized by a total carbohydrate content of at least about 25, at least about 50, about 100, about 200, about 300, about 400, and/or about 500 g.
  • one or more food component(s), excipient component(s), and/or food composition(s) is characterized by a total protein content of at least about 100, at least about 200, about 300, about 400, about 500, about 600, and/or about 700 g.
  • one or more food component(s), excipient component(s), and/or food composition(s) is characterized by a total fat content of at least about 12, at least about 25, about 50, about 100, about 200, about 300, and/or about 400 g. Page 129 of 315 11645787v1 Docket No.: 2017299-0086 [0572]
  • one or more food component(s), excipient component(s), and/or food composition(s) is characterized by a ratio of carbohydrates to fats, by dry weight, is between about 3 and about 12.
  • one or more food component(s), excipient component(s), and/or food composition(s) is characterized by a ratio of proteins to fats, by dry weight, is between about 0.5 and about 5. In certain embodiments, one or more food component(s), excipient component(s), and/or food composition(s) is characterized by a ratio of carbohydrates to proteins, by dry weight, is between about 0.5 and about 10. [0573] In certain embodiments, the total amount of macronutrients and/or macronutrient balance comprising one or more food component(s), excipient component(s), and/or food composition(s) refers to that which is present upon manufacture.
  • the total amount of macronutrients and/or macronutrient balance comprising one or more food component(s), excipient component(s), and/or food composition(s) refers to that which is released over a given period of time in one or more dissolution solvent(s). In certain embodiments, the total amount of macronutrients and/or macronutrient balance comprising one or more food component(s), excipient component(s), and/or food composition(s) refers to that which is absorbed by one or more animals. (iii) Enzyme inhibitors [0574] In certain embodiments, a means of providing a nutritional benefit comprises an effective dose of one or more enzyme inhibitor(s).
  • one or more enzyme inhibitor(s) is characterized by reducing the activity of gastrointestinal enzymes. Without wishing to be bound by any particular theory, it is contemplated that one or more enzyme inhibitor(s) prolongs the digestion of one or more food component(s), thereby prolonging absorption and reducing daily meal frequency.
  • means of reducing the activity of gastrointestinal enzymes e.g., enzyme inhibitors
  • an effective dose of one or more enzyme inhibitor(s) comprising one or more food component(s), excipient component(s), and/or food composition(s) is characterized by an increased stability of one or more food component(s) in one or more dissolution solvent(s) comprising a digestive enzyme.
  • an Page 130 of 315 11645787v1 Docket No.: 2017299-0086 effective dose of one or more enzyme inhibitor(s) increases the half-life of one or more food component(s) by at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 75%, about 90%, and/or about 100% in simulated intestinal fluid comprising pancreatin.
  • an effective dose of one or more enzyme inhibitor(s) increases the half-life of one or more food component(s) by at least about 1-fold, 2-fold, 3-fold, 5-fold, 10-fold, 20-fold, and/or 50-fold in simulated intestinal fluid comprising pancreatin.
  • one or more enzyme inhibitor(s) is comprised of at least one or more food component(s), excipient component(s), and/or food composition(s).
  • one or more enzyme inhibitor(s) is characterized by one or more release profile(s), as described herein. Without wishing to be bound by any particular theory, it is contemplated that the release profile of one or more enzyme inhibitor(s) is critical to its function.
  • controlled release is applied to one or more food component(s), excipient component(s), and/or food composition(s) comprising an enzyme inhibitor.
  • an enzyme inhibitor may be comprised of at least one of amylostatin Y, amylostatin S-AI, adiposin, gurmarin, zeamatin, helianthamide, lipstatin, orlistat, esterastin, valilactone, panclicin D, ebelactone, vibralactone, soybean trypsin inhibitor, serpin A1, serpin A3, serpin A4, serpin E1, serpin C1, Elafin, TIMP-1, TIMP-2, TIMP-3, TIMP-4, and/or an antioxidant, as described herein [0578] Having read the present disclosure, one skilled in the art will appreciate that one or more texture modifier(s) further include, but are not limited to, substance(s) identified by one or more governing bodies as safe (e.g., generally
  • texture modifier(s) are or may be selected from those substance(s) recognized as Generally Regarded as Safe (i.e., GRAS) by the U.S. Food and Drug Administration. In some instances, those skilled in the art will appreciate that texture modifier(s) are or may be selected from those substance(s) recognized in 21 C.F.R.184. In some instances, those skilled in the art will appreciate that texture modifier(s) are or may be selected from those substance(s) recognized in GB2760-2014 by the National Health and Family Planning Commission of the People’s Republic of China.
  • one or more absorption enhancers comprise, on a dry weight basis, at least about 0%, about 1%, about 5%, about 10%, about 15%, about 20%, about 25%, about 50%, about 75%, about 90%, about 95%, about 99%, and/or about 100% of one or more means of reducing daily meal frequency.
  • one or more enzyme inhibitor(s) reduces the caloric content and/or mass, as provided herein, characterizing one or more food component(s), excipient component(s), and/or food composition(s).
  • one or more food composition(s) comprising one or more enzyme inhibitor(s) provides a means of reducing daily meal frequency by providing a means of inducing satisfaction and satiety further characterized by caloric restriction.
  • the provided disclosure is of particular benefit to one or more animal(s) requiring body weight management and/or characterized as diabetic.
  • a means of providing a nutritional benefit comprises an effective dose of one or more absorption enhancer(s).
  • one or more absorption enhancer(s) is characterized by increasing the gastrointestinal absorption of one or more food component(s).
  • a means of increasing nutrient absorption reduces the required caloric density, meal size, and reduces daily meal frequency.
  • means of increasing the absorption of one or more food component(s) are comprised of one or more food component(s), excipient component(s), and/or food composition(s), as provided herein.
  • an effective dose of one or more absorption enhancer(s) comprising one or more food component(s), excipient component(s), and/or food composition(s) is characterized by an increase in the oral bioavailability of one or more food component(s).
  • an effective dose of one or more absorption enhancer(s) increases the bioavailability of one or more food component(s) by at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 75%, about 90%, and/or about 100%.
  • an effective dose of one or more absorption Page 132 of 315 11645787v1 Docket No.: 2017299-0086 enhancer(s) increases the bioavailability of one or more food component(s) by at least about 1- fold, 2-fold, 3-fold, 5-fold, 10-fold, 20-fold, and/or 50-fold.
  • one or more absorption enhancers is comprised of at least one or more food component(s), excipient component(s), and/or food composition(s).
  • one or more absorption enhancers is characterized by one or more release profile(s), as described herein. Without wishing to be bound by any particular theory, it is contemplated that the release profile of one or more absorption enhancer(s) is critical to its function.
  • controlled release as provided herein, is applied to one or more food component(s), excipient component(s), and/or food composition(s) comprising an absorption enhancer.
  • an absorption enhancer may be comprised of at least one of sodium caprylate, sodium caprate, sodium laurate, sodium oleate, sodium linoleate, propyl gallate, propyl syringate, propyl shikimate, octyl gallate, octyl syringate, octyl shikimate, ammoniated glycyrrhizin, quillaia extract, tocopherol PEG succinate, lauroyl polyoxylglycerides, polysorbate 80, ethanol, propylene glycol, poly(ethylene glycol), diethylene glycol monoethyl ether, sodium citrate, medium chain triglycerides, lipase, sodium lauryl sulfate, and/or ascorbyl palmitate.
  • one or more texture modifier(s) further include, but are not limited to, substance(s) identified by one or more governing bodies as safe (e.g., generally regarded as safe and/or food additives).
  • texture modifier(s) are or may be selected from those substance(s) recognized as Generally Regarded as Safe (i.e., GRAS) by the U.S. Food and Drug Administration.
  • texture modifier(s) are or may be selected from those substance(s) recognized in 21 C.F.R.184.
  • one or more absorption enhancers comprise, on a dry weight basis, at least about 0%, about 1%, about 5%, about 10%, about 15%, about 20%, about Page 133 of 315 11645787v1 Docket No.: 2017299-0086 25%, about 50%, about 75%, about 90%, about 95%, about 99%, and/or about 100% of one or more means of reducing daily meal frequency.
  • composition(s), and/or component(s) thereof are subjected to one or more assessments, for example to characterize one or more structural features and/or functional properties thereof (e.g., for quality control and/or after storage under particular conditions and for a particular period of time). In some embodiments, batches that do not meet designated criteria may be discarded or not further utilized.
  • assessments for example to characterize one or more structural features and/or functional properties thereof (e.g., for quality control and/or after storage under particular conditions and for a particular period of time). In some embodiments, batches that do not meet designated criteria may be discarded or not further utilized.
  • EXEMPLIFICATION [0588] The following examples are intended to illustrate but not limit the disclosed embodiments. The following examples are useful to confirm aspects of the disclosure described above and to exemplify certain embodiments of the disclosure.
  • provided food and/or beverage compositions may be characterized by significant improvements, including, for example, (i) improved absorption and/or bioavailability of payloads, (ii) improved shelf-life and resistance to degradation at decreased temperatures (e.g., -80°C, -20°C, and/or 4°C), elevated temperatures (e.g., 22°C, 25°C, 30°C, 35°C, and/or 40°C), in food and/or food products, in beverages and/or beverage products, in supplements, in dry powders, in the presence of high relative humidity (e.g., up to 100%) or moisture, or a combination thereof; (iii) prolonged residence time or transit time in the gastrointestinal tract or gastrointestinal tract compartments, (iv) controlled release or sustained release of payload components in the gastrointestinal tract, (v) controlled spatial distribution of payload
  • a food composition is comprised of one or more macronutrient(s), one or more micronutrient(s), and/or one or more excipient component(s).
  • the provided food composition is comprised of a caloric content suitable for the needs of one or more animal(s) for a 24-hour period.
  • the provided food composition is comprised of one or more of a protein, a carbohydrate, and/or a fat.
  • a provided food composition is comprised of a caloric content of 1500 kcal with 112 g of carbohydrate, 150 g of protein, 50 g of fat, 2.5 ⁇ g of vitamin B12, 15 ⁇ g of vitamin D, 15 mg of vitamin E.
  • a provided food composition is comprised of a caloric content of 2000 kcal with 250 g of carbohydrate, 100 g of protein, 67 g of fat, 2.5 ⁇ g of vitamin B12, 15 ⁇ g of vitamin D, 15 mg of vitamin E.
  • a provided food composition is comprised of a caloric Page 135 of 315 11645787v1 Docket No.: 2017299-0086 content of 2500 kcal with 250 g of carbohydrate, 125 g of protein, 111 g of fat, 2.5 ⁇ g of vitamin B12, 15 ⁇ g of vitamin D, 15 mg of vitamin E. Therefore, the relative ratios of calories that are derived from carbohydrates vs. proteins vs. fats may vary from one composition to the next.
  • Table 1 Nutritional values of exemplary food composition(s). Composition Carbohydrates (g) Proteins (g) Fats (g) Calories (kcal) B.
  • Example 2 Encapsulation of macronutrients
  • one or more food component(s) characterized as a macronutrient are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • one or macronutrients is encapsulated in a core- shell preparation further characterized as a particle preparation.
  • a food composition comprised of a carbohydrate (e.g., a solute component) is embedded within a carbohydrate (e.g., a matrix component), further characterized as encapsulation of a carbohydrate.
  • a food composition comprised of an encapsulated carbohydrate (e.g., a matrix preparation) is encapsulated by a protein (e.g., a core-shell preparation).
  • a core-shell preparation is further characterized as a particle preparation.
  • sucrose is dispersed within a wet amylose matrix, the slurry sprayed into cool air to generate particles of controlled diameter. The encapsulation of sucrose within amylose is calculated to be 92%, on a dry weight basis.
  • particles comprising encapsulated sucrose (92% loading, 1 mm diameter) are further coated (e.g., spray pan coating) with a 10% ethanolic solution of Zein with a colorant (e.g., excipient component).
  • Brightfield micrographs reveal increased surface roughness and a red coloring, indicative of successful coating.
  • Example 3 Encapsulation of micronutrients
  • one or more food component(s) characterized as a micronutrient are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • a food composition comprised of a vitamin (e.g., a solute component) is embedded within a protein (e.g., a matrix component), further characterized as encapsulation of a vitamin.
  • a vitamin e.g., a solute component
  • a protein e.g., a matrix component
  • riboflavin 0.25% w/v
  • a 10% gelatin solution heated to 65 oC, homogenized, and subsequently cooled for 1 hour at 20 oC.
  • one or more food composition(s) are characterized as one or more of a core-shell preparation, matrix preparation, and/or particle preparation. In certain embodiments, one or more food composition(s) are characterized as a core-shell preparation and a matrix preparation.
  • a food composition is comprised of a matrix preparation, further characterized as a core component, coated with one or more shell components.
  • one or more core component(s) is comprised of, on a dry weight basis, at least 90% of one or more food component(s) and/or one or more shell component(s).
  • the non-limiting instance of an exemplary combination matrix and core-shell preparation, as provided in this example, is comprised of a matrix preparation further comprised of 10% (w/w) gelatin and 2% (w/w) whey protein.
  • FIGs.6A and 6B illustrate the gross morphology of the non-limiting exemplary food composition prior to and following coating.
  • Example 5 Exemplary multi-layered core-shell preparations [0599]
  • one or more food composition(s) are characterized as a multi-layered core-shell preparation. Described herein is a non-limiting example of one multi- layered core-shell preparation comprising a food composition.
  • a food composition is comprised of a core-shell preparation, as shown in FIG.6B, comprised of gelatin, whey protein isolate, and cellulose acetate phthalate.
  • This food composition is subsequently coated 4 times (e.g., dip coating), allowing for drying, in a 10% ethanolic solution of Zein with a colorant (e.g., excipient component).
  • a colorant e.g., excipient component
  • the solubility of the polymer in the first layer e.g, cellulose acetate phthalate
  • the second coating polymer e.g., Zein
  • FIG.7A and 7B Brightfield micrographs (FIGs.7A and 7B) illustrate the cross-sectional morphology of the non-limiting exemplary food composition prior to and following coating with a second layer.
  • F. Example 6 Exemplary coating formulation protocols [0601] This example describes two non-limiting processes of arranging one or more food component(s) as a shell component to one or more food component(s) characterized as a core component via spray pan coating and/or fluidized bed spray coating.
  • a schematic of an exemplary coating procedure, method, or protocol 800 is presented in FIG.8. At step 802, the method 800 may include solubilizing an exemplary amount of encapsulant via melting or solvent-solubilization.
  • the method 800 may include adding an exemplary nutrient payload to pan coater or fluidized bed coater or other coater.
  • the method 800 may include applying fluidization or mixing or rotation of the payload in the pan coater or fluidized bed coater.
  • the method 800 may include applying spraying or coating or administration or atomization of the melted or solubilized encapsulant to the mixed, rotated and/or fluidized payload.
  • the method 800 may include adding anti-caking or flow- aid agents before, during and/or after the coating process.
  • the method 800 may include collecting the coated particles and thoroughly mixing (e.g., until uniform powder is Page 138 of 315 11645787v1 Docket No.: 2017299-0086 achieved).
  • the method 800 may include characterizing the coated particles via size analysis, shape analysis, release profile, water activity, etc.
  • food composition(s) are prepared in core-shell preparations using the procedure described below.
  • Particle preparations comprising sucrose encapsulated in amylose (10 g) are coated using a spray pan coater with an inlet air temperature of 80 oC, pan temperature of 70 oC, rotation speed of 2 Hz, and spray rate of 0.5 mL/s.
  • a 10% (w/v) ethanolic (90% ethanol) solution of Zein with 1% (v/v) Propylene Glycol and 0.5% (w/v) Talc powder is applied as a thin film over 5 minutes to the encapsulated sucrose.
  • the volume- normalized weight gain due to coating is 120%].
  • the concentration of formulated food product in this embodiment, on a dry weight basis, is 100% (w/w).
  • Whey protein isolate powder (100 g) is coated using a fluidized bed spray coater (Glatt) with a 67 oC inlet temperature, 45 oC outlet temperature, a spray rate of 3 g/min, and a flow rate of 25 mL/min.
  • Example 7 Exemplary matrix formulation protocol [0604] This example describes two non-limiting processes of arranging one or more food component(s) as a matrix component to one or more food component(s) characterized as a solute component via melt-gelation.
  • a schematic of an exemplary matrix formulation procedure, method, or protocol 900 is presented in FIG.9.
  • the method 900 may include solubilizing an exemplary amount of encapsulant and payload via melting or solvent- solubilization.
  • the method 900 may include mixing melted or solubilized encapsulant or payload together under agitation or mixing or static conditions.
  • the method 900 may include removing the solubilizing agent (e.g., drying, lyophilization, etc.) or decreasing the temperature to initiate solidification of the encapsulant and payload.
  • step 906 may include filtering, purifying and/or separating particles from the solubilizing agent.
  • the method 900 may include adding anti- Page 139 of 315 11645787v1 Docket No.: 2017299-0086 caking or flow-aid agents after the separation and/or drying process(es).
  • the method 900 may include collecting particles and mixing (e.g., until uniform powder is achieved) and/or collecting individual food compositions.
  • the method 900 may include characterizing particles or food compositions via size analysis, shape analysis, release profile, water activity, etc.
  • food composition(s) are prepared in matrix preparation using the procedure described below. Gelatin (10 g) is suspended in 100 mL of stirring deionized water and the suspension is heated to 65 oC. Following complete solubilization of the gelatin at elevated temperature, 2 g of whey protein isolate powder are added and allowed to dissolve for 5 minutes. The resulting clear solution is poured into a polypropylene mold and allowed to cool for 1 hour at 20 oC.
  • Example 8 Exemplary dissolution protocol [0606] This example describes one non-limiting process of assessing the release (e.g., controlled release) of one or more food component(s) from one or more dissolution solvent(s).
  • a schematic of an exemplary dissolution procedure, method, or protocol 1000 is presented in FIG. 10.
  • the method 1000 may include warming an exemplary amount of dissolution media to a desired temperature.
  • the method 1000 may include adding an exemplary food or beverage composition to the dissolution media.
  • the method 1000 may include initiating dissolution assay with one or more desired conditions (e.g., via mixing, temperature, pH, etc.).
  • the method 1000 may include collecting dissolution media and/or a percentage of dissolution media at various time points.
  • the method 1000 may include performing analytical assays (e.g., quantification of payload and/or encapsulant via HPLC, UV-vis, spectroscopy, etc.) to determine release or dissolution characteristics.
  • a food composition characterized as a core-shell preparation e.g., Zein-coated amylose encapsulating sucrose
  • a core-shell preparation e.g., Zein-coated amylose encapsulating sucrose
  • an aqueous dissolution solvent e.g., 10 mM phosphate buffered saline, pH 7.4
  • 12 mL of 10 mM phosphate buffered saline are added to a polypropylene 15 mL centrifuge tube and allowed to equilibrate for 30 min while rotating at 10 rpm on a laboratory rotator.
  • Exemplary core-shell preparations comprising Zein, sucrose, and amylose (500 mg) are added to the rotating tube.100 ⁇ L aliquots are sampled at time points of 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, and 60 minutes following addition of core-shell preparations and stored in 1.5 mL centrifuge tubes. The concentration of sucrose in collected aliquots is assayed using an enzymatic electrochemical method. Sucrose concentration, mass, and percent release is plotted with respect to incubation period to construct a release profile. I.
  • Example 9 Exemplary controlled release profiles
  • one or more food and/or beverage composition(s) is characterized by controlled release of one or more food component(s). Selection of release profile, as described herein, is intended to confer a benefit (as described herein) one or more animal(s). The following example depicts anticipated (e.g., theoretical) non-limiting release profiles exhibited by one or more food composition(s).
  • the release of one or more food component(s) is characterized as a single bolus release, as measured by concentration present in one or more dissolution solvent(s) over time, as shown in FIG.11A.
  • the release of one or more food component(s) is characterized as release with constant rate, as measured by concentration present in one or more dissolution solvent(s) over time, as shown in FIG.11B.
  • the release of one or more food component(s) is characterized as multiple bolus dose (e.g., pulsatile) release, as measured by concentration present in one or more dissolution solvent(s) over time, as shown in FIG.11C.
  • the release of one or more food component(s) is characterized as a combination of multiple bolus dose and constant release rate, as measured by concentration present in one or more dissolution solvent(s) over time, as shown in FIG.11D.
  • Example 10 Exemplary controlled release profile from a food composition
  • sucrose-containing food composition(s) 500 mg
  • Zein 100 mM phosphate buffered saline solution
  • the centrifuge tube was allowed to rotate at 10 rpm at 20 oC, and 100 ⁇ L samples were collected every 15 minutes.
  • sucrose Release of sucrose was quantified by a dual enzymatic electrochemical assay, first converting sucrose to glucose using Invertase from Yeast, followed by application to a glucometer. As shown in FIG.12, the Zein coated sucrose particle preparations exhibited slower ( ⁇ 50 mg/dL) release of sucrose over 15 minutes relative to uncoated sucrose particle preparations (>150 mg/dL) over 15 minutes.
  • sucrose-containing food composition(s) 500 mg coated with, on a dry weight basis, 77% Zein (e.g., protein component), 21% Glycerol Monostearate (e.g., fat component), and 2% propylene glycol (e.g., excipient component) were added to a 15 mL conical centrifuge tube filled (12 mL) with 10 mM phosphate buffered saline solution. The centrifuge tube was allowed to rotate at 10 rpm at 20 oC and 100 ⁇ L samples were collected every 15 minutes.
  • Zein e.g., protein component
  • Glycerol Monostearate e.g., fat component
  • propylene glycol e.g., excipient component
  • sucrose Release of sucrose was quantified by a dual enzymatic electrochemical assay, first converting sucrose to glucose using Invertase from Yeast, followed by application to a glucometer. As shown in FIG.13A, the coated sucrose particle preparations exhibited slower ( ⁇ 50%) release of sucrose over 30 minutes relative to uncoated sucrose particle preparations (>90% in 10 minutes). Additionally, examination of release rate, shown in FIG. 13B, indicates that uncoated particle preparations exhibit bolus release while coated particle preparations exhibit constant sucrose release.
  • whey protein-containing food composition(s) (2 cm 3 ) coated with cellulose acetate phthalate were added to a 15 mL conical centrifuge tube filled (12 mL) with simulated intestinal fluid (SIF) at pH 6.8. The centrifuge tube was allowed to rotate at 10 rpm at 20 oC and 100 ⁇ L samples were collected at 5, 10, 15, 30, 45, 60, and 90 minutes. Release of protein (e.g., whey protein and Zein) was quantified by BCA assay at each time point to construct a release profile.
  • SIF simulated intestinal fluid
  • FIG.15A demonstrates that food compositions herein provided do not gain moisture content, even when exposed to controlled relative humidity of 33%, 53%, or 75% for 4 days.
  • Unformulated food e.g., dehydrated milk powder
  • FIG.15B reveals that formulated food compositions exhibit a smaller increase in water activity as compared to un-encapsulated food.
  • Example 12 Incorporation of food composition(s) into food and/or beverage products [0616] This example illustrates homogeneous mixtures of disclosed food composition(s) within food and/or beverage products (e.g., MRE, nutritional beverage, water) as demonstrated in FIGs.16A-D.
  • food and/or beverage products e.g., MRE, nutritional beverage, water
  • beverage compositions e.g., formulated ingestibles
  • other food products such as freeze dried powder, protein powder, solid bars, domestic pet food (pellets), liquid shakes, pudding, etc.
  • Homogenization can be achieved without additional processing aid or improved through addition of processing aid/excipients, through the use of mixing apparatuses such as a homogenizer, stand mixer, paddle blender, stir bar, spatula, etc.
  • size characteristics and/or compositions of certain provided food composition(s) may surprisingly contribute desirable and/or useful attribute(s) to such particles, specifically including, for example, amenability to homogenous combination with other component(s).
  • desirable and/or useful attribute(s) to such particles, specifically including, for example, amenability to homogenous combination with other component(s).
  • FIGs. 16B-D incorporation of alginate beads, gelatin beads, each encapsulating whey protein isolate, and/or sucrose-encapsulating beads into MRE and Ensure is homogeneous and associated with minimal change in visual appearance.
  • incorporation of food composition(s) within one or more food and/or beverage products is associated with structural changes.
  • Example 13 Food compositions exhibiting triggered release
  • Controlled release of one or more food component(s) from a formulated food and/or beverage composition is characterized as triggered release.
  • the following example demonstrates controlled release of one or more food component(s) in response to a trigger.
  • whey protein-containing food composition(s) (2 cm 3 ) coated with cellulose acetate phthalate were added to a 15 mL conical centrifuge tube filled (12 mL) with simulated intestinal fluid (SIF) at pH 6.8 and a 15 mL conical centrifuge tube filled (12 mL) with simulated gastric fluid (SGF) at pH 1.2.
  • the centrifuge tubes were allowed to rotate at 10 rpm at 20 oC and 100 ⁇ L samples were collected at 5, 10, 15, 30, 45, 60, and 90 minutes. Release of protein (e.g., whey protein and zein) was quantified by BCA assay at each time point to construct a release profile.
  • Example 14 One or more food component(s) and/or excipient component(s) establishes a means of controlling the release of one or more food component(s) [0619] As provided herein, one or more food and/or beverage composition(s) is characterized by controlled release of one or more food component(s).
  • one or more food component(s) and/or excipient component(s) establishes a means of controlling the release of one or more food component(s).
  • the release rate of whey protein isolate from one or more food and/or beverage composition(s) comprising one or more food component(s) establishing a means of controlling release is reduced relative to food and/or beverage composition(s) comprising one or more food component(s) not establishing a means of controlling release.
  • the release of one or more food component(s) in one or more release environment(s) is measured to quantify establishment of a means of controlling release.
  • one or more food composition(s) further characterized as matrix preparations comprising 5% (w/v) agarose and 10% (w/v) whey protein isolate exhibit substantial differences in protein release depending on included excipient component(s) (FIG.19A).
  • these exemplary matrix preparations further comprising 2% (w/v) sodium carboxymethylcellulose (white squares) exhibit nearly 75% release of loaded whey protein isolate over 24 hours, while preparations comprising 1% (w/v) Tween 60 (grey squares) or 2% (w/v) poly(acrylic acid) (black squares) exhibit only 60% and 45% release at 24 hours, respectively.
  • Comparisons of release kinetics indicate inclusion of 2% (w/v) poly(acrylic acid) substantially reduces whey protein isolate release rate to ⁇ 0.005 %/min relative to inclusion of 2% (w/v) sodium carboxymethylcellulose (>0.015 %/min) in 3% (w/v) agarose matrix formulations.
  • formulation of whey in matrices comprising different matrix component(s) influences the release of whey, demonstrating that matrix component(s) are a means of controlling whey release.
  • unformulated whey releases rapidly, with nearly 100% dissolution in under 5 minutes while 100% release of whey is prolonged to about 30 minutes when formulated in a matrix Page 145 of 315 11645787v1 Docket No.: 2017299-0086 comprising agarose and hydroxypropyl methylcellulose.
  • formulation of whey protein in either hydrogenated oils, waxes, or oleogels further prolongs whey protein release from 30 minutes to almost 24 hours in the case of a matrix preparation comprising 27-stearine, sitosterol, and oryzanol.
  • a food composition is comprised of one or more macronutrient(s), one or more micronutrient(s), and/or one or more excipient component(s).
  • the provided food composition is comprised of a caloric content suitable for the needs of one or more animal(s) for a 24-hour period.
  • the provided food composition is comprised of one or more of a protein, a carbohydrate, and/or a fat.
  • a provided food composition is comprised of a caloric content of 1500 kcal with 112 g of carbohydrate, 150 g of protein, 50 g of fat, 2.5 ⁇ g of vitamin B12, 15 ⁇ g of vitamin D, 15 mg of vitamin E.
  • a provided food composition is comprised of a caloric content of 2000 kcal with 250 g of carbohydrate, 100 g of protein, 67 g of fat, 2.5 ⁇ g of vitamin B12, 15 ⁇ g of vitamin D, 15 mg of vitamin E.
  • a provided food composition is comprised of a caloric content of 2500 kcal with 250 g of carbohydrate, 125 g of protein, 111 g of fat, 2.5 ⁇ g of vitamin B12, 15 ⁇ g of vitamin D, 15 mg of vitamin E. Therefore, the relative ratios of calories that are derived from carbohydrates vs. proteins vs. fats may vary from one composition to the next. Table 2.
  • Composition Carbohydrates (g) Proteins (g) Fats (g) Calories (kcal) Page 146 of 315 11645787v1 Docket No.: 2017299-0086 1 112 150 50 1500 2 250 100 67 2000 P.
  • Example 16 Encapsulation of carbohydrates [0623]
  • one or more food component(s) characterized as a carbohydrate is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • one or more carbohydrate(s) is or are encapsulated in a core-shell preparation further characterized as a particle preparation.
  • a food composition comprised of a carbohydrate (e.g., a solute component) further characterized as a monosaccharide is embedded within a carbohydrate (e.g., a matrix component) further characterized as a polysaccharide, demonstrating exemplary encapsulation of a carbohydrate.
  • a food composition comprised of a carbohydrate (e.g., a solute component) further characterized as a polysaccharide is embedded within a carbohydrate (e.g., a matrix component) further characterized as a polysaccharide, demonstrating exemplary encapsulation of a carbohydrate.
  • a food composition comprised of an encapsulated carbohydrate is encapsulated by a polymer (e.g., excipient component) (e.g., a core-shell preparation).
  • a food composition comprised of an encapsulated carbohydrate is encapsulated by a protein (e.g., a core-shell preparation).
  • a core- shell preparation is further characterized as a particle preparation.
  • FIG 4 illustrates a comparison between gross morphologies of unencapsulated (FIG 4A) and encapsulated (FIGs 4B-E) carbohydrates.
  • sucrose is dispersed within a wet amylose matrix, the slurry sprayed into cool air to generate particles of controlled diameter.
  • the encapsulation of sucrose within amylose is calculated to be 92%, on a dry weight basis.
  • particles comprising encapsulated sucrose (92% loading, 1 mm diameter) are further coated (e.g., spray pan coating) with a 90% (v/v) solution of Zein with a colorant (e.g., excipient component).
  • a colorant e.g., excipient component
  • Brightfield micrographs reveal increased Page 147 of 315 11645787v1 Docket No.: 2017299-0086 surface roughness and a red coloring, indicative of successful coating.
  • 14 g of glucose is added to 6 mL of a stirring 5% (w/v) pectin solution held at 110 oC and the resulting mixture is stirred for 3 minutes, or until all glucose is dissolved.
  • 1.0 mL of 1 M citric acid in distilled water is added to the stirring mixture, which is further mixed for 15 seconds before pouring into molds coated with loose glucose crystals and setting for 1 hour at 20 oC.
  • inulin from dahlia tubers
  • 100 mg of inulin is dissolved in 5 mL of distilled water and warmed to 60 oC while stirring.5 mL of a 5% (w/v) solution of agarose at 130 oC is added to the stirring mixture, which is further mixed for 15 seconds before pouring into molds and setting for 1 hour at 20 oC.
  • 10 mL of a stirring 20% (w/v) suspension of calcium caseinate is added to 10 mL of a stirring 60 oC mixture of 5% (w/v) solution of sodium alginate and 2% (w/v) inulin (from dahlia tuber).
  • one or more food component(s) characterized as a protein is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • one or more protein(s) is or are encapsulated in a core-shell preparation further characterized as a particle preparation.
  • a food composition comprised of a protein is embedded within a lipid (e.g., a matrix component), demonstrating exemplary encapsulation of a protein.
  • a food composition comprised of a protein is embedded within a carbohydrate (e.g., a matrix component) further characterized as a polysaccharide, demonstrating exemplary encapsulation of a protein.
  • a food composition comprised of an encapsulated protein is encapsulated by a polymer (e.g., excipient component) (e.g., a core-shell preparation).
  • a food composition comprised of an encapsulated protein is encapsulated by a carbohydrate (e.g., a core-shell preparation).
  • a core-shell preparation is further characterized as a particle preparation.
  • FIG 24 illustrates a comparison between gross morphologies of unencapsulated (FIG 24A, whey protein isolate) and encapsulated (FIGs 24B-D, encapsulated) protein.
  • FIG 24B whey protein isolate powder is dispersed at 10000 rpm using a high-shear homogenizer within molten beeswax and the resulting dispersion is poured into a mold to set for 1 hour at 20 oC.
  • whey protein isolate powder is dispersed at 10000 rpm using a high-shear homogenizer within molten hydrogenated soy oil and the resulting dispersion is poured into a mold to set for 1 hour at 20 oC.
  • 5 mL of 5% (w/v) agarose solution at 130 oC is mixed with 5 mL of a solution comprising 20% (w/v) whey protein isolate and 2% (w/v) chitosan) at pH 5 and 60 oC.
  • the resulting mixture is allowed to stir for 15 seconds before pouring into molds and setting for 1 hour at 20 oC.
  • the formulations generated using the methods of manufacture outlined for FIG 24B-D are cohesive particle preparation(s) indicating successful encapsulation.
  • one or more food component(s) characterized as a lipid is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • one or more lipid(s) is or are encapsulated in a core-shell preparation further characterized as a particle preparation.
  • a food composition comprised of a lipid is embedded within a lipid (e.g., a matrix component), demonstrating exemplary encapsulation of a lipid.
  • a food composition comprised of a lipid e.g., a solute component
  • a carbohydrate e.g., a matrix component
  • a polysaccharide demonstrating exemplary encapsulation of a lipid.
  • a food composition comprised of an encapsulated lipid is encapsulated by a polymer (e.g., excipient component) (e.g., a core-shell preparation).
  • a food composition comprised of an encapsulated lipid is encapsulated by a carbohydrate (e.g., a core-shell preparation).
  • a core-shell preparation is further characterized as a particle preparation.
  • FIG 25 illustrates a comparison between gross morphologies of unencapsulated (FIG 25A, oleic acid) and encapsulated (FIGs 25B-E, encapsulated) lipid.
  • FIG 25B 8 mL of oleic acid is heated, while stirring, to 130 oC, followed by the addition of 2.0 g of ethyl cellulose (100 cP). The mixture is kept stirring at 130 oC for 10 minutes, or until all solids are dissolved, and the resulting clear solution is then poured into an aluminum pan to set at 20 oC for 1 hour.
  • FIG 25C 8 mL of oleic acid is heated, while stirring, to 90 oC, followed by the addition of 2.0 g of beeswax. The mixture is kept stirring at 90 oC for 10 minutes, or until all solids are dissolved, and the resulting clear solution is poured into an aluminum pan to set at 20 oC for 1 hour.
  • FIG 25D 6.5 mL of oleic acid is heated, while stirring, to 130 oC, followed by the addition of 1.0 g of carnauba wax and 1.5 g of ethyl cellulose. The mixture is kept stirring at 130 oC for 10 minutes, or until all solids are dissolved, and 1.0 g of whey protein isolate is added.
  • the suspension is poured into an aluminum pan and allowed to set at 20 oC for 1 hour.
  • the resulting waxy solid is then immersed and wrapped in an interfacial thin film comprised of chitosan-polyphosphate and allowed to dry at 50 oC for 6 hours.
  • core component(s) prepared as described in FIG 25D are instead coated by dipping into a 15% (w/v) solution of cellulose acetate phthalate in acetone and drying under air at 40 oC.
  • the formulations generated using the methods of manufacture outlined for FIG 25B-E are solid, cohesive particle preparation(s) indicating successful encapsulation. S.
  • Example 19 Release of carbohydrates from one or more food composition(s) [0632]
  • one or more food component(s) characterized as a carbohydrate is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • the encapsulation of one or more carbohydrate(s) in one or more matrix and/or core-shell preparation(s) is further characterized by the release of encapsulated carbohydrate(s) in one or more release environment(s).
  • the release profile(s), as provided herein, of carbohydrate(s) encapsulated in one or more matrix and/or core-shell preparation(s) illustrate controlled release of carbohydrate(s).
  • one or more food composition(s) comprising carbohydrate(s) further characterized as core-shell preparation(s) and/or matrix preparation(s) provide a means of controlling carbohydrate release.
  • the selection of Page 150 of 315 11645787v1 Docket No.: 2017299-0086 one or more core component(s), shell component(s), and/or matrix component(s) and their relative concentration(s) provide a means of controlling release of carbohydrate(s).
  • exemplary release profile(s) are provided by food composition(s) further characterized as matrix preparation(s), core-shell preparation(s), and/or combinations of matrix and core-shell preparation(s).
  • the release profile(s) provided by one or more food composition(s) changes in different release environment(s).
  • the release profile(s) provided by one or more food composition(s) remains constant in different release environment(s).
  • the release profile(s) provided by one or more food composition(s) illustrated in FIG 26 enable the selection of food composition(s) conferring desirable release profile(s) upon one or more carbohydrates, for example, to reduce meal frequency in one or more mammal(s).
  • one or more food composition(s) providing for 80% release of encapsulated carbohydrate within 30 minutes is or may be advantageous.
  • one or more food composition(s) providing for 80% release of encapsulated carbohydrate within 100 minutes is or may be advantageous.
  • one or more food composition(s) providing for 80% release of encapsulated carbohydrate within 240 minutes is or may be advantageous.
  • the time required to reach 80% (w/w) release of encapsulated carbohydrate(s) can vary from ⁇ 7 minutes to >280 min depending on the concentration(s) and/or identity of one or more core component(s), shell component(s), and/or matrix component(s) comprising one or more food composition(s).
  • a complete list of exemplary food composition(s), their associated core component(s), shell component(s) and/or matrix component(s), their respective concentration(s), and release rates are provided in Appendix 1.
  • the exemplary release profiles provided in FIG 26 aid in the selection of desirable food composition structure (e.g., core-shell preparation, matrix preparation, particle preparation). In some cases, the exemplary release profiles provided in FIG 26 aid in the selection and relative Page 151 of 315 11645787v1 Docket No.: 2017299-0086 concentration(s) of one or more core component(s), shell component(s), and/or matrix component(s). [0636] As shown in FIG 26, the release rate of glucose from one or more exemplary food composition(s) varies substantially by food composition structure (e.g., core-shell preparation, matrix preparation, particle preparation).
  • Core-shell preparations wherein one or more core component(s) further comprise a matrix preparation generally offer slower release kinetics ( ⁇ 0.03 min -1 ) relative to uncoated matrix preparations (> 0.03 min -1 ).
  • T. Example 20 Release of proteins from one or more food composition(s) [0637]
  • one or more food component(s) characterized as a protein is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • the encapsulation of one or more protein(s) in one or more matrix and/or core-shell preparation(s) is further characterized by the release of encapsulated protein(s) in one or more release environment(s).
  • the release profile(s), as provided herein, of protein(s) encapsulated in one or more matrix and/or core-shell preparation(s) illustrate controlled release of protein(s).
  • one or more food composition(s) comprising protein(s) further characterized as core-shell preparation(s) and/or matrix preparation(s) provide a means of controlling protein release.
  • the selection of one or more core component(s), shell component(s), and/or matrix component(s) and their relative concentration(s) provide a means of controlling release of protein(s).
  • exemplary release profile(s) are provided by food composition(s) further characterized as matrix preparation(s), core-shell preparation(s), and/or combinations of matrix and core-shell preparation(s).
  • the release profile(s) provided by one or more food composition(s) changes in different release environment(s).
  • the release profile(s) provided by one or more food composition(s) remains constant in different release environment(s).
  • the release Page 152 of 315 11645787v1 Docket No.: 2017299-0086 profile(s) provided by one or more food composition(s) illustrated in FIG 27 enable the selection of food composition(s) conferring desirable release profile(s) upon one or more carbohydrates, for example, to reduce meal frequency in one or more mammal(s).
  • one or more food composition(s) providing for 80% release of encapsulated protein within 60 minutes is or may be advantageous.
  • one or more food composition(s) providing for 80% release of encapsulated protein within 200 minutes is or may be advantageous.
  • one or more food composition(s) providing for 80% release of encapsulated protein within 1000 minutes is or may be advantageous.
  • the time required to reach 80% (w/w) release of encapsulated protein(s) can vary from ⁇ 30 minutes to >1000 min depending on the concentration(s) and/or identity of one or more core component(s), shell component(s), and/or matrix component(s) comprising one or more food composition(s).
  • a complete list of exemplary food composition(s), their associated core component(s), shell component(s) and/or matrix component(s), their respective concentration(s), and release rates are provided in Appendix 1.
  • the exemplary release profiles provided in FIG 27 aid in the selection of desirable food composition structure (e.g., core-shell preparation, matrix preparation, particle preparation). In some cases, the exemplary release profiles provided in FIG 27 aid in the selection and relative concentration(s) of one or more core component(s), shell component(s), and/or matrix component(s). [0641] As shown in FIG 27, the release rate of protein from one or more exemplary food composition(s) remains consistent regardless of food composition structure (e.g., core-shell preparation, matrix preparation, particle preparation).
  • Core-shell preparations wherein one or more core component(s) further comprise a matrix preparation offer comparable release kinetics (0.002 – 0.02 min -1 ) relative to the majority of exemplary uncoated matrix preparations (0.001 – 0.03 min -1 ).
  • Example 21 Release of lipids from one or more food composition(s) [0642]
  • one or more food component(s) characterized as a lipid is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • the encapsulation of one or more lipid(s) in one or more matrix and/or core-shell preparation(s) is further characterized by the release of encapsulated lipid(s) in one or more release environment(s).
  • the release profile(s), as provided herein, of lipid(s) encapsulated in one or more matrix and/or core-shell preparation(s) illustrate controlled release of lipid(s).
  • one or more food composition(s) comprising lipid(s) further characterized as core-shell preparation(s) and/or matrix preparation(s) provide a means of controlling lipid release.
  • the selection of one or more core component(s), shell component(s), and/or matrix component(s) and their relative concentration(s) provide a means of controlling release of lipid(s).
  • exemplary release profile(s) are provided by food composition(s) further characterized as matrix preparation(s), core-shell preparation(s), and/or combinations of matrix and core-shell preparation(s).
  • the release profile(s) provided by one or more food composition(s) changes in different release environment(s). In some instances, the release profile(s) provided by one or more food composition(s) remains constant in different release environment(s). In certain preferred embodiments, the release profile(s) provided by one or more food composition(s) illustrated in FIG 28 enable the selection of food composition(s) conferring desirable release profile(s) upon one or more carbohydrates, for example, to reduce meal frequency in one or more mammal(s). [0644] In some non-limiting instances, one or more food composition(s) providing for 20% release of encapsulated lipid within 20 minutes is or may be advantageous.
  • one or more food composition(s) providing for 20% release of encapsulated lipid within 200 minutes is or may be advantageous.
  • one or more food composition(s) providing for 20% release of encapsulated lipid within 1000 minutes is or may be advantageous.
  • the time required to reach 20% (w/w) release of encapsulated lipid(s) can vary from ⁇ 30 minutes to >1000 min depending on the concentration(s) Page 154 of 315 11645787v1 Docket No.: 2017299-0086 and/or identity of one or more core component(s), shell component(s), and/or matrix component(s) comprising one or more food composition(s).
  • a complete list of exemplary food composition(s), their associated core component(s), shell component(s) and/or matrix component(s), their respective concentration(s), and release rates are provided in Appendix 1.
  • the exemplary release profiles provided in FIG 28 aid in the selection of desirable food composition structure (e.g., core-shell preparation, matrix preparation, particle preparation).
  • the exemplary release profiles provided in FIG 28 aid in the selection and relative concentration(s) of one or more core component(s), shell component(s), and/or matrix component(s).
  • the release rate of lipid from one or more exemplary food composition(s) characterized as matrix preparation(s) varies depending on selected matrix component(s).
  • one or more food component(s) characterized as a lipid is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • the encapsulation of one or more lipid(s) in one or more matrix and/or core-shell preparation(s) is further characterized by the release of encapsulated lipid(s) in one or more release environment(s).
  • the release profile(s), as provided herein, of lipid(s) encapsulated in one or more matrix and/or core-shell preparation(s) illustrate controlled release of lipid(s).
  • an exemplary lipid encapsulated in provided food composition(s) may be oleic acid.
  • linoleic acid, docosahexaenoic acid, and/or eicosapentaenoic acid may be encapsulated and exhibit controlled release within and from provided food composition(s), respectively.
  • one or more food component(s) characterized as a protein is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • the encapsulation of one or more protein(s) in one or more matrix and/or Page 155 of 315 11645787v1 Docket No.: 2017299-0086 core-shell preparation(s) is further characterized by the release of encapsulated protein(s) in one or more release environment(s).
  • the release profile(s), as provided herein, of protein(s) encapsulated in one or more matrix and/or core-shell preparation(s) illustrate controlled release of protein(s).
  • an exemplary protein encapsulated in provided food composition(s) may be whey protein.
  • gelatin, collagen, casein, oat protein isolate, soy protein isolate, and/or pea protein isolate may be encapsulated and exhibit controlled release within and from provided food composition(s), respectively.
  • one or more food component(s) characterized as a polyphenol is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • the encapsulation of one or more polyphenol(s) in one or more matrix and/or core-shell preparation(s) is further characterized by the release of encapsulated polyphenol(s) in one or more release environment(s).
  • the release profile(s), as provided herein, of polyphenol(s) encapsulated in one or more matrix and/or core- shell preparation(s) illustrate controlled release of polyphenol(s).
  • a food composition comprised of a polyphenol (e.g., a solute component) is embedded within a protein (e.g., a shell component), demonstrating exemplary encapsulation of a polyphenol.
  • FIG 29 illustrates a comparison between gross morphologies of unencapsulated (FIG 29A, cyanidin chloride) and encapsulated (FIG 29C, encapsulated) polyphenol.
  • an ethanol solution (90% (w/v)) of zein is prepared with the addition of 1% (w/w) cyanidin chloride to form a purple solution, the purple solution then applied to a matrix preparation comprising agarose and glucose (FIG 29B) via paint coating.
  • a matrix preparation comprising agarose and glucose (FIG 29B) via paint coating.
  • the formulations generated using the methods of manufacture outlined are solid, cohesive particle preparation(s) with a smooth coating, indicating successful encapsulation.
  • encapsulated polyphenol food composition(s) demonstrate controlled release.
  • FIG 29D illustrates a comparison in flavonoid release from a formulation containing encapsulated cyanidin chloride (3% (w/w) agarose, 1% Page 156 of 315 11645787v1 Docket No.: 2017299-0086 (w/w) glycyrrhetinic acid, 10% (w/w) whey protein isolate, and 20% (w/w) glucose in the core, 42% (w/w) Zein, 56% (w/w) glycerol, and 2% (w/w) cyanidin chloride in the shell) (black triangles) and a formulation containing no cyanidin chloride (3% (w/w) agarose, 1% (w/w) glycyrrhetinic acid, 10% (w/w) whey protein isolate, and 20% (w/w) glucose in the core) (black circles).
  • one or more food component(s) characterized as a carbohydrate is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • the encapsulation of one or more carbohydrate(s) in one or more matrix and/or core-shell preparation(s) is further characterized by the release of encapsulated carbohydrate(s) in one or more release environment(s).
  • the release profile(s), as provided herein, of carbohydrate(s) encapsulated in one or more matrix and/or core-shell preparation(s) illustrate controlled release of carbohydrate(s).
  • an exemplary carbohydrate encapsulated in provided food composition(s) may be glucose.
  • sucrose, tagatose, psicose, and/or isomaltulose may be encapsulated and exhibit controlled release within and from provided food composition(s), respectively.
  • a food composition comprised of inulin (e.g., a solute component) is embedded within a carbohydrate (e.g., a matrix component), demonstrating exemplary encapsulation of a carbohydrate.
  • FIG 30 illustrates a comparison between gross morphologies of unencapsulated (FIG 30A, inulin) and encapsulated (FIG 30B, encapsulated) carbohydrate.
  • an aqueous solution of 10% (w/w) inulin and 20% (w/w) glucose is prepared, followed by the addition of 3% (w/w) agarose powder.
  • encapsulated carbohydrate food composition(s) demonstrate controlled release.
  • FIG 30C illustrates a carbohydrate release from a Page 157 of 315 11645787v1 Docket No.: 2017299-0086 formulation containing encapsulated inulin.
  • inulin releases from the exemplary food composition(s) (5% (w/w) agarose, 0.2% (w/w) locust bean gum, 5% (w/w) calcium caseinate, and 1% (w/w) inulin), reaching 100% release by 24 hours in phosphate buffered saline, pH 7.4.
  • one or more food component(s) characterized as a ketone is or are encapsulated in one or more core-shell preparations and/or matrix preparations.
  • the encapsulation of one or more ketone(s) in one or more matrix and/or core-shell preparation(s) is further characterized by the release of encapsulated ketone(s) in one or more release environment(s).
  • the release profile(s), as provided herein, of ketone(s) encapsulated in one or more matrix and/or core-shell preparation(s) illustrate controlled release of ketone(s).
  • 3-hydroxybutyrate, acetoacetic acid, and/or 3-hydroxybutyl-3-hydroxybutyrate may be encapsulated and exhibit controlled release within and from provided food composition(s), respectively. W.
  • Example 23 Cross-sectional morphology of one or more food composition(s)
  • one or more food composition(s) is further characterized as matrix preparation(s) and/or core-shell preparation(s).
  • microscopy is useful to illustrate the micro-scale morphology of one or more matrix preparation(s) and/or core-shell preparation(s).
  • microscopy is or may be useful to quantify and/or qualify gross characteristics, surface characteristics, and/or cross-sectional characteristics of one or more food composition(s).
  • quantification and/or qualification of gross characteristics is or may refer to shape, morphology, and/or diameter of one or more particle preparation(s).
  • quantification and/or qualification of surface characteristics is or may refer to color, texture, and/or extent of surface coating of one or more particle preparation(s).
  • quantification and/or qualification of cross-sectional characteristics is or may refer to coating thickness, spatial arrangement, homogeneity, and/or porosity of one or more particle preparation(s).
  • the spatial arrangement, coating thickness, and extent of surface coating of a core-shell preparation comprising sucrose, amylose, and Zein are clearly illustrated in the micrograph of FIG 31A.
  • the porosity of a matrix preparation comprising inulin and alginate is clearly illustrated in the micrograph of FIG 31B.
  • the color, homogeneity, and lack of porosity of a matrix preparation comprising inulin and agarose are clearly illustrated in the micrograph of FIG 31C.
  • a core-shell preparation comprising a core component further characterized as a matrix of glucose, agarose, and inulin, coated with a shell component of cellulose acetate phthalate are clearly illustrated in the micrograph of FIG 31D.
  • the spatial arrangement, color, extent of coating, and coating thickness of a core-shell preparation comprising a core component further characterized as a matrix of whey protein isolate and fully hydrogenated soy oil, coated with a shell component of cellulose acetate phthalate are clearly illustrated in the micrograph of FIG 31E.
  • the color, homogeneity, and lack of porosity of a matrix formulation comprising whey protein isolate and beeswax are clearly illustrated in the micrograph of FIG 31F.
  • the spatial arrangement, extent of coating, and coating thickness of a core-shell preparation comprising a core component further characterized as a matrix of whey protein isolate and agarose, coated with a shell component of cellulose acetate phthalate are clearly illustrated in the micrograph of FIG 31G.
  • the color and homogeneity of a matrix preparation comprising oleic acid and ethyl cellulose are clearly illustrated in the micrograph of FIG 31H.
  • the color and homogeneity of a matrix preparation comprising oleic acid and carnauba wax are clearly illustrated in the micrograph of FIG 31I.
  • the color, homogeneity, lack of porosity, spatial arrangement, extent of coating, and coating thickness of a core-shell preparation comprising a core component further characterized as a matrix preparation comprising whey protein isolate, oleic acid, ethyl cellulose, and carnauba wax encapsulated in a shell component of cellulose acetate phthalate are clearly illustrated in the micrograph of FIG 31J.
  • Example 24 Exemplary coating formulation protocols [0661] This example describes two non-limiting processes of arranging one or more food component(s) as a shell component to one or more food component(s) characterized as a core component via spray pan coating and/or fluidized bed spray coating.
  • a schematic of an Page 159 of 315 11645787v1 Docket No.: 2017299-0086 exemplary coating procedure, method, or protocol 800 is presented in FIG 32.
  • the method 800 may include solubilizing an exemplary amount of encapsulant via melting or solvent-solubilization.
  • the method 800 may include adding an exemplary nutrient payload to pan coater or fluidized bed coater or other coater.
  • the method 800 may include applying fluidization or mixing or rotation of the payload in the pan coater or fluidized bed coater.
  • the method 800 may include applying spraying or coating or administration or atomization of the melted or solubilized encapsulant to the mixed, rotated and/or fluidized payload.
  • the method 800 may include adding anti-caking or flow- aid agents before, during and/or after the coating process.
  • the method 800 may include collecting the coated particles and thoroughly mixing (e.g., until uniform powder is achieved).
  • the method 800 may include characterizing the coated particles via size analysis, shape analysis, release profile, water activity, etc.
  • food composition(s) are prepared in core-shell preparations using the procedure described below.
  • Particle preparations comprising sucrose encapsulated in amylose (10 g) are coated using a spray pan coater with an inlet air temperature of 80 oC, pan temperature of 70 oC, rotation speed of 2 Hz, and spray rate of 0.5 mL/s.
  • a 10% (w/v) ethanolic (90% ethanol) solution of Zein with 1% (v/v) Propylene Glycol and 0.5% (w/v) Talc powder is applied as a thin film over 5 minutes to the encapsulated sucrose.
  • the volume- normalized weight gain due to coating is 120%.
  • the concentration of formulated food product in this embodiment, on a dry weight basis, is 100% (w/w).
  • Whey protein isolate powder 100 g is coated using a fluidized bed spray coater (Glatt) with a 67 oC inlet temperature, 45 oC outlet temperature, a spray rate of 3 g/min, and a flow rate of 25 mL/min.
  • Glatt fluidized bed spray coater
  • a 20% (w/v) aqueous suspension of ethyl cellulose is applied as a thin film over 5 min to the fluidized whey protein powder.
  • the volume-normalized weight gain due to coating is 110%.
  • the concentration of formulated food product in this embodiment is 100% (w/w). Y.
  • Example 25 Core-shell preparation(s) as a means of controlling the release of one or more food component(s) [0664]
  • the spatial arrangement of one or more food component(s) establishes a means of controlling the release of one or more food component(s).
  • the spatial arrangement of one or more food component(s) comprising one or more food composition(s) is further characterized as a matrix preparation and/or a core- shell preparation.
  • the spatial arrangement of one or more food composition(s) further characterized as a core-shell preparation establishes a means of controlling the release of one or more food component(s) from one or more food composition(s).
  • a food composition comprised of a monosaccharide (e.g., sucrose) is embedded within a polysaccharide (e.g., amylose), further characterized as a matrix preparation.
  • This matrix preparation is subsequently coated with a solution of 10% (w/v) Zein, 1.5% (w/v) propylene glycol, and 2% (w/v) glycerol monostearate in a 90% (v/v) ethanolic solution using the methodology outlined in Example 9.
  • the applied shell component(s) comprising Zein depicted in FIG 33B, confer water-resistance towards one or more food composition(s) and reduce release.
  • a food composition comprised of a protein (e.g., whey protein isolate, FIG 33D) is encapsulated within a polysaccharide (e.g., chitosan polyphosphate), further characterized as a core-shell preparation (FIG 33E).
  • a protein e.g., whey protein isolate, FIG 33D
  • a polysaccharide e.g., chitosan polyphosphate
  • a 1.25% (w/v) chitosan solution is prepared in 1% acetic acid in distilled water, followed by the addition of 10% (w/v) whey protein isolate.
  • the resulting viscous solution is added dropwise to a 30% (w/v) solution of sodium hexametaphosphate at room temperature; formed particles are allowed to cross-link for 10 minutes and separated from the aqueous medium by filtration.
  • the gelatinous chitosan polyphosphate particles comprising whey protein isolate are subsequently dried at 50 oC for 4 hours to yield hard, spherical particles (FIG 33E).
  • a shell component comprising chitosan polyphosphate exhibits slower release of encapsulated whey protein isolate in simulated gastric fluid (filled circles) vs simulated intestinal fluid (filled squares).
  • food composition(s) comprised of a protein e.g., whey protein isolate, FIG 33D
  • a polysaccharide e.g., Page 161 of 315 11645787v1 Docket No.: 2017299-0086 agarose
  • a 20% (w/v) aqueous solution of the exemplary protein at 50 oC is added an equal portion of 6% (w/v) agarose solution at 75 oC.
  • the mixture is briefly homogenized at 50 oC before pouring into a mold.
  • the gelatinous formulation is coated using an ethanolic solution of Zein with additives (e.g., chitosan, poly(vinyl acetate), citric acid esters of diglycerides) as provided in Example 9, thus demonstrating encapsulation of a protein within a protein, a carbohydrate, and/or a polymer.
  • additives e.g., chitosan, poly(vinyl acetate), citric acid esters of diglycerides
  • the result core-shell preparation(s) delay the release of whey protein relative to uncoated whey/agarose matrix preparation(s) (dark grey).
  • food composition(s) comprised of a protein e.g., whey protein isolate, FIG 33D
  • a polysaccharide e.g., agarose
  • Example 26 Exemplary matrix formulation protocol [0669] This example describes two non-limiting processes of arranging one or more food component(s) as a matrix component to one or more food component(s) characterized as a solute component via melt-gelation.
  • a schematic of an exemplary matrix formulation procedure, method, or protocol 900 is presented in FIG 34.
  • the method 900 may include solubilizing an exemplary amount of encapsulant and payload via melting or solvent- solubilization.
  • the method 900 may include mixing melted or solubilized encapsulant or payload together under agitation or mixing or static conditions.
  • the method 900 may include removing the solubilizing agent (e.g., drying, lyophilization, etc.) or decreasing the temperature to initiate solidification of the encapsulant and payload.
  • step 906 may include filtering, purifying and/or separating particles from the solubilizing agent.
  • the method 900 may include adding anti- caking or flow-aid agents after the separation and/or drying process(es).
  • the method 900 may include collecting particles and mixing (e.g., until uniform powder is achieved) and/or collecting individual food compositions.
  • the method 900 may include Page 162 of 315 11645787v1 Docket No.: 2017299-0086 characterizing particles or food compositions via size analysis, shape analysis, release profile, water activity, etc.
  • food composition(s) are prepared in matrix preparation using the procedure described below. Gelatin (10 g) is suspended in 100 mL of stirring deionized water and the suspension is heated to 65 oC. Following complete solubilization of the gelatin at elevated temperature, 2 g of whey protein isolate powder are added and allowed to dissolve for 5 minutes.
  • Example 27 Matrix preparation(s) as a means of controlling the release of one or more food component(s) [0671] In certain embodiments, the spatial arrangement of one or more food component(s) establishes a means of controlling the release of one or more food component(s).
  • the spatial arrangement of one or more food component(s) comprising one or more food composition(s) is further characterized as a matrix preparation and/or a core- shell preparation.
  • the spatial arrangement of one or more food composition(s) further characterized as a matrix preparation establishes a means of controlling the release of one or more food component(s) from one or more food composition(s).
  • one or more food composition(s) characterized as matrix preparation(s) is or are prepared by encapsulating whey protein isolate (FIG 35A) within carbohydrate and/or lipid matrix component(s) (FIGs 14B-D).
  • the matrix preparation illustrated in FIG 35B comprises 70% (w/v) oleic acid, 20% (w/v) ethyl cellulose, and 10% (w/v) whey protein isolate, wherein, without wishing to be bound by any particular theory, the hydrophobic matrix preparation reduces solubilization of the entrapped whey protein isolate. As shown in FIG 35B, ⁇ 15% of loaded whey protein isolate is released after a 4-hour dissolution period.
  • the matrix preparation illustrated in FIG 35C comprises 1.9% (w/v) chitosan, 10% (w/v) whey, and 1% (w/v) genipin, wherein, without wishing to be bound by any particular theory, chemical crosslinking of whey protein isolate to chitosan reduces solubilization of the entrapped whey protein isolate.
  • Page 163 of 315 11645787v1 Docket No.: 2017299-0086 ⁇ 40% of loaded whey protein isolate is released after a 4-hour dissolution period.
  • the matrix preparation illustrated in FIG 35D comprises 3% (w/v) agarose, 1% (w/v) chitosan, and 10% (w/v) whey protein isolate wherein, without wishing to be bound by any particular theory, a combination of agarose porosity and charge interactions with chitosan reduces solubilization of the entrapped whey protein isolate. As shown in FIG 35D, ⁇ 50% of loaded whey protein isolate is released after a 4-hour dissolution period. BB.
  • Example 28 Exemplary combination matrix and core-shell preparations [0673]
  • one or more food composition(s) are characterized as one or more of a core-shell preparation, matrix preparation, and/or particle preparation.
  • one or more food composition(s) are characterized as a core-shell preparation and a matrix preparation.
  • a food composition is comprised of a matrix preparation, further characterized as a core component, coated with one or more shell components.
  • one or more core component(s) is comprised of, on a dry weight basis, at least 90% of one or more food component(s) and/or one or more shell component(s).
  • one or more core component(s) comprising oleic acid, ethyl cellulose, carnauba wax, and whey protein isolate (FIG 36A) is coated 4 times with a 15% (w/v) solution of cellulose acetate phthalate in acetone.
  • the resulting exemplary core-shell preparation exhibits a smooth, reflective, and non-tacky surface indicative of complete and successful coating.
  • one or more core component(s) comprising glucose and pectin (FIG 36B) is coated 4 times with a 15% (w/v) solution of cellulose acetate phthalate in acetone.
  • Example 29 Exemplary dissolution protocol [0677] This example describes one non-limiting process of assessing the release (e.g., controlled release) of one or more food component(s) from one or more dissolution solvent(s).
  • a schematic of an exemplary dissolution procedure, method, or protocol 1000 is presented in FIG Page 164 of 315 11645787v1 Docket No.: 2017299-0086 37.
  • the method 1000 may include warming an exemplary amount of dissolution media to a desired temperature.
  • the method 1000 may include adding an exemplary food or beverage composition to the dissolution media.
  • the method 1000 may include initiating dissolution assay with one or more desired conditions (e.g., via mixing, temperature, pH, etc.).
  • the method 1000 may include collecting dissolution media and/or a percentage of dissolution media at various time points.
  • the method 1000 may include performing analytical assays (e.g., quantification of payload and/or encapsulant via HPLC, UV-vis, spectroscopy, etc.) to determine release or dissolution characteristics.
  • a food composition characterized as a core-shell preparation e.g., Zein-coated amylose encapsulating sucrose
  • an aqueous dissolution solvent e.g., 10 mM phosphate buffered saline, pH 7.4
  • 12 mL of 10 mM phosphate buffered saline are added to a polypropylene 15 mL centrifuge tube and allowed to equilibrate for 30 min while rotating at 10 rpm on a laboratory rotator.
  • Exemplary core-shell preparations comprising Zein, sucrose, and amylose (500 mg) are added to the rotating tube.100 ⁇ L aliquots are sampled at time points of 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, and 60 minutes following addition of core-shell preparations and stored in 1.5 mL centrifuge tubes. The concentration of sucrose in collected aliquots is assayed using an enzymatic electrochemical method. Sucrose concentration, mass, and percent release is plotted with respect to incubation period to construct a release profile. DD.
  • Example 30 Release of food component(s) in one or more release environment(s) [0679]
  • one or more food component(s) are released from one or more food composition(s) in one or more release environment(s).
  • one or more release environment(s) provides similar pH, ionic strength, solubilizers, and/or chemical components as in one or more biological compartment(s).
  • the release of one or more food component(s) from one or more food composition(s) in one or more release environment(s) predicts the release of one or more food component(s) from one or more food composition(s) in one or more biological compartment(s).
  • the release of glucose from one or more food composition(s) is measured in 10 mM phosphate buffered saline solution at pH 7.4 with 1% (w/v) hydroxypropyl methylcellulose over a 60-minute period (FIG 38A).
  • the release of whey protein isolate from one or more food composition(s) is measured in 10 mM phosphate buffered saline at pH 7.4 over a 240-minute period (FIG 38B).
  • the release of whey protein isolate from one or more food composition(s) is measured in simulated intestinal fluid (i.e., SIF) and simulated gastric fluid (i.e., SGF) over a 240-minute period (FIG 38C).
  • SIF simulated intestinal fluid
  • SGF simulated gastric fluid
  • Example 31 Exemplary control of release of one or more food component(s) by one or more pH-responsive polymer(s).
  • the spatial arrangement of one or more food component(s) in one or more food composition(s) establishes a means of controlling the release of one or more food component(s).
  • the spatial arrangement of one or more food composition(s) is further characterized as a core-shell preparation.
  • the shell component(s) of one or more core-shell preparation(s) establishes a means of controlling the release of one or more food component(s).
  • the shell component(s) of one or more core-shell preparation(s) are further comprised of pH-responsive polymer(s).
  • one or more pH-responsive polymer(s) comprising the shell component(s) of one or more non-limiting core-shell preparation(s) provide for increased and/or decreased release of one or more food component(s) in response to the pH of one or more release environment(s).
  • one or more pH-responsive polymer(s) may increase the release of one or more food component(s) in simulated intestinal fluid and/or simulated gastric fluid.
  • one or more pH-responsive polymer(s) may decrease the release of one or more food component(s) in simulated intestinal fluid and/or simulated gastric fluid.
  • one or more food composition(s) further characterized as a core-shell preparation wherein the shell component(s) comprise cellulose acetate phthalate exhibit responsiveness, and concomitant whey protein isolate release, to the pH of simulated intestinal fluid (FIG 39A).
  • one or more food composition(s) further characterized as a core-shell preparation wherein the shell component(s) comprise cellulose acetate phthalate exhibit resistance, and concomitant reduction of whey protein isolate release, to the pH of simulated gastric fluid (FIG 39B).
  • FF concomitant reduction of whey protein isolate release
  • Example 32 Theoretical release profiles provided by exemplary food and/or beverage composition(s).
  • one or more food and/or beverage composition(s) is characterized by controlled release of one or more food component(s). Selection of release profile, as described herein, is intended to confer a benefit (as described herein) one or more animal(s).
  • the following example depicts anticipated (e.g., theoretical) non-limiting release profiles exhibited by one or more food composition(s).
  • the release of one or more food component(s) is characterized as a single bolus release, as measured by concentration present in one or more dissolution solvent(s) over time, as shown in FIG 40A.
  • the release of one or more food component(s) is characterized as release with constant rate, as measured by concentration present in one or more dissolution solvent(s) over time, as shown in FIG 40B.
  • the release of one or more food component(s) is characterized as multiple bolus dose (e.g., pulsatile) release, as measured by concentration present in one or more dissolution solvent(s) over time, as shown in FIG 40C.
  • the release of one or more food component(s) is characterized as a combination of multiple bolus dose and constant release rate, as measured by concentration present in one or more dissolution solvent(s) over time, as shown in FIG 40D. GG.
  • Example 33 One or more food component(s) and/or excipient component(s) establishes a means of controlling the release of one or more food component(s) [0687]
  • the present disclosure provides one or more means of controlling the release of one or more food component(s) from one or more food composition(s).
  • the spatial arrangement of one or more food component(s) provides one or Page 167 of 315 11645787v1 Docket No.: 2017299-0086 more means of controlling the release of one or more food component(s) from one or more food composition(s).
  • one or more food composition(s) further characterized as matrix preparations comprising 5% (w/v) agarose and 10% (w/v) whey protein isolate exhibit substantial differences in protein release depending on included excipient component(s) (FIG 41A).
  • matrix preparations further comprising 2% (w/v) sodium carboxymethylcellulose (white squares) exhibit nearly 75% release of loaded whey protein isolate over 24 hours, while preparations comprising 1% (w/v) Tween 60 (grey squares) or 2% (w/v) poly(acrylic acid) (black squares) exhibit only 60% and 45% release at 24 hours, respectively.
  • one or more food composition(s) further characterized as matrix preparations comprising candelilla wax, gelucire 50/13 and whey protein isolate exhibit substantial differences in protein release depending on the selected concentration(s) of food component(s) (FIG 42).
  • these exemplary matrix preparations further comprising 75% (w/v) candelilla wax (white circles) exhibit nearly 100% release of loaded whey protein isolate over 24 hours, while preparations comprising 85% (w/v) (grey circles) or 80% (w/v) candelilla wax (black circles) exhibit only 80% and 45% release at 24 hours, respectively.
  • This example demonstrates the importance of food component(s) concentration in tuning the controlled release of one or more food component(s) from one or more food composition(s).
  • one or more food composition(s) further characterized as matrix preparations exhibit substantial differences in protein release depending on the selected matrix component(s) (FIG 43).
  • these exemplary matrix preparations further comprising an agarose-based matrix exhibit nearly 100% release of loaded whey protein isolate over 240 minutes, while matrix preparations comprising lipid and surfactant (grey triangles) or oleogels (black triangles) exhibit only 80% and 45% release at 24 hours, respectively.
  • This example demonstrates the importance of selecting food component(s) as matrix component(s) in tuning the controlled release of one or more food Page 168 of 315 11645787v1 Docket No.: 2017299-0086 component(s) from one or more food composition(s) further characterized as a matrix preparation.
  • HH is demonstrating the importance of selecting food component(s) as matrix component(s) in tuning the controlled release of one or more food Page 168 of 315 11645787v1 Docket No.: 2017299-0086 component(s) from one or more food composition(s) further characterized as a matrix preparation.
  • Example 34 Food compositions exhibiting low water activity and moisture content
  • the presence of water and/or water activity is a common factor underlying instability in one or more food and/or beverage composition(s).
  • the following example illustrates the ability of one or more food components in the provided food compositions to retain integrity in high-moisture conditions, resist water uptake, and thereby mitigate instability of the food component(s) included therein.
  • FIG 44A demonstrates that food compositions herein provided do not gain moisture content, even when exposed to controlled relative humidity of 33%, 53%, or 75% for 4 days.
  • Unformulated food e.g., dehydrated milk powder
  • FIG 44B reveals that formulated food compositions exhibit a smaller increase in water activity as compared to un-encapsulated food. For example, even when the initial level of water activity is higher, as shown in FIG 44B, the encapsulated food compositions demonstrate a lower level of water activity increase when exposed to increasing amounts of humidity. As such, even when exposed to 75% relative humidity, the water activity of the exemplary food compositions demonstrate lower water activity levels than un-encapsulated food, II.
  • Example 35 Incorporation of food composition(s) into food and/or beverage products
  • non-limiting exemplary embodiments of food and beverage compositions can be homogeneously mixed with other food products such as freeze dried powder, protein powder, solid bars, domestic pet food (pellets), liquid shakes, pudding, etc. Homogenization can be achieved without additional processing aid or improved through addition of processing aid/excipients, through the use of mixing apparatuses such as a homogenizer, stand mixer, paddle blender, stir bar, spatula, etc.
  • size Page 169 of 315 11645787v1 Docket No.: 2017299-0086 characteristics and/or compositions of certain provided food composition(s) may surprisingly contribute desirable and/or useful attribute(s) to such particles, specifically including, for example, amenability to homogenous combination with other component(s).
  • incorporation of alginate beads, gelatin beads, each encapsulating whey protein isolate, and/or sucrose-encapsulating beads into MRE and Ensure is homogeneous and associated with minimal change in visual appearance.
  • incorporation of food composition(s) within one or more food and/or beverage products is associated with structural changes.
  • FIGs 24A-D food composition(s) are shown to change morphology over a 1-hour incubation period, with gelatin and alginate beads exhibiting expansion and sucrose-encapsulating beads exhibiting dissolution.
  • Example 36 Exemplary protocol for matrix preparation(s) comprising one or more fat(s), protein(s) and excipient component(s) [0694]
  • matrix preparation(s) comprising one or more fat(s), one or more protein(s), and/or one or more excipient component(s).
  • Example 37 Exemplary protocol for matrix preparation(s) comprising one or more fat(s), protein(s), and excipient component(s) [0696] The following non-limiting example describes the preparation of provided food composition(s) further characterized as matrix preparation(s) comprising one or more fat(s), one or more protein(s), and/or one or more excipient component(s).
  • Example 38 Exemplary protocol for extrusion of one or more food composition(s)
  • the following non-limiting example describes the preparation of provided food composition(s) by a method of extrusion.
  • 7.5 g of carnauba wax, 1.5 g of soy lecithin, and 1.0 g of whey protein isolate powders were pre-mixed by manual shaking in a 50 mL centrifuge tube.
  • the mixed contents were extruded using a ThermoFisher MiniLab3 held at 72oC, 30 RPM. All contents were pneumatically loaded into the extruder which exited through a small, rectangular die. Bypass was set to OFF to ensure no circulation of the included formulation around the extruder channel. Extruded formulations were collected on a small metal ramp for rapid cooling and allowed to cool for 15 minutes at 20 oC until further processing. Formulations were segmented into approximately 0.5” (1.26 cm) particles and stored for future dissolution analysis. MM.
  • Example 39 Exemplary protocol for matrix preparation(s) comprising one or more carbohydrate(s), protein(s), and excipient component(s)
  • the following non-limiting example describes the preparation of provided food composition(s) further characterized as matrix preparation(s) comprising one or more carbohydrate(s), one or more protein(s), and/or one or more excipient component(s).
  • 50 mL of a 6% (w/v) agarose suspension is heated to 130 oC in a 100 mL glass beaker stirring at 300 rpm.
  • Example 40 Exemplary protocol for matrix preparation(s) comprising one or more carbohydrate(s)
  • the following non-limiting example describes the preparation of provided food composition(s) further characterized as matrix preparation(s) comprising one or more carbohydrate(s).
  • 50 mL of a 5% (w/v) pectin suspension is heated to 150 oC in a 100 mL glass beaker stirring at 300 rpm.6 mL of the stirring, heated pectin solution is transferred to a 150 mL glass beaker, followed by the addition of 14 g of glucose.
  • the added solids are solubilized, yielding a clear solution.
  • Example 41 Exemplary protocol for quantification of release of protein(s) from one or more food composition(s).
  • Tubes filled with 12 mL of 10 mM phosphate buffered saline (PBS), pH were added to a rotating incubator set at 37 oC. An initial 100 ⁇ L sample was collected from each tube and transferred into a 96 well polypropylene plate.
  • PBS phosphate buffered saline
  • each 500 mg sample was placed into its corresponding tube and the timer was promptly started.100 ⁇ L samples were collected from the warmed, rotating tubes at subsequent timepoints of 5, 15, 30, 60, 90, 120, and 240 minutes.
  • a BCA reagent mixture was prepared with reagent A (23228, Thermo Scientific Pierce, Waltham, MA) and reagent B (23224, Thermo Scientific Pierce, Waltham, MA) in a 50:1 ratio.25 ⁇ L of each sample or standard was pipetted into a 96 well polystyrene plate followed by addition of 200 ⁇ L of BCA reagent mixture. The plate was then incubated for 25 minutes at 37 oC followed by measurement of absorbance at 567 nm.
  • Example 42 Exemplary protocol for quantification of release of protein(s) from one or more food composition(s).
  • Tubes filled with 12 mL of 10 mM phosphate buffered saline (PBS), pH were added to a rotating incubator set at 37 oC.
  • An initial 100 ⁇ L sample was collected from each tube and transferred into a 96 well polypropylene plate. Then, each 500 mg sample was placed into its corresponding tube and the timer was promptly started.100 ⁇ L samples were collected from the warmed, rotating tubes at subsequent timepoints of 5, 15, 30, 60, 90, 120, and 240 minutes.
  • a BCA reagent mixture was prepared with reagent A (23228, Thermo Scientific Pierce, Waltham, MA) and reagent B (23224, Thermo Scientific Pierce, Waltham, MA) in a 50:1 ratio.25 ⁇ L of each sample or standard was pipetted into a 96 well polystyrene plate followed by addition of 200 ⁇ L of BCA reagent mixture. The plate was then incubated for 25 minutes at 37 oC followed by measurement of absorbance at 567 nm. QQ.
  • Example 43 Exemplary protocol for quantification of release of carbohydrate(s) from one or more food composition(s).
  • Tubes filled with 12 mL of 10 mM phosphate buffered saline (PBS), pH were added to a rotating incubator set at 37 oC.
  • An initial 100 ⁇ L sample was collected from each tube and transferred into a 96 well polypropylene plate. Then, each 500 mg sample was placed into its corresponding tube and the timer was promptly started.100 ⁇ L samples were collected from the warmed, rotating tubes at subsequent timepoints of 5, 15, 30, 60, 90, 120, and 240 minutes.
  • PBS phosphate buffered saline
  • An Amplex Red reagent mixture was prepared by mixing 4.75 mL of 50 mM phosphate buffer pH 7.4, 100 ⁇ L of 10 U/mL horseradish peroxidase, 100 ⁇ L of 100 U/mL glucose oxidase, and 50 ⁇ L of 2.5 mg/mL Amplex Red in DMSO.50 ⁇ L of each sample or standard was pipetted into a 96 well polystyrene plate followed by addition of 50 ⁇ L of Amplex Red reagent mixture. The plate was then incubated for 25 minutes at 37 oC followed by measurement of fluorescence with excitation of 565 nm and emission of 590 nm. RR.
  • Example 44 Exemplary formulations [0707]
  • Non-limiting exemplary embodiments in accordance with the present disclosure e.g., exemplary formulations, e.g., exemplary compositions
  • Table 3 Exemplary Formulations Page 173 of 315 11645787v1 Docket No.: 2017299-0086 Formulation F ormulation ID Manufacturing Manufacturing Component Component Entry Technique 1 Technique 2 Abbreviation Component Name wt% 27STE- 27STE 27-Stearin 4000% 11645787v1 Docket No.: 2017299-0086 27STE-EC:100- ACETEM- Hot Melt High ACETEM Acetic acid esters of mono- a nd diglycerides 2.00% WPI 300-180- Shear EC:100 Ethyl Cellulose 100 cP 1800% 11645787v1 Docket No.: 2017299-0086 27STE-GMS- Hot Melt High WPI_400-200- Shear WPI Whey Protein Isolate 40.00% 400
  • the spatial orientation of one or more layer(s) comprising one or more core- shell preparation(s) was found to be a means of controlling the release of one or more protein(s) from one or more core-shell preparation(s).
  • an inner shell comprising an exemplary polysaccharide Hypromellose, with a viscosity of 100 cP, and outer shell comprising a different exemplary polysaccharide, Ethyl cellulose was found to enable faster release than an inner shell comprising an exemplary polysaccharide, Ethyl cellulose, and an outer shell comprising Hypromellose.
  • micellar casein 55% micellar casein, 30% directly compressible starch, 10% lactose, and 5% inulin was granulated using a Caleva Multi- Lab, followed by extrusion and spheronization via 1 mm x 1 mm dies with constant addition of Dry-Flo starch. The resulting spherical particles were dried in an oven at 45 oC for 16 hours and passed through a 14-mesh sieve.
  • the final concentration of all constituents in the particle preparation was 50% (w/w) casein, 27% (w/w) starch, 9% (w/w) lactose, 4% (w/w) inulin, 5% (w/w) Hypromellose, and 5% (w/w) ethyl cellulose.
  • Nine (9) 15 mL centrifuge tubes were filled with PBS at 37 oC.
  • To 3 tubes each was added either 55 mg of micellar casein, 100 mg of casein particles with Coating A, or 100 mg of casein particles with Coating B.
  • formulated core-shell particles comprising protein exhibit a spherical morphology with a 14-mesh size.
  • Example 46 Exemplary matrix preparation exhibiting pH-controlled release of protein(s) [0711]
  • the following non-limiting example describes one or more matrix preparations comprising one or more protein(s) and one or more polysaccharide(s) further characterized as pH-responsive.
  • one or more pH-responsive polysaccharide(s) exhibited one or more change(s) upon exposure to varying pH.
  • sodium alginate was one or more pH-responsive polysaccharides.
  • a suspension comprising 2% (w/v) sodium alginate, 4% (w/v) calcium caseinate, 0.15% (w/v) calcium hydrogen phosphate, and 1% (w/v) succinic acid in distilled water was prepared and the pH was adjusted to 8 using ammonium hydroxide.
  • passing said suspension through a Buchi B-290 Spray Dryer equipped with an ultrasonic nozzle with an inlet temperature of 90 oC, nozzle temperature of 50 oC, and outlet temperature of 40 oC yielded solid spherical particles (Figure 47A) comprising sodium alginate and calcium caseinate.
  • Particle size analysis of said spherical particles indicates an average particle diameter, Dv50, of 19.2 ⁇ m.
  • Three (3) 15 mL centrifuge tubes were filled with simulated gastric fluid (SGF) at 37 oC, with a pH of 1.
  • Three (3) 15 mL centrifuge tubes were filled with simulated intestinal fluid (SIF) at 37 oC, with a pH of 6.8.
  • SGF gastric fluid
  • SIF simulated intestinal fluid
  • Example 47 Exemplary matrix preparation exhibiting sustained release of fatty acid in one or more release environment(s) [0713]
  • the following non-limiting example describes one or more matrix preparations comprising one or more fatty acid(s) and one or more lipid(s).
  • one or more release environment(s) was comprised of one or more component(s) simulating digestive Page 240 of 315 11645787v1 Docket No.: 2017299-0086 condition(s) of the gastrointestinal tract of one or more mammal(s).
  • the release and/or absorption of one or more payload(s) further characterized as one or more fatty acid(s) may bemediated by bile salt(s), for example, sodium taurocholate.
  • bile salt(s) for example, sodium taurocholate.
  • the following non-limiting example demonstrates one or more matrix preparation comprising one or more fatty acid(s) resistant to release and/or absorption in a bile salt-rich environment simulating digestive condition(s) of the gastrointestinal tract of one or more mammal(s).
  • Formulated linoleic acid microparticles were added to 3 of these 6 tubes, while unformulated linoleic acid was added to the remaining 3 tubes.
  • unformulated linoleic acid was rapidly emulsified in the bile-salt rich simulated intestinal fluid indicating rapid release in a simulated duodenum environment.
  • formulated linoleic acid resists emulsification, with only 50% of loaded fatty acid released by 4 hours. VV.
  • Example 48 Exemplary core-shell preparation exhibiting pH-responsive release of carbohydrate(s)
  • the following non-limiting example describes one or more core-shell preparation(s) comprising a core further comprising carbohydrate and multiple shells further comprising carbohydrate(s).
  • One or more shell layer(s) was found to confer pH responsiveness towards said core-shell preparation(s).
  • a powdered mixture of 55% micellar casein, 30% directly compressible starch, 10% lactose, and 5% glucose was granulated using a Caleva Multi- Lab, followed by extrusion and spheronization via 1 mm x 1 mm dies with constant addition of Dry-Flo starch.
  • the resulting spherical particles were dried in an oven at 45 oC for 16 hours and passed through a 14-mesh sieve.
  • Individual free particles were weighed and loaded into a VFC- LAB Micro FLO-COATER (Freund Vector) and sprayed with a 10% (w/v) hypromellose acetate Page 241 of 315 11645787v1 Docket No.: 2017299-0086 succinate dispersion in water followed by a 2% (w/v) sodium alginate solution in water.
  • a 5% coating weight gain was targeted for each layer, resulting in a total 10% weight gain coating for glucose-containing microparticles.
  • the final concentration of all constituents in the particle preparation was 50% (w/w) casein, 27% (w/w) starch, 9% (w/w) lactose, 4% (w/w) glucose, 5% (w/w) hypromellose acetate succinate, and 5% (w/w) sodium alginate.
  • Three (3) 15 mL centrifuge tubes were filled with simulated gastric fluid (SGF) at 37 oC, with a pH of 1.
  • Three (3) 15 mL centrifuge tubes were filled with simulated intestinal fluid (SIF) at 37 oC, with a pH of 6.8.180 mg of coated glucose-containing particles were added to each tube (Figure 49A).
  • Example 49 Exemplary core-shell preparation exhibiting pH-responsive release of protein(s) [0717]
  • the following non-limiting example describes one or more core-shell preparation(s) comprising a core further comprised of protein and multiple shells further comprising carbohydrate(s).
  • One or more shell layer(s) is found to confer pH responsiveness towards said core-shell preparation(s).
  • micellar casein 50% micellar casein, 20% directly compressible starch, 15% lactose, and 15% inulin was granulated using a Caleva Multi- Lab, followed by extrusion and spheronization via 1 mm x 1 mm dies with constant addition of Dry-Flo starch. The resulting spherical particles were dried in an oven at 45 oC for 16 hours and passed through a 14-mesh sieve.
  • Example 50 Exemplary core-shell preparations derived from several manufacturing processes and incorporation of particle preparations into commercial products
  • the following non-limiting example illustrates particle preparation(s) deriving from methods of manufacture of one or more food and/or beverage composition(s).
  • One or more methods of manufacture of one or more food and/or beverage composition(s) is or may be selected to provide for desired characteristic(s) exhibited by particle preparation(s).
  • one or more methods of manufacture is or may be employed to generate particle(s) exhibiting one or more size distributions.
  • one or more size distribution(s) resulting from one or more methods of manufacture may be ascertained using microscopy.
  • one or more methods of manufacture is or may be employed to generate particle(s) exhibiting one or more size distributions.
  • one or more size distribution(s) resulting from one or more methods of manufacture may be ascertained using laser diffraction particle size analysis.
  • size distribution(s) exhibited by one or more particle preparation(s) are particularly advantageous for homogenous mixing within food and/or beverage product matrices.
  • size distribution(s) exhibited by one or more particle preparation(s) are particularly advantageous for minimizing sensory impact for consumers.
  • several particle preparation(s) were generated using one or more methods of manufacture, with commensurate microscopy and particle size analysis data.
  • Methods of manufacture comprising hot high shear homogenization of matrix component(s) and payload component(s) yielded solid “bars”, of which one non-limiting example is provided in FIG.51A.
  • the provided “bar” was macroscopic, with a diameter of 20 mm, and had a composition of 60% (w/w) oleic acid, 20% (w/w) ethyl cellulose 100 cP, and 20% (w/w) whey protein.
  • Methods of manufacture comprising granulation, extrusion, and spheronization of matrix component(s) and payload component(s) yielded solid pellets, of which one non-limiting example is provided in FIG.51B.
  • the provided pellets were macroscopic, with Page 243 of 315 11645787v1 Docket No.: 2017299-0086 a diameter of 1 mm, and had a composition of 50% (w/w) casein, 27% (w/w) starch, 9% (w/w) lactose, 4% (w/w) inulin, 5% (w/w) Hypromellose, and 5% (w/w) ethyl cellulose.
  • Methods of manufacture comprising hot melt extrusion and hammer milling of matrix component(s) and payload component(s) yielded a coarse powder, of which one non-limiting example is provided in FIG.51C.
  • the provided pellets were microscopic, with an average diameter, Dv50, of 171 ⁇ m, and had a composition of 50% (w/w) whey, 30% (w/w) 27 Stearine, and 20% (w/w) ethyl cellulose 100 cP.
  • Methods of manufacture comprising hot melt extrusion and hammer milling of matrix component(s) and payload component(s) yielded a coarse powder, of which one non- limiting example is provided in FIG.51D.
  • the provided pellets were microscopic, with an average diameter, Dv 50 , of 171 ⁇ m, and had a composition of 40% (w/w) whey, 40% (w/w) 27 Stearine, and 20% (w/w) calcium hydroxybutyrate.
  • Methods of manufacture comprising spray drying of matrix component(s) and payload component(s) yielded a fine powder, of which one non-limiting example is provided in FIG.51E.
  • the provided powder was microscopic, with an average diameter, Dv50, of 7.4 ⁇ m, and had a composition of 40% (w/w) whey, 40% (w/w) sodium alginate, and 20% (w/w) succinic acid.
  • FIG.51B Incorporation of spheronized particles (FIG.51B) into commercial whey protein powder (Muscle Milk, Pepsi) exhibits poor integration (FIG.51I) in contrast to incorporation of spray dried particle preparation(s) (FIG.51E) into commercial whey protein powder (Muscle Milk, Pepsi), illustrated in FIG.51J, where no differences in texture or color were observed.
  • FIG.51D milled preparation(s) into liquids, illustrated in FIGs.51K-51M, was challenging, leading to particle agglomeration at the liquid-air interface (FIG.51K).
  • Inclusion of 5% soybean lecithin improved mixing of formulation (FIG.
  • microparticle preparations can be manufactured having high percentages (e.g., at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% w/w) of food component.
  • FIG.52A shows a microscopic image of an exemplary microparticle preparation incorporating, on a dry weight basis, 50% (w/w) whey protein isolate, 30% (w/w) ethyl cellulose 100 cP, and 20% (w/w) 27 Stearin.
  • 30 g of 27 Stearin was melted at 150 oC on a hot plate, followed by addition of 20 g of ethyl cellulose 100 cP.
  • the mixture was (i) stirred using a magnetic stir bar for at least 30 minutes; (ii) cooled to at least -50 oC, -78 oC, -150 oC, or -196 oC; and (iii) milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, and/or 100 ⁇ m screen filter.
  • the fine powder (50 g) was mixed with 50 g of whey protein isolate powder in a sealed glass bottle and the mixed powders were added to a Thermo Scientific Haake MiniLab3 extruder with the extrusion chamber set to at least at 140 oC, 145 oC, 150 oC, 155 oC, or 160 oC.
  • the collected extrudate was milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • FIG.52B shows a microscopic image of an exemplary microparticle preparation incorporating, on a dry weight basis, 66% (w/w) hydrolyzed whey protein isolate, 22% (w/w) sodium alginate, and 12% (w/w) succinic acid.
  • 22 g of sodium alginate was dissolved in 900 mL of water overnight at 40 oC, followed by the dissolution of 66 g of hydrolyzed whey protein isolate and 12 g of succinic acid.
  • the pH of the solution was adjusted to at least 7.2, at least 7.4, at least 7.6, at least 7.8, at least 8.0, at least 8.2, or at least 8.4 using ammonium hydroxide.
  • the solution was then spray-dried using a Buchi B-290 benchtop spray drier with inlet temperature at least 120 oC, at least 125 oC, at least 130 oC, at least 135 oC, at least 140 oC, or at least 145 oC; flow rate at 20%; and sweep gas at 414 L/h.
  • FIG.52C shows a microscopic image of an exemplary microparticle preparation incorporating, on a dry weight basis, 80% (w/w) whey protein isolate, 19% (w/w) hydroxypropyl methylcellulose 100 cP, and 1% (w/w) microbial transglutaminase (1000 U/g).
  • 19 g of hydroxypropyl methylcellulose 100 cP was dissolved in 900 mL of water at 40 oC, followed by the dissolution of 80 g of whey protein isolate and 1 g of microbial transglutaminase (1000 U/g).
  • FIG.52D shows a microscopic image of an exemplary microparticle preparation incorporating, on a dry weight basis, 90% (w/w) micellar casein, 5% (w/w) StarTab, 3% (w/w) lactose, 1% (w/w) magnesium stearate, and 1% (w/w) microbial transglutaminase.
  • 10g of total formulation was added into a Caleva Multi Lab instrument granulating bowl (Caleva Process Solutions Ltd., Dorset, England). 4 mL of Milli-Q water was added to the granulating bowl while granulating screws mixed the formulation at 35 rpm.
  • FIG.53A-53B are theoretical data plots showing a non-linear increase in viscosity with increasing concentrations of food component payload (FIG.53A).
  • FIG.53C-53F are images of preparations of 27 stearin mixed with whey protein isolate powder at ratios of 95:5, 75:25, 60:40, and 25:75 (% w/w on a dry weight basis). Powder mixtures were thoroughly mixed by vortexing then heated with overhead stirring (250 rpm) to 90 oC on a hot plate. Following melting and dispersion of the whey protein isolate, samples were removed via spatula and the mixture was allowed to freely flow from the spatula tip.
  • Example 52 Incorporation of exemplary microparticle preparations into food compositions.
  • This example shows that microparticle preparations incorporating different co- excipients have different physical characteristics that may or may not be conducive for integrating the preparations into particular food compositions.
  • FIG.54A shows an image of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 39% (w/w) hydrolyzed whey protein isolate, 2% (w/w) locust bean gum, and 20% (w/w) hydroxyapatite mixed in Chobani® yogurt (top panel) or a Clif TM bar (bottom panel).
  • the mixture was allowed to cool to 15 oC, 20 oC, or 25 oC then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the microparticle preparation was mixed at 10% (w/w) into Chobani® yogurt (FIG.54A, top panel) or ClifTM bar (FIG.54A, bottom panel). No textural or color differences were observed when incorporated into Chobani® yogurt or ClifTM bar food products.
  • FIG.54B shows an image of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 39% (w/w) hydrolyzed whey protein isolate, 2% (w/w) locust bean gum, and 20% (w/w) gellan gum mixed in Chobani® yogurt (top panel) or a Clif TM bar (bottom panel).
  • the mixture was allowed to cool to 15 oC, 20 oC, or 25 oC then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the microparticle preparation was mixed at 10% (w/w) into Chobani® yogurt (FIG.54B, top panel) or ClifTM bar (FIG.54B, bottom panel). No textural or color differences were observed when incorporated into Chobani® yogurt or ClifTM bar food products.
  • FIG.54C shows an image of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 39% (w/w) hydrolyzed whey protein isolate, 2% (w/w) locust bean gum, and 20% (w/w) iota carrageenan mixed in Chobani® yogurt (top panel) or a Clif TM bar (bottom panel).
  • 20 g of iota carrageenan was dissolved in 780 mL of 10 mM phosphate buffered saline (PBS), followed by the dissolution of 39 g of hydrolyzed whey protein isolate.
  • PBS phosphate buffered saline
  • the microparticle preparation was mixed at 10% (w/w) into Chobani® yogurt (FIG.54C, top panel) or ClifTM bar (FIG.54C, bottom panel). Unlike the preparations in FIG.54A and FIG.54B, preparations including iota carrageenan as a co- excipient caused observable textural and color changes when incorporated into Chobani® yogurt or ClifTM bar food products. Page 248 of 315 11645787v1 Docket No.: 2017299-0086 AAA.
  • Example 53 Manufacturing processes influence incorporation of microparticle preparations into food products. [0739] This example shows that some manufacturing processes result in microparticle preparations having physical characteristics that may or may not be conducive for integrating the preparations into particular food compositions.
  • FIG.55A shows an image of an exemplary microparticle preparation having, on a dry weight basis, 50% (w/w) whey protein isolate, 20% (w/w) ethyl cellulose 100 cP, and 30% (w/w) 27 Stearin prepared by hot melt extrusion and mixed in Chobani® yogurt (top panel) or a Clif TM bar (bottom panel).
  • 30 g of 27 Stearin was melted at 150 oC on a hot plate, followed by the addition of 20 g of ethyl cellulose 100 cP.
  • the mixture was stirred using a magnetic stir bar for at least 30 minutes then cooled to at least -50 oC, -78 oC, -150 oC, or-196 oC and milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the fine powder (50 g) was mixed with 50 g of whey protein isolate powder in a sealed glass bottle and the mixed powders were added to a Thermo Scientific Haake MiniLab3 extruder with extrusion chamber set at least at 140 oC, 145 oC, 150 oC, 155 oC, and/or 160 oC.
  • FIG.55B shows an image of an exemplary microparticle preparation having the same composition as the preparation of FIG.55A but prepared by dispersion via high shear homogenization and mixed in Chobani® yogurt (top panel) or a Clif TM bar (bottom panel).
  • the mixture was subsequently cooled to at least -50 oC, -78 oC, -150 oC, and/or-196 oC and Page 249 of 315 11645787v1 Docket No.: 2017299-0086 milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, and/or 100 ⁇ m screen filter.
  • the microparticle preparation was mixed at 10% (w/w) into Chobani® yogurt (FIG.55B, top panel) or ClifTM bar (FIG.55B, bottom panel).
  • a preparation prepared via dispersion caused observable textural and color changes when incorporated into Chobani® yogurt or ClifTM bar food products.
  • Example 54 Microparticle preparation coatings influence incorporation of microparticle preparations into food products. [0744] This example shows that the addition of some coatings can result in microparticle preparations having physical characteristics that may or may not be conducive for integrating the preparations into particular food compositions.
  • FIG.56A shows an image of an exemplary microparticle preparation having a core including, on a dry weight basis, 19% (w/w) carnauba wax, 5% (w/w) ethyl cellulose 100 cP, 5% (w/w) stearic acid, 1% (w/w) folic acid, 20% (w/w) whey protein isolate; and a coating including, on a dry weight basis, 29.5% (w/w) ethyl cellulose, 17.5% (w/w) Eudragit control, and 3% sodium alginate, and mixed with MuscleMilk TM protein shake.
  • a core including, on a dry weight basis, 19% (w/w) carnauba wax, 5% (w/w) ethyl cellulose 100 cP, 5% (w/w) stearic acid, 1% (w/w) folic acid, 20% (w/w) whey protein isolate; and a coating including, on a dry weight basis
  • the mixture was stirred using an overhead stirrer for at least 30 minutes, then 10 g of stearic acid, 2 g of folic acid, and 40 g of spray dried whey protein isolate was added to the mixture.
  • the mixture was subsequently cooled to at least -50 oC, -78 oC, -150 oC, or-196 oC and milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, and/or 100 ⁇ m screen filter.
  • ethyl cellulose 300 cP final 29.5% (w/w)
  • Eudragit control final 17.5% (w/w)
  • sodium alginate final 3% (w/w)
  • the fluid bed parameters were as follows: Spray on/off: 0.8/0.8, 50 revolutions per minute, pump rev: 6 seconds, inlet temp: 50 °C. Spraying occurred until 20% (w/w) of ethyl cellulose 300 cP was added to the particles, consistently monitoring the fluidization of the particles. All tubing was Page 250 of 315 11645787v1 Docket No.: 2017299-0086 cleaned by first pumping ethanol, then water, through the tubing at 60 revolutions per minute.
  • the NS Enteric solution was placed on a scale and to track coating weight in grams as spraying occurs.
  • the fluid bed parameters were as follows: Spray on/off: 0.0/0.0, 15 revolutions per minute, pump rev: 5 seconds, inlet temp: 80 °C. Spraying occurred until 2.5% (w/w) of NS Enteric was added to the particles, consistently monitoring the fluidization of the particles.
  • FIG.56B shows an image of an exemplary microparticle preparation having a core including, on a dry weight basis, 38% (w/w) carnauba wax, 10% (w/w) ethyl cellulose 100 cP, 10% (w/w) stearic acid, 2% (w/w) folic acid, 40% (w/w) whey protein isolate; without coating, and mixed with MuscleMilk TM protein shake.
  • the mixture was stirred using an overhead stirrer for at least 30 minutes, then 10 g of stearic acid, 2 g of folic acid, and 40 g of spray dried whey protein isolate was added to the mixture.
  • the mixture was subsequently cooled to at least -50 oC, -78 oC, -150 oC, or-196 oC and milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • FIGs.57A-57F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 50% (w/w) whey protein isolate, 47% (w/w) beeswax, and 3% Tween 85.
  • 47 g of white beeswax was melted at 80 oC on a hot plate, followed by addition of 3 g of Tween 85.
  • the mixture was cooled to at least -50 oC, -78 oC, -150 oC, or-196 oC and milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the fine powder (50 g) was mixed with 50 g of whey protein isolate powder in a sealed glass bottle and the mixed powders were added to a Thermo Scientific Haake MiniLab3 extruder with extrusion chamber set at least at 30 oC, 35 oC, 40 oC, 45 oC, or 50 oC.
  • the collected extrudate was cooled to -196 oC and milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 34%, with 5 unit processes and 0 g of generated waste.
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 32.1 ⁇ m, 131 ⁇ m, and 338 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • FIGs.58A-58F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 50% (w/w) whey protein isolate, 20% (w/w) ethyl cellulose 100 cP, and 30% (w/w) 27 Stearin.
  • the resulting fine powder (50 g) was mixed with 50 g of whey protein isolate powder in a sealed glass bottle and the mixed powders were added to a Thermo Scientific Haake MiniLab3 extruder with an extrusion chamber set at least at 140 oC, 145 oC, 150 oC, 155 oC, or 160 oC.
  • the collected extrudate was milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter. The yield of recovered particles was 56%, with 5 unit processes and 0 g of generated waste.
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 18.5 ⁇ m, 70.5 ⁇ m, and 242 ⁇ m, respectively.
  • the particles were polydisperse, burnt orange in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.58D) or ClifTM bar (FIG.58E)
  • no textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was mixed with water, microparticles did not incorporate (FIG.58F).
  • FIGs.59A-59F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) iota carrageenan, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the Page 253 of 315 11645787v1 Docket No.: 2017299-0086 molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 90%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 45.6 ⁇ m, 137 ⁇ m, and 304 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.59D) or ClifTM bar (FIG.59E)
  • no textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles were well distributed (FIG.59F).
  • FIGs.60A-60F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) karaya gum, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • 20 g of karaya gum was dissolved in 780 mL of 10 mM PBS overnight at 4 oC, followed by dissolution of 39 g of hydrolyzed whey protein isolate.39 g of agarose powder and 2 g of locust bean gum powder were then added to the mixture using an overhead stirrer.
  • the suspension was then heated to 95 oC until the agarose and locust bean gum were completely dissolved.
  • the molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter. The yield of recovered particles was 69%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 32.3 ⁇ m, 101 ⁇ m, and 218 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle Page 254 of 315 11645787v1 Docket No.: 2017299-0086 preparation was incorporated into Chobani ® yogurt (FIG.60D) or ClifTM bar (FIG.60E), no textural or color alterations of the food product was observed.
  • FIGs.61A-61F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) methyl cellulose 4000 cP, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 89%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 53.7 ⁇ m, 156 ⁇ m, and 345 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.61D) or ClifTM bar (FIG.61E)
  • no textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles were well distributed (FIG.61F).
  • FIGs.62A-62E show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) poly(ethylene glycol), 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 82%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 26.0 ⁇ m, 153 ⁇ m, and 399 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG. 62C) or ClifTM bar (FIG.62D)
  • no textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles were well distributed (FIG.62E).
  • FIGs.63A-63F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) hydroxypropyl methylcellulose 100 cP, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.63D) or ClifTM bar (FIG.63E)
  • no textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles were well distributed (FIG.63F).
  • FIGs.64A-64F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) Evonik Eudraguard ProtectTM, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 100%, with 3 unit processes and 780 g of generated waste water and acetic acid (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 24.1 ⁇ m, 173 ⁇ m, and 395 ⁇ m, respectively.
  • the particles were polydisperse, light yellow in color, and had a jagged morphology.
  • FIGs.65A-65F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) hydroxyapatite 5 ⁇ m, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 62 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 100%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 26 ⁇ m, 159 ⁇ m, and 385 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.65D) or ClifTM bar (FIG.65E)
  • no textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles were well distributed (FIG.65F).
  • FIGs.66A-66F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 10% (w/w) hydroxyapatite 5 ⁇ m, 10% (w/w) low molecular weight chitosan, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 63 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 100%, with 3 unit processes and 780 g of generated waste water and acetic acid (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 34.3 ⁇ m, 171 ⁇ m, and 383 ⁇ m, respectively.
  • the particles were polydisperse, light yellow in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.66D) or ClifTM bar (FIG.66E)
  • no textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles were well distributed (FIG.66F).
  • FIGs.67A-67F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 50% (w/w) whey protein isolate, 47% (w/w) carnauba wax, and 3% (w/w) Tween 85.
  • 47 g of carnauba wax was melted at 80 oC on a hot plate, followed by addition of 3 g Tween 85. The mixture was stirred using an overhead stirrer for at least 30 minutes, then 50 g of whey protein isolate was added to the mixture.
  • the mixture was subsequently cooled to at least -50 oC, -78 oC, -150 oC, or-196 oC and milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 59%, with 2 unit processes and 0 g of generated waste.
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 26.3 ⁇ m, 113 ⁇ m, and 277 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.67D) or ClifTM bar (FIG.67E)
  • no Page 259 of 315 11645787v1 Docket No.: 2017299-0086 textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles were well distributed (FIG.67F).
  • FIGs.68A-68F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 40% (w/w) whey protein isolate, 20% (w/w) beeswax, and 40% (w/w) glycol monostearate.
  • 20 g of white beeswax was melted at 80 oC on a hot plate, followed by addition of 40 g of propylene glycol monostearate. The mixture was stirred using an overhead stirrer for at least 30 minutes, then 40 g whey protein isolate was added to the mixture.
  • the mixture was subsequently cooled to at least -50 oC, -78 oC, -150 oC, or -196 oC and milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 44%, with 2 unit processes and 0 g of generated waste.
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 20.7 ⁇ m, 79.6 ⁇ m, and 170 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.68D) or ClifTM bar (FIG.68E)
  • no textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles were well distributed (FIG.68F).
  • FIGs.69A-69F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) croscarmellose, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • 20 g of croscarmellose sodium was dissolved in 780 mL of 10 mM PBS, followed by dissolution of 39 g of hydrolyzed whey protein isolate.39 g of agarose powder and 2 g of locust bean gum powder were dispersed within the mixture using an overhead stirrer.
  • the suspension was then heated to 95 oC, until the agarose and locust bean gum were completely dissolved.
  • the molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at either 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an Page 260 of 315 11645787v1 Docket No.: 2017299-0086 IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • FIGs.70A-70F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) quillaia saponin, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 83%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 48.8 ⁇ m, 191 ⁇ m, and 390 ⁇ m, respectively.
  • the particles were polydisperse, tan in color, and had a jagged morphology.
  • FIGs.71A-71E show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 40% (w/w) whey protein isolate, 20% (w/w) calcium hydroxybutyrate, and 40% (w/w) stearin 27.
  • the yield of recovered particles was 60%, with 2 unit processes and 0 g of generated waste.
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 20.0 ⁇ m, 73 ⁇ m, and 177 ⁇ m, respectively.
  • the particles were polydisperse and cream white in color.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.71C) or ClifTM bar (FIG.71D)
  • significant adverse textural and/or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was mixed with water, microparticles did not incorporate (FIG.71E).
  • FIGs.72A-72E show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 50% (w/w) whey protein isolate, 20% (w/w) ethyl cellulose 100 cP, and 30% (w/w) 27 Stearin.
  • 30 g of 27 stearin was melted at 150 oC on a hot plate, followed by addition of 20 g ethyl cellulose 100 cP via high shear homogenization. The mixture was stirred using an overhead stirrer for at least 30 minutes, then 50 g of whey protein isolate was added to the mixture.
  • the mixture was subsequently cooled to at least -50 oC, -78 oC, -150 oC, or-196 oC and milled using an IKA M10 Page 262 of 315 11645787v1 Docket No.: 2017299-0086 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 44%, with 2 unit processes and 0 g of generated waste.
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 12.4 ⁇ m, 44.7 ⁇ m, and 157 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG. 72C) or ClifTM bar (FIG.72D)
  • significant textural and/or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was mixed with water, microparticles did not incorporate (FIG.72E).
  • FIGs.73A-73C show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 38% (w/w) sodium alginate, 24% (w/w) succinic acid, and 38% (w/w) hydrolyzed whey protein isolate.
  • 38 g of sodium alginate was dissolved in 900 mL of water overnight at 40 oC, followed by dissolution of 24 g of succinic acid, followed by dissolution of 38 g of hydrolyzed whey protein isolate.
  • the pH of the solution was adjusted to at least 7.2, at least 7.4, at least 7.6, at least 7.8, at least 8.0, at least 8.2, or at least 8.4 using ammonium hydroxide.
  • the solution was then spray-dried using a Buchi B-290 benchtop spray drier with inlet temperature at least 120 oC, at least 125 oC, at least 130 oC, at least 135 oC, at least 140 oC, or at least 145 oC; low rate at 20%; and sweep gas at 414 L/h.
  • the yield of recovered particles was 60%, with 1 unit process and 900 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 2.19 ⁇ m, 7.41 ⁇ m, and 21.8 ⁇ m, respectively.
  • the particles were polydisperse, white in color, and had a spherical morphology.
  • FIGs.74A-74F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 35% (w/w) sodium alginate, 17% (w/w) succinic acid, 3% (w/w) calcium carbonate, 9% (w/w) hydroxypropyl methylcellulose 40 cP, 35% (w/w) inulin, and 1% (w/w) fluorescein isothiocyanate inulin.
  • the solution was then spray-dried using a Buchi B-290 benchtop spray drier with an inlet temperature of at least 120 oC, at least 125 oC, at least 130 oC, at least 135 oC, at least 140 oC, or at least 145 oC; flow rate at 20%; and sweep gas at 414 L/h.
  • the yield of recovered particles was 71%, with 1 unit process and 900 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 2.20 ⁇ m, 8.81 ⁇ m, and 501 ⁇ m, respectively.
  • the particles were polydisperse, white in color, and had a spherical morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.74D) or ClifTM bar (FIG.74E)
  • significant adverse textural and/or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles did not incorporate (FIG. 74F).
  • FIGs.75A-75B show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 50% (w/w) microcrystalline cellulose, 5% (w/w) hydroxypropyl cellulose, 5% (w/w) corn starch, 38% (w/w) inulin, and 2% (w/w) fluorescein isothiocyate inulin.
  • FIGs.76A-76C show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 38% (w/w) carnauba wax, 10% (w/w) ethyl cellulose 100 cP, 10% (w/w) stearic acid, 2% (w/w) folic acid, and 40% (w/w) whey protein isolate.
  • the mixture was stirred using an overhead stirrer for at least 30 minutes, and 10 g of stearic acid, 2 g of folic acid, and 40 g of spray dried whey protein isolate was added to the mixture.
  • the mixture was subsequently cooled to at least -50 oC, -78 oC, -150 oC, or-196 oC and milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 27%, with 3 unit processes and 720 g of aqueous waste.
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 9.59 ⁇ m, 62.5 ⁇ m, and 267 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • FIGs.77A-77F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 19% (w/w) carnauba wax, 5% (w/w) ethyl cellulose 100 cP, 5% (w/w) stearic acid, 1% (w/w) folic acid, 20% (w/w) whey protein isolate, 29.5% (w/w) ethylcellulose 300 cP, 17.5% (w/w) Eudragit control, and 3% (w/w) sodium alginate.
  • the recovered yield was 50%.38 g of carnauba wax was melted at 150 oC on a hot plate, followed by the addition of 10 g ethyl cellulose 100 cP in small portions via high shear homogenization. The mixture was stirred using an overhead stirrer for at least 30 minutes, then 10 g of stearic acid, 2 g of folic acid, and 40 g of spray dried whey protein isolate was added to the mixture.
  • the mixture was subsequently cooled to at least -50 oC, -78 oC, -150 oC, or-196 oC and milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, and/or 100 ⁇ m screen filter. Particles were subsequently coated using 3 layers: ethyl cellulose 300 cP (final 29.5% (w/w)), Eudragit control (final 17.5% (w/w)), and sodium alginate (final 3% (w/w)).
  • the fluid bed parameters were as follows: Spray on/off: 0.8/0.8, 50 revolutions per minute, pump rev: 6 seconds, inlet temp: 50 °C.
  • a solution of 2% (w/w) sodium alginate in 100 mL of water was prepared on a hot plate, stirring at 400 revolutions per minute at100 °C for 30 mins, or until the NS Enteric appear solubilized.
  • the NS Enteric solution was placed on a scale and to track coating weight in grams as spraying occurs.
  • the fluid bed parameters were as follows: Spray on/off: 0.0/0.0, 15 revolutions per minute, pump rev: 5 seconds, inlet temp: 80 °C. Spraying occurred until 2.5% (w/w) of NS Enteric was added to the particles, consistently monitoring the fluidization of the particles.
  • the yield of recovered particles was 12%, with 6 unit processes and 2100 g of generated waste.
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 267 ⁇ m, 472 ⁇ m, and 849 ⁇ m, respectively.
  • the particles were aggregated, tan in color, and had a smooth morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.77D) or ClifTM bar (FIG.77E)
  • significant adverse Page 266 of 315 11645787v1 Docket No.: 2017299-0086 textural and/or color alterations of the food product was observed.
  • FIGs.78A-78F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 10% (w/w) chitosan low molecular weight, 10% (w/w) karaya gum, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 750 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 99%, with 3 unit processes and 780 g of generated waste water and acetic acid (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 63.8 ⁇ m, 194 ⁇ m, and 495 ⁇ m, respectively.
  • the particles were polydisperse, light yellow in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.78D) or ClifTM bar (FIG.78E), no textural or color alterations of the food product was observed.
  • FIGs.79A-79F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) sodium carboxymethylcellulose, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 760 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 87%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 32.8 ⁇ m, 187 ⁇ m, and 418 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • 10% (w/w) of microparticle preparation was incorporated into Chobani ® yogurt (FIG.79D) or ClifTM bar (FIG.79E)
  • no textural or color alterations of the food product was observed.
  • 10% (w/w) of microparticle preparation was incorporated into water, microparticles were well distributed (FIG.79F).
  • FIGs.80A-80F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) manganese sulfate, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • 20 g of manganese sulfate was dissolved in 780 mL of 10 mM PBS, followed by dissolution of 39 g of hydrolyzed whey protein isolate.39 g of agarose powder and 2 g of locust bean gum powder were then added to the mixture using an overhead stirrer.
  • the suspension was then heated to 95 oC until the agarose and locust bean gum were completely dissolved.
  • the molten mixture was allowed to cool to 15 oC, 20 oC, or 25 oC and then transferred to an aluminum sheet to be stored at 40 oC, 50 oC, 60 oC, or 70 oC overnight.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 770 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter. The yield of recovered particles was 73%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • FIGs.81A-81F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) hydroxyapatite 200 nm, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 780 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 100%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 23.5 ⁇ m, 155 ⁇ m, and 373 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • FIGs.82A-82F show the physical characteristics of an exemplary microparticle preparation having, on a dry weight basis, 39% (w/w) agarose, 20% (w/w) gellan gum, 2% (w/w) locust bean gum, and 39% (w/w) hydrolyzed whey protein isolate.
  • the resulting dry chips were milled using an IKA M10 hammer mill equipped with a 1000 ⁇ m, 790 ⁇ m, 500 ⁇ m, 250 ⁇ m, or 100 ⁇ m screen filter.
  • the yield of recovered particles was 84%, with 3 unit processes and 780 g of generated waste water (e.g., evaporated).
  • particle size analysis indicated Dv10, Dv50, and Dv90 values of 45.3 ⁇ m, 193 ⁇ m, and 470 ⁇ m, respectively.
  • the particles were polydisperse, cream white in color, and had a jagged morphology.
  • microparticle preparation excipients can interfere with assays quantifying food components. [0827] This example shows that some microparticle preparation excipients can interfere with the quantification of one or more food components in standard protein quantification assays.
  • each exemplary excipient was prepared at three concentrations (target concentration, 3X below target concentration, and 3X above target concentration) according to Table 4, with a fixed concentration of isolated whey protein (2000 ⁇ g/ml) and mixed in PBS.
  • each exemplary excipient was prepared at three concentrations Page 272 of 315 11645787v1 Docket No.: 2017299-0086 (target concentration, 3X below target concentration, and 3X above target concentration) according to Table 4, with a fixed concentration of glucose (3.6 ⁇ g/ml) and mixed in PBS.
  • a glucose oxidase amplex red assay (Thermo Scientific, Waltham, MA) was performed according to the manufacturer’s instructions.
  • DNS dinitrosalicylic
  • each exemplary excipient was prepared at three concentrations (target concentration, 3X below target concentration, and 3X above target concentration) according to Table 4, with a fixed concentration of linoleic acid (1872 ⁇ g/ml), docosahexaenoic acid (2300 ⁇ /ml) or eicosapentaenoic acid (1512 ⁇ g/ml) and mixed in PBS.
  • a non-esterified fatty acid Wako (HR-2) assay (Fujifilm, Tokyo, JP) was performed to determine fatty acid concentration according to the manufacturer’s instructions but modified by using 10% bovine serum albumin as the assay buffer.
  • each exemplary excipient was prepared at three concentrations (target concentration, 3X below target concentration, and 3X above target concentration) according to Table 4, with a fixed concentration of FITC inulin (250 ⁇ g/ml) and mixed in PBS.
  • FITC inulin 250 ⁇ g/ml
  • a fluorometric FITC inulin assay was performed to quantify inulin in the presence of excipients.
  • DNS dinitrosalicylic
  • the plate was allowed to cool briefly before 33 ⁇ L of Rochelle’s salt was added to each well and the plate is read on a plate reader at an absorbance of 540 nm.
  • various excipients including sodium alginate, calcium caseinate, low molecular weight chitosan, ethyl gallate, 450 kDa poly(acrylic acid), phytic acid, tannic acid, and whey protein isolate, were found to interfere with the quantification of inulin, a determination of interfering being established as when the detected inulin concentration differed from the expected value exceeds a threshold value of a factor.
  • each exemplary excipient was prepared at three concentrations (target concentration, 3X below target concentration, and 3X above target concentration) according to Table 4, with a fixed concentration of cyanidin chloride, quercitin, rutin, or tannic acid (18.5 ⁇ g/mL, 18.5 ⁇ g/mL, 40 ⁇ g/mL, and 1000 ⁇ g/mL, respectively) and mixed in PBS.
  • flavonoids e.g., cyanidin chloride, quercitin, rutin, tannic acid
  • a Distek apparatus was used for automated dissolution testing in 500 mL of PBS pH 6.8, 37 oC with a USP Type II paddle apparatus, over 720 minutes.
  • a filter protocol was used to prevent particles passing into sample collection values and filter clogging.
  • a “bubble” of moisture resistant mesh around the probe tip to provide a large surface area for filtering large particles
  • a screen filter fit inside of the probe filter cap atop the filter disc having a mesh size around the DV50 size of the particle preparation being tested e.g., a 160 ( ⁇ 90 micron) or 250 ( ⁇ 62 micron) mesh
  • a UHMW polyethylene 10 micron or 45 micron filter Protein concentrations in collected samples were measured using a standard BCA assay according to the manufacturer’s instructions.
  • the dissolution method described above can also be used to measuring protein release for microparticle preparations distributed in other biorelevant buffers, e.g., fasted state simulated gastric fluid buffer (FaSSGF, Biorelevant, London, UK).
  • FaSSGF fasted state simulated gastric fluid buffer
  • FIG.89C-89E the method described above was capable of measuring whey protein isolate release from 40% (w/w) Stearin 27, 20% (w/w) hydroxybutyrate calcium salt, and 40% (w/w) whey protein isolate preparations in both PBS and FaSSGF (FIG. 89C).
  • the method described above was also capable of measuring whey protein isolate release from (i) 40% (w/w) Stearin 27, 20% (w/w) hydroxybutyrate calcium salt, and 40% (w/w) whey protein isolate (FIG.89D) and (ii) 30% (w/w) Stearin 27, 3% (w/w) acetic acid esters of mono and digylcerides (ACETEM), 17% (w/w) ethyl cellulose 100 cP, 49% (w/w) whey protein isolate, and 1% FITC BSA (FIG.89E) preparations mixed with Muscle MilkTM protein powder in a 50:50 ratio. FFF.
  • Example 58 Exemplary matrix compositions for regulating release of food components from microparticle preparations
  • This example shows exemplary matrix compositions incorporating one or more excipients for regulating the release of food components from microparticle preparations.
  • common base formulations incorporating 40% (w/w) 27 stearin and 40% (w/w) whey protein isolate were prepared. The remaining 20% (w/w) of the formulation included beeswax, carnauba wax, tristearin, stearic acid, ethyl cellulose, sitosterol, cholesterol, thiamine, or folic acid.
  • Dissolution experiments were performed by distributing 150 mg of each formulation in 12 mL of PBS (pH 7.4) and allowing the formulation to freely rotate in a Benchmark Roto-Therm Mini set to 37 °C at Page 276 of 315 11645787v1 Docket No.: 2017299-0086 20RPM for 24 hours.
  • FIG.90A-90D various matrix compositions slowed the release of whey protein isolate into solution. GGG.
  • Example 59 Particle sizes of exemplary microparticle preparations affect release of food components
  • This example shows that the particle size of a microparticle preparation affects the release of food components into solution.
  • approximately 25g of whey protein isolate was spray dried with 2% (w/w) sucrose monopalmitate (98% (w/w) whey protein isolate, 2% (w/w) sucrose monopalmitate).
  • resulting particles had a Dv50 of 8.7 ⁇ m, which is significantly smaller than unformulated whey protein powder (Dv50 of 163 ⁇ m; FIG.91C).
  • whey protein isolate was spray dried with 15% (w/w) aspartic acid and mixed with 2% (w/w) silicon dioxide particles (10- 20 nm) (83% (w/w) whey protein isolate, 15% (w/w) aspartic acid, 2% (w/w) silicon dioxide 10 nm particles).
  • resulting particles had a Dv50 of 6.7 ⁇ m.
  • Both exemplary preparations were significantly smaller than unformulated whey protein powder (Dv50 of 163 ⁇ m; FIG.91C).
  • the exemplary microparticle preparations shown in FIG.91A and FIG.91B, and the unformulated whey protein powder shown in FIG.91C, were further added (40% w/w) to a lipid formulation mixture including 38% (w/w) carnauba wax, 10% (w/w) ethyl cellulose 100 cP, 10% (w/w) stearic acid, and 2% (w/w) bulk phytosterols (practical grade, 60% sitosterol) and heated to 215 °C and stirred at 150 RPM for 5-10 minutes to ensure homogenous distribution. Preparations were then poured into a 75mm aluminum pan and allowed to rest for 30 minutes or until the formulation reached room temperature.
  • each bulk preparation was broken into approximately 1 in 3 chunks and run through an IKA MF-Basic Hammer Mill at 5500 RPM using a 500 ⁇ m sieve.
  • lipid formulated microparticle preparations had Dv50s of 186 ⁇ m, 211 ⁇ m, and 118.8 ⁇ m, for the starting Page 277 of 315 11645787v1 Docket No.: 2017299-0086 preparations shown in FIG.91A, FIG.91B, and FIG.91C, respectively.
  • Exemplary preparations had irregular particle shape as shown in FIG.91K.
  • Lipid formulated preparations were also visually inspected. As shown in FIG.
  • lipid formulation preparation incorporating monopalmitate (38% (w/w) carnauba wax, 10% (w/w) ethyl cellulose 100 cP, 10% (w/w) stearic acid, 2% (w/w) bulk phytosterols (practical grade, 60% sitosterol), 39.2% (w/w) whey protein isolate, and 0.8% (w/w) sucrose monopalmitate) produced a visually smoother, more homogenous, preparation as compared to preparation incorporating silicon dioxide (38% (w/w) carnauba wax, 10% (w/w) ethyl cellulose100 cP, 10% (w/w) stearic acid, 2% (w/w) bulk phytosterols (practical grade, 60% sitosterol), 33.2% (w/w) whey protein isolate, 6% (w/w) aspartic acid, and 0.8% silicon dioxide 10 nm particles; FIG.91I) and unformulated whey protein isolate (38% (w/w) carnauba
  • Example 60 Solidification of liquid food components [0855] This example shows that low mass fractions of an excipient can solidify (i.e., gelate) liquid food components (e.g., fatty acids).
  • Successful gelation was characterized as a material’s ability to resist its own flow (e.g., material does not flow in a container when tilted). Melting/homogenization and 15 minute rest periods were repeated after addition of 5%, 10%, and 20% (w/w) of ethyl cellulose. Analogous experiments were performed substituting ethyl cellulose with phytosterols, stearic acid, or hydroxypropyl methyl cellulose (15 cP). For all excipients tested, an increased mass fraction resulted in an increase in melting temperature (FIG. 92D). III.
  • Example 61 Exemplary microparticle preparation excipients allow tunable release rates of food components
  • This example shows that a wide range of food component release rates are achievable depending on which excipient is selected for incorporating into a microparticle preparation.
  • Microparticle preparations incorporating 40% (w/w) dritex, 40% (w/w) whey protein isolate, and 20% (w/w) of cholesterol, ethyl cellulose, folic acid, polyoxyethylene (40) stearate, pluronic f-127, sitosterol, tween 40, or tween 80, were formulated by mixing 8g of dritex, 4g of the selected excipient, and 8g of whey protein isolate.
  • microparticle preparations incorporating 40% (w/w) dritex, 40% (w/w) alpha linoleic acid, and 20% (w/w) of beeswax, cholesterol, ethyl cellulose, folic acid, kolliphor k-188, propylene glycol monostearate, sitosterol, or stearic acid, were formulated by mixing 8g of dritex, 4g of the selected excipient, and 8g of linoleic acid. Mixtures were heated to 135 °C to 215 °C and stirred at 150 – 300 RPM for 5-10 minutes to ensure homogeneity.
  • Preparations were then poured into a 75mm aluminum pan and allowed to rest for 30 minutes or until the preparation reached room temperature.
  • 150 mg samples of each preparation were assessed for fatty acid release using a non-esterified fatty acid Wako (HR-2) assay (Fujifilm, Tokyo, JP) as previously described in Example 56.
  • HR-2 non-esterified fatty acid Wako
  • FIG.93B a wide range of fatty acid release rates were achievable depending on the excipient used in a preparation.
  • microparticle preparations incorporating 40% (w/w) dritex, 40% (w/w) quercetin, and 20% (w/w) of kolliphor k-188, folic acid, propylene glycol monostearate, cholesterol, lecithin, beeswax, or stearic acid, were formulated by mixing 4g of dritex, 2g of the selected excipient, and 4g of quercetin. Mixtures were heated to 135 °C to 215 °C and stirred at 150 – 300 RPM for 5-10 minutes to ensure homogeneity. Preparations were then poured into a 75mm aluminum pan and allowed to rest for 30 minutes or until the preparation reached room temperature.
  • Example 62 Excipients in agarose hydrogel matrices affect rates of food component release from an exemplary microparticle preparation.
  • This example shows that the presence of one or more excipients in agarose hydrogel matrices can affect the release of a food component from an exemplary microparticle preparation.
  • agarose hydrogels were prepared by mixing 20-30 mg/mL of agarose with 20 mL of PBS (pH 7.4) and 100 mg/mL whey protein isolate. Excipients selected from chitosan (Sigma Aldrich Chemical, St. Louis, MO), Eudragit E PO (Vikram Thermo, Gujarat, India), or hydroxyapatite (diameter 5 ⁇ m obtained from Sigma Aldrich Chemical, St. Louis, MO), were added to the agarose/whey protein solution at specified concentrations (3-10 mg/mL in final solution).
  • Dissolution analysis assay of preparations was performed using a benchtop Roto-Therm incubator (Benchmark Scientific, Sayreville, NJ) at 37 °C. Dissolution was performed using 200 mg replicates in triplicate using 15 mL Falcon tubes containing 12 mL of PBS (pH 7.4). Aliquots of 200 ⁇ L were sampled at times 0, 5, 15, 30, 60, 90, 120, 240, and 1440 minutes and transferred to a polypropylene 96-well microplate. Protein present in samples was quantified using a PierceTM BCA assay (Thermo Scientific, Waltham, MA) according to the manufacturer’s instructions.
  • agarose hydrogel preparations are capable of releasing up to 100% of whey protein isolate after 1440 minutes in excipient-containing microparticle preparations. In the absence of excipient, nearly 70% of whey protein isolate is released after 1440 minutes.
  • agarose hydrogels were prepared by mixing 10-100 mg/mL of agarose with 20 mL of PBS (pH 7.4) and 50-200 mg/mL calcium caseinate. Locust bean gum excipient (Spectrum Chemical, New Brunswick, NJ) was added to the agarose/caseinate to achieve a 2 mg/mL final solution.
  • the mixture was heated at 120°C for 1 minute and subsequently cooled to room temperature to form solid hydrogel preparations.
  • a portion of the preparation was incubated in a drying oven at 60 °C overnight before milling via hammer mill (MF-10 Basic, IKA, Wilmington, NC) at 5500 rpm.
  • Dissolution analysis assay of the preparation was performed using a benchtop Roto-Therm incubator (Benchmark Scientific, Sayreville, NJ) at 37 °C. Dissolution was performed using 200 mg replicates in triplicate using 15 mL Falcon tubes containing 12 mL of PBS (pH 7.4).
  • agarose hydrogels were prepared by mixing 50 mg/mL of agarose with 20 mL of PBS (pH 7.4) and 50 mg/mL calcium caseinate.
  • a portion of the preparation was incubated in a drying oven at 60 °C overnight before milling via hammer mill (MF-10 Basic, IKA, Wilmington, NC) at 5500 rpm.
  • Dissolution analysis assay of the preparation was performed using a benchtop Roto-Therm incubator (Benchmark Scientific, Sayreville, NJ) at 37 °C. Dissolution was performed using 200 mg replicates in triplicate using 15 mL Falcon tubes containing 12 mL of PBS (pH 7.4). Aliquots of 200 ⁇ L were sampled at times 0, 5, 15, 30, 60, 90, 120, 240, and 1440 minutes and transferred to a polypropylene 96-well microplate.
  • agarose hydrogels were prepared by mixing 50 mg/mL of agarose with 20 mL of PBS (pH 7.4) and 50 mg/mL calcium caseinate, 50 mg/ml hydrolyzed whey protein isolate, or 100 mg/ml whey protein isolate.
  • Locust bean gum (Spectrum Chemical, New Brunswick, NJ) was added to the agarose/calcium caseinate or agarose/whey protein solutions to achieve a final concentration of 2 mg/mL. The mixtures were heated at 120°C for 1 minute and subsequently cooled to room temperature to form solid hydrogel preparations. A portion of the preparation was incubated in a drying oven at 60 °C overnight before milling via hammer mill (MF-10 Basic, IKA, Wilmington, NC) at 5500 rpm. Dissolution analysis assay of the preparation was performed using a benchtop Roto-Therm incubator (Benchmark Scientific, Page 282 of 315 11645787v1 Docket No.: 2017299-0086 Sayreville, NJ) at 37 °C.
  • agarose matrices incorporating hydrolyzed whey protein isolate had substantially lower rates of release and total release of food component payload over 24 hours as compared to calcium caseinate preparations or non-hydrolyzed whey protein preparations.
  • agarose hydrogels were prepared by mixing 50 mg/mL of agarose with 20 mL of PBS (pH 7.4) and 50 mg/ml hydrolyzed whey protein isolate.
  • Locust bean gum (Spectrum Chemical, New Brunswick, NJ) was added to the agarose/calcium caseinate or agarose/whey protein solutions to achieve a final concentration of 2 mg/mL.
  • An excipient selected from chitosan (Sigma Aldrich, St. Louis, MO) or Eudragit E PO (Vikram Thermo, Gujurat, India) were mixed in the agarose/hydrolyzed whey protein isolate/locust bean gum solution to achieve a 25 mg/ml final solution.
  • the mixtures were heated at 120°C for 1 minute and subsequently cooled to room temperature to form solid hydrogel preparations.
  • a portion of the preparation was incubated in a drying oven at 60 °C overnight before milling via hammer mill (MF-10 Basic, IKA, Wilmington, NC) at 5500 rpm.
  • Dissolution analysis assay of the preparation was performed using a benchtop Roto-Therm incubator (Benchmark Scientific, Sayreville, NJ) at 37 °C. Dissolution was performed using 200 mg replicates in triplicate using 15 mL Falcon tubes containing 12 mL of PBS (pH 7.4).
  • agarose hydrogels were prepared by mixing 50 mg/mL of agarose with 20 mL of PBS (pH 7.4) and 50 mg/ml hydrolyzed whey protein isolate.
  • Locust Page 283 of 315 11645787v1 Docket No.: 2017299-0086 bean gum (Spectrum Chemical, New Brunswick, NJ) was added to the agarose/calcium caseinate or agarose/whey protein solutions to achieve a final concentration of 2 mg/mL.
  • An excipient selected from chitosan (Sigma Aldrich, St. Louis, MO) and/or karaya gum (Sigma Aldrich, St. Louis, MO) were mixed in the agarose/hydrolyzed whey protein isolate/locust bean gum solution to achieve a 25 mg/ml final solution. The mixtures were heated at 120°C for 1 minute and subsequently cooled to room temperature to form solid hydrogel preparations.
  • a portion of the preparation was incubated in a drying oven at 60 °C overnight before milling via hammer mill (MF-10 Basic, IKA, Wilmington, NC) at 5500 rpm.
  • Dissolution analysis assay of the preparation was performed using a benchtop Roto-Therm incubator (Benchmark Scientific, Sayreville, NJ) at 37 °C. Dissolution was performed using 200 mg replicates in triplicate using 15 mL Falcon tubes containing 12 mL of PBS (pH 7.4). Aliquots of 200 ⁇ L were sampled at times 0, 5, 15, 30, 60, 90, 120, 240, and 1440 minutes and transferred to a polypropylene 96-well microplate.
  • micellar casein 29% (w/w) StarTab, 15% (w/w) d-lactose, and 1% (w/w) d-glucose;
  • 35% (w/w) VitaSmooth 15% (w/w) d-lactose and 50% (w/w) d-glucose;
  • 12.5% (w/w) microcrystalline cellulose 12.5% (w/w) d-lactose and 75% (w/w) micellar casein; or
  • preparations incorporating 5% (w/w) StarTab, 3% (w/w) lactose, and 1% (w/w) magnesium stearate achieved high food component payload loading (e.g., greater than 90% w/w).
  • a preparation incorporating 90% (w/w) micellar casein, 5% (w/w) StarTab compressible starch, 3% (w/w) lactose, 1% (w/w) magnesium stearate, and 1% (w/w) microbial transglutaminase had a significantly reduced release rate as compared to a preparation incorporating 90% (w/w) micellar casein, 9% (w/w) microcrystalline cellulose, and 1% (w/w) microbial transglutaminase. LLL.
  • Example 64 Incorporation of exemplary microparticle preparations into food compositions
  • This example shows that the component excipient and matrices of exemplary microparticle preparations can affect incorporation into food compositions (e.g., food products).
  • an exemplary milled protein particle preparation (first panel) containing 39% (w/w) agarose (VWR, Rador, PA), 20% (w/w) Eudragit E PO (Vikram Thermo, India), 2% (w/w) locust bean gum (Spectrum Chemical, New Brunswick, NJ), 39% (w/w) hydrolyzed whey protein isolate (AMCO Proteins, Burlington, NJ) was incorporated into vanilla protein powder (Muscle Milk TM, PepsiCo, Purchase, NY; second panel), strawberry Greek yogurt (ChobaniTM, Norwich, NY; third panel), nutrition shake (NutrenTM, Nestle, Bridgewater, NJ; fourth panel), or lemon-lime sports drink (G
  • Images show the food compositions (e.g., food products) in the absence (left) or absence (right) of microparticle preparation.
  • Added protein to each food composition was an additional 10 grams, 5 grams, 5 grams, or 5 grams of protein per serving of protein powder, yogurt, nutrition shake or sports drink, respectively.
  • Samples of 1 gram of vanilla protein powder, 10 grams of Greek yogurt, 10 mL of nutrition shake, or 10 mL of sports drink were transferred to a 20 mL scintillation vial or polypropylene weigh boat and mixed with adequate mass of formulated agarose protein particles to increase the protein content of a sample Page 285 of 315 11645787v1 Docket No.: 2017299-0086 to 10 grams of protein per serving of vanilla protein powder, 5 grams per serving of Greek yogurt, 5 grams per serving of nutrition shake, or 5 grams per serving of sports drink. Scintillation vials were homogenized via vortexing on high for 60 seconds prior to imaging.
  • FIG.97A addition of exemplary particle preparation to dry protein powder, Greek yogurt and nutrition shake resulted in minimal visual alterations.
  • the exemplary particle preparation did not incorporate well into the sports drink food product as particles were observed to settle at the bottom of the beverage.
  • FIG.97B an exemplary milled particle preparation containing 39% (w/w) agarose (VWR, Rador, PA), 20% (w/w) hydroxyapatite 5 ⁇ m (Sigma Aldrich, St.
  • vanilla protein powder Muscle Milk TM, PepsiCo, Purchase, NY; second panel
  • strawberry Greek yogurt ChiobaniTM, Norwich, NY; third panel
  • nutrition shake NutrenTM, Nestle, Bridgewater, NJ; fourth panel
  • lemon-lime sports drink Gatorade TM, PepsiCo, Purchase, NY; fifth panel.
  • Images show the food compositions (e.g., food products) in the absence (left) or absence (right) of microparticle preparation.
  • Added protein to each food composition was an additional 10 grams, 5 grams, 5 grams, or 5 grams of protein per serving of protein powder, yogurt, nutrition shake or sports drink, respectively.
  • Samples of 1 gram of vanilla protein powder, 10 grams of Greek yogurt, 10 mL of nutrition shake, or 10 mL of sports drink were transferred to a 20 mL scintillation vial or polypropylene weigh boat and mixed with adequate mass of formulated agarose protein particles to increase the protein content of a sample to 10 grams of protein per serving of vanilla protein powder, 5 grams per serving of Greek yogurt, 5 grams per serving of nutrition shake, or 5 grams per serving of sports drink. Scintillation vials were homogenized via vortexing on high for 60 seconds prior to imaging.
  • FIG. 97B addition of exemplary particle preparation to dry protein powder, Greek yogurt and nutrition shake resulted in minimal visual alterations.
  • the exemplary particle preparation did not incorporate well into the sports drink food product as particles were observed to settle at the bottom of the beverage.
  • FIG.97C an exemplary spray-dried, cross-linked, alginate microparticle (CLAM) preparation containing 40% (w/w) alginate (Sigma Aldrich, St.
  • Images show the food compositions (e.g., food products) in the absence (left) or absence (right) of microparticle preparation.
  • Added protein to each food composition was an additional 10 grams, 5 grams, 5 grams, or 5 grams of protein per serving of protein powder, yogurt, nutrition shake or sports drink, respectively.
  • Samples of 1 gram of vanilla protein powder, 10 grams of Greek yogurt, 10 mL of nutrition shake, or 10 mL of sports drink were transferred to a 20 mL scintillation vial or polypropylene weigh boat and mixed with adequate mass of formulated agarose protein particles to increase the protein content of a sample to 10 grams of protein per serving of vanilla protein powder, 5 grams per serving of Greek yogurt, 5 grams per serving of nutrition shake, or 5 grams per serving of sports drink. Scintillation vials were homogenized via vortexing on high for 60 seconds prior to imaging. As shown in FIG. 97C, addition of exemplary particle preparation to dry protein powder, resulted in minimal visual alterations.
  • vanilla protein powder Muscle Milk TM, PepsiCo, Purchase, NY; second panel
  • strawberry Greek yogurt ChobaniTM, Norwich, NY; third panel
  • nutrition shake NutrenTM, Nestle, Bridgewater, NJ; fourth panel
  • lemon-lime sports drink Gatorade TM, PepsiCo, Purchase, NY; fifth panel
  • compositions e.g., food products
  • Added protein to each food Page 287 of 315 11645787v1 Docket No.: 2017299-0086 composition was an additional 10 grams, 5 grams, 5 grams, or 5 grams of protein per serving of protein powder, yogurt, nutrition shake or sports drink, respectively.
  • Samples of 1 gram of vanilla protein powder, 10 grams of Greek yogurt, 10 mL of nutrition shake, or 10 mL of sports drink were transferred to a 20 mL scintillation vial or polypropylene weigh boat and mixed with adequate mass of CLAMs.
  • vanilla protein powder Muscle Milk TM, PepsiCo, Purchase, NY; second panel
  • strawberry Greek yogurt ChobaniTM, Norwich, NY; third panel
  • nutrition shake NutrenTM, Nestle, Bridgewater, NJ; fourth panel
  • lemon-lime sports drink Gatorade TM, PepsiCo, Purchase, NY; fifth panel.
  • Images show the food compositions (e.g., food products) in the absence (left) or absence (right) of microparticle preparation.
  • Samples of 1 gram of vanilla protein powder, 10 grams of Greek yogurt, 10 mL of nutrition shake, or 10 mL of sports drink were transferred to a 20 mL scintillation vial or polypropylene weigh boat and mixed with adequate mass of inulin preparation. Scintillation vials were homogenized via vortexing on high for 60 seconds prior to imaging. As shown in FIG.97E, addition of exemplary particle preparation to dry protein powder, resulted in minimal visual alterations. Addition of exemplary particle preparation to Greek yogurt, nutrition shake, and sports drink significantly increased the viscosity. Large clumps were observed when added to Greek yogurt, and incorporation of air into the sports drink was observed (e.g., formation of an unstable foam).
  • Example 65 Exemplary spray dried microparticle preparations can achieve small particle sizes
  • This example shows that exemplary microparticle preparations manufactured using a spray dried process can result in a decreased particle size as compared to commercial food components.
  • whey protein isolate AMCO Proteins, Burlington, NJ
  • particle size is approximately 300 ⁇ m (as shown in FIG.98F), meaning that milled particle formulations ranging from 200-300 ⁇ m are ineffective at entrapping this protein. Solubilization and subsequent spray drying of whey protein can reduce particle size to that of individual whey proteins on a nanometer scale.
  • a 500 mL solution of 10% (w/v) whey protein isolate and 0.2% (w/v) L-arginine (Millipore Corp., Darmstadt, Germany) in Milli-Q water was prepared at room temperature over a stir plate.
  • the solution was then spray dried using a Buchi B-290 mini spray dryer (Buchi, New Castle, DE) operating at an inlet temperature of 130 °C, an outlet temperature of 51 °C, pump 30%, needle valve at 45mm and aspirator set to 100%.
  • the resulting powder (FIG.98A, left) was mixed with silicon dioxide 10-20 nm (Sigma Aldrich, St.
  • the resulting powder (FIG.98B, left) was mixed with silicon dioxide 10-20nm (Sigma Aldrich, St. Louis, MO) using an IKA Eurostar overhead stirrer (IKA, Wilmington, NC) at 800 rpm (FIG. 98B, right).
  • IKA IKA Eurostar overhead stirrer
  • FIG. 98B right
  • a 500 mL solution of 10% (w/v) whey protein isolate and 0.2% (w/v) aspartic acid (Sigma Aldrich, St. Louis, MO) in Milli-Q water was prepared at room temperature over a stir plate.
  • the solution was then spray dried using a Buchi B-290 mini spray dryer (Buchi, New Castle, DE) operating at an inlet temperature of 130 °C, outlet temperature of 51 °C, pump 30%, needle valve at 45mm and aspirator set to 100%.
  • the resulting powder (FIG. Page 289 of 315 11645787v1 Docket No.: 2017299-0086 98C, left) was mixed with silicon dioxide 10-20nm (Sigma Aldrich, St. Louis, MO) using an IKA Eurostar overhead stirrer (IKA, Wilmington, NC) at 800 rpm (FIG.98C, right).
  • a 500 mL solution of 10% (w/v) whey protein isolate and 1.5% (w/v) aspartic acid (Sigma Aldrich, St. Louis, NO) in Milli-Q water was prepared at room temperature over a stir plate.
  • the solution was then spray dried using a Buchi B-290 mini spray dryer (Buchi, New Castle, DE) operating at an inlet temperature of 130 °C, outlet temperature of 51 °C, pump 30%, needle valve at 45mm and aspirator set to 100%.
  • the resulting powder (FIG. 98D, left) was mixed with silicon dioxide 10-20nm (Sigma Aldrich, St.
  • Example 66 Methods for manufacturing exemplary microparticle preparations can be scaled up
  • This example shows that methods for manufacturing exemplary microparticle preparations can be scaled up.
  • hydrolyzed whey protein food component e.g., payload
  • a matrix composition further comprising agarose was scaled up to 30g.
  • a stock mixture of 50:2 agarose:locust bean gum was prepared.
  • FIG.99A shows a flow chart of the scaled-up manufacturing process.
  • FIG.99B, FIG.99C, and FIG.99D show a microscopic image, photographic image, and volume density distribution plot, respectively, of the resulting microparticle preparations.
  • a mixture of 12g of 27 Stearin (Bunge Loders Croklaan), 6.8 g of ethyl cellulose 100 cP (Sigma-Aldrich), 1.2 g of acetic acids of mono and di-glycerides (DANISCO), 19.6g of bovine serum albumin (Sigma-Aldrich), and 0.4g of FITC bovine serum albumin (Sigma-Aldrich) was mixed in a closed glass container by vigorously shaking for 20 minutes.
  • a Haake MiniLab 3 Extruder (Thermo Scientific) was assembled with counter-rotating twin screws set to 165 oC and 30 RPM. The mixture was fed into the extruder using a pneumatic feeder in 500 mg portions.
  • FIG.99E shows a flow chart of the scaled-up melt-extrusion manufacturing process.
  • FIG.99F, FIG.99G, and FIG.99H show a microscopic image, photographic image, and volume density distribution plot, respectively, of the resulting microparticle preparations. OOO.
  • Example 67 Exemplary multi-coated microparticle preparations
  • this example shows microparticle preparations having two coating layers: one hydrophobic layer, and a hydrophilic layer.
  • a 2% (w/w) solution of hydroxypropyl methylcellulose in 100 mL water was stirred at 400 RPM at 100 °C for 30 mins.
  • a fluid bed coater was assembled in accordance with the manufacturer’s instructions.
  • a 1mm diameter microparticle preparation incorporating 55% Page 291 of 315 11645787v1 Docket No.: 2017299-0086 (w/w) micellar casein, 15% (w/w) StarTab, 15% (w/w) lactose, and 5% (w/w) inulin was obtained and the mass was recorded.
  • the hydroxypropyl methylcellulose solution was placed on a hot plate set to 50 ⁇ C and 250 RPM and pumped through the tubing of the fluid bed coater.
  • the fluid bed coater parameters were set as follows: spray on/off: 0.4/0.6, 12 RPM, pump rev: 5 seconds, inlet temp: 30 ⁇ C.
  • the particles were consistently monitored to assure fluidization and that the nozzle did not clog. Spraying occurred until 5% of hydroxypropyl methylcellulose was coated onto particles. The single-coated particle mass was recorded. All tubing was cleaned with water followed by ethanol by pumping the two solutions through the tubing at 60 RPM.
  • a 5% (w/w) ethyl cellulose 100 cP solution in 100 mL ethanol was stirred at 400 RPM at 100 ⁇ C for 30 minutes.
  • the solution was then placed on a hot plate set to 80 ⁇ C and 250 RPM.
  • the fluid bed coater parameters were as follows: spray on/off: 0.2/0.8, 15 RPM, pump rev: 5 seconds, inlet temp: 80 ⁇ C.
  • the particles were consistently monitored to assure fluidization and that the nozzle did not clog. Coating occurred until 8% ethyl cellulose was coated onto particles.
  • the dual- coated particle mass was recorded. The same dual-coating process was repeated but with the order of hydroxypropyl methylcellulose and ethyl cellulose coatings reversed.
  • Particle dissolution assays of both dual-coated coated particles and uncoated particles were performed in triplicates in 12 mL PBS and simulated gastric fluid.200 ⁇ L of sample was taken at 0, 5, 15, 30, 60, 120, 240, and 1440 mins. A standard BCA assay was then performed. As shown in FIG. 100A and FIG.100B, a microparticle preparation having a hydrophobic base coat and a hydrophilic top coat was more effective at delaying release of food component (e.g., payload) in both neutral and acidic conditions (i.e., PBS; FIG.100A, and simulated gastric fluid, FIG.100B, respectively).
  • food component e.g., payload
  • 10% (w/w) hydroxypropyl methylcellulose acetate succinate was added to 100 mL of water and stirred at 400 RPM at 100 ⁇ C for 30 mins.
  • a fluid bed coater was assembled in accordance with the manufacturer’s instructions.
  • a 1mm diameter microparticle preparation incorporating 55% (w/w) micellar casein, 15% (w/w) StarTab, 15% (w/w) lactose, and 5% (w/w) inulin was obtained and the mass was recorded.
  • the hydroxypropyl methylcellulose acetate succinate solution was placed on a hot plate set to 50 ⁇ C and 250 RPM and pumped through the fluid bed coater tubing.
  • the fluid bed coater parameters were as follows: Spray on/off: 0.6/0.4, 18 RPM, pump rev: 5 seconds, inlet temp: 25 ⁇ C.
  • the Page 292 of 315 11645787v1 Docket No.: 2017299-0086 particles were consistently monitored to assure fluidization and that the nozzle did not clog. Coating occurred until 14% hydroxypropyl methylcellulose acetate succinate was added to the particles. The single-coated particle mass was recorded. All tubing was cleaned with water by pumping through the tubing at 60 RPM. 2% (w/w) of NS Enteric (Sodium Alginate) in 100 mL of water was stirred at 400 RPM at 100 ⁇ C until NS Enteric appeared solubilized.
  • the NS Enteric solution was then placed on a hot plate set to 80 ⁇ C and 250 RPM.
  • the fluid bed coater parameters were as follows: Spray on/off: 1.0/0.4, 11 RPM, pump rev: 5 seconds, inlet temp: 80 ⁇ C.
  • the particles were consistently monitored to assure fluidization and that the nozzle did not clog. Spraying occurred until 6 % of NS Enteric was coated onto the particles.
  • the dual-coated particle mass was recorded. The same dual-coating process was repeated but with the order of hydroxypropyl methylcellulose acetate succinate and NS Enteric coatings reversed.
  • Particle dissolution assays of both dual-coated coated particles and uncoated particles were performed in triplicates in 12 mL PBS and simulated gastric fluid.200 ⁇ L of sample was taken at 0, 5, 15, 30, 60, 120, 240, and 1440 mins. A standard BCA assay was then performed. As shown in FIG. 100E and FIG.100F, a microparticle preparation having a hydrophobic base coat and a hydrophilic top coat was more effective at delaying release of food component (e.g., payload) in both neutral and acidic conditions (i.e., PBS, FIG.100E and simulated gastric fluid, FIG. 100F ⁇ respectively).
  • food component e.g., payload
  • 5% (w/w) ethyl cellulose 300 cP solution in water was prepared by mixing on a stir plate at 400 RPM and 100 ⁇ C for 30 mins.
  • the fluid bed coater was assembled in accordance with the manufacturer’s instructions.
  • a 0.5 mm diameter microparticle preparation incorporating 50% (w/w) microcrystalline cellulose, 5% (w/w) hydroxypropyl cellulose grade SSL, 5% (w/w) DryFlo, 38% (w/w) inulin, and 2% (w/w) FITC-inulin was obtained and the mass was recorded.
  • the ethyl cellulose 300 cP solution was placed on a scale and pumped through the fluid bed coater tubing at 60 RPM.
  • the fluid bed coater parameters were as follows: Spray on/off: 0.4/0.6, 17 RPM, pump rev: 5 seconds, inlet temp: 80 ⁇ C.
  • the particles were consistently monitored to assure fluidization and that the nozzle did not clog. Coating occurred until 9.5% of ethyl cellulose was coated onto the particles. The single-coated particle mass was recorded. All tubing was cleaned with ethanol followed by water by pumping the two solutions through the tubing at 60 RPM.
  • a solution containing 5% (w/w) ethyl cellulose 300 cP in 100 mL ethanol was stirred at 400 RPM at 100 ⁇ C for 30 mins.
  • the fluid bed coater was assembled according to the manufacturer’s instructions. Particles incorporating 38% (w/w) carnauba wax, 10% (w/w) ethyl cellulose 100, 10% (w/w) stearic acid, 2% (w/w) folic acid, and 40% (w/w) whey protein isolate were obtained.
  • the ethyl cellulose 300 cP solution was placed on a scale to track coating weight in grams as spraying occurred.
  • the fluid bed parameters were as follows: spray on/off: 0.8/0.8, 50 RPM, pump rev: 6 seconds, inlet temp: 50 ⁇ C. Spraying occurred until 20% (w/w) of ethyl cellulose 300 cP was added to the particles. The particles were consistently monitored to assure fluidization and that the nozzle did not clog. All tubing was cleaned with ethanol followed by water by pumping the two solutions through the tubing at 60 RPM.100 mL of Eudragit Control (Eudragit L100) was obtained. The Eudragit L100 solution was placed on a scale to track coating weight in grams as spraying occurred.
  • the fluid bed coater parameters were as follows: spray on/off: 0.8/0.8, 50 RPM, pump rev: 6 seconds, inlet temp: 30 ⁇ C. Spraying occurred until 12% (w/w) of Eudragit L100 was added to the particles. All tubing was cleaned with water by pumping it through the tubing at 60 RPM. Next, a solution of 2% (w/w) NS Enteric in 100 mL of water was prepared on a 100 ⁇ C hot plate, stirring at 400 RPM for 30 mins. The NS Enteric solution was placed on a scale to track coating weight in grams as spraying occurred.
  • the fluid bed coater parameters were as follows: spray on/off: 0.0/0.0, 15 RPM, pump rev: 5 seconds, inlet temp: 80 ⁇ C.
  • an exemplary dual-coated microparticle preparation can delay the release of food component (e.g., payload) in both acidic and neutral conditions (i.e., PBS, FIG.101A, and simulated gastric fluid, FIG.101B, respectively).
  • PBS acidic and neutral conditions
  • FIG.101C uncoated particles
  • FIG.101D coated particles
  • FIGs.101F-101I show microscopy images at 10x magnification.
  • PPP Example 68: Methods for manufacturing exemplary high-loaded microparticle preparations
  • This example shows an exemplary method for manufacturing a high-loaded microparticle preparation having a small particle size.
  • particle size analysis using a laser diffraction particle sizer analyzer (Malvern Mastersizer 3000) of an enteric spray dry-encapsulated protein formulation (40% (w/w) sodium alginate, 20% (w/w) succinic acid, 40% (w/w) hydrolyzed whey protein)) indicated an exemplary microparticle exhibited a DV50 of ⁇ 8 ⁇ m.
  • Microscopy of exemplary spray dry-encapsulated inulin particle preparations (35% (w/w) sodium alginate, 17.5% (w/w) succinic acid, 3.5% (w/w) calcium carbonate, 8.5% (w/w) hydroxypropyl methylcellulose 40 cP, 36% (w/w) inulin) indicates spherical morphology (FIG.102D).75 mg portions of exemplary spray dried particles were added to 15 mL conical centrifuge tubes holding 12 mL of either simulated intestinal fluid (pH 7.5) or simulated gastric fluid (pH 1) at 37 oC and rotating at 20 rpm.200 ⁇ L samples were collected at 5, 15, 30, 60, 90, 120, 240, and 1440 minutes.
  • simulated intestinal fluid pH 7.5
  • simulated gastric fluid pH 1
  • this exemplary microparticle preparation 22 g of sodium alginate was dissolved in 900 mL of water overnight at 40 oC, followed by the dissolution of 66 g of hydrolyzed whey protein isolate and 12 g of succinic acid. The pH of the solution was adjusted to at least 7.2, at least 7.4, at least 7.6, at least 7.8, at least 8.0, at least 8.2, or at least 8.4 using ammonium hydroxide.
  • Example 69 Exemplary microparticle preparations increase bioavailability of food components
  • This example shows that an exemplary microparticle preparation can increase bioavailability of a food component (e.g., payload) by increasing intestinal permeability.
  • a food component e.g., payload
  • Approximately 40,000 Caco-2 cells were seeded in the upper chamber of a 12- well 0.4 ⁇ m polycarbonate transwell assay system (Nunc Cat# 141078). After 21 days in culture, cells were switched into pre-warmed Hank’s balanced salt solution (HBSS) and equilibrated for 30 minutes at 37 oC.
  • HBSS pre-warmed Hank’s balanced salt solution
  • TEER vales were measured for each well before and after addition of dosing solutions using a Millicell ERS-2 Voltohmmeter (Millipore Sigma Cat# MERS00002). TEER for each well was calculated as ohms per cm 2 , using the formula (R Sample -R blank )*A where A is the culture area in cm 2 . [0913] TEER measurements and permeability samples were collected simultaneously. 400 uL of HBSS (negative control) or a dosing solution was added to the upper (apical) compartment of the transwell system, and 800 uL of HBSS was added to the lower (basal) compartment.
  • Percent permeability was calculated as the (Clower/Cdosed)*100. Data shown as cumulative percent permeability over the course of 4 hours. Page 297 of 315 11645787v1 Docket No.: 2017299-0086 [0914] Dosing solutions were selected from 100 ⁇ M Lucifer yellow, 10 mM caffeine, 1 mM cyanidin chloride, or 1 mM FITC-inulin.
  • Exemplary preparations containing cyanidin chloride or FITC inulin food components had either a low (cyanidin chloride – 0.5 mM, FITC inulin – 1mM) or high (cyanidin chloride – 1 mM, FITC inulin - 2 mM) particle loading.
  • Cyanidin chloride was formulated in a liquid preconcentrate comprising 22% Kolliphor RH40, 4% sodium decanoate, 2% cholesterol, 73% cyanidin chloride.
  • FITC inulin was formulated in a liquid preconcentrate comprising: 61% Kappa-carrageenan, 24% Locust bean gum, 2% sodium decanoate, and 12% FITC inulin.
  • FIG.103A shows TEER measurements following dosing with formulated versus unformulated FITC inulin. Exemplary low and high dose formulations of FITC inulin appeared to cause a decrease in resistance (i.e., permeability) as compared to unformulated FITC inulin and negative control.
  • FIG.103B and FIG.103C show percent permeability and P eff , respectively, of lucifer yellow, caffeine, unformulated FITC inulin, and low and high doses of formulated FITC inulin. Exemplary low and high dose formulations of FITC inulin appeared to have greater permeability across the Caco-2 monolayer as compared to unformulated FITC inulin and Lucifer yellow, but less than the permeability of caffeine.
  • FIG.103D shows TEER measurements following dosing with formulated versus unformulated cyanidin chloride.
  • Exemplary low and high dose formulations of cyanidin chloride appeared to cause a decrease in resistance (i.e., permeability) as compared to unformulated cyanidin chloride and negative control.
  • FIG.103E and FIG.103F show percent permeability and P eff , respectively, of lucifer yellow, unformulated cyanidin chloride, and low and high doses of formulated cyanidin chloride.
  • Exemplary low and high dose formulations of cyanidin chloride appeared to have greater permeability across the Caco-2 monolayer as compared to unformulated cyanidin chloride and Lucifer yellow.
  • the TEER measurements were taken for cell culture monolayers dosed with the exemplary low or high dose FITC inulin formulations, or the exemplary low or high dose cyanidin chloride formulations.
  • minimal Page 298 of 315 11645787v1 Docket No.: 2017299-0086 barrier disruption and/or cell death was observed after dosing of exemplary formulations.
  • TEER measurements were statistically different from Caco-2 monolaters having permanent barrier disruption. Data is shown as mean +/- standard deviation. * p ⁇ 0.05, ** p ⁇ 0.01. RRR.
  • Example 70 Exemplary dual-coated microparticle preparations can release food components in a sequential manner
  • exemplary dual-coated microparticle preparation can release food components (e.g., payload) in a manner specific to coating order-specific or sequence.
  • base microparticles incorporated 47% (w/w) micellar casein, 25% (w/w) startab starch, 15% (w/w) lactose, and 4% (w/w) inulin.
  • solids were weighed and dissolved in the appropriate solvent with stirring at >300 RPM until no solids remained.
  • Exemplary coating solutions were as follows: 15% (w/v) hydroxypropyl methylcellulose acetate succinate (HPMCas) dissolved in water, 2% (w/v) NS enteric (NT - Colorcon) dissolved in water, 5% (w/v) ethyl cellulose (EC - 100 cP) dissolved in ethanol, and 5% (w/v) hydroxypropyl methylcellulose (HPMC) dissolved in cold water. 100 mL of each exemplary coating solution was used for fluid-bed coating. [0922] All fluid-bed coating was conducted on a Freund-Vector benchtop mini fluid-bed coater which was assembled and operated in accordance with the manufacturer’s instructions.
  • Exemplary coating solutions were run through the peristaltic pump and spray rates were calculated as grams per minute prior to attachment to the spray nozzle. Spray rates in grams/minute varied based on the polymer. The spray rates used were as follows: HPMCas – 0.6 grams/minute, NT – 0.4 grams/minute, EC – 0.4 grams/minute, and HPMC 0.54 grams/minute. Each exemplary coating layer was sprayed until the base particle had a minimum percentage weight gain of 3%, and each top coat was sprayed until particles had a minimum percentage weight gain of 2%. [0923] 100 mg of both coated and uncoated pelletized inulin particles were used for each dissolution assay. The same base formulation was used to assess the dual coating strategy and pH responsiveness.
  • BCA bicinchoninic
  • coated particles contained a base layer of 9% hydroxypropylmethyl cellulose acetate succinate and an outer coat of 6% sodium alginate or “NS Enteric”(Colorcon).
  • coated particles contained a base coat of 3% ethyl cellulose and top coat of 9% hydroxypropylmethyl cellulose acetate succinate.
  • coated particles contained a base coat of 2% ethyl cellulose and a top coat of 7% hydroxypropylmethyl cellulose.

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Abstract

Une préparation à libération prolongée comprend un composant de support et un composant de charge, le composant de charge étant encapsulé dans le composant de support, le support et/ou le composant de charge comprenant au moins un composant à libération prolongée, et le composant de charge comprenant au moins un composant de type macronutriment.
PCT/US2023/035547 2022-10-19 2023-10-19 Produits alimentaires formulés WO2024086307A1 (fr)

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US202363487165P 2023-02-27 2023-02-27
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US202363459570P 2023-04-14 2023-04-14
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Citations (3)

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Publication number Priority date Publication date Assignee Title
US20050142193A1 (en) * 2003-12-31 2005-06-30 Lijuan Tang Galantamine formulations
US20050152974A1 (en) * 2003-12-31 2005-07-14 Garth Boehm Atomoxetine formulations
US20050158383A1 (en) * 2003-10-21 2005-07-21 Garth Boehm Quetiapine formulations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050158383A1 (en) * 2003-10-21 2005-07-21 Garth Boehm Quetiapine formulations
US20050142193A1 (en) * 2003-12-31 2005-06-30 Lijuan Tang Galantamine formulations
US20050152974A1 (en) * 2003-12-31 2005-07-14 Garth Boehm Atomoxetine formulations

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