WO2014151329A1 - Particules pour appareil de pulvérisation en aérosol - Google Patents

Particules pour appareil de pulvérisation en aérosol Download PDF

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Publication number
WO2014151329A1
WO2014151329A1 PCT/US2014/025481 US2014025481W WO2014151329A1 WO 2014151329 A1 WO2014151329 A1 WO 2014151329A1 US 2014025481 W US2014025481 W US 2014025481W WO 2014151329 A1 WO2014151329 A1 WO 2014151329A1
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WO
WIPO (PCT)
Prior art keywords
extract
powder
vitamin
compound
ingestible
Prior art date
Application number
PCT/US2014/025481
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English (en)
Inventor
David A. Edwards
Cecily Lalor
Deen BHATTA
Anmol GIRI
John A. LAMPPA
Original Assignee
Aerodesigns, Inc.
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Application filed by Aerodesigns, Inc. filed Critical Aerodesigns, Inc.
Publication of WO2014151329A1 publication Critical patent/WO2014151329A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G1/00—Cocoa; Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/30—Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/56—Cocoa products, e.g. chocolate; Substitutes therefor making liquid products, e.g. for making chocolate milk drinks and the products for their preparation, pastes for spreading, milk crumb
    • 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
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/86—Addition of bitterness inhibitors
    • 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
    • A23L33/15—Vitamins
    • 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
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the invention relates generally to aerosolized products and apparatus for the containment, aerosolization, and/or delivery thereof.
  • Light, consumable particles can be drawn into a user's mouth for deposition on surfaces of the mouth for consumption through transdermal surfaces and/or through the digestive tract (e.g., ingestion via intake into the stomach and gastrointestinal tract by means of enteral administration).
  • ingestion via intake into the stomach and gastrointestinal tract by means of enteral administration e.g., ingestion via intake into the stomach and gastrointestinal tract by means of enteral administration.
  • consuming particles that are sufficiently light to be drawn into a user's mouth by inhalation one must address the risk of those particles reaching the back of the mouth or lungs and causing coughing or other adverse events, especially when the goal is, for example, to provide taste, nourishment, dietary supplementation, medicinal absorption, etc., involving the mouth, tongue, etc.
  • approaches to deliver materials to the mouth via the airborne route have largely (if not exclusively) focused on directed, non-breath-actuated delivery, where the force of the air current and size of the particles are such that particle trajectories are primarily limited to within the mouth.
  • Described herein are approaches by which a casual or forced breathing maneuver (such as normal inhalation) leads to the delivery of food, drink, vitamins, medication, and/or various other particles to the mouth. The transport of these particles occurs with the flowing air, to the back of the throat with limited delivery the throat and lungs.
  • Manufactured formulations using various powdered ingredients are developed allowing for the controlled inertia and gravitational influence of the consumable particles and therefore optimal oral delivery of powdered formulations.
  • Particles are delivered towards surfaces of the mouth, not reaching the back of the throat and lungs.
  • Formulations are described for a variety of payloads including, but not limited to, energy supplements, pharmaceutical compounds, over-the-counter pharmaceutical compounds, sleep-aid compounds, weight-loss compounds, nutraceuticals, antioxidants, and oral health compounds.
  • Particle size is extremely important to our delivery system, namely that the particles need to be small enough to remain airborne during casual breathing, but large enough to be directed and deposited primarily in the mouth while limiting throat and lung deposition.
  • Typical pathways of aerosol particles through an aerosolizing device and out of a corresponding mouthpiece are directed to varying degrees away from the back of the throat.
  • an ingestible powder for use in an aerosolizing delivery apparatus can be made of particles, at least of which about 50% have a volume median distribution between about 20 microns and about 220 microns.
  • the powder can be ingestible, and be made of one or more of the following: a flavoring agent, at least one dietary supplement, and at least one of an energy supplement, a
  • an oral health compound an over-the-counter pharmaceutical compound, a sleep-aid compound, a weight-loss compound, and an oral health compound.
  • the flavoring agent of the ingestible powder can be a masking agent, an artificial sweetener, a natural sweetener, a flavor compound, and/or an acidulant.
  • the ingestible powder further includes an antioxidant compound, for example a carotenoid, a flavonoid, an isoflavone, a tocopherol, a tocotrienol, lipoic acid, melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, selenium and/or ascorbic acid.
  • an antioxidant compound for example a carotenoid, a flavonoid, an isoflavone, a tocopherol, a tocotrienol, lipoic acid, melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, selenium and/or ascorbic acid.
  • the flavonoid the ingestible powder can be one or more of esveratrol, quercetin, rutin, catechin, proanthocyanidins, acai berry extract, raspberry extract, cranberry extract, pomegranate extract, plum extract, cherry extract and rosemary extract.
  • the carotenoid can be one or more of of alpha-carotene, beta- carotene, cryptoxanthin, lycopene, lutein and zeaxathin.
  • the isoflavone of the ingestible powder is one or more of genistein, daidzein, biochanin A, formononetin.
  • the ingestible powder the dietary supplement may be at least one of coenzyme Q 10, folic acid, NADH, vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B8, vitamin B9, vitamin B12, inositol, vitamin C, vitamin D, vitamin D2, vitamin D3, vitamin E, pyroxidine HCL, niacin, niacinamide, pantothenic acid, thiamin, calcium, iron, magnesium, phosphorous, zinc, copper, biotin, chromium, selenium, niacin, pyridoxine, and cyanocobalamin and complexes thereof.
  • the dietary supplement can be botanical dietary supplement.
  • the dietary supplement can be a specialty
  • the energy supplement of the ingestible powder is at least one of American ginseng, Red ginseng, Siberian ginseng, maca, rhodiola, ginger, guarana, turmeric, acetyl-L-carnitine, L-carnitine, creatine, taurine, L-phenylalanine, L-arginine, tyrosine, acetyl-tyrosine, N-acetyl L-tyrosine, ginko biloba, yerba-mate, kola nut, gotu kola, maitake, cordyceps sinensis, guarana, acai-berry, L-theanine, caffeine, quercitine, synephrine, green tea extract, theophylline, epigallocatechin gallate (EGCG),capsaicin, bee pollen, alpha-lipoic acid, and 1,3 dimethylamylamine (geranium), D-rib
  • the weight-loss compound of the ingestible powder can be an appetite suppressant compound and/or a thermogenic compound.
  • the weight loss compound can be hoodia, chitosan, chromium picolinate, conjugated linoleic acid, glucomannan, green tea extract, guar gum, guarana, guggal, senna, ephedra, bitter orange, fucoxanthin, white bean extract, vitamin D, human chorionic gonadotropin, resveratrol, capsaicin, chia, hoodia, L- carnitine, raspberry ketones, banaba leaf, red clover, ginger, almonds, acai berry, flax seeds, leucine and/or lipodrene.
  • the sleep aid compound of the ingestible powder can be melatonin, 5-hydroxytryptophan, 5-hydroxytrypatmine, diphenhydramine, doxylamine, benzodiazepine, kava, serenite, chamomile, phenibut, catnip herb, chamomile, glycine, hops, L-theanine, L-tryptophan, glycine, GABA, and/or valerian.
  • the ingestible powder may further comprise an excipient, a plant oil extract, an enzyme, a hormone and a probiotic.
  • the pharmaceutical compound of the ingestible powder can be an anti-depressant compound, an anti-anxiety compound, antibiotic compound, an allergy medicine, an/or an anti-inflammatory compound.
  • the oral health compound can be fluoride, vitamin C, vitamin B, zinc, menthol, thymol, eucaleptic, sodium bicarbonate, vitamin K, chlorhexidine, and/or xylitol.
  • embodiments of the ingestible powder include: an energy supplement, a dietary supplement, a flavoring agent, and sodium bicarbonate; wherein a mean size of particles of the ingestible powder is greater than 10 microns and less than 500 microns.
  • the ingestible powder also includes an energy supplement; a dietary supplement; and a flavoring agent, wherein a mean size of particles of the ingestible powder is between 18 and 70 microns.
  • Some embodiments of the ingestible powder includes citric acid.
  • the ingestible powder contains more citric acid than sodium bicarbonate, particularly wherein the weight ratio of citric acid to sodium bicarbonate is between 45 to 38 and 1 to 1.
  • the flavoring agent comprises thaumatin and stevia.
  • the weight ratio of thamatin to stevia is between 11 to 4 and 9 to 6.
  • the weight ratio of the energy supplement to thaumatin and stevia combined is between 25 to 220 and 90 to 17.
  • the flavoring agent of the ingestible powder is a natural flavoring agent.
  • the dietary supplement comprises at least one of niacin, pyridoxine, and cyanocobalamin.
  • the mean size of particles of the ingestible powder is between 18 and 70 microns.
  • an ingestible powder for use in an aerosolizing delivery apparatus comprises particles, at least of which about 50% have a volume median distribution between about 20 microns and about 220 microns; and the ingestible powder comprises at least one flavoring agent; and an oral health compound.
  • the ingestible powder comprises xylitol powder, spearmint powder, menthol crystals, and sodium bicarbonate powder.
  • the ingestible powder comprises about 75% xylitol by weight, about 22% spearmint powder by weight, about 1.5% menthol crystals by weight, and about 1.5% sodium bicarbonate powder by weight.
  • Embodiments can include one or more of the described features, alone or in combination. Brief Description of Drawings
  • Figure 1 is a graph from a HELOS-RODOS particle size analysis of crushed and sieved mint leaves.
  • Figure 2 is a graph from a HELOS-RODOS particle size analysis of a sample apple flavored energy supplement powder.
  • Figure 3 is a graph from a HELOS RODOS particle size analysis of a sample vitamin dietary supplement powder.
  • Figure 4 is a graph from a HELOS-RODOS particle size analysis of two sample flavored-chocolate powders.
  • the approach presented herein is based, at least in part, on the realization of a new form of ingestible particles and methods and apparatus for the delivery thereof. More specifically, the approach is directed to aerosolizable, dry powder products for use in aerosolizing apparatuses used to deliver powder formulations to the mouth. Exemplary devices for use with the embodiments of the present invention are described in, for example, Patent application # PCT/US2008/079214 and US Patent Application 61/705,081 (both incorporated herein in their entirety).
  • Physical and chemical aspects of particles, specific particle ingredient combinations, ingredients and formulations are optimized for 1) use in aerosolizing apparatuses, resulting in minimal or no pulmonary delivery to the back of the mouth, onto tongue, palate, etc., and 2) payload performance characteristics (taste, solubility) for enhanced user experience.
  • a primary consideration for physical and performance aspects of the particles making up the payload and product formulations is particle size, distribution of particle sizes in a formulation, and population density of particle sizes in a formulation.
  • the aerosolized product should be of a pre-determined size, i.e., of sufficient size to limit entry into the respiratory tract but of small enough size to allow for suspension in the air.
  • particles should be greater than approximately 10 microns to prevent pulmonary delivery. Additionally, particles greater than about 500 microns generally do not have sufficient airborne suspension characteristics for use in an aerosolizing apparatus, and therefore are undesirable.
  • the particle size distribution of a particular formulation can effect: user experience, solubility of the powder when contacting tissue, flight performance, manufacturing tolerances, manufacturing processes, and/or segregation/settling of various components of the formulation. Therefore, optimal or preferred particle size ranges and distributions for one ingestible powder formula may differ from another formulation.
  • volume mean distribution size of the aerosolized food product is at least 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 75, 80, 95, 100, 105, 1 10, 1 15, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235, 240, 245, 250, 255, 260, 265, 270, 275, 280, 285, 290, 295, 300, 325, 350, 375, 400, 425, 450, 475, or 500 microns.
  • the predetermined, volume mean distribution size of the aerosolized food product is less than 500, 450, 400, 350, 325, 300, 275, 250, 245, 240, 235, 230, 225, 220, 215, 210, 205, 200, 195, 190, 185, 180, 175, 150, 140, 130, 120, 1 10, 100, 90, 80, 70, 60, 50, 40, 30, 20, or 10 microns in size. Ranges intermediate to those recited above, e.g., about 50 microns to about 215 microns, are also intended to be part of this disclosure. For example, ranges of values using a combination of any of the above recited values as upper and/or lower limits are intended to be included.
  • a size range/distribution of the ingestible powder particles wherein 50%, 60%, 70%, 80%, 90%, 95% or higher of the particles of a specific formulation have a volume median distribution between 10 and 100 microns, between 20 and 100 microns, between 30 and 100 microns, between 40 and 100 microns, between 20 and 90 microns, between 20 and 80 microns, between 20 and 70 microns, between 20 and 60 microns, between 20 and 120 microns, between 30 and 120 microns, between 40 and 120 microns, between 50 and 120 microns, between 60 and 120 microns, between 40 and 140 microns, between 50 and 140 microns, between 60 and 140 microns, between 70 and 140 microns, between 80 and 140 microns, between 60 and 160 microns, between 70 and 160 microns, between 80 and 160 microns, between 90 and 160 microns, between 100 and 160 microns, between 80 and 180 microns, between 90 and 180 microns, between 10 and 100 micron
  • Figure 1 shows the density distribution and cumulative distribution of a volume mean diameter determination of ground mint leaves using a HELOS-RODOS particle sizing system.
  • minimum particle size is an important feature of the approach.
  • the food aerosol particles are designed to be substantially delivered and deposited into the mouth, for example by the forces of gravity or inertial impaction, but to not be easily delivered and deposited substantially further into the respiratory tract, for example the trachea or lungs. Such food particles would thus possess a size larger than that which focuses penetration into the lungs (i.e., larger than about 10 microns).
  • maximum particle size is an important feature of the approach.
  • the aerosol cloud must remain suspended in air for at least a brief time so that displacement into the mouth can occur.
  • the particles must not be so large such that they rapidly settle from the air. This will greatly depend on the force(s) and/or mechanism(s) by which the particles are held in the air (e.g., by "natural” forces alone, such as inertia, diffusion, etc., or by additional forces, such as an impeller, air currents, convection, etc.).
  • the particles should be less than about 500 microns, less than about 400 microns, less than about 300 microns under typical suspension forces and mechanisms.
  • the aerosol may be carried via inhaled air that flows all the way to the lungs (for example, like the inhalation a smoker may have, which carries air and smoke through/from the cigarette, into the lungs).
  • the aerosol may be carried via "sucked” air that "stops” in the mouth (more like the approach used with a typical straw and beverage, or with cigars). (In some cases, elements of both approaches may be suitable.)
  • This potential distinction may have important implications for an aerosolizable, ingestible powder. For example, in the case in which the particles are carried by air that continues directly to the lungs, preventing deposition of particles too far into the respiratory tract may significantly depend on the physical parameters of the particles. Preliminary tests have shown that the water-solubility of the dry powders used plays a role in the taste and potential coughing reflex resulting from intake of the aerosolized food product.
  • Powders of particles that tend to be more rapidly water- soluble for example, ground chocolate bars, or certain chocolate-based powders, give rise to a generally pleasing reaction upon contact of the particles with the tongue and other surfaces within the mouth.
  • ground chocolate bars for example, the effect is in some cases similar to that of sensing chocolate melt very rapidly in one's mouth.
  • Particles that are less water-soluble, such as certain ground-cocoa-based powder products tend to be considered harsher and more likely to elicit less pleasurable reactions, such as a dry-mouth sensation or coughing.
  • a combination of both kinds of powders, in varying proportions provides interesting flavor complexity.
  • solubility of particles may be enhanced by combining the target payload ingredient (for example, an energy supplement, a pharmaceutical compound, and over the counter compound, etc.) with excipients or penetration enhancers including, but not limited to, solubilizing agents such as sucrose, for example Tweens (polysorbates), and spans (sorbitan esters) in the final formulation.
  • solubilizing agents such as sucrose, for example Tweens (polysorbates), and spans (sorbitan esters) in the final formulation.
  • a particle size is associated with solubility, with larger size particles being less soluble than smaller size particles of the same formulation or ingredient compound, wherein the effective surface area of the final formulation product is maximized. Therefore, optimizing the solubility and/or performance of the payload is a function of balancing particle size, inherent solubility, and/or excipients added to the formulation.
  • Dry powder particles can be created through a number of different methods.
  • the ingredients of a formulation may be dehydrated.
  • the ingredient may be frozen first to facilitate subsequent grinding or chopping.
  • the ingredient may subsequently be ground to form particle products of the appropriate size. Grinding of the products can be performed by use of a mortar and pestle. Alternatively or in addition, products may be chopped, for example using a mechanical or electrical grinder, knives, etc. The resulting ground or chopped particles can subsequently be filtered through sieves (for example by hand, using an electrical or mechanical sieve shaker, by an air classification system, by a screening system, etc.) to achieve the appropriate particle size.
  • a powder mill grinds down larger particles into predefined sizes.
  • spray drying in which a mixture of water and the material to be dried is forced through a nozzle into a high-temperature drum, instantly evaporating the water droplets clinging to the material, may be utilized. Spray drying gives the most consistent desired particle size distribution and population density, increasing the output of particles having the desired performance characteristics.
  • the particles By designing a dry powder formulation that can be aerosolized (particles much larger than 500 microns fall quickly out of the air unless supported by an external force) and yet has sufficiently large particles (greater than approximately 1, 2, 3, 4, 5, 10, 15 or 20 microns) such that few or no particles enter the lungs on inspiration, our technology results in deposition and delivery into the mouth.
  • the particles would be designed (sized) such that, for example, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, at least about 97%, or at least about 99% of the particles deposit in the mouth and do not extend further into the respiratory tract.
  • the design of the particles should also take into consideration reducing any tendency to cough, gag, or otherwise react unfavorably to the ingestible powder when aerosolized.
  • aerosolizable products e.g. food powders, dietary supplements, pharmaceuticals, etc.
  • aerosolizable, consumable product it may be desirable to increase or decrease the number (or mass) of particles of a first size range (representing a subset of the overall initial size distribution), relative to the number (or mass) of particles of a second size range (representing a subset of the overall initial size distribution).
  • the initial particle size distribution of a consumable, aerosolizable formulation or ingredient may not be desirable for a variety of reasons.
  • the formulation contains several different ingredients, which are mixed or otherwise combined together.
  • the ingredients may include naturally-occurring powders that already have a particular particle size distribution.
  • various ingredients may have different physical/chemical properties, such as different crystalline shapes and sizes, which naturally lend themselves to form particles of a certain size upon crushing, milling, atomization, or some other process by which they are made into powders.
  • Some ingredients may typically be used in applications where a particular size distribution is appropriate. For example, caffeine commercially available in particulate form typically has a median particle size of roughly 15-20 microns (e.g., about 18 microns).
  • Certain commercially-available vitamins in particulate form such as B vitamins (e.g., B3 as niacin, B6 as pyridoxine, or B 12 as cyanocobalamin), may also have a typical median particle size below a desirable range. This may also be the case for other ingredients, such as the sweeteners stevia and/or thaumatin. Any such "pre-existing" distributions may not be ideal for the aerosol product being prepared and its intended use. Compositions and methods have been discovered that can lead to substantially increased mean (or median) particle sizes of powders.
  • a consumable oil when added to certain powdered ingredients, has been found to play a role in shifting the particle size distribution "upward" (i.e., to larger values), and to play a role in reducing the number/mass of smaller particles relative to larger particles.
  • a hypothesis as to why this occurs is that smaller particles agglomerate onto each other, and/or into the oil, and/or onto larger particles, and/or "self-agglomerate," creating relatively stable larger particles.
  • sample powders prepared with consumable oils for modulating particle size distribution contained chocolate and sugar.
  • a flavoring agent was further incorporated (e.g., peppermint and cherry flavoring agents).
  • BFC001C sample cherry-chocolate flavored powder
  • BFC001P sample peppermint chocolate flavored powder
  • the original ingredients typically had an initial particle size distribution with a cumulative density distribution below a desired value (e.g., an overall mean or median particle size of less than about 5, 10, 15, 20, 25, 30, 40, 50, 75, 100, 125, 150, 175, 200, 225, 250, 275, 300 microns).
  • a consumable oil representing roughly 2% of the total formulation (e.g., about 0.5%, 1%, 2%, 3%, 4%, or 5%)
  • the cumulative density distribution at 10% was found to shift upward (increase) substantially (e.g., by about 1, 2, 3, 4, 5, or 10 microns, or more).
  • changing a consumable, aerosolizable product from a first size distribution to a second size distribution is done in a way that preserves (or enhances) useful or desirable qualities.
  • the water-solubility of a consumable aerosol product may impact its dissolution within the mouth (e.g., into saliva), the taste it elicits, the risk of coughing, etc.
  • Changing the particle size distribution should be done using a process that does not substantially interfere with or eliminate such properties or processes, and ideally enhances them.
  • caffeine commercially available in particulate form typically has a median particle size of roughly 15-20 microns (e.g., about 18 microns).
  • Certain commercially-available vitamins in particulate form such as B vitamins (e.g., B3 as niacin, B6 as pyridoxine, or B 12 as cyanocobalamin), may also have a typical median particle size below a desirable range. This may also be the case for other ingredients, such as the sweeteners stevia and/or thaumatin. Any such "preexisting" distributions may not be ideal for the aerosol product being prepared and its intended use. Compositions and methods have been discovered that can lead to substantially increased mean (or median) particle sizes of powders.
  • a consumable oil when added to certain powdered ingredients, has been found to play a role in shifting the particle size distribution "upward" (i.e., to larger values), and to play a role in reducing the number/mass of smaller particles relative to larger particles.
  • a hypothesis as to why this occurs is that smaller particles agglomerate onto each other, and/or into the oil, and/or onto larger particles, and/or "self-agglomerate," creating relatively stable larger particles.
  • Upon intake of such powders using an aerosol delivery device it was found that often the powder was less likely to hit the back of the throat and thus less likely to elicit an unpleasant sensation or coughing.
  • agglomeration methods commonly known and applied by those in the art may use any one or more consumable oils, including, but not limited to, Aloe Vera, Artichoke Oil, Black Currant Seed Oil 14% GLA, Black Currant Seed Oil 15% GLA, Borage Oil 20% GLA, Borage Oil 22% GLA, Boswellia Serrata Oil, CLA Conjugated Linolic Acid 75% min., Evening Primrose Oil 10% GLA, Evening Primrose Oil 9% GLA, Flax Seed Oil 50% ALA, Garlic Oil, Grape Seed Oil, Guggul Lipid Oil, Olive Leak Extract, Oregano Oil, Perilla Oil 60% ALA, Pumpkin Seed Oil, Pygeum Oil, Rosehip Oil, Rosemary Oil, Saw Palmetto Oil, Sterols, Tocotrienol Palm Oil, Walnut Oil, Wheat Germ Oil, Sesame Seed Oil, Dill Seed Oil, Clove Bud Oil, Ginger Root Oil, Cinnamon Leaf Oil, Fennel Seed Oil, Curcuma Longa Oil, Cummin
  • ingredients processed to a certain size may be further processed in combination with one or more additional ingredients.
  • a desired particle size, distribution and density can be acquired by, for example, agglomeration techniques as known to those in the art.
  • the resultant agglomerated heterogenous particle can be combined into a specific formulation using other homogenous or heterogenous particles acquired by milling, spray drying, or agglomeration, and combined in a batch process.
  • certain embodiments may use any one technique, or any combination of two or more particle production techniques, for the production of particles in the size distribution and population density desired.
  • agglomeration techniques can result in a subset of ingredients having the desired particle size, another agglomeration preparation can result in the remainder of ingredients having the desired particle size, and the two processed particles can be quantitatively combined in a batch process.
  • agglomerated particles can be combined with another preparation of other ingredients (spray dried, for example) to develop a final consumable product formulation.
  • Dry powder particles could be created from a single ingredient, such as chocolate, coffee, or truffles, or from a combination of ingredients.
  • chocolate chocolate bars, chocolate powder, cocoa powder, and other forms and varieties of foods derived from the cocoa plant may be used.
  • spices and other (natural or artificial) flavorings may be used alone or in combination with such food ingredients to create other tastes or sensations (e.g., natural or artificial chocolate, raspberry, mango, mint, vanilla, cinnamon, caramel, and/or coffee flavors).
  • the food product may be stored and/or contained in the form of a tablet or pill, in a blister pack, within a capsule, as simply a powder in ajar-like container, and/or in a tray, box, container, thermos, bottle, etc.
  • formulations of the payload have a pleasant flavor, deliver effectively a desired target payload to the consumer, have stability both with respect to ingredient flavoring and biological activity, and have commercial stability with respect to manufacturing, processing and commerce activity (e.g., warehousing and transport).
  • Ingredients are broadly considered as flavoring agents, dietary
  • supplements, and target payloads including, but not limited to, energy products, over- the-counter pharmaceuticals, prescription pharmaceuticals, antioxidants, sleep-aids, weight-loss products, nutraceuticals, oral health compounds, and novelty products. While some of the compounds included herein are included and described under one category, it is understood that, based on the ingredient function, individual ingredients can be included in more than one category.
  • Vitamin C is considered both a vitamin and an anti-oxidant
  • quercitin is considered an energy supplement as well as an anti-oxidant.
  • Embodiments of the present invention are drawn to formulations for the delivery of ingestable, aerosolizable powders with specific target payloads.
  • Formulations can vary substantially to optimize payload delivery and performance, such as solubility, user experience (e.g., a desired flavoring, minimizing bitterness or unpleasant tastes or odors), and target payload activity (e.g. combinations of ingredients to enhance a particular effect, for example as a sleep aid, an energy compound, or kinetics of absorption of a pharmaceutical product).
  • a target payload may have a particular flavoring agent (for example a sweetener) that another target payload (for example, an ingredient already providing sweetened experience to the user) would not require for palatable flavor, or would require in different concentrations for a pleasant consumption experience, and/or for the desired delivery and performance characteristics.
  • Flavoring agents as used herein, can include, but are not limited to, a masking agent, an artificial sweetener, a natural sweetener, a flavor compound, an acidulant, and combinations thereof.
  • masking agents are used to manage or deflect taste, odor, visual characteristics of the payload, alter the mouth feel of the delivered payload, and to generate certain sensory perceptions of the payload.
  • Certain embodiments of the masking agents contemplated in the present invention include, but are not limited to, B-cyclodextrin, glycyrrizin, polymers (methylcellulose, polyvinylpyrrolidone, hydroxymethylcellulose,
  • Natural and artificial sweeteners are generally used to sweeten the payload sensory perception, deflect sensory aspects away from an undesired perception to a desired sensory perception. Sweeteners can also be used as flavor enhancers.
  • the choice of sweetener can be part of the overall characteristics desired in the aerosolizable powder (performance, user perception, manufacturing and commerce requirements, etc).
  • Natural sweeteners are produced directly from natural products (plants), wherein artificial sweeteners are synthesized de novo or are modified natural sweeteners.
  • Natural and artificial flavors contemplated in the present invention include, but are not limited to, stevia rebaudioside A, glycyrrizin, thaumatin, sorbitol, erythritol, mannitol, monk fruit, pentadin, xylitol, brazen, sugar, dextrose, crystalline fructose, maltodextrin, trehalose, molasses, aspartame, aspartame acesulfame salt, neotame, acesulfame, saccharin, sucralose, neohesperidin dihydrochalcone, sodium, saccharin, cyclamates, alitame and dulcim.
  • Flavoring compounds may be used to give the formulation payload a taste preferred by the end user, increase or enhance particular flavors or the perception of flavors. Flavors choices can include any fruit or vegetable flavor, or any artificial flavor, to elicit a desired taste perception (sweet, sour, bitter, salty and/or umami, and associated food or flavoring, e.g. mint, taste), as well as herbal or plant flavors that can otherwise be considered non-food (eg. Cinnamon), such as coffee, chocolate, and other confectionary flavors. Other flavor compounds considered as a novelty flavoring, including beer and other alcoholic beverages, hemp, vomitus, and novel combinations of flavors (e.g., beer flavoring with caffeine).
  • Acidulants may be considered as additives or compounds that change or maintain the final product acidity or alkalinity.
  • Acidulants can be organic or mineral acids, bases, neutralizing agents or buffering agents.
  • Acidulants contemplated as embodiments in the present invention include, but are not limited to, citric acid, malic acid, lactic acid, glycolic acid, tartaric acid, fumaric acid, oxalacetic acid, succinic acid, lactoisocitric acid, shikmik acid, eulagic acid and/or glutamic acid.
  • Another embodiment may be sodium bicarbonate, also serving the dual role of providing an effervescence effect to the palate and/or tongue upon contact dissolution.
  • dietary supplements may be considered as vitamins and/or minerals taken in addition to naturally obtained vitamins/minerals in food. Dietary supplements are taken 1) to enhance the physical well-being or state of health of the end user, 2) as a health related supplement, or 3) as supplements required to enhance deficient vitamin/mineral states in the end user. Dietary supplements can also add to a higher quality or perceived quality of the health state of the end user.
  • dietary supplements include, but are not limited to, Ascorbic Acid (Vitamin C), B Vitamins, Biotin, Fat Soluble Vitamins, Folic Acid, HCA (Hydroxycitric Acid), Inositol, pyruvate, Mineral Ascorbates, Mixed
  • Niacin Vitamin B3
  • Orotic Acid PABA (Para-Aminobenzoic Acid)
  • Pantothenates Pantothenic Acid
  • Pantothenic Acid Vitamin B5
  • Pyridoxine Hydrochloride Vitamin B6
  • Riboflavin Vitamin B2
  • Synthetic Vitamins Thiamine (Vitamin Bl)
  • Vitamin A Vitamin D, Vitamin E, Vitamin F, Vitamin K, Vitamin Oils, Vitamin Premixes, Vitamin-Mineral Premixes, Water Soluble Vitamins, arsenic, boron, calcium, chloride, chromium, cobalt, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorous, potassium, selenium, silicon, sodium, strontium, sulfur, vanadium and zinc.
  • Target payloads are contemplated for which an end user will obtain a desired effect upon ingestion of the specific powder compound.
  • Target payloads broadly include, but not limited to, energy supplements, over-the-counter pharmaceuticals, prescription pharmaceuticals, antioxidants, sleep-aids, weight-loss products, nutraceuticals, oral health compounds, and novelty product compounds.
  • ingestible powdered formulations for the present invention include, but are not limited to, American ginseng, Red ginseng, Siberian ginseng, maca, rhodiola, ginger, guarana, turmeric, acetyl-L-carnitine, L- carnitine, creatine, taurine, L-phenylalanine, L-arginine, tyrosine, acetyl-tyrosine, N- acetyl L-tyrosine, ginko biloba, yerba-mate, kola nut, gotu kola, maitake, cordyceps sinensis, guarana, acai-berry, L-theanine, caffeine, quercitine, synephrine, green tea extract, theophylline, epigallocatechin gallate (EGCG), capsaicin, bee pollen, al
  • EGCG epigallocatechin gallate
  • Oral health compounds contribute to decreasing unwanted bacterial flora and/or covering up unwanted odors and/or flavors. Control of the unwanted flora decreases incidence of tooth decay, halitosis, and potentially contributes to long-term health benefits including incidence of heart disease.
  • oral health compounds for use in the present invention include, but are not limited to, fluoride, vitamin C, vitamin B, zinc, menthol, thymol, eucaleptic, sodium bicarbonate, vitamin K, chlorhexidine, and xylitol.
  • Weight loss compounds are commonly divided into groups categorized as appetite suppressants, acting to manipulate hormonal and chemical processes in the body that otherwise increase hunger and/or the sense of feeling satiated (e.g.
  • Weight loss compounds can be synthetic or natural.
  • weight loss compositions contemplated herein include, but are not limited to, hoodia, chitosan, chromium picolinate, conjugated linoleic acid, glucomannan, green tea extract, guar gum, guarana, guggal, senna, ephedra, bitter orange, fucoxanthin, white bean extract, vitamin D, human chorionic gonadotropin, resveratrol, capsaicin, chia, hoodia, L- carnitine, raspberry ketones, banaba leaf, red clover, ginger, almonds, acai berry, flax seeds, leucine and lipodrene.
  • sleep-aid compounds assist in slowing the metabolic resting rate of an individual to allow one to relax and gain more restful or longer sleep periods.
  • sleep aid compositions contemplated herein include, but are not limited to melatonin, 5-hydroxytryptophan, 5- hydroxytrypatmine, diphenhydramine, doxylamine, benzodiazepine, kava, serenite, chamomile, phenibut, catnip herb, chamomile, glycine, hops, L-theanine, L- tryptophan, glycine, GABA and valerian.
  • over-the-counter (OTC) and prescription are examples of over-the-counter (OTC) and prescription
  • (pharmaceutical) drugs include, but are not limited to, amikacin, gentamicin, kanamycin, neomycin, netilmicin, tobramycin, paromomycin, geldanamycin, herbimycin, loracarbef, ertapenem, doripenim, imipenem/cilastatin, meropenem, cefadroxil, cefazolin, cefalotin, cefalexin, cefaclor, cefamandole, cefoxitin, cefprozil, cefuroxime, cefixime, cefdinir, cefditoren, cefoperazone, cefotaxime, cefpodoxime, ceftazidime, ceftibuten, ceftizoxime, ceftriaxone, cefepime, ceftobiprole, teicoplanin, vancomycin, telavancin, clindamycin, lincomycin
  • pyrazinamide rifampicin, rifabutin, rifapentine, streptomycin, arsphenamine, chloramphenicol, fosfomycin, fusidic acid, linezolid, metronidazole, mupriocin, platensimycin, quinupristin/dalfopristin, rifaximin, thiamphenicol, tigecycline, tinidazole, Fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram, mirtazapine, triazolam, quazepam, estazolam, temazepam, Zolpidem eszopiclone zalepon, Trazodone, Citalopram, escitalopram, desvenlafaxine, duloxetine, milnacipran, venlafaxine, tramadol, sibutramine, etoperidone,
  • clomipramine desipramine, dosulepin, doxepin, imipramine, iprindole, lofepramine, melitracen, nortriptyline, opipramol, protriptyline, trimipramine, amoxapine, maprotiline, mianserin, mirtazapine, isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine, pirlindone, busipirone, tandospirone, aripiprazole, vilazodone, quetiapine, agomelatine, nefazodone, quetiapine, asenapine,
  • Various other compounds are contemplated for use as target payload ingredients in ingestable powder formulations.
  • antioxidants, hormones and other proteins, enzymes, amino acids, probiotics, etc. are desirable target payloads.
  • hormones are used for hormone replacement and supplementation.
  • Various hormones contemplated for use in the invention described herein include, but are not limited to, apidonectin, aldosterone, androgen, natriuretic peptide, 7-Keto-DHEA, Androstenedione, dihydroepiandrosterone (DHEA), Melatonin, Nor- Androstenedione, pregnenolone, progesterone, 19 Nor-4-
  • Androstendiol 19 Nor-4-Androstenedione, 19 Nor-5-Androstenediol, 19 or-5- Androstendione, 3-Indolebutyric Acid, 4 Androstendiol, 4 Androstendione, 6 Furfurylaminopurene, 6-Benzylaminopurine, calcitonin, Cortisol, erythropoietin, gonadotropin, human growth hormone (HGH), incretins, leptin, lutenizing hormone, orexin, parathyroid hormone, pregnenolone, progesterone, prolactin, relaxin, renin, testosterone, and vasopressin.
  • HGH human growth hormone
  • enzymes and amino acids include, but are not limited to, alpha galactosidase, amylase, bromelain, cellulase, papain, peptidase, protease, proteolytic enzymes, superoxide dismutase, trypsin, betaine, casein, glutamic Acid, L-alanine, L-arginine, L-cysteine, L-glutamine, L- glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-ornithine, L- phenylalanine, L-proline, L-taurine, L-threonine, L-tryptophan, L-tyrosine, L-valine, N-acetly-L-cysteine, protein soluble soy, soy protein isolates, and whey protein isolates.
  • antioxidants for use in powder formulations include, but are not limited to, carotenoids, flavonoids, isoflavones, tocopherol, tocotrienol, lipoic acid, melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, selenium and ascorbic acid.
  • carotenoids contemplated for use in the present invention include alpha-carotene, beta-carotene, cryptoxanthin, lycopene, lutein, zeaxathin, apocarotenal astaxanthin, canthaxanthin, lutein/lutein esters, etc.
  • flavonoid used in the formulations include esveratrol, quercetin, rutin, catechin, proanthocyanidins, acai berry extract, raspberry extract, cranberry extract, pomegranate extract, plum extract, cherry extract, rosemary extract, etc.
  • isoflavones are used, including, but not limited to, genistein, daidzein, biochanin A, and formononetin.
  • probiotics for use in the present invention include, but are not limited to, Bacillus coagulans GBI-30, 6086, Bifidobacterium animalis subsp. lactis BB-12, Bifidobacterium longum subsp.
  • infantis 35624 Lactobacillus acidophilus NCFM, Lactobacillus paracasei Stl 1 (or NCC2461), Lactobacillus johnsonii NCC533), Lactobacillus plantarum 299v, Lactobacillus reuteri ATCC 55730 ⁇ Lactobacillus reuteri SD21 12), Lactobacillus reuteri Protectis (DSM 17938, daughter strain of ATCC 55730), Saccharomyces boulardii, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14,
  • Plants and plant extracts can provide compositions for dietary supplements, energy products, antioxidants, sleep-aids, weight-loss products, nutraceuticals, oral health compounds, novelty products, etc. Such compositions may be categorized as botanical supplements and botanical extracts. Aqueous or oil based botanical supplements can be combined at low volume with powdered components and or be used in, for example, agglomeration processes.
  • botanical extracts and plant-based supplements include, but are not limited to, Acerola Extracts, Alfalfa, Blue Green algea, Aloe, Amla, Angelica Root, Bacopa Monnieri, Mucuna Pruriens, Anise Seed, Arnica, Artichoke, Ashwagandha, Astragalus, Ayurvedic Herbs, Barberry, Barley Grass,
  • Barley Sprout Extract Benzoin, Bilberry, Bioflavonoids, Bitter Melon, Bitter Orange, Black Cohosh, Black Currant, Black Walnut, Bladderwrack, Blue Cohosh, Blueberry, Boswellia, Brahmi, Broccoli, Burdock, Butcher's Broom, Calendula, Capsicum, Cascara Sagrada, Cat's Claw, Catnip herb, Cayenne, Celery Seed, Certified Organic Herbs, Chamomile, Chapparal, Chaste Berry, Chicory Root, Chinese Herbs,
  • Chlorella Chlorophyll, Citrus Aurantium, Cocoa, Coriander, Corn Silk, Cranberry, Curcuminoids, Damiana, Dandelion, Devil's Claw, Diosgenin, Dong Quai, Echinacea, Elderberry, Elecampane Root, Ephedra, Essential Oils, Eucalyptus, Evening Primrose, Eyebright, Fennel, Fenugreek, Feverfew, Flax Products, Garcinia, Cambogia, Garlic, Gentian, Ginger, Ginkgo, Biloba, Ginseng (American), Ginseng (Panax), Ginseng (Siberian), Goldenseal, Gotu Kola, Grape Seed Extract, Grape Skin Extract,
  • Grapefruit Seed Extract Green Food Products, Green Lipped Mussel Powder, Green Tea, Griffonia simplicifolia, Guarana, Guggul, Gymnema Sylvestre, Hawthorne, Herbal Extracts, Herbal Teas, Hops, Horehound, Horse Chestnut, Horsetail, Hysop, Ipriflavone, Jojoba Oil, Juniper Berries, Kava Kava, Kelp Extract, Kombucha, Kudzu, Larch, Lavender, Lemon Balm, Licorice Extract, Linden Flowers, Lobelia, Maca, Maitake Mushroom, Marshmallow, Milk Thistle, Molasses, Mushrooms, Neem, Nettle, Noni, Nopal, Oatstraw, Octacosanol, Olive Extract, Orange Peel Extract, Oregano Oil, Oregon Mountain Grape, Organic Sweeteners, Parsley, Passion Flower, Pau d'Arco, Pennyroyal, Peppermint, Pfaffia Paniculata, Pine Bark Extract, Piper Longum,
  • Cistanches Extract 5 1, Citrus Aurantium Extract 6%, Citrus Bioflavonoid Complex 13%, Citrus Peel Extract 5: 1, Clove Extract 5: 1, Clove Powder, Coca Extract 4: 1, Codonopsis Pilosula Extract 5: 1, Colostrum, Common Peony Extract 8: 1, Cordyceps Extract 7%, Cornsilk Extract 4: 1, Cornsilk Powder, Corydalis Extract 10: 1, Cranberry Extract 4: 1, Cranberry Powder, Curcumin Extract 95%, Cuscuta Extract 5: 1, Damiana Extract 4: 1, Damiana Leaves Powder, Dandelion Powder, Dandelion Root Extract 6: 1, Danshen Extract 80%, D-Calcium Pantothenate, Devil's Claw Extract 2.5%, Devil's Claw Extract 4: 1, Devil's Claw Root Powder, DHEA 99%, Diosgenin 95%, DL-Phenyl Alanine, DMAE Bitartrate, Dong Quai Extract 10: 1, Dong Quai Extract 4: 1, Dong Quai
  • Periwinkle Extract 4 1, Pharbitidis Extract 4: 1, Phosphatidyl Serine 20%, Pine Bark Extract 4: 1, Plantago Asiatica Leaf Extract 5: 1, Polygala Tenoifolia Extract 4: 1, Polygonum Extract, Polygonum Extract 4: 1, Pregnenolone 99%, Propolis Extract 3%, Pseudoginseng Extract, Psyllium extract 4: 1, Pumpkin Seed Extract 4: 1, Purple Willow Bark Extract 4: 1, Purslane Herb Extract 4: 1, Pygeum Extract 4: 1, Quercetin, Radish Extract 4: 1, Radix Isatidis Extract 4: 1, Radix Polygoni Extract 4: 1, Red Clover Extract 4: 1, Red Pepper Extract 4: 1, Red Yeast Rice, Red Yeast Rice Extract 10: 1, Red Yeast Rice Powder, Rehmannia Root Extract 4: 1, Reishi Mushroom Extract 4: 1, Rhodiola Rosea Extract 4: 1, Rhododendron Extract 4: 1, Rhododendron Powder, Rhubarb Extract 4: 1, Rhu
  • Mushroom Extract Siberian Ginseng Extract 0.8%, Siberian Ginseng Extract 4: 1, Siberian Ginseng Powder, Skullcap Extract 4: 1, Skullcap Extract 4: 1, Slippery Elm Powder, Sodium-Pyruvate 99%, Songaria Cynomorium Extract 4: 1, Songaricum Powder, Spirulina Powder, St. John's Wort Extract 0.3%, St. John's Wort Extract 4: 1, St. John's Wort Powder, Stanol 50%, Stephania Extract 4: 1, Stevia Extract 4: 1,
  • Nutraceuticals are generally thought of as food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease, and can be defined as a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food.
  • a nutraceutical may have a physiological benefit or provide protection against chronic disease.
  • Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered foods, herbal products, and processed foods such as cereals, soups, and beverages.
  • nutraceuticals are used, including, but not limited to, 5-Hydroxytryptophan, Acetyl L-Carnitine, Alpha Lipoic Acid, Alpha-Ketoglutarates, Bee Products, Betaine Hydrochloride, Bovine Cartilage, Caffeine, Cetyl Myristoleate, Charcoal, Chitosan, Choline, Chondroitin Sulfate, Coenzyme Q10, Collagen, Colostrum, Creatine, Cyanocobalamin (Vitamin B12), DMAE, Fumaric Acid, Germanium Sesquioxide, Glandular Products, Glucosamine HCL, Glucosamine Sulfate, HMB (Hydroxyl Methyl Butyrate), Immunoglobulin (Immune System
  • Lactic Acid Lactic Acid
  • L-Carnitine Liver Products
  • Malic Acid Maltose-anhydrous
  • Mannose Mannose
  • MSM Other Carnitine Products
  • Phytosterols Picolinic Acid, Pyruvate, Red Yeast Extract, S-adenylmethionine (SAMe), Selenium Yeast, Shark Cartilage, Theobromine, Vanadyl Sulfate, Velvet Deer Antler, Yeast, ATP, Forskolin, Sterol Esters, Stanol Esters, Probiotics, Lactoferin, Lutein Esters, Zeaxanthin, Immunoglobulins, Ipriflavone, Isoflavones, Fructo-Oligo-Saccharides, Inulin,
  • Huperzine A Melatonin, Medicinal Mushrooms, Bile Products, Peptone Products, Glandular Products, Pancreatic Products, Thyroid Products, Ribose, Probiotics, oleo resins, Dill Seed oleo resin, Black Pepper oleo resin, and Capsicum oleoresin.
  • formulations may contain a processing aid, for example talc or Nu-FLOW® (Ribus, Inc. of St. Louis, MO) a synthetic aid with characteristics similar to silicon to allow for a desired flowability upon manufacturing and/or delivery during aerosolizing device actuation.
  • a processing aid for example talc or Nu-FLOW® (Ribus, Inc. of St. Louis, MO) a synthetic aid with characteristics similar to silicon to allow for a desired flowability upon manufacturing and/or delivery during aerosolizing device actuation.
  • Other excipients may include penetration enhancers and/or solubility agents including, but not limited to, tweens (polysorbates), spans (sorbitan esters), sodium lauryl sulfate and other surfactants.
  • component ingredients may serve to provide several functions.
  • certain botanical extracts and botanical products may have multiple functions (for example as a flavoring agent, dietary supplement, sleep aid and as an appetite suppressant).
  • synergistic interactions between and among ingredients in the formulations may provide advantages in taste, product performance, manufacturing and handling attributes.
  • formulations consider that taste, in addition to intended use or benefits of the product (providing energy/high caffeine, providing vitamins, providing flavor, etc.), as well as regulatory restrictions on the use of particular products in particular jurisdictions, all may contribute to the individual ingredient quantities and/or concentrations used.
  • Example 1 Oral hygiene/breath freshener, serving size 200 milligrams
  • Example 2 Oral hygiene/breath freshener, serving size 200 milligrams Ingredient List % w/w
  • Example 4 Oral hygiene/breath freshener, serving size 200 milligrams Ingredient List % w/w
  • Example 6 Novelty powder: Stout flavored beer, serving size 300 milligrams
  • Example 8 Sleep aid: Melatonin Formula (DS) serving size 300 mg
  • Example 9 Pharmaceutical compound: ciprofloxacin, serving size 500 milligrams
  • Example 10 OTC allergy pharmaceutical: Claritin, serving size 200 milligrams
  • Example 11 Diet aid: Hoodia, serving size 400 milligrams
  • Example 12 Vitamin/Mineral/Supplement Formula (a). 400 mg
  • Vitamin C (ascorbic acid) 25%
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 riboflavin 0.4% Vitamin A (beta carotene) 5000 IU(20%) 1%
  • Example 13 Vitamin/Mineral/SuDDlement Formula (b). 400 me
  • Vitamin C (ascorbic acid) 30%
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 (riboflavin) 0.4%
  • Vitamin A (beta carotene) 5000 IU(20%) 1%
  • Example 14 Vitamin/Mineral/SuDDlement Formula (c). 400 me
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 (riboflavin) 0.4%
  • Vitamin A (beta carotene) 5000 IU(20%) 1 % Lysine 8%
  • Example 15 Vitamin/Mineral/Supplement Formula (d). 400 mg
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 (riboflavin) 0.4%
  • Vitamin A (beta carotene) 5000 IU(20%) 1 %
  • Example 16 Vitamin/Mineral/SuDDlement Formula (e). 400 me
  • Vitamin C (ascorbic acid) 35%
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 (riboflavin) 0.4%
  • Vitamin A (beta carotene) 5000 IU(20%) 1%
  • Example 17 Enerev (caffeine) Formula (Grape). 300 me
  • Example 20 Energy (caffeine) Formula (Strawberry 2). 300 mg
  • Example 22 Energy (caffeine) Formula (Coffee). 300 mg
  • Example 23 Energy (caffeine) Formula (Watermelon 1). 300 mg
  • Example 24 Energy (caffeine) Formula (Watermelon 2). 300 mg Ingredient List % w/w
  • Example 25 Oral hygiene/breath freshener, serving size 300 milligrams Ingredient List % w/w

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Abstract

L'invention concerne des formulations et des descriptions de dimension de particule pour une poudre comestible destinée à être utilisée dans un appareil de distribution d'aérosol. Des formulations de particule sont conçues pour être pulvérisées en aérosol pour une distribution dans la bouche d'un utilisateur. Des formulations peuvent être conçues pour avoir une performance optimale de distribution et de charge utile, un arôme optimal, un confort optimal et une expérience sensorielle optimale d'un destinataire. Des formulations sont conçues pour des compléments énergétiques, des composés pharmaceutiques, des composés pharmaceutiques en vente libre, des composés de somnifère, des composés de perte de poids et des composés de santé buccale.
PCT/US2014/025481 2013-03-15 2014-03-13 Particules pour appareil de pulvérisation en aérosol WO2014151329A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361788212P 2013-03-15 2013-03-15
US61/788,212 2013-03-15
US201461942410P 2014-02-20 2014-02-20
US61/942,410 2014-02-20

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WO2014151329A1 true WO2014151329A1 (fr) 2014-09-25

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Cited By (11)

* Cited by examiner, † Cited by third party
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US9795579B1 (en) * 2017-04-24 2017-10-24 Knoze Jr. Corporation Oral microbiota promoting method
CN107373484A (zh) * 2017-07-12 2017-11-24 新时代健康产业（集团）有限公司 一种具有消炎作用的蔓越莓组合物及其制备方法与应用
US10137164B2 (en) 2015-01-02 2018-11-27 Melaleuca, Inc. Dietary supplement compositions
US10576112B2 (en) 2015-01-02 2020-03-03 Melaleuca, Inc. Bacterial compositions
CN111802644A (zh) * 2020-07-20 2020-10-23 花姐生物科技(杭州)有限公司 助睡眠的食品组合物
CN111840279A (zh) * 2020-08-24 2020-10-30 上海百山生物技术有限公司 一种褪黑素组合物在制备减重降脂药物中的应用
CN112118855A (zh) * 2018-03-20 2020-12-22 爱瑟金股份有限公司 体重管理组合物
WO2021184070A1 (fr) * 2020-03-17 2021-09-23 Advance NanoTek Ltd. Composition antivirale de soins bucco-dentaires
US11207388B2 (en) 2015-01-02 2021-12-28 Melaleuca, Inc. Multi-supplement compositions
US11617772B2 (en) * 2018-09-11 2023-04-04 Direct Digital Llc Nutritional supplements and therapeutic compositions comprising probiotics
US11846919B2 (en) 2013-03-15 2023-12-19 Vapor Communications, Inc. Systems, methods and articles to provide olfactory sensations

Citations (4)

* Cited by examiner, † Cited by third party
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WO2008042951A2 (fr) * 2006-10-03 2008-04-10 Manta Product Development Dispositifs d'inhalation et procédés associés
US20110011394A1 (en) * 2007-12-14 2011-01-20 Edwards David A Delivering aerosolizable food products
US20110186047A1 (en) * 2008-10-01 2011-08-04 Scott Alexander Lewis Dry Powder Inhalers with Rotating Piercing Mechanisms and Related Devices and Methods
WO2013006809A2 (fr) * 2011-07-06 2013-01-10 Breathable Foods, Inc. Particules aérosolisantes

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008042951A2 (fr) * 2006-10-03 2008-04-10 Manta Product Development Dispositifs d'inhalation et procédés associés
US20110011394A1 (en) * 2007-12-14 2011-01-20 Edwards David A Delivering aerosolizable food products
US20110186047A1 (en) * 2008-10-01 2011-08-04 Scott Alexander Lewis Dry Powder Inhalers with Rotating Piercing Mechanisms and Related Devices and Methods
WO2013006809A2 (fr) * 2011-07-06 2013-01-10 Breathable Foods, Inc. Particules aérosolisantes

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11846919B2 (en) 2013-03-15 2023-12-19 Vapor Communications, Inc. Systems, methods and articles to provide olfactory sensations
US11207388B2 (en) 2015-01-02 2021-12-28 Melaleuca, Inc. Multi-supplement compositions
US10137164B2 (en) 2015-01-02 2018-11-27 Melaleuca, Inc. Dietary supplement compositions
US10576112B2 (en) 2015-01-02 2020-03-03 Melaleuca, Inc. Bacterial compositions
US11273195B2 (en) 2015-01-02 2022-03-15 Melaleuca, Inc. Dietary supplement compositions
US11433107B2 (en) 2015-01-02 2022-09-06 Melaleuca, Inc. Bacterial compositions
US9795579B1 (en) * 2017-04-24 2017-10-24 Knoze Jr. Corporation Oral microbiota promoting method
CN107373484B (zh) * 2017-07-12 2021-06-15 国珍健康科技（北京）有限公司 一种具有消炎作用的蔓越莓组合物及其制备方法与应用
CN107373484A (zh) * 2017-07-12 2017-11-24 新时代健康产业（集团）有限公司 一种具有消炎作用的蔓越莓组合物及其制备方法与应用
CN112118855A (zh) * 2018-03-20 2020-12-22 爱瑟金股份有限公司 体重管理组合物
US11617772B2 (en) * 2018-09-11 2023-04-04 Direct Digital Llc Nutritional supplements and therapeutic compositions comprising probiotics
WO2021184070A1 (fr) * 2020-03-17 2021-09-23 Advance NanoTek Ltd. Composition antivirale de soins bucco-dentaires
CN111802644A (zh) * 2020-07-20 2020-10-23 花姐生物科技(杭州)有限公司 助睡眠的食品组合物
CN111840279A (zh) * 2020-08-24 2020-10-30 上海百山生物技术有限公司 一种褪黑素组合物在制备减重降脂药物中的应用

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