WO2019161408A1 - Compositions for coating edible substrates, and methods of making and using the same - Google Patents

Compositions for coating edible substrates, and methods of making and using the same Download PDF

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Publication number
WO2019161408A1
WO2019161408A1 PCT/US2019/018635 US2019018635W WO2019161408A1 WO 2019161408 A1 WO2019161408 A1 WO 2019161408A1 US 2019018635 W US2019018635 W US 2019018635W WO 2019161408 A1 WO2019161408 A1 WO 2019161408A1
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WO
WIPO (PCT)
Prior art keywords
composition
less
hpmc
coating
relative
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Application number
PCT/US2019/018635
Other languages
French (fr)
Inventor
Beverly A. Schad
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Sensient Colors Llc
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Publication of WO2019161408A1 publication Critical patent/WO2019161408A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/212Starch; Modified starch; Starch derivatives, e.g. esters or ethers
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/262Cellulose; Derivatives thereof, e.g. ethers
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/30Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
    • A23L29/35Degradation products of starch, e.g. hydrolysates, dextrins; Enzymatically modified starches
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23PSHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P20/00Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
    • A23P20/10Coating with edible coatings, e.g. with oils or fats
    • A23P20/105Coating with compositions containing vegetable or microbial fermentation gums, e.g. cellulose or derivatives; Coating with edible polymers, e.g. polyvinyalcohol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Definitions

  • the present disclosure relates to compositions for coating edible substrates and methods for making and using the same, for use in the food, pharmaceutical, and nutraceutical industries.
  • Film coating is an effective way of providing physical and chemical protection for a substrate.
  • Film coatings include film forming agents, generally polymers that are soluble or dispersible in a solvent.
  • Various additives may be used to facilitate the coating process and/or obtain specific coating properties.
  • film coatings should be one or more of stable, economical, and easy to process and should use food-approved ingredients to facilitate commercial implementation.
  • a composition for coating an edible substrate including about 25 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 15 wt% to about 20 wt% rice starch, about 8 wt% to about 20 wt% glycerin, about 2 wt% to about 14 wt% gum acacia, and about 1 wt% to about 12 wt% an oligofructose, relative to the total weight of non-water components of the composition.
  • HPMC hydroxypropyl methylcellulose
  • compositions for coating an edible substrate including about 25 wt% to about 65 wt% cellulose film former, about 1 wt% to about! 2 wt% an oligofructose, an opacifier selected from starch, gum acacia, and a combination thereof, where the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and genetically modified organisms and the weight percentages are relative to the total weight of non-water components of the composition.
  • composition for coating an edible substrate including about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 8 wt% to about 25 wt% glycerin, and about 10 wt% to about 30 wt % maltodextrin, relative to the total weight of non- water components of the composition.
  • HPMC hydroxypropyl methylcellulose
  • composition for coating an edible substrate including about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 8 wt% to about 30 wt% plasticizing agent selected from glycerin, sorbitol, or a combination thereof, and about 25 wt% to about 45 wt% of starch comprising rice starch, maltodextrin, or combinations thereof, relative to the total weight of non-water components of the composition.
  • HPMC hydroxypropyl methylcellulose
  • compositions for coating an edible substrate including about 25 wt% to about 65 wt% cellulose film former, a plasticizing agent, and an opacifier comprising starch, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms, and the weight percentages being relative to the total weight of non-water components of the composition.
  • compositions for coating an edible substrate including about 25 wt% to about 65 wt% cellulose film former, a plasticizing agent, and an opacifier comprising starch and/or maltodextrin, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms, and the weight percentages being relative to the total weight of non-water components of the composition.
  • compositions for coating of an edible substrate wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms, and the weight percentages being relative to the total weight of non-water components of the composition and also the inclusion of flavors and biomass extracts.
  • a method of making a composition for coating an edible substrate comprising blending a cellulose film former, a plasticizing agent, and an opacifier to form a , mixture, adding water to the blend to form a slurry, and drying the slurry for at least about 30 minutes such that the plasticizing agent absorbs onto the cellulose film former and opacifier.
  • a method is provided of forming an edible coating on an edible substrate including spraying the composition onto the substrate.
  • a nutritional supplement including an edible substrate and the composition thereon.
  • FIG. 1 shows that at 16% rice starch and 21 % rice starch addition will afford the best whiteness when added to the total formulation. Subsequently 16% is preferred to create better rheological properties of the film
  • FIG. 2 shows that HPMC grade 2910, 15 cPs added to the formulation of at least 1 % affords better whiteness and minimizes color differentiation.
  • FIG. 3 shows that sorbitol has an equivalent opacification to the starting formulation per usage rate.
  • FIG. 4 A, FIG. 4B, and FIG. 4C show increasing weight gain (as indicated by increasing number) increases opacification, minimizes the vitamin and mineral appearance seen from the core, and increases the natural color hue.
  • FIG. 5 shows film cracking results if HPMC 2910 15cPs is not added in at least 5% and more preferentially at 10% to 15% of the formulation.
  • any numerical range recited herein includes all values from the lower value to the upper value. For example, if a concentration range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1% to 3%, etc., are expressly enumerated in tins specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this application. It also is understood that for the recitation of numeric ranges herein, each intervening number there between with the same degree of precision is explicitly contemplated.
  • the numbers 7 and 8 are contemplated in addition to 6 and 9, and for the range 6.0-7.0, the number 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, and 7.0 are explicitly contemplated.
  • the term“about” is used synonymously with the term“approximately.”
  • the use of the term“about” indicates that a recited value may include additional values slightly outside the recited values. This variation may be due to conditions such as experimental error, manufacturing tolerances, variations m equilibrium conditions, and the like.
  • the term“about” may include the cited value plus or minus 2.5%, 5%, 7.5%, or 10%, among others. It is to be understood that when the term“about” is used to modify a value, the value being modified is also expressly included. For example,“at least about 5” expressly includes at least 5, in addition to at least about 5. Similarly, by way of example,“at most about 95” expressly includes at most 95, in addition to at most about 95.
  • compositions comprises less than about 5%, less than about 4%, less than about 3%, less than about 2%, less than about 1%, less than about 0.9%, less than about 0.8%, less than about 0.7%, less than about 0.6%, less than about 0.5%, less than about 0.4%, less than about 0.3%, less than about 0.2%, less than about 0.1%, less than about 0.05% or less than about 0.01% by weight of, or none of the indicated component.
  • the disclosure provides affordable, immediate-release, and easy-to- use coatings that meet FDA regulations.
  • the disclosed compositions, suspensions, and coatings may be used in coating substrates such as, for example, nutritional supplements,
  • the diy film coating compositions may comprise at least one of a cellulose film former, an oligofructose fiber, a plasticizing agent, a processing aid, a slip aid, a detackifier, a lubricant, an opacifier, a colorant, a surfactant, a buffering agent, and/or combinations thereof.
  • the compositions may be substantially free of one or more of titanium dioxide, calcium carbonate, minerals, and/or components derived from genetically modified organisms (GMO).
  • the dry film coating composition may comprise a cellulose film former, an oligofructose, and an opacifier.
  • the dry film coating composition may comprise hydroxypropyl methylcellulose (HPMC), rice starch, glycerin, gum acacia, and an oligofructose (e.g , inulin).
  • the dry film coating composition may comprise hydroxypropyl methylcellulose (HPMC), rice starch, maltodextrin and glycerin. At least one of these material s may be approved for food use.
  • the dry film coating composition When mixed with one or more solvents, the dry film coating composition may form a film coating suspension.
  • the disclosed film coating suspensions may have high solution solids content, low viscosity', low foam, low heavy metals content, and/or low lead content.
  • the film coating suspensions When applied to a substrate, the film coating suspensions may form a dry' film coating.
  • the disclosed dry' film coatings may possess one or more of the following characteristics: high slip, high gloss, low heavy metals content, low lead content, and/or high color stability
  • the disclosed dry film coating compositions, film coating suspensions, and dry' film coatings may be stable, economical, and easy to use, offering simple, rapid, and efficient processing.
  • a cellulose film former may include a molecule comprising at least one cellulose polymer or derivative modified with small amounts of propylene glycol ether groups attached to the cellulose anhydroglucose chain affording binding properties that enhance the reinforcing film properties of film applications.
  • Cellulose film formers may provide smooth, clear, film-forming coating suspensions and enhance the rheological mechanical strength properties of dry film coating gel matrices.
  • cellulose film formers include, but are not limited to, hydroxypropyl methyl cellulose ("HPMC”), carboxymethyl cellulose (“CMC”) or salts thereof, hydroxypropyl cellulose ("HPC”), methylcellulose (“MC”), hydroxy ethyl cellulose (“HEC”), methylethyl cellulose (“MEC”), and the like.
  • HPMC hydroxypropyl methyl cellulose
  • CMC carboxymethyl cellulose
  • HPC hydroxypropyl cellulose
  • MC methylcellulose
  • HEC hydroxy ethyl cellulose
  • MEC methylethyl cellulose
  • An oligofructose (also referred to herein as an oligofructose fiber) may include any
  • oligosaccharide that includes one or more fructose molecules.
  • oligofructose fibers include, but are not limited to, inulin, oligofructose, fructoohgosaccharides, and combinations thereof.
  • Inulm, oligofructose, and fructooligosaccharides are oligosaccharide molecules composed of fructose units linked by (2-1) bonds and often terminated by a glucose unit.
  • Oligofructose fibers may be obtained using any suitable method and/or source. For example, some embodiments provide for oligofructose fibers that can be derived from natural sources, such as chicory, garlic, asparagus, onion, leek, banana, and Jerusalem artichoke. In some embodiments, oligofructose and fructooiigosaceharide molecules may be obtained by partial enzymatic hydrolysis of inulin. Examples of commercially available
  • oligofructose fibers include, for example, Orafti ® P95, Orafti ® HSI, and Orafti ® L58 Organic (available from BENEO, Inc.).
  • Plasticizing agents may enhance the film characteristics of the dry film coating, such as adhesion, flexibility, permeability, and the like.
  • plasticizing agents include medium chain triglycerides, fatty acids, fatty acid derivatives, and combinations thereof.
  • examples of plasticizing agents may include, but are not limited to, propylene glycol
  • dicaprylate/dicaprate medium chain triglycerides (e.g., fractionated coconut oil), glyceryl monostearate, propylene glycol, polypropylene glycol, polyethylene glycol, triacetin, glycerin, dibutyl sebacate, triglycerides, acetylated monoglycerides, glycerol monstearates, glycerin monostearate, oleic acid, stearic acid, sorbitol, tributyl citrate, acety!tnbutyl citrate, dibutyl phfhalate, tri ethyl citrate,
  • medium chain triglycerides e.g., fractionated coconut oil
  • glyceryl monostearate e.g., propylene glycol, polypropylene glycol, polyethylene glycol
  • triacetin, glycerin, dibutyl sebacate triglycerides,
  • propylene glycol dicaprylate/dicaprate examples include, for example, Miglyol ® 840 (available from Sasol GmbH) and Neobee ®1 M-20 (available from Stepan Co.).
  • Processing aids may improve coating process parameters or optical or mechanical film performance, enhancing film functionality and quality.
  • processing aids include, but are not limited to, talc, calcium carbonate, clay, ammonium chloride, silica, sodium sulfate, calcium phosphate, propylene glycol dicaprylate/dicaprate, medium chain triglycerides (e.g., fractionated coconut oil), glyceryl monostearate, propylene glycol, polypropylene glycol, polyethylene glycol, triacetin, glycerin, dibutyl sebacate, triglycerides, acetylated monoglycerides, glycerol monstearates, glycerin
  • suitable processing aids may be substantially free of calcium carbonate, minerals (e.g., talc, clay, silica), magnesium stearate, ingredients derived from genetically modified organisms, and emulsifiers and antioxidants of natural origin.
  • Slip aids may increase surface-to-surface tablet contact, aiding in coating uniformity' from tablet-to-tablet interfacial contact during the coating process.
  • the final tablet slip also aids m esophageal transit.
  • slip aids include, but are not limited to, talc, natural and synthetic waxes, metal stearates, silica, natural and synthetic oils, fatty acids, and triglycerides.
  • suitable slip aids may not include minerals (e.g., talc, silica) and ingredients derived from genetically modified organisms.
  • Detackifiers may inhibit formation of collective particles and facilitate coalescence during film formation and at minimum film temperatures.
  • detackifiers include, but are not limited to, talc, aluminum hydrate, acetylated glycerides, diglycerides, acetylated monoglyceride,
  • suitable detackifiers may not include minerals (e.g., talc, mineral oil, kaolin) and ingredients derived from genetically modified organisms.
  • Lubricants may enhance esophageal transit ease, film slipperiness, and surface flowability.
  • examples of lubricants include, but are not limited to, talc, metallic stearates, silicon dioxide, sodium stearyl fumarate, palmitic acid, fatty acid esters, fatty acids, faty alcohols, mineral oil, paraffins, leucine, polyethylene glycols, metallic !auryl sulfates, stearic acid, hydrogenated vegetable oil, triethyl citrate, PEG 3350, and combinations thereof.
  • suitable lubricants may not include minerals (e.g., talc, mineral oil) and ingredients derived from genetically modified organisms.
  • Opacifiers may impart dispersed fine particles in dry film coatings, providing opaque films with high optical densities.
  • examples of opacifiers include, but are not limited to, starch, gum acacia, and a combination thereof.
  • the compositions may be substantially free or free of titanium dioxide, zinc oxide, and calcium carbonate. In some embodiments, the compositions are substantially free of gum acacia.
  • Starch opacifiers may be modified or non-modified starches. Modified starches may include dextnns and maltodextrms from sourced materials of corn, wheat, tapioca, potatoes, other vegetable sources (including, for example pea, sweet potato, mung bean, etc.) and rice and starches thereof.
  • colorants include dyes, lakes, and pigments and may include, but are not limited to, titanium dioxide, iron oxides, dyes such as, for example, FD&C Lakes, Carmine Lake, FD&C Blue no. 1, FD&C Red no. 3, FD&C Red no. 40, FD&C Yellow- no. 5, FD&C Yellow no. 6, FD&C Green no.
  • suitable colorants may not include titanium dioxide, calcium carbonate, minerals (e.g., alumina, talc), and ingredients derived from genetically modified organisms.
  • Surfactants may function as wetting agents, lowering surface tension and interfacial tension and facilitating film coalescence.
  • surfactants include, but are not limited to, polysorbates (polyethoxy lated sorbitan faty acid derivatives) such as, for example, polysorbate 80; polyglyceryl 10 laurate; lecithins (e.g., sunflower lecithin); mono- and di -glycerides; propylene glycol; sodium laury!
  • suitable surfactants may not include ingredients derived from genetically modified organisms.
  • Buffering agents may impart anionic/cationic ratios of minerals of sodium, potassium, magnesium, and/or calcium.
  • buffering agents include, but are not limited to, citric acid and sodium citrate.
  • Suitable buffering agents can be selected based on the particular formulation and/or application (e.g., based on requirements of composition elements such as, for example, pharmaceutical actives, and/or route of administration) in certain embodiments, suitable buffering agents may not include minerals.
  • solvents may include, but are not limited to, ethanol, water, isopropanol and combinations thereof. Unless indicated otherwise, the percentages identified below are listed in terms of weight of the dry composition.
  • compositions disclosed herein may also comprise additional components know to those of skill in the art, including, without limitation, flavorings and or extracts from biomass.
  • flavorings may be synthetic or artificial flavorings, natural flavorings or any mixture thereof and may include, but are not limited to, sensates, flavonoids, antioxidants, natural flavorants, synthetic flavorants, bioflavonoids, flavones, flavone, flavonol, flavanonol, isoflavones, ethyl vanillin, tangerine flavor, lemon flavor, lemon extract, liquid caramel, spearmint oil, orange flavor, almond, amaretto, apple, green apple, apple-cherry-berry, apple-honey, apricot, bacon, balls of fire, banana, barbeque, beef, roast beef, beef steak, berry, berry blue, birch beer/spruce beer, blackberry, bloody mary, blueberry, boysenberry, brandy, bubble gum, butter, butter pecan, buttermilk, butterscotch, candy corn, cantaloupe, cantaloupe lime, caramel, carrot, cassia, caviar, celery, cereal, champagne,
  • o orange creamsicle orange creme, orange peach mango, orange strawberry banana, creamy orange, mandarin orange, orange- passion-guava, orange-pineapple, papaya, passion fruit, peach, peach mango, peanut, roasted peanut, pear, pecan damsh type, pecan praline, pepper, peppermint, pimento, pma colada, pma colada/pineapple-coconut, pineapple, pineapple-orange, pistachio, pizza, pomegranate, pork fat type, baked potato, prune, punch, citrus punch, tropical punch, cherry fruit punch, grape punch, raspberry, black raspberry, blue raspberry, red raspberry, raspberry-blackberry, raspberry-ginger ale, rasp berry- lime, roast type, root beer, rum, sangria, sarsaparilla, sassafras, sausage, sausage pizza, savory, seafood, shrimp, hickory smoke, mesquite smoke, sour, sour cream, sour cream
  • the disclosure provides a dry film coating composition.
  • the dry film coating composition may include a cellulose film former.
  • the dry film coating may include a cellulose film former.
  • composition may include at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, at least about 30%, at least about 31%, at least about 32%, at least about 33%, at least about 34%, at least about 35%, at least about 36%, at least about 37%, at least about 38%, at least about 39%, at least about 40%, at least about 41%, at least about 42%, at least about 43%, at least about 44%, at least about 45%, at least about 46%, at least about 47%, at least about 48%, at least about 49%, at least about 50%, at least about 51%, at least about 52%, at least about 53%, at least about 54%, at least about 55%, at least about 56%, at least about 57%, at least about 58%, at least about 59%, at least about 60%, at least about 61%, at least about 62%, at least about 63%, or at least about 64% cellulose film former.
  • the dry film coating composition may include less than about 65%, less than about 64%, less than about 63%, less than about 62%, less than about 61%, less than about 60%, less than about 59%, less than about 58%, less than about 57%, less than about 56%, less than about 55%, less than about 54%, less than about 53%, less than about 52%, less than about 51 %, less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26% cellulose film former. This includes, for example
  • the cellulose film former may comprise, for example, HPMC.
  • the cellulose film former may comprise, for example, HPMC having a dynamic viscosity of about 3 cps, HPMC having a dynamic viscosity of about 5 cps, HPMC having a dynamic viscosity of about 6 cps, or HPMC having a dynamic viscosity of about 15 cps, or any combination thereof.
  • the cellulose film former is solely HPMC having a dynamic viscosity of about 15 cps.
  • the cellulose film former may comprise, for example, HPMC having a dynamic viscosity of about 5 cps.
  • the dry film coating composition may include at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, at least about 30%, at least about 31%, at least about 32%, at least about 33%, at least about 34%, at least about 35%, at least about 36%, at least about 37%, at least about 38%, at least about 39%, at least about 40%, at least about 41%, at least about 42%, at least about 43%, or at least about 44%, at least about 45%, at least about 46%, at least about 47%, at least about 48%, at least about 49%, at least about 50%, at least about 51%, at least about 52%, at least about 53%, or at least about 54% HPMC having a dynamic viscosity of about 5 cps.
  • the dry film coating composition may include less than about 55%, less than about 54%, less than about 53%, less than about 52%, less than about 51%, less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26% HPMC having a dynamic viscosity of about 5 cps. This includes, for example, about 25% to about 55%, about 30% to about 45%, or about 25% to about 45% HPMC having a dynamic viscosity of about 5 cps.
  • the cellulose film former may comprise, for example, HPMC having a dynamic viscosity of about 6 cps.
  • the dry' film coating composition may include at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, at least about 30%, at least about 31%, at least about 32%, at least about 33%, at least about 34%, at least about 35%, at least about 36%, at least about 37%, at least about 38%, at least about 39%, at least about 40%, at least about 41%, at least about 42%, at least about 43%, or at least about 44%, at least about 45%, at least about 46%, at least about 47%, at least about 48%, at least about 49%, at least about 50%, at least about 51%, at least about 52%, at least about 53%, or at least about 54% HPMC having a dynamic viscosity of about 6 cps.
  • the dry film coating composition may include less than about 55%, less than about 54%, less than about 53%, less than about 52%, less than about 51%, less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26% HPMC having a dynamic viscosity of about 6 cps. This includes, for example, about 25% to about 55%, about 30% to about 45%, or about 25% to about 45%HPMC having a dynamic viscosity of about 6 cps.
  • the dry film coating composition may include HPMC having a dynamic viscosity of about 3 cps.
  • the dry film coating composition may include at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 1 1%, at least about 12%, at least about 13%, at least about 14%, at least about 15%, at least about 16%, at least about 17%, at least about 18%, at least about 19%, at least about 20%, at least about 21 %, at least about 22%, at least about 23%, or at least about 24% HPMC having a dynamic viscosity of about 3 cps.
  • the dry film coating composition may include less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18%, less than about 17%, less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, less than about 1 1 %, less than about 10%, less than about 9%, less than about 8%, less than about 7%, or less than about 6% HPMC having a dynamic viscosity of about 3 cps. This includes, for example, about 5% to about 25% HPMC having a dynamic viscosity of about 3 cps.
  • the dry film coating composition may include HPMC having a dynamic viscosity of about 15 cps.
  • the dry film coating composition may include at least about 0.01%, at least about 0.05%, at least about 0.10%, at least about 0.15%, at least about 0.20%, at least about 0.25%, at least about 0.30%, at least about 0.35%, at least about 0.40%, at least about 0.45%, at least about 0.50%, at least about 0.55%, at least about 0.65%, at least about 0.70%, at least about 0.75%, at least about 0.80%, at least about 0.85%, at least about 0.90%, at least about 0.95%, at least about 1.00%, at least about 1.25%, at least about 1.50%, at least about 1.75%, at least about 2.00%, at least about 2.25%, at least about 2.50%, at least about 2.75%, at least about 3.00%, at least about 3.25%, at least about 3.50%, at least about 3.75%
  • the dry film coating composition may include less than about 5.00%, less than about 4.75%, less than about 4.50%, less than about 4.25%, less than about 4.00%, less than about 3.75%, less than about 3.50%, less than about 3.25%, less than about 3.00%, less than about 2.75%, less than about 2.50%, less than about 2.25%, less than about 2 00%, less than about 1.75%, less than about 1.50%, less than about 1 25%, less than about 1.00%, less than about 0 95%, less than about 0.90%, less than about 0.85%, less than about 0 80%, less than about 0 75%, less than about 0.70%, less than about 0.65%, less than about 0 60%, less than about 0.55%, less than about 0 50%, less than about 0.45%, less than about 0.40%, less than about 0 35%, less than about 0 30%, less than about 0.25%, less than about 0.20%, less than about 0 15%, less than about 0.10%, or less than
  • the dry film coating composition may include at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 1 1 %, at least about 12%, at least about 13%. at least about 14%, at least about 15%, at least about 16% at least about 17%. at least about
  • the dry film coating composition may include less than about 65%, less than about 64%, less than about 63%, less than about 62%, less than about 61%, less than about 60%, less than about 59%, less than about 58%, less than about 57%, less than about 56%, less than about 55%, less than about 54%, less than about 53%, less than about 52%, less than about 51%, less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 24%,
  • the dry film coating composition may include an oligofructose fiber.
  • the dry film coating composition may include at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, or at least about 11% oligofructose fiber.
  • the dry film coating composition may include less than about 12%, less than about 1 1%, less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, or less than about 2% oligofructose fiber. This includes, for example, about 1% to about 12%, about 3% to about 8%, or about 3% to about 5% oligofructose fiber.
  • the oligofructose fiber may comprise, for example, inulin.
  • the dry film coating composition may include an opacifier.
  • the dry film coating composition may include at least about 10%, at least about 1 1%, at least about 12%, at least about 13%, or at least about 14%, at least about 1 5%, at least about 16%, at least about 17%, at least about 18%, at least about 19%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, at least about 30%, at least about 31%, at least about 32%, at least about 33%, at least about 34% opacifier, or at least 35% opacifier.
  • the dry film coating composition may include less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, or less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18%, less than about 17%, or less than about 16% opacifier.
  • the opacifier may include starch, gum acacia or a combination thereof. In some embodiments, more than one starch may be used.
  • the compositions may comprise rice starch and maltodextrin.
  • the composition and the opacifier are substantially free of both titanium dioxide and calcium carbonate.
  • the opacifier may include starch.
  • the dry' film coating composition may include at least about 10%, at least about 11%, at least about 12%, at least about 13%, at least about 14%, at least about 15%, at least about 16%, at least about 17%, at least about
  • the dry film coating composition may include less than about 50%, less than about 45%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31 %, less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26%, less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18%, less than about 17%, less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, or less than about 11% of starch.
  • the starch may comprise modified starches, non-modified starches, or combinations thereof. Modified starches may include dextrms and maltodextrins.
  • the dry film coating composition may include at least about 10%, at least about 11%, at least about 12%, at least about 13%, at least about 14%, at least about 15%, at least about 16%, at least about 17%, at least about 18%, at least about 19%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, or at least about 29% of dextrin or maltodextrin.
  • the dry film coating composition may include less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26%, less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18%, less than about 17%, less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, or less than about 11% of dextrin or maltodextrin.
  • the composition may include rice starch.
  • the composition may comprise at least about 10 wt%, at least about 1 1 wt%, at least about 12 wt%, at least about 13 wt%, at least about 14 wt%, at least about 15 wt%, at least about 16 wt%, at least aboutl 7 wt.%, at least about 1 8 wt%, or at least about 19 wt% rice starch.
  • the composition may comprise less than about 25 wt%, less than about 24 wt%, less than about 23 wt%, less than about 22 wt%, less than about 21 wt.%, less than about 20 wt%, less than about 19 wt%, less than about 18 wt.%, less than about 17 wt%, less than about 16 wt%, less than about 15 wt%, less than about 14 wt%, less than about 13 wt%, less than about 12 wt%, or less than about 11 wt% rice starch.
  • the starch may comprise maltodextrin and sources of maltodextrin thereof and rice starch.
  • the opacifier may include gum acacia.
  • the dry film coating composition may include at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 11%, at least about 12%, at least about 13% gum acacia, at least about 14%, or at least about 15%.
  • the dry film coating composition may include less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, less than about 11%, less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, or less than about 3% gum acacia. This includes, for example, about 2% to about 16%, about 5% to about 16%, about 10% to about 14%, or about 12% to about 14% gum acacia.
  • the dry film coating composition may be substantially fee of gum acacia.
  • the dry film coating composition may include a plasticizing agent.
  • the dry film coating composition may include at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 11%, at least about 12%, at least about 13%, at least about 14%, at least about 15%, at least about 16%, at least about
  • the dry film coating composition may include less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about
  • plasticizing agent less than about 17%, less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, less than about 1 1%, less than about 10%, less than about 9%, less than about 8%, less than about 7%, or less than about 6% plasticizing agent. This includes, for example, about 8% to about
  • plasticizing agent 20%, about 8% to about 12%, about 5% to about 11%, or about 6% to about 7% plasticizing agent. This includes, for example, about 8% to about 25% plasticizing agent or about 5% to about 25% plasticizing agent.
  • the plasticizing agent is selected from medium chain triglycerides, faty acids, fatty acid derivatives, glycerin, sorbitol, or any combination thereof.
  • the plasticizing agent may comprise medium chain triglycerides, fatty acids, fatty acid derivatives, or combinations thereof. In some embodiments, the plasticizing agent may comprise greater than 0 wt% to about 5 wt% medium chain triglycerides, faty acids, fatty acid derivatives, or a combination thereof. In some embodiments, the plasticizing agent may comprise greater than 0 wt%, greater than about 1 wt%, greater than about 2 wt%, greater than about 3 wt%, or greater than about 4 wt% medium chain triglycerides, faty acids, fatty acid derivatives, or a combination thereof.
  • the plasticizing agent may comprise less than about 5 wt%, less than about 4 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% medium chain triglycerides, fatty acids, fatty acid derivatives, or a combination thereof.
  • the plasticizing agent may comprise, for example, glycerin, sorbitol, or combinations thereof. In some embodiments, the plasticizing agent may comprise, for example, about 8% to about 20% or about 8% to about 12% glycerin and about 5% to about 11% or about 6% to about 7% sorbitol.
  • the dry film coating composition may include a lubricant.
  • the dry film coating composition may include at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, and at least about 30% lubricant.
  • the dry film coating composition may include less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 20%, and less than about 15% lubricant. This includes about 5% to about 35%, about 5% to about 30%, and about 8% to about 30% lubricant. [0060] In some embodiments, the dry film coating composition may include a slip aid.
  • the dry film coating composition may include at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, and at least about 30% slip aid.
  • the dry film coating composition may include less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 20%, and less than about 15% slip aid. This includes about 5% to about 35%, about 5% to about 30%, and about 8% to about 30% slip aid.
  • the dry film coating composition may include a detaekifier.
  • the diy film coating composition may include at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, and at least about 30% detaekifier.
  • the diy film coating composition may include less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 20%, and less than about 15% detaekifier. This includes about 5% to about 35%, about 5% to about 30%, and about 8% to about 30% detaekifier.
  • the dry film coating composition may include a processing aid.
  • the dry film coating composition may include at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, and at least about 30% processing aid.
  • the dry film coating composition may include less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 20%, and less than about 1 5% processing aid. This includes about 5% to about 35%, about 5% to about 30%, and about 8% to about 30% processing aid.
  • the dry' film coating composition may include an intentional colorant.
  • the diy film coating composition may include at least about 0.05%, at least about 0.06%, at least about 0.07%, at least about 0.08%, at least about 0.09%, at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 10%, and at least about 15% colorant.
  • the dry film coating composition may include less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, less than about 1%, and less than about 0.1% colorant. This includes, for example, about 0.05% to about 30%, about 1% to about 30%, about 0.05% to about 25%, and about 0.1% to about 20% colorant.
  • the dry film coating composition may contain no intentional colorants.
  • the dry film coating composition may include a surfactant.
  • dry film coating composition may include at least about 0.1%, at least about 0.5%, at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, and at least about 10% surfactant.
  • the dry film coating composition may include less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, and less than about 1% surfactant. This includes, for example, about 0.1% to about 10%, about 1% to about 6%, and about 1% to about 4% surfactant.
  • the dry film coating composition may include a buffering agent.
  • the dry film coating composition may include at least about 0.1%, at least about 0.2%, at least about 0.3%, at least about 0.4%, at least about 0.5%, at least about 0.6%, at least about 0.7%, at least about 0.8%, at least about 0.9%, at least about 1%, at least about 2%, at least about 3%, at least about 4%, and at least about 5% buffering agent.
  • the dry film coating composition may include less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, and less than about 1% buffering agent. This includes, for example, about 0.1% to about 10%, 1% to about 6%, and about 2% to about 5%, about 0.1% to about 0.5%, about 0.1% to about 0.4%, and about 0.1% to about 0.35% buffering agent.
  • the disclosure provides a film coating suspension.
  • the film coating suspension may include at least about 0%, at least about 0.1%, at least about 0.5%, at least about
  • the film coating suspension may include less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, and less than about 1% buffering agent. This includes, for example, about 0% to about 10%, about 0.1% to about 5%, and about 1% to about 3% buffering agent.
  • the film coating suspension may include at least about 0.01 M, at least about 0.02 M, at least about 0.03 M, and at least about 0.04 M buffering agent.
  • the film coating suspension may include less than about 0.1 M, less than about 0.09 M, less than about 0.08 M, less than about 0.07 M, less than about 0.06 M, less than about 0.05 M, and less than about 0.04 M buffering agent. This includes, for example, about 0.01 M to about 0.1 M, and about 0.01 to about 0.05 M buffering agent.
  • the balance of the film coating suspension may comprise solvent (e.g., water).
  • the film coating suspension may include at least about 5% solvent or at least about 10% solvent.
  • the film coating suspension may include less than about 15% solvent or less than about 10% solvent. This includes, for example, about 5% to about 15%, about 5% to about 10%, or about 10% to about 15%.
  • the film coating suspension may include less than about 95%, less than about 90%, less than about 85%, less than about 80%, and less than about 75% solvent. This includes, for example, about 30% to about 95%, about 60% to about 90%, and about 70% to about 85% solvent.
  • the film coating suspension may include at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 65%, at least about 70%, at least about 71%, at least about 72%, at least about 73%, at least about 74%, at least about 75%, at least about 76%, at least about 77%, at least about 78%, at least about 79%, at least about 80%, at least about 81%, at least about 82%, at least about 83%, at least about 84%, at least about 85%, at least about 86%, at least about 87%, at least about 88%, at least about 89%, and at least about 90% solvent.
  • the disclosed film coating suspension suitably exhibits low' viscosity and/or high solution solids content.
  • embodiments provide a coating suspension that exhibits a low' viscosity relative to the amount of solids content.
  • the disclosed film coating suspensions may include high solution solids content.
  • a film coating suspension having high solution solids content may include, for example, at least about 5%, at least about 10%, at least about 15%, and at least about 20% solution solids.
  • a film coating suspension may include, for example, less than about 20%, less than about 15%, less than about 10%, and less than about 5% solution solids.
  • the disclosed film coating suspensions may have low viscosity.
  • film coating suspension having low viscosity may have viscosity of less than about 450 centipoise (cps), less than about 350 cps, less than about 300 cps, less than about 250 cps, less than about 200 cps, less than about 150 cps, and less than about 100 cps.
  • a film coating suspension may have viscosity of at least about 100 cps, at least about 150 cps, at least about 200 cps, at least about 250 cps, at least about 300 cps, at least about 350 cps, at least about 400 cps, and at least about 450 cps.
  • the disclosed film coating suspensions may have high solution solids content and low viscosity.
  • Viscosity may be assessed by any suitable method such as, for example, using a Brookfield viscometer equipped with a UL Adapter Assembly and UL Spindle (available from Brookfield
  • the film coating suspension or other test sample is poured into a clean graduated cylinder or other sample container, and the spindle is immersed m the sample. After starting the viscometer motor, the speed is adjusted to achieve a percent torque between 45-75%, and the viscosity (cps) of the sample is recorded .
  • a dry film coating may be formed on a substrate after application of the film coating suspension to the substrate.
  • the dry film coating formed on the substrate may contain little or no solvent (e.g., after the solvent evaporates).
  • the disclosure provides a dry film coating.
  • the disclosed dry film coatings may have a high gloss.
  • a dry film coating having high gloss may have gloss of at least about 5, at least about 6, at least about 7, at least about 8, at least about 9, at least about 10, at least about 11, at least about 12, at least about 13, at least about 14, at least about 15, at least about 20, or at least about 25 gloss units. This includes, for example, about 5 to about 30 gloss units and about 7 to about 12 gloss units.
  • Gloss of coatings such as the disclosed dry film coatings may be assessed using a Novo-CurveTM Glossmeter (available from Elcometer Instruments Ltd.).
  • the glossmeter is calibrated according to manufacturer's instructions, and a coated tablet is placed over the sample orifice to measure gloss. Each sample can be tested multiple times (e.g., in triplicate) in order to obtain an average gloss reading in embodiments, the disclosed dry film coatings may exhibit gloss that equals and/or exceeds the loss of a traditional film coating.
  • the disclosed dry film coatings may have high slip and/or increase the slip characteristics of a coated substrate relative to an uncoated substrate, or a substrate that comprises a different coating.
  • a dr film coating having high slip may have slip of less than about 100, less than about 90, less than about 80, less than about 70, less than about 60, less than about 55, less than about 50, less than about 45, less than about 44, less than about 43, less than about 42, less than about 41, less than about 40, less than about 39, less than about 38, less than about 37, less than about 36, less than about 35, less than about 34, less than about 33, less than about 32, less than about 31, less than about 30, less than about 29, less than about 28, less than about 27, less than about 26, less than about 25, or less than about 20 g tension force. This includes, for example, about 20 g tension force to about 100 g tension force and about 30 g tension force to about 40 g tension force.
  • Slip may be assessed using a TA.TX Texture Analyzer with a vertical friction rig serving as a force arm.
  • the probe height and force may be calibrated and the return force arm positioned 5 mm from the bottom of the container.
  • a non-friction gliding object such as a piece of paper tissue, may be attached to the vertical probe of the rig using heavy-duty double-sided tape.
  • a tablet or other substrate coated with a coating may be attached to the vertical wall of the rig using heavy-duty double-sided tape.
  • a weight e.g., 100 g is added to the horizontal plate of the probe, and incremental increases of force are applied to the non-friction gliding object in contact with the coating until the gliding object slips or moves.
  • the disclosed dry film coatings may exhibit slip that equals and/or exceeds the slip of a traditional film coating.
  • the disclosed diy film coatings may exhibit strong adhesion to a substrate.
  • Adhesion of the dry film coatings may be measured using a TA.TX Texture Analyzer (available from TA.TX Texture Analyzer (available from TA.TX Texture Analyzer).
  • Texture Technologies Corp. equipped with a 25 mm stainless steel cylindrical probe.
  • a round placebo tablet coated with a coating is scored around its hemisphere with a sharp blade and then attached to the top of the flat platform of the texture analyzer using heavy-duty double-sided tape (available from 3M).
  • Another piece of heavy-duty double-sided tape is pressed to the bottom of the cylindrical probe, and the probe is then compressed to 800 g force onto the Tablet for 10 seconds.
  • the probe is then pulled away from the Tablet at a rate of 1 mm/second, measuring the tension force until either (1) the coating separates from the softgei, or (2) the tape separates from the coating. Where the coating remains on the substrate, the measured force equals the force required to pull the double-sided tape away from the coating, and the adhesion force of the coating to the Tablet is thus greater than the measured adhesion force between the tape and the coating.
  • a dr film coating having strong adhesion may exhibit an adhesion force between the coating and the placebo or vitamin/active containing tablet of at least about 0.5, at least about 0.6, at least about 0.7, at least about 0.8, at least about 0.9, at least about 1 , at least about 1.1, at least about 1.2, at least about 1.3, at least about 1.4, at least about 1.5, at least about 1.6, at least about 1.7, at least about 1.8, at least about 1.9, or at least about 2 g force.
  • the disclosed dry film coating compositions, film coating suspensions, and/or dry film coatings may comprise a cellulose film former, an oiigofructose fiber, and an opacifier.
  • some embodiments provide dry film coating compositions comprising about 25% to about 65% cellulose film former, about 1% to about 12% oiigofructose fiber, and about 15% to about 35% opacifier.
  • some embodiments provide film coating compositions comprising about 25% to about 65% HPMC, about 15 wt% to about 20 wt% rice starch, about 8 wt% to about 20 wt% glycerin, about 2 wt% to about 14 wt% gum acacia, and about 1 wt% to about 12 wt% an oiigofructose.
  • the disclosed dry film coating compositions, film coating suspensions, and/or dry film coatings may comprise HPMC, rice starch, glycerin, gum acacia, and inulm.
  • the dry film coating composition, film coating suspensions, and/or dry film coatings may comprise a cellulose film former, a plasticizing agent and a starch.
  • the dry film coating composition, film coating suspensions, and/or dry film coatings may comprise HPMC, glycerin and maltodextrin.
  • the dry film coating composition, film coating suspensions, and/or diy film coatings may comprise HPMC, a plasticizing agent selected from glycerin, sorbitol, erythritol, and xylitol polyols or combination thereof, and a starch comprising rice starch, maltodextrin of potato or corn, or combinations thereof.
  • the disclosed dry film coating compositions may be substantially free of titanium dioxide, calcium carbonate, minerals, and/or components derived from genetically modified organisms.
  • compositions and suspensions described herein can be manufactured using techniques and equipment that are known and commonly used in the art.
  • Equipment known m the industry for standard tablet coating are Thomas Engineering, Inc., and Vector Corporation Hi-Coater® tablet coating systems. Manufacturing steps such as order of component addition, mixing temperatures (heating and/or cooling) mixing mixing time, mixing speed, etc. can be driven by either by formulation or equipment
  • the manufacturing processes can further include separate steps for validating the resulting composition (e.g., the total amounts, ratios, and even distribution of components in the composition, etc.).
  • the film coating suspension may be formed as follows. Components of a dry- film coating composition comprising at least one of a cellulose film former, an oligofructose fiber, a plasticizing agent, a processing aid, a slip aid, a detaekifier, a lubricant, an opacifier, a colorant, a surfactant, a buffering agent, and combinations thereof may be mixed with, for example, a plow r mixer. If included, one or more plasticizing agents may be added last to the dry film coating composition. Solvent (e.g., water) may be added to a mixing tank equipped with a high-shear overhead mixer and brought to a medium vortex. The dry film coating composition may be added into the medium vortex, and mixing may continue for at least about 30 minutes and/or until the suspension achieves a smooth consistency with no visible lumps.
  • Solvent e.g., water
  • a coating pan may be charged with a substrate such as, for example, capsules (single-piece or two-piece), tablets, and/or softgels.
  • the bed may be warmed to about 33°C to about 40°C.
  • the processing parameters may be as set forth below.
  • the film coating suspensions may, at a suitable concentration that is spraying system dependent, be sprayed using commercially available equipment to form coatings on substrates.
  • the film coating suspension may be applied to a substrate by loading substrate into a vented coating pan, such as, for example, a 15-inch, 24-inch, 36-inch, 48-inch, 60-inch or 66-inch side- vented coating pan.
  • the inlet temperature may be at least about 45°C , at least about 50°C, at least about 55°C, at least about 58°C, at least about 60°C, at least about 65°C, and at least about 70°C.
  • the inlet temperature may be less than about 75°C, less than about 70°C, less than about 65°C, and less than about 60. This includes, for example, about 50°C to about 75°C, about 50 to about 65°C, and about 55°C to about 75°C.
  • the outlet temperature may be at least about 32°C, at least about 35°C, at least about 40°C, and at least about 45°C.
  • the outlet temperature may be less than about 55°C, less than about 50°C, less than about 50°C, and less than about 45°C. This includes, for example, about 32°C to about 55°C, about 35°C to about 45°C, and about 40°C to about 50°C.
  • the atomizing air pressure may be at least about 20 psi, at least about 21 psi, at least about 25 psi, at least about 30 psi, at least about 35 psi, at least about 40 psi, at least about 45 psi, at least about 50 psi, and at least about 55 psi.
  • the atomizing air pressure may be less than about 75 psi, less than about 70 psi, less than about 65 psi, less than about 60 psi, less than about 55 psi, less than about 50 psi, less than about 40 psi, and less than about 30 psi.
  • the coating time may be from about 5 minutes to about 3 hours.
  • the film coating suspension can be allowed to dry, forming a dry film coating on the substrate.
  • Exemplar ⁇ ' coating parameters are provided in Table 1 y coating parameters
  • the dry film coatings may he flexible with tensile strength.
  • the dry film coating may be consistent batch-to-batch, may meet current FDA regulations for dietary supplements, may be robust (easy to use and prepare), and may coat various surfaces (softgels, capsules, tablets, gelatin, vegetable, etc.).
  • the dry film coating may be cost effective and economical.
  • Substrates coated with the disclosed dry film coatings may pass an immediate release disintegration test, such as, for example, USP32/NF27 S2, Chapter 2040 (Disintegration and Dissolution of Dietary Supplements), Chapter 701 (Disintegration) testing criteria.
  • the dry film coatings can be GRAS (Generally Recognized as Safe) and may be vegetarian.
  • the dry film coatings may be able to be applied at a fast rate and broad temperature while providing good film adhesion and flexibility.
  • the dry film coating compositions may be used in food, pharmaceutical, or nutraceutical applications intended for use in mammals, including, without limitation, rodents, canines, felines, non- human primates, ungulates, and humans. They can be used to coat pharmaceutical or non- pharmaceutical dosage units.
  • the edible coatings may have reduced moisture uptake in a humid environment compared to conventional HPMC coatings.
  • Moisture uptake is a measure of the amount of water taken up as measured by weight gam of a sample that has been placed in a controlled environment of a set humidity. Moisture uptake can be measured by any suitable method known to one of skill in the art.
  • Examples of procedures for measuring moisture uptake include, but are not limited to, exposing a coated substrate to 60% relative humidity' at 25° C (“storage condition H2”) or 75% relative humidity at 40° C (“storage condition H4”), or 40-60% relative humidity at 20° C (room conditions) and comparing the initial mass or weight of the sample to the mass or weight at various time intervals, such as, for example, 5 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 5 days, 7 days, 10 days, 14 days, 21 days, 25 days, 1 month, 2 months, 3 months, 6 months, 1 year, and the like. Stable mass or weight indicates a low' moisture uptake.
  • a substrate may be coated with an edible coating composition or suspension to form an edible coating at a 1 % weight gain, a 2% weight gain, a 3% weight gam, a 4% weight gam, a 5% weight gain, a 6% weight gam, a 7% weight gain, a 8% weight gam, a 9% weight gain, or a 10% weight gain compared to the uncoated substrate.
  • the coated substrate or edible coating may exhibit a moisture uptake of at most about 4.0%, at most about 3.0%, at most about 2.5%, at most about 2.0%, at most about 1.9%, at most about 1.8%, at most about 1.7%, at most about 1.6%, at most about 1.5%, at most about 1.4%, at most about 1.3%, at most about 1.2%, at most about 1.1%, at most about 1.0%, at most about 0.95%, at most about 0.90%, at most about 0.85%, at most about 0.80%
  • the coated substrate or edible coating may have a moisture uptake, as measured by weight gam over time after exposure to storage condition H2, H4, or room conditions for the above-mentioned time durations, of at most about 0.1 grams per hour (g/hr), at most about 0.05 g/hr, at most about 0.04 g/hr, at most about 0.03 g/hr, at most about 0.02 g/hr, at most about 0.015 g/hr, at most about 0.01 g/hr, at most about 0.009 g/hr, at most about 0.008 g/hr, at most about 0.007 g/hr, at most about 0.006 g/hr, at most about 0.005 g/hr, at most about 0.004 g/hr, at most about 0.003 g/hr, at most about 0.002 g/hr, at most about 0.001 g/hr, or at most about 0.0005 g/
  • the coated substrate or edible coating may have a moisture uptake, as measured by weight gain over time after exposure to storage condition H2, H4, or room conditions for the above- mentioned time durations, of at most about 0 01 inches per hour (in/hr), at most about 0.005 in/hr, at most about 0.004 in/hr, at most about 0 003 in/hr, at most about 0 002 in/hr, at most about 0.001 5 in/hr, at most about 0.001 in/hr, at most about 0.0009 m/hr, at most about 0.0008 m/hr, at most about 0.0007 m/hr, at most about 0.0006 in/hr, at most about 0.0005 in/hr, at most about 0.0004 in/hr, at most about 0.0003 in/hr, at most about 0.0002 m/hr, at most about 0.0001 m/hr, or at most about 0.00005 m/hr.
  • a moisture uptake as
  • the coatings may exhibit good clarity.
  • procedures for measuring clarity include, but are not limited to, measuring the lightness, whiteness, or yellowness of an uncoated sample and comparing to the respective lightness, whiteness, or yellowness of a coated sample. Smaller changes correspond to higher clarity.
  • Lightness can be assessed by any suitable method such as, for example, measuring the Lightness Index according to ASTM Method E313 wath a D65/10 0 illumination source (referred to as“E313 [D65/10]”) using a Lab Scan XE spectrophotometer (available from HunterLab, Inc.).
  • a sample is loaded into the instrument’s sample port and scanned, and the Lightness Index (E313 [D65/10]) value is calculated using measurements taken on the CIE L*a*b* color scale.
  • the resulting Lightness Index value is used to assess lightness of the sample.
  • Whiteness can be assessed by any suitable method, such as, for example, measuring the Whiteness Index according to ASTM Method E313 wath a D65/10° illumination source (referred to as“WI E313 [1)65/ 10]”) using a LabScan XE spectrophotometer (available from HunterLab, Inc.).
  • a sample substrate coated with a film coating is loaded into the instrument’s sample port and scanned, and the Whiteness Index (WI E313 [D65/10]) value is calculated using measurements taken on the CIE L*a*b* color scale.
  • the resulting Whiteness Index value is used to assess whiteness of the sample. Yellowness can be assessed by any suitable method, such as, for example, measuring the Yellowness Index according to ASTM Method E313 with a D65/10 0 illumination source (referred to as“YI E313 [D65/I0]”) using a LabScan XE spectrophotometer.
  • a sample substrate coated with a film coating is loaded into the instrument’s sample port and scanned, and the resulting YI E313 [D65/10] value is used to assess yellowness of the sample.
  • the change in lightness, whiteness, or yellowness may be less than about 50%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, or less than about 1%.
  • the coatings may have high whiteness and/or high opacity'.
  • Whiteness can be assessed as described above.
  • Opacity can be assessed by evaluating the Whiteness Index achieved upon coating one or more colored substrate cores with edible coatings as described herein. For example, when coating a colored substrate, the Whiteness Index will increase with additional weight gain until high and/or full opacity is reached. Upon reaching high and/or full opacity, the Whiteness Index may level off relative to further increases in weight gain.
  • the disclosed film coatings may provide high and/or full opacity at a weight gain of less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, and less than about 2% weight gain.
  • the disclosed edible coatings may provide high and/or full opacity at weight gains ranging from about 1% to about 10%, such as weight gams ranging from about 3% to about 9%, and weight gains ranging from about 2% to about 6%.
  • the disclosed film coating compositions, film coating suspensions, and/or film coatings comprise an opacifying agent in amounts sufficient to provide a film coating with high whiteness and/or full/high opacity at low weight gain.
  • applying the composition to an edible substrate produces a coated edible substrate, the edible substrate and the coated edible substrate each having a gloss, wherein the gloss of the coated edible substrate may be from about 0% to about 500% greater than the gloss of the edible substrate.
  • the gloss of the coated edible substrate may be at least about 5% greater, at least about 10% greater, at least about 50% greater, at least about 100% greater, at least about 150% greater, at least about 200% greater, at least about 300% greater, at least about 400, or at least about 500% greater.
  • applying the composition to an edible substrate produces a coated edible substrate, the edible substrate and the coated edible substrate each having a reflectance spectrum having a peak wavelength, a peak width, and an integrated area, wherein the peak wavelength, peak width, or integrated area may vary' by less than about 50% from edible substrate to coated edible substrate.
  • the peak wavelength, peak width, or integrated area may vary by less than about 50%, less than about 40%, less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, less than about 1%, less than about 0.5%, or less than about 0.1%.
  • applying the composition to an edible substrate produces an edible coating on the edible substrate, the edible coating having a transmission haze of less than about 50% as measured by ASTM D1003-95,“Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics” or a reflection haze of less than about 50% as measured by ASTM E430-91, “Standard Test Methods for Measurement of Gloss of High-Gloss Surfaces by Goniophotometry.”
  • Gloss may be measured using Novocure equipment (Rhopomt Instruments, UK).
  • the coatings may exhibit good stability. Stability indicates the ability for a coating to remain functional under normal or abnormal storage conditions.
  • One example of a means of testing stability is exposing a coated substrate to 60% relative humidity at 25° C (“storage condition H2”), 75% relative humidity at 40° C (“storage condition H4”), or room conditions and evaluating a measurable property. Changes in the measurable property over time are an indication of lack of stability with respect to that measurable property and the particular conditions studied.
  • the measurable property may change by less than about 50%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, less than about 1%, less than about 0.1%, or less than about 0.01% over a period of time of at least about 30 minutes, at least about 1 hours, at least about 6 hours, at least about 12 hours, at least about 24 hours, at least about 7 days, at least about two weeks, at least about one month, at least about three months, at least about six months, or at least about one year.
  • Examples of measurable properties include, but are not limited to, whiteness, brightness, yellowness, clarity, opacity, gloss, size, smoothness, friability, transmission haze, adhesion, hardness, and moisture barrier.
  • the dry film coating composition comprises about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 8 wt% to about 25 wt% glycerin, about 10 wt% to about 30 wt % maltodextrm of vegetable source, relative to the total weight of non-water components of the composition.
  • HPMC hydroxypropyl methylcellulose
  • the dry film coating composition comprises about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 8 wt% to about 25 wt% plasticizing agent selected from glycerin, sorbitol, or a combination thereof, and about 10 wt% to about 45 wt% of starch comprising rice starch, maltodextrin of a vegetabl e source, or combinations thereof, relative to the total weight of non- water components of the composition.
  • HPMC hydroxypropyl methylcellulose
  • plasticizing agent selected from glycerin, sorbitol, or a combination thereof
  • starch comprising rice starch, maltodextrin of a vegetabl e source, or combinations thereof
  • the disclosure provides a nutritional supplement, a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, a sugar sphere, or a seed comprising an edible substrate and a coating thereon, the coating being a dried suspension of the compositions described herein.
  • the capsule may be a single-piece capsule or a two-piece capsule.
  • the disclosure provides a nutritional supplement comprising an edible substrate and a coating thereon, the coating being a dried suspension of the composition described herein.
  • the disclosure provides a method of making a composition for coating an edible substrate, the method comprising blending a cellulose film former, a plasticizing agent, and an opacifier to form a mixture, adding water to the blend to form a slurry, and drying the slurry for at least about 30 minutes such that the plasticizing agent absorbs onto the cellulose film former and opacifier.
  • the cellulose film former, the plasticizing agent and the opacifier may be mixed with, for example, m a plow former.
  • Other components of the dry film coating composition comprising which may include, for example, an oligofructose fiber, polyols, polysaccharides, a processing aid, a slip aid, a detackifier, a lubricant, a colorant, a surfactant, a buffering agent, and combinations thereof may be included for mixing in the plow' former.
  • Water (or another solvent) may be added to a mixing tank equipped with a high-shear overhead mixer to form a slurry.
  • the dry film coating composition may be added into the high-shear overhead mixer at medium vortex, and mixing may continue for at least about 30 minutes or until the slu achieves a smooth consistency with no visible lumps.
  • the resulting slurry may be dried for at least about 30 minutes, at least about 40 minutes, at least about 50 minutes, or at least about 60 minutes such that the plasticizing agent absorbs onto the cellulose film former and opacifier.
  • the dried slurry may be further chopped before additional usage.
  • Manufacturing steps such as order of component addition, mixing temperatures (heating and/or cooling), mixing time, mixing speed, etc. can be driven by either by formulation or equipment requirements, or both. A number of parameters can be modified during the manufacturing process without substantial effect on the efficacy of the resulting product.
  • the manufacturing processes can further include separate steps for validating the resulting composition (e.g , the total amounts, ratios, and even distribution of components in the composition, etc.).
  • HPMC preparations including HPMC 3, HPMC 5, HPMC 6, and HPMC 15, wherein the numbers 3, 5, 6, and 15 indicate the HPMC preparation's viscosity in 1% aqueous solution (i.e., "HPMC 3" indicates an HPMC preparation that exhibits a viscosity of 3 cps when mixed with water to make a 1% (w/w) HPMC solution).
  • HPMC 3 indicates an HPMC preparation that exhibits a viscosity of 3 cps when mixed with water to make a 1% (w/w) HPMC solution.
  • Commercially available examples include SpectracelTM 3, 5, 6, and 15 (available from Sensient Technologies).
  • the rice starch was obtained from Penford Food Ingredients, Co. The rice is grown in and the starch is produced m Thailand.
  • Example 1 produced a coating that was unstable at room temperature. In some instances, the coating energetically fractured after being applied to an edible substrate.
  • Example 2 produced a coating with an attractive appearance a good slip properties.
  • Example 3 produced a coating with an attractive appearance and good slip properties.
  • Example 4 produced a coating with an attractive appearance and good slip properties.
  • the coatings were prepared in the same manner as described in Example 5. The resulting coatings had an insufficient opacity, even at 6% weight gam.
  • the coatings were prepared in the same manner as described in Example 5. The resulting coatings had good opacification at 6% weight gain.
  • the coatings were prepared in a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 6.41 The resulting coatings had poor logo fill, even at 4% weight gain.
  • the coatings were prepared in a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 6.60 The resulting coatings had poor logo fill, even at 4% weight gain.
  • Example 11 The coatings were prepared in a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 6.60. The resulting coatings had better logo fill than Examples 8 and 9 Example 11
  • Example 5 The coatings were prepared m a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 6.60. The resulting coatings had better logo fill than Examples 8 and 9.
  • the coatings were prepared in a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 5.50. The resulting coatings showed bearding and slower weight gain. However, the opacity at 6% weight gam looked fairly good.
  • Example 12 The coatings were prepared m a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 5.50. The resulting coatings did not have an issue with bearding, but the opacity was lower than Example 12.
  • 14A, 14B, and 14C are of the formula below, but each has a different colorant. Results for example 12 are also shown below.
  • the colorants are turmeric, red radish, natural blue and annatto.
  • HPMC high shear mixer
  • maltodextrin and citric acid were added to a high shear mixer and mixed until uniform.
  • red powder and spirulina were added and the mixture was mixed again until uniform.
  • sunflower lecithin and glycerin were added and mixed again until a uniform a pink powder was formed.
  • the dry mixture was combined with water using an overhead conventional mixture set at 750 rpm for at least 30 minutes or until a homogeneous solution was formed.
  • the resulting purple to maroon-colored solution was 82.0% water by weight and had a viscosity of 473 cP and a pH of 4.08.
  • Vitamin tablet cores were sprayed with the solution until an about 4% weight gain was achieved.
  • the coating at a 4% weight gain provided good opacity, barrier protection and gloss.
  • formulations such as that above may include sunflower lecithin and or coconut oil.
  • Clause 1 A composition for coating an edible substrate, the composition comprising:
  • HPMC hydroxypropyl rnethylcellulose
  • a composition for coating an edible substrate comprising; about 30 wt% to about 65 wt% hydroxypropyl rnethylcellulose (HPMC);
  • plasticizing agent selected from glycerin, sorbitol, or a combination thereof;
  • starch comprising rice starch, maltodextrin, or combinations thereof;
  • Clause 3 A composition for coating an edible substrate, the composition comprising:
  • an opacifier comprising starch
  • composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms,
  • the weight percentages being relative to the total weight of non-water components of the composition.
  • Clause 4 The composition of clause 3, wherein the cellulose film former comprises hydroxypropyl rnethylcellulose (HPMC).
  • Clause 5 The composition of any of clauses 1-4, wherein the composition comprises about 25 wt% to about 55 wt% HPMC having a dynamic viscosity of about 5 cps or HPMC having a dynamic viscosity of about 6 cps.
  • Clause 6 The composition of any of clauses 1-5, wherein the composition comprises about 5 wt% to about 30 wt% HPMC having a dynamic viscosity of about 15 cps.
  • Clause 7 The composition of any of clauses 3-6, wherein the plasticizing agent is selected from medium chain triglycerides, fatty acids, fatty acid derivatives, glycerin, sorbitol, or any combination thereof.
  • the plasticizing agent is selected from medium chain triglycerides, fatty acids, fatty acid derivatives, glycerin, sorbitol, or any combination thereof.
  • Clause 8 The composition of any of clauses 3-7, wherein the plasticizing agent is present in amount from about 5 wt% to about 30 wt% relative to the total weight of non- water components of the composition.
  • Clause 10 The composition of any of clauses 2-8, wherein the plasticizing agent comprises about 8 wt% to about 15 wt% glycerin.
  • Clause 1 1. The composition of any of clauses 3-10, wherein the composition comprises about 10 wt% to about 40 wt% opacifier relative to the total weight of non- water components of the composition.
  • Clause 12 The composition of any of clauses 2-11 , wherein the starch comprises modified starches, non-rnodified starches, or combinations thereof.
  • Clause 13 The composition of any of clauses 2-12, wherein the starch comprises maltodextrin.
  • Clause 14 The composition of any of clauses 2-13, wherein the composition comprises about
  • Clause 15 The composition of any of clauses 1-14, wherein the composition comprises about 20-25 wt% maltodextrin.
  • Clause 16 The composition of any of clauses 2-15, wherein the starch comprises rice starch.
  • Clause 17 The composition of any of clauses 2-16, wherein the composition comprises about 10 wt% to about 25 wt% rice starch.
  • Clause 18 The composition of any of clauses 1 -17, further comprising about 1 wt% to about 30 wt% colorant relative to the total weight of non- water components of the composition.
  • Clause 19 The composition of any of clauses 1 -18, further comprising greater than 0 wt% and less than or equal to 2 wt% ci tric acid relative to the total weight of non-water components of the composition.
  • Clause 20 The composition of clause l, further comprising about 10 wt% to about 20 wt% rice starch.
  • Clause 21 The composition of any of clauses 1-20, wherein the composition further comprises a flavoring
  • Clause 22 The composition of any of clauses 1-21, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms.
  • Clause 23 The composition of any of clauses 1-22, wherein the composition is substantially free of gum acacia.
  • Clause 25 The method of clause 24, wherein the edible substrate is a nutritional supplement, pharmaceutical, a tablet, a capsule, a softge!, a granule, a microparticle, a nanoparticle, a seed, a sugar sphere, gum chew base, chewable gel, or a gummy substrate.
  • Clause 26 The method of clause 24 or clause 25, wherein the edible coating has CIE L*a*b color scale measurements that change less than 1% over a period of 3 months as assessed by ASTM Method E313 with a D65/10 0 illumination source using a spectrophotometer.
  • Clause 27 The method of any of clauses 24-26, wherein the edible coating has a color index as assessed by CIE L*a*b color scale measurements that provides high and/or full opacity at about 3% weight gain.
  • Clause 28 A nutritional supplement, a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, or a seed comprising an edible substrate and a coating thereon, the coating being a dried suspension of the composition of any one of clauses 1-23 thereon.
  • Clause 29 A nutritional supplement comprising an edible substrate and a coating thereon, the coating being a dried suspension of the composition of any one of clauses 1-23 thereon.
  • Clause 30 A method of making a composition for coating an edible substrate, the method comprising:
  • Clause 31 The method of clause 30, wherein the composition is any of clauses 1-23.
  • Clause 32 A composition for coating an edible substrate, the composition comprising:
  • HPMC hydroxypropyl methylcellulose
  • plasticizer selected from glycerin, sorbitol, and a combination thereof;
  • Clause 33 A composition for coating an edible substrate, the composition comprising: about 30 wt% to about 65 wt% cellulose film former;
  • an opacifier selected from a starch, gum acacia, and a combination thereof,
  • composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified orgamsms,
  • the weight percentages being relative to the total weight of non-water components of the composition.
  • Clause 34 The composition of clause 33, wherein the plasticizing agent is selected from medium chain triglycerides, fatty acids, fatty acid derivatives, and combinations thereof.
  • Clause 35 The composition of clause 34, wherein the plasticizing agent is glycerin, sorbitol, or a combination thereof.
  • Clause 36 The composition of any of clauses 33-35, wherein the plasticizing agent is present in amount from about 8 wt% to about 25 wt%.
  • Clause 37 The composition of any of clauses 33-36, wherein the plasticizing agent comprises about 8 wt% to about 20 wt% glycerin.
  • Clause 38 The composition of any of clauses 33-37, wherein the plasticizing agent comprises about 5 wt% to about 11 wt% sorbitol.
  • Clause 39 The composition of any of clauses 33-38, wherein the opacifier comprises about 15 wt% to about 20 wt% of the starch.
  • Clause 40 The composition of any of clauses 33-39, wherein the opacifier comprises about 5 wt% to about 16% of the gum acacia.
  • Clause 41 The composition of any of clauses 33-40, wherein the composition comprises about 20 wt% to about 36 wt% opacifier
  • Clause 42 The composition of any of clauses 33-41, wherein the cellulose film former comprises [0174] Clause 43.
  • Clause 44 The composition of any of clauses 32-43, wherein the composition comprises about 30 wt% to about 45 wt% HPMC relative to the total weight of non-water components of the
  • Clause 45 The composition of any of clauses 32-44, wiierein the composition comprises about 35 wt% to about 40 wt% HPMC relative to the total weight of non- water components of the
  • Clause 46 The composition of any of clauses 32-45, wherein the HPMC comprises about 30 wt% to about 45 wt% HPMC having a dynamic viscosity of about 5 cps.
  • Clause 47 The composition of any of clauses 32-46, wherein the HPMC comprises about 40 wt% HPMC having a dynamic viscosity of about 5 cps.
  • Clause 48 The composition of any of clauses 32-47 wherein the HPMC comprises greater than 0 wt% and less than or equal to 5 wt% HPMC having a dynamic viscosity of about 15 cps.
  • Clause 49 The composition of any of clauses 32-48, wherein the HPMC comprises about 3.25 wt% HPMC having a dynamic viscosity of about 15 cps.
  • Clause 50 The composition of any of clauses 32-49, wherein the composition comprises about 8 wt% to about 12 wt% glycerin relative to the total weight of non- water components of the
  • Clause 51 The composition of any of clauses 32-50 wherein the compositions comprises about 6 wt% to about 7 wt% sorbitol relative to the total weight of non-water components of the composition.
  • Clause 52 The composition of any of clauses 32-51, wherein the composition comprises about 12 wt% to about 14 wt% gum acacia relative to the total weight of non- water components of the composition.
  • Clause 53 The composition of any of clauses 32-52, wherein the composition comprises about 14 wt% gum acacia relative to the total weight of non- water components of the composition.
  • Clause 54 The composition of any of clauses 32-53, further comprising an oligofructose.
  • Clause 55 The composition of any of clauses 32-54, wherein the composition comprises about 1 wt% to about 12 wt% an oligofructose relative to the total weight of non-water components of the composition.
  • Clause 56 The composition of any of clauses 32-55, wherein the composition comprises about 3 wt% to about 8 wt% an oligofructose relative to the total weight of non-water components of the composition.
  • Clause 57 The composition of any of clauses 32-56, wherein the composition comprises about 3 wt% to about 5 wt% an oligofructose relative to the total weight of non-water components of the composition.
  • Clause 58 The composition of any of clauses 54-57, wherein the oligofructose comprises inulin.
  • Clause 59 The composition of any of clauses 32-58, further comprising about 1 wt% to about 30 wt% colorant relative to the total weight of non- ater components of the composition.
  • Clause 60 The composition of any of clauses 32-59, further comprising greater than 0 wt% and less than or equal to 2 wt% citric acid relative to the total weight of non-water components of the composition.
  • Clause 61 The composition of any of clauses 32-60, further compri sing greater than 0 wt% and less than or equal to 2 wt% an oil or a fatty acid.
  • Clause 62 The composition of any of clauses 32-61 further comprising greater than 0 wt% and less than or equal to 0.5 wt% an oil or a fatty acid.
  • Clause 63 The composition of any of clauses 32-62, wherein the starch is rice starch.
  • Clause 64 The composition of any of clauses 32-63, wherein the starch is present in an amount from about 17 wt% to about 20 wt%.
  • Clause 65 The composition of any of clauses 32-64, wherein the starch is present in an amount of about 19 wt%.
  • Clause 66 A method of forming an edible coating on an edible substrate comprising; spraying the composition of any of clauses 32-65 onto the substrate.
  • Clause 67 The method of clause 66, wherein the edible substrate is a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, or a seed.
  • Clause 68 The method of clause 66 or clause 67, wherein the edible coating has CIE L*a*b color scale measurements that change less than 1 % over a period of 3 months as assessed by ASTM Method E313 with a D65/10 0 illumination source using a spectrophotometer.
  • Clause 69 The method of any of clauses 66-68, wherein the edible coating has CIE L*a*b color scale measurements that change less than 1% over a period of 12 months as assessed by ASTM Method E313 with a D65/10 0 illumination source using a spectrophotometer.
  • Clause 70 A nutritional supplement, a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, or a seed comprising an edible substrate and the composition of clauses 32-65 thereon.

Abstract

A composition for coating an edible substrate comprising a cellulose film former, a plasticizing agent, an opacifier comprising starch, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms. Also provided is a composition for coating an edible substrate including about 25 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 15 wt% to about 20 wt% rice starch, about 8 wt% to about 20 wt% glycerin, about 2 wt% to about 14 wt% gum acacia, and about 1 wt% to about 12 wt% an oligofructose, relative to the total weight of non-water components of the composition.

Description

COMPOSITIONS FOR COATING EDIBLE SUBSTRATES,
AND METHODS OF MAKING AND USING THE SAME
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Application No. 62/632,392, filed February 19, 2018, which is hereby incorporated by reference m its entirety.
TECHNICAL FIELD
[0002] The present disclosure relates to compositions for coating edible substrates and methods for making and using the same, for use in the food, pharmaceutical, and nutraceutical industries.
INTRODUCTION
[0003] Film coating is an effective way of providing physical and chemical protection for a substrate. Film coatings include film forming agents, generally polymers that are soluble or dispersible in a solvent. Various additives may be used to facilitate the coating process and/or obtain specific coating properties. Ideally, film coatings should be one or more of stable, economical, and easy to process and should use food-approved ingredients to facilitate commercial implementation.
[0004] There is a need for a commercially viable cellulose-based composition to provide hydrophilic edible films that have good barrier properties.
SUMMARY
[0005] In one aspect, provided is a composition for coating an edible substrate including about 25 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 15 wt% to about 20 wt% rice starch, about 8 wt% to about 20 wt% glycerin, about 2 wt% to about 14 wt% gum acacia, and about 1 wt% to about 12 wt% an oligofructose, relative to the total weight of non-water components of the composition.
[0006] In another aspect, provided is a composition for coating an edible substrate including about 25 wt% to about 65 wt% cellulose film former, about 1 wt% to about! 2 wt% an oligofructose, an opacifier selected from starch, gum acacia, and a combination thereof, where the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and genetically modified organisms and the weight percentages are relative to the total weight of non-water components of the composition. [0007] In another aspect, provided is a composition for coating an edible substrate including about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 8 wt% to about 25 wt% glycerin, and about 10 wt% to about 30 wt % maltodextrin, relative to the total weight of non- water components of the composition.
[0008] In another aspect, provided is a composition for coating an edible substrate including about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 8 wt% to about 30 wt% plasticizing agent selected from glycerin, sorbitol, or a combination thereof, and about 25 wt% to about 45 wt% of starch comprising rice starch, maltodextrin, or combinations thereof, relative to the total weight of non-water components of the composition.
[0009] In another aspect, provided is a composition for coating an edible substrate including about 25 wt% to about 65 wt% cellulose film former, a plasticizing agent, and an opacifier comprising starch, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms, and the weight percentages being relative to the total weight of non-water components of the composition.
[0010] In another aspect, provided is a composition for coating an edible substrate including about 25 wt% to about 65 wt% cellulose film former, a plasticizing agent, and an opacifier comprising starch and/or maltodextrin, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms, and the weight percentages being relative to the total weight of non-water components of the composition.
[0011] In another aspect, provided is a composition for coating of an edible substrate wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms, and the weight percentages being relative to the total weight of non-water components of the composition and also the inclusion of flavors and biomass extracts.
[0012] In another aspect, a method of making a composition for coating an edible substrate is provided comprising blending a cellulose film former, a plasticizing agent, and an opacifier to form a , mixture, adding water to the blend to form a slurry, and drying the slurry for at least about 30 minutes such that the plasticizing agent absorbs onto the cellulose film former and opacifier.
[0013] In another aspect, a method is provided of forming an edible coating on an edible substrate including spraying the composition onto the substrate.
[0014] In another aspect, a nutritional supplement, a pharmaceutical, a tablet, a capsule, a granule, a softgel, a microparticle, a nanoparticle, a seed, a sugar sphere, gum chew base, chewable gel, or a gummy substrate is provided including an edible substrate and the composition thereon.
BRIEF DESCRIPTION OF THE FIGURES
[0015] FIG. 1 shows that at 16% rice starch and 21 % rice starch addition will afford the best whiteness when added to the total formulation. Subsequently 16% is preferred to create better rheological properties of the film
[0016] FIG. 2 shows that HPMC grade 2910, 15 cPs added to the formulation of at least 1 % affords better whiteness and minimizes color differentiation.
[0017] FIG. 3 shows that sorbitol has an equivalent opacification to the starting formulation per usage rate.
[0018] FIG. 4 A, FIG. 4B, and FIG. 4C show increasing weight gain (as indicated by increasing number) increases opacification, minimizes the vitamin and mineral appearance seen from the core, and increases the natural color hue.
[0019] FIG. 5 shows film cracking results if HPMC 2910 15cPs is not added in at least 5% and more preferentially at 10% to 15% of the formulation.
DETAILED DESCRIPTION
[0020] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description. The disclosed invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of“including,”“comprising,” or“having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The present disclosure also contemplates other embodiments“comprising,”“consisting of’ and“consisting essentially of,” the embodiments or elements presented herein, whether explicitly set forth or not.
[0021] It also is understood that any numerical range recited herein includes all values from the lower value to the upper value. For example, if a concentration range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1% to 3%, etc., are expressly enumerated in tins specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this application. It also is understood that for the recitation of numeric ranges herein, each intervening number there between with the same degree of precision is explicitly contemplated. For example, for the range of 6-9, the numbers 7 and 8 are contemplated in addition to 6 and 9, and for the range 6.0-7.0, the number 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, and 7.0 are explicitly contemplated.
[0022] As used herein, the term“about” is used synonymously with the term“approximately.” Illustratively, the use of the term“about” indicates that a recited value may include additional values slightly outside the recited values. This variation may be due to conditions such as experimental error, manufacturing tolerances, variations m equilibrium conditions, and the like. In some embodiments, the term“about” may include the cited value plus or minus 2.5%, 5%, 7.5%, or 10%, among others. It is to be understood that when the term“about” is used to modify a value, the value being modified is also expressly included. For example,“at least about 5” expressly includes at least 5, in addition to at least about 5. Similarly, by way of example,“at most about 95” expressly includes at most 95, in addition to at most about 95.
[0023] The term“substantially free,” as used herein unless otherwise defined, means that a composition comprises less than about 5%, less than about 4%, less than about 3%, less than about 2%, less than about 1%, less than about 0.9%, less than about 0.8%, less than about 0.7%, less than about 0.6%, less than about 0.5%, less than about 0.4%, less than about 0.3%, less than about 0.2%, less than about 0.1%, less than about 0.05% or less than about 0.01% by weight of, or none of the indicated component. [0024] In an aspect, the disclosure provides affordable, immediate-release, and easy-to- use coatings that meet FDA regulations. In some embodiments, the disclosed compositions, suspensions, and coatings may be used in coating substrates such as, for example, nutritional supplements,
pharmaceuticals, tablets, capsules (single-piece or two-piece), softgels, granules, particles (e.g., micro- and nano-particles), agricultural seeds, and the like. In embodiments, the diy film coating compositions may comprise at least one of a cellulose film former, an oligofructose fiber, a plasticizing agent, a processing aid, a slip aid, a detackifier, a lubricant, an opacifier, a colorant, a surfactant, a buffering agent, and/or combinations thereof. The compositions may be substantially free of one or more of titanium dioxide, calcium carbonate, minerals, and/or components derived from genetically modified organisms (GMO). In some embodiments, the dry film coating composition may comprise a cellulose film former, an oligofructose, and an opacifier. In certain other embodiments, the dry film coating composition may comprise hydroxypropyl methylcellulose (HPMC), rice starch, glycerin, gum acacia, and an oligofructose (e.g , inulin). In certain other embodiments, the dry film coating composition may comprise hydroxypropyl methylcellulose (HPMC), rice starch, maltodextrin and glycerin. At least one of these material s may be approved for food use.
[0025] When mixed with one or more solvents, the dry film coating composition may form a film coating suspension. The disclosed film coating suspensions may have high solution solids content, low viscosity', low foam, low heavy metals content, and/or low lead content. When applied to a substrate, the film coating suspensions may form a dry' film coating. The disclosed dry' film coatings may possess one or more of the following characteristics: high slip, high gloss, low heavy metals content, low lead content, and/or high color stability Suitably, the disclosed dry film coating compositions, film coating suspensions, and dry' film coatings may be stable, economical, and easy to use, offering simple, rapid, and efficient processing.
[0026] A cellulose film former may include a molecule comprising at least one cellulose polymer or derivative modified with small amounts of propylene glycol ether groups attached to the cellulose anhydroglucose chain affording binding properties that enhance the reinforcing film properties of film applications. Cellulose film formers may provide smooth, clear, film-forming coating suspensions and enhance the rheological mechanical strength properties of dry film coating gel matrices. Examples of cellulose film formers include, but are not limited to, hydroxypropyl methyl cellulose ("HPMC"), carboxymethyl cellulose ("CMC") or salts thereof, hydroxypropyl cellulose ("HPC"), methylcellulose ("MC"), hydroxy ethyl cellulose ("HEC"), methylethyl cellulose ("MEC"), and the like. A variety of examples of commercially available cellulose film formers exist and may include, for example,
SpectraceJ™ and Mantrocel™ HPMC compositions (available from Sensient Technologies).
[0027] An oligofructose (also referred to herein as an oligofructose fiber) may include any
oligosaccharide that includes one or more fructose molecules. Examples of oligofructose fibers include, but are not limited to, inulin, oligofructose, fructoohgosaccharides, and combinations thereof. Inulm, oligofructose, and fructooligosaccharides are oligosaccharide molecules composed of fructose units linked by (2-1) bonds and often terminated by a glucose unit. Oligofructose fibers may be obtained using any suitable method and/or source. For example, some embodiments provide for oligofructose fibers that can be derived from natural sources, such as chicory, garlic, asparagus, onion, leek, banana, and Jerusalem artichoke. In some embodiments, oligofructose and fructooiigosaceharide molecules may be obtained by partial enzymatic hydrolysis of inulin. Examples of commercially available
oligofructose fibers include, for example, Orafti® P95, Orafti® HSI, and Orafti® L58 Organic (available from BENEO, Inc.).
[0028] Plasticizing agents may enhance the film characteristics of the dry film coating, such as adhesion, flexibility, permeability, and the like. In embodiments, plasticizing agents include medium chain triglycerides, fatty acids, fatty acid derivatives, and combinations thereof. In some embodiments, examples of plasticizing agents may include, but are not limited to, propylene glycol
dicaprylate/dicaprate, medium chain triglycerides (e.g., fractionated coconut oil), glyceryl monostearate, propylene glycol, polypropylene glycol, polyethylene glycol, triacetin, glycerin, dibutyl sebacate, triglycerides, acetylated monoglycerides, glycerol monstearates, glycerin monostearate, oleic acid, stearic acid, sorbitol, tributyl citrate, acety!tnbutyl citrate, dibutyl phfhalate, tri ethyl citrate,
triethanolamine, aqueous emulsions of glyceryl monostearate and triethyl citrate, erythritol, and combinations thereof. Commercially available examples of propylene glycol dicaprylate/dicaprate include, for example, Miglyol® 840 (available from Sasol GmbH) and Neobee®1 M-20 (available from Stepan Co.).
[0029] Processing aids may improve coating process parameters or optical or mechanical film performance, enhancing film functionality and quality. Examples of processing aids include, but are not limited to, talc, calcium carbonate, clay, ammonium chloride, silica, sodium sulfate, calcium phosphate, propylene glycol dicaprylate/dicaprate, medium chain triglycerides (e.g., fractionated coconut oil), glyceryl monostearate, propylene glycol, polypropylene glycol, polyethylene glycol, triacetin, glycerin, dibutyl sebacate, triglycerides, acetylated monoglycerides, glycerol monstearates, glycerin
monostearate, oleic acid, stearic acid, sorbitol, tributyl citrate, acetyltributyl citrate, dibutyl phthaiate, triethyl citrate, triethanolamine, aqueous emulsions of glyceryl monostearate and triethyl citrate, and combinations thereof. In certain embodiments, suitable processing aids may be substantially free of calcium carbonate, minerals (e.g., talc, clay, silica), magnesium stearate, ingredients derived from genetically modified organisms, and emulsifiers and antioxidants of natural origin.
[QQ30] Slip aids may increase surface-to-surface tablet contact, aiding in coating uniformity' from tablet-to-tablet interfacial contact during the coating process. The final tablet slip also aids m esophageal transit. Examples of slip aids include, but are not limited to, talc, natural and synthetic waxes, metal stearates, silica, natural and synthetic oils, fatty acids, and triglycerides. In certain embodiments, suitable slip aids may not include minerals (e.g., talc, silica) and ingredients derived from genetically modified organisms.
[QQ31] Detackifiers may inhibit formation of collective particles and facilitate coalescence during film formation and at minimum film temperatures. Examples of detackifiers include, but are not limited to, talc, aluminum hydrate, acetylated glycerides, diglycerides, acetylated monoglyceride,
polyvinylpyrrolidone, sorbitan monostearate, polyglycerol esters, ethyl acetate, glyceryl monostearate, monoglycerides, poloxamers, stearic acid, triacetin, triethyl citrate, mineral oil, kaolin, and combinations thereof. In certain embodiments, suitable detackifiers may not include minerals (e.g., talc, mineral oil, kaolin) and ingredients derived from genetically modified organisms.
[0032] Lubricants may enhance esophageal transit ease, film slipperiness, and surface flowability. Examples of lubricants include, but are not limited to, talc, metallic stearates, silicon dioxide, sodium stearyl fumarate, palmitic acid, fatty acid esters, fatty acids, faty alcohols, mineral oil, paraffins, leucine, polyethylene glycols, metallic !auryl sulfates, stearic acid, hydrogenated vegetable oil, triethyl citrate, PEG 3350, and combinations thereof. In certain embodiments, suitable lubricants may not include minerals (e.g., talc, mineral oil) and ingredients derived from genetically modified organisms. [0033] Opacifiers may impart dispersed fine particles in dry film coatings, providing opaque films with high optical densities. Examples of opacifiers include, but are not limited to, starch, gum acacia, and a combination thereof. The compositions may be substantially free or free of titanium dioxide, zinc oxide, and calcium carbonate. In some embodiments, the compositions are substantially free of gum acacia. Starch opacifiers may be modified or non-modified starches. Modified starches may include dextnns and maltodextrms from sourced materials of corn, wheat, tapioca, potatoes, other vegetable sources (including, for example pea, sweet potato, mung bean, etc.) and rice and starches thereof.
[0034] Examples of colorants include dyes, lakes, and pigments and may include, but are not limited to, titanium dioxide, iron oxides, dyes such as, for example, FD&C Lakes, Carmine Lake, FD&C Blue no. 1, FD&C Red no. 3, FD&C Red no. 40, FD&C Yellow- no. 5, FD&C Yellow no. 6, FD&C Green no. 3, alumina, talc, annatto extract, calcium carbonate, canthaxanthin, caramel, 13-carotene, carmine, dihydroxyacetone, turmeric oleoresin, cochineal extract, gardenia yellow; gardenia blue, beet powder, red powder, grape skin extract, riboflavin, purple sweet potato, red sweet potato, spirulma, chlorophyll- containing extracts, pearlescent pigments, SensiPearl™ Blue, Silver, and Bright Silver (available from Sensient Colors, Inc.), natural colorants, and the like. Other examples of colorants are found in 21
C.F.R. §§ 73 and 74, which are hereby fully incorporated by reference. In certain embodiments, suitable colorants may not include titanium dioxide, calcium carbonate, minerals (e.g., alumina, talc), and ingredients derived from genetically modified organisms.
[0035] Surfactants may function as wetting agents, lowering surface tension and interfacial tension and facilitating film coalescence. Examples of surfactants include, but are not limited to, polysorbates (polyethoxy lated sorbitan faty acid derivatives) such as, for example, polysorbate 80; polyglyceryl 10 laurate; lecithins (e.g., sunflower lecithin); mono- and di -glycerides; propylene glycol; sodium laury! sulfate; acety lated monoglycerides; additives of propyl gallate and citric acid and stabilizers therein; alcohol; alkali metal and ammonium salts of ethylene diamine tetracetic acid, nitrilo tiacetie acid, citric acid, phosphoric acid, tartaric acid, glycolic acid, malic acid, lactic acid, acetic acid, and benzoic acid; and also natural surfactant and emulsifiers and combinations thereof. In certain embodiments, suitable surfactants may not include ingredients derived from genetically modified organisms.
[0036] Buffering agents may impart anionic/cationic ratios of minerals of sodium, potassium, magnesium, and/or calcium. Examples of buffering agents include, but are not limited to, citric acid and sodium citrate. Suitable buffering agents can be selected based on the particular formulation and/or application (e.g., based on requirements of composition elements such as, for example, pharmaceutical actives, and/or route of administration) in certain embodiments, suitable buffering agents may not include minerals.
[0037] Examples of solvents may include, but are not limited to, ethanol, water, isopropanol and combinations thereof. Unless indicated otherwise, the percentages identified below are listed in terms of weight of the dry composition.
[0038] The compositions disclosed herein, may also comprise additional components know to those of skill in the art, including, without limitation, flavorings and or extracts from biomass.
[0039] Examples of flavorings may be synthetic or artificial flavorings, natural flavorings or any mixture thereof and may include, but are not limited to, sensates, flavonoids, antioxidants, natural flavorants, synthetic flavorants, bioflavonoids, flavones, flavone, flavonol, flavanonol, isoflavones, ethyl vanillin, tangerine flavor, lemon flavor, lemon extract, liquid caramel, spearmint oil, orange flavor, almond, amaretto, apple, green apple, apple-cherry-berry, apple-honey, apricot, bacon, balls of fire, banana, barbeque, beef, roast beef, beef steak, berry, berry blue, birch beer/spruce beer, blackberry, bloody mary, blueberry, boysenberry, brandy, bubble gum, butter, butter pecan, buttermilk, butterscotch, candy corn, cantaloupe, cantaloupe lime, caramel, carrot, cassia, caviar, celery, cereal, champagne, cherry, cherry' cola, cherry maraschino, wild cherry, black cherry, red cherry, cherry-cola, chicken, chocolate, chocolate almond, cinnamon spice, citrus, citrus blend, citrus-strawberry', clam, cocoa, coconut, toasted coconut, coffee, coffee almond, cola, cola-vanilla, cookies & cream, cool, cotton candy, cranberry, cranberry-raspberry, cream, cream soda, dairy type cream, creme de menthe, cucumber, black currant, dulce de leche, egg nog, pork fat, type fat, anchovy fish, herring fish, sardine fish, frankfurter, fiery hot, fried garlic, sauteed garlic, gin, ginger ale, ginger beer, graham cracker type, grape, grape grapefruit, grapefruit-lemon, grapefruit-lime, grenadine, grill, guarana, guava, hazelnut, honey, hot, roasted honey, ice cream cone, jalapeno, key' lime, kiwi, kiwi-banana, kiwi-lemon-lime, kiwi- strawberry, kola champagne, lard type, lemon, lemon custard, lemonade, pink lemonade, lemon-lime, lime, malt, malted milk, mango, mango-pineapple, maple, margarita, marshmallow, meat type, condensed milk, cooked milk, mint, mirepoix, mocha, mochacinna, molasses, mushroom, sauteed mushroom, muskmelon, nectarine, neapolitan, green onion, sauteed onion, orange, orange cordial,
o orange creamsicle, orange creme, orange peach mango, orange strawberry banana, creamy orange, mandarin orange, orange- passion-guava, orange-pineapple, papaya, passion fruit, peach, peach mango, peanut, roasted peanut, pear, pecan damsh type, pecan praline, pepper, peppermint, pimento, pma colada, pma colada/pineapple-coconut, pineapple, pineapple-orange, pistachio, pizza, pomegranate, pork fat type, baked potato, prune, punch, citrus punch, tropical punch, cherry fruit punch, grape punch, raspberry, black raspberry, blue raspberry, red raspberry, raspberry-blackberry, raspberry-ginger ale, rasp berry- lime, roast type, root beer, rum, sangria, sarsaparilla, sassafras, sausage, sausage pizza, savory, seafood, shrimp, hickory smoke, mesquite smoke, sour, sour cream, sour cream and onion, spearmint, spicy, strawberry, strawberry margarita, jam type strawberry, strawberry-kiwi, burnt sugar, sweet & sour, tallow, tamarind, tangerine-lime, tangerine, tea, tequila type, toffee, triple sec, tropical fruit mix, turkey, tutti frutti, vanilla, vanilla cream, vanilla custard, french vanilla, vegetable, vermouth, vinegar, balsamic vinegar, watermelon, whiskey, wildberry, wine, and yogurt, and the like.
[0040] In an aspect, the disclosure provides a dry film coating composition. The dry film coating composition may include a cellulose film former. In some embodiments, the dry film coating
composition may include at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, at least about 30%, at least about 31%, at least about 32%, at least about 33%, at least about 34%, at least about 35%, at least about 36%, at least about 37%, at least about 38%, at least about 39%, at least about 40%, at least about 41%, at least about 42%, at least about 43%, at least about 44%, at least about 45%, at least about 46%, at least about 47%, at least about 48%, at least about 49%, at least about 50%, at least about 51%, at least about 52%, at least about 53%, at least about 54%, at least about 55%, at least about 56%, at least about 57%, at least about 58%, at least about 59%, at least about 60%, at least about 61%, at least about 62%, at least about 63%, or at least about 64% cellulose film former. The dry film coating composition may include less than about 65%, less than about 64%, less than about 63%, less than about 62%, less than about 61%, less than about 60%, less than about 59%, less than about 58%, less than about 57%, less than about 56%, less than about 55%, less than about 54%, less than about 53%, less than about 52%, less than about 51 %, less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26% cellulose film former. This includes, for example, about 25% to about 65%, about 30% to about 45%, about 25% to about 65%, about 30% to about 65%, or about 35% to about 40% cellulose film former.
[0041] In some embodiments, the cellulose film former may comprise, for example, HPMC. In some embodiments, the cellulose film former may comprise, for example, HPMC having a dynamic viscosity of about 3 cps, HPMC having a dynamic viscosity of about 5 cps, HPMC having a dynamic viscosity of about 6 cps, or HPMC having a dynamic viscosity of about 15 cps, or any combination thereof. In some embodiments, the cellulose film former is solely HPMC having a dynamic viscosity of about 15 cps.
[0042] In some embodiments, the cellulose film former may comprise, for example, HPMC having a dynamic viscosity of about 5 cps. In some embodiments, the dry film coating composition may include at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, at least about 30%, at least about 31%, at least about 32%, at least about 33%, at least about 34%, at least about 35%, at least about 36%, at least about 37%, at least about 38%, at least about 39%, at least about 40%, at least about 41%, at least about 42%, at least about 43%, or at least about 44%, at least about 45%, at least about 46%, at least about 47%, at least about 48%, at least about 49%, at least about 50%, at least about 51%, at least about 52%, at least about 53%, or at least about 54% HPMC having a dynamic viscosity of about 5 cps. The dry film coating composition may include less than about 55%, less than about 54%, less than about 53%, less than about 52%, less than about 51%, less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26% HPMC having a dynamic viscosity of about 5 cps. This includes, for example, about 25% to about 55%, about 30% to about 45%, or about 25% to about 45% HPMC having a dynamic viscosity of about 5 cps.
[0043] In some embodiments, the cellulose film former may comprise, for example, HPMC having a dynamic viscosity of about 6 cps. In some embodiments, the dry' film coating composition may include at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, at least about 30%, at least about 31%, at least about 32%, at least about 33%, at least about 34%, at least about 35%, at least about 36%, at least about 37%, at least about 38%, at least about 39%, at least about 40%, at least about 41%, at least about 42%, at least about 43%, or at least about 44%, at least about 45%, at least about 46%, at least about 47%, at least about 48%, at least about 49%, at least about 50%, at least about 51%, at least about 52%, at least about 53%, or at least about 54% HPMC having a dynamic viscosity of about 6 cps. The dry film coating composition may include less than about 55%, less than about 54%, less than about 53%, less than about 52%, less than about 51%, less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26% HPMC having a dynamic viscosity of about 6 cps. This includes, for example, about 25% to about 55%, about 30% to about 45%, or about 25% to about 45%HPMC having a dynamic viscosity of about 6 cps.
[0044] In some embodiments, the dry film coating composition may include HPMC having a dynamic viscosity of about 3 cps. In some embodiments, the dry film coating composition may include at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 1 1%, at least about 12%, at least about 13%, at least about 14%, at least about 15%, at least about 16%, at least about 17%, at least about 18%, at least about 19%, at least about 20%, at least about 21 %, at least about 22%, at least about 23%, or at least about 24% HPMC having a dynamic viscosity of about 3 cps. The dry film coating composition may include less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18%, less than about 17%, less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, less than about 1 1 %, less than about 10%, less than about 9%, less than about 8%, less than about 7%, or less than about 6% HPMC having a dynamic viscosity of about 3 cps. This includes, for example, about 5% to about 25% HPMC having a dynamic viscosity of about 3 cps. [0045] In some embodiments, the dry film coating composition may include HPMC having a dynamic viscosity of about 15 cps. In some embodiments, the dry film coating composition may include at least about 0.01%, at least about 0.05%, at least about 0.10%, at least about 0.15%, at least about 0.20%, at least about 0.25%, at least about 0.30%, at least about 0.35%, at least about 0.40%, at least about 0.45%, at least about 0.50%, at least about 0.55%, at least about 0.65%, at least about 0.70%, at least about 0.75%, at least about 0.80%, at least about 0.85%, at least about 0.90%, at least about 0.95%, at least about 1.00%, at least about 1.25%, at least about 1.50%, at least about 1.75%, at least about 2.00%, at least about 2.25%, at least about 2.50%, at least about 2.75%, at least about 3.00%, at least about 3.25%, at least about 3.50%, at least about 3.75%, at least about 4.00%, at least about 4.25%, at least about 4.50%, or at least about 4.75% HPMC having a dynamic viscosity of about 15 cps. The dry film coating composition may include less than about 5.00%, less than about 4.75%, less than about 4.50%, less than about 4.25%, less than about 4.00%, less than about 3.75%, less than about 3.50%, less than about 3.25%, less than about 3.00%, less than about 2.75%, less than about 2.50%, less than about 2.25%, less than about 2 00%, less than about 1.75%, less than about 1.50%, less than about 1 25%, less than about 1.00%, less than about 0 95%, less than about 0.90%, less than about 0.85%, less than about 0 80%, less than about 0 75%, less than about 0.70%, less than about 0.65%, less than about 0 60%, less than about 0.55%, less than about 0 50%, less than about 0.45%, less than about 0.40%, less than about 0 35%, less than about 0 30%, less than about 0.25%, less than about 0.20%, less than about 0 15%, less than about 0.10%, or less than about 0.05% HPMC having a dynamic viscosity of about 15 cps. This includes, for example, greater than 0% and less than about 5%, greater than 0% and less than about 3.5%, greater than 0% and less than about 1% HPMC having a dynamic viscosity of about 15 cps or about 3.25% HPMC having a dynamic viscosity of about 1 5 cps.
[0046] In some embodiments, the dry film coating composition may include at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 1 1 %, at least about 12%, at least about 13%. at least about 14%, at least about 15%, at least about 16% at least about 17%. at least about
18%, at least about 19%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, at least about 30%, at least about 31%, at least about 32%, at least about 33%, at least about 34%, at least about 35%, at least about 36%, at least about 37%, at least about 38%, at least about 39%, at least about 40%, at least about 41%, at least about 42%, at least about 43%, at least about 44%, at least about 45%, at least about 46%, at least about 47%, at least about 48%, at least about 49%, at least about 50%, at least about 51%, at least about 52%, at least about 53%, at least about 54%, at least about 55%, at least about 56%, at least about 57%, at least about 58%, at least about 59%, at least about 60%, at least about 61%, at least about 62%, at least about 63%, or at least about 64% HPMC having a dynamic viscosity of about 15 cps. The dry film coating composition may include less than about 65%, less than about 64%, less than about 63%, less than about 62%, less than about 61%, less than about 60%, less than about 59%, less than about 58%, less than about 57%, less than about 56%, less than about 55%, less than about 54%, less than about 53%, less than about 52%, less than about 51%, less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18%, less than about 17%, less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, less than about 11%, less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, or less than about 1 % HPMC having a dynamic viscosity of about 15 cps. This includes, for example, about 1% to about 30%, about 1 to about 12%, about 5% to about 30%, about 10% to about 65% and about 5% to about 10% HPMC having a dynamic viscosity of about 15 cps.
[0047] In some embodiments, the dry film coating composition may include an oligofructose fiber. In some embodiments, the dry film coating composition may include at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, or at least about 11% oligofructose fiber. The dry film coating composition may include less than about 12%, less than about 1 1%, less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, or less than about 2% oligofructose fiber. This includes, for example, about 1% to about 12%, about 3% to about 8%, or about 3% to about 5% oligofructose fiber. In some embodiments, the oligofructose fiber may comprise, for example, inulin.
[0048] In some embodiments, the dry film coating composition may include an opacifier. In some embodiments, the dry film coating composition may include at least about 10%, at least about 1 1%, at least about 12%, at least about 13%, or at least about 14%, at least about 1 5%, at least about 16%, at least about 17%, at least about 18%, at least about 19%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, at least about 30%, at least about 31%, at least about 32%, at least about 33%, at least about 34% opacifier, or at least 35% opacifier. The dry film coating composition may include less than about 50%, less than about 49%, less than about 48%, less than about 47%, less than about 46%, less than about 45%, less than about 44%, less than about 43%, less than about 42%, less than about 41%, less than about 40%, less than about 39%, less than about 38%, or less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18%, less than about 17%, or less than about 16% opacifier. This includes, for example, about 15% to about 36%, about 22% to about 42%, about 25% to about 36%, about 17% to about 20%, about 17% to about 34%, about 25% to about 34%, about 10% to about 40%, about 20% to about 36%, or about 10% to about 30% opacifier. In some embodiments, more than one opacifier may be used.
[0049] In some embodiments, the opacifier may include starch, gum acacia or a combination thereof. In some embodiments, more than one starch may be used. For example, the compositions may comprise rice starch and maltodextrin. Preferably, the composition and the opacifier are substantially free of both titanium dioxide and calcium carbonate.
[0050] In some embodiments, the opacifier may include starch. In some embodiments, the dry' film coating composition may include at least about 10%, at least about 11%, at least about 12%, at least about 13%, at least about 14%, at least about 15%, at least about 16%, at least about 17%, at least about
18%, at least about 19%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, or at least about 29% of starch. The dry film coating composition may include less than about 50%, less than about 45%, less than about 40%, less than about 39%, less than about 38%, less than about 37%, less than about 36%, less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31 %, less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26%, less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18%, less than about 17%, less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, or less than about 11% of starch. This includes about 10% to about 50%, about 15% to about 45%, about 15% to about 20%, about 17% to about 20%, about 20% to about 45%, or about 10% to about 30%, about 20 wt% to about 25 wt%, or about 10 wt% to about 25 wt% of starch.
[0051] The starch may comprise modified starches, non-modified starches, or combinations thereof. Modified starches may include dextrms and maltodextrins. In some embodiments, the dry film coating composition may include at least about 10%, at least about 11%, at least about 12%, at least about 13%, at least about 14%, at least about 15%, at least about 16%, at least about 17%, at least about 18%, at least about 19%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, or at least about 29% of dextrin or maltodextrin. The dry film coating composition may include less than about 30%, less than about 29%, less than about 28%, less than about 27%, or less than about 26%, less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18%, less than about 17%, less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, or less than about 11% of dextrin or maltodextrin. This includes dry film coating compositions including about 10 wt% to about 30 wt%, 10 wt% to about 25 wt%, or about 20 wt.% to about 25 wt% of dextrin or maltodextrin
[0052] In some embodiments, the composition may include rice starch. The composition may comprise at least about 10 wt%, at least about 1 1 wt%, at least about 12 wt%, at least about 13 wt%, at least about 14 wt%, at least about 15 wt%, at least about 16 wt%, at least aboutl 7 wt.%, at least about 1 8 wt%, or at least about 19 wt% rice starch. The composition may comprise less than about 25 wt%, less than about 24 wt%, less than about 23 wt%, less than about 22 wt%, less than about 21 wt.%, less than about 20 wt%, less than about 19 wt%, less than about 18 wt.%, less than about 17 wt%, less than about 16 wt%, less than about 15 wt%, less than about 14 wt%, less than about 13 wt%, less than about 12 wt%, or less than about 11 wt% rice starch. This includes dry film coating compositions including about 10 wt% to about 25 wt% or about 10 wt% to about 20 wt% rice starch.
[0053] In some embodiments, the starch may comprise maltodextrin and sources of maltodextrin thereof and rice starch.
[0054] In some embodiments, the opacifier may include gum acacia. In some embodiments, the dry film coating composition may include at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 11%, at least about 12%, at least about 13% gum acacia, at least about 14%, or at least about 15%. The dry film coating composition may include less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, less than about 11%, less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, or less than about 3% gum acacia. This includes, for example, about 2% to about 16%, about 5% to about 16%, about 10% to about 14%, or about 12% to about 14% gum acacia.
In some embodiments, the dry film coating composition may be substantially fee of gum acacia.
[0055] In some embodiments, the dry film coating composition may include a plasticizing agent. In some embodiments, the dry film coating composition may include at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 11%, at least about 12%, at least about 13%, at least about 14%, at least about 15%, at least about 16%, at least about
17%, at least about 18%, at least about 19%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29% plasticizing agent. The dry film coating composition may include less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about
26%, less than about 25%, less than about 24%, less than about 23%, less than about 22%, less than about 21%, less than about 20%, less than about 19%, less than about 18% plasticizing agent, less than about 17%, less than about 16%, less than about 15%, less than about 14%, less than about 13%, less than about 12%, less than about 1 1%, less than about 10%, less than about 9%, less than about 8%, less than about 7%, or less than about 6% plasticizing agent. This includes, for example, about 8% to about
20%, about 8% to about 12%, about 5% to about 11%, or about 6% to about 7% plasticizing agent. This includes, for example, about 8% to about 25% plasticizing agent or about 5% to about 25% plasticizing agent.
[0056] In some embodiments, the plasticizing agent is selected from medium chain triglycerides, faty acids, fatty acid derivatives, glycerin, sorbitol, or any combination thereof.
[0057] In some embodiments, the plasticizing agent may comprise medium chain triglycerides, fatty acids, fatty acid derivatives, or combinations thereof. In some embodiments, the plasticizing agent may comprise greater than 0 wt% to about 5 wt% medium chain triglycerides, faty acids, fatty acid derivatives, or a combination thereof. In some embodiments, the plasticizing agent may comprise greater than 0 wt%, greater than about 1 wt%, greater than about 2 wt%, greater than about 3 wt%, or greater than about 4 wt% medium chain triglycerides, faty acids, fatty acid derivatives, or a combination thereof. In some embodiments, the plasticizing agent may comprise less than about 5 wt%, less than about 4 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% medium chain triglycerides, fatty acids, fatty acid derivatives, or a combination thereof.
[0058] In some embodiments, the plasticizing agent may comprise, for example, glycerin, sorbitol, or combinations thereof. In some embodiments, the plasticizing agent may comprise, for example, about 8% to about 20% or about 8% to about 12% glycerin and about 5% to about 11% or about 6% to about 7% sorbitol.
[0059] In some embodiments, the dry film coating composition may include a lubricant. In some embodiments, the dry film coating composition may include at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, and at least about 30% lubricant. The dry film coating composition may include less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 20%, and less than about 15% lubricant. This includes about 5% to about 35%, about 5% to about 30%, and about 8% to about 30% lubricant. [0060] In some embodiments, the dry film coating composition may include a slip aid. In some embodiments, the dry film coating composition may include at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, and at least about 30% slip aid. The dry film coating composition may include less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 20%, and less than about 15% slip aid. This includes about 5% to about 35%, about 5% to about 30%, and about 8% to about 30% slip aid.
[0061] In some embodiments, the dry film coating composition may include a detaekifier. In some embodiments, the diy film coating composition may include at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, and at least about 30% detaekifier. The diy film coating composition may include less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 20%, and less than about 15% detaekifier. This includes about 5% to about 35%, about 5% to about 30%, and about 8% to about 30% detaekifier.
[0062] In some embodiments, the dry film coating composition may include a processing aid. In some embodiments, the dry film coating composition may include at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 21%, at least about 22%, at least about 23%, at least about 24%, at least about 25%, at least about 26%, at least about 27%, at least about 28%, at least about 29%, and at least about 30% processing aid. The dry film coating composition may include less than about 35%, less than about 34%, less than about 33%, less than about 32%, less than about 31%, less than about 30%, less than about 29%, less than about 28%, less than about 27%, less than about 26%, less than about 25%, less than about 20%, and less than about 1 5% processing aid. This includes about 5% to about 35%, about 5% to about 30%, and about 8% to about 30% processing aid.
[0063] In some embodiments, the dry' film coating composition may include an intentional colorant. In some embodiments, the diy film coating composition may include at least about 0.05%, at least about 0.06%, at least about 0.07%, at least about 0.08%, at least about 0.09%, at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 10%, and at least about 15% colorant. The dry film coating composition may include less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, less than about 1%, and less than about 0.1% colorant. This includes, for example, about 0.05% to about 30%, about 1% to about 30%, about 0.05% to about 25%, and about 0.1% to about 20% colorant. In some embodiments, the dry film coating composition may contain no intentional colorants.
[0064] In some embodiments, the dry film coating composition may include a surfactant. In some embodiments, dry film coating composition may include at least about 0.1%, at least about 0.5%, at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, and at least about 10% surfactant. The dry film coating composition may include less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, and less than about 1% surfactant. This includes, for example, about 0.1% to about 10%, about 1% to about 6%, and about 1% to about 4% surfactant.
[QQ65] In some embodiments, the dry film coating composition may include a buffering agent. In some embodiments, the dry film coating composition may include at least about 0.1%, at least about 0.2%, at least about 0.3%, at least about 0.4%, at least about 0.5%, at least about 0.6%, at least about 0.7%, at least about 0.8%, at least about 0.9%, at least about 1%, at least about 2%, at least about 3%, at least about 4%, and at least about 5% buffering agent. The dry film coating composition may include less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, and less than about 1% buffering agent. This includes, for example, about 0.1% to about 10%, 1% to about 6%, and about 2% to about 5%, about 0.1% to about 0.5%, about 0.1% to about 0.4%, and about 0.1% to about 0.35% buffering agent.
[0066] In an aspect, the disclosure provides a film coating suspension. In some embodiments, the film coating suspension may include at least about 0%, at least about 0.1%, at least about 0.5%, at least about
1%, at least about 2%, at least about 3%, at least about 4%, and at least about 5% buffering agent. The film coating suspension may include less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, and less than about 1% buffering agent. This includes, for example, about 0% to about 10%, about 0.1% to about 5%, and about 1% to about 3% buffering agent. In some embodiments, the film coating suspension may include at least about 0.01 M, at least about 0.02 M, at least about 0.03 M, and at least about 0.04 M buffering agent. In some embodiments, the film coating suspension may include less than about 0.1 M, less than about 0.09 M, less than about 0.08 M, less than about 0.07 M, less than about 0.06 M, less than about 0.05 M, and less than about 0.04 M buffering agent. This includes, for example, about 0.01 M to about 0.1 M, and about 0.01 to about 0.05 M buffering agent.
[0067] The balance of the film coating suspension may comprise solvent (e.g., water). In some embodiments, the film coating suspension may include at least about 5% solvent or at least about 10% solvent. In some embodiments, the film coating suspension may include less than about 15% solvent or less than about 10% solvent. This includes, for example, about 5% to about 15%, about 5% to about 10%, or about 10% to about 15%. The film coating suspension may include less than about 95%, less than about 90%, less than about 85%, less than about 80%, and less than about 75% solvent. This includes, for example, about 30% to about 95%, about 60% to about 90%, and about 70% to about 85% solvent. In some embodiments, the film coating suspension may include at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 65%, at least about 70%, at least about 71%, at least about 72%, at least about 73%, at least about 74%, at least about 75%, at least about 76%, at least about 77%, at least about 78%, at least about 79%, at least about 80%, at least about 81%, at least about 82%, at least about 83%, at least about 84%, at least about 85%, at least about 86%, at least about 87%, at least about 88%, at least about 89%, and at least about 90% solvent.
[0068] In some embodiments, the disclosed film coating suspension suitably exhibits low' viscosity and/or high solution solids content. Thus, embodiments provide a coating suspension that exhibits a low' viscosity relative to the amount of solids content. In some embodiments, the disclosed film coating suspensions may include high solution solids content. Suitably, a film coating suspension having high solution solids content may include, for example, at least about 5%, at least about 10%, at least about 15%, and at least about 20% solution solids. In other embodiments, a film coating suspension may include, for example, less than about 20%, less than about 15%, less than about 10%, and less than about 5% solution solids. f 0069] In some embodiments, the disclosed film coating suspensions may have low viscosity.
Suitably, film coating suspension having low viscosity may have viscosity of less than about 450 centipoise (cps), less than about 350 cps, less than about 300 cps, less than about 250 cps, less than about 200 cps, less than about 150 cps, and less than about 100 cps. in other embodiments, a film coating suspension may have viscosity of at least about 100 cps, at least about 150 cps, at least about 200 cps, at least about 250 cps, at least about 300 cps, at least about 350 cps, at least about 400 cps, and at least about 450 cps. In some embodiments, the disclosed film coating suspensions may have high solution solids content and low viscosity.
[0070] Viscosity may be assessed by any suitable method such as, for example, using a Brookfield viscometer equipped with a UL Adapter Assembly and UL Spindle (available from Brookfield
Engineering Labs., Inc.). The film coating suspension or other test sample is poured into a clean graduated cylinder or other sample container, and the spindle is immersed m the sample. After starting the viscometer motor, the speed is adjusted to achieve a percent torque between 45-75%, and the viscosity (cps) of the sample is recorded .
[0071] In an aspect, a dry film coating may be formed on a substrate after application of the film coating suspension to the substrate. In some embodiments, the dry film coating formed on the substrate may contain little or no solvent (e.g., after the solvent evaporates).
[QQ72] In another aspect, the disclosure provides a dry film coating.
[0073] In some embodiments, the disclosed dry film coatings may have a high gloss. Suitably, a dry film coating having high gloss may have gloss of at least about 5, at least about 6, at least about 7, at least about 8, at least about 9, at least about 10, at least about 11, at least about 12, at least about 13, at least about 14, at least about 15, at least about 20, or at least about 25 gloss units. This includes, for example, about 5 to about 30 gloss units and about 7 to about 12 gloss units. Gloss of coatings such as the disclosed dry film coatings may be assessed using a Novo-Curve™ Glossmeter (available from Elcometer Instruments Ltd.).
[QQ74] The glossmeter is calibrated according to manufacturer's instructions, and a coated tablet is placed over the sample orifice to measure gloss. Each sample can be tested multiple times (e.g., in triplicate) in order to obtain an average gloss reading in embodiments, the disclosed dry film coatings may exhibit gloss that equals and/or exceeds the loss of a traditional film coating.
[0075] In some embodiments, the disclosed dry film coatings may have high slip and/or increase the slip characteristics of a coated substrate relative to an uncoated substrate, or a substrate that comprises a different coating. Suitably, a dr film coating having high slip may have slip of less than about 100, less than about 90, less than about 80, less than about 70, less than about 60, less than about 55, less than about 50, less than about 45, less than about 44, less than about 43, less than about 42, less than about 41, less than about 40, less than about 39, less than about 38, less than about 37, less than about 36, less than about 35, less than about 34, less than about 33, less than about 32, less than about 31, less than about 30, less than about 29, less than about 28, less than about 27, less than about 26, less than about 25, or less than about 20 g tension force. This includes, for example, about 20 g tension force to about 100 g tension force and about 30 g tension force to about 40 g tension force.
[0076] Slip may be assessed using a TA.TX Texture Analyzer with a vertical friction rig serving as a force arm. The probe height and force may be calibrated and the return force arm positioned 5 mm from the bottom of the container. A non-friction gliding object, such as a piece of paper tissue, may be attached to the vertical probe of the rig using heavy-duty double-sided tape. A tablet or other substrate coated with a coating may be attached to the vertical wall of the rig using heavy-duty double-sided tape. To measure the tension force, a weight (e.g., 100 g) is added to the horizontal plate of the probe, and incremental increases of force are applied to the non-friction gliding object in contact with the coating until the gliding object slips or moves. In embodiments, the disclosed dry film coatings may exhibit slip that equals and/or exceeds the slip of a traditional film coating.
[QQ77] In embodiments, the disclosed diy film coatings may exhibit strong adhesion to a substrate.
Adhesion of the dry film coatings may be measured using a TA.TX Texture Analyzer (available from
Texture Technologies Corp.) equipped with a 25 mm stainless steel cylindrical probe. A round placebo tablet coated with a coating is scored around its hemisphere with a sharp blade and then attached to the top of the flat platform of the texture analyzer using heavy-duty double-sided tape (available from 3M).
Another piece of heavy-duty double-sided tape is pressed to the bottom of the cylindrical probe, and the probe is then compressed to 800 g force onto the Tablet for 10 seconds. The probe is then pulled away from the Tablet at a rate of 1 mm/second, measuring the tension force until either (1) the coating separates from the softgei, or (2) the tape separates from the coating. Where the coating remains on the substrate, the measured force equals the force required to pull the double-sided tape away from the coating, and the adhesion force of the coating to the Tablet is thus greater than the measured adhesion force between the tape and the coating.
[0078] Suitably, a dr film coating having strong adhesion may exhibit an adhesion force between the coating and the placebo or vitamin/active containing tablet of at least about 0.5, at least about 0.6, at least about 0.7, at least about 0.8, at least about 0.9, at least about 1 , at least about 1.1, at least about 1.2, at least about 1.3, at least about 1.4, at least about 1.5, at least about 1.6, at least about 1.7, at least about 1.8, at least about 1.9, or at least about 2 g force. This includes, for example, about 0.8 g force to about 1.5 g force and about 1.1 g force to about 1.3 g force.
[0079] In embodiments, the disclosed dry film coating compositions, film coating suspensions, and/or dry film coatings may comprise a cellulose film former, an oiigofructose fiber, and an opacifier. For example, some embodiments provide dry film coating compositions comprising about 25% to about 65% cellulose film former, about 1% to about 12% oiigofructose fiber, and about 15% to about 35% opacifier. In another example, some embodiments provide film coating compositions comprising about 25% to about 65% HPMC, about 15 wt% to about 20 wt% rice starch, about 8 wt% to about 20 wt% glycerin, about 2 wt% to about 14 wt% gum acacia, and about 1 wt% to about 12 wt% an oiigofructose.
[QQ80] In some embodiments, the disclosed dry film coating compositions, film coating suspensions, and/or dry film coatings may comprise HPMC, rice starch, glycerin, gum acacia, and inulm.
[QQ81] In some embodiments, the dry film coating composition, film coating suspensions, and/or dry film coatings may comprise a cellulose film former, a plasticizing agent and a starch. In other embodiments, the dry film coating composition, film coating suspensions, and/or dry film coatings may comprise HPMC, glycerin and maltodextrin. In other embodiments, the dry film coating composition, film coating suspensions, and/or diy film coatings may comprise HPMC, a plasticizing agent selected from glycerin, sorbitol, erythritol, and xylitol polyols or combination thereof, and a starch comprising rice starch, maltodextrin of potato or corn, or combinations thereof. [0082] Additionally or alternately, the disclosed dry film coating compositions may be substantially free of titanium dioxide, calcium carbonate, minerals, and/or components derived from genetically modified organisms.
[0083] The compositions and suspensions described herein can be manufactured using techniques and equipment that are known and commonly used in the art. Equipment known m the industry for standard tablet coating are Thomas Engineering, Inc., and Vector Corporation Hi-Coater® tablet coating systems. Manufacturing steps such as order of component addition, mixing temperatures (heating and/or cooling) mixing mixing time, mixing speed, etc. can be driven by either by formulation or equipment
requirements, or both. A number of parameters can be modified during the manufacturing process without substantial effect on the efficacy of the resulting product. The manufacturing processes can further include separate steps for validating the resulting composition (e.g., the total amounts, ratios, and even distribution of components in the composition, etc.).
[0084] In an embodiment, the film coating suspension may be formed as follows. Components of a dry- film coating composition comprising at least one of a cellulose film former, an oligofructose fiber, a plasticizing agent, a processing aid, a slip aid, a detaekifier, a lubricant, an opacifier, a colorant, a surfactant, a buffering agent, and combinations thereof may be mixed with, for example, a plowr mixer. If included, one or more plasticizing agents may be added last to the dry film coating composition. Solvent (e.g., water) may be added to a mixing tank equipped with a high-shear overhead mixer and brought to a medium vortex. The dry film coating composition may be added into the medium vortex, and mixing may continue for at least about 30 minutes and/or until the suspension achieves a smooth consistency with no visible lumps.
[0085] The application techniques are described below. In some embodiments, a coating pan may be charged with a substrate such as, for example, capsules (single-piece or two-piece), tablets, and/or softgels. In some embodiments, the bed may be warmed to about 33°C to about 40°C. The processing parameters may be as set forth below.
[0086] The film coating suspensions may, at a suitable concentration that is spraying system dependent, be sprayed using commercially available equipment to form coatings on substrates. In some embodiments, the film coating suspension may be applied to a substrate by loading substrate into a vented coating pan, such as, for example, a 15-inch, 24-inch, 36-inch, 48-inch, 60-inch or 66-inch side- vented coating pan. The inlet temperature may be at least about 45°C , at least about 50°C, at least about 55°C, at least about 58°C, at least about 60°C, at least about 65°C, and at least about 70°C. The inlet temperature may be less than about 75°C, less than about 70°C, less than about 65°C, and less than about 60. This includes, for example, about 50°C to about 75°C, about 50 to about 65°C, and about 55°C to about 75°C. The outlet temperature may be at least about 32°C, at least about 35°C, at least about 40°C, and at least about 45°C. The outlet temperature may be less than about 55°C, less than about 50°C, less than about 50°C, and less than about 45°C. This includes, for example, about 32°C to about 55°C, about 35°C to about 45°C, and about 40°C to about 50°C. The atomizing air pressure may be at least about 20 psi, at least about 21 psi, at least about 25 psi, at least about 30 psi, at least about 35 psi, at least about 40 psi, at least about 45 psi, at least about 50 psi, and at least about 55 psi. The atomizing air pressure may be less than about 75 psi, less than about 70 psi, less than about 65 psi, less than about 60 psi, less than about 55 psi, less than about 50 psi, less than about 40 psi, and less than about 30 psi. This includes, for example, about 20 to about 75 psi, about 21 to about 23 psi, about 25 to about 30 psi, about 50 to about 55 psi, and about 50 to about 70 psi. The coating time may be from about 5 minutes to about 3 hours. The film coating suspension can be allowed to dry, forming a dry film coating on the substrate. Exemplar}' coating parameters are provided in Table 1 y coating parameters
Figure imgf000028_0001
[0087] The dry film coatings may he flexible with tensile strength. The dry film coating may be consistent batch-to-batch, may meet current FDA regulations for dietary supplements, may be robust (easy to use and prepare), and may coat various surfaces (softgels, capsules, tablets, gelatin, vegetable, etc.). The dry film coating may be cost effective and economical. Substrates coated with the disclosed dry film coatings may pass an immediate release disintegration test, such as, for example, USP32/NF27 S2, Chapter 2040 (Disintegration and Dissolution of Dietary Supplements), Chapter 701 (Disintegration) testing criteria. In some embodiments, the dry film coatings can be GRAS (Generally Recognized as Safe) and may be vegetarian. The dry film coatings may be able to be applied at a fast rate and broad temperature while providing good film adhesion and flexibility.
[QQ88] The dry film coating compositions may be used in food, pharmaceutical, or nutraceutical applications intended for use in mammals, including, without limitation, rodents, canines, felines, non- human primates, ungulates, and humans. They can be used to coat pharmaceutical or non- pharmaceutical dosage units.
[QQ89] In some embodiments, the edible coatings may have reduced moisture uptake in a humid environment compared to conventional HPMC coatings. Moisture uptake is a measure of the amount of water taken up as measured by weight gam of a sample that has been placed in a controlled environment of a set humidity. Moisture uptake can be measured by any suitable method known to one of skill in the art. Examples of procedures for measuring moisture uptake include, but are not limited to, exposing a coated substrate to 60% relative humidity' at 25° C (“storage condition H2”) or 75% relative humidity at 40° C (“storage condition H4”), or 40-60% relative humidity at 20° C (room conditions) and comparing the initial mass or weight of the sample to the mass or weight at various time intervals, such as, for example, 5 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 5 days, 7 days, 10 days, 14 days, 21 days, 25 days, 1 month, 2 months, 3 months, 6 months, 1 year, and the like. Stable mass or weight indicates a low' moisture uptake. Without wishing to be limited by any particular theory, it is believed that the physical dimensions of an edible coating increase at a rate that corresponds to the moisture uptake. Accordingly, the moisture uptake can be investigated by measuring the physical size of the edible coating at various tune intervals, as indicated above. [0090] In some embodiments, a substrate may be coated with an edible coating composition or suspension to form an edible coating at a 1 % weight gain, a 2% weight gain, a 3% weight gam, a 4% weight gam, a 5% weight gain, a 6% weight gam, a 7% weight gain, a 8% weight gam, a 9% weight gain, or a 10% weight gain compared to the uncoated substrate.
[0091] When exposed to storage condition H2, H4, or room conditions for a period of time equaling or exceeding 5 minutes, 30 minutes, 60 minutes, 90 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 5 days, 7 days, 10 days, 14 days, 21 days, 25 days, 1 month, 2 months, 3 months, 6 months, 1 year, and the like as measured by a VTI-SA Sorption Analyzer (available commercially from TA Instruments, New Castle, DE), the coated substrate or edible coating may exhibit a moisture uptake of at most about 4.0%, at most about 3.0%, at most about 2.5%, at most about 2.0%, at most about 1.9%, at most about 1.8%, at most about 1.7%, at most about 1.6%, at most about 1.5%, at most about 1.4%, at most about 1.3%, at most about 1.2%, at most about 1.1%, at most about 1.0%, at most about 0.95%, at most about 0.90%, at most about 0.85%, at most about 0.80%, at most about 0.75%, at most about 0.70%, at most about 0.65%, at most about 0.60%, at most about 0.55%, at most about 0.50%, at most about 0.45%, at most about 0.40%, at most about 0.35%, at most about 0.30%, at most about 0.25%, at most about 0.20%, at most about 0.15%, at most about 0.10% or at most 0.001%.
[0092] In some embodiments, the coated substrate or edible coating may have a moisture uptake, as measured by weight gam over time after exposure to storage condition H2, H4, or room conditions for the above-mentioned time durations, of at most about 0.1 grams per hour (g/hr), at most about 0.05 g/hr, at most about 0.04 g/hr, at most about 0.03 g/hr, at most about 0.02 g/hr, at most about 0.015 g/hr, at most about 0.01 g/hr, at most about 0.009 g/hr, at most about 0.008 g/hr, at most about 0.007 g/hr, at most about 0.006 g/hr, at most about 0.005 g/hr, at most about 0.004 g/hr, at most about 0.003 g/hr, at most about 0.002 g/hr, at most about 0.001 g/hr, or at most about 0.0005 g/hr. In some embodiments, the coated substrate or edible coating may have a moisture uptake, as measured by weight gain over time after exposure to storage condition H2, H4, or room conditions for the above- mentioned time durations, of at most about 0 01 inches per hour (in/hr), at most about 0.005 in/hr, at most about 0.004 in/hr, at most about 0 003 in/hr, at most about 0 002 in/hr, at most about 0.001 5 in/hr, at most about 0.001 in/hr, at most about 0.0009 m/hr, at most about 0.0008 m/hr, at most about 0.0007 m/hr, at most about 0.0006 in/hr, at most about 0.0005 in/hr, at most about 0.0004 in/hr, at most about 0.0003 in/hr, at most about 0.0002 m/hr, at most about 0.0001 m/hr, or at most about 0.00005 m/hr.
[0093] In some embodiments, the coatings may exhibit good clarity. Examples of procedures for measuring clarity include, but are not limited to, measuring the lightness, whiteness, or yellowness of an uncoated sample and comparing to the respective lightness, whiteness, or yellowness of a coated sample. Smaller changes correspond to higher clarity. Lightness can be assessed by any suitable method such as, for example, measuring the Lightness Index according to ASTM Method E313 wath a D65/100 illumination source (referred to as“E313 [D65/10]”) using a Lab Scan XE spectrophotometer (available from HunterLab, Inc.). A sample is loaded into the instrument’s sample port and scanned, and the Lightness Index (E313 [D65/10]) value is calculated using measurements taken on the CIE L*a*b* color scale. The resulting Lightness Index value is used to assess lightness of the sample. Whiteness can be assessed by any suitable method, such as, for example, measuring the Whiteness Index according to ASTM Method E313 wath a D65/10° illumination source (referred to as“WI E313 [1)65/ 10]”) using a LabScan XE spectrophotometer (available from HunterLab, Inc.). A sample substrate coated with a film coating is loaded into the instrument’s sample port and scanned, and the Whiteness Index (WI E313 [D65/10]) value is calculated using measurements taken on the CIE L*a*b* color scale. The resulting Whiteness Index value is used to assess whiteness of the sample. Yellowness can be assessed by any suitable method, such as, for example, measuring the Yellowness Index according to ASTM Method E313 with a D65/100 illumination source (referred to as“YI E313 [D65/I0]”) using a LabScan XE spectrophotometer. A sample substrate coated with a film coating is loaded into the instrument’s sample port and scanned, and the resulting YI E313 [D65/10] value is used to assess yellowness of the sample.
In some embodiments, the change in lightness, whiteness, or yellowness may be less than about 50%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, or less than about 1%.
[0094] In some embodiments, the coatings may have high whiteness and/or high opacity'. Whiteness can be assessed as described above. Opacity can be assessed by evaluating the Whiteness Index achieved upon coating one or more colored substrate cores with edible coatings as described herein. For example, when coating a colored substrate, the Whiteness Index will increase with additional weight gain until high and/or full opacity is reached. Upon reaching high and/or full opacity, the Whiteness Index may level off relative to further increases in weight gain. Suitably, the disclosed film coatings may provide high and/or full opacity at a weight gain of less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, and less than about 2% weight gain. For example, the disclosed edible coatings may provide high and/or full opacity at weight gains ranging from about 1% to about 10%, such as weight gams ranging from about 3% to about 9%, and weight gains ranging from about 2% to about 6%. In some embodiments, the disclosed film coating compositions, film coating suspensions, and/or film coatings comprise an opacifying agent in amounts sufficient to provide a film coating with high whiteness and/or full/high opacity at low weight gain.
[QQ95] In some embodiments, applying the composition to an edible substrate produces a coated edible substrate, the edible substrate and the coated edible substrate each having a gloss, wherein the gloss of the coated edible substrate may be from about 0% to about 500% greater than the gloss of the edible substrate. In some embodiments, the gloss of the coated edible substrate may be at least about 5% greater, at least about 10% greater, at least about 50% greater, at least about 100% greater, at least about 150% greater, at least about 200% greater, at least about 300% greater, at least about 400, or at least about 500% greater.
[0096] In some embodiments, applying the composition to an edible substrate produces a coated edible substrate, the edible substrate and the coated edible substrate each having a reflectance spectrum having a peak wavelength, a peak width, and an integrated area, wherein the peak wavelength, peak width, or integrated area may vary' by less than about 50% from edible substrate to coated edible substrate. In some embodiments, the peak wavelength, peak width, or integrated area may vary by less than about 50%, less than about 40%, less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, less than about 1%, less than about 0.5%, or less than about 0.1%.
[0097] In some embodiments, applying the composition to an edible substrate produces an edible coating on the edible substrate, the edible coating having a transmission haze of less than about 50% as measured by ASTM D1003-95,“Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics” or a reflection haze of less than about 50% as measured by ASTM E430-91, “Standard Test Methods for Measurement of Gloss of High-Gloss Surfaces by Goniophotometry.”
Gloss may be measured using Novocure equipment (Rhopomt Instruments, UK).
[0098] In some embodiments, the coatings may exhibit good stability. Stability indicates the ability for a coating to remain functional under normal or abnormal storage conditions. One example of a means of testing stability is exposing a coated substrate to 60% relative humidity at 25° C (“storage condition H2”), 75% relative humidity at 40° C (“storage condition H4”), or room conditions and evaluating a measurable property. Changes in the measurable property over time are an indication of lack of stability with respect to that measurable property and the particular conditions studied. In some embodiments, the measurable property may change by less than about 50%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, less than about 1%, less than about 0.1%, or less than about 0.01% over a period of time of at least about 30 minutes, at least about 1 hours, at least about 6 hours, at least about 12 hours, at least about 24 hours, at least about 7 days, at least about two weeks, at least about one month, at least about three months, at least about six months, or at least about one year. Examples of measurable properties include, but are not limited to, whiteness, brightness, yellowness, clarity, opacity, gloss, size, smoothness, friability, transmission haze, adhesion, hardness, and moisture barrier.
[0099] In some embodiments, the dry film coating composition comprises about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 8 wt% to about 25 wt% glycerin, about 10 wt% to about 30 wt % maltodextrm of vegetable source, relative to the total weight of non-water components of the composition.
[0100] In some embodiments, the dry film coating composition comprises about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC), about 8 wt% to about 25 wt% plasticizing agent selected from glycerin, sorbitol, or a combination thereof, and about 10 wt% to about 45 wt% of starch comprising rice starch, maltodextrin of a vegetabl e source, or combinations thereof, relative to the total weight of non- water components of the composition.
[0101] In an aspect, the disclosure provides a nutritional supplement, a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, a sugar sphere, or a seed comprising an edible substrate and a coating thereon, the coating being a dried suspension of the compositions described herein. The capsule may be a single-piece capsule or a two-piece capsule. In another aspect, the disclosure provides a nutritional supplement comprising an edible substrate and a coating thereon, the coating being a dried suspension of the composition described herein.
[0102] In an aspect, the disclosure provides a method of making a composition for coating an edible substrate, the method comprising blending a cellulose film former, a plasticizing agent, and an opacifier to form a mixture, adding water to the blend to form a slurry, and drying the slurry for at least about 30 minutes such that the plasticizing agent absorbs onto the cellulose film former and opacifier.
[0103] The cellulose film former, the plasticizing agent and the opacifier may be mixed with, for example, m a plow former. Other components of the dry film coating composition comprising which may include, for example, an oligofructose fiber, polyols, polysaccharides, a processing aid, a slip aid, a detackifier, a lubricant, a colorant, a surfactant, a buffering agent, and combinations thereof may be included for mixing in the plow' former. Water (or another solvent) may be added to a mixing tank equipped with a high-shear overhead mixer to form a slurry. The dry film coating composition may be added into the high-shear overhead mixer at medium vortex, and mixing may continue for at least about 30 minutes or until the slu achieves a smooth consistency with no visible lumps. The resulting slurry may be dried for at least about 30 minutes, at least about 40 minutes, at least about 50 minutes, or at least about 60 minutes such that the plasticizing agent absorbs onto the cellulose film former and opacifier. The dried slurry may be further chopped before additional usage.
[0104] Manufacturing steps such as order of component addition, mixing temperatures (heating and/or cooling), mixing time, mixing speed, etc. can be driven by either by formulation or equipment requirements, or both. A number of parameters can be modified during the manufacturing process without substantial effect on the efficacy of the resulting product. The manufacturing processes can further include separate steps for validating the resulting composition (e.g , the total amounts, ratios, and even distribution of components in the composition, etc.).
|Ό105] Exemplar embodiments of the disclosure are provided in the following examples. The following examples are provided merely to illustrate certain embodiments of the disclosure and to assist one of ordinar skill in making and using the same, are not to be interpreted to limit the scope of the disclosure or the appended claims.
[0106] Materials. Inulin preparations including Grain K/ P95 and Orafti® HS1 (available from
BENEO, Inc.); HPMC preparations including HPMC 3, HPMC 5, HPMC 6, and HPMC 15, wherein the numbers 3, 5, 6, and 15 indicate the HPMC preparation's viscosity in 1% aqueous solution (i.e., "HPMC 3" indicates an HPMC preparation that exhibits a viscosity of 3 cps when mixed with water to make a 1% (w/w) HPMC solution). Commercially available examples include Spectracel™ 3, 5, 6, and 15 (available from Sensient Technologies). The rice starch was obtained from Penford Food Ingredients, Co. The rice is grown in and the starch is produced m Thailand.
Figure imgf000035_0001
[0107] Example 1 produced a coating that was unstable at room temperature. In some instances, the coating energetically fractured after being applied to an edible substrate.
Example 2
Figure imgf000036_0001
[0108] Example 2 produced a coating with an attractive appearance a good slip properties.
Figure imgf000036_0002
[0109] Example 3 produced a coating with an attractive appearance and good slip properties.
Example 4
Figure imgf000037_0001
[0110] Example 4 produced a coating with an attractive appearance and good slip properties.
Figure imgf000037_0002
[01 I I] All dry ingredients were added to a high shear mixer, which were mixed until uniform. Then glycerin was added and the mixture was mixed again until uniform. The resulting powder was off white and fluffv.
[0112] Then the dry mixture was mixed together with water until dispersed using an overhead conventional mixture set at 750 rprn for 30 minutes. The resulting solution was 82.0% water by weight. The solution appeared smooth, creaming, and non-foaming. The solution had a viscosity of 218 cP and a pH of 6.50.
[0113] Then 12 vitamin tablets were combined with placebo to reach 200 g in weight. The tablets were sprayed with the solution until 2%, 4%, or 6% weight gain was achieved. 0114] The resulting coatings had an insufficient opacity, even at 6% weight gain.
Figure imgf000038_0001
[0115] The coatings were prepared in the same manner as described in Example 5. The resulting coatings had an insufficient opacity, even at 6% weight gam.
Example 7
Figure imgf000038_0002
[0116] The coatings were prepared in the same manner as described in Example 5. The resulting coatings had good opacification at 6% weight gain.
Figure imgf000038_0003
[0117] The coatings were prepared in a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 6.41 The resulting coatings had poor logo fill, even at 4% weight gain.
Figure imgf000039_0002
[0118] The coatings were prepared in a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 6.60 The resulting coatings had poor logo fill, even at 4% weight gain.
Figure imgf000039_0001
Figure imgf000039_0003
[0119] The coatings were prepared in a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 6.60. The resulting coatings had better logo fill than Examples 8 and 9 Example 11
Figure imgf000040_0002
[0120] The coatings were prepared m a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 6.60. The resulting coatings had better logo fill than Examples 8 and 9.
Figure imgf000040_0001
Figure imgf000040_0003
[0121] The coatings were prepared in a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 5.50. The resulting coatings showed bearding and slower weight gain. However, the opacity at 6% weight gam looked fairly good.
Example 13
Figure imgf000041_0002
[0122] The coatings were prepared m a similar manner as described for Example 5. The solution appeared smooth, creamy, and foamy with a pH of 5.50. The resulting coatings did not have an issue with bearding, but the opacity was lower than Example 12.
Figure imgf000041_0001
[0123] Several formulations were tested for opacity as a function of amount of sorbitol (shown in Table 2) and compared with Bayer One a Day commercial multivitamins
[0124] 14A, 14B, and 14C are of the formula below, but each has a different colorant. Results for example 12 are also shown below. The colorants are turmeric, red radish, natural blue and annatto.
Figure imgf000041_0003
Table 2: Opacity Values
Figure imgf000041_0004
Figure imgf000042_0001
Figure imgf000043_0001
[0125] These tests are illustrated in FIG. 3, which shows a linear correlation. This indicates that sorbitol has an equivalent opacification to the starting formulation per usage rate.
[Q126] Although the opacify continues to increase with an increase of sorbitol, higher amounts of sorbitol may also increase spray difficulty. Example 15
Figure imgf000044_0002
[0127] HPMC, rice starch, maltodextrin and citric acid were added to a high shear mixer and mixed until uniform. Then red powder and spirulina were added and the mixture was mixed again until uniform. Finally, the sunflower lecithin and glycerin were added and mixed again until a uniform a pink powder was formed.
[0128] The dry mixture was combined with water using an overhead conventional mixture set at 750 rpm for at least 30 minutes or until a homogeneous solution was formed. The resulting purple to maroon-colored solution was 82.0% water by weight and had a viscosity of 473 cP and a pH of 4.08.
[0129] Vitamin tablet cores were sprayed with the solution until an about 4% weight gain was achieved. The coating at a 4% weight gain provided good opacity, barrier protection and gloss.
Figure imgf000044_0001
Figure imgf000044_0003
[0130] The coatmgs were prepared in a similar manner as described for Example 5 Other
formulations such as that above may include sunflower lecithin and or coconut oil. [0131] For reasons of completeness, various aspects of the invention are set out in the following numbered clauses;
[0132] Clause 1 A composition for coating an edible substrate, the composition comprising:
about 30 wt% to about 65 wt% hydroxypropyl rnethylcellulose (HPMC);
about 8 wt% to about 25 wt% glycerin;
about 10 wt% to about 30 wt % maltodextrin;
relative to the total weight of non-water components of the composition.
[0133] Clause 2, A composition for coating an edible substrate, the composition comprising; about 30 wt% to about 65 wt% hydroxypropyl rnethylcellulose (HPMC);
about 8 wt% to about 25 wt% plasticizing agent selected from glycerin, sorbitol, or a combination thereof; and
about 25 wt% to about 45 wt% of starch comprising rice starch, maltodextrin, or combinations thereof;
relative to the total weight of non- water components of the composition.
[0134] Clause 3 A composition for coating an edible substrate, the composition comprising:
about 25 wt% to about 65 wt% cellulose film former;
a plasticizing agent; and
an opacifier comprising starch;
wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms,
the weight percentages being relative to the total weight of non-water components of the composition.
[0135] Clause 4 The composition of clause 3, wherein the cellulose film former comprises hydroxypropyl rnethylcellulose (HPMC). [0136] Clause 5. The composition of any of clauses 1-4, wherein the composition comprises about 25 wt% to about 55 wt% HPMC having a dynamic viscosity of about 5 cps or HPMC having a dynamic viscosity of about 6 cps.
[0137] Clause 6. The composition of any of clauses 1-5, wherein the composition comprises about 5 wt% to about 30 wt% HPMC having a dynamic viscosity of about 15 cps.
[0138] Clause 7. The composition of any of clauses 3-6, wherein the plasticizing agent is selected from medium chain triglycerides, fatty acids, fatty acid derivatives, glycerin, sorbitol, or any
combination thereof.
[0139] Clause 8 The composition of any of clauses 3-7, wherein the plasticizing agent is present in amount from about 5 wt% to about 30 wt% relative to the total weight of non- water components of the composition.
[0140] Clause 9. The composition of any of clauses 3-8, wherein the plasticizing agent comprises erythntol.
[0141] Clause 10. The composition of any of clauses 2-8, wherein the plasticizing agent comprises about 8 wt% to about 15 wt% glycerin.
[0142] Clause 1 1. The composition of any of clauses 3-10, wherein the composition comprises about 10 wt% to about 40 wt% opacifier relative to the total weight of non- water components of the composition.
[0143] Clause 12 The composition of any of clauses 2-11 , wherein the starch comprises modified starches, non-rnodified starches, or combinations thereof.
[0144] Clause 13 The composition of any of clauses 2-12, wherein the starch comprises maltodextrin.
[0145] Clause 14. The composition of any of clauses 2-13, wherein the composition comprises about
10 wt% to about 30 wt% maltodextrin.
[0146] Clause 15. The composition of any of clauses 1-14, wherein the composition comprises about 20-25 wt% maltodextrin. [0147] Clause 16. The composition of any of clauses 2-15, wherein the starch comprises rice starch.
[0148] Clause 17. The composition of any of clauses 2-16, wherein the composition comprises about 10 wt% to about 25 wt% rice starch.
[0149] Clause 18. The composition of any of clauses 1 -17, further comprising about 1 wt% to about 30 wt% colorant relative to the total weight of non- water components of the composition.
[0150] Clause 19. The composition of any of clauses 1 -18, further comprising greater than 0 wt% and less than or equal to 2 wt% ci tric acid relative to the total weight of non-water components of the composition.
[0151] Clause 20 The composition of clause l, further comprising about 10 wt% to about 20 wt% rice starch.
[0152] Clause 21 The composition of any of clauses 1-20, wherein the composition further comprises a flavoring
[0153] Clause 22 The composition of any of clauses 1-21, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms.
[0154] Clause 23. The composition of any of clauses 1-22, wherein the composition is substantially free of gum acacia.
[0155] Clause 24. A method of forming an edible coating on an edible substrate comprising:
forming a suspension comprising water and the composition of any of clauses 1-23; and spraying the suspension onto the substrate.
[0156] Clause 25 The method of clause 24, wherein the edible substrate is a nutritional supplement, pharmaceutical, a tablet, a capsule, a softge!, a granule, a microparticle, a nanoparticle, a seed, a sugar sphere, gum chew base, chewable gel, or a gummy substrate. [0157] Clause 26. The method of clause 24 or clause 25, wherein the edible coating has CIE L*a*b color scale measurements that change less than 1% over a period of 3 months as assessed by ASTM Method E313 with a D65/100 illumination source using a spectrophotometer.
[0158] Clause 27. The method of any of clauses 24-26, wherein the edible coating has a color index as assessed by CIE L*a*b color scale measurements that provides high and/or full opacity at about 3% weight gain.
[0159] Clause 28. A nutritional supplement, a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, or a seed comprising an edible substrate and a coating thereon, the coating being a dried suspension of the composition of any one of clauses 1-23 thereon.
[0160] Clause 29. A nutritional supplement comprising an edible substrate and a coating thereon, the coating being a dried suspension of the composition of any one of clauses 1-23 thereon.
[0161] Clause 30. A method of making a composition for coating an edible substrate, the method comprising:
blending a cellulose film former, a plasticizing agent, and an opacifier to form a mixture;
adding water to the blend to form a slurry ; and
drying the slurry for at least about 30 minutes such that the plasticizing agent absorbs onto the cellulose film former and opacifier.
[0162] Clause 31. The method of clause 30, wherein the composition is any of clauses 1-23.
[0163] Clause 32 A composition for coating an edible substrate, the composition comprising:
about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC); about 15 wt% to about 20 wt% of a starch;
about 8 wt% to about 25 wt% plasticizer selected from glycerin, sorbitol, and a combination thereof;
about 5 wt% to about 16 wt% gum acacia; and
relative to the total weight of non-water components of the composition.
[0164] Clause 33. A composition for coating an edible substrate, the composition comprising: about 30 wt% to about 65 wt% cellulose film former;
a plasticizing agent; and
an opacifier selected from a starch, gum acacia, and a combination thereof,
wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified orgamsms,
the weight percentages being relative to the total weight of non-water components of the composition.
[0165] Clause 34. The composition of clause 33, wherein the plasticizing agent is selected from medium chain triglycerides, fatty acids, fatty acid derivatives, and combinations thereof.
[0166] Clause 35. The composition of clause 34, wherein the plasticizing agent is glycerin, sorbitol, or a combination thereof.
[0167] Clause 36. The composition of any of clauses 33-35, wherein the plasticizing agent is present in amount from about 8 wt% to about 25 wt%.
[0168] Clause 37 The composition of any of clauses 33-36, wherein the plasticizing agent comprises about 8 wt% to about 20 wt% glycerin.
[0169] Clause 38 The composition of any of clauses 33-37, wherein the plasticizing agent comprises about 5 wt% to about 11 wt% sorbitol.
[0170] Clause 39 The composition of any of clauses 33-38, wherein the opacifier comprises about 15 wt% to about 20 wt% of the starch.
[0171] Clause 40 The composition of any of clauses 33-39, wherein the opacifier comprises about 5 wt% to about 16% of the gum acacia.
[0172] Clause 41 The composition of any of clauses 33-40, wherein the composition comprises about 20 wt% to about 36 wt% opacifier
[0173] Clause 42 The composition of any of clauses 33-41, wherein the cellulose film former comprises [0174] Clause 43. The composition of clause 32, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms.
[0175] Clause 44. The composition of any of clauses 32-43, wherein the composition comprises about 30 wt% to about 45 wt% HPMC relative to the total weight of non-water components of the
composition.
[0176] Clause 45. The composition of any of clauses 32-44, wiierein the composition comprises about 35 wt% to about 40 wt% HPMC relative to the total weight of non- water components of the
composition.
[0177] Clause 46. The composition of any of clauses 32-45, wherein the HPMC comprises about 30 wt% to about 45 wt% HPMC having a dynamic viscosity of about 5 cps.
[0178] Clause 47. The composition of any of clauses 32-46, wherein the HPMC comprises about 40 wt% HPMC having a dynamic viscosity of about 5 cps.
[0179] Clause 48. The composition of any of clauses 32-47 wherein the HPMC comprises greater than 0 wt% and less than or equal to 5 wt% HPMC having a dynamic viscosity of about 15 cps.
[0180] Clause 49. The composition of any of clauses 32-48, wherein the HPMC comprises about 3.25 wt% HPMC having a dynamic viscosity of about 15 cps.
[0181] Clause 50. The composition of any of clauses 32-49, wherein the composition comprises about 8 wt% to about 12 wt% glycerin relative to the total weight of non- water components of the
composition.
[0182] Clause 51 The composition of any of clauses 32-50 wherein the compositions comprises about 6 wt% to about 7 wt% sorbitol relative to the total weight of non-water components of the composition.
[0183] Clause 52 The composition of any of clauses 32-51, wherein the composition comprises about 12 wt% to about 14 wt% gum acacia relative to the total weight of non- water components of the composition. [0184] Clause 53 The composition of any of clauses 32-52, wherein the composition comprises about 14 wt% gum acacia relative to the total weight of non- water components of the composition.
[0185] Clause 54 The composition of any of clauses 32-53, further comprising an oligofructose.
[0186] Clause 55. The composition of any of clauses 32-54, wherein the composition comprises about 1 wt% to about 12 wt% an oligofructose relative to the total weight of non-water components of the composition.
[0187] Clause 56 The composition of any of clauses 32-55, wherein the composition comprises about 3 wt% to about 8 wt% an oligofructose relative to the total weight of non-water components of the composition.
[0188] Clause 57. The composition of any of clauses 32-56, wherein the composition comprises about 3 wt% to about 5 wt% an oligofructose relative to the total weight of non-water components of the composition.
[0189] Clause 58 The composition of any of clauses 54-57, wherein the oligofructose comprises inulin.
[0190] Clause 59 The composition of any of clauses 32-58, further comprising about 1 wt% to about 30 wt% colorant relative to the total weight of non- ater components of the composition.
[0191] Clause 60 The composition of any of clauses 32-59, further comprising greater than 0 wt% and less than or equal to 2 wt% citric acid relative to the total weight of non-water components of the composition.
[0192] Clause 61. The composition of any of clauses 32-60, further compri sing greater than 0 wt% and less than or equal to 2 wt% an oil or a fatty acid.
[0193] Clause 62. The composition of any of clauses 32-61 further comprising greater than 0 wt% and less than or equal to 0.5 wt% an oil or a fatty acid.
[0194] Clause 63. The composition of any of clauses 32-62, wherein the starch is rice starch. [0195] Clause 64. The composition of any of clauses 32-63, wherein the starch is present in an amount from about 17 wt% to about 20 wt%.
[0196] Clause 65. The composition of any of clauses 32-64, wherein the starch is present in an amount of about 19 wt%.
[0197] Clause 66 A method of forming an edible coating on an edible substrate comprising; spraying the composition of any of clauses 32-65 onto the substrate.
[0198] Clause 67 The method of clause 66, wherein the edible substrate is a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, or a seed.
[0199] Clause 68 The method of clause 66 or clause 67, wherein the edible coating has CIE L*a*b color scale measurements that change less than 1 % over a period of 3 months as assessed by ASTM Method E313 with a D65/100 illumination source using a spectrophotometer.
[0200] Clause 69. The method of any of clauses 66-68, wherein the edible coating has CIE L*a*b color scale measurements that change less than 1% over a period of 12 months as assessed by ASTM Method E313 with a D65/100 illumination source using a spectrophotometer.
[0:201] Clause 70 A nutritional supplement, a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, or a seed comprising an edible substrate and the composition of clauses 32-65 thereon.

Claims

What is claimed is:
1. A composition for coating an edible substrate, the composition comprising:
about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC);
about 8 wt% to about 25 wt% glycerin;
about 10 wt% to about 30 wt % maltodextrin;
relative to the total weight of non- water components of the composition.
2. A composition for coating an edible substrate, the composition comprising:
about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC);
about 8 wt% to about 25 wt% plasticizing agent selected from glycerin, sorbitol, or a combination thereof; and
about 25 wt% to about 45 wt% of starch comprising rice starch, maltodextrin, or combinations thereof;
relative to the total weight of non- water components of the composition.
3. A composition for coating an edible substrate, the composition comprising:
about 25 wt% to about 65 wt% cellulose film former;
a plasticizing agent; and
an opacifier comprising starch;
wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms,
the weight percentages being relative to the total weight of non-water components of the composition.
4. The composition of claim 3, wherein the cellulose film former comprises hydroxypropyl methylcellulose (HPMC).
5. The composition of any of claims 1 -4, wherein the composition comprises about 25 wt% to about 55 wt% HPMC having a dynamic viscosity of about 5 cps or HPMC having a dynamic viscosity of about 6 cps.
6. The composition of any of claims 1-5, wherein the composition comprises about 5 wt% to about 30 wt% HPMC having a dynamic viscosity of about 15 cps.
7. The composition of any of claims 3-6, wherein the plasticizing agent is selected from medium chain triglycerides, fatty acids, fatty acid derivatives, glycerin, sorbitol, or any combination thereof.
8. The composition of any of claims 3-7, wherein the plasticizing agent is present in amount from about 5 wt% to about 30 wt% relative to the total weight of non-water components of the composition.
9. The composition of any of claims 3-8, wherein the plasticizing agent comprises erythritol.
10. The composition of any of claims 2-8, wherein the plasticizing agent comprises about 8 wt% to about 15 wt% glycerin.
11. The composition of any of claims 3-10, wherein the composition comprises about 10 wt% to about 40 wt% opacifier relative to the total weight of non-water components of the composition.
12. The composition of any of claims 2-11, wherein the starch comprises modified starches, non- modified starches, or combinations thereof.
13. The composition of any of claims 2-12, wherein the starch comprises maitodextrin.
14. The composition of any of claims 2-13, wherein the composition comprises about 10 wt% to about 30 wt% maitodextrin.
15. The composition of any of claims 1-14, wherein the composition comprises about 20-25 wt% maitodextrin.
16. The composition of any of claims 2-15, wherein the starch comprises rice starch.
17. The composition of any of claims 2-16, wherein the composition comprises about 10 wt% to about 25 wt% rice starch.
18. The composition of any of claims 1-17, further comprising about 1 wt% to about 30 wt% colorant relative to the total w¾ight of non-water components of the composition.
19. The composition of any of claims 1-18, further comprising greater than 0 wt% and less than or equal to 2 wt% citric acid relative to the total weight of non-water components of the composition.
20. The composition of claim 1 , further comprising about 10 wt% to about 20 wt% rice starch.
21. The composition of any of claims 1-20, wherein the composition further comprises a flavoring.
22. The composition of any of claims 1 -21, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms.
23. The composition of any of claims 1-22, wherein the composition is substantially free of gum acacia.
24. A method of forming an edible coating on an edible substrate comprising:
forming a suspension comprising water and the composition of any of claims 1-23; and spraying the suspension onto the substrate.
25. The method of claim 24, wherein the edible substrate is a nutritional supplement,
pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, a seed, a sugar sphere, gum chew base, chewable gel, or a gummy substrate.
26. The method of claim 24 or claim 25, wherein the edible coating has CIE L*a*b color scale measurements that change less than 1% over a period of 3 months as assessed by ASTM Method E313 with a D65/100 illumination source using a spectrophotometer.
27. The method of any of claims 24-26, wherein the edible coating has a color index as assessed by CIE L*a*b color scale measurements that provides high and/or full opacity' at about 3% weight gain.
28. A nutritional supplement, a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, or a seed comprising an edible substrate and a coating thereon, the coating being a dried suspension of the composition of any one of claims 1-23 thereon
29. A nutritional supplement comprising an edible substrate and a coating thereon, the coating being a dried suspension of the composition of any one of claims 1-23 thereon.
30. A method of making a composition for coating an edible substrate, the method comprising: blending a cellulose film former, a plasticizing agent, and an opacifier to form a mixture;
adding water to the blend to form a slurry ; and
drying the slurry for at least about 30 minutes such that the plasticizing agent absorbs onto the cellulose film former and opacifier.
31. The method of claim 30, wherein the composition is any of claims 1-23.
32. A composition for coating an edible substrate, the composition comprising:
about 30 wt% to about 65 wt% hydroxypropyl methylcellulose (HPMC); about 15 wt% to about 20 wt% of a starch;
about 8 wt% to about 25 wt% plasticizer selected from glycerin, sorbitol, and a combination thereof;
about 5 wt% to about 16 wt% gum acacia; and
relative to the total weight of non-water components of the composition.
33. A composition for coating an edible substrate, the composition comprising:
about 30 wt% to about 65 wt% cellulose film former;
a plasticizing agent; and
an opacifier selected from a starch, gum acacia, and a combination thereof,
wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms,
the weight percentages being relative to the total weight of non-water components of the composition.
34. The composition of claim 33, wherein the plasticizing agent is selected from medium chain triglycerides, fatty acids, fatty acid derivatives, and combinations thereof.
35. The composition of claim 34, wherein the plasticizing agent is glycerin, sorbitol, or a combination thereof.
36. The composition of any of claims 33-35, wherein the plasticizing agent is present in amount from about 8 wt% to about 25 wt%.
37. The composition of any of claims 33-36, wherein the plasticizing agent comprises about 8 wt% to about 20 wt% glycerin.
38. The composition of any of claims 33-37, wherein the plasticizing agent comprises about 5 wt% to about 11 wt% sorbitol.
39. The composition of any of claims 33-38, wherein the opacifier comprises about 15 wt% to about 20 wt% of the s tarch.
40. The composition of any of claims 33-39, wherein the opacifier comprises about 5 wt% to about 16% of the gum acacia.
41. The composition of any of claims 33-40, wherein the composition comprises about 20 wt% to about 36 wt% opacifier.
42. The composition of any of claims 33-41, wherein the cellulose film former comprises HPMC.
43. The composition of claim 32, wherein the composition is substantially free of titanium dioxide, calcium carbonate, minerals, and components derived from genetically modified organisms.
44. The composition of any of claims 32-43, wherein the composition comprises about 30 wt% to about 45 wt% HPMC relative to the total weight of non-water components of the composition.
45. The composition of any of claims 32-44, wherein the composition comprises about 35 w4% to about 40 w4% HPMC relative to the total weight of non-water components of the composition.
46. The composition of any of claims 32-45, wherein the HPMC comprises about 30 wt% to about 45 w4% HPMC having a dynamic viscosity of about 5 cps.
47. The composition of any of claims 32-46, wherein the HPMC comprises about 40 wt% HPMC having a dynamic viscosity of about 5 cps.
48. The composition of any of claims 32-47 wherein the HPMC comprises greater than 0 w4% and less than or equal to 5 w4% HPMC having a dynamic viscosity of about 15 cps.
49. The composition of any of claims 32-48, wherein the HPMC comprises about 3.25 wt% HPMC having a dynamic viscosity of about 15 cps.
50. The composition of any of claims 32-49, wherein the composition comprises about 8 wt% to about 12 wt% glycerin relative to the total weight of non- water components of the composition.
51. The composition of any of claims 32-50 wherein the compositions comprises about 6 wt% to about 7 wt% sorbitol relative to the total weight of non-water components of the composition.
52. The composition of any of claims 32-51, wherein the composition comprises about 12 wt% to about 14 wt% gum acacia relative to the total weight of non-water components of the composition.
53. The composition of any of claims 32-52, wherein the composition comprises about 14 wt% gum acacia relative to the total weight of non- water components of the composition.
54. The composition of any of claims 32-53, further comprising an oligofructose.
55. The composition of any of claims 32-54, wherein the composition comprises about 1 wt% to about 12 wt% an oligofructose relative to the total weight of non- water components of the composition.
56. The composition of any of claims 32-55, wherein the composition comprises about 3 wt% to about 8 wt% an oligofructose relative to the total weight of non-water components of the composition.
57. The composition of any of claims 32-56, wherein the composition comprises about 3 wt% to about 5 wt% an oligofructose relative to the total weight of non-water components of the composition.
58. The composition of any of claims 54-57, wherein the oligofructose comprises inulin.
59. The composition of any of claims 32-58, further comprising about 1 wt% to about 30 wt% colorant relative to the total weight of non-water components of the composition.
60. The composition of any of claims 32-59, further comprising greater than 0 wt.% and less than or equal to 2 wt% citric acid relative to the total weight of non-water components of the composition.
61. The composition of any of claims 32-60, further comprising greater than 0 wt% and less than or equal to 2 wt% an oil or a fatty acid.
62. The composition of any of claims 32-61 further comprising greater than 0 wt% and less than or equal to 0.5 wt.% an oil or a fatty acid.
63. The composition of any of claims 32-62, wherein the starch is rice starch.
64. The composition of any of claims 32-63, wherein the starch is present in an amount from about 17 wt% to about 20 wt%.
65. The composition of any of claims 32-64, wherein the starch is present in an amount of about 19 wt%.
66. A method of forming an edible coating on an edible substrate comprising: spraying the composition of any of claims 32-65 onto the substrate.
67. The method of claim 66, wdierein the edible substrate is a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, or a seed.
68. The method of claim 66 or claim 67, wherein the edible coating has CIE L*a*b color scale measurements that change less than 1% over a period of 3 months as assessed by ASTM Method E313 with a D65/100 illumination source using a spectrophotometer.
69. The method of any of claims 66-68, wherein the edible coating has CIE L*a*b color scale measurements that change less than 1% over a period of 12 months as assessed by ASTM Method E313 with a 1)65/10° illumination source using a spectrophotometer.
70. A nutritional supplement, a pharmaceutical, a tablet, a capsule, a softgel, a granule, a microparticle, a nanoparticle, or a seed comprising an edible substrate and the composition of claims 32-65 thereon.
PCT/US2019/018635 2018-02-19 2019-02-19 Compositions for coating edible substrates, and methods of making and using the same WO2019161408A1 (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113181135A (en) * 2021-05-13 2021-07-30 青岛益青生物科技股份有限公司 Gelatin hollow capsule with new formula and preparation method thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991015548A1 (en) * 1990-04-04 1991-10-17 Berwind Pharmaceutical Services, Inc. Aqueous maltodextrin and cellulosic polymer film coatings
US20040096503A1 (en) * 2000-09-06 2004-05-20 Chr. Hansen, Inc. Dry-powder film coating composition and method of preparation
US20170281553A1 (en) * 2010-05-11 2017-10-05 Sensient Colors Llc Film coating composition and methods of making and using the same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991015548A1 (en) * 1990-04-04 1991-10-17 Berwind Pharmaceutical Services, Inc. Aqueous maltodextrin and cellulosic polymer film coatings
US5470581A (en) * 1990-04-04 1995-11-28 Berwind Pharmaceutical Services, Inc. Aqueous maltodextrin and cellulosic polymer film coatings
US20040096503A1 (en) * 2000-09-06 2004-05-20 Chr. Hansen, Inc. Dry-powder film coating composition and method of preparation
US20170281553A1 (en) * 2010-05-11 2017-10-05 Sensient Colors Llc Film coating composition and methods of making and using the same

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
"METHOCEL Cellulose Ethers in Aqueous Systems for Tablet Coating", July 2002 (2002-07-01), pages 1 - 32, XP055044564 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113181135A (en) * 2021-05-13 2021-07-30 青岛益青生物科技股份有限公司 Gelatin hollow capsule with new formula and preparation method thereof

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