WO2010056957A1 - Controlled release food formulations - Google Patents

Controlled release food formulations Download PDF

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Publication number
WO2010056957A1
WO2010056957A1 PCT/US2009/064337 US2009064337W WO2010056957A1 WO 2010056957 A1 WO2010056957 A1 WO 2010056957A1 US 2009064337 W US2009064337 W US 2009064337W WO 2010056957 A1 WO2010056957 A1 WO 2010056957A1
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WO
WIPO (PCT)
Prior art keywords
oil
food
particle
composition
forming agent
Prior art date
Application number
PCT/US2009/064337
Other languages
French (fr)
Inventor
Stephen Turner
Karla Laporte
Samer Al-Murrani
Larry Hayward
Original Assignee
Scolr Pharma, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Scolr Pharma, Inc. filed Critical Scolr Pharma, Inc.
Publication of WO2010056957A1 publication Critical patent/WO2010056957A1/en

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Classifications

    • 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15Vitamins
    • 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
    • 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115Fatty acids or derivatives thereof; Fats or oils
    • 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
    • A23P10/00Shaping or working of foodstuffs characterised by the products
    • A23P10/30Encapsulation of particles, e.g. foodstuff additives

Definitions

  • the invention features particles comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within or adsorbed to the capsule forming agent.
  • the particles When contacted with an aqueous solvent, the particles release at least 50% of the oil or water soluble nutrient over a period of time, preferably between 0.5 to 24 hours, more preferably between 1 and 18 hours, and still more preferably between 2 and 12 hours.
  • the water soluble nutrient can be any protein, carbohydrate, mineral, vitamin, and the like, which are capable of being dissolved by water.
  • the oil soluble nutrient (shortened herein simply to "oil”) can be any oil such as a vegetable oil, fish oil, or omega-3, or omega-6 fatty acid.
  • the particle can further comprise lipid soluble vitamins.
  • the capsule forming agent can be comprised of a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix, or a gum or starch, or any combination thereof. Hydroxypropylmethyl cellulose, microcrystalline cellulose, and corn starch are preferred constituents of the matrix.
  • the capsule forming agent can be comprised of carrageenan gum or sodium alginate, or can be comprised of one or more modified food starches. Also featured are various methods for producing the controlled release particles, including particles that control the release of oil or water-soluble nutrients.
  • the methods comprise mixing at least one oil or water soluble nutrient with an emulsifying agent to form an emulsion, mixing the emulsion with the capsule forming agent to form a slurry, and adding the slurry to a salt solution to form a particle.
  • the capsule forming agent can be comprised of a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix, a gum or starch, carrageenan gum, sodium alginate, or one or more modified food starches.
  • the methods comprise contacting a first hydrophilic polymer with at least one oil or water soluble nutrient for a period of time of time sufficient for the oil or water soluble nutrient to become encapsulated within the polymer, thereby forming a particle.
  • the particle can be coated with a second hydrophilic polymer.
  • the methods comprise mixing a modified food starch, emulsifying agent, and polysaccharide in an aqueous solvent to form a suspension, mixing at least one oil and/or water soluble nutrient with the suspension to form a slurry, and spray drying the slurry to form particles.
  • the suspension can be sprayed and subsequently dried.
  • the emulsifying agent is preferably lecithin
  • the polysaccharide is preferably xanthan gum.
  • the invention also features food compositions.
  • the food compositions comprise a food component and a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within the capsule forming agent.
  • the concentration of oil or water soluble nutrient in the food composition can be from about 0.2% to about 20% (w/w) of the food composition.
  • the particles gradually release the oil or nutrients in a controlled release manner over a period of time and at least 50% of the oil or nutrients are released. Preferably, 100% of the nutrients are released.
  • the food composition can be comprised of pet food or food products formulated for human consumption.
  • the nutrients can be any water soluble nutrient.
  • the oil can be any oil such as a vegetable oil, fish oil, or omega-3, or omega-6 fatty acid.
  • the particle can further comprise lipid soluble vitamins.
  • the capsule forming agent can be comprised of a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix, or a gum or starch, or any combination thereof. Hydroxypropylmethyl cellulose, microcrystalline cellulose, and corn starch are preferred constituents of the matrix.
  • the capsule forming agent can be comprised of carrageenan gum or sodium alginate, or can be comprised of one or more modified food starches. Also featured are methods for manufacturing food compositions.
  • the methods comprise mixing a food component with a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within the capsule forming agent.
  • the food component can be pet food or a food product formulated for human consumption.
  • the methods can further comprise extruding the food composition into at least one predetermined shape.
  • the methods can further comprise baking or frying the food composition.
  • the methods comprise applying a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within the capsule forming agent to the surface of a food component.
  • the application can comprise spray-drying.
  • the food component can be pet food or a food product formulated for human consumption.
  • the methods can further comprise baking or frying the food composition.
  • a "dietary supplement” is a product that is intended to be ingested in addition to the normal diet of an animal or a human being.
  • a "food product formulated for human consumption” is any food, food component, or food composition intended for ingestion by a human being.
  • Food or “food component” are used interchangeably herein, and refer to any source of nourishment intended for ingestion by an animal or human being.
  • oil encapsulation modalities can be improved in terms of make-up, integrity, and stability, and can be used to control release of dietary oils from food such that oil-containing particles can be mixed with food, and the oils will gradually release from the particles during digestion.
  • utility of the particles is not limited to oils, and that the particles can be adapted to contain and control the release of water and water soluble nutrients as well.
  • the invention features particles comprising capsule forming agents and oils or water soluble nutrients, wherein the oils or water soluble nutrients are released from the particle over a period of time.
  • the controlled release particles of the invention differ from traditionally used controlled release particles as they are comprised of higher amounts of capsule forming agents and lower amounts of oil or water soluble nutrients.
  • the particles comprise from about 10% to about 80% (w/w) of a capsule forming agent. More preferably, the particles comprise from about 30% to about 60% (w/w) of a capsule forming agent, and more preferably about 30% to about 50% (w/w) of a capsule forming agent. In some aspects, the particles comprise about 30% (w/w) of a capsule forming agent. In some aspects, the particles comprise about 35%, about 40%, about 45%, about 50%, about 55%, or about 60% (w/w) of a capsule forming agent, although greater or lesser percentages can be used.
  • the particles can preferably comprise from about 2% to about 75% (w/w) oil and/or oil soluble nutrients, more preferably comprise from about 5% to about 60% (w/w) oil and/or oil soluble nutrients, and more preferably comprise from about 30% to about 60% (w/w) of oil and/or oil soluble nutrients.
  • Other preferred concentration ranges of oil and/or oil soluble nutrients include from about 15% to about 40% (w/w), about 15% to about 30% (w/w), about 20% to about 40% (w/w), about 20% to about 50% (w/w), 30% to about 40% (w/w), from about 50% to about 70% (w/w), from about 50% to about 60% (w/w), and from about 60% to about 70% (w/w).
  • the particles comprise about 2% (w/w) of at least one oil and/or soluble nutrient. In some aspects, the particles comprise at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 70%, or about 75% (w/w) of at least one oil and/or oil soluble nutrient, although greater or lesser percentages can be used.
  • the particles can further comprise a suitable amount of other ingredients such as binders, fillers, and the like, which are well known by and available to those of skill in the art.
  • the particles can preferably comprise from about 2% to about 75% (w/w) water soluble nutrients, more preferably comprise from about 5% to about 60% (w/w) water soluble nutrients, and more preferably comprise from about 30% to about 60% (w/w) of water soluble nutrients.
  • Other preferred concentration ranges of water soluble nutrients include from about 15% to about 40% (w/w), about 15% to about 30% (w/w), about 20% to about 40% (w/w), about 20% to about 50% (w/w), from about 30% to about 40% (w/w), from about 50% to about 70% (w/w), from about 50% to about 60% (w/w), and from about 60% to about 70% (w/w).
  • the particles comprise about 2% (w/w) of at least one water soluble nutrient.
  • the particles comprise about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 70%, or about 75% (w/w) of at least one water soluble nutrient, although greater or lesser percentages can be used.
  • the particles can further comprise a suitable amount of other ingredients such as binders, fillers, and the like, which are well known by and available to those of skill in the art.
  • the capsule forming agent comprises a polymer that is comprised of biomolecule subunits, such as polysaccharides or polypeptides.
  • biomolecule subunits such as polysaccharides or polypeptides.
  • the capsule forming agent can be comprised of a chemical polymer, preferably where the polymer is non-toxic or otherwise compatible with animal or human ingestion.
  • a polymer is sodium alginate.
  • the capsule forming agent can also comprise a matrix, for example, a hydrophilic matrix, a hydrophobic matrix, or any combination or mixture thereof.
  • suitable hydrophilic matrices include Hydroxypropylmethyl cellulose (HMPC), microcrystalline cellulose (MCC), xanthan gum, guar gum, locust bean gum, and acacia gum. HMPC and MCC are particularly preferred.
  • suitable hydrophobic matrices include various waxes.
  • the matrix can further comprise one or more starches, including corn starch, zein, rice flour, potato starch, and tapioca. Corn starch is most preferred.
  • the capsule forming agent can also comprise a modified food starch.
  • Modified food starches are any starches whose properties have been changed through any suitable chemical or physical treatment.
  • Modified starches suitable for use in the present invention include Hi-Cap® starches, available from National Starch.
  • Other modified starches include the following, which are coded according to the International Numbering System for Food Additives (INS) : 1401 Acid-treated starch, 1402 Alkaline treated starch, 1403 Bleached starch, 1404 Oxidized starch, 1405 Starches, enzyme- treated, 1410 Monostarch phosphate, 1411 Distarch glycerol, 1412 Distarch phosphate esterified with sodium t ⁇ metaphosphate, 1413 Phosphated distarch phosphate, 1414 Acetylated distarch phosphate, 1420 Starch acetate esterified with acetic anhydride, 1421 Starch acetate esterified with vinyl acetate, 1422 Acetylated distarch
  • oils that is suitable for ingestion by an animal can be used in the particles.
  • the oils can be obtained or derived from any natural or synthetic source. More than one oil can be in the particle, and in any proportion .
  • suitable oils include vegetable oils, fruit oils, seed oils, legume oils, plant oils, nut oils, and any animal fat or fat product that is desired. Examples of each of these are known and available to those of skill in the art.
  • Particularly preferred oils include fish oils, which are known for their health benefits. Even more preferred are omega-3 fatty acids and omega-6 fatty acids, which are known for their positive benefits on neurological development, eye and sight development, and blood lipid lowering effects.
  • omega-3 fatty acids include alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), eicosapentaenoic acid (EPA), eicosatetraenoic acid (ETA), and stearidonic acid (SDA).
  • Omega-3 fatty acids also include synthetic or naturally occurring omega-3 fatty acids, such as those found in fish oil, flax seed oil, walnut oil, wheat germ oil, rapeseed oil, soybeans, and seaweed.
  • omega-6 fatty acid is arachidomc acid (AA) .
  • the particles can also comprise in addition to or instead of the oils, one or more water soluble nutrients.
  • such materials comprise supplementary materials such as minerals, vitamins, salts, condiments, colorants, and/or preservatives.
  • supplementary minerals include calcium, phosphorous, potassium, sodium, iron, chloride, boron, copper, zinc, manganese, iodine, selenium and the like.
  • water soluble supplementary vitamins include the various B vitamins, and vitamin C.
  • Additional dietary supplements may also be included, for example, niacin, pantothenic acid, inulin, folic acid, biotin, ammo acids, plant extracts, flavonoids, anthocyanins, carotenoids, herbs, and the like.
  • the particles can comprise one or more hpid-soluble materials such as hpid-soluble vitamins, which are highly preferred.
  • Lipid soluble vitamins include vitamin A, vitamin D, vitamin E, and vitamin K.
  • a flavor enhancer to the particles to i mprove palatability or otherwise mask unpalatable flavors of any constituents of the particle.
  • a sweetener to the particles. Suitable flavor enhancers and/or sweeteners can vary according to the particular application to which the particle is being put, and are known and available to those of skill in the art.
  • the invention also features methods for making the particle described and exemplified herein .
  • the methods comprise mixing at least one oil with an emulsifying agent to form an oil emulsion, and mixing the oil emulsion with one or more capsule forming agents to form a slurry, adding the slurry to a salt solution to encapsulate the oil, and collecting and drying the encapsulated oil to form a particle.
  • the methods comprise mixing at least one water soluble nutrient with an emulsifying agent to form an aqueous emulsion, mixing the aqueous emulsion with one or more capsule forming agents to form a slurry, and adding the slurry to a salt solution to form a particle.
  • Suitable emulsifying agents are known to those of skill in the art, and include surfactants, acacia, lecithin, egg yolks, and the like.
  • Preferred examples of food-grade emulsifiers include egg yolk (where the mam emulsifying chemical is lecithin), honey, and mustard, where a variety of chemicals in the mucilage surrounding the seed hull act as emulsifiers, proteins and low-molecular weight emulsifiers.
  • Preferred capsule forming agents for this method of production are carrageenan and sodium alginate, although combinations of these agents as well as the inclusion of other suitable agents is contemplated.
  • Particular polymers such as carrageenan and sodium alginate, when mixed with an emulsion, have been determined to form a gel around the emulsion. This gel can be hydrated when mixed with an appropriate salt solution. The hydrated gel slows dissolution of the gel, resulting in a controlled-release effect.
  • the encapsulated oils are particlized by adding them to a salt solution.
  • the addition and particlization can proceed by any means suitable in the art.
  • the encapsulated oils can be added to the salt solution dropwise, or mixed into the salt solution and vortexed, sonicated, or pumped or sprayed into the solution, to form particles of a desired size.
  • Any salt solution suitable in the art for hydrating the encapsulated oils can be used.
  • Non-limiting examples of such salt solutions include potassium chloride, potassium carbonate, calcium chloride, magnesium chloride, and the like, including combinations thereof.
  • the methods comprise contacting a polymer with at least one oil for a period of time sufficient for the oil to become encapsulated within the particle.
  • the methods can comprise contacting a polymer with at least one water soluble nutrient for a period of time sufficient for the water soluble nutrient to become encapsulated within the particle.
  • the polymer can comprise one or more hydrophilic matrices, hydrophobic matrices, or combinations or mixtures of hydrophilic and hydrophobic matrices.
  • the polymer is preferably hydrophilic.
  • HMPC and MCC are preferred hydrophilic matrices.
  • the polymer can comprise one or more starches.
  • one or more starches can be mixed with the matrix to form the polymer.
  • Food starches are preferred for this purpose, and include without limitation, corn starch, potato starch, nee flour, tapioca, and zein.
  • the oil-encapsulated particle formed by this method can be coated with a second polymer.
  • the second polymer can be the same polymer or a different polymer than the polymer mixed with the oil.
  • the second polymer can comprise one or more hydrophilic matrices, hydrophobic matrices, or combinations or mixtures of hydrophilic and hydrophobic matrices such as those described and exemplified herein.
  • the methods comprise mixing a modified food starch, emulsifier, and polysaccharide in an aqueous solvent to form a suspension, mixing at least one oil with the suspension to form a slurry, and spraying the slurry to form particles.
  • the aqueous solvent can comprise one or more desirable water soluble nutrients, and in some aspects, the oil can be omitted entirely.
  • the particles are subsequently dried. Preferably, the particles are dried as they are sprayed.
  • suitable emulsifiers include phospholipids such as lecithin, honey, milk, proteins, and mustard.
  • suitable polysaccharides include xanthan gum, lactose, maltose, guar gum, locust bean gum, and gum acacia. Spray drying techniques are well known to those of skill in the art.
  • inventive particles are particularly useful in the food industry, for example, for producing foods with controlled release features such as controlled release health- enhancing/supporting agents.
  • the invention also features food compositions comprising a food component and a particle comprising at least one encapsulated oil and/or encapsulated water soluble nutrients, wherein the oil and/or water soluble nutrients are gradually released from the particle over a period of time.
  • the compositions are food products formulated for human consumption.
  • Such food products include breakfast products such as cereals, pastries, toaster pastries, pancakes, waffles, cookies, snack cakes, and the like, as well as dry- mix formulations prepackaged for the production of such breakfast products, e.g., pancake mix, etc.
  • Other examples include dairy products such as butters and spreads, yogurts, ice cream, "smoothies,” milk shakes, and the like.
  • Some highly preferred examples of other food products include controlled release vitamins, controlled release dietary supplements, diet "shakes” and dry mixes thereof, and the like.
  • compositions are pet food compositions. These will advantageously include foods intended to supply necessary dietary requirements for the animal, as well as treats (e.g., biscuits) or other dietary supplements.
  • the pet food compositions can be a dry composition (for example, kibble), semi-moist composition, wet composition, or any mixture or combination thereof. In some highly preferred aspects, the compositions are extruded.
  • the composition can be a nutritionally balanced pet food.
  • the pet food may be a wet food, a dry food, or a food of intermediate moisture content, as would be recognized by those skilled in the art of pet food formulation and manufacturing
  • “Wet food” describes pet food that is typically sold in cans or foil bags, and has a moisture content typically in the range of about 70% to about 90%.
  • “Dry food” describes pet food which is of a similar composition to wet food, but contains a limited moisture content, typically in the range of about 5% to about 15%, and therefore is presented, for example, as small biscuit-like kibbles.
  • the composition is a dietary supplement, such as a gravy, beverage, yogurt, chew, morsel, treat, or snack, and can be in the form of a powder, granule, paste, suspension, emulsion, pellet, pill, capsule, tablet, or any other suitable delivery form.
  • the dietary supplement can comprise a high concentration of controlled release oil granules such that the supplement can be administered to the animal in small amounts, or in the alternative, can be diluted before administration to an animal.
  • the dietary supplement may require admixing with a liquid carrier prior to administration to the animal. Any suitable liquid carrier, including aqueous or oil-based carriers can be used.
  • pet food compositions of the invention can comprise, on a dry matter basis, from about 15% to about 50% crude protein, by weight of the composition.
  • the crude protein material may comprise vegetable proteins such as soybean, cottonseed, and peanut, or animal proteins such as casein, albumin, and meat protein.
  • meat protein useful herein include pork, cow, lamb, equine, poultry, fish, and mixtures thereof.
  • the pet food compositions may further comprise, on a dry matter basis, from about 5% to about 40% fat, by weight of the composition.
  • the pet food compositions may further comprise one or more carbohydrates.
  • the compositions may comprise, on a dry matter basis, from about 15% to about 60% carbohydrate, by weight of the composition.
  • Non-limiting examples of such carbohydrates include grains or cereals such as rice, corn, milo, sorghum, alfalfa, barley, soybeans, canola, oats, wheat, and mixtures thereof.
  • the pet food compositions may also comprise at least one fiber source.
  • a variety of soluble or insoluble fibers may be utilized, as will be known to those of ordinary skill in the art.
  • the fiber source can be beet pulp (from sugar beet), gum arable, gum talha, psyllium, rice bran, carob bean gum, citrus pulp, pectin, fructooligosaccharide additional to the short chain oligofructose, mannanoligofructose, soy fiber, arabinogalactan, galactooligosaccha ⁇ de, arabmoxylan, or mixtures thereof.
  • the fiber source can be a fermentable fiber.
  • Fermentable fiber has previously been described to provide a benefit to the immune system of a companion animal.
  • Fermentable fiber or other compositions known to those of skill in the art which provide a prebiotic composition to enhance the growth of probiotic microorganisms within the intestine may also be incorporated into the composition to aid in the enhancement of the benefit provided by the present invention to the digestive system of an animal.
  • the compositions can be formulated for any animal, including zoo animals, farm animals such as horses, cows, pigs, sheep, donkeys, goats, and the like, and companion animals such as dogs and cats.
  • compositions can be specially formulated for adult animals, or for older or young animals, for example, a "puppy diet,” “kitten diet,” or “senior” formulation.
  • the compositions can be specially formulated for animals with particular health or metabolic issues, for example, for overweight animals, animals with sensitive digestive tracts, and the like.
  • specialized formulations will comprise energy and nutritional requirements appropriate for animals at different stages of development or age.
  • the make-up of the food composition will depend on a number of variables, including the species, breed, size, height, weight, age, overall health of the animal, the manner of digestion of the animal ⁇ e.g , ruminal), the pH of the different subsections of the digestive system (e.g., stomach, intestine), the type of formulation, and the mode or manner or administration, among others.
  • the inventive food compositions including pet food compositions and food products formulated for human consumption, can be refrigerated or frozen for extended storage.
  • the oil-containing particles may be pre-blended with the other components of the composition to provide the beneficial amounts needed, may be coated onto a food composition, for example, by a suitable spray-coating technique, or may be added to the composition prior to consumption, for example, using a sprinkled powder or a mix.
  • the food compositions of the invention can comprise oil in any amount suitable for the purpose to which the composition is made.
  • the amount of oil preferably ranges from about 0.1% to about 50% of the dry weight of the composition.
  • the amount of oil preferably ranges from about 1% to about 30%, from about 10% to about 20%, from about 15% to about 40%, from about 15% to about 30%, from about 30% to about 50%, from about 10% to about 30%, and from about 15% to about 20% of the dry matter weight of the composition, although greater or lesser percentages can be supplied.
  • the amount of oil is about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, or more of the composition on a dry matter basis.
  • a preferred concentration of oil is about 10%, and a more preferred concentration is about 15%.
  • a preferred concentration of oil is about 30%, and a more preferred concentration is about 50%.
  • the food compositions can comprise lipid soluble vitamins such as vitamins A, D, E, or K in any suitable amount, measured as a percentage of the dry matter weight of the composition.
  • the amount of vitamin ranges from about 0.1% to about 30% of the dry weight of the composition, although greater or lesser percentages can be supplied.
  • the amount of vitamin ranges from about 1% to about 25%, from about 10% to about 20%, from about 0.3% to about 1%, from about 0.2% to about 1%, from about 0.5% to about 1%, from about 1% to about 5%, from about 1% to about 10%, from about 3% to about 15% of the dry weight of the composition.
  • the amount of vitamin is about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, or more of the composition on a dry matter basis.
  • the amount of vitamin is at or near the recommended daily allowance for the vitamin.
  • Dietary supplements may be formulated to contain several-fold higher concentrations of oil, water soluble nutrients, and/or vitamins to be amenable for ingestion or administration by diluting a concentrated form before administration, such as by dilution in a suitable liquid, mixing in with a food component, and other similar modes of administration.
  • a particle-containing food composition can be mixed with the same type or a different type of food composition that lacks the particles (or has a lower concentration of particles) so as to lower the concentration of oil, water soluble nutrients, and/or vitamins that are ingested by the animal or human being.
  • the food compositions can be further processed after the food product is mixed with the particles.
  • the food compositions can be baked, roasted, fried, flash frozen, and the like.
  • the food composition can be extruded into one or more predetermined forms or shapes.
  • the particle gradually releases the encapsulated oils or water soluble nutrients over a period of time.
  • the particles can be considered extended release particles for materials contained within the particle.
  • the period of time can range from about one minute to about twenty four hours, although greater or lesser periods of time can be employed.
  • the particle provides a sustained release of oil or water soluble nutrients.
  • This release can be measured by a known example for determining in vitro release.
  • the values for in vitro release are determined using an agitated aqueous medium, such as stirring at 50 rpm in a 0.5M SDS solution over the desired period of time, for example, 12 hours.
  • the pH of the solution preferably will range from about 6.8 to about 7.2, with vigorous stirring.
  • the release profile can be measured using this test, and the particles of the invention achieve a release profile such that at least 50% of the oil or water soluble nutrient is released over a period of time, preferably at some time between about 0.5 to 24 hours, more preferably from about 1 to 18 hours, and even more preferably from about 2 hours to about 12 hours, and still more preferably from about 3 hours to about 8 hours.
  • the compositions can be formulated for an appropriate release duration, depending on the intended use of the food product.
  • the duration of release will be longer when the particle is mixed within a food composition because the food component will not hydrate immediately.
  • any given in vitro dissolution time e.g., 12 hours
  • the food component can therefore be selected to achieve the desired serum profile based on a number of factors, such as those listed above.
  • the duration of release will depend on a number of factors such as the relative rate of digestion of the animal to which the composition is administered. In some aspects, about 50% of the oil or water soluble nutrient will be released from a food composition will proceed gradually over a period of up to about 30 hours, including a period of about 24 hours.
  • the rate of release can be measured or established by any means suitable in the art, including those described and exemplified herein.
  • the rate of release can be based on in vitro or in vivo release profiles.
  • the rate of release can be based on the release profile of the particle itself, or of a food composition comprising the particle.
  • the particles release at least about 30% of the oil or water soluble nutrients encapsulated within or adsorbed to the particle.
  • At least about 40% is released, more preferably, at least about 50% is released, more preferably, at least about 55% is released, preferably, at least about 60% is released, preferably, at least about 65% is released, preferably, at least about 70% is released, preferably, at least about 75% is released, preferably, at least about 80% is released, preferably, at least about 85% is released, preferably, at least about 90% is released, preferably, at least about 95% is released, and most preferably, 100% is released.
  • Carrageenan gum According to the FMC Reference Manual, iota and kappa carrageenans can be used for the entrapment and encapsulation of oils. Encapsulation is accomplished by combining oil with an emulsifying agent and adding this combination into a carrageenan solution to encapsulate the oil droplets with carrageenan gum. The carrageenan-encapsulated oil is then dropped into a potassium chloride solution to induce the carrageenan to gel around the oil droplet. The carrageenan on the surface of the granule will slowly hydrate and create a thin gel layer around the remaining dry granule. The gel layer restricts water mobility and slows penetration into the granule matrix. Method.
  • a 1.5% solution of carrageenan gum was prepared by mixing 6.0 grams of carrageenan into 400 mis of water and stirring until the gum was completely solubihzed.
  • a 1 : 1 solution of 0.05M sodium dodecyl sulfate (SDS) and vegetable oil was prepared by combining 26 grams of oil and 26 grams of 0.05M SDS and stirring until emulsified.
  • the emulsified oil and the 1.5% carageenan solution was combined in a 1.1 ratio and stirred completely.
  • droplets of the oiled carrageenan solution were dropped into a 2M KCI solution. As soon as the droplet hit the KCI soluation, the carrageenan gelled, forming an oil enclosed bead.
  • a second solution was prepared so that the resulting bead had an oil concentration of 70.7%, a carrageenan gum concentration of 28.3% and an SDS concentration of 1.0%.
  • a yellow oil soluble dye was added to the mix in order to monitor the take up and release of the oil.
  • the process was automated using a peristaltic pump in order to produce very uniform droplets. After drying as above, the resulting beads had a dry "crunchy" feel to them, and upon hand-squeezing, the oil was not released. In addition, the oil did not wick out of the dried bead when placed on an absorbent paper towel.
  • the beads produced from the second solution were used to prepare a dog food pellet (CG-I) by combining a commercially prepared dog food granule, some extra- granular microcrystalline cellulose (MCC) and Natrasorb® (Multisorb Technologies, Buffalo, NY), which is a maltodext ⁇ n designed to absorb oil. Hardness was evaluated using the Knoop system for determining microhardness. The resulting tablet had an average hardness of about 9.5kp, as shown in Table 2. Table 2. Kibble Compilation CG-I .
  • a second dog food pellet (CG-2) was prepared using the beads produced from the second solution along with Hi-Cap 200® (National Starch)l.
  • Hi-Cap 200® is a modified food starch, and can be used as an additional source of calories for the dog food kibble.
  • the effective hardness of this formula was 9.7 kp, as shown in Table 3.
  • Hi-Cap 200® was mixed with the dry dog food powder in a 50:50 ratio (CG-3). The resulting hardness was very low at 2.6kp. MCC was added to this mixture to see if hardness could be increased.
  • a 1 : 1: 1 ratio of dog food, Hi Cap 200 and MCC produced an acceptable hardness of 10.8 (CG-5).
  • the carrageenan-oil granules then were added in to see how the hardness was affected.
  • the hardness was reduced to 3.8kp (CG-6). Varying levels of the dog food, MCC and Hi-Cap 200® were combined with the oiled carrageenan beads, blended, compressed and tested for hardness. It was found that as the percentage of dog food in the formula was increased, the hardness was decreased. The hardness of the formula could be increased by increasing the level of MCC
  • a dry carrageenan gum granule can be produced containing up to 70% oil . Oil is fully encapsulated by the carrageenan gum and does not leech out over time. Kibbles with adequate hardness can be produced using the oil encapsulated carrageenan gum granules. Production of these carrageenan gum and oil granules can be automated and scaled up to produce a large scale batch. Hi-Cap 200® acts as a moderate oil absorber and aides in increasing the hardness of the tablet with the added benefit of providing an additional source of calories to the kibble.
  • a carrageenan gum was prepared as follows: A 1.0% solution of carrageenan gum was dispersed and allowed to fully hydrate in water. Meanwhile, a 50: 50 mixture of oil and 0.05M SDS was emulsified. Once emulsified, the oil blend was then added to the 1.0% carrageenan solution in the ratio of 8 grams of emulsified liquid to 15 grams of carrageenan solution and stirred until uniform. Next, drops of the oiled carrageenan gum solution were added to a IM KCI solution. The salt caused the carrageenan gum to gel up into beads, and in doing so entrapped the oil. These carrageenan beads were collected and allowed to air dry overnight. The resulting carrageenan granule was determined to have an oil concentration of ⁇ 72%, a carrageenan gum concentration of ⁇ 27%, and an SDS concentration of ⁇ 1.0% (Table 5).
  • the granules had a dry "crunchy" feel to them, and upon hand-squeezing, did not release the contained oil. In addition, the oil did not wick out of the dried bead when placed on an absorbent paper towel.
  • an oil soluble dye can be added to monitor the release of the oil from the granule, or a brown dye can be added to camouflage the granule within the dog food.
  • These granules can either be mixed with a dog food granule and compressed into a kibble, or the carrageenan-encapsulated oil granules can be added to the dog food and extruded in the current dog food manufacturing procedure.
  • the dog food was granulated with a modified food starch derived from waxy maize (Table 6). It is suited for high oil loading and it is characterized by excellent resistance to oxidation. Granulating the dog food with the modified food starch improved the flow and compressibility of the dog food powder. Table 6. Dog food-starch formulation.
  • Modified Food Starch 25 25 00% dog food 75 75 00% water qs qs
  • Characteristics of the carrageenan granule kibble were compared with the characteristics of the original dog food kibble, and the results are presented in Table 8.
  • the thickness of the carrageenan granule kibble to the original kibble was comparable, as was the hardness and the friability.
  • the carrageenan granule kibble was heavier than the original kibble due to the kibble being compressed into a tablet form.
  • the overall food content of the two kibbles was equivalent with 59% of the carrageenan granule kibble contributing to caloric intake for a total of 0.5990 grams of food content in the carrageenan granule kibble to the 0.5640 grams in the original kibble.
  • the carrageenan granule kibbles contained the required 20% fish oil and 1.5% vitamin E, and the oils were released at a controlled rate. The remaining 20% of the formula was filler necessary to compress the carrageenan granule kibble into a tablet form, thereby protecting the oils from heat degradation.
  • An oil can be encapsulated by producing a hard porous polymer granule in which oil can migrate via a spray-coating technique.
  • the oiled polymer can then be compressed with a dog food granule into a kibble. As the kibble is digested the polymer will swell and begin to slowly hydrate thereby releasing the oil at a controlled rate
  • Hydroxypropylmethylcellulose (HPMC) and MCC were mixed in a 50:50 ratio and wet granulated in a V-blender using an mtensifier bar.
  • a combination of powdered dog food, xanthan gum and MCC was mixed in a 400:75: 75 ratio and wet granulated in a V-blender using an mtensifier bar. Both granulations were allowed to air dry over night.
  • HPMC fish oil 75 grams HPMC fish oil from HPMC Gran 25 15 5% Granulation HPMC 25 15 5%
  • Characteristics of the double granulation kibble were compared with the characteristics of the original dog food kibble, and the results are presented in Tables 10 and 11.
  • the double granulation kibble was again slightly higher in weight than the original kibble due to the kibble being compressed into a tablet form.
  • the thickness and hardness of the double granulation kibble was slightly less than the original kibble, but still adequate for a tablet form.
  • the friability was equivalent between the two kibbles.
  • the oil content was slightly less than optimal at 15.5%.
  • the dog food content was 33.5% of the formula. At the higher weight, this equates to 0.2756 grams of dog food, which is nearly 50% of the original kibble.
  • the carrageenan gum formula of Example 2 more closely matched the physical characteristics of the original kibble than the double granulation formula, however both kibble formulas produce acceptable tablets.
  • the carrageenan gum formula also had a higher food content per kibble than the granulation formula so that total food consumption should be the same.
  • the granulation was allowed to air dry over night after passing through a size 8 mesh sieve. Once the HPMC/corn starch granulate was dried, a measured amount was placed in a pan coater. While the pan was turning, oil was slowly sprayed onto the granules. The oil to granulate ratio was 1 :3 Finally, the granules were coated with an HPMC IOOLV solution using a wurster coating technique in a fluidized air bed. The make-up of the granules is described in Table 12.
  • Step 1 Granulate in V-Blender w/ HPMC 375 35 2% lntensifier Bar Cornstarch 375 35 2% water qs Trace
  • Step 2 Spray in Pan Coater Vegetable Oil 250 23 5%
  • Step 3 Coat granules in Fluid Bed HPMC 100LV 64 6 0%
  • coated oiled granules will be mixed with a commercial dog food formulation and manufactured into kibbles.
  • the coated oiled corn starch granules will be processed to form a traditional "baked" kibble, which is believed will improve texture and provide a more pleasant mouth feel .
  • Spray drying is a commonly used method of drying a liquid feed through a hot gas
  • this hot gas is air but nitrogen gas can be used for sensitive materials which require oxygen-free drying, such as fish oil .
  • This spray drying technique is often used to encapsulate substances within an amphipathic carrier via a homogenized suspension in water.
  • the slurry formed is then fed into a spray drier, usually a tower heated to temperatures well over the boiling point of water. As the slurry enters the tower, it is atomized. Because of the high surface tension of water and the hydrophobic/hydrophilic interactions, the atomized slurry forms micelles. The small size of the drops (averaging 100 micrometers in diameter) results in a relatively large surface area which dries quickly.
  • the carrier forms a hardened shell around the load.
  • Method. A modified food starch, lecithin, and xanthan gum were solubihzed in water (Table 13) . Oil was added to make a slurry at a 1 : 1 ratio with the solid additions to achieve a 50% concentration upon spray drying. This slurry was spray dried using a fluid bed apparatus. Table 13. Spray Dried Granulation Formulation .
  • the oil was encapsulated by producing a hard porous polymer granule via the wet granulation of HPMC and cornstarch. Oil was then applied to the granule in a 1 : 2 ratio using a spray coating technique. Following the uptake of oil, the granules were coated with an HPMC solution to prevent oil loss.
  • Spray Dried Technique A modified food starch, lecithin, and xanthan gum were solubilized in water. Oil was added to make a slurry at a 1 : 1 ratio with the solid additions to achieve a 50% concentration upon spray drying. The slurry was spray dried using a fluid bed apparatus. Microbead Technique. Encapsulation was accomplished by combining oil with an emulsifying agent and adding this into either a carageenan solution or a sodium alginate solution to encapsulate the oil droplets with the polymer The polymer- encapsulated oil was then dropped into either a potassium chloride solution to induce the carrageenan polymer to gel around the oil droplet or a calcium chloride solution to induce the sodium alginate to encapsulate the oil.
  • the simple granulation technique was the most cost-effective and easiest for scale up manufacturability. However, it was the least efficient for entrapping oil . Maximum oil absorbed was on the order of 25%. Oil retention was adequate when a protective coating was applied. The granulation technique was very effective in controlling the release of oil in dissolution over time.
  • the sodium alginate and carrageenan beads were very efficient for trapping oil . Micro-beads could be manufactured with up to 95% oil content. However, the ruggedness of the micro-beads decreased as oil content increased. Coating the beads helped retain their integrity, however, and oil retention was reduced. Special equipment is necessary for the production of micro-beads making this method the least cost-effective of the methods investigated .
  • the spray dried material was made with a red chili oil to aid in oil release observations.
  • the hydrophylic polymers of the simple granulation formula were completely hydrated after 12 hours as was the polymers in the spray dried formula, resulting in complete release of oil within 12 hours.
  • the sodium alginate beads had swelled and released approximately 50% of the oil after 12 hours, while the carrageenan beads retained most of the oil in the 12 hours of dissolution testing.
  • the simple granulation and the spray dried techniques are both cost effective methods for encapsulating oil .
  • the spray dried technique is more efficient with the ability to entrap 50% oil compared to the simple granulation technique with 25% oil entrapment.
  • Hydrophilic Particles Comprising Water Soluble Nutrients
  • the active agents can be dissolved in an aqueous media such as water with the capsule forming materials.
  • This solution can then be used to create a slurry using an inert oil, and then particles can be formed in the same manners as above.
  • Inert oil could be any conventional, approved edible oil.
  • Another approach would be to first create a oihwater emulsion of the active agent in an aqueous media, which can then be combined with the capsule forming agent in a second emulsion step followed by encapsulation.
  • Additional approaches for particle formation include solubilizing the active agent in a suitable aqueous solvent and spraying this solution onto the pre-formed particles to allow the solution to be absorbed into the particle in a manner similar to the manners described herein. Another approach would be to incorporate the active agent into the particle with subsequent functional coating as needed.
  • Spray-drying techniques are also amenable to water soluble agents. Similar to the techniques described for oil, a slurry or solution containing the agents would be produced and then spray congealed (spray dried) to produce coated particles. In this case, however, an oihwater emulsion would not need to be created because it is anticipated that it would most likely be all aqueous. High solids content can be achieved by combining the active along with the capsule forming agents.
  • These particles can be mixed with a food component such as a pet food or food product formulated for human consumption.

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Abstract

Particles for controlled release of oils or water soluble nutrients are disclosed. The particles are particularly well suited for use in food compositions where controlled release of one or more constituents of the food composition is desirable. Also provided are methods for producing particles for controlled release of oils or water soluble nutrients.

Description

CONTROLLED RELEASE FOOD FORMULATIONS
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. Provisional Application No. 61/114,898, filed November 14, 2008, the contents of which are incorporated by reference herein, in their entirety.
BACKGROUND
Various publications, including patents, published applications, technical articles and scholarly articles are cited throughout the specification. Each of these cited publications is incorporated by reference herein, in its entirety. Certain food products are manufactured containing fish oils and lipid soluble vitamins to promote or maintain health. However, aspects of the manufacturing process such as heat, light, moisture, and exposure to oxygen degrade nutrients in the food, including the oils and lipid and water soluble vitamins, resulting in a loss of product, loss of potency, discoloration, and the imparting of undesirable flavors. As such, many manufacturers of products containing fish oils and vitamins may use antioxidants during the manufacture process, at great expense.
There is thus a need for processes to protect nutrients and oils from the damaging effect of heat, light, and oxidation, that is simple and cost-effective for manufactures. SUMMARY
The invention features particles comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within or adsorbed to the capsule forming agent. When contacted with an aqueous solvent, the particles release at least 50% of the oil or water soluble nutrient over a period of time, preferably between 0.5 to 24 hours, more preferably between 1 and 18 hours, and still more preferably between 2 and 12 hours. The water soluble nutrient can be any protein, carbohydrate, mineral, vitamin, and the like, which are capable of being dissolved by water. The oil soluble nutrient (shortened herein simply to "oil") can be any oil such as a vegetable oil, fish oil, or omega-3, or omega-6 fatty acid. The particle can further comprise lipid soluble vitamins.
The capsule forming agent can be comprised of a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix, or a gum or starch, or any combination thereof. Hydroxypropylmethyl cellulose, microcrystalline cellulose, and corn starch are preferred constituents of the matrix. The capsule forming agent can be comprised of carrageenan gum or sodium alginate, or can be comprised of one or more modified food starches. Also featured are various methods for producing the controlled release particles, including particles that control the release of oil or water-soluble nutrients. In some aspects, the methods comprise mixing at least one oil or water soluble nutrient with an emulsifying agent to form an emulsion, mixing the emulsion with the capsule forming agent to form a slurry, and adding the slurry to a salt solution to form a particle. The capsule forming agent can be comprised of a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix, a gum or starch, carrageenan gum, sodium alginate, or one or more modified food starches.
In some aspects, the methods comprise contacting a first hydrophilic polymer with at least one oil or water soluble nutrient for a period of time of time sufficient for the oil or water soluble nutrient to become encapsulated within the polymer, thereby forming a particle. Optionally, the particle can be coated with a second hydrophilic polymer.
In some aspects, the methods comprise mixing a modified food starch, emulsifying agent, and polysaccharide in an aqueous solvent to form a suspension, mixing at least one oil and/or water soluble nutrient with the suspension to form a slurry, and spray drying the slurry to form particles. Optionally, the suspension can be sprayed and subsequently dried. The emulsifying agent is preferably lecithin, and the polysaccharide is preferably xanthan gum. The invention also features food compositions. The food compositions comprise a food component and a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within the capsule forming agent. The concentration of oil or water soluble nutrient in the food composition can be from about 0.2% to about 20% (w/w) of the food composition. The particles gradually release the oil or nutrients in a controlled release manner over a period of time and at least 50% of the oil or nutrients are released. Preferably, 100% of the nutrients are released.
The food composition can be comprised of pet food or food products formulated for human consumption. The nutrients can be any water soluble nutrient. The oil can be any oil such as a vegetable oil, fish oil, or omega-3, or omega-6 fatty acid. The particle can further comprise lipid soluble vitamins.
The capsule forming agent can be comprised of a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix, or a gum or starch, or any combination thereof. Hydroxypropylmethyl cellulose, microcrystalline cellulose, and corn starch are preferred constituents of the matrix. The capsule forming agent can be comprised of carrageenan gum or sodium alginate, or can be comprised of one or more modified food starches. Also featured are methods for manufacturing food compositions. In some aspects, the methods comprise mixing a food component with a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within the capsule forming agent. The food component can be pet food or a food product formulated for human consumption. The methods can further comprise extruding the food composition into at least one predetermined shape. The methods can further comprise baking or frying the food composition.
In some aspects, the methods comprise applying a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within the capsule forming agent to the surface of a food component. The application can comprise spray-drying. The food component can be pet food or a food product formulated for human consumption. The methods can further comprise baking or frying the food composition.
DETAILED DESCRIPTION
Various terms relating to the methods and other aspects of the present invention are used throughout the specification and claims. Such terms are to be given their ordinary meaning in the art unless otherwise indicated. Other specifically defined terms are to be construed in a manner consistent with the definition provided herein. The term "about" as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20% or ±10%, more preferably ±5%, even more preferably ±1%, and still more preferably ±0.1% from the specified value. As used herein, the term "pet food" refers to any source of nourishment intended for ingestion by a companion animal. A "nutritionally balanced pet food," is pet food that contains nutrients in appropriate amounts and proportions based on recommendations of recognized authorities in the relevant field of animal nutrition. Nutritionally balanced pet food compositions are widely known and widely used in the art.
As used herein, a "dietary supplement" is a product that is intended to be ingested in addition to the normal diet of an animal or a human being.
As used herein, a "food product formulated for human consumption" is any food, food component, or food composition intended for ingestion by a human being. "Food" or "food component" are used interchangeably herein, and refer to any source of nourishment intended for ingestion by an animal or human being.
It has been observed in accordance with the present invention that oil encapsulation modalities can be improved in terms of make-up, integrity, and stability, and can be used to control release of dietary oils from food such that oil-containing particles can be mixed with food, and the oils will gradually release from the particles during digestion. It has been further observed that the utility of the particles is not limited to oils, and that the particles can be adapted to contain and control the release of water and water soluble nutrients as well. Accordingly, the invention features particles comprising capsule forming agents and oils or water soluble nutrients, wherein the oils or water soluble nutrients are released from the particle over a period of time.
The controlled release particles of the invention differ from traditionally used controlled release particles as they are comprised of higher amounts of capsule forming agents and lower amounts of oil or water soluble nutrients. Thus, in one aspect, the particles comprise from about 10% to about 80% (w/w) of a capsule forming agent. More preferably, the particles comprise from about 30% to about 60% (w/w) of a capsule forming agent, and more preferably about 30% to about 50% (w/w) of a capsule forming agent. In some aspects, the particles comprise about 30% (w/w) of a capsule forming agent. In some aspects, the particles comprise about 35%, about 40%, about 45%, about 50%, about 55%, or about 60% (w/w) of a capsule forming agent, although greater or lesser percentages can be used.
The particles can preferably comprise from about 2% to about 75% (w/w) oil and/or oil soluble nutrients, more preferably comprise from about 5% to about 60% (w/w) oil and/or oil soluble nutrients, and more preferably comprise from about 30% to about 60% (w/w) of oil and/or oil soluble nutrients. Other preferred concentration ranges of oil and/or oil soluble nutrients include from about 15% to about 40% (w/w), about 15% to about 30% (w/w), about 20% to about 40% (w/w), about 20% to about 50% (w/w), 30% to about 40% (w/w), from about 50% to about 70% (w/w), from about 50% to about 60% (w/w), and from about 60% to about 70% (w/w). In some aspects, the particles comprise about 2% (w/w) of at least one oil and/or soluble nutrient. In some aspects, the particles comprise at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 70%, or about 75% (w/w) of at least one oil and/or oil soluble nutrient, although greater or lesser percentages can be used. The particles can further comprise a suitable amount of other ingredients such as binders, fillers, and the like, which are well known by and available to those of skill in the art.
The particles can preferably comprise from about 2% to about 75% (w/w) water soluble nutrients, more preferably comprise from about 5% to about 60% (w/w) water soluble nutrients, and more preferably comprise from about 30% to about 60% (w/w) of water soluble nutrients. Other preferred concentration ranges of water soluble nutrients include from about 15% to about 40% (w/w), about 15% to about 30% (w/w), about 20% to about 40% (w/w), about 20% to about 50% (w/w), from about 30% to about 40% (w/w), from about 50% to about 70% (w/w), from about 50% to about 60% (w/w), and from about 60% to about 70% (w/w). In some aspects, the particles comprise about 2% (w/w) of at least one water soluble nutrient. In some aspects, the particles comprise about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 70%, or about 75% (w/w) of at least one water soluble nutrient, although greater or lesser percentages can be used. The particles can further comprise a suitable amount of other ingredients such as binders, fillers, and the like, which are well known by and available to those of skill in the art. In some preferred aspects, the capsule forming agent comprises a polymer that is comprised of biomolecule subunits, such as polysaccharides or polypeptides. One highly preferred but non-limiting example of such a polymer is carrageenan. Other examples include gelatin, agar, and the like. Iota and Kappa carrageenan can be used to make particles. In addition, the capsule forming agent can be comprised of a chemical polymer, preferably where the polymer is non-toxic or otherwise compatible with animal or human ingestion. One highly preferred example of such a polymer is sodium alginate.
The capsule forming agent can also comprise a matrix, for example, a hydrophilic matrix, a hydrophobic matrix, or any combination or mixture thereof. Non- limiting examples of suitable hydrophilic matrices include Hydroxypropylmethyl cellulose (HMPC), microcrystalline cellulose (MCC), xanthan gum, guar gum, locust bean gum, and acacia gum. HMPC and MCC are particularly preferred. Non-limiting examples of suitable hydrophobic matrices include various waxes. In some highly preferred aspects, the matrix can further comprise one or more starches, including corn starch, zein, rice flour, potato starch, and tapioca. Corn starch is most preferred.
The capsule forming agent can also comprise a modified food starch. Modified food starches are any starches whose properties have been changed through any suitable chemical or physical treatment. Modified starches suitable for use in the present invention include Hi-Cap® starches, available from National Starch. Other modified starches include the following, which are coded according to the International Numbering System for Food Additives (INS) : 1401 Acid-treated starch, 1402 Alkaline treated starch, 1403 Bleached starch, 1404 Oxidized starch, 1405 Starches, enzyme- treated, 1410 Monostarch phosphate, 1411 Distarch glycerol, 1412 Distarch phosphate esterified with sodium tπmetaphosphate, 1413 Phosphated distarch phosphate, 1414 Acetylated distarch phosphate, 1420 Starch acetate esterified with acetic anhydride, 1421 Starch acetate esterified with vinyl acetate, 1422 Acetylated distarch adipate, 1423 Acetylated distarch glycerol, 1440 Hydroxypropyl starch, 1442 Hydroxypropyl distarch phosphate, 1443 Hydroxypropyl distarch glycerol, and 1450 Starch sodium octenyl succinate.
Any oil that is suitable for ingestion by an animal can be used in the particles. The oils can be obtained or derived from any natural or synthetic source. More than one oil can be in the particle, and in any proportion . Non-limiting examples of suitable oils include vegetable oils, fruit oils, seed oils, legume oils, plant oils, nut oils, and any animal fat or fat product that is desired. Examples of each of these are known and available to those of skill in the art. Particularly preferred oils include fish oils, which are known for their health benefits. Even more preferred are omega-3 fatty acids and omega-6 fatty acids, which are known for their positive benefits on neurological development, eye and sight development, and blood lipid lowering effects.
Non-limiting examples of omega-3 fatty acids include alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), eicosapentaenoic acid (EPA), eicosatetraenoic acid (ETA), and stearidonic acid (SDA). Omega-3 fatty acids also include synthetic or naturally occurring omega-3 fatty acids, such as those found in fish oil, flax seed oil, walnut oil, wheat germ oil, rapeseed oil, soybeans, and seaweed. One non-limiting example of an omega-6 fatty acid is arachidomc acid (AA) .
The particles can also comprise in addition to or instead of the oils, one or more water soluble nutrients. Preferably, such materials comprise supplementary materials such as minerals, vitamins, salts, condiments, colorants, and/or preservatives. Non- li miting examples of supplementary minerals include calcium, phosphorous, potassium, sodium, iron, chloride, boron, copper, zinc, manganese, iodine, selenium and the like. Non-limiting examples of water soluble supplementary vitamins include the various B vitamins, and vitamin C. Additional dietary supplements may also be included, for example, niacin, pantothenic acid, inulin, folic acid, biotin, ammo acids, plant extracts, flavonoids, anthocyanins, carotenoids, herbs, and the like.
In some aspects, the particles can comprise one or more hpid-soluble materials such as hpid-soluble vitamins, which are highly preferred. Lipid soluble vitamins include vitamin A, vitamin D, vitamin E, and vitamin K. For some applications, it may be desirable to add a flavor enhancer to the particles to i mprove palatability or otherwise mask unpalatable flavors of any constituents of the particle. In addition, it may be desirable to add a sweetener to the particles. Suitable flavor enhancers and/or sweeteners can vary according to the particular application to which the particle is being put, and are known and available to those of skill in the art.
The invention also features methods for making the particle described and exemplified herein . Thus, in one aspect, the methods comprise mixing at least one oil with an emulsifying agent to form an oil emulsion, and mixing the oil emulsion with one or more capsule forming agents to form a slurry, adding the slurry to a salt solution to encapsulate the oil, and collecting and drying the encapsulated oil to form a particle. In other aspects, the methods comprise mixing at least one water soluble nutrient with an emulsifying agent to form an aqueous emulsion, mixing the aqueous emulsion with one or more capsule forming agents to form a slurry, and adding the slurry to a salt solution to form a particle.
Suitable emulsifying agents are known to those of skill in the art, and include surfactants, acacia, lecithin, egg yolks, and the like. Preferred examples of food-grade emulsifiers include egg yolk (where the mam emulsifying chemical is lecithin), honey, and mustard, where a variety of chemicals in the mucilage surrounding the seed hull act as emulsifiers, proteins and low-molecular weight emulsifiers.
Preferred capsule forming agents for this method of production are carrageenan and sodium alginate, although combinations of these agents as well as the inclusion of other suitable agents is contemplated. Particular polymers such as carrageenan and sodium alginate, when mixed with an emulsion, have been determined to form a gel around the emulsion. This gel can be hydrated when mixed with an appropriate salt solution. The hydrated gel slows dissolution of the gel, resulting in a controlled-release effect.
Once the emulsion and capsule forming agents are mixed, the encapsulated oils are particlized by adding them to a salt solution. The addition and particlization can proceed by any means suitable in the art. For example, the encapsulated oils can be added to the salt solution dropwise, or mixed into the salt solution and vortexed, sonicated, or pumped or sprayed into the solution, to form particles of a desired size. Any salt solution suitable in the art for hydrating the encapsulated oils can be used. Non-limiting examples of such salt solutions include potassium chloride, potassium carbonate, calcium chloride, magnesium chloride, and the like, including combinations thereof.
In some aspects, the methods comprise contacting a polymer with at least one oil for a period of time sufficient for the oil to become encapsulated within the particle. In addition, the methods can comprise contacting a polymer with at least one water soluble nutrient for a period of time sufficient for the water soluble nutrient to become encapsulated within the particle.
The polymer can comprise one or more hydrophilic matrices, hydrophobic matrices, or combinations or mixtures of hydrophilic and hydrophobic matrices. The polymer is preferably hydrophilic. HMPC and MCC are preferred hydrophilic matrices. In some aspects, the polymer can comprise one or more starches. Thus, for example, one or more starches can be mixed with the matrix to form the polymer. Food starches are preferred for this purpose, and include without limitation, corn starch, potato starch, nee flour, tapioca, and zein. In some aspects, the oil-encapsulated particle formed by this method can be coated with a second polymer. The second polymer can be the same polymer or a different polymer than the polymer mixed with the oil. Thus, for example, the second polymer can comprise one or more hydrophilic matrices, hydrophobic matrices, or combinations or mixtures of hydrophilic and hydrophobic matrices such as those described and exemplified herein.
In some aspects, the methods comprise mixing a modified food starch, emulsifier, and polysaccharide in an aqueous solvent to form a suspension, mixing at least one oil with the suspension to form a slurry, and spraying the slurry to form particles. In some aspects, the aqueous solvent can comprise one or more desirable water soluble nutrients, and in some aspects, the oil can be omitted entirely. In some aspects, the particles are subsequently dried. Preferably, the particles are dried as they are sprayed. Non-limiting examples of suitable emulsifiers include phospholipids such as lecithin, honey, milk, proteins, and mustard. Non-limiting examples of suitable polysaccharides include xanthan gum, lactose, maltose, guar gum, locust bean gum, and gum acacia. Spray drying techniques are well known to those of skill in the art.
The inventive particles are particularly useful in the food industry, for example, for producing foods with controlled release features such as controlled release health- enhancing/supporting agents. Thus, the invention also features food compositions comprising a food component and a particle comprising at least one encapsulated oil and/or encapsulated water soluble nutrients, wherein the oil and/or water soluble nutrients are gradually released from the particle over a period of time.
It has been observed that the controlled release particles are particularly well suited for food products formulated for human consumption. Thus, in one aspect, the compositions are food products formulated for human consumption. Non-limiting examples of such food products include breakfast products such as cereals, pastries, toaster pastries, pancakes, waffles, cookies, snack cakes, and the like, as well as dry- mix formulations prepackaged for the production of such breakfast products, e.g., pancake mix, etc. Other examples include dairy products such as butters and spreads, yogurts, ice cream, "smoothies," milk shakes, and the like. Some highly preferred examples of other food products include controlled release vitamins, controlled release dietary supplements, diet "shakes" and dry mixes thereof, and the like. Particularly preferred examples of food products include health and energy bars, sport supplements, gel packs, and the like. It has further been observed that controlled release preparations are particularly well suited for pet foods. Thus, in one aspect, the compositions are pet food compositions. These will advantageously include foods intended to supply necessary dietary requirements for the animal, as well as treats (e.g., biscuits) or other dietary supplements. The pet food compositions can be a dry composition (for example, kibble), semi-moist composition, wet composition, or any mixture or combination thereof. In some highly preferred aspects, the compositions are extruded.
In one aspect, the composition can be a nutritionally balanced pet food. In this context, the pet food may be a wet food, a dry food, or a food of intermediate moisture content, as would be recognized by those skilled in the art of pet food formulation and manufacturing "Wet food" describes pet food that is typically sold in cans or foil bags, and has a moisture content typically in the range of about 70% to about 90%. "Dry food" describes pet food which is of a similar composition to wet food, but contains a limited moisture content, typically in the range of about 5% to about 15%, and therefore is presented, for example, as small biscuit-like kibbles.
In another aspect, the composition is a dietary supplement, such as a gravy, beverage, yogurt, chew, morsel, treat, or snack, and can be in the form of a powder, granule, paste, suspension, emulsion, pellet, pill, capsule, tablet, or any other suitable delivery form. The dietary supplement can comprise a high concentration of controlled release oil granules such that the supplement can be administered to the animal in small amounts, or in the alternative, can be diluted before administration to an animal. The dietary supplement may require admixing with a liquid carrier prior to administration to the animal. Any suitable liquid carrier, including aqueous or oil-based carriers can be used.
In some aspects, pet food compositions of the invention can comprise, on a dry matter basis, from about 15% to about 50% crude protein, by weight of the composition. The crude protein material may comprise vegetable proteins such as soybean, cottonseed, and peanut, or animal proteins such as casein, albumin, and meat protein. Non-limiting examples of meat protein useful herein include pork, cow, lamb, equine, poultry, fish, and mixtures thereof.
The pet food compositions may further comprise, on a dry matter basis, from about 5% to about 40% fat, by weight of the composition.
The pet food compositions may further comprise one or more carbohydrates. The compositions may comprise, on a dry matter basis, from about 15% to about 60% carbohydrate, by weight of the composition. Non-limiting examples of such carbohydrates include grains or cereals such as rice, corn, milo, sorghum, alfalfa, barley, soybeans, canola, oats, wheat, and mixtures thereof.
The pet food compositions may also comprise at least one fiber source. A variety of soluble or insoluble fibers may be utilized, as will be known to those of ordinary skill in the art. The fiber source can be beet pulp (from sugar beet), gum arable, gum talha, psyllium, rice bran, carob bean gum, citrus pulp, pectin, fructooligosaccharide additional to the short chain oligofructose, mannanoligofructose, soy fiber, arabinogalactan, galactooligosacchaπde, arabmoxylan, or mixtures thereof.
Alternatively, the fiber source can be a fermentable fiber. Fermentable fiber has previously been described to provide a benefit to the immune system of a companion animal. Fermentable fiber or other compositions known to those of skill in the art which provide a prebiotic composition to enhance the growth of probiotic microorganisms within the intestine may also be incorporated into the composition to aid in the enhancement of the benefit provided by the present invention to the digestive system of an animal. The compositions can be formulated for any animal, including zoo animals, farm animals such as horses, cows, pigs, sheep, donkeys, goats, and the like, and companion animals such as dogs and cats. The compositions can be specially formulated for adult animals, or for older or young animals, for example, a "puppy diet," "kitten diet," or "senior" formulation. The compositions can be specially formulated for animals with particular health or metabolic issues, for example, for overweight animals, animals with sensitive digestive tracts, and the like. In general, specialized formulations will comprise energy and nutritional requirements appropriate for animals at different stages of development or age. Those of skill in the art will understand that to achieve a desired serum profile, the make-up of the food composition will depend on a number of variables, including the species, breed, size, height, weight, age, overall health of the animal, the manner of digestion of the animal {e.g , ruminal), the pH of the different subsections of the digestive system (e.g., stomach, intestine), the type of formulation, and the mode or manner or administration, among others. In general, the inventive food compositions, including pet food compositions and food products formulated for human consumption, can be refrigerated or frozen for extended storage. The oil-containing particles may be pre-blended with the other components of the composition to provide the beneficial amounts needed, may be coated onto a food composition, for example, by a suitable spray-coating technique, or may be added to the composition prior to consumption, for example, using a sprinkled powder or a mix.
The food compositions of the invention can comprise oil in any amount suitable for the purpose to which the composition is made. For example, the amount of oil preferably ranges from about 0.1% to about 50% of the dry weight of the composition. In some aspects, the amount of oil preferably ranges from about 1% to about 30%, from about 10% to about 20%, from about 15% to about 40%, from about 15% to about 30%, from about 30% to about 50%, from about 10% to about 30%, and from about 15% to about 20% of the dry matter weight of the composition, although greater or lesser percentages can be supplied. In various aspects, the amount of oil is about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, or more of the composition on a dry matter basis. For hydrophilic compositions, a preferred concentration of oil is about 10%, and a more preferred concentration is about 15%. For encapsulated oils formed by reaction with a salt solution, a preferred concentration of oil is about 30%, and a more preferred concentration is about 50%.
The food compositions can comprise lipid soluble vitamins such as vitamins A, D, E, or K in any suitable amount, measured as a percentage of the dry matter weight of the composition. Preferably, the amount of vitamin ranges from about 0.1% to about 30% of the dry weight of the composition, although greater or lesser percentages can be supplied. In some aspects, the amount of vitamin ranges from about 1% to about 25%, from about 10% to about 20%, from about 0.3% to about 1%, from about 0.2% to about 1%, from about 0.5% to about 1%, from about 1% to about 5%, from about 1% to about 10%, from about 3% to about 15% of the dry weight of the composition. In various aspects, the amount of vitamin is about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, or more of the composition on a dry matter basis. In some highly preferred aspects, the amount of vitamin is at or near the recommended daily allowance for the vitamin. Dietary supplements may be formulated to contain several-fold higher concentrations of oil, water soluble nutrients, and/or vitamins to be amenable for ingestion or administration by diluting a concentrated form before administration, such as by dilution in a suitable liquid, mixing in with a food component, and other similar modes of administration. Thus, for example, a particle-containing food composition can be mixed with the same type or a different type of food composition that lacks the particles (or has a lower concentration of particles) so as to lower the concentration of oil, water soluble nutrients, and/or vitamins that are ingested by the animal or human being.
The food compositions can be further processed after the food product is mixed with the particles. Thus, for example, the food compositions can be baked, roasted, fried, flash frozen, and the like. In addition, the food composition can be extruded into one or more predetermined forms or shapes. It is highly preferable that the particle gradually releases the encapsulated oils or water soluble nutrients over a period of time. Thus, for example, the particles can be considered extended release particles for materials contained within the particle. The period of time can range from about one minute to about twenty four hours, although greater or lesser periods of time can be employed.
The particle provides a sustained release of oil or water soluble nutrients. This release can be measured by a known example for determining in vitro release. Herein, the values for in vitro release are determined using an agitated aqueous medium, such as stirring at 50 rpm in a 0.5M SDS solution over the desired period of time, for example, 12 hours. The pH of the solution preferably will range from about 6.8 to about 7.2, with vigorous stirring. The release profile can be measured using this test, and the particles of the invention achieve a release profile such that at least 50% of the oil or water soluble nutrient is released over a period of time, preferably at some time between about 0.5 to 24 hours, more preferably from about 1 to 18 hours, and even more preferably from about 2 hours to about 12 hours, and still more preferably from about 3 hours to about 8 hours.
As will be appreciated by those of skill in the art, the compositions can be formulated for an appropriate release duration, depending on the intended use of the food product. Typically, the duration of release will be longer when the particle is mixed within a food composition because the food component will not hydrate immediately. Thus, any given in vitro dissolution time (e.g., 12 hours) will correspond to an increased time of the same extent of dissolution when the particle is incorporated in a food component (e.g., 24 hours). As will be appreciated by one of ordinary skill in the art, the food component can therefore be selected to achieve the desired serum profile based on a number of factors, such as those listed above. In addition, the duration of release will depend on a number of factors such as the relative rate of digestion of the animal to which the composition is administered. In some aspects, about 50% of the oil or water soluble nutrient will be released from a food composition will proceed gradually over a period of up to about 30 hours, including a period of about 24 hours.
The rate of release can be measured or established by any means suitable in the art, including those described and exemplified herein. The rate of release can be based on in vitro or in vivo release profiles. In addition, the rate of release can be based on the release profile of the particle itself, or of a food composition comprising the particle. Preferably, over whatever period of time the particles are formulated for, the particles release at least about 30% of the oil or water soluble nutrients encapsulated within or adsorbed to the particle. More preferably, at least about 40% is released, more preferably, at least about 50% is released, more preferably, at least about 55% is released, preferably, at least about 60% is released, preferably, at least about 65% is released, preferably, at least about 70% is released, preferably, at least about 75% is released, preferably, at least about 80% is released, preferably, at least about 85% is released, preferably, at least about 90% is released, preferably, at least about 95% is released, and most preferably, 100% is released.
It is believed that he rancidity of the oils and/or oil-soluble nutrients comprised in the particles described or exemplified herein which are comprised in food will be equivalent to or less than the rancidity observed for oils and/or oil-soluble nutrients comprised in food that does not comprise such particles, when stored under the same conditions.
The following examples are provided to describe the invention in greater detail. The examples are intended illustrate, not to limit, the invention.
EXAMPLE 1
Preparation of a Carraqeenan Gum-Encapsulated Oil Experiments were undertaken to formulate a dog food kibble with up to 20% oil content into a controlled released matrix with similar hardness and friability characteristics as the original kibble. These experiments evaluated the feasibility of extending the release of fish oil and vitamin E from the kibble, reducing the need for an antioxidant to inhibit oxidation of the fish oil in the formula, and manufacturing kibbles without heat to avoid degradation of vitamin E. The intent was to closely match the physical characteristics of the original kibble shown in Table 1. Table 1. Physical characteristics of the un-modified dog food kibble.
Figure imgf000014_0001
Carrageenan gum. According to the FMC Reference Manual, iota and kappa carrageenans can be used for the entrapment and encapsulation of oils. Encapsulation is accomplished by combining oil with an emulsifying agent and adding this combination into a carrageenan solution to encapsulate the oil droplets with carrageenan gum. The carrageenan-encapsulated oil is then dropped into a potassium chloride solution to induce the carrageenan to gel around the oil droplet. The carrageenan on the surface of the granule will slowly hydrate and create a thin gel layer around the remaining dry granule. The gel layer restricts water mobility and slows penetration into the granule matrix. Method. A 1.5% solution of carrageenan gum was prepared by mixing 6.0 grams of carrageenan into 400 mis of water and stirring until the gum was completely solubihzed. Next, a 1 : 1 solution of 0.05M sodium dodecyl sulfate (SDS) and vegetable oil was prepared by combining 26 grams of oil and 26 grams of 0.05M SDS and stirring until emulsified. The emulsified oil and the 1.5% carageenan solution was combined in a 1.1 ratio and stirred completely. With a disposable pipet, droplets of the oiled carrageenan solution were dropped into a 2M KCI solution. As soon as the droplet hit the KCI soluation, the carrageenan gelled, forming an oil enclosed bead. These beads were collected and dried overnight. After the water had evaporated, the resulting bead was determined to consist of 96.75% oil, 2.87% carrageenan gum, and 1.38% SDS. The beads were firm to the touch. Upon hand-squeezing, the bead would burst and release the encapsulated oil.
A second solution was prepared so that the resulting bead had an oil concentration of 70.7%, a carrageenan gum concentration of 28.3% and an SDS concentration of 1.0%. A yellow oil soluble dye was added to the mix in order to monitor the take up and release of the oil. The process was automated using a peristaltic pump in order to produce very uniform droplets. After drying as above, the resulting beads had a dry "crunchy" feel to them, and upon hand-squeezing, the oil was not released. In addition, the oil did not wick out of the dried bead when placed on an absorbent paper towel.
The beads produced from the second solution were used to prepare a dog food pellet (CG-I) by combining a commercially prepared dog food granule, some extra- granular microcrystalline cellulose (MCC) and Natrasorb® (Multisorb Technologies, Buffalo, NY), which is a maltodextπn designed to absorb oil. Hardness was evaluated using the Knoop system for determining microhardness. The resulting tablet had an average hardness of about 9.5kp, as shown in Table 2. Table 2. Kibble Compilation CG-I .
Figure imgf000015_0001
A second dog food pellet (CG-2) was prepared using the beads produced from the second solution along with Hi-Cap 200® (National Starch)l. Hi-Cap 200® is a modified food starch, and can be used as an additional source of calories for the dog food kibble. The effective hardness of this formula was 9.7 kp, as shown in Table 3.
Table 3. Kibble Compilation CG-2.
Figure imgf000016_0001
Next, dog food kibbles were produced using non-granulated dog food powder. Table 4 summarizes the raw materials used in each formula and the hardness (kp) was obtained.
Table 4. Kibble Compilation CG-3 to CG-Il and hardness values.
Figure imgf000016_0002
Hi-Cap 200® compressed alone produces an extremely hard tablet. Hi-Cap 200® was mixed with the dry dog food powder in a 50:50 ratio (CG-3). The resulting hardness was very low at 2.6kp. MCC was added to this mixture to see if hardness could be increased. A 1 : 1: 1 ratio of dog food, Hi Cap 200 and MCC produced an acceptable hardness of 10.8 (CG-5). The carrageenan-oil granules then were added in to see how the hardness was affected. The hardness was reduced to 3.8kp (CG-6). Varying levels of the dog food, MCC and Hi-Cap 200® were combined with the oiled carrageenan beads, blended, compressed and tested for hardness. It was found that as the percentage of dog food in the formula was increased, the hardness was decreased. The hardness of the formula could be increased by increasing the level of MCC
Results. The following observations were made based on the experiments described in this Example. A dry carrageenan gum granule can be produced containing up to 70% oil . Oil is fully encapsulated by the carrageenan gum and does not leech out over time. Kibbles with adequate hardness can be produced using the oil encapsulated carrageenan gum granules. Production of these carrageenan gum and oil granules can be automated and scaled up to produce a large scale batch. Hi-Cap 200® acts as a moderate oil absorber and aides in increasing the hardness of the tablet with the added benefit of providing an additional source of calories to the kibble.
EXAMPLE 2 Evaluation of Carrageenan Gum-Encapsulated Pet Food Kibbles
Method. A carrageenan gum was prepared as follows: A 1.0% solution of carrageenan gum was dispersed and allowed to fully hydrate in water. Meanwhile, a 50: 50 mixture of oil and 0.05M SDS was emulsified. Once emulsified, the oil blend was then added to the 1.0% carrageenan solution in the ratio of 8 grams of emulsified liquid to 15 grams of carrageenan solution and stirred until uniform. Next, drops of the oiled carrageenan gum solution were added to a IM KCI solution. The salt caused the carrageenan gum to gel up into beads, and in doing so entrapped the oil. These carrageenan beads were collected and allowed to air dry overnight. The resulting carrageenan granule was determined to have an oil concentration of ~72%, a carrageenan gum concentration of ~27%, and an SDS concentration of ~1.0% (Table 5).
Table 5. Carrageenan Granule Make-up, carrageenan beads
Raw Material grams w/w% carrageenan gum 30 27 03%
Fish oil/vit E blend 80 72 07% sds 1 0 0 90%
Total 111 0 100 00%
The granules had a dry "crunchy" feel to them, and upon hand-squeezing, did not release the contained oil. In addition, the oil did not wick out of the dried bead when placed on an absorbent paper towel. Although not earned out in the course of the experiments described in this Example, an oil soluble dye can be added to monitor the release of the oil from the granule, or a brown dye can be added to camouflage the granule within the dog food. These granules can either be mixed with a dog food granule and compressed into a kibble, or the carrageenan-encapsulated oil granules can be added to the dog food and extruded in the current dog food manufacturing procedure.
The dog food was granulated with a modified food starch derived from waxy maize (Table 6). It is suited for high oil loading and it is characterized by excellent resistance to oxidation. Granulating the dog food with the modified food starch improved the flow and compressibility of the dog food powder. Table 6. Dog food-starch formulation.
Raw Material gram w/w%
S
Modified Food Starch 25 25 00% dog food 75 75 00% water qs qs
Total 100 100 00%
The dog food granulation and the oiled carrageenan granules were blended together with 2% silicon dioxide to absorb any potential oil loss during compression, along with 9% MCC and 9% modified food starch to improve hardness (Table 7). Table 7. Carrageenan Granule Kibble Formula. oarrageenan t sranuie ι-ormuιa grams w/w%
15 grams fish oil/vit E in car gum 10 8 21 60% carrageenan beads carrageenan gum 4 05 8 10%
SDS 0 15 0 30%
25 grams dog food dog food 18 75 37 50% granulation #4 Modified Food Starch 6 25 12 50%
MCC PH 200 4 5 9 00%
Modified Food Starch 4 5 9 00%
SιO2 1 2 00%
Total 50 100 00%
Characteristics of the carrageenan granule kibble were compared with the characteristics of the original dog food kibble, and the results are presented in Table 8. The thickness of the carrageenan granule kibble to the original kibble was comparable, as was the hardness and the friability. However, the carrageenan granule kibble was heavier than the original kibble due to the kibble being compressed into a tablet form. The overall food content of the two kibbles was equivalent with 59% of the carrageenan granule kibble contributing to caloric intake for a total of 0.5990 grams of food content in the carrageenan granule kibble to the 0.5640 grams in the original kibble. The carrageenan granule kibbles contained the required 20% fish oil and 1.5% vitamin E, and the oils were released at a controlled rate. The remaining 20% of the formula was filler necessary to compress the carrageenan granule kibble into a tablet form, thereby protecting the oils from heat degradation.
Table 8. Characteristics of the original kibble compared with the carrageenan granule kibble.
Figure imgf000019_0001
EXAMPLE 3 HPMC Granulation with Xanthan Gum and Dog Food Formula
An oil can be encapsulated by producing a hard porous polymer granule in which oil can migrate via a spray-coating technique. The oiled polymer can then be compressed with a dog food granule into a kibble. As the kibble is digested the polymer will swell and begin to slowly hydrate thereby releasing the oil at a controlled rate
Method. Hydroxypropylmethylcellulose (HPMC) and MCC were mixed in a 50:50 ratio and wet granulated in a V-blender using an mtensifier bar. Next, a combination of powdered dog food, xanthan gum and MCC was mixed in a 400:75: 75 ratio and wet granulated in a V-blender using an mtensifier bar. Both granulations were allowed to air dry over night.
Once the HPMC/MCC granulate was dried, a measured amount was placed in a pan coater. While the pan was turning, oil was slowly sprayed onto the granules. The oil to granulate ratio was 1 : 2. When most of the oil was taken up by the HPMC/MCC granules, a measured amount of dog food/xanthan gum/MCC granulation was added to the pan coater to help absorb any remaining oil. In the final blend step, silicon dioxide and MCC were added and mixed in a V-blender for 10 minutes. This blend was then compressed into kibble tablets (Table 9). Table 9. Double Granulation Kibble Formula.
Double Granulation Super Kibble Formula grams w/w%
75 grams HPMC fish oil from HPMC Gran 25 15 5% Granulation HPMC 25 15 5%
MCC 25 15 5%
75 grams dog food dog food 54 24 33 5% granulation #1 Xanthan Gum 10 23 6 3%
MCC 10 23 6 3%
MCC 7 5 4 6%
SιO2 4 5 2 8%
Total 161 7 100 0%
Characteristics of the double granulation kibble were compared with the characteristics of the original dog food kibble, and the results are presented in Tables 10 and 11. The double granulation kibble was again slightly higher in weight than the original kibble due to the kibble being compressed into a tablet form. The thickness and hardness of the double granulation kibble was slightly less than the original kibble, but still adequate for a tablet form. The friability was equivalent between the two kibbles. The oil content was slightly less than optimal at 15.5%. The dog food content was 33.5% of the formula. At the higher weight, this equates to 0.2756 grams of dog food, which is nearly 50% of the original kibble. The remaining 45% of the formula was filler necessary to compress the kibble into a tablet form. This granulation method was found to both protect the oils from degradation due to heat, and to release the oil in an extended release manner It is believed that it should also protect the oil from oxidation, reducing the need for expensive antioxidants.
Table 10. Characteristics of the original kibble compared with the double granulation kibble.
Figure imgf000020_0001
Table 11. Additional characteristics of the original kibble compared with the double granulation kibble.
Figure imgf000020_0002
Figure imgf000021_0001
The carrageenan gum formula of Example 2 more closely matched the physical characteristics of the original kibble than the double granulation formula, however both kibble formulas produce acceptable tablets. The carrageenan gum formula also had a higher food content per kibble than the granulation formula so that total food consumption should be the same.
EXAMPLE 4
Preparation of a Palatable Controlled Release Pet Food Kibble Several prototype dog food formulations were developed to contain controlled release capsules as described in the foregoing examples. It was determined that the compressed dog food prepared with spray coated oil had an unappealing taste and texture when compared to the traditional kibble in a dog food taste trial. The excipients necessary to produce the compressed tablet were unflavored and the texture of the tablet was different than the traditional baked kibble. In addition, because the prototype formulations contained about ten times more fish oil than the original recipe, dogs did not prefer to eat the resultant kibble.
Coated Corn Starch Granulation Approach. In the previous formulation, oil was encapsulated by producing a hard porous polymer and MCC granule in which oil was applied via a spray coating technique. In order to improve palatabihty, MCC was replaced with corn starch within the granulation matrix and the resulting granule was covered with a polymer coating. The polymer coating significantly improved oil retention of the cornstarch and HPMC granule. Without the protection of a coating, oil freely migrated from the granules. At a 4% polymer coating, oil loss was nearly eliminated. Method. Corn starch and HPMC K4M was mixed in a 50: 50 ratio and wet- granulated in a V-blender using an intensifier bar. The granulation was allowed to air dry over night after passing through a size 8 mesh sieve. Once the HPMC/corn starch granulate was dried, a measured amount was placed in a pan coater. While the pan was turning, oil was slowly sprayed onto the granules. The oil to granulate ratio was 1 :3 Finally, the granules were coated with an HPMC IOOLV solution using a wurster coating technique in a fluidized air bed. The make-up of the granules is described in Table 12.
Table 12. Coated Cornstarch Granulation Formulation .
Steps Method Raw Material Grams (g) w/w%
Step 1 Granulate in V-Blender w/ HPMC 375 35 2% lntensifier Bar Cornstarch 375 35 2% water qs Trace
Step 2 Spray in Pan Coater Vegetable Oil 250 23 5%
Step 3 Coat granules in Fluid Bed HPMC 100LV 64 6 0%
Total 1064 100 00%
Previously, the oiled granules were compressed with a dog food granule using common pharmaceutical excipients. However, resultant kibble was found to be unappetizing in a dog food taste trial. In the next taste trial, coated oiled granules will be mixed with a commercial dog food formulation and manufactured into kibbles. The coated oiled corn starch granules will be processed to form a traditional "baked" kibble, which is believed will improve texture and provide a more pleasant mouth feel .
EXAMPLE 5
Spray Dried Granulation Approach
Spray drying is a commonly used method of drying a liquid feed through a hot gas Typically, this hot gas is air but nitrogen gas can be used for sensitive materials which require oxygen-free drying, such as fish oil . This spray drying technique is often used to encapsulate substances within an amphipathic carrier via a homogenized suspension in water. The slurry formed is then fed into a spray drier, usually a tower heated to temperatures well over the boiling point of water. As the slurry enters the tower, it is atomized. Because of the high surface tension of water and the hydrophobic/hydrophilic interactions, the atomized slurry forms micelles. The small size of the drops (averaging 100 micrometers in diameter) results in a relatively large surface area which dries quickly. As the water dries, the carrier forms a hardened shell around the load. Method. A modified food starch, lecithin, and xanthan gum were solubihzed in water (Table 13) . Oil was added to make a slurry at a 1 : 1 ratio with the solid additions to achieve a 50% concentration upon spray drying. This slurry was spray dried using a fluid bed apparatus. Table 13. Spray Dried Granulation Formulation .
Method Raw Material Grams (g) w/w%
Solubihze in 100OmIs H2O Hi Cap 100 500 47 6% Lecithin 20 1 9%
Xaπthan Gum 5 0 5
Emulsify oil Vegetable Oil 525 50 0%
Total 1050 100 00%
Prior to large scale production of the above spray dried controlled release fish oil and vitamin E formulation, a commercially supplied spray dried material was purchased in order to evaluate the feasibility of adding the encapsulated oils into the dog food wet mass and extruding, using current manufacturing equipment and procedures of a commercial pet food supplier.
EXAMPLE 6
Encapsulation to Control Oil Release and Improve Shelf Life Stability Methods. Spray drying, carrageenan micro-beads, sodium alginate micro-beads, and simple granulations were investigated as mechanisms for oil entrapment. Encapsulation efficiency, oil retention over time and scale up feasibility were evaluated for each method. Controlled-release was visually assessed in dissolution.
Simple Granulation Technique. The oil was encapsulated by producing a hard porous polymer granule via the wet granulation of HPMC and cornstarch. Oil was then applied to the granule in a 1 : 2 ratio using a spray coating technique. Following the uptake of oil, the granules were coated with an HPMC solution to prevent oil loss.
Spray Dried Technique. A modified food starch, lecithin, and xanthan gum were solubilized in water. Oil was added to make a slurry at a 1 : 1 ratio with the solid additions to achieve a 50% concentration upon spray drying. The slurry was spray dried using a fluid bed apparatus. Microbead Technique. Encapsulation was accomplished by combining oil with an emulsifying agent and adding this into either a carageenan solution or a sodium alginate solution to encapsulate the oil droplets with the polymer The polymer- encapsulated oil was then dropped into either a potassium chloride solution to induce the carrageenan polymer to gel around the oil droplet or a calcium chloride solution to induce the sodium alginate to encapsulate the oil.
Results. The simple granulation technique was the most cost-effective and easiest for scale up manufacturability. However, it was the least efficient for entrapping oil . Maximum oil absorbed was on the order of 25%. Oil retention was adequate when a protective coating was applied. The granulation technique was very effective in controlling the release of oil in dissolution over time. The sodium alginate and carrageenan beads were very efficient for trapping oil . Micro-beads could be manufactured with up to 95% oil content. However, the ruggedness of the micro-beads decreased as oil content increased. Coating the beads helped retain their integrity, however, and oil retention was reduced. Special equipment is necessary for the production of micro-beads making this method the least cost-effective of the methods investigated .
The technique of spray drying an oil emulsion had an oil absorption capacity of approximately 50%. The spray dried material was too dense to be coated in a fluid bed However, oil retention of the material was sufficient without the need for coating oil was not observed to migrate out onto oil absorbent paper over time. The addition of a polymer to the oil emulsion prior to spray drying provided controlled-release to the oil. With the proper equipment, spray drying is a relatively inexpensive method and is feasible for scale up. Controlled Release Observations. In vitro dissolution was performed in 500 mis of 0 5M SDS. In most cases, a fluorescent dye was added to the oil and the vessels were lit from behind with a black light to aid in the observation of oil release. However, so as not to contaminate the lines of the fluid bed with fluorescent dye, the spray dried material was made with a red chili oil to aid in oil release observations. . The hydrophylic polymers of the simple granulation formula were completely hydrated after 12 hours as was the polymers in the spray dried formula, resulting in complete release of oil within 12 hours. The sodium alginate beads had swelled and released approximately 50% of the oil after 12 hours, while the carrageenan beads retained most of the oil in the 12 hours of dissolution testing. The simple granulation and the spray dried techniques are both cost effective methods for encapsulating oil . However, the spray dried technique is more efficient with the ability to entrap 50% oil compared to the simple granulation technique with 25% oil entrapment. While oil is retained in the spray dried material as is, the simple granulation material requires a 4% coating to retain oil over time and improve shelf life stability. The production of carrageenan beads and sodium alginate beads is more involved and requires special equipment making it a less cost effective technique. However, the microbeads are very effective in retaining oil over time without the need of coating, and they perform very well in dissolution with over 12 hours of sustained- release. EXAMPLE 7
Hydrophilic Particles Comprising Water Soluble Nutrients This is a prophetic example. To produce particles comprising, in addition to or in the absence of oils, the procedures described and exemplified herein can generally be followed, with slight modifications to accommodate the presence of water soluble nutrients.
For example, in one method, the active agents can be dissolved in an aqueous media such as water with the capsule forming materials. This solution can then be used to create a slurry using an inert oil, and then particles can be formed in the same manners as above. One consideration would be to not focus on high oil content, but rather to balance the concentration of the soluble active with the capsule forming agent and include just enough oil to create uniform spheres. Inert oil could be any conventional, approved edible oil. Another approach would be to first create a oihwater emulsion of the active agent in an aqueous media, which can then be combined with the capsule forming agent in a second emulsion step followed by encapsulation.
Additional approaches for particle formation include solubilizing the active agent in a suitable aqueous solvent and spraying this solution onto the pre-formed particles to allow the solution to be absorbed into the particle in a manner similar to the manners described herein. Another approach would be to incorporate the active agent into the particle with subsequent functional coating as needed.
Spray-drying techniques are also amenable to water soluble agents. Similar to the techniques described for oil, a slurry or solution containing the agents would be produced and then spray congealed (spray dried) to produce coated particles. In this case, however, an oihwater emulsion would not need to be created because it is anticipated that it would most likely be all aqueous. High solids content can be achieved by combining the active along with the capsule forming agents.
These particles can be mixed with a food component such as a pet food or food product formulated for human consumption.

Claims

What is Claimed :
1. A particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within or adsorbed to the capsule forming agent, wherein the particle, when contacted with an aqueous solvent, gradually releases at least 50% of the oil or water soluble nutrient over a 2-12 hour period .
2. The particle of claim 1, wherein the oil is a fish oil .
3. The particle of claim 1, wherein the oil is an omega-3 fatty acid, omega-6 fatty acid, or combinations thereof.
4. The particle of claim 1, further comprising one or more lipid soluble vitamins.
5. The particle of claim 1, wherein the capsule forming agent comprises a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix.
6. The particle of claim 5, wherein the hydrophilic matrix comprises hydroxypropylmethyl cellulose (HPMC), microcrystalline cellulose (MCC), guar gum, xanthan gum, or combinations thereof.
7. The particle of claim 6, wherein the hydrophilic matrix further comprises corn starch .
8. The particle of claim 1, wherein the capsule forming agent is carrageenan gum or sodium alginate.
9. The particle of claim 1, wherein the capsule forming agent comprises at least one modified food starch .
10. A method for producing an oil-containing particle, comprising mixing at least one oil with an emulsifying agent to form an oil emulsion, mixing the oil emulsion with a capsule forming agent to form a slurry, and adding the slurry to a salt solution to form a particle.
11. The method of clai m 10, wherein the capsule forming agent comprises carrageenan gum or sodium alginate.
12. The method of claim 10, wherein the salt solution is a potassium chloride, potassium carbonate, calcium chloride, or magnesium chloride solution .
13. The method of claim 10, wherein the emulsifying agent is a surfactant.
14. A method for producing an oil-containing particle, comprising contacting a first polymer with at least one oil for a period of time sufficient for the oil to become encapsulated within the polymer, thereby forming a particle; and, optionally coating the particle with a second polymer.
15. The method of claim 14, wherein the first polymer comprises HPMC or MCC.
16. The method of claim 14, wherein the second polymer comprises HPMC or MCC.
17 The method of claim 14, further comprising mixing a food starch with the first polymer.
18. A method for producing an oil-containing particle, comprising mixing a modified food starch, emulsifying agent, and polysaccharide in an aqueous solvent to form a suspension, mixing at least one oil with the suspension to form a slurry, and spray drying the slurry to form particles.
19. The method of claim 18, wherein the emulsifying agent is lecithin.
20. The method of claim 18, wherein the polysaccharide is xanthan gum.
21. A food composition comprising a food component and a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil encapsulated within the capsule forming agent, wherein the concentration of oil in the food composition is from about 0.2% to about 20% by weight of the food composition, and wherein the particle, when contacted with an aqueous solvent, gradually releases at least 50% of the oil over a 2-12 hour period.
22 The composition of claim 21, wherein the food component is pet food.
23. The composition of claim 21, wherein the food component is a food product formulated for human consumption.
24. The composition of claim 21, wherein the encapsulated oil is a fish oil.
25. The composition of claim 21, wherein the oil is an omega-3 fatty acid, an omega-6 fatty acid, or combinations thereof.
26. The composition of claim 21, wherein the particle further comprises one or more lipid soluble vitamins.
27. The composition of claim 26, wherein the lipid soluble vitamin is vitamin A, vitamin D, vitamin E, or vitamin K.
28. The composition of claim 21, wherein the capsule forming agent is carrageenan gum or sodium alginate.
29 The composition of claim 21, wherein the capsule forming agent comprises a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix.
30. The composition of claim 29, wherein the hydrophilic matrix comprises hydroxypropylmethyl cellulose (HPMC), microcrystalline cellulose (MCC), guar gum, xanthan gum, or combinations thereof.
31. The composition of claim 30, wherein the hydrophilic matrix further comprises corn starch.
32. The composition of claim 21, wherein the particle is mixed into the food component.
33. The composition of claim 21, wherein the particle is spray-dried on the surface of the food component.
34. The composition of claim 21, wherein the oil is gradually released from the particle during digestion by an ani mal .
35. The composition of claim 21, wherein the oil comprises from about 10% to about 30% of the dry matter weight of the composition .
36. The composition of claim 21, wherein the oil comprises about 20% of the dry matter weight of the composition .
37. The composition of claim 21, wherein the oil comprises about 25% of the dry matter weight of the composition .
38. A method for manufacturing a food composition, comprising mixing a food component with the particle of clai m 1.
39. The method of claim 38, wherein the food component is pet food.
40. The method of claim 38, wherein the food component is a food product formulated for human consumption .
41 The method of claim 38, further comprising extruding the food composition into at least one predetermined shape.
42. The method of claim 38, further comprising baking or frying the food composition .
43. The method of claim 38, wherein the particle further comprises one or more lipid soluble vitamins.
44. The method of claim 43, wherein the lipid soluble vitamin is vitamin A, vitamin D, vitamin E, or vitamin K.
45. A method for manufacturing a food composition, comprising applying the particle of claim 1 to the surface of a food component.
46. The method of claim 45, wherein the food component is pet food.
47. The method of claim 45, wherein the food component is a food product formulated for human consumption .
48. The method of claim 45, further comprising baking or frying the food composition.
49. The method of claim 45, wherein the applying comprises spray-drying .
50. The method of claim 45, wherein the particle further comprises one or more lipid soluble vitamins.
51. The method of claim 50, wherein the lipid soluble vitamin is vitamin A, vitamin D, vitamin E, or vitamin K.
52. A food composition comprising a food component and a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one water soluble nutrient encapsulated within the capsule forming agent, wherein the concentration of water soluble nutrient in the food composition is from about 0.2% to about 20% by weight of the food composition, and wherein the particle, when contacted with an aqueous solvent, gradually releases at least 50% of the nutrient over a 2-12 hour period.
53. The composition of claim 52, wherein the food component is pet food.
54. The composition of claim 52, wherein the food component is a food product formulated for human consumption.
55. The composition of claim 52, wherein the capsule forming agent comprises a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix.
56. The composition of claim 55, wherein the hydrophilic matrix comprises hydroxypropylmethyl cellulose (HPMC), microcrystalline cellulose (MCC), guar gum, xanthan gum, or combinations thereof.
57. The composition of claim 56, wherein the hydrophilic matrix further comprises corn starch.
58. The composition of claim 52, wherein the capsule forming agent is carrageenan gum or sodium alginate.
59. The composition of claim 52, wherein the capsule forming agent comprises at least one modified food starch.
60. The composition of claim 52, wherein the water soluble nutrient is a vitamin.
61. The method of claim 14, wherein the first polymer comprises a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix.
62. The method of claim 14, wherein the second polymer comprises a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix.
63. The method of claim 14, wherein the first polymer and second polymer are the same.
64. The composition of claim 21, wherein the capsule forming agent comprises at least one modified food starch.
65. A method for producing a water soluble nutrient-containing particle, comprising mixing at least one water soluble nutrient with an emulsifying agent to form an aqueous emulsion, mixing the aqueous emulsion with a capsule forming agent to form a slurry, and adding the slurry to a salt solution to form a particle.
66. The method of claim 65, wherein the capsule forming agent comprises carrageenan gum or sodium alginate.
67. The method of claim 65, wherein the salt solution is a potassium chloride, potassium carbonate, calcium chloride, or magnesium chloride solution.
68. The method of claim 65, wherein the emulsifying agent is a surfactant.
69. A method for producing a water soluble nutrient-containing particle, comprising contacting a first polymer with at least one water soluble nutrient for a period of time of time sufficient for the water soluble nutrient to become encapsulated within the polymer, thereby forming a particle; and, optionally coating the particle with a second polymer.
70. The method of claim 69, wherein the first polymer comprises a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix.
71. The method of claim 69, wherein the second polymer comprises a hydrophilic matrix, hydrophobic matrix, or a mixture of a hydrophilic and hydrophobic matrix.
72. The method of claim 69, wherein the first polymer and second polymer are the same.
73 The method of claim 69, wherein the first polymer comprises HPMC or MCC.
74. The method of claim 69, wherein the second polymer comprises HPMC or MCC.
75. The method of claim 69, further comprising mixing a food starch with the first polymer.
76. A method for producing a water soluble nutrient-containing particle, comprising mixing a modified food starch, emulsifying agent, and polysaccharide in an aqueous solvent to form a suspension, mixing at least one water soluble nutrient with the suspension to form a slurry, and spray drying the slurry to form particles.
77. The method of claim 18, wherein the emulsifying agent is lecithin .
78. The method of claim 18, wherein the polysaccharide is xanthan gum.
79. A method for manufacturing a food composition, comprising mixing a food component with the particle of claim 52.
80 The method of claim 79, wherein the food component is pet food .
81. The method of claim 79, wherein the food component is a food product formulated for human consumption.
82. The method of claim 79, further comprising extruding the food composition into at least one predetermined shape.
83. The method of clai m 79, further comprising baking or frying the food composition .
84. The method of claim 79, wherein the particle further comprises one or more lipid soluble vitamins.
85. The method of clai m 84, wherein the lipid soluble vitamin is vitamin A, vitamin D, vitamin E, or vitamin K.
86. A method for manufacturing a food composition, comprising applying the particle of claim 52 to the surface of a food component.
87. The method of claim 86, wherein the food component is pet food.
88. The method of claim 86, wherein the food component is a food product 5 formulated for human consumption.
89. The method of claim 86, further comprising baking or frying the food composition .
90. The method of claim 86, wherein the applying comprises spray-drying .
91. The method of claim 86, wherein the particle further comprises one or more lipido soluble vitamins.
92. The method of claim 91, wherein the lipid soluble vitamin is vitamin A, vitamin D, vitamin E, or vitamin K.
93. A mixture comprising a first food component comprising a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from abouts 2% to about 75% (w/w) of at least one oil encapsulated within the capsule forming agent, wherein the concentration of oil is from about 0.2% to about 20% by weight of the first food component, and a second food component lacking the oil or having a concentration of the oil less than the concentration of oil in the first food component. o
94. A mixture comprising a first food component comprising a particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one water soluble nutrient encapsulated within the capsule forming agent, wherein the concentration of water soluble nutrient is from about 0.2% to about 20% by weight of the first food 5 component, and a second food component lacking the water soluble nutrient or having a concentration of the water soluble nutrient less than the concentration of water soluble nutrient in the first food component.
95. A particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water0 soluble nutrient encapsulated within or adsorbed to the capsule forming agent, wherein the particle, when contacted with an aqueous solvent, gradually releases at least 50% of the oil or water soluble nutrient over a period of time.
96. A particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water5 soluble nutrient encapsulated within or adsorbed to the capsule forming agent, wherein the particle, when contacted with an aqueous solvent, gradually releases at least 50% of the oil or water soluble nutrient over a 0.5-24 hour period. A particle comprising from about 10% to about 80% (w/w) of a capsule forming agent and from about 2% to about 75% (w/w) of at least one oil or water soluble nutrient encapsulated within or adsorbed to the capsule forming agent, wherein the particle, when contacted with an aqueous solvent, gradually releases at least 50% of the oil or water soluble nutrient over a 1-18 hour period.
PCT/US2009/064337 2008-11-14 2009-11-13 Controlled release food formulations WO2010056957A1 (en)

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