Heat-treated extended-release formulations

Abstract

The present disclosure provides heat-treated extended-release formulations comprising one or more food components and one or more release modulators. The present example also provides methods of manufacturing heat-treated extended-release formulations.

Description

[0001] HEAT-TREATED EXTENDED-RELEASE FORMULATIONS

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] [1] This application claims priority to U.S. Provisional Patent Application No. 63 / 572,899, filed April 1, 2024; the title of which is “Heat-Treated Protein Preparations” and the content of which is incorporated herein by reference in its entirety.

[0004] BACKGROUND

[0005] [2] The health benefits of formulated foods, formulated beverages, formulated supplements, and their nutritional constituents to mammals such as humans have been studied for several decades. However, in many cases, the challenges associated with controlled delivery, absorption, nutrient absorption, and energy acquisition from formulated meals, foods, beverages, supplements, and / or their food components (e.g., nutritional constituents) remain unsolved. As such, formulated meals, foods, beverages, supplements, and / or their food components (e.g., nutritional constituents) have yet to realize their full potential.

[0006] SUMMARY

[0007] [3] The present disclosure relates to novel compositions, preparations, and methods for providing a controlled, extended, and / or delayed release of one or more payloads (e.g., one or more food components) to a subject (e.g., a human or animal) ingesting said compositions or preparations.

[0008] [4] In some embodiments, the present disclosure provides a preparation comprising an extended-release composition comprising: a protein payload; and a release modulator. In some embodiments, a release modulator interacts with a protein payload to prevent access of water molecules and / or one or more enzymes to the protein payload in the preparation. In some embodiments, a protein payload is released in a subject over an extended period following ingestion of the preparation by a subject as compared to ingestion of the protein payload alone.

[0009] [5] In some embodiments, a protein payload is heat-treated. In some embodiments, a protein payload is heat-treated at about 72 °C to about 112 °C for about 60 minutes to about 120 minutes; at about 77 °C to about 107 °C for about 75 minutes to about 105 minutes; or about 92 °C for about 90 minutes. In some embodiments, a protein payload is heat-treated at a pH of about 4 to about 8; about 4.5 to about 7.5; or about 5 to about 7. [6] In some embodiments, an extended-release composition of the present disclosure comprises 60% (w / w) to 85% (w / w) of a protein payload. In some embodiments, a protein payload comprises whey protein isolate, whey protein concentrate, pea protein isolate, pea protein concentrate, oat protein isolate, oat protein concentrate, soy protein isolate, soy protein concentrate, wheat protein isolate, wheat protein concentrate, egg protein isolate, egg protein concentrate, dairy protein, plant-based protein, casein, bovine serum albumin, ovalbumin, a- lactalbumin, P-lactoglobulin, collagen, glutanin, gliadin, kefirin, avenin, zein, silk, gelatin, hordein, sodium carboxymethylcellulose, or a combination thereof. In some embodiments, a protein payload comprises whey protein isolate, whey protein concentrate, casein, lactalbumin, P-lactoglobulin, or a combination thereof. In some embodiments, a protein payload comprises whey protein isolate, whey protein concentrate, pea protein isolate, oat protein isolate, soy protein isolate, wheat protein isolate, plant-based protein, or a combination thereof.

[0010] [7] In some embodiments, an extended-release composition of the present disclosure comprises 15% (w / w) to 40% (w / w) of the release modulator. In some embodiments, a release modulator comprises a hydrocolloid. In some embodiments, a hydrocolloid comprises pectin, alginate, carrageenan, or a combination thereof. In some embodiments, an extended-release composition comprises 10% (w / w) to 40% (w / w) of pectin. In some embodiments, an extended- release composition comprises 0.75% (w / w) to 1.25% (w / w) alginate.

[0011] [8] In some embodiments, a release modulator comprises a gelator. In some embodiments, a gelator comprises dicalcium phosphate, gluconolactone, calcium carbonate, or a combination thereof. In some embodiments, a release modulator comprises 7.5 parts or less of hydrocolloid by dry weight for every 1 part of gelator by dry weight.

[0012] [9] In some embodiments, a release modulator comprises a carbohydrate. In some embodiments, a carbohydrate comprises hypromellose acetate succinate, rice starch, corn starch, inulin, oat fiber, glucose, tapioca polydextrose, maltodextrin, chitosan, sucrose palmitate, or a combination thereof.

[0013]

[0010] In some embodiments, a release modulator comprises a surfactant. In some embodiments, a surfactant comprises Pluronic F68, Tween 85, triacetin, or Span 60.

[0014]

[0011] In some embodiments, a release modulator comprises shellac. In some embodiments, a release modulator comprises gum arabic.

[0012] In some embodiments, an extended-release composition of the present disclosure comprises: 75% (w / w) to 85% (w / w) protein payload; 10% (w / w) to 20% (w / w) hydrocolloid; and 2% (w / w) to 10% (w / w) gelator.

[0015]

[0013] In some embodiments, an extended-release composition of the present disclosure comprises: 75% (w / w) to 85% (w / w) heat-treated whey protein; 10% (w / w) to 20% (w / w) alginate; 0.5% (w / w) to 2% (w / w) gluconolactone; and 0.5% (w / w) to 2% (w / w) dicalcium phosphate.

[0016]

[0014] In some embodiments, an extended-release composition of the present disclosure comprises: 75% (w / w) to 85% (w / w) heat-treated whey protein; 10% (w / w) to 20% (w / w) pectin or carrageenan; 0.5% (w / w) to 1.5% (w / w) alginate; 0.5% (w / w) to 2% (w / w) gluconolactone; 0.5% (w / w) to 2% (w / w) dicalcium phosphate; and 1.5% (w / w) to 6% (w / w) chitosan.

[0017]

[0015] In some embodiments, a preparation of the present disclosure comprises one or more excipients. In some embodiments, a preparation comprises 0.01% (w / w) to 10% (w / w) of one or more excipients. In some embodiments, one or more excipients comprises an anti-caking aid. In some embodiments, an anti-caking aid comprises silica. In some embodiments, a preparation comprises 0.5% (w / w) to 5% (w / w) silica.

[0018]

[0016] In some embodiments, one or more excipients comprises a sequestrant. In some embodiments, a sequestrant comprises sodium hexametaphosphate. In some embodiments, a preparation comprises 1% (w / w) to 4% (w / w) of sodium hexametaphosphate. In some embodiments, one or more excipients comprises chitosan. In some embodiments, a preparation comprises 2.5% (w / w) to 7.5% (w / w) of chitosan.

[0019]

[0017] In some embodiments, one or more excipients comprises a stabilizer. In some embodiments, a stabilizer comprises xanthan gum. In some embodiments, a preparation comprises 0.01% (w / w) to 0.1% (w / w) of chitosan.

[0020]

[0018] In some embodiments, a preparation of the present disclosure further comprises one or more coatings. In some embodiments, one or more coatings encapsulate the extended- release composition. In some embodiments, one or more coatings comprise a hydrophobic coat. In some embodiments, a hydrophobic coat comprises ethyl cellulose, a basic methacrylic copolymer, aqueous latex, or methylcellulose acetate succinate. In some embodiments, a hydrophilic coat encapsulates a hydrophobic coat. In some embodiments, a hydrophilic coat comprises hydroxypropyl mcthylccllulosc or sodium alginate.

[0021]

[0019] In some embodiments, a preparation of the present disclosure comprises one or more probiotics. In some embodiments, a preparation of the present disclosure comprises 1 x 107to 1 x IO10CFUs of the one or more probiotics per gram of the preparation.

[0022]

[0020] In some embodiments, a preparation comprises one or more additional components including a protein, a polypeptide, a peptide, an amino acid, a carbohydrate, a sugar, a monosaccharide, a polysaccharide, a dietary fiber, a fat, a fatty acid, a lipid, a nutrient, a nutraceutical, a macronutrient, a micronutrient, a vitamin, a mineral, a polypeptide, a carotenoid, an element, a ketone body, a prebiotic (e.g., a prebiotic fiber), a flavonoid, an antioxidant, an electrolyte, a salt, a circadian rhythm modulator, a supplement, a nootropic, an energy source, or a combination thereof. In some embodiments, a preparation comprises 0.01% (w / w) to 20% (w / w) of the one or more additional components. In some embodimnets, one or more additional components comprise inulin, arabino xylans, beta glucans, fructooligosaccharides, galactooligosaccharides, xyloglucans, psyllium, cellulose, guar gum, pectin, locust bean gum, hydroxypropylmethyl cellulose, alginate, resistant starch, polydextrose, resistant maltodextrin, mixed plant cell wall fibers, or a combination thereof.

[0023]

[0021] In some embodiments, a preparation is characterized as having a Dvso less than 100 pm. In some embodiments, a preparation is characterized as having a water activity of less than 0.2. In some embodiments, a 100 mg / mL solution of a preparation in water at 20 °C is characterized as having a viscosity of 1 - 100 cP as measured using a 20 mm rotating disk. In some embodiments, a preparation is characterized as having a Hausner ratio of less than 1.5.

[0024]

[0022] In some embodiments, an extended-release composition is characterized as having an extended duration of release of at least 2 hours, at least 4 hours, at least 6 hours, at least 12 hours, or at least 24 hours. In some embodiments, an extended-release composition does not release a maximum amount of releasable protein payload into a solution of simulated gastric fluid containing 60 units / ml of pepsin at 37 °C until after 2 hours of incubation in the solution, after 4 hours of incubation in the solution, or after 6 hours of incubation in the solution.

[0025]

[0023] In some embodiments, the present disclosure additionally provides a food or beverage product comprising a preparation comprising an extended-release composition comprising: a protein payload; and a release modulator. In some embodiments, a food or beverage product is a protein powder, snack bar, carbonated beverage, salty snack, confectionary, sports drink, yogurt, or gummy.

[0026]

[0024] In some embodiments, the present disclosure further provides a method of preparing a preparation comprising an extended-release composition comprising: a protein payload. In some embodiments, a method for preparing a preparation of the present disclosure comprises: (i) hydrating a protein payload to form a solubilized protein solution; (ii) hydrating a release modulator to form a solubilized release modulator solution; (iii) mixing the solubilized protein solution and the solubilized release modulator solution to form a mixed solution; (iv) incubating the mixed solution for 4 hours to 24 hours at 2 °C to 30 °C; (v) heat-treating the mixed solution to form a heat-treated solution; (vi) diluting the heat-treated solution with an acid to form a diluted heat-treated solution; (vii) homogenizing the diluted heat-treated solution to from a homogenate; (viii) filtering the homogenate form a filtered homogenate; (ix) spray drying the filtered homogenate to form a spray-dried preparation; lyophilizing the filtered homogenate to form a lyophilized preparation; or oven-drying the filtered homogenate to form a oven-dried preparation; and (x) milling the spray-dried preparation, lyophilized preparation, or oven-dried preparation to form an extended-release product.

[0027]

[0025] In some embodiments, a solubilized protein solution in a method of the present disclosure comprises 2% (w / v) to 35% (w / v) of protein payload. In some embodiments, a solubilized protein solution in a method of the present disclosure is pH adjusted to pH 3 to pH 10. In some embodiments, a release modulator solution in a method of the present disclosure comprises 1% (w / v) to 10% (w / v) of release modulator. In some embodiments, 0.01% (w / v) to 5% (w / v) dicalcium phosphate is added to a mixed solution in a method of the present disclosure. In some embodiments, 0.01% (w / v) to 5% (w / v) gluconolactone is added to a mixed solution in a method of the present disclosure. In some embodiments, a mixed solution in a method of the present disclosure is heated for 0.5 hrs. to 5 hrs. at 85 °C to 100 °C. In some embodiments, a heat-treated solution in a method of the present disclosure is diluted with 5% (v / v) to 200% (v / v) of 0.01% (w / v) to 2% (w / v) acetic acid. In some embodiments, 0.01% (w / v) to 3% (w / v) chitosan is added to a heat-treated solution in a method of the present disclosure. In some embodiments, a diluted heat-treated solution in a method of the present disclosure is homogenized at 3000 rpm to 20000 rpm for 1 . min to 20 min. In some embodiments, a homogenate in a method of the present disclosure is passed through a 200 pm to 2000 pm screen filter. In some embodiments, 0.01% (w / v) to 0.5% (w / v) of one or more excipients is added to the filtered homogenate. In some embodiments, a method of the present disclosure comprises spray drying with an inlet temperature of 110 °C to 275 °C, an outlet temperature of 60 °C to 95 °C, an atomization pressure of 0.75 bar to 4 bar, or a combination thereof. In some embodiments, an extended-release product produced using a method of the present disclosure is characterized as having a moisture content under 6% (w / w). In some embodiments, a method of the present disclosure further comprises milling an extended-release product using a 100 pm to 1000 m screen filter to form a milled extended-release product.

[0028] BRIEF DESCRIPTION OF THE DRAWING

[0029]

[0026] Figures are presented herein for illustration purposes, not for limitation. The foregoing and other objects, aspects, features, and advantages of the disclosure will become more apparent and may be better understood by referring to the following description taken in conjunction with the accompanying drawings.

[0030]

[0027] FIG. 1 is a flow diagram showing an exemplary production process for whey protein formulations characterized as having controlled, extended, and / or delayed release.

[0031]

[0028] FIG. 2 is a line graph showing percent amino acid and / or peptide release as determined using a bicinchoninic acid (BCA) assay from a heat-treated (92 °C for 90 min.) whey protein isolate preparation placed in simulated gastric fluid with 60 U / ml of pepsin at 8%, 11%, or 15% (w / v).

[0032]

[0029] FIG. 3 is a line graph showing percent amino acid and / or peptide release as determined using a BCA assay from a heat-treated (92 °C for 90 min. at pH 4.5. 6.3, or 7.5) whey protein isolate preparation at 11% (w / v) in simulated gastric fluid with 60 U / ml of pepsin.

[0033]

[0030] FIG. 4 is a line graph showing percent amino acid and / or peptide release as determined using a BCA assay from a heat-treated (92 °C for 90 min. at pH 7.5) whey protein isolate preparation at 11% (w / v) heat-treated whey protein prepared at pH 7.5 in the presence of formulated with various release modulators (Tween 85, Span 60, Gum Arabic, and Triacetin) in simulated gastric fluid with 60 U / ml of pepsin.

[0031] FIG. 5 A is a ribbon diagram showing whey protein isolate secondary structure.

[0034]

[0032] FIG. 5B is an image of whey protein isolate in dry powder form.

[0035]

[0033] FIG. 5C is a microscopy image of whey protein isolate in a dry powder form.

[0036]

[0034] FIG. 5D is an image of whey protein isolate powder incorporated into a conventional milkshake (Muscle Milk® vanilla shake) at a ratio of 1:1 (w / v).

[0037]

[0035] FIG. 5E is a line graph showing percent amino acid and / or peptide release as determined by a BCA assay from untreated whey protein isolate powder in 500 mL of simulated gastric fluid (SGF) with 60 U / mL pepsin, at a pH of 1.2 and at 37 °C.

[0038]

[0036] FIG. 5F is a line graph showing percent amino acid and / or peptide release as determined by a BCA assay from untreated whey protein isolate powder mixed with a conventional milkshake (Muscle Milk® vanilla shake) at a 1:1 ratio (w / v).

[0039]

[0037] FIG. 6A is a diagram showing the chemical structure of Pluronic F68.

[0040]

[0038] FIG. 6B is an image showing an 83% (w / w) heat-treated whey protein isolate preparation including 17% (w / w) Pluronic F68 in a dry powder form.

[0041]

[0039] FIG. 6C is a microscopy image showing an 83% (w / w) heat-treated whey protein isolate preparation including 17% (w / w) Pluronic F68 in a dry powder form.

[0042]

[0040] FIG. 6D is an image of an 83% (w / w) heat-treated whey protein isolate preparation including 17% (w / w) Pluronic F68 incorporated into a conventional milkshake (Muscle Milk® vanilla shake) at a ratio of 1:1 (w / v).

[0043]

[0041] FIG. 6E is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from whey protein isolate powder and a 91% (w / w) heat-treated whey protein isolate preparation including 9% (w / w) Pluronic F68 in 500 mL of simulated gastric fluid with 60U / ml pepsin, at pH 1.2, 37 °C.

[0044]

[0042] FIG. 6F is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from an 83% (w / w) heat-treated whey protein isolate preparation including 17% (w / w) Pluronic F68 incorporated into a conventional milkshake (Muscle Milk® vanilla shake) at a 1 : 1 (w / v) ratio (open circles) and from a conventional milkshake (Muscle Milk® vanilla shake) alone (closed circles).

[0043] FIG. 7 A is a diagram showing the chemical structure of sucrose palmitate.

[0045]

[0044] FIG. 7B is an image of a 91 % (w / w) heat-treated whey protein isolate preparation including 9% w / w) sucrose palmitate in a dry powder form.

[0046]

[0045] FIG. 7C is a microscopy image of a 91% (w / w) heat-treated whey protein isolate preparation including 9% (w / w) sucrose palmitate in a dry powder form.

[0047]

[0046] FIG. 7D is an image of a 91% (w / w) heat-treated whey protein isolate preparation including sucrose palmitate incorporated into a conventional milkshake (Muscle Milk® vanilla shake) at a ratio of 1:1 (w / v).

[0048]

[0047] FIG. 7E is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from whey protein isolate powder and a 91% (w / w) heat-treated whey protein isolate preparation including 9% (w / w) sucrose palmitate in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0049]

[0048] FIG. 7F is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a 91% (w / w) heat-treated whey protein isolate preparation including 9% (w / w) sucrose palmitate incorporated into a conventional milkshake (Muscle Milk® vanilla shake) at a 1:1 (w / v) ratio and from a conventional milkshake (Muscle Milk® vanilla shake) alone.

[0050]

[0049] FIG. 8A is a diagram showing the chemical structure of glucose.

[0051]

[0050] FIG. 8B is an image of a 91 % (w / w) heat-treated whey protein isolate preparation including 9% (w / w) glucose in a dry powder form.

[0052]

[0051] FIG. 8C is a microscopy image of a 91% (w / w) heat-treated whey protein isolate preparation including 9% (w / w) glucose in a dry powder form.

[0053]

[0052] FIG. 8D is an image of a 91% (w / w) heat-treated whey protein isolate preparation including 9% (w / w) glucose incorporated into a conventional milkshake (Muscle Milk® vanilla shake) at a ratio of 1 : 1 (w / v).

[0054]

[0053] FIG. 8E is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a 91% (w / w) heat-treated whey protein isolate preparation including 9% (w / w) glucose in 500 mL of simulated gastric fluid with 60 U / mL pepsin, pH 1 .2, 37 °C.

[0055]

[0054] FIG. 8F is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a 91% (w / w) heat-treated whey protein isolate preparation including 9% (w / w) glucose incorporated into a conventional milkshake (Muscle Milk® vanilla shake) at a 1:1 (w / v) ratio and from conventional milkshake (Muscle Milk® vanilla shake) alone.

[0056]

[0055] FIG. 9A is a diagram showing an exemplary coating process of heat-treated whey protein formulations to obtain a core- shell structure.

[0057]

[0056] FIG. 9B is a graph showing particle size distribution for uncoated heat-treated whey -protein and an exemplary 85% (w / w) heat-treated whey protein isolate preparation coated with 15% (w / w) ETHOCEL Standard 300.

[0058]

[0057] FIG. 9C is a microscopy image of unformulated whey protein isolate.

[0059]

[0058] FIG. 9D is an image of heat-treated whey protein isolate incorporated into a conventional milkshake (Muscle Milk® chocolate shake) at a ratio of 1:1 (w / v).

[0060]

[0059] FIG. 9E is a microscopy image of an uncoated heat-treated whey protein isolate preparation.

[0061]

[0060] FIG. 9F is an image of an uncoated heat-treated whey protein isolate preparation incorporated into a conventional milkshake (Muscle Milk® chocolate shake) at a ratio of 1 : 1 (w / v).

[0062]

[0061] FIG. 9G is a microscopy image of an 85% (w / w) heat treated whey protein isolate preparation coated with 15% (w / w) ETHOCEL Standard 300.

[0063]

[0062] FIG. 9H is an image of 85% (w / w) heat treated whey protein isolate preparation coated with 15% (w / w) ETHOCEL standard 300 incorporated into a conventional milkshake (Muscle Milk® chocolate shake).

[0064]

[0063] FIG. 91 is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from unformulated whey protein isolate, uncoated heat-treated whey protein isolate preparation, and an exemplary heat-treated whey protein isolate preparation coated with 15% (w / w) ETHOCEL standard 300, each mixed with a conventional milkshake (Muscle Milk® chocolate shake) at a 1:1 (w / v) ratio.

[0065]

[0064] FIG. 10A is a flow diagram showing a simulated digestion of whey protein isolate in fasted state simulated gastric fluid (FaSSGF) with pepsin and subsequent analysis of resulting peptide digests via mass spectrometry.

[0066]

[0065] FIG. 10B is an exemplary mass-spectrum of FaSSGF / pepsin digests of unformulated whey protein isolate and heat-treated whey protein isolate.

[0067]

[0066] FIG. 10C is a diagram depicting characteristic peptide fragments of P- lactoglobulin “TKIPAVFK” from whey protein isolate.

[0068]

[0067] FIG. 10D is an exemplary mass-spectrograph of whey protein isolate FaSSFG / pepsin digest or heat-treated whey protein isolate FaSSGF / pepsin digest with values of characteristic peaks for b2 and y2 fragments circled.

[0069]

[0068] FIG. HA is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from various heat-treated whey protein isolate preparations including water-soluble cellulose ether polymers (e.g., 91% (w / v) heat-treated whey protein isolate, 9% (w / v) Methocel™ 15LV (open circles); 91% (w / v) heat-treated whey protein isolate, 9% (w / v) Methocel™ 4C (open squares); 91% (w / v) heat-treated whey protein isolate, 9% (w / v) Methocel™ 15C (down-turned open triangles); 91% (w / v) heat-treated whey protein isolate, 9% (w / v) Methocel™ 4M (open diamonds)), amino acids (e.g., 91% (w / v) heat-treated whey protein isolate, 9% (w / v) glycine (up-turned open triangles); 91% (w / v) heat-treated whey protein isolate, 9% (w / v) lysine (open hexagons)), sodium alginate (e.g., 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Vivapharm™ PHR5 (closed circles); 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Vivapharm™ PH155 (closed squares); 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Vivapharm™ PH176 (down-turned closed triangles); 76% (w / w) heat- treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) dicalcium phosphate, 15% (w / w) Vivapharm™ PH155 (closed diamonds)), or low methoxyl amidated pectin (e.g., 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Pectner™ APC210 (up-turned closed triangles); 66% (w / w) heat-treated whey protein isolate, 5% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 26% (w / w) Pectner™ APC220 (closed hexagons)) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0070]

[0069] FIG. 11B is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a heat-treated whey protein isolate preparation including an amino acid (open circles; 91% (w / w) heat-treated whey protein isolate, 9% (w / w) glycine) and a heat-treated whey protein isolate powder preparation including a hydrocolloid (closed circles;

[0071] 91% (w / w) heat-treated whey protein isolate, 9% (w / w) iota carrageenan) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0072]

[0070] FIG. 11C is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a heat-treated whey protein isolate preparation including an amino acid (open circles; 91% (w / w) heat-treated whey protein isolate, 9% (w / w) glycine) and a heat-treated whey protein isolate powder preparation including a hydrocolloid (closed circles;

[0073] 91% (w / w) heat-treated whey protein isolate, 9% (w / w) lambda carrageenan) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0074]

[0071] FIG. 11D is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from heat-treated whey protein isolate preparations including gluconolactone with a high methoxyl pectin (open circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Pectner™ APC169B) or sodium alginate (closed circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Vivapharm™ PHR5) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0075]

[0072] FIG. HE is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from heat-treated whey protein isolate preparations including gluconolactone with a high methoxyl pectin (open circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Pectner™ 169B) or sodium alginate (closed circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Vivapharm™ PH155) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0073] FIG. 11F is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from heat-treated whey protein isolate preparations including gluconolactone with a high methoxyl pectin (open circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Pectner1MAPC169B) or calcium-crosslinked low methoxyl amidated pectin (closed circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Pectner™ APC210) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0076]

[0074] FIG. 11G is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from heat-treated whey protein isolate preparations including gluconolactone with a high methoxyl pectin (open circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Pectner™ 169B) or sodium alginate (closed circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Vivapharm™ PH176) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0077]

[0075] FIG. 11H is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from heat-treated whey protein isolate preparations including gluconolactone and calcium carbonate with a high methoxyl pectin (open circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Pectner™ APC169B), gluconolactone and calcium carbonate with a low methoxyl amidated pectin (closed squares; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) calcium carbonate, 15% (w / w) Vivapharm™ PH176), or gluconolactone and dicalcium phosphate with a low methoxyl amidated pectin (closed circles; 76% (w / w) heat-treated whey protein isolate, 6% (w / w) gluconolactone, 3% (w / w) dicalcium phosphate, 15% (w / w) Vivapharm™ PH155) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0078]

[0076] FIG. 12A is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a heat-treated whey protein isolate preparation including an amino acid (open circles; 91% (w / w) heat-treated whey protein isolate, 9% (w / w) glycine) and a heat-treated whey protein isolate preparation including a hypromellose (closed circles; 91% (w / w) heat-treated whey protein isolate, 9% (w / w) hypromellose acetate succinate) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0079]

[0077] FIG. 12B is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a preparation including 71% (w / w) heat-treated whey protein isolate, 27% (w / w) nutritional yeast, 2% (w / w) transglutaminase (open circles), or a preparation including 71.4% (w / w) heat-treated whey protein isolate, 14.3% (w / w) maltodextrin DE16, 14.3% (w / w) functional rice starch (closed circles) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0080]

[0078] FIG. 12C is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a preparation including 71% (w / w) heat-treated whey protein isolate, 27% (w / w) nutritional yeast, 2% (w / w) transglutaminase (open circles), or a preparation including 71.4% (w / w) heat-treated whey protein isolate, 14.3% (w / w) maltodextrin DE16, 14.3% (w / w) corn starch (closed circles) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0081]

[0079] FIG. 12D is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a heat-treated whey protein isolate preparation including an amino acid (open circles; 91% (w / w) heat-treated whey protein isolate, 9% (w / w) glycine), or a preparation including 91% (w / w) heat-treated whey protein isolate, 9% (w / w) ORAFTI inulin GR (closed circles) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0082]

[0080] FIG. 12E is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a heat-treated whey protein isolate preparation including an amino acid (open circles; 91% (w / w) heat-treated whey protein isolate, 9% (w / w) glycine), or a preparation including 91% (w / w) heat-treated whey protein isolate, 9% (w / w) PromOat Fiber (closed circles) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0083]

[0081] FIG. 12F is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a heat-treated whey protein isolate preparation including an amino acid (open circles; 91% (w / w) heat-treated whey protein isolate, 9% (w / w) glycine), or a preparation including 91% (w / w) heat-treated whey protein isolate, 9% (w / w) glucose (closed circles) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0082] FIG. 12G is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a heat-treated whey protein isolate preparation including an amino acid (open circles; 91% (w / w) heat-treated whey protein isolate, 9% (w / w) glycine), or a preparation including 91% (w / w) heat-treated whey protein isolate, 9% (w / w) functional rice starch (closed circles) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0084]

[0083] FIG. 12H is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a heat-treated whey protein isolate preparation including an amino acid (open circles; 91% (w / w) heat-treated whey protein isolate, 9% (w / w) glycine), or a preparation including 91% (w / w) heat-treated whey protein isolate, 9% (w / w) tapioca polydextrose (closed circles) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1 .2, 37 °C.

[0085]

[0084] FIG. 13A is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a preparation including 83% (w / w) heat-treated whey protein isolate, 8% (w / w) sodium silicate, 9% (w / w) calcium carbonate (open circles), or a preparation including 82.6% (w / w) heat-treated whey protein isolate, 15.1% (w / w) Vivapur™ alginate FD176, 1.5% (w / w) gluconolactone, 0.8% (w / w) dicalcium phosphate (closed circles) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0086]

[0085] FIG. 13B is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a preparation including 83% (w / w) heat-treated whey protein isolate, 8% (w / w) sodium silicate, 9% (w / w) calcium carbonate (open circles), or a preparation including 80% (w / w) heat-treated whey protein isolate, 13.4% (w / w) Swanlac™ ASL , 0.9% (w / w) Vivapur™ alginate FD176, 2.9% (w / w) chitosan, 1.4% (w / w) gluconolactone, 1.4% (w / w) dicalcium phosphate (closed circles) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0087]

[0086] FIG. 14A is a graph showing particle diameter distributions (volume density %) of a preparation including 81.2% (w / w) heat-treated whey protein isolate, 16.2% (w / w) rice starch, 1% (w / w) chitosan, 1% (w / w) tannic acid, 0.6% w / w laccase.

[0088]

[0087] FIG. 14B is a graph showing particle diameter distributions (volume density %) of a preparation including 78% (w / w) heat-treated whey protein isolate, 15% (w / w) Vivapharm™ PH 176, 5% (w / w) dicalcium phosphate, 2% (w / w) gluconolactone.

[0088] FIG. 14C is a graph showing particle diameter distributions (volume density %) of a preparation including 71% (w / w) heat-treated whey protein isolate, 27% (w / w) nutritional yeast, 2% (w / w) transglutaminase.

[0089]

[0089] FIG. 14D is a graph showing particle diameter distributions (volume density %) of a preparation including 82.4% (w / w) heat-treated whey protein isolate, 13.8% (w / w) Pectner™ APC169B, 0.9% (w / w) Vivapharm™ PH176, 1.45% (w / w) gluconolactone, 1.45% (w / w) calcium hydrogen phosphate anhydrous.

[0090]

[0090] FIG. 15 is a flow diagram showing an exemplary production process for an exemplary heat-treated whey protein isolate formulation.

[0091]

[0091] FIG. 16A is a photograph showing an exemplary preparation including 82.6% (w / w) heat-treated whey protein isolate, 15.1% (w / w) Vivapur™ alginate FD176, 1.5% (w / w) gluconolactone, 0.8% (w / w) dicalcium phosphate prepared according to an exemplary method as shown in the flow diagram of FIG. 15.

[0092]

[0092] FIG. 16B is a photograph showing Crystal Lite™ powder.

[0093]

[0093] FIG. 16C is a photograph showing a 2:1 mixture of Crystal Lite™ powder and exemplary preparation of FIG. 16A.

[0094]

[0094] FIG. 16D is a photograph showing commercial protein powder.

[0095]

[0095] FIG. 16E is a photograph showing a 1:2 mixture of commercial protein powder and exemplary preparation of FIG. 16A.

[0096]

[0096] FIG. 17A is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from a preparation of FIG. 16A including 82.6% (w / w) heat-treated whey protein isolate, 15.1% (w / w) Vivapur™ alginate FD176, 1.5% (w / w) gluconolactone, 0.8% (w / w) dicalcium phosphate mixed with 2 pails of Cystal Lite™ as shown in FIG. 16C.

[0097]

[0097] FIG. 17B is a line graph showing amino acid and / or peptide release as measured by a BCA assay from a preparation of FIG. 16A including 82.6% (w / w) heat-treated whey protein isolate, 15.1% (w / w) Vivapur™ alginate FD176, 1.5% (w / w) gluconolactonc, 0.8% (w / w) dicalcium phosphate mixed with 1 pail of commercial protein powder as shown in FIG.

[0098] 16E.

[0098] FIG. 18A is a line graph showing amino acid and / or peptide release as measured by a BCA assay from a preparation of FIG. 16A including 82.6% (w / w) heat-treated whey protein isolate, 15.1% (w / w) Vivapur™ alginate FD176, 1.5% (w / w) gluconolactone, 0.8% (w / w) dicalcium phosphate stored for 14 days in various conditions (closed circle, -4 °F, 40% relative humidity, vacuum, desiccant, mylar bag; closed square, 80 °F, 40% relative humidity, vacuum, desiccant, mylar bag; open square, 100 °F, 40% relative humidity, vacuum, desiccant, mylar bag; closed triangle, 80 °F, 75% relative humidity, vacuum, desiccant, mylar bag; open triangle, 80 °F, 40% relative humidity, nitrogen, desiccant, glass vial; open hexagon, 80 °F, 40% relative humidity, nitrogen, desiccant, mylar bag; hatched hexagon, 80 °F, 40% relative humidity, air, desiccant, mylar bag; closed star, 80 °F, 40% relative humidity, vacuum, no desiccant, mylar bag) or without storage (open circle) in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0099]

[0099] FIG. 18B is a line graph showing amino acid and / or peptide release as measured by a BCA assay from a preparation of FIG. 16A including 82.6% (w / w) heat-treated whey protein isolate, 15.1% (w / w) Vivapur™ alginate FD176, 1.5% (w / w) gluconolactone, 0.8% (w / w) dicalcium phosphate stored for 28 days in various conditions (closed circle, -4 °F, 40% relative humidity, vacuum, desiccant, mylar bag; closed square, 80 °F, 40% relative humidity, vacuum, desiccant, mylar bag; open square, 100 °F, 40% relative humidity, vacuum, desiccant, mylar bag; closed triangle, 80 °F, 75% relative humidity, vacuum, desiccant, mylar bag; open triangle, 80 °F, 40% relative humidity, nitrogen, desiccant, glass vial; open hexagon, 80 °F, 40% relative humidity, nitrogen, desiccant, mylar bag; hatched hexagon, 80 °F, 40% relative humidity, air, desiccant, mylar bag; closed star, 80 °F, 40% relative humidity, vacuum, no desiccant, mylar bag) or without storage (open circle) in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0100]

[0100] FIG. 19 is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from various exemplary preparations (i) closed circles, 70% (w / w) heat-treated whey protein isolate, 23.5% (w / w) Pectner™ APC210, 1.6% (w / w) Vivapur™ alginate FD176, 2.4% (w / w) gluconolactone, 2.4% (w / w) dicalcium phosphate; (ii) open circles, 75% (w / w) heat-treated whey protein isolate, 19.6% (w / w) Pectner™ APC210, 1.3% (w / w) Vivapur™ alginate FD176, 2% (w / w) gluconolactone, 2% (w / w) di calcium phosphate; (iii) closed squares, 80% (w / w) heat-treated whey protein isolate, 15.7% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.6% (w / w) gluconolactonc, 1.6% (w / w) dicalcium phosphate; (iv) open squares, 85% (w / w) heat-treated whey protein isolate, 11.7% (w / w) Pectner1MAPC210, 0.8% (w / w) Vivapur™ alginate FD176, 1.2% (w / w) gluconolactone, 1.2% (w / w) di calcium phosphate; (v) closed diamond, 90% (w / w) heat-treated whey protein isolate, 7.8% (w / w) Pectner™ APC210, 0.5% (w / w) Vivapur™ alginate FD176, 0.8% (w / w) gluconolactone, 0.8% (w / w) dicalcium phosphate) in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0101]

[0101] FIG. 20A is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from various exemplary preparations (closed circle, 90.8 (w / w) heat- treated whey protein isolate, 5% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.6% (w / w) gluconolactone, 1.6% (w / w) dicalcium phosphate; closed square, 86% (w / w) heat-treated whey protein isolate, 10% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.5% (w / w) gluconolactone, 1.5% (w / w) dicalcium phosphate; closed triangle, 81.2% (w / w) heat-treated whey protein isolate, 15% (w / w) Pectner™ APC210, 0.9% (w / w) Vivapur™ alginate FD176, 1.4% (w / w) gluconolactone, 1.4% (w / w) dicalcium phosphate) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0102]

[0102] FIG. 20B is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from various exemplary preparations (closed circle, 83 (w / w) heat- treated whey protein isolate, 13.9% (w / w) Pectner™ APC210, 0.2% (w / w) Vivapur™ alginate FD176, 1.4% (w / w) gluconolactone, 1.5% (w / w) dicalcium phosphate; open circle, 81.9% (w / w) heat-treated whey protein isolate, 13.7% (w / w) Pectner™ APC210, 1.5% (w / w) Vivapur™ alginate FD176, 1.4% (w / w) gluconolactone, 1.4% (w / w) dicalcium phosphate; closed square, 80.7% (w / w) heat-treated whey protein isolate, 13.5% (w / w) Pectner™ APC210, 3% (w / w) Vivapur™ alginate FD176, 1.4% (w / w) gluconolactone, 1.4% (w / w) dicalcium phosphate) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0103]

[0103] FIG. 20C is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from various exemplary preparations (closed circle, 83 (w / w) heat- treated whey protein isolate, 13.9% (w / w) Pectner™ APC210, 0.2% (w / w) Vivapur™ alginate FD176, 1.4% (w / w) gluconolactone, 1.5% (w / w) dicalcium phosphate; open circle, 81.9% (w / w) heat-treated whey protein isolate, 13.7% (w / w) Pectner™ APC210, 1 .5% (w / w) Vivapur™ alginate FD176, 1.4% (w / w) gluconolactone, 1.4% (w / w) dicalcium phosphate; closed square, 80.7% (w / w) heat-treated whey protein isolate, 13.5% (w / w) Pectner™ APC210, 3% (w / w) Vivapur™ alginate FD176, 1.4% (w / w) gluconolactone, 1.4% (w / w) dicalcium phosphate) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0104]

[0104] FIG. 20D is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from various exemplary preparations (closed circle, 82.4% (w / w) heat-treated whey protein isolate, 9.9% (w / w) Pectner™ APC210, 0.7% (w / w) Vivapur™ alginate FD176, 3.5% (w / w) gluconolactone, 3.5% (w / w) dicalcium phosphate; open circle, 82.4% (w / w) heat-treated whey protein isolate, 11 .4% (w / w) Pectner™ APC210, 0.8% (w / w) Vivapur™ alginate FD176, 2.7% (w / w) gluconolactone, 2.7% (w / w) dicalcium phosphate; closed square, 82.4% (w / w) heat-treated whey protein isolate, 12.8% (w / w) Pectner™ APC210, 0.9% (w / w) Vivapur™ alginate FD176, 2% (w / w) gluconolactone, 1.9% (w / w) dicalcium phosphate); open square, 82.4% (w / w) heat-treated whey protein isolate, 13.5% (w / w) Pectner™ APC210, 0.9% (w / w) Vivapur™ alginate FD176, 1.6% (w / w) gluconolactone, 1.6% (w / w) dicalcium phosphate); closed diamond, 82.4% (w / w) heat-treated whey protein isolate, 14.3% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.1% (w / w) gluconolactone, 1.2% (w / w) dicalcium phosphate); open diamond, 82.4% (w / w) heat-treated whey protein isolate, 14.5% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1% (w / w) gluconolactone, 1% (w / w) dicalcium phosphate) in 12 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0105]

[0105] FIG. 21A is a graph showing particle diameter distributions (volume density %) of untreated whey protein isolate (open circle); heat-treated whey protein isolate (Dvso > 100 pm; open square); heat-treated whey protein isolate (Dvso < 100 pm; closed circle); and an exemplary preparation including 80% (w / w) heat-treated whey protein isolate (Glanbia Proven 190), 13.4% (w / w) kappa carrageenan, 0.86% (w / w) Vivapur™ alginate FD176, 2.9% (w / w) chitolytic, 1.4% (w / w) gluconolactone, 1.5% (w / w) dicalcium phosphate (Dvso < 100 pm; closed square).

[0106]

[0106] FIG. 21B is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from untreated whey protein isolate (open circle); heat-treated whey protein isolate (Dvso > 100 pm; open square); heat-treated whey protein isolate (Dvso < 100 pm; closed circle); and a formulation including 80% (w / w) heat-treated whey protein isolate (Glanbia Proven 190), 13.4% (w / w) kappa carrageenan, 0.86% (w / w) Vivapur™ alginate FD176, 2.9% (w / w) chito lytic, 1.4% (w / w) gluconolactone, 1.5% (w / w) dicalcium phosphate (Dvso < 100 pm; closed square).

[0107]

[0107] FIG. 22 is a bar graph showing the viscosity (cP) of exemplary preparations including: 82.4% (w / w) heat-treated whey protein isolate, 13.8% (w / w) Pectner™ APC169B, 0.9% (w / w) Vivapharm™ alginate PH176, 1.45% (w / w) gluconolactone, 1.45% (w / w) calcium hydrogen phosphate anhydrous (Formulation A); 80% (w / w) heat-treated whey protein isolate (Glanbia Provon 190), 13.4% (w / w) Pectner™ APC210, 0.86% (w / w) Vivapur™ alginate FD176, 2.9% (w / w) chitolytic, 1.4% (w / w) gluconolactone, 1.4% (w / w) dicalcium phosphate (Formulation B), or untreated whey protein (Premier whey protein (vanilla) (Formulation C)).

[0108]

[0108] FIG. 23A is a graph showing particle diameter distributions (volume density %) of an exemplary preparation including 80.2% (w / w) heat-treated whey protein isolate, 13.3% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 3.2% (w / w) gluconolactone, 2.1% (w / w) dicalcium phosphate.

[0109]

[0109] FIG. 23B is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from an exemplary preparation including 78.3% (w / w) heat-treated whey protein isolate, 13.1% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 2.4% (w / w) Sipemat 22s, 3.1% (w / w) gluconolactone, 2.1% (w / w) dicalcium phosphate in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0110]

[0110] FIG. 23C is a graph showing particle diameter distributions (volume density %) of an exemplary preparation including 78.3% (w / w) heat-treated whey protein isolate, 13.1% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 2.4% (w / w) Sipernat 22s, 3.1% (w / w) gluconolactone, 2.1% (w / w) dicalcium phosphate.

[0111]

[0111] FIG. 23D is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from an exemplary preparation including 78.3% (w / w) heat-treated whey protein isolate, 13.1% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.2% (w / w) Sipemat 22s, 1.2% (w / w) aquafaba, 3.1% (w / w) gluconolactone, 2.1% (w / w) dicalcium phosphate in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0112] FIG. 23E is a graph showing particle diameter distributions (volume density %) of an exemplary preparation including 78.3% (w / w) heat-treated whey protein isolate, 13.1% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.2% (w / w) Sipernat 22s, 1.2% (w / w) aquafaba, 3.1% (w / w) gluconolactone, 2.1% (w / w) dicalcium phosphate.

[0112]

[0113] FIG. 23F is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from an exemplary preparation including 77% (w / w) heat-treated whey protein isolate, 12.8% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.2% (w / w) chitosan, 1.2% (w / w) Sipernat 22s, 1.2% (w / w) aquafaba, 3.1% (w / w) gluconolactone, 2% (w / w) dicalcium phosphate in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1 .2, 37 °C.

[0113]

[0114] FIG. 23G is a graph showing particle diameter distributions (volume density %) of an exemplary preparation including 77% (w / w) heat-treated whey protein isolate, 12.8% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.2% (w / w) chitosan, 1.2% (w / w) Sipernat 22s, 1.2% (w / w) aquafaba, 3.1% (w / w) gluconolactone, 2% (w / w) dicalcium phosphate.

[0114]

[0115] FIG. 23H is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from an exemplary preparation including 77% (w / w) heat-treated whey protein isolate, 12.8% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.2% (w / w) chitosan, 1.2% (w / w) HiCaplOO, 1.2% (w / w) aquafaba, 3.1% (w / w) gluconolactone, 2% (w / w) dicalcium phosphate in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0115]

[0116] FIG. 231 is a graph showing particle diameter distributions (volume density %) of an exemplary preparation including 77% (w / w) heat-treated whey protein isolate, 12.8% (w / w) Pectner™ APC210, 1% (w / w) Vivapur™ alginate FD176, 1.2% (w / w) chitosan, 1.2% (w / w) HiCaplOO, 1.2% (w / w) aquafaba, 3.1% (w / w) gluconolactone, 2% (w / w) dicalcium phosphate.

[0116]

[0117] FIG. 23J is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from an exemplary preparation including 83.8% (w / w) heat-treated whey protein isolate, 4% (w / w) Ticaloid 710H, 1% (w / w) Vivapur™ alginate FD176, 5.5% (w / w) chitosan, 3.4% (w / w) gluconolactone, 2.2% (w / w) dicalcium phosphate in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0118] FIG. 23K is a graph showing particle diameter distributions (volume density %) of an exemplary preparation including 83.8% (w / w) heat-treated whey protein isolate, 4% (w / w) Ticaloid 710H, 1% (w / w) Vivapur™ alginate FD176, 5.5% (w / w) chitosan, 3.4% (w / w) gluconolactone, 2.2% (w / w) dicalcium phosphate.

[0117]

[0119] FIG. 23L is a line graph showing percent amino acid and / or peptide release as measured by a BCA assay from an exemplary preparation including 81.1% (w / w) heat-treated whey protein isolate, 3.9% (w / w) Ticaloid 710H, 1% (w / w) Vivapur™ alginate FD176, 5.4% (w / w) chitosan, 2.6% (w / w) Sipemat 50s, 3.3% (w / w) gluconolactone, 2.2% (w / w) dicalcium phosphate in 500 mL of simulated gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C.

[0118]

[0120] FIG. 23M is a graph showing particle diameter distributions (volume density %) of an exemplary preparation including 81.1% (w / w) heat-treated whey protein isolate, 3.9% (w / w) Ticaloid 710H, 1% (w / w) Vivapur™ alginate FD176, 5.4% (w / w) chitosan, 2.6% (w / w) Sipemat 50s, 3.3% (w / w) gluconolactone, 2.2% (w / w) dicalcium phosphate.

[0119]

[0121] FIG. 23N is a graph showing particle diameter distributions (volume density %) of an exemplary preparation including 81.1% (w / w) heat-treated whey protein isolate, 3.9% (w / w) Ticaloid 710H, 1% (w / w) Vivapur™ alginate FD176, 5.4% (w / w) chitosan, 1.3% (w / w) Sipemat 50s, 1.3% (w / w) aquafaba, 3.3% (w / w) gluconolactone, 2.2% (w / w) dicalcium phosphate.

[0120]

[0122] FIG. 24 is a bar graph showing the permeation capacity (%) of amino acids across a human intestinal epithelial cell layer in a Transwell® cell culture insert after 30 min, 120 min, and 240 min incubation following application of various samples to the apical side of the cell layer. Samples applied were pH-neutralized gastric fluid digests (500 mL gastric fluid with 60 U / mL pepsin, at pH 1.2, 37 °C) of untreated whey protein isolate (after 1080 min. incubation), heat-treated whey protein isolate (after 1080 min. incubation), or an exemplary preparation including 80% (w / w) heat-treated whey protein isolate (Glanbia™ Proven 190), 13.4% (w / w) Pectner™ APC210, 0.86% (w / w) Vivapur™ alginate FD176, 2.9% (w / w) chitosan, 1.4% (w / w) gluconolactone, 1.4% (w / w) dicalcium phosphate (after incubation at various time points (e.g., between 5 min. and 1080 min.)).

[0121]

[0123] FIG. 25 is a bar graph showing the viscosity of exemplary preparations after mixture into water at a concentration of 100 mg / mL as compared to the viscosity of unformulated whey protein isolate and commercial whey protein powder. The white bar (Glanbia) is unformulatcd whey protein isolate; the grey bar (VK2) is an exemplary preparation including 78.3% (w / w) heat-treated whey protein isolate, 13.1% (w / w) Pectner™APC210, 1% (w / w) Vivapur™ Alginate FD176, 3.1% (w / w) gluconolactone, 2.1% (w / w) Dicalcium phosphate, 2.4% (w / w) Sipemat™ 22S; the checkered bar (VK8) is an exemplary preparation including 76.4% (w / w) heat-treated Glanbia Provon™ 190 whey protein isolate, 12.8% (w / w) Pectner™ APC 210, 0.9% (w / w) Vivapur™ FD 176, 2.0% (w / w) gluconolactone, 2.0% (w / w) dicalcium phosphate, and 5.9% (w / w) Chitolytic chitosan; the vertical line bar (VK8 + 3% SHMP) is an exemplary preparation including 74.1% (w / w) heat-treated Glanbia Provon™ 190 whey protein isolate, 12.4% (w / w) Pectner™ APC 210, 0.9% (w / w) Vivapur™ FD 176, 1.9% (w / w) gluconolactone, 2.0% (w / w) dicalcium phosphate, 5.7% (w / w) Chitolytic chitosan, and 3% (w / w) sodium hexametaphosphate; and the black bar is commercial Muscle Milk vanilla protein powder.

[0122]

[0124] FIG. 26 is a line graph showing the percent amino acid and / or peptide release as measured by a BCA assay from exemplary preparations including 74.1% (w / w) heat-treated Glanbia Provon™ 190 whey protein isolate, 12.4% (w / w) Pectner™ APC 210, 0.9% (w / w) Vivapur™ FD 176, 1.9% (w / w) gluconolactone, 2.0% (w / w) dicalcium phosphate, 5.7% (w / w) Chitolytic chitosan, and 3% (w / w) sodium hexametaphosphate (closed squares); 76.4% (w / w) heat-treated Glanbia Provon™ 190 whey protein isolate, 12.8% (w / w) Pectner™ APC 210, 0.9% (w / w) Vivapur™ FD 176, 2.0% (w / w) gluconolactone, 2.0% (w / w) dicalcium phosphate, and 5.9% (w / w) Chitolytic chitosan (closed circles); and 97% (w / w) unformulated whey protein isolate with 3% (w / w) sodium hexametaphosphate (open squares).

[0123] DEFINITIONS

[0124]

[0125] Unless defined otherwise, technical and scientific terms used herein have the same meaning as is commonly understood to which the claimed subject matter belongs. In the event that there are a plurality of definitions for terms herein, those in this section prevail.

[0125]

[0126] It is to be understood that the general description and the detailed description are exemplary and explanatory only and are not restrictive of any subject matter claimed. In this application, the use of the singular includes the plural unless specifically stated otherwise. It must be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. In this application, the use of “or” means “and / or” unless stated otherwise. Furthermore, use of the term “including” as well as other forms, such as “include”, “includes,” and “included,” is not limiting.

[0126]

[0127] Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense, that is, as “including, but not limited to.” Further, headings provided herein arc for convenience only and do not interpret the scope or meaning of the claimed invention.

[0127]

[0128] Definition of standard chemistry terms may be found in reference works, including but not limited to, Carey and Sundberg “Advanced Organic Chemistry 4th Ed.” Vols. A (2000) and B (2001), Plenum Press, New York.

[0128]

[0129] As used herein, the symbol “<” means less than or fewer than. As used herein, the symbol “>” means more than.

[0129]

[0130] As used herein, the term “about” or “approximately” means within 10%, preferably within 10%, and more preferably within 5% of a given value or range.

[0130]

[0131] Ambient: The term “ambient”, as used herein, refers to a typical indoor (e.g., climate-controlled) temperature, usually within a range of about 18 °C to about 32 °C, and / or typical indoor (e.g., climate-controlled) humidity, usually within a range of about 30% to 50%. In some embodiments, ambient temperature is within a range of about 20 °C to about 30 °C . In some embodiments, ambient temperature is 25±5 °C . In some embodiments, ambient temperature is approximately 21 °C . In some embodiments, ambient temperature is 18 °C . In some embodiments, ambient temperature is 19 °C . In some embodiments, ambient temperature is 20 °C . In some embodiments, ambient temperature is 21 °C . In some embodiments, ambient temperature is 22 °C . In some embodiments, ambient temperature is 23 °C . In some embodiments, ambient temperature is 24 °C . In some embodiments, ambient temperature is 25 °C . In some embodiments, ambient temperature is 26 °C . In some embodiments, ambient temperature is 27 °C . In some embodiments, ambient temperature is 28 °C . In some embodiments, ambient temperature is 29 °C . In some embodiments, ambient temperature is 30 °C . In some embodiments, ambient may be used to describe outdoor conditions, and may include temperatures ranging from about 15 °C to about 40 °C , or from about 25 °C to about 40 °C . In some embodiments, ambient humidity is within a range of about 35% to about 45%. In some embodiments, ambient humidity is 35%. In some embodiments, ambient humidity is 36%. In some embodiments, ambient humidity is 37%. In some embodiments, ambient humidity is 38%. In some embodiments, ambient humidity is 39%. In some embodiments, ambient humidity is 40%. In some embodiments, ambient humidity is 41%. In some embodiments, ambient humidity is 42%. In some embodiments, ambient humidity is 43%. In some embodiments, ambient humidity is 44%. In some embodiments, ambient humidity is 45%.

[0131]

[0132] Beverage: As used herein, the term “beverage” is used to refer to a potable liquid (e.g., that can be ingested, swallowed, drunk, or consumed by a person or animal without material risk to the person or animal). For example, a beverage can be or comprise beer, juice, milk, sports drink, tea, water, soda, yogurt, etc. In some embodiments, a “beverage” may be or comprise a pharmaceutical formulation in liquid form.

[0132]

[0133] Biocompatible: As used herein, the term “biocompatible” is used to describe a characteristic of not causing significant detectable harm to living tissue when placed in contact therewith e.g., in vivo. In certain embodiments, materials are “biocompatible” if they are not significantly toxic to cells, e.g., when contacted therewith in a relevant amount and / or under relevant conditions such as over a relevant period of time. In certain embodiments, materials are “biocompatible” if their addition to cells in vitro results in less than or equal to 20% cell death, and / or their administration in vivo does not induce significant inflammation or other adverse effects.

[0133]

[0134] Comparable: As used herein, the term “comparable” refers to two or more agents, entities, situations, sets of conditions, etc., that may not be identical to one another but that are sufficiently similar to permit comparison therebetween so that one skilled in the art will appreciate that conclusions may reasonably be drawn based on differences or similarities observed. In some embodiments, comparable sets of conditions, circumstances, individuals, or populations are characterized by a plurality of substantially identical features and one or a small number of varied features. Those of ordinary skill in the art will understand, in context, what degree of identity is required in any given circumstance for two or more such agents, entities, situations, sets of conditions, etc. to be considered comparable. For example, those of ordinary skill in the art will appreciate that sets of circumstances, individuals, or populations are comparable to one another when characterized by a sufficient number and type of substantially identical features to warrant a reasonable conclusion that differences in results obtained or phenomena observed under or with different sets of circumstances, individuals, or populations are caused by or indicative of the variation in those features that are varied.

[0134]

[0135] Controlled release: As used herein, the term “controlled release” refers to release of one or more components (e.g., one or more food components) where the release is temporally regulated, locationally regulated, environmentally regulated or a combination thereof. In some embodiments, “controlled release” may additionally refer to regulation of the magnitude to which one or more components (e.g., one or more food components) is released.

[0135]

[0136] Degradation: As used herein, the term “degradation” refers to a change in chemical structure and often involves breakage of at least one chemical bond. To say that a chemical compound is degraded typically means that the chemical structure of the chemical compound has changed (e.g., a chemical bond is broken). Common mechanisms of degradation include, for example, oxidation, hydrolysis, isomerization, fragmentation, or a combination thereof.

[0136]

[0137] Delayed release: As used herein, the term “delayed release” is used to refer to a postponed release of one or more component (e.g., one or more food components) by a formulation, composition, and / or preparation beyond: a pre-determined time, a time in which the one or more components would naturally be released, a time in which the one or more components would be released in the absence of a manipulation, or a combination thereof.

[0137]

[0138] Delivery: As used herein, the term “delivery” is used to refer to the carrying and / or deposition and / or moving of nutrients (e.g., macronutrients, micronutrients, ketones, flavanols, prebiotics, etc.) and / or encapsulants to particular location (e.g., into and / or throughout the body). In some embodiments, for example, delivery may refer to payload delivery to the epithelial cells in the gastrointestinal tract. In some embodiments, for example, delivery may refer to payload delivery to into the blood stream (e.g., systemic absorption). In some embodiments, for example, delivery may refer to ingestion at the point of consumption for a shelf-stable food composition containing a nutrient payload.

[0138]

[0139] Diameter: As used herein, the term “diameter” is used to refer to the longest distance from one end of a particle to another end of the particle. Those skilled in the art will appreciate that a variety of techniques are available for use in characterizing particle diameters (i.c., particle sizes). In some embodiments, for example, size of particles (e.g., diameter of particles) can be measured by a Coulter Counter. In some embodiments, for example, size of particles (e.g., diameter of particles) can be measured by a Malvern Mastersizer. In some embodiments, a population of particles is characterized by an average size (e.g., D[3,2], D[4,3], etc.) and / or by particular- characteristics of size distribution (e.g., absence of particles above or below particular sizes [e.g., DvlO, Dv20, Dv30, Dv40, Dv50, Dv60, Dv70, Dv80, Dv90, Dv99, etc.], a unimodal, bimodal, or multimodal distribution, etc.).

[0139]

[0140] Dissolution Solvent: As used herein, the term “dissolution solvent” refers to a fluid in which a solute dissolves or into which a component (e.g., a food component) is released. In some embodiments, dissolution solvents include fluids naturally found within one or more gastrointestinal compartments, simulated gastric fluids, simulated intestinal fluids, water or phosphate buffered saline.

[0140]

[0141] Dispersity: As used herein, the term “dispersity” is used to refer to the breadth of particle size distribution relative to the average particle size. In some embodiments, for example, size of particles (e.g., diameter of particles) can be measured by a Coulter Counter. In some embodiments, for example, size of particles (e.g., diameter of particles) can be measured by a Malvern Mastersizer. In some embodiments, the population of particles is characterized by, for example, an average size (e.g., Dv50) and, for example, a corresponding standard deviation. In some embodiments, the dispersity of a population of particles refers to double (e.g., 2-fold) the ratio of standard deviation (e.g., G) to average particle diameter (e.g., Dv50).

[0141]

[0142] Elastic modulus: As used herein, the term “elastic modulus” is used to refer to a measure of how much stress is needed to deform a gel, hydrocolloid, matrix, interpenetrating polymer network, or release modulator, without permanently changing its shape.

[0142]

[0143] Encapsulant: As used herein, the term “encapsulant” is used to refer to anything that is used to encapsulate a payload. For example, in some embodiments of the present disclosure, a payload component (e.g., a nutrient component) is described as being encapsulated by an encapsulant (e.g., polymer component, food component, material component, etc.).

[0143]

[0144] Encapsulated: As used herein, the term “encapsulated” is used to refer to a characteristic of being physically associated with, and in some embodiments partly or wholly covered or coated. For example, in some embodiments of the present disclosure, a payload component (e.g., a microbe component and / or a nutrient component) is described as being encapsulated by a polymer component.

[0144]

[0145] Excipient: As used herein, the term “excipient” is used to refer to any substance in a composition and / or preparation other than one or more food components that is included in the manufacturing process of a composition and / or preparation or is contained in a final product. In some embodiment, an excipient includes a substance that stabilizes a composition and / or preparation (e.g., a stabilizer). In some embodiments, an excipient includes agents that prevent clumping (e.g., anti-caking agents). In some embodiments, an excipient includes a substance that binds or removes another substance (e.g., a sequestrant).

[0145]

[0146] Extended-release: As used herein, the term “extended-release” is used to refer to a prolonged (i.e., lengthened) period of time during which a composition and / or formulation continues to release one or more components (e.g., one or more food components) beyond: a predetermined time, a time in which the one or more components would naturally be released, a time in which the one or more components would be released in the absence of a manipulation, or a combination thereof. In some embodiments, “extended-release” refers to release of a food component (e.g., payload) over a period of at least 2 hours, at least 4 hours, at least 6 hours, at least 12 hours, at least 18 hours, or at least 24 hours,

[0146]

[0147] Extended-release Product: As used herein, the term “extended-release product” is used to refer to a ingestible product (e.g., formulated food or formulated beverage) incorporating one or more formulated composition and / or formulated preparation that provides health benefits (e.g., gastrointestinal health, cardiovascular health, neurological health, endocrine health, musculoskeletal health, dermatological health, immune health; energy; nutrition; performance; general well-being) resulting from controlled, delayed, or extended release, absorption, spatial access, concentration, and / or residence time of nutrients.

[0147]

[0148] Flowability: As used herein, the term “flowability” is used to refer to the ability a material, substance, composition, or preparation to move or flow.

[0148]

[0149] Food: As used herein, the term “food” is used to refer to an edible solid (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal). For example, food include, but is not limited to, protein powder, whey powder, baby formula, dry food powder, protein bar, snack bar, yogurt, supplements, bread, candy, cake, cereal, chip, chocolate, confectionary, cookie, food additive, gummy, ice cream, kefir, rice, pasta, dry food, nutrition supplement, packaged food, pet feed, pet food, protein powder, sachet, salad dressing, salty snack, seed, smoothie, spice, Meal Ready-to-Eat (MRE), frozen food, medical food, fermented food, protein shakes, drink mix powders, dairy milk, oat milk, almond milk, soy milk, coffee grinds, Meal Ready-to-Drink (RTD), ready-to-drink low phenylalanine medical food, electrolyte beverages, sports beverages, water, hard seltzers, alcoholic seltzers, beer, wine, soda, coffee, tea, fermented beverages, carbonated beverage, Gatorade™, Truly™ , Ensure™, PKU Sphere ™ Liquid. In some embodiments, a “food” may be or comprise a pharmaceutical formulation in solid form. In some embodiments, a “food” may generally refer to a food and / or beverage product. In some embodiments, a “food” may generally refer to an edible object that is intended to confer a benefit to a subject (e.g., gastrointestinal health, cardiovascular health, neurological health, endocrine health, musculoskeletal health, dermatological health, immune health; energy; nutrition; performance; general well-being).

[0149]

[0150] Food Component: As used herein, the term “food component” is used to refer to a component of a food and / or beverage that may or may not provide a nutritional benefit to a subject when consumed. In some embodiments, a food component may include a protein, a polypeptide, a peptide, an amino acid, a carbohydrate, a sugar, a monosaccharide, a polysaccharide, a dietary fiber, a fat, a fatty acid, a lipid, a nutrient, a nutraceutical, a macronutrient, a micronutrient, a vitamin, a mineral, a polypeptide, a carotenoid, an element, a ketone body, a prebiotic (e.g., a prebiotic fiber), a flavonoid, an antioxidant, an electrolyte, a salt, a circadian rhythm modulator, a supplement, a nootropic, an energy source, or a combination thereof

[0150]

[0151] Food and / or Beverage Product: As used herein, the term “food and / or beverage product,” refers to an ingestible food, and / or combination of one or more ingestible foods, that is commercially available to a subject. Example food and / or beverage products include, but are not limited to, protein powder, whey powder, baby formula, dry food powder, protein bar, snack bar, yogurt, supplements, bread, candy, cake, cereal, chip, chocolate, confectionary, cookie, food additive, gummy, ice cream, kefir, rice, pasta, dry food, nutrition supplement, packaged food, pet feed, pet food, protein powder, sachet, salad dressing, salty snack, seed, smoothie, spice, Meal Ready-to-Eat (MRE), frozen food, medical food, fermented food, protein shakes, drink mix powders, dairy milk, oat milk, almond milk, soy milk, coffee grinds, Meal Rcady-to-Drink (RTD), ready-to-drink low phenylalanine medical food, electrolyte beverages, sports beverages, water, hard seltzers, alcoholic seltzers, beer, wine, soda, coffee, tea, fermented beverages, carbonated beverage, Gatorade™, Truly™ , Ensure™, PKU Sphere ™ Liquid.

[0151]

[0152] Formulated Beverages: As used herein, the term “formulated beverages” is used to refer to an ingestible liquid (e.g., that can be ingested, swallowed, drank, or consumed by a person or animal without material risk to the person or animal) that provides health benefits (e.g., gastrointestinal health, cardiovascular health, neurological health, endocrine health, musculoskeletal health, dermatological health, immune health; energy; nutrition; performance; general well-being) resulting from controlled, delayed, or extended release, absorption, spatial access, concentration, and / or residence time of nutrients. Examples of formulated beverages include, but are not limited to, protein shakes, drink mix powders, dairy milk, oat milk, almond milk, soy milk, coffee grinds, Meal Ready-to-Drink (RTD), ready-to-drink low phenylalanine medical food, electrolyte beverages, sports beverages, water, hard seltzers, alcoholic seltzers, beer, wine, soda, coffee, tea, fermented beverages, carbonated beverage, Gatorade™, Truly™ , Ensure™, PKU Sphere ™ Liquid. In some embodiments, a formulated beverage may incorporate a formulated composition and / or formulated preparation.

[0152]

[0153] Formulated Foods: As used herein, the term “formulated foods” is used to refer to an edible solid (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) that provides health benefits (e.g., gastrointestinal health, cardiovascular health, neurological health, endocrine health, musculoskeletal health, dermatological health, immune health; energy; nutrition; performance; general well-being) resulting from controlled, delayed, or extended release, absorption, spatial access, concentration, and / or residence time of nutrients. Examples of formulated foods include, but are not limited to, protein powder, whey powder, baby formula, dry food powder, protein bar, snack bar, yogurt, supplements, bread, candy, cake, cereal, chip, chocolate, confectionary, cookie, food additive, gummy, ice cream, kefir, rice, pasta, dry food, nutrition supplement, packaged food, pet feed, pet food, protein powder, sachet, salad dressing, salty snack, seed, smoothie, spice, Meal Ready-to-Eat (MRE), frozen food, medical food, fermented food, protein shakes, drink mix powders, dairy milk, oat milk, almond milk, soy milk, coffee grinds, Meal Rcady-to-Drink (RTD), rcady-to-drink low phenylalanine medical food, electrolyte beverages, sports beverages, water, hard seltzers, alcoholic seltzers, beer, wine, soda, coffee, tea, fermented beverages, carbonated beverage, Gatorade™, Truly™ , Ensure™, PKU Sphere ™ Liquid.

[0153]

[0154] Formulated Composition: As used herein, the term “formulated composition” (also referred to as a “food and / or beverage composition,” “formulated ingestible,” or “extended- release composition”) is used to refer to an edible mixture of two or more components (e.g., one or more food components and one or more release modulators) that can be ingested, drank, swallowed, chewed, or consumed by a subject (e.g., person or animal) without material risk to the subject and that provides health benefits (e.g., gastrointestinal health, cardiovascular health, neurological health, endocrine health, musculoskeletal health, dermatological health, immune health; energy; nutrition; performance; general well-being) resulting from controlled, delayed, or extended release, absorption, spatial access, concentration, and / or residence time of nutrients. In some embodiments, a formulated composition may be in the form of a particle, microparticle, coated particle, coated, microparticle, core-shell, or a matrix.

[0154]

[0155] Formulated Meals: As used herein, the term “formulated meals” is used to refer to a solid meal (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) such as microwavable meals, freshly prepared meals, frozen meals, MREs, etc., that provides health benefits (e.g., gastrointestinal health, cardiovascular health, neurological health, endocrine health, musculoskeletal health, dermatological health, immune health; energy; nutrition; performance; general well-being) resulting from controlled, delayed, or extended release, absorption, spatial access, concentration, and / or residence time of nutrients. In some embodiments, a formulated meal may incorporate a formulated composition and / or formulated preparation.

[0155]

[0156] Formulated Preparation: As used herein, the term “formulated preparation” is used to refer to an edible mixture of two or more formulated compositions (e.g., two or more particles, microparticles, coated particles, coated microparticles, core-shells, or matrices ) that can be ingested, drank, swallowed, chewed, or consumed by a subject (e.g., person or animal) without material risk to the subject and that provides health benefits (e.g., gastrointestinal health, cardiovascular health, neurological health, endocrine health, musculoskeletal health, dermatological health, immune health; energy; nutrition; performance; general well-being) resulting from controlled, delayed, or extended release, absorption, spatial access, concentration, and / or residence time of nutrients. In some embodiments, a formulated composition may be in the form of a particle, microparticle, coated particle, coated, microparticle, core-shell, or a matrix. In some embodiments, a formulated preparation may include one or more excipients, probiotics, prebiotics, postbiotics, or additional components.

[0156]

[0157] Formulated Supplements: As used herein, the term “formulated supplements” is used to refer to an edible dosage form (e.g., that can be ingested, swallowed, chewed, or consumed by a subject (e.g., a person or animal) without material risk to the subject) such as a powder (e.g., protein powder, whey protein powder, etc.), pill, capsule, tablet, etc. that provides health benefits (e.g., gastrointestinal health, cardiovascular health, neurological health, endocrine health, musculoskeletal health, dermatological health, immune health; energy; nutrition; performance; general well-being) resulting from controlled, delayed, or extended release, absorption, spatial access, concentration, and / or residence time of nutrients.

[0157]

[0158] Formulation: As used herein, the term “formulation” is used to refer to a combination of two or more components, where the amounts and / or relative proportions of the two or more components is known and / or determined.

[0158]

[0159] Gelator: As used herein, the term “gelator” refers to a substance that forms a three-dimensional network (i.e., a gel) that traps a large volume of solvent. As used herein, the term “gelator” further refers to a mixture of dicalcium phosphate and gluconolactone that forms a gel.

[0159]

[0160] Hard Seltzers: As used herein, the term “hard seltzer” is used to refer to an ingestible liquid that contains alcohol and carbonated water.

[0160]

[0161] HLB: As used herein, the term “HLB” is used to refer to the hydrophilic lipophilic balance that is an inherent property of, for example, a nonionic surfactant. In some embodiments, the HLB value of a given non-ionic surfactant is obtained from a commonly accessible tabular source. In some embodiments, non-ionic surfactants characterized as having a low HLB value (e.g., < 8) are compatible emulsifiers for lipid systems. In some embodiments, nonionic surfactants characterized as having a high HLB value (e.g., >15) are compatible emulsifiers for aqueous systems. In some embodiments, non-ionic surfactants characterized as having an intermediate HLB value (e.g., >8 and <15) are compatible emulsifiers with both lipid and aqueous systems.

[0161]

[0162] Homogeneous: As used herein, the term “homogeneous” means of substantially uniform structure and / or composition throughout.

[0162]

[0163] Hydrocolloid: As used herein, the term “hydrocolloid” refers to a group of polysaccharides and / or proteins that form gels or viscous solutions in water. As used herein, the term “hydrocolloid” further refers to a mixture of pectins, alginates, and carrageenans.

[0163]

[0164] Hydrophobic: As used herein, the term “hydrophobic” is used to refer to the propensity of a material to reject association, chemically and / or physically, with water. In some embodiments, a material characterized as being hydrophobic is biologically derived and / or synthetically derived. In some embodiments, a material characterized as being hydrophobic is a lipid, protein, and / or carbohydrate. In some embodiments, a material characterized as being hydrophobic is a polymer and / or small molecule. Alternatively, or additionally, in some embodiments, composites, mixtures, blends, or super-structures of several materials are collectively referred to as hydrophobic based on their observed propensity to reject association, chemically and / or physically, with water.

[0164]

[0165] Incorporation: As used herein, the term “incorporation” is used to refer to a characteristic of being physically associated with, and in some embodiments, dispersed within, embedded within, or mixed in a bulk material (e.g., a lipid matrix component).

[0165]

[0166] Layer: As used herein, the term “layer” typically refers to a material disposed above or below a distinguishable material. In some embodiments, a particular entity or preparation (e.g., particle preparation) is described as “layered” if it is prepared via a process in which a first material is laid down and then a second material is applied atop or underneath the first material(e.g., as by dipping or spraying, etc.); in some such embodiments, physical or chemical distinctness of layers may be maintained over time, whereas in some such embodiments, physical or chemical distinctness of layers may decay over time, at least at layer interface(s). Alternatively or additionally, in some embodiments, a particular sample or preparation may be described as layered, independent of its mode of preparation, so long as at a particular point in time and / or using a particular mode of assessment, distinct materials can be identified in a layered structure. In some embodiments, a “layered” particle may include one or more layers that wholly encapsulate a material below. In some embodiments, a “layered” particle may include one or more layers that docs not wholly encapsulate a material below. In some embodiments, at least one layer of a layered preparation is or comprises a polymer, e.g., a hydrophobic polymer or hydrophilic polymer. In some embodiments, each layer of a layered preparation is or comprises a polymer, e.g., a pH responsive polymer or a temperature-responsive polymer.

[0166]

[0167] Lipid: As used herein, the term “lipid” is used to refer to a class of chemical structures characterized as hydrophobic materials. In some embodiments, a lipid material is derived from a biological source. In other embodiments, a lipid material is derived from a synthetic source. In some embodiments, a lipid is comprised of one or more aliphatic alcohols and / or acids linked by glycerol and / or glycol moieties. In other embodiments, a lipid is comprised of aliphatic chains, linear conjugated, aromatic, and / or cyclic aliphatic moieties. In some embodiments, a lipid refers to a pure chemical entity. In other embodiments, a lipid refers to a mixture of several pure chemical entities. For example, lipids include, but are not limited to: paraffin wax, montan wax, microcrystalline wax, polyethylene wax, petrolatum wax, ozokerite wax, ceresin wax, beeswax, lanolin wax, spermaceti wax, tallow wax, lac wax, Chinese insect wax, ambergris wax, soy wax, carnauba wax, candelilla wax, coconut wax, palm kernel wax, rice bran wax, butyric acid, n-butanol, pentanoic acid, n-pentanol, hexanoic acid, n-hexanol, heptanoic acid, n-heptanol, caprylic acid, n-octanol, nonanoic acid, n-nonanol, capric acid, n- decanol, lauric acid, n-dodecanol, myristic acid, n-tetradecanol, palmitic acid, n-hexadecanol, stearic acid, n-octadecanol, arachidonic acid, n-icosanol, fatty alcohol monoglyceride ethers, fatty acid monoglyceride esters, fatty alcohol diglyceride ethers, fatty acid diglyceride esters, fatty alcohol triglyceride ethers, fatty acid triglyceride esters, fatty alcohol glycol monoether, fatty acid glycol monoesters, fatty alcohol glycol diethers, fatty acid glycol diesters, fatty alcohol poly(glycerol) ethers, fatty acid poly(glycerol) esters, fatty alcohol poly(glycol) ethers, fatty acid poly(glycol) esters, coconut oil, corn oil, cottonseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil, sunflower oil, almond oil, pine nut oil, cashew oil, fully hydrogenated palm oil, partially hydrogenated palm oil, fully hydrogenated sunflower oil, partially hydrogenated sunflower oil, fully hydrogenated soybean oil, partially hydrogenated soybean oil, fully hydrogenated vegetable oil, partially hydrogenated vegetable oil, fully hydrogenated cottonseed oil, partially hydrogenated cottonseed oil, cholesterol, cholenic acid, ursolic acid, or bctulinic acid.

[0167]

[0168] Lyophilized: As used herein, the term “lyophilized” is used to refer to the endproduct of a process by which water is removed from a material via sublimation. In some embodiments, prior to sublimation of water, the material is cooled to < -10 °C, < -20 °C, < -30 °C, < -40°C, < -50°C, < -60°C, and / or < -70 °C. In some embodiments, prior to the sublimation of water, the pressure is lowered to < 200 torr, < 150 torr, < 100 torr, < 50 torr, < 10 torr, < 5 torr, and / or < 1 torr. Those skilled in the art recognize that the cooling temperature and pressure influence the physicochemical properties of the end product; it is understood that “lyophilized” encompasses all suitable manners of cooling and vacuum protocol.

[0168]

[0169] Medical Foods: As used herein, the term “medical foods” is used to refer to an edible dosage form (e.g., that can be ingested, swallowed, chewed, or consumed by a person or animal without material risk to the person or animal) such as a pill, capsule, tablet, etc. that provides health benefits resulting from controlled release, absorption, spatial access, concentration, and / or residence time of nutrients.

[0169]

[0170] Nutraceutical: As used herein, the terms “nutraceutical” or “nutraceutical composition” refer to a substance or material that is or comprises a nutraceutical agent (e.g., a nutraceutical). Those skilled in the art will be aware of a variety of agents understood in the art to be nutraceutical agents such as, for example, agents that are or comprise one or more antioxidants, macronutrients, micronutrients, minerals, prebiotics, probiotics, probiotic powders, probiotic ingredients, probiotic food ingredients, probiotic supplement ingredients, prebiotics, vitamins, or combinations thereof. In some embodiments, a nutraceutical is or comprises a carotenoid compound such as alpha-lipoic acid, astaxanthin, adonixanthin, adonirubin, betacarotene, coenzyme Q10, lutein, lycopene, or zeaxanthin. In some embodiments, a nutraceutical is or comprises a vitamin such as vitamin D. In some embodiments, a nutraceutical is a natural product, and in certain such embodiments it is a product produced by plants. In some embodiments, nutraceutical agents are compounds that have been reported or demonstrated to confer a benefit or provide protection against a disease in an animal or a plant. In some cases, nutraceuticals may be used to improve health, delay the aging process, protect against chronic diseases, increase life expectancy, or support the structure or function of the body of an animal, such as a human, a pet animal, an agricultural animal, or another domesticated animal. As such, as used in the present disclosure, the terms “nutraceutical composition,” “food preparation,” “food composition,” “particle preparation,” etc. may all be generally understood to describe compositions, preparations, and / or particles that include one or more food components (for example, encapsulated food component(s)).

[0170]

[0171] Nutrient: As used herein, the term “nutrient” is used to refer to a nutraceutical, a macronutrient, a carbohydrate, a sugar, a polysaccharide, a dietary fiber, a fat, a fatty acid, a lipid, a short-chain fatty acid, a protein, an amino acid, a peptide, a micronutrient, a vitamin, a mineral, a carotenoid, an element, a ketone body, a prebiotic, a probiotic, a postbiotic, a bacteria, a yeast, a polyphenol, a flavonoid, an antioxidant, an electrolyte, a salt, a circadian rhythm modulator, a supplement, a nootropic, and / or a source of energy.

[0171]

[0172] Overfortification: As used herein, the term “overfortification” is used to refer to the addition of a nutrient in excess of a label claim, due to expected nutrient degradation or loss of stability during manufacturing, processing, and / or shelf-life. This additional amount of nutrient is used to account for losses during manufacturing, processing, and / or shelf-life to still meet the nutrient label claim.

[0172]

[0173] Particle: As used herein, the term “particle” is used to refer to a discrete physical entity, typically having a size (e.g., a longest cross-section, such as a diameter) within a range. For example, a particle can have a size of about 5-3000 pm, about 5-2000 pm, about 5-1000 pm, about 5-500 pm, about 5-50 pm, about 5-300 pm, about 5-200 pm, about 5-100 pm, about 5-50 pm, about 5-25 pm, or about 5-10 pm. In some embodiments, a particle may describe or include animal pellets ranging in size up to 1 mm, 5 mm, 10 mm, 25 mm, and even about 50 mm (about 2 inches) in diameter. A “particle” is not limited to a particular shape or form, for example, having a cross-section shape of a sphere, an oval, a triangle, a square, a hexagon, or an irregular shape. In some cases, particles can be solid particles. In some cases, particles can be liquid particles. In some cases, particles can be gel or gel-like particles. In some cases, particles may have a particle-in-particle structure wherein a layer of one material (e.g., one type of polymer component) encapsulates another material (e.g., another type of polymer component, which may itself encapsulate yet another, or rather may be or comprise a “core” - e.g., a polymer matrix core - of the particle).

[0174] Parts per million (ppm): As used herein, 1 ppm (“parts per million”) is equivalent to 1 milligram per liter (mg / L) or 1 milligram per kilogram (mg / kg).

[0173]

[0175] Payload: In general, the term “payload”, as used herein, refers to an agent that may be delivered or transported by association with another entity. In some embodiments, such association may be or include a covalent linkage; in some embodiments such association may be or include non-covalent interactions. In some embodiments, association may be direct; in some embodiments, association may be indirect. In some embodiments, a payload comprises one or more food components. The term “pay load” is not limited to a particular chemical identity or type; for example, in some embodiments, a payload may be or comprise, for example, an entity of any chemical class including, for example, a nutrient, a lipid, a metal, a nucleic acid, a polypeptide, a saccharide (e.g., a polysaccharide), small molecule, or a combination or complex thereof. In some embodiments, a nutrient may include a lipid, a saccharide, a protein, etc. In some embodiments, a payload may be or comprise a biological modifier, a detectable agent (e.g., a dye, a fluorophore, a radiolabel, etc.), a detecting agent, a nutrient, a therapeutic agent, etc., or a combination thereof. In some embodiments, a payload may be or comprise a cell or organism, or a fraction, extract, or component thereof. In some embodiments, a payload may be or comprise a natural product in that it is found in and / or is obtained from nature; alternatively or additionally, in some embodiments, the term may be used to refer to one or more entities that is man-made in that it is designed, engineered, and / or produced through action of the hand of man and / or is not found in nature. In some embodiments, a payload may be or comprise an agent in isolated or pure form; in some embodiments, such agent may be in crude form.

[0174]

[0176] pH Responsive: The term “pH-responsive” is used to refer to certain polymer components as described herein, and in particular means that the relevant polymer component is characterized in that one or more aspects of its structure or arrangement is altered when exposed to a change in pH condition (e.g., to a particular pH and / or to a pH change of particular magnitude). In some embodiments, a polymer component is considered to be “pH-responsive” if, when the relevant polymer component is associated with a payload component in a particle preparation as described herein, the particle preparation releases the payload component under specific pH conditions. In some embodiments, >90% of payload component is released from a particle preparation that includes a pH-responsive polymer component within 15 minutes when the particle preparation is exposed to a particular defined pH condition (e.g., within a range of defined pH values and / or at a specific pH value); in some embodiments, such release results when such contacting occurs at temperatures between 33-40°C, and in aqueous-based buffers of ionic strength ranging from 0.001-0.151 M (e.g., water, simulated gastric fluid, gastric fluid, simulated intestinal fluid, intestinal fluid) with osmolality between 1-615 mOsm / kg. In some embodiments, a pH-responsive polymer component is one that degrades when exposed to a particular pH or pH change. Alternatively or additionally, in some embodiments, a pH- responsive polymer component is one that becomes soluble, or significantly (e.g., (e.g., by at least about 5%) increases its solubility when exposed to a particular pH level, or pH change. In some embodiments, a pH-responsive polymer component includes one or more moieties whose protonation state changes at the relevant pH or in response to the relevant pH change. For example, in some embodiments, a pH responsive polymer component includes one or more amine moieties that become protonated upon exposure to a relevant pH or pH chance.

[0175]

[0177] Polyphenols: As used herein, the term “polyphenol” is used to refer to naturally occurring organic compounds, comprising one or multiple aromatic groups with one or more hydroxyl groups or hydroxyl derivatives (e.g., methoxyl, ethoxyl, acetyl, etc.) and / or deriving from the shikimate, phenylpropanoid, and / or polyketide pathways. For example, a polyphenol may be phenolic acids, flavonoids, stilbenes, and lignans, antioxidants, tannins, and / or combinations thereof.

[0176]

[0178] Prebiotic: As used herein, the term “prebiotic” is used to refer to a nondigestible food ingredient that promotes the growth of beneficial microorganisms in the intestines.

[0177]

[0179] Reference: As used herein describes a standard or control relative to which a comparison is made. For example, in some embodiments, an agent, animal, individual, population, sample, sequence or value of interest is compared with a reference or control agent, animal, individual, population, sample, sequence or value. In some embodiments, a reference or control is tested and / or determined substantially simultaneously with the testing or determination of interest. In some embodiments, a reference or control is a historical reference or control, optionally embodied in a tangible medium. Typically, as would be understood by those skilled in the art, a reference or control is determined or characterized under comparable conditions or circumstances to those under assessment. Those skilled in the ail will appreciate when sufficient similarities are present to justify reliance on and / or comparison to a particular possible reference or control.

[0178]

[0180] Release: As used herein, the term “release” refers to the separation and solubilization of one or more food components into a dissolution solvent.

[0179]

[0181] Release profile: As used herein, the term “release profile” refers to a characteristic pattern (e.g., a curve) by which one or more components (e.g., one or more food components) is released by a composition or formulation.

[0180]

[0182] Residual solvent: As used herein, the term “residual solvent” refers to a solvent that remains in a material after manufacture or processing of the material. In some embodiments, level of residual solvent is assessed by HPLC, mass spec, NMR, FTIR, and / or gas chromatography.

[0181]

[0183] Satiety: As used herein, the term “satiety” refers to being full and / or sated; for example, feeling satisfied due to ingestion of a food and / or beverage composition or having a desire removed following ingestion of a food and / or beverage composition.

[0182]

[0184] Satisfaction: As used herein, the term “satisfaction,” refers to a sensation of contentment experienced by a subject.

[0183]

[0185] Stable: The terms “stable,” and “stability,” when applied to compositions herein, means that the compositions maintain (e.g., as determined by one or more analytical assessments) one or more aspects of their physical structure and / or performance charactcristic(s) (e.g., activity) over a period of time and / or under a designated set of conditions. When an assessed composition is a particle composition, in some embodiments, as will be clear from context to those skilled in the art, the term “stable” refers to maintenance of a characteristic such as average particle size, maximum and / or minimum particle size, range of particle sizes, and / or distribution of particle sizes (i.e., the percentage of particles above a designated size and / or outside a designated range of sizes) over a period of time and / or under a designated set of conditions. For food and / or beverage compositions, stable often refers to maintenance or preservation of delivery functions (e.g., controlled release, extended-release, controlled residence time, extended residence time, etc.).

[0186] Sustained release: As used herein, the term “sustained release” refers a period of time in which the release of one or more components (c.g., one or more food components) is continuous and at a relatively constant rate.

[0184]

[0187] Temperature-responsive: As used herein, the term “temperature-responsive” is used to refer to certain polymer component(s) as described herein, and in particular means that the relevant polymer component is characterized in that one or more aspects of its structure or arrangement is altered when exposed to a change in temperature condition (e.g., to a particular temperature and / or to a temperature change of particular magnitude). In some embodiments, a polymer component is considered to be “temperature-responsive” if, when the relevant polymer component is associated with a payload component in a particle preparation as described herein, amorphous regions of the polymer component experience a transition from a rigid state (e.g., glassy state) to a more fluid-like flexible state (e.g., more conducive to flow), at a temperature close to the point of transition from the solid state to rubbery state (e.g., glass transition).

[0185]

[0188] Water activity: As used herein, “water activity” of a material is an indication (e.g., a measurement) of how much free (i.e., available to bind or react) water is present in the material and is typically determined as the ratio of the vapor pressure of water in a material (p) to the vapor pressure of pure water (pO) at the same temperature. For example, a water activity of 0.80 means the vapor pressure is 80 percent of that of pure water. Water activity typically increases with temperature. Those skilled in the art will be familiar with three basic water activity measurement systems: Preventive Electrolytic Hygrometers (REH), Capacitance Hygrometers, and Dew Point Hygrometers (sometimes called chilled mirror).

[0186]

[0189] Unformulated: As used herein, the term “unformulated,” is used to refer to a composition or component that has not been modified and / or combined with one or more other compositions or components.

[0187]

[0190] Untreated: As used herein, the term “untreated,” refers to a composition or component (e.g., a food component) that has not been subject to a particular modification and / or manipulation (i.e., treatment). DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

[0188]

[0191] The present disclosure provides formulated compositions for providing one of more food components to a subject and related technologies (e.g., methods).

[0189] I. Formulated compositions

[0190]

[0192] The present disclosure, among other things, provides formulated compositions comprising one or more food components and one or more release modulators. In some embodiments, a formulated composition of the present disclosure is characterized as having controlled release of one or more food components from the formulated composition. In some embodiments, a formulated composition of the present disclosure is characterized as having extended-release of one or more food components from the formulated composition.

[0191] A. Food Components

[0192]

[0193] In some embodiments, a formulated composition of the present disclosure comprises one or more food components.

[0193]

[0194] In some embodiments, a formulated composition of the present disclosure comprises 1 or more food components. In some embodiments, a formulated composition of the present disclosure comprises 1 to 25, 5 to 25, 10 to 25, 15 to 25, 20 to 25, 1 to 20, 5 to 20, 10 to 20, 15 to 20, 1 to 15, 5 to 15, 10 to 15, 1 to 10, 5 to 10, or 1 to 5 food components. For example, in some embodiments, a formulated composition comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,.16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 food components.

[0194]

[0195] In some embodiments, a food component comprises a protein, a polypeptide, a peptide, an amino acid, a carbohydrate, a sugar, a monosaccharide, a polysaccharide, a dietary fiber, a fat, a fatty acid, a lipid, a nutrient, a nutraceutical, a macronutrient, a micronutrient, a vitamin, a mineral, a polypeptide, a carotenoid, an element, a ketone body, a prebiotic (e.g., a prebiotic fiber), a flavonoid, an antioxidant, an electrolyte, a salt, a circadian rhythm modulator, a supplement, a nootropic, an energy source, or a combination thereof.

[0195]

[0196] In some embodiments, one or more food components comprise a protein (e.g., a protein pay load). In some embodiments, one or more food components comprise whey protein isolate, whey protein concentrate, pea protein isolate, pea protein concentrate, oat protein isolate, oat protein concentrate, soy protein isolate, soy protein concentrate, wheat protein isolate, wheat protein concentrate, egg protein isolate, egg protein concentrate, dairy protein, plant-based protein, casein, bovine scrum albumin, ovalbumin, a-lactalbumin, P-lactoglobulin, collagen, glutanin, gliadin, kefirin, avenin, zein, silk, gelatin, hordein, legumin, one or more digest fragments thereof, or a combination thereof.

[0196]

[0197] In some embodiments, one or more food components comprise a peptide. In some embodiments, one or more food components comprise aspartame, GLP-1, GLP-2, collagen, sermorelin, tesamorelin, lenomorelin, anamorelin, ipamorelin, macimorelin, ghrelin, tabimorelin, alexamorelin, GHRP-1, GHRP-2, GHRP-3, GHRP-4, GHRP-5, GHRP-6, hexarelin, one or more digest fragments thereof, or a combination thereof.

[0197]

[0198] In some embodiments, one or more food components comprise an amino acid. In some embodiments, one or more food components comprise alanine, arginine, asparagine, aspartic acid, cysteine, selenocysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, norvaline, norleucine, pipecolic acid, ornithine, homocysteine, homoserine, isovaline, sarcosine, or a combination thereof.

[0198]

[0199] In some embodiments, one or more food components comprise a carbohydrate. In some embodiments, one or more food components comprise glucose, fructose, mannitol, allulose, sorbitol, xylitol, erythritol, lactitol, galactose, sucrose, maltodextrin, isomaltulose, glycogen, chitosan, guar gum, pullulan, cellulose, dextrins, amylose, amylopectin, pectin, inulin, lignin, chitin, xanthan gum, sodium alginate, potassium alginate, calcium alginate, ammonium alginate, propylene glycol alginate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, agar, agarose, carrageenan, raffinose, cellulose acetate, methyl cellulose, ethyl cellulose, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, or a combination thereof.

[0199]

[0200] In some embodiments, one or more food components comprise a dietary fiber. In some embodiments, one or more food components comprise cellulose, dextrin, amylose, amylopectin, pectin, inulin, lignin, chitin, xanthan gum, sodium alginate, potassium alginate, calcium alginate, ammonium alginate, propylene glycol alginate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, agar, agarose, carrageenan, raffinose, cellulose acetate, methyl cellulose, ethyl cellulose, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate succinate, hydroxypropyl mcthylccllulosc, hydroxypropyl cellulose, sodium carboxy methylcellulose, naturally occurring fiber (e.g., vegetable fiber, whole grain fiber, fruit fiber, cereal bran fiber, flaked cereal fiber, flour fiber), P-glucan soluble fiber, psyllium husk, guar gum, locust bean gum, mixed plant cell wall fibers (e.g., sugar cane fiber, apple fiber), arabinoxylan, alginate, inulin-type fructans, high amylose starch, galactooligosaccharide, polydextrose, maltodextrin, cross-linked phosphorylated RS4, glucomannan, acacia (gum Arabic), or a combination thereof.

[0200]

[0201] In some embodiments, one or more food components comprise a fat. In some embodiments, one or more food components comprise a paraffin wax, montan wax, microcrystalline wax, polyethylene wax, petrolatum wax, ozokerite wax, ceresin wax, beeswax, lanolin wax, spermaceti wax, tallow wax, lac wax, Chinese insect wax, ambergris wax, soy wax, carnauba wax, candelilla wax, coconut wax, palm kernel wax, rice bran wax, butyric acid, n- butanol, pentanoic acid, n-pentanol, hexanoic acid, n-hexanol, heptanoic acid, n-heptanol, caprylic acid, n-octanol, nonanoic acid, n-nonanol, capric acid, n-decanol, lauric acid, n- dodecanol, myristic acid, n-tetradecanol, palmitic acid, n-hexadecanol, stearic acid, n- octadecanol, arachidonic acid, n-icosanol, fatty alcohol monoglyceride ethers, fatty acid monoglyceride esters, fatty alcohol diglyceride ethers, fatty acid diglyceride esters, fatty alcohol triglyceride ethers, fatty acid triglyceride esters, fatty alcohol glycol monoether, fatty acid glycol monoesters, fatty alcohol glycol diethers, fatty acid glycol diesters, fatty alcohol poly(glycerol) ethers, fatty acid poly(glycerol) esters, fatty alcohol poly(glycol) ethers, fatty acid poly(glycol) esters, coconut oil, corn oil, cottonseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil, sunflower oil, almond oil, pine nut oil, cashew oil, fully hydrogenated palm oil, partially hydrogenated palm oil, fully hydrogenated sunflower oil, partially hydrogenated sunflower oil, fully hydrogenated soybean oil, partially hydrogenated soybean oil, fully hydrogenated vegetable oil, partially hydrogenated vegetable oil, fully hydrogenated cottonseed oil, partially hydrogenated cottonseed oil, cholesterol, cholenic acid, ursolic acid, and / or betulinic acid.

[0201]

[0202] In some embodiments, one or more food components comprise a fatty acid. In some embodiments, one or more food components comprise a short-chain fatty acid, medium- chain fatty acid, long-chain fatty acid, polyunsaturated fatty acid, docosahexaenoic acid, arachidonic acid, linoleic acid, linolenic acid, oleic acid, parinaric acid, rumcnic acid, eicosapentaenoic acid, acetate, propionate, butyrate, or a combination thereof.

[0202]

[0203] In some embodiments, one or more food components comprise a carotenoid. In some embodiments, one or more food components comprise alpha-lipoic acid, lycopene, |3- carotene, lutein, zeaxanthin, adonixxanthin, adonirubin, meso-zeaxanthin, astaxanthin, capsanthin, citroxanthin, echinenone, astacein, bixin, crocetin, peridin, or a combination thereof.

[0203]

[0204] In some embodiments, one or more food components comprise a vitamin. In some embodiments, one or more food components comprise trans-retinol, trans-P-carotene, thiamine, riboflavin, niacin, niacinamide, nicotinamide riboside, pantothenic acid, pyridoxine, pyridoxamine, pyridoxal, biotin, folic acid, cyanocobalamin, hydroxocobalamin, methylcobalamin, adenosylcobalamin, ascorbic acid, cholecalciferol, ergocalciferol, tocopherol, tocotrienol, phylloquinone, menaquinone, or a combination thereof.

[0204]

[0205] In some embodiments, one or more food components comprise an antioxidant or polyphenol. In some embodiments, one or more food components comprise tannic acid, ellagitannin, apigenin, luteolin, tangeritin, isorhamnetin, kaempferol, myricetin, quercetin, rutin, eriodictyol, genipin, hesperetin, naringcnin. catechin, gallocatechin, epicatechin, epigallocatechin, theaflavin, daidzein, genistein, glycitein, resveratrol, pterostilbene, hydroxytyrosol, cyanidin, delphinidin, malvidin, pelargonidin, peonidin, petunidin, chicoric acid, chlorogenic acid, cinnamic acid, ellagic acid, gallic acid, sinapic acid, rosmarinic acid, salicylic acid, curcumin, piperine, silymarin, silybin, eugenol, betanin, or a combination thereof.

[0205]

[0206] In some embodiments, one or more food components comprise an element. In some embodiments, one or more food components comprise calcium, chromium, cobalt, copper, iodine, iron, magnesium, manganese, molybdenum, potassium, selenium, sodium, zinc, or a combination thereof.

[0206]

[0207] In some embodiments, one or more food components comprise a salt and / or mineral. In some embodiments, one or more food components comprise sodium chloride, potassium chloride, iron oxide, calcium chloride, calcium carbonate, calcium hydroxyapatite, potassium iodide, sodium iodide, potassium fluoride, sodium fluoride, or a combination thereof.

[0208] In some embodiments, one or more food components comprise a cofactor. In some embodiments, one or more food components comprise nicotinamide adenine dinuclcotidc, flavin adenine dinucleotide, adenosine triphosphate, 5-adenosylmethionine, Coenzyme Q, glutathione, heme, lipoamide, molybdopterin, tetrahydrobiopterin, or a combination thereof.

[0207]

[0209] In some embodiments, one or more food components comprise a metabolic intermediate. In some embodiments, a metabolic intermediate is a ketone body. Those skilled in the art will appreciate that metabolic intermediates (e.g., ketone bodies) offer an alternative energy source to digestible carbohydrates, fats, and proteins. Without wishing to be bound by any particular theory, ingestion of a formulation of the present disclosure comprising one or more metabolic intermediates may provide energy (e.g., calories) to said subject while mitigating one or more metabolic responses (e.g., insulin release, drowsiness, fat storage). In some embodiments, one or more food components comprise acetoacetate, R-P-hydroxybutyl R- [3- hydroxybutyrate, [3-hydroxybutyrate, R-3-hydroxybutyl R-3-hydroxybutyrate monoester, 1,3- butanediol, or a combination thereof.

[0208]

[0210] In some embodiments, one or more food components comprise a circadian rhythm modulator. In some embodiments, one or more food components comprise melatonin, methylcobalamin, adrafinil, cathine, cathinone, dextroamphetamine, ephedrine, epinephrine, armodafinil, modafinil, phenylethylamine, synephrine, theanine, 5-hydroxytryptophan, caffeine, theobromine, taurine, or a combination thereof.

[0209]

[0211] In some embodiments, a formulated composition of the present disclosure comprises a complex mixture of one or more food components that recapitulates the food components, or a portion of food components, found in a prepared meal, cooked meat, cooked vegetables, cooed dairy products, raw meat, raw vegetables, raw dairy products, microbial products, or botanical extracts.

[0210]

[0212] In some embodiments, one or more food components is purified using techniques including, but not limited to, liquid-liquid extraction, solid phase extraction, steam distillation, liquid chromatography, vacuum distillation, filtration, or a combination thereof.

[0211]

[0213] In some embodiments, one or more food components is characterized as maintaining and / or supporting the health of a subject that has ingested said formulation. In some embodiments, maintaining and / or supporting the health of a subject includes, but is not limited to, supporting an endogenous enzymatic or metabolic process (e.g., metals, cofactors, vitamins), resisting oxidation (c.g., antioxidants), supporting bone and / or tooth health (e.g., minerals), supporting growth (e.g., amino acids, peptides, proteins), supporting digestive function (e.g., dietary fiber), supporting sensory tissue (e.g., carotenoids), supporting microbiome health (e.g., polyphenols, prebiotics), supporting circadian rhythm, supporting psychological well-being (e.g., lipids), supporting energy requirements (e.g., caloric intake), or a combination thereof.

[0212]

[0214] In some embodiments, a formulated composition of the present disclosure comprises, on a dry weight basis, at least 50% of one or more food components. In some embodiments, a formulated composition comprises, on a dry weight basis, about 50% to 99%, about 55% to 99%, about 60% to 99%, about 65% to 99%, about 70% to 99%, about 75% to 99%, about 80% to 99%, about 85% to 99%, about 90% to 99%, about 95% to 99%, about 50% to 98%, about 55% to 98%, about 60% to 98%, about 65% to 98%, about 70% to 98%, about 75% to 98%, about 80% to 98%, about 85% to 98%, about 90% to 98%, about 95% to 98%, about 50% to 97%, about 55% to 97%, about 60% to 97%, about 65% to 97%, about 70% to 97%, about 75% to 97%, about 80% to 97%, about 85% to 97%, about 90% to 97%, about 95% to 97%, about 50% to 96%, about 55% to 96%, about 60% to 96%, about 65% to 96%, about 70% to 96%, about 75% to 96%, about 80% to 96%, about 85% to 96%, about 90% to 96%, about 95% to 96%, about 50% to 95%, about 55% to 95%, about 60% to 95%, about 65% to 95%, about 70% to 95%, about 75% to 95%, about 80% to 95%, about 85% to 95%, about 90% to 95%, 50% to 90%, about 55% to 90%, about 60% to 90%, about 65% to 90%, about 70% to 90%, about 75% to 90%, about 80% to 90%, about 85% to 90%, about 50% to 85%, about 55% to 85%, about 60% to 85%, about 65% to 85%, about 70% to 85%, about 75% to 85%, about 80% to 85%, about 50% to 80%, about 55% to 80%, about 60% to 80%, about 65% to 80%, about 70% to 80%, about 75% to 80%, about 50% to 75%, about 55% to 75%, about 60% to 75%, about 65% to 75%, about 70% to 75%, about 50% to 70%, about 55% to 70%, about 60% to 70%, about 65% to 70%, about 50% to 65%, about 55% to 65%, about 60% to 65%, about 50% to 60%, about 55% to 60%, or about 50% to 55% of one or more food components. For example, in some embodiments, a formulated composition comprises about 60% to 98% (w / w) of one or more food components.

[0215] For example, in some embodiments, a formulated composition of the present disclosure comprises about 50% (w / w), about 50.5% (w / w), about 51% (w / w), about 51.5% (w / w), about 52% (w / w), about 52.5% (w / w), about 53% (w / w), about 53.5% (w / w), about 54% (w / w), about 54.5% (w / w), about 55% (w / w), about 55.5% (w / w), about 56% (w / w), about 56.5% (w / w), about 57% (w / w), about 57.5% (w / w), about 58% (w / w), about 58.5% (w / w), about 59% (w / w), about 59.5% (w / w), about 60% (w / w), about 60.5% (w / w), about 61% (w / w), about 61.5% (w / w), about 62% (w / w), about 62.5% (w / w), about 63% (w / w), about 63.5% (w / w), about 64% (w / w), about 64.5% (w / w), about 65% (w / w), about 65.5% (w / w), about 66% (w / w), about 66.5% (w / w), about 67% (w / w), about 67.5% (w / w), about 68% (w / w), about 68.5% (w / w), about 69% (w / w), about 69.5% (w / w), about 70% (w / w), about 70.5% (w / w), about 71% (w / w), about 71.5% (w / w), about 72% (w / w), about 72.5% (w / w), about 73% (w / w), about 73.5% (w / w), about 74% (w / w), about 74.5% (w / w), about 75% (w / w), about 75.5% (w / w), about 76% (w / w), about 76.5% (w / w), about 77% (w / w), about 77.5% (w / w), about 78% (w / w), about 78.5% (w / w), about 79% (w / w), about 79.5% (w / w), about 80% (w / w), about 80.5% (w / w), about 81% (w / w), about 81.5% (w / w), about 82% (w / w), about 82.5% (w / w), about 83% (w / w), about 83.5% (w / w), about 84% (w / w), about 84.5% (w / w), about 85% (w / w), about 85.5% (w / w), about 86% (w / w), about 86.5% (w / w), about 87% (w / w), about 87.5% (w / w), about 88% (w / w), about 88.5% (w / w), about 89% (w / w), about 89.5% (w / w), about 90% (w / w), about 90.5% (w / w), about 91% (w / w), about 91.5% (w / w), about 92% (w / w), about 92.5% (w / w), about 93% (w / w), about 93.5% (w / w), about 94% (w / w), about 94.5% (w / w), about 95% (w / w), about 95.5% (w / w), about 96% (w / w), about 96.5% (w / w), about 97% (w / w), about 97.5% (w / w), about 98% (w / w), about 98.5% (w / w), about 99% (w / w), or about 99.5% (w / w) of one or more food components.

[0213]

[0216] In some embodiments, one or more food components is physically and / or chemically arranged in a formulated composition in a manner that controls the release of one or more food components from a formulation. In some embodiments, one or more food components is physically and / or chemically arranged in a formulated composition in a manner that extends the duration of release of one or more food components from the formulation.

[0214]

[0217] In some embodiments, the physical and / or chemical properties of one or more food component controls the release of one or more food components from a formulation. In some embodiments, the physical and / or chemical properties of one or more food component extends the duration of release of one or more food components from a formulation. In some embodiments, the mucoadhesion of one or more food component controls the release of one or more food components from a formulation. In some embodiments, the mucoadhesion of one or more food component extends the duration of release of one or more food components from a formulation. In some embodiments, the bioadhesion of one or more food component controls the release of one or more food components from a formulation. In some embodiments, the bioadhesion of one or more food component extends the duration of release of one or more food components from a formulation. In some embodiments, the buoyancy of one or more food component controls the release of one or more food components from a formulation. In some embodiments, the buoyancy of one or more food component extends the duration of release of one or more food components from a formulation. In some embodiments, the physical size of one or more food component controls the release of one or more food components from a formulation. In some embodiments, the physical size of one or more food component extends the duration of release of one or more food components from a formulation. In some embodiments, the physical shape of one or more food component controls the release of one or more food components from a formulation. In some embodiments, the physical shape of one or more food component extends the duration of release of one or more food components from a formulation.

[0215]

[0218] In some embodiments, the physical and / or chemical properties of one or more food component prevents the access of water to one or more food components in a formulated composition. In some embodiments, the physical and / or chemical properties of one or more food component prevents the access of an enzyme (e.g., digestive enzyme) to one or more food components in a formulated composition.

[0216]

[0219] In some embodiments, the physical and / or chemical interaction of one food component with one or more release modulators controls the release of one or more food components from a formulation. In some embodiments, the physical and / or chemical properties of one food component with one or more release modulators extends the duration of release of one or more food components from a formulation.

[0220] In some embodiments, the physical and / or chemical interaction of one food component with one or more other food components controls the release of one or more food components from a formulation. In some embodiments, the physical and / or chemical properties of one food component with one or more other food components extends the duration of release of one or more food components from a formulation.

[0217]

[0221] In some embodiments, one or more food components are responsive to one or more environmental factors, wherein the response controls the release of one or more food components from a formulation. In some embodiments, one or more food components are responsive to one or more environmental factors, wherein the response extends the duration of release of one or more food components from a formulation. In some embodiments, one or more environmental factors include, but is not limited to, pH, temperature, water, mechanical forces, chemicals (e.g., chemicals exogenous or endogenous to a subject that ingests a formulation of the present disclosure), enzymes (e.g., enzymes exogenous or endogenous to a subject that ingests a formulation of the present disclosure), and osmotic pressure.

[0218]

[0222] In some embodiments, a formulated composition of the present disclosure comprises one or more food components in an amount sufficient to satisfy an hourly, daily, weekly, and / or monthly, nutritional requirement of a subject that has ingested the formulation. In some embodiments, a formulated composition of the present disclosure comprises one or more food components in an amount sufficient to satisfy an hourly, daily, weekly, and / or monthly caloric requirement of a subject that has ingested the formulation.

[0219]

[0223] In some embodiments, a formulated composition of the present disclosure comprises one or more food components in an amount having a caloric value of about 250 kcal to 4500 kcal, about 500 kcal to 4500 kcal, about 750 kcal to 4500 kcal, about 1000 kcal to 4500 kcal, about 1250 kcal to 4500 kcal, about 1500 kcal to 4500 kcal, about 1750 kcal to 4500 kcal, about 2000 kcal to 4500 kcal, about 2250 kcal to 4500 kcal, about 2500 kcal to 4500 kcal, about 2750 kcal to 4500 kcal, about 3000 kcal to 4500 kcal, about 3250 kcal to 4500 kcal, about 3500 kcal to 4500 kcal, about 3750 kcal to 4500 kcal, about 4000 kcal to 4500 kcal, about 4250 kcal to 4500 kcal, about 250 kcal to 4000 kcal, about 500 kcal to 4000 kcal, about 750 kcal to 4000 kcal, about 1000 kcal to 4000 kcal, about 1250 kcal to 4000 kcal, about 1500 kcal to 4000 kcal, about 1750 kcal to 4000 kcal, about 2000 kcal to 4000 kcal, about 2250 kcal to 4000 kcal, about 2500 kcal to 4000 kcal, about 2750 kcal to 4000 kcal, about 3000 kcal to 4000 kcal, about 3250 kcal to 4000 kcal, about 3500 kcal to 4000 kcal, about 3750 kcal to 4000 kcal, about 250 kcal to 3500 kcal, about 500 kcal to 3500 kcal, about 750 kcal to 3500 kcal, about 1000 kcal to 3500 kcal, about 1250 kcal to 3500 kcal, about 1500 kcal to 3500 kcal, about 1750 kcal to 3500 kcal, about 2000 kcal to 3500 kcal, about 2250 kcal to 3500 kcal, about 2500 kcal to 3500 kcal, about 2750 kcal to 3500 kcal, about 3000 kcal to 3500 kcal, about 3250 kcal to 3500 kcal, about 250 kcal to 3000 kcal, about 500 kcal to 3000 kcal, about 750 kcal to 3000 kcal, about 1000 kcal to 3000 kcal, about 1250 kcal to 3000 kcal, about 1500 kcal to 3000 kcal, about 1750 kcal to 3000 kcal, about 2000 kcal to 3000 kcal, about 2250 kcal to 3000 kcal, about 2500 kcal to 3000 kcal, about 2750 kcal to 3000 kcal, about 250 kcal to 2500 kcal, about 500 kcal to 2500 kcal, about 750 kcal to 2500 kcal, about 1000 kcal to 2500 kcal, about 1250 kcal to 2500 kcal, about 1500 kcal to 2500 kcal, about 1750 kcal to 2500 kcal, about 2000 kcal to 2500 kcal, about 2250 kcal to 2500 kcal, about 250 kcal to 2000 kcal, about 500 kcal to 2000 kcal, about 750 kcal to 2000 kcal, about 1000 kcal to 2000 kcal, about 1250 kcal to 2000 kcal, about 1500 kcal to 2000 kcal, about 1750 kcal to 2000 kcal, about 250 kcal to 1500 kcal, about 500 kcal to 1500 kcal, about 750 kcal to 1500 kcal, about 1000 kcal to 1500 kcal, about 1250 kcal to 1500 kcal, about 250 kcal to 1000 kcal, about 500 kcal to 1000 kcal, about 750 kcal to 1000 kcal, or about 250 kcal to 500 kcal.

[0220]

[0224] Those skilled in the art will recognize that caloric content can be a surrogate measure for the amount of energy provided by one or more food components. In some embodiments, caloric content can be quantified using calorimetry. In some embodiments, the caloric content of one or more food components is a measure of the theoretical maximum carbon content available for oxidation (e.g., to metabolically harness via aerobic respiration).

[0221] Additionally, without wishing to be bound by any particular theory, it is contemplated that, while correlated, the caloric value of one or more food components is not necessarily indicative of a nutritional benefit.

[0222]

[0225] In some embodiments, a formulated composition of the present disclosure comprises one or more food components in an amount sufficient to support microbiome health in a subject ingesting said formulation. Without wishing to be bound by any particular theory, promoting microbiome health includes supporting the growth, proliferation, and / or diversity of commensal microbiota of a subject ingesting a formulation of the present disclosure.

[0226] In some embodiments, a formulated composition of the present disclosure comprises one or more food components in an amount sufficient to promote osmotic balance when released into an anatomical compartment of a subject ingesting said formulation. Without wishing to be bound by any particular theory, promoting osmotic balance includes maintaining the content of electrolytes in bodily fluids (e.g., interstitial fluid, luminal fluid, blood, urine, tears, and / or sweat) of a subject ingesting a formulation of the present disclosure.

[0223] 1. Heat- Treatment

[0224]

[0227] In some embodiments, a formulated composition of the present disclosure comprises one or more food components that has been heat-treated.

[0225]

[0228] In some embodiments, one or more food components is heated to about 60 °C to about 140 In some embodiments, one or more food components is heated to about 60 C to about 130 °C. In some embodiments, one or more food components is heated to about 60 °C to about 120 In some embodiments, one or more food components is heated to about 60 °C to about 110 In some embodiments, one or more food components is heated to about 60 C to about 100 In some embodiments, one or more food components is heated to about 60 °C to about 95 In some embodiments, one or more food components is heated to about 60 °C to about 90 In some embodiments, one or more food components is heated to about 60 C to about 80 °C. In some embodiments, one or more food components is heated to about 60 °C to about 70 In some embodiments, one or more food components is heated to about 70 to about 140 In some embodiments, one or more food components is heated to about 70 °C to about 130 In some embodiments, one or more food components is heated to about 70 °C to about 120 In some embodiments, one or more food components is heated to about 70 C to about 110 In some embodiments, one or more food components is heated to about 70 °C to about 100 In some embodiments, one or more food components is heated to about 70 °C to about 95 In some embodiments, one or more food components is heated to about 70 C to about 90 In some embodiments, one or more food components is heated to about 70 °C to about 80 In some embodiments, one or more food components is heated to about 80 °C to about 140 In some embodiments, one or more food components is heated to about 80 C to about 130 °C. In some embodiments, one or more food components is heated to about 80 °C to about 120 In some embodiments, one or more food components is heated to about 80 C to about 110 °C. In some embodiments, one or more food components is heated to about 80 °C to about 100 °C. In some embodiments, one or more food components is heated to about 80 °C to about 95 °C. In some embodiments, one or more food components is heated to about 80 °C to about 90 °C. In some embodiments, one or more food components is heated to about 90 °C to about 140 °C. In some embodiments, one or more food components is heated to about 90 °C to about 130 °C. In some embodiments, one or more food components is heated to about 90 °C to about 120 °C. In some embodiments, one or more food components is heated to about 90 °C to about 110 °C. In some embodiments, one or more food components is heated to about 90 °C to about 100 °C. In some embodiments, one or more food components is heated to about 90 °C to about 95 °C. In some embodiments, one or more food components is heated to about 95 °C to about 140 °C. In some embodiments, one or more food components is heated to about 95 °C to about 130 °C. In some embodiments, one or more food components is heated to about 95 °C to about 120 °C. In some embodiments, one or more food components is heated to about 95 °C to about 110 °C. In some embodiments, one or more food components is heated to about 95 °C to about 100 °C. In some embodiments, one or more food components is heated to about 100 °C to about 140 °C. In some embodiments, one or more food components is heated to about 100 °C to about 130 °C. In some embodiments, one or more food components is heated to about 100 °C to about 120 °C. In some embodiments, one or more food components is heated to about 100 °C to about 110 °C. In some embodiments, one or more food components is heated to about 110 °C to about 140 °C. In some embodiments, one or more food components is heated to about 110 °C to about 130 °C. In some embodiments, one or more food components is heated to about 110 °C to about 120 °C. In some embodiments, one or more food components is heated to about 120 °C to about 140 °C. In some embodiments, one or more food components is heated to about 120 °C to about 130 °C. In some embodiments, one or more food components is heated to about 130 °C to about 140 °C.

[0226]

[0229] In some embodiments, one or more food components is heated to about 85 °C. In some embodiments, one or more food components is heated to about 90 °C. In some embodiments, one or more food components is heated to about 92 °C. In some embodiments, one or more food components is heated to about 94 °C. In some embodiments, one or more food components is heated to about 95 °C. In some embodiments, one or more food components is heated to about 96 °C. In some embodiments, one or more food components is heated to about 85 °C. In some embodiments, one or more food components is heated to about 100 °C. In some embodiments, one or more food components is heated to about 105 °C.

[0227]

[0230] In some embodiments, one or more food components is heated for about 60 min to about 120 min. In some embodiments, one or more food components is heated for about 60 min to about 110 min. In some embodiments, one or more food components is heated for about 60 min to about 100 min. In some embodiments, one or more food components is heated for about 60 min to about 90 min. In some embodiments, one or more food components is heated for about 60 min to about 80 min. In some embodiments, one or more food components is heated for about 60 min to about 70 min. In some embodiments, one or more food components is heated for about 70 min to about 120 min. In some embodiments, one or more food components is heated for about 70 min to about 110 min. In some embodiments, one or more food components is heated for about 70 min to about 100 min. In some embodiments, one or more food components is heated for about 70 min to about 90 min. In some embodiments, one or more food components is heated for about 70 min to about 80 min. In some embodiments, one or more food components is heated for about 80 min to about 120 min. In some embodiments, one or more food components is heated for about 80 min to about 110 min. In some embodiments, one or more food components is heated for about 80 min to about 100 min. In some embodiments, one or more food components is heated for about 80 min to about 90 min. In some embodiments, one or more food components is heated for about 90 min to about 120 min. In some embodiments, one or more food components is heated for about 90 min to about 110 min. In some embodiments, one or more food components is heated for about 90 min to about 100 min. In some embodiments, one or more food components is heated for about 100 min to about 120 min. In some embodiments, one or more food components is heated for about 100 min to about 110 min. In some embodiments, one or more food components is heated for about 110 min to about 120 min.

[0228]

[0231] In some embodiments, one or more food components is heated for about 60 min. In some embodiments, one or more food components is heated for about 70 min. In some embodiments, one or more food components is heated for about 80 min. In some embodiments, one or more food components is heated for about 90 min. In some embodiments, one or more food components is heated for about 100 min. In some embodiments, one or more food components is heated for about 1 10 min. In some embodiments, one or more food components is heated for about 120 min.

[0229]

[0232] In some embodiments, one or more food components is heat-treated at a pH of about 5 to about 8. In some embodiments, one or more food components is heat-treated at a pH of about 5.5 to about 8. In some embodiments, one or more food components is heat-treated at a pH of about 6 to about 8. In some embodiments, one or more food components is heat-treated at a pH of about 6.5 to about 8. In some embodiments, one or more food components is heat- treated at a pH of about 7 to about 8. In some embodiments, one or more food components is heat-treated at a pH of about 7.5 to about 8. In some embodiments, one or more food components is heat-treated at a pH of about 5 to about 7.5. In some embodiments, one or more food components is heat-treated at a pH of about 5.5 to about 7.5. In some embodiments, one or more food components is heat-treated at a pH of about 6 to about 7.5. In some embodiments, one or more food components is heat-treated at a pH of about 6.5 to about 7.5. In some embodiments, one or more food components is heat-treated at a pH of about 7 to about 7.5. In some embodiments, one or more food components is heat-treated at a pH of about 5 to about 7. In some embodiments, one or more food components is heat-treated at a pH of about 5.5 to about 7. In some embodiments, one or more food components is heat-treated at a pH of about 6 to about 7. In some embodiments, one or more food components is heat-treated at a pH of about 6.5 to about 7. In some embodiments, one or more food components is heat-treated at a pH of about 5 to about 6.5. In some embodiments, one or more food components is heat-treated at a pH of about 5.5 to about 6.5. In some embodiments, one or more food components is heat- treated at a pH of about 6 to about 6.5. In some embodiments, one or more food components is heat-treated at a pH of about 5 to about 6. In some embodiments, one or more food components is heat-treated at a pH of about 5.5 to about 6. In some embodiments, one or more food components is heat-treated at a pH of about 5 to about 5.5.

[0230]

[0233] In some embodiments, one or more food components is heat-treated at a pH of about 5. In some embodiments, one or more food components is heat-treated at a pH of about 5.5. In some embodiments, one or more food components is heat-treated at a pH of about 6. In some embodiments, one or more food components is heat-treated at a pH of about 6.3. In some embodiments, one or more food components is heat-treated at a pH of about 6.5. In some embodiments, one or more food components is heat-treated at a pH of about 6.8. In some embodiments, one or more food components is heat-treated at a pH of about 7. In some embodiments, one or more food components is heat-treated at a pH of about 7.5. In some embodiments, one or more food components is heat-treated at a pH of about 8.

[0231]

[0234] In some embodiments, one or more food components comprises a heat-treated protein, polypeptide, peptide, amino acid, carbohydrate, sugar, monosaccharide, polysaccharide, dietary fiber, fat, fatty acid, lipid, nutrient, nutraceutical, macronutrient, micronutrient, vitamin, mineral, polypeptide, carotenoid, element, ketone body, prebiotic (e.g., prebiotic fiber), flavonoid, antioxidant, electrolyte, salt, circadian rhythm modulator, supplement, nootropic, or energy source.

[0232]

[0235] In some embodiments, a formulated composition of the present disclosure comprises about 50% to 99% (w / w), about 55% to 99% (w / w), about 60% to 99% (w / w), about 65% to 99% (w / w), about 70% to 99% (w / w), about 75% to 99% (w / w), about 80% to 99% (w / w), about 85% to 99% (w / w), about 90% to 99% (w / w), about 95% to 99% (w / w), about 50% to 98% (w / w), about 55% to 98% (w / w), about 60% to 98% (w / w), about 65% to 98% (w / w), about 70% to 98% (w / w), about 75% to 98% (w / w), about 80% to 98% (w / w), about 85% to 98% (w / w), about 90% to 98% (w / w), about 95% to 98% (w / w), about 50% to 97% (w / w), about 55% to 97% (w / w), about 60% to 97% (w / w), about 65% to 97% (w / w), about 70% to 97% (w / w), about 75% to 97% (w / w), about 80% to 97% (w / w), about 85% to 97% (w / w), about 90% to 97% (w / w), about 95% to 97% (w / w), about 50% to 96% (w / w), about 55% to 96% (w / w), about 60% to 96% (w / w), about 65% to 96% (w / w), about 70% to 96% (w / w), about 75% to 96% (w / w), about 80% to 96% (w / w), about 85% to 96% (w / w), about 90% to 96% (w / w), about 95% to 96% (w / w), about 50% to 95% (w / w), about 55% to 95% (w / w), about 60% to 95% (w / w), about 65% to 95% (w / w), about 70% to 95% (w / w), about 75% to 95% (w / w), about 80% to 95% (w / w), about 85% to 95% (w / w), about 90% to 95% (w / w), 50% to 90% (w / w), about 55% to 90% (w / w), about 60% to 90% (w / w), about 65% to 90% (w / w), about 70% to 90% (w / w), about 75% to 90% (w / w), about 80% to 90% (w / w), about 85% to 90% (w / w), about 50% to 85% (w / w), about 55% to 85% (w / w), about 60% to 85% (w / w), about 65% to 85% (w / w), about 70% to 85% (w / w), about 75% to 85% (w / w), about 80% to 85% (w / w), about 50% to 80% (w / w), about 55% to 80% (w / w), about 60% to 80% (w / w), about 65% to 80% (w / w), about 70% to 80% (w / w), about 75% to 80% (w / w), about 50% to 75% (w / w), about 55% to 75% (w / w), about 60% to 75% (w / w), about 65% to 75% (w / w), about 70% to 75% (w / w), about 50% to 70% (w / w), about 55% to 70% (w / w), about 60% to 70% (w / w), about 65% to 70% (w / w), about 50% to 65% (w / w), about 55% to 65% (w / w), about 60% to 65% (w / w), about 50% to 60% (w / w), about 55% to 60% (w / w), or about 50% to 55% of one or more heat-treated food components. For example, in some embodiments, a formulated composition comprises about 60% to 98% (w / w) of one or more heat-treated food components.

[0233]

[0236] In some embodiments, one or more food components comprises a heat-treated protein. In some embodiments, a heat treatment comprises heating an about 1% to 30% (w / v), 5% to 30% (w / v), 10% to 30% (w / v), 15% to 30% (w / v), 20% to 30% (w / v), 25% to 30% (w / v), 1% to 25% (w / v), 5% to 25% (w / v), 10% to 25% (w / v), 15% to 25% (w / v), 20% to 25% (w / v), 1% to 20% (w / v), 5% to 20% (w / v), 10% to 20% (w / v), 15% to 20% (w / v), 1% to 15% (w / v), 5% to 15% (w / v), 10% to 15% (w / v), 1% to 10% (w / v), 5% to 10% (w / v), or 1% to 5% (w / v) solution of protein. For example, in some embodiments, a heat treatment comprises heating an about 8% to 15% (w / v) solution of protein.

[0234]

[0237] In some embodiments, a heat treatment comprises heating a protein solution to a temperature of about 50 °C to 150 °C, 60 °C to 150 °C, 70 °C to 150 °C, 80 °C to 150 °C, 90 °C to 150 °C, 100 °C to 150 °C, 110 °C to 150 °C, 120 °C to 150 °C, 130 °C to 150 °C, 140 °C to 150 °C, 50 °C to 100 °C, 60 °C to 100 °C, 70 °C to 100 °C, 80 °C to 100 °C, or 90 °C to 100 °C. For example, in some embodiments, a heat treatment comprises heating a protein solution to a temperature of about 60 °C to 140 °C.

[0235]

[0238] In some embodiments, a heat treatment comprises heating a protein solution for about 20 min. to 160 min., 40 min. to 160 min., 60 min. to 160 min., 80 min. to 160 min., 100 min. to 160 min., 120 min. to 160 min., 140 min. to 160 min., 20 min. to 140 min., 40 min. to 140 min., 60 min. to 140 min., 80 min. to 140 min., 100 min. to 140 min., 120 min. to 140 min., 20 min. to 120 min., 40 min. to 120 min., 60 min. to 120 min., 80 min. to 120 min., 100 min. to 120 min., 20 min. to 100 min., 40 min. to 100 min., 60 min. to 100 min., 80 min. to 100 min., 20 min. to 80 min., 40 min. to 80 min., 60 min. to 80 min., 20 min. to 60 min., 40 min. to 60 min., or 20 min. to 40 min. For example, in some embodiments, a heat treatment comprises heating a protein solution for about 60 min. to 120 min.

[0239] In some embodiments, a heat treatment comprises heating a protein solution at a pH of about 4 to 10, 5 to 10, 6 to 10, 7 to 10, 8 to 10, 9 to 10, 4 to 9, 5 to 9, 6 to 9, 7 to 9, 8 to 9, 4 to 8, 5 to 8, 6 to 8, 7 to 8, 4 to 7, 5 to 7, 6 to 7, 4 to 6, 5 to 6, or 4 to 5. For example, in some embodiments, a heat treatment comprises heating a protein solution at a pH of about 5 to 8.

[0236]

[0240] In some embodiments, a heat treatment comprises heating an about 8% to 15% (w / v) solution of protein at pH 5 to 8, to a temperature of about 60 °C to 140 °C for about 60 min. to 120 min.

[0237]

[0241] In some embodiments, a heat treatment comprises heating a protein solution that is left standing (e.g., no agitation). In some embodiments, a heat treatment comprises heating a protein solution that is agitated by techniques including, but not limited to, overhead stirring, high shear homogenization, high pressure homogenization, ultrasonic homogenization, magnetic stir bar, or a combination thereof.

[0238]

[0242] Without wishing to be bound by any particular theory, in some embodiments, heat-treating a protein solution at a concentration of about 8% to 15% (w / v) in the presence of one or more volatile acids achieves formulated compositions characterized as having an extended duration of release of the heat-treated protein.

[0239]

[0243] In some embodiments, a formulated composition of the present disclosure comprises about 50% to 99% (w / w), about 55% to 99% (w / w), about 60% to 99% (w / w), about 65% to 99% (w / w), about 70% to 99% (w / w), about 75% to 99% (w / w), about 80% to 99% (w / w), about 85% to 99% (w / w), about 90% to 99% (w / w), about 95% to 99% (w / w), about 50% to 98% (w / w), about 55% to 98% (w / w), about 60% to 98% (w / w), about 65% to 98% (w / w), about 70% to 98% (w / w), about 75% to 98% (w / w), about 80% to 98% (w / w), about 85% to 98% (w / w), about 90% to 98% (w / w), about 95% to 98% (w / w), about 50% to 97% (w / w), about 55% to 97% (w / w), about 60% to 97% (w / w), about 65% to 97% (w / w), about 70% to 97% (w / w), about 75% to 97% (w / w), about 80% to 97% (w / w), about 85% to 97% (w / w), about 90% to 97% (w / w), about 95% to 97% (w / w), about 50% to 96% (w / w), about 55% to 96% (w / w), about 60% to 96% (w / w), about 65% to 96% (w / w), about 70% to 96% (w / w), about 75% to 96% (w / w), about 80% to 96% (w / w), about 85% to 96% (w / w), about 90% to 96% (w / w), about 95% to 96% (w / w), about 50% to 95% (w / w), about 55% to 95% (w / w), about 60% to 95% (w / w), about 65% to 95% (w / w), about 70% to 95% (w / w), about 75% to 95% (w / w), about 80% to 95% (w / w), about 85% to 95% (w / w), about 90% to 95% (w / w), 50% to 90% (w / w), about 55% to 90% (w / w), about 60% to 90% (w / w), about 65% to 90% (w / w), about 70% to 90% (w / w), about 75% to 90% (w / w), about 80% to 90% (w / w), about 85% to 90% (w / w), about 50% to 85% (w / w), about 55% to 85% (w / w), about 60% to 85% (w / w), about 65% to 85% (w / w), about 70% to 85% (w / w), about 75% to 85% (w / w), about 80% to 85% (w / w), about 50% to 80% (w / w), about 55% to 80% (w / w), about 60% to 80% (w / w), about 65% to 80% (w / w), about 70% to 80% (w / w), about 75% to 80% (w / w), about 50% to 75% (w / w), about 55% to 75% (w / w), about 60% to 75% (w / w), about 65% to 75% (w / w), about 70% to 75% (w / w), about 50% to 70% (w / w), about 55% to 70% (w / w), about 60% to 70% (w / w), about 65% to 70% (w / w), about 50% to 65% (w / w), about 55% to 65% (w / w), about 60% to 65% (w / w), about 50% to 60% (w / w), about 55% to 60% (w / w), or about 50% to 55% of a heat-treated protein. For example, in some embodiments, a formulated composition comprises about 60% to 98% (w / w) of a heat-treated protein.

[0240]

[0244] In some embodiments, a formulated composition of the present disclosure is heat- treated. In some embodiments, a formulated composition is heat-treated at about 70 °C to about 120 °C, about 80 °C to about 120 °C, about 90 °C to about 120 °C, about 100 °C to about 120 °C, about 110 °C to about 120 °C, about 70 °C to about 110 °C, about 80 °C to about 110 °C, about 90 °C to about 110 °C, about 100 °C to about 110 °C, about 70 °C to about 100 °C, about 80 °C to about 100 °C, about 90 °C to about 100 °C, about 70 °C to about 90 °C, about 80 °C to about 90 °C, or about 70 °C to about 80 °C. For example, in some embodiments, a formulated composition is heat-treated at about 70 °C, about 72 °C, about 74 °C, about 76 °C, about 78 °C, about 80 °C, about 82 °C, about 84 °C, about 86 °C, about 88 °C, about 90 °C, about 92 °C, about 94 °C, about 96 °C, about 98 °C, about 100 °C, about 102 °C, about 104 °C, about 106 °C, about 108 °C, about 110 °C, about 112 °C, about 114 °C, about 116 °C, about 118 °C, or about 120 °C.

[0241]

[0245] In some embodiments, a formulated composition is heat-treated for about 60 minutes to about 120 minutes, about 70 minutes to about 120 minutes, about 80 minutes to about 120 minutes, about 90 minutes to about 120 minutes, about 100 minutes to about 120 minutes, about 110 minutes to about 120 minutes, about 60 minutes to about 110 minutes, about 70 minutes to about 110 minutes, about 80 minutes to about 110 minutes, about 90 minutes to about 110 minutes, about 100 minutes to about 110 minutes, about 60 minutes to about 100 minutes, about 70 minutes to about 100 minutes, about 80 minutes to about 100 minutes, about 90 minutes to about 100 minutes, about 60 minutes to about 90 minutes, about 70 minutes to about 90 minutes, about 80 minutes to about 90 minutes, about 60 minutes to about 80 minutes, about 70 minutes to about 80 minutes, or about 60 minutes to about 70 minutes. For example, in some embodiments, a formulated composition is heat-treated for about 60 minutes, about 65 minutes, about 70 minutes, about 75 minutes, about 80 minutes, about 85 minutes, about 90 minutes, about 100 minutes, about 105 minutes, about 110 minutes, about 115 minutes, or about 120 minutes.

[0242] In some embodiments, a formulated composition is heat-treated at about pH 4 to about pH 8, about pH 4.5 to pH 8, about pH 5 to pH 8, about pH 5.5 to pH 8, about pH 6 to pH 8, about pH 6.5 to pH 8, about pH 7 to pH 8, about pH 7.5 to pH 8, about pH 4 to about pH 7.5, about pH 4.5 to pH 7.5, about pH 5 to pH 7.5, about pH 5.5 to pH 7.5, about pH 6 to pH 7.5, about pH 6.5 to pH 7.5, about pH 7 to pH 7.5, about pH 4 to about pH 7, about pH 4.5 to pH 7, about pH 5 to pH 7, about pH 5.5 to pH 7, about pH 6 to pH 7, about pH 6.5 to pH 7, about pH 4 to about pH 6.5, about pH 4.5 to pH 6.5, about pH 5 to pH 6.5, about pH 5.5 to pH 6.5, about pH 6 to pH 6.5, about pH 4 to about pH 6.5, about pH 4.5 to pH 6.5, about pH 5 to pH 6.5, about pH 5.5 to pH 6.5, about pH 6 to pH 6.5, about pH 4 to about pH 6, about pH 4.5 to pH 6, about pH 5 to pH 6, about pH 5.5 to pH 6, about pH 4 to about pH 5.5, about pH 4.5 to pH 5.5, about pH 5 to pH 5.5, about pH 4 to about pH 5, about pH 4.5 to pH 5, or about pH 4 to about pH 4.5. In some embodiments, a formulated composition is heat-treated at about pH 4, about pH 4.5, about pH 5, about pH 5.5, about pH 6, about pH 6.5, about pH 7, about pH 7.5, or about pH 8.

[0243] B. Release Modulators

[0244]

[0246] In some embodiments, a formulated composition of the present disclosure comprises one or more release modulators. In some embodiments, a release modulator can control the release of one or more food components from a formulated composition of the present disclosure. In some embodiments, a release modulator can extend the duration of release of one or more food components from a formulated composition of the present disclosure.

[0245]

[0247] In some embodiments, a release modulator can interact with one or more food components to prevent water from accessing or interacting with the one or more food components. For example, in some embodiments, a release modulator can interact with a protein (e.g., a heat-treated protein) in a formulated composition to prevent water from accessing or interacting with one or more food components in said formulation.

[0246]

[0248] In some embodiments, a release modulator can interact with one or more food components to prevent an enzyme (e.g., a digestive enzyme) from accessing or interacting with the one or more food components. For example, in some embodiments, a release modulator can interact with a protein (e.g., a heat-treated protein) in a formulated composition to prevent an enzyme (e.g., a digestive enzyme) from accessing or interacting with one or more food components in said formulation.

[0247]

[0249] In some embodiments, a release modulator may comprise one or more release modulator components. In some embodiments, one or more release modulators and / or release modulator components comprise Pluronic™ F68, sucrose palmitate, triacetin, gum arabic, Tween™ 85, Span™ 60, glucose, dicalcium phosphate, calcium carbonate, gluconolactone, sodium alginate, low methoxyl pectins, shellac, hypromellose acetate succinate, rice starch, maltodextrins, oat fiber, inulin, carrageenans, or a combination thereof. In some embodiments, a release modulator is Pluronic™ F68. In some embodiments, a release modulator is sucrose palmitate. In some embodiments, a release modulator is glucose. In some embodiments, a release modulator is triacetin. In some embodiments, a release modulator is gum arabic. In some embodiments, a release modulator is Tween™ 85. In some embodiments, a release modulator is Span™ 60.

[0248]

[0250] In some embodiments, a formulated composition of the present disclosure comprises one or more release modulators that chemically interact with one or more food components. For example, in some embodiments, one or more release modulators chemically interact with a heat-treated protein. In some embodiments, one or release modulators comprising hypromellose acetate succinate, rice starch, glucose, maltodextrins, oat fiber, inulin, carrageenans, or a combination thereof, chemically interact with a heat-treated protein (e.g., heat-treated whey protein isolate).

[0249]

[0251] In some embodiments, a formulated composition of the present disclosure comprises 1 or more release modulators. In some embodiments, a formulated composition of the present disclosure comprises 1 to 25, 5 to 25, 10 to 25, 15 to 25, 20 to 25, 1 to 20, 5 to 20, 10 to 20, 15 to 20, 1 to 15, 5 to 15, 10 to 15, 1 to 10, 5 to 10, or 1 to 5 release modulators or release modulator components. For example, in some embodiments, a formulated composition of the present disclosure comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 release modulators or release modulator components.

[0250]

[0252] In some embodiments, a formulated composition of the present disclosure comprises about 1% to 50% (w / w), 2% to 50%, 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 1% to 45% (w / w), 2% to 45%, 5% to 45% (w / w), 10% to 45% (w / w), 15% to 45% (w / w), 20% to 45% (w / w), 25% to 45% (w / w), 30% to 45% (w / w), 35% to 45% (w / w), 40% to 45% (w / w), 1% to 40% (w / w), 2% to 40%, 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 1% to 35% (w / w), 2% to 35%, 5% to 35% (w / w), 10% to 35% (w / w), 15% to 35% (w / w), 20% to 35% (w / w), 25% to 35% (w / w), 30% to 35% (w / w), 1% to 30% (w / w), 2% to 30%, 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 1% to 25% (w / w), 2% to 25%, 5% to 25% (w / w), 10% to 25% (w / w), 15% to 25% (w / w), 20% to 25% (w / w), 1% to 20% (w / w), 2% to 20%, 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), 1% to 15% (w / w), 2% to 150%, 5% to 15% (w / w), 10% to 15% (w / w), 1% to 10% (w / w), 5% to 10% (w / w), 1% to 5% (w / w) or 2% to 5% (w / w) of one or more release modulators. For example, in some embodiments, a formulated composition of the present disclosure comprises about 1% (w / w), 2% (w / w), 3% (w / w), 4% (w / w), 5% (w / w), 6% (w / w), 7% (w / w), 8% (w / w), 9% (w / w), 10% (w / w), 11% (w / w), 12% (w / w), 13% (w / w), 14% (w / w), 15% (w / w), 16% (w / w), 17% (w / w), 18% (w / w), 19% (w / w), 20% (w / w), 21% (w / w), 22% (w / w), 23% (w / w), 24% (w / w), 25% (w / w), 26% (w / w), 27% (w / w), 28% (w / w), 29% (w / w), 30% (w / w), 31% (w / w), 32% (w / w), 33% (w / w), 34% (w / w), 35% (w / w), 36% (w / w), 37% (w / w), 38% (w / w), 39% (w / w), 40% (w / w), 41% (w / w), 42% (w / w), 43% (w / w), 44% (w / w), 45% (w / w), 46% (w / w), 47% (w / w), 48% (w / w), 49% (w / w), or 50% (w / w) of one or more release modulators.

[0251]

[0253] In some embodiments, one or more release modulators may be characterized as having one or more physicochemical properties (e.g., pH, viscosity, osmolarity, etc.) that are conducive to mixture with one or more food components (e.g., more homogeneous incorporation), long-term storage, incorporation into one or more food and / or beverage products (c.g., protein powder), or a combination thereof.

[0252] 1. Interpenetrating Polymer Networks

[0253]

[0254] In some embodiments, one or more release modulator comprises an interpenetrating polymer network. In some embodiments, two or more release modulator components form an interpenetrating polymer network. In some embodiments, one or more release modulator components capable of forming interpenetrating polymer networks comprise dicalcium phosphate, calcium carbonate, gluconolactone, sodium alginate, low methoxyl pectins, shellac, carrageenans, or a combination thereof. In some embodiments, an interpenetrating network comprises a hydrogel. In some embodiments, an interpenetrating polymer network comprises an alginate hydrogel. In some embodiments, an interpenetrating polymer network comprises a hydrogel and an additional release modular component. In some embodiments, an interpenetrating polymer network comprises a hydrogel and 2 additional release modular components. In some embodiments, an interpenetrating polymer network comprises a hydrogel and 3 additional release modular components. In some embodiments, an interpenetrating polymer network comprises a hydrogel and 4 additional release modular components. In some embodiments an interpenetrating polymer network may physically and / or chemically interact with one or more food components in a formulated composition. In some embodiments an interpenetrating polymer network does not physically and / or chemically interact with one or more food components in a formulated composition. In some embodiments, an interpenetrating network controls the release of one or more food components from a formulated composition of the present disclosure. In some embodiments, an interpenetrating network extends the duration of release of one or more food components from a formulated composition of the present disclosure.

[0254]

[0255] In some embodiments, mixture of one or more food components with one or more release modulators forms a gel. In some embodiments, the elastic modulus of an aqueous mixture of one or more food components and one or more release modulators increases by less than 2-fold over a period of at least about 30 minutes to 12 hours, at least about 1 hour to 12 hours, at least about 2 hours to 12 hours, at least about 4 hours to 12 hours, at least about 6 hours to 12 hours, at least about 8 hours to 12 hours, or at least about 10 hours to 12 hours upon standing at a temperature of about 2 °C to about 30 °C.

[0255]

[0256] In some embodiments, the elastic modulus of an aqueous mixture of one or more food components and one or more release modulators increases by less than 4-fold over a period of at least about 30 minutes to 12 hours, at least about 1 hour to 12 hours, at least about 2 hours to 12 hours, at least about 4 hours to 12 hours, at least about 6 hours to 12 hours, at least about 8 hours to 12 hours, or at least about 10 hours to 12 hours upon standing at a temperature of about 2 °C to about 30 °C

[0256]

[0257] In some embodiments, the elastic modulus of an aqueous mixture of one or more food components and one or more release modulators increases by less than 8-fold over a period of at least about 30 minutes to 12 hours, at least about 1 hour to 12 hours, at least about 2 hours to 12 hours, at least about 4 hours to 12 hours, at least about 6 hours to 12 hours, at least about 8 hours to 12 hours, or at least about 10 hours to 12 hours upon standing at a temperature of about 2 °C to about 30 °C.

[0257]

[0258] In some embodiments, the elastic modulus of an aqueous mixture of one or more food components and one or more release modulators increases by at least 2-fold over a period of at least about 30 minutes to 12 hours, at least about 1 hour to 12 hours, at least about 2 hours to 12 hours, at least about 4 hours to 12 hours, at least about 6 hours to 12 hours, at least about 8 hours to 12 hours, or at least about 10 hours to 12 hours upon standing at a temperature of about 2 °C to about 30 °C.

[0258]

[0259] In some embodiments, the elastic modulus of an aqueous mixture of one or more food components and one or more release modulators increases by at least 4-fold over a period of at least about 30 minutes to 12 hours, at least about 1 hour to 12 hours, at least about 2 hours to 12 hours, at least about 4 hours to 12 hours, at least about 6 hours to 12 hours, at least about 8 hours to 12 hours, or at least about 10 hours to 12 hours upon standing at a temperature of about 2 °C to about 30 °C.

[0259]

[0260] In some embodiments, the elastic modulus of an aqueous mixture of one or more food components and one or more release modulators increases by at least 8-fold over a period of at least about 30 minutes to 12 hours, at least about 1 hour to 12 hours, at least about 2 hours to 12 hours, at least about 4 hours to 12 hours, at least about 6 hours to 12 hours, at least about 8 hours to 12 hours, or at least about 10 hours to 12 hours upon standing at a temperature of about 2 °C to about 30 °C.

[0260]

[0261] In some embodiments, the elastic modulus of an aqueous mixture of one or more food components and one or more release modulators increases by at least 10-fold over a period of at least about 30 minutes to 12 hours, at least about 1 hour to 12 hours, at least about 2 hours to 12 hours, at least about 4 hours to 12 hours, at least about 6 hours to 12 hours, at least about 8 hours to 12 hours, or at least about 10 hours to 12 hours upon standing at a temperature of about 2 °C to about 30 °C.

[0261]

[0262] Without wishing to be bound by any particular theory, it is contemplated that the longer it takes for a mixture of one or more food components and one or more release modulators to increase its elastic modulus (i.e., gel), the more homogeneous the resulting interpenetrating polymer network.

[0262]

[0263] In some embodiments, one or more food components and one or more release modulators are heat-treated together to form an interpenetrating polymer network. In some embodiments, a mixture of one or more food components and one or more release modulators is heated to about 85 °C to 105 °C, 90 °C to 105 °C, 95 °C to 105 °C, 100 °C to 105 °C, 85 °C to 100 °C, 90 °C to 100 °C, 95 °C to 100 °C, 85 °C to 95 °C, 90 °C to 95 °C, or 85 °C to 90 °C. For example, in some embodiments a mixture of one or more food components and one or more release modulators is heated to about 90 °C, 91 °C, 92 °C, 93 °C, 94 °C, 95 °C, 96 °C, 97 °C,

[0263] 98 °C, 99 °C, or 100 °C.

[0264]

[0264] In some embodiments, a mixture of one or more food components and one or more release modulators is heated for about 1 hour to 3 hours, 1.5 hours to 3 hours, 2 hours to 3 hours, 2.5 hours to 3 hours, I hour to 2.5 hours, 1.5 hours to 2.5 hours, 2 hours to 2.5 hours, 1 hour to 2 hours, 1.5 hours to 2 hours, or 1 hour to 1.5 hours. For example, in some embodiments a mixture of one or more food components and one or more release modulators is heated for about 1 hours, 1.5 hours, 2 hours, 2.5 hours, or 3 hours.

[0265]

[0265] In some embodiments, a mixture of one or more food components and one or more release modulators is heated without agitation. In some embodiments, a mixture of one or more food components and one or more release modulators is heated with agitation. In some embodiments, a mixture of one or more food components and one or more release modulators is heated in one or more batch processes. Tn some embodiments, a mixture of one or more food components and one or more release modulators is heated in a continuous process.

[0266]

[0266] In some embodiments, a heat-treated protein (e.g., heat-treated whey protein isolated) is mixed with one or more release modulators to form a crosslinked (e.g., calcium crosslinked) gelatinous polymer network. In some embodiments, a mixture of a protein (e.g., a whey protein isolate) and one or more release modulators is heated to about 95 °C for about 2 hours to form an interpenetrating polymer network.

[0267]

[0267] In some embodiments, a release modulator or release modulator component comprises a hydrocolloid. In some embodiments, a hydrocolloid comprises pectin, alginate, carrageenan, or a combination thereof.

[0268]

[0268] In some embodiments, a formulated composition comprises about 5% (w / w) to about 50% (w / w), about 10% (w / w) to about 50% (w / w), about 15% (w / w) to about 50% (w / w), about 20% (w / w) to about 50% (w / w), about 25% (w / w) to about 50% (w / w), about 30% (w / w) to about 50% (w / w), about 35% (w / w) to about 50% (w / w), about 40% (w / w) to about 50% (w / w), about 45% (w / w) to about 50% (w / w), about 5% (w / w) to about 45% (w / w), about 10% (w / w) to about 45% (w / w), about 15% (w / w) to about 45% (w / w), about 20% (w / w) to about 45% (w / w), about 25% (w / w) to about 45% (w / w), about 30% (w / w) to about 45% (w / w), about 35% (w / w) to about 45% (w / w), about 40% (w / w) to about 45% (w / w), about 5% (w / w) to about 40% (w / w), about 10% (w / w) to about 40% (w / w), about 15% (w / w) to about 40% (w / w), about 20% (w / w) to about 40% (w / w), about 25% (w / w) to about 40% (w / w), about 30% (w / w) to about 40% (w / w), about 35% (w / w) to about 40% (w / w), about 5% (w / w) to about 35% (w / w), about 10% (w / w) to about 35% (w / w), about 15% (w / w) to about 35% (w / w), about 20% (w / w) to about 35% (w / w), about 25% (w / w) to about 35% (w / w), about 30% (w / w) to about 35% (w / w), about 5% (w / w) to about 30% (w / w), about 10% (w / w) to about 30% (w / w), about 15% (w / w) to about 30% (w / w), about 20% (w / w) to about 30% (w / w), about 25% (w / w) to about 30% (w / w), about 5% (w / w) to about 25% (w / w), about 10% (w / w) to about 25% (w / w), about 15% (w / w) to about 25% (w / w), about 20% (w / w) to about 25% (w / w), about 5% (w / w) to about 20% (w / w), about 10% (w / w) to about 20% (w / w), about 15% (w / w) to about 20% (w / w), about 5% (w / w) to about 15% (w / w), about 10% (w / w) to about 15% (w / w), about 5% (w / w) to about 10% (w / w), or about 5% (w / w) to about 10% (w / w) hydrocolloid. In some embodiments, a formulated composition comprises about 5% (w / w), about 10% (w / w), about 15% (w / w), about 20% (w / w), about 25% (w / w), about 30% (w / w), about 35% (w / w), about 40% (w / w), about 45% (w / w), or about 50% (w / w) hydrocolloid.

[0269]

[0269] In some embodiments, a release modulator or release modulator component comprises a gelator. In some embodiments, a gelator comprises dicalcium phosphate, gluconolactone, calcium carbonate, or a combination thereof.

[0270]

[0270] In some embodiments, a formulated composition comprises about 1% (w / w) to about 20% (w / w), about 2% (w / w) to about 20% (w / w), about 4% (w / w) to about 20% (w / w), about 6% (w / w) to about 20% (w / w), about 8% (w / w) to about 20% (w / w), about 10% (w / w) to about 20% (w / w), about 12% (w / w) to about 20% (w / w), about 14% (w / w) to about 20% (w / w), about 16% (w / w) to about 20% (w / w), about 18% (w / w) to about 20% (w / w), 1% (w / w) to about 15% (w / w), about 2% (w / w) to about 15% (w / w), about 4% (w / w) to about 15% (w / w), about 6% (w / w) to about 15% (w / w), about 8% (w / w) to about 15% (w / w), about 10% (w / w) to about 15% (w / w), about 12% (w / w) to about 15% (w / w), about 14% (w / w) to about 15% (w / w), about 1% (w / w) to about 10% (w / w), about 2% (w / w) to about 10% (w / w), about 4% (w / w) to about 10% (w / w), about 6% (w / w) to about 10% (w / w), about 8% (w / w) to about 10% (w / w), about 1% (w / w) to about 5% (w / w), about 2% (w / w) to about 5% (w / w), about 4% (w / w) to about 5%, or about 1% (w / w) to about 2% (w / w) gelator. In some embodiments, , a formulated composition comprises about 1 % (w / w), about 2% (w / w), about 4% (w / w), about 6% (w / w), about 8% (w / w), about 10% (w / w), about 12% (w / w), about 14% (w / w), about 16% (w / w), about 18% (w / w), or about 20% (w / w) gelator.

[0271]

[0271] In some embodiments, a release modulator comprises about 7.5 parts (w / w) or less of hydrocolloid to about 1 part (w / w) of gelator (e.g., about 7.5 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 7 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 6.5 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 6 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 5.5 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 5 pails (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 4.5 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 4 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 3.5 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 3 pails (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 2.5 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 2 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, about 1.5 parts (w / w) of hydrocolloid to about 1 part (w / w) of gelator, or about 1 part (w / w) of hydrocolloid to about 1 part (w / w) of gelator).

[0272]

[0272] In some embodiments, a formulated composition comprises about 5% (w / w) to about 50% (w / w), about 10% (w / w) to about 50% (w / w), about 15% (w / w) to about 50% (w / w), about 20% (w / w) to about 50% (w / w), about 25% (w / w) to about 50% (w / w), about 30% (w / w) to about 50% (w / w), about 35% (w / w) to about 50% (w / w), about 40% (w / w) to about 50% (w / w), about 45% (w / w) to about 50% (w / w), about 5% (w / w) to about 45% (w / w), about 10% (w / w) to about 45% (w / w), about 15% (w / w) to about 45% (w / w), about 20% (w / w) to about 45% (w / w), about 25% (w / w) to about 45% (w / w), about 30% (w / w) to about 45% (w / w), about 35% (w / w) to about 45% (w / w), about 40% (w / w) to about 45% (w / w), about 5% (w / w) to about 40% (w / w), about 10% (w / w) to about 40% (w / w), about 15% (w / w) to about 40% (w / w), about 20% (w / w) to about 40% (w / w), about 25% (w / w) to about 40% (w / w), about 30% (w / w) to about 40% (w / w), about 35% (w / w) to about 40% (w / w), about 5% (w / w) to about 35% (w / w), about 10% (w / w) to about 35% (w / w), about 15% (w / w) to about 35% (w / w), about 20% (w / w) to about 35% (w / w), about 25% (w / w) to about 35% (w / w), about 30% (w / w) to about 35% (w / w), about 5% (w / w) to about 30% (w / w), about 10% (w / w) to about 30% (w / w), about 15% (w / w) to about 30% (w / w), about 20% (w / w) to about 30% (w / w), about 25% (w / w) to about 30% (w / w), about 5% (w / w) to about 25% (w / w), about 10% (w / w) to about 25% (w / w), about 15% (w / w) to about 25% (w / w), about 20% (w / w) to about 25% (w / w), about 5% (w / w) to about 20% (w / w), about 10% (w / w) to about 20% (w / w), about 15% (w / w) to about 20% (w / w), about 5% (w / w) to about 15% (w / w), about 10% (w / w) to about 15% (w / w), about 5% (w / w) to about 10% (w / w), or about 5% (w / w) to about 10% (w / w) alginate. In some embodiments, a formulated composition comprises about 5% (w / w), about 10% (w / w), about 15% (w / w), about 20% (w / w), about 25% (w / w), about 30% (w / w), about 35% (w / w), about 40% (w / w), about 45% (w / w), or about 50% (w / w) alginate.

[0273]

[0273] In some embodiments, a formulated composition comprises about 0.5% (w / w) to about 1.5% (w / w), about 0.75% (w / w) to about 1.5% (w / w), about 1% (w / w) to about 1.5% (w / w), about 1.25% (w / w) to about 1.5% (w / w), about 0.5% (w / w) to about 1.25% (w / w), about 0.75% (w / w) to about 1 .25% (w / w), about 1 % (w / w) to about 1 .25% (w / w), about 0.5% (w / w) to about 1% (w / w), about 0.75% (w / w) to about 1% (w / w), or about 0.5% (w / w) to about 0.75% (w / w) alginate. In some embodiments, a formulated composition comprises about 0.5% (w / w), about 0.75% (w / w), about 1% (w / w), about 1.25% (w / w), or about 1.5% (w / w) alginate.

[0274]

[0274] In some embodiments, a formulated composition comprises about 5% (w / w) to about 50% (w / w), about 10% (w / w) to about 50% (w / w), about 15% (w / w) to about 50% (w / w), about 20% (w / w) to about 50% (w / w), about 25% (w / w) to about 50% (w / w), about 30% (w / w) to about 50% (w / w), about 35% (w / w) to about 50% (w / w), about 40% (w / w) to about 50% (w / w), about 45% (w / w) to about 50% (w / w), about 5% (w / w) to about 45% (w / w), about 10% (w / w) to about 45% (w / w), about 15% (w / w) to about 45% (w / w), about 20% (w / w) to about 45% (w / w), about 25% (w / w) to about 45% (w / w), about 30% (w / w) to about 45% (w / w), about 35% (w / w) to about 45% (w / w), about 40% (w / w) to about 45% (w / w), about 5% (w / w) to about 40% (w / w), about 10% (w / w) to about 40% (w / w), about 15% (w / w) to about 40% (w / w), about 20% (w / w) to about 40% (w / w), about 25% (w / w) to about 40% (w / w), about 30% (w / w) to about 40% (w / w), about 35% (w / w) to about 40% (w / w), about 5% (w / w) to about 35% (w / w), about 10% (w / w) to about 35% (w / w), about 15% (w / w) to about 35% (w / w), about 20% (w / w) to about 35% (w / w), about 25% (w / w) to about 35% (w / w), about 30% (w / w) to about 35% (w / w), about 5% (w / w) to about 30% (w / w), about 10% (w / w) to about 30% (w / w), about 15% (w / w) to about 30% (w / w), about 20% (w / w) to about 30% (w / w), about 25% (w / w) to about 30% (w / w), about 5% (w / w) to about 25% (w / w), about 10% (w / w) to about 25% (w / w), about 15% (w / w) to about 25% (w / w), about 20% (w / w) to about 25% (w / w), about 5% (w / w) to about 20% (w / w), about 10% (w / w) to about 20% (w / w), about 15% (w / w) to about 20% (w / w), about 5% (w / w) to about 15% (w / w), about 10% (w / w) to about 15% (w / w), about 5% (w / w) to about 10% (w / w), or about 5% (w / w) to about 10% (w / w) pectin. In some embodiments, a formulated composition comprises about 5% (w / w), about 10% (w / w), about 15% (w / w), about 20% (w / w), about 25% (w / w), about 30% (w / w), about 35% (w / w), about 40% (w / w), about 45% (w / w), or about 50% (w / w) pectin.

[0275]

[0275] In some embodiments, a formulated composition comprises about 5% (w / w) to about 50% (w / w), about 10% (w / w) to about 50% (w / w), about 15% (w / w) to about 50% (w / w), about 20% (w / w) to about 50% (w / w), about 25% (w / w) to about 50% (w / w), about 30% (w / w) to about 50% (w / w), about 35% (w / w) to about 50% (w / w), about 40% (w / w) to about 50% (w / w), about 45% (w / w) to about 50% (w / w), about 5% (w / w) to about 45% (w / w), about 10% (w / w) to about 45% (w / w), about 15% (w / w) to about 45% (w / w), about 20% (w / w) to about 45% (w / w), about 25% (w / w) to about 45% (w / w), about 30% (w / w) to about 45% (w / w), about 35% (w / w) to about 45% (w / w), about 40% (w / w) to about 45% (w / w), about 5% (w / w) to about 40% (w / w), about 10% (w / w) to about 40% (w / w), about 15% (w / w) to about 40% (w / w), about 20% (w / w) to about 40% (w / w), about 25% (w / w) to about 40% (w / w), about 30% (w / w) to about 40% (w / w), about 35% (w / w) to about 40% (w / w), about 5% (w / w) to about 35% (w / w), about 10% (w / w) to about 35% (w / w), about 15% (w / w) to about 35% (w / w), about 20% (w / w) to about 35% (w / w), about 25% (w / w) to about 35% (w / w), about 30% (w / w) to about 35% (w / w), about 5% (w / w) to about 30% (w / w), about 10% (w / w) to about 30% (w / w), about 15% (w / w) to about 30% (w / w), about 20% (w / w) to about 30% (w / w), about 25% (w / w) to about 30% (w / w), about 5% (w / w) to about 25% (w / w), about 10% (w / w) to about 25% (w / w), about 15% (w / w) to about 25% (w / w), about 20% (w / w) to about 25% (w / w), about 5% (w / w) to about 20% (w / w), about 10% (w / w) to about 20% (w / w), about 15% (w / w) to about 20% (w / w), about 5% (w / w) to about 15% (w / w), about 10% (w / w) to about 15% (w / w), about 5% (w / w) to about 10% (w / w), or about 5% (w / w) to about 10% (w / w) carrageenan. In some embodiments, a formulated composition comprises about 5% (w / w), about 10% (w / w), about 15% (w / w), about 20% (w / w), about 25% (w / w), about 30% (w / w), about 35% (w / w), about 40% (w / w), about 45% (w / w), or about 50% (w / w) carrageenan.

[0276]

[0276] In some embodiments, a formulated composition comprises about 0.25% (w / w) to about 2% (w / w), about 0.5% (w / w) to about 2% (w / w), about 0.75% (w / w) to about 2% (w / w), about 1% (w / w) to about 2% (w / w), about 1.25% (w / w) to about 2% (w / w), about 1.5% (w / w) to about 2% (w / w), about 1.75% (w / w) to about 2% (w / w), about 0.25% (w / w) to about 1.75 (w / w), about 0.5% (w / w) to about 1.75 (w / w), about 0.75% (w / w) to about 1.75 (w / w), about 1% (w / w) to about 1.75 (w / w), about 1.25% (w / w) to about 1.75 (w / w), about 1.5% (w / w) to about 1.75 (w / w), about 0.25% (w / w) to about 1.5 (w / w), about 0.5% (w / w) to about 1.5 (w / w), about 0.75% (w / w) to about 1.5 (w / w), about 1% (w / w) to about 1.5 (w / w), about 1.25% (w / w) to about 1 .5 (w / w), about 0.25% (w / w) to about 1 (w / w), about 0.5% (w / w) to about 1 (w / w), about 0.75% (w / w) to about 1 (w / w), about 0.25% (w / w) to about 0.75 (w / w), about 0.5% (w / w) to about 0.75 (w / w), or about 0.25% (w / w) to about 0.5% (w / w) gluconolactone. In some embodiments, a formulated composition comprises about 0.25% (w / w), about 0.5% (w / w), about 0.75% (w / w), about 1% (w / w), about 1.25% (w / w), about 1.5% (w / w), about 1.75% (w / w), or about 2% (w / w) gluconolactone.

[0277]

[0277] In some embodiments, a formulated composition comprises about 0.25% (w / w) to about 2% (w / w), about 0.5% (w / w) to about 2% (w / w), about 0.75% (w / w) to about 2% (w / w), about 1% (w / w) to about 2% (w / w), about 1.25% (w / w) to about 2% (w / w), about 1.5% (w / w) to about 2% (w / w), about 1.75% (w / w) to about 2% (w / w), about 0.25% (w / w) to about 1.75 (w / w), about 0.5% (w / w) to about 1.75 (w / w), about 0.75% (w / w) to about 1.75 (w / w), about 1% (w / w) to about 1.75 (w / w), about 1.25% (w / w) to about 1.75 (w / w), about 1.5% (w / w) to about 1.75 (w / w), about 0.25% (w / w) to about 1 .5 (w / w), about 0.5% (w / w) to about 1 .5 (w / w), about 0.75% (w / w) to about 1.5 (w / w), about 1% (w / w) to about 1.5 (w / w), about 1.25% (w / w) to about 1.5 (w / w), about 0.25% (w / w) to about 1 (w / w), about 0.5% (w / w) to about 1 (w / w), about 0.75% (w / w) to about 1 (w / w), about 0.25% (w / w) to about 0.75 (w / w), about 0.5% (w / w) to about 0.75 (w / w), or about 0.25% (w / w) to about 0.5% (w / w) dicalcium phosphate. In some embodiments, a formulated composition comprises about 0.25% (w / w), about 0.5% (w / w), about 0.75% (w / w), about 1% (w / w), about 1.25% (w / w), about 1.5% (w / w), about 1.75% (w / w), or about 2% (w / w) dicalcium phosphate.

[0278] C. Additional Components

[0279]

[0278] In some embodiments, a formulated composition of the present disclosure comprises 1 or more components in addition to one or more food component and one or more release modulators. In some embodiments, a formulated composition of the present disclosure comprises 1 to 25, 5 to 25, 10 to 25, 15 to 25, 20 to 25, 1 to 20, 5 to 20, 10 to 20, 15 to 20, 1 to 15, 5 to 15, 10 to 15, 1 to 10, 5 to 10, or 1 to 5 components in addition to one or more food component and one or more release modulators. For example, in some embodiments, a formulated composition of the present disclosure comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 components in addition to one or more food component and one or more release modulators.

[0280] 1. Coatings

[0281]

[0279] In some embodiments, a formulated composition of the present disclosure comprises one or more coatings that encapsulates one or more food components and one or more release modulators. In some embodiments, a coating comprises one or more hydrophobic materials, one or more hydrophilic materials, or one or more amphiphilic materials.

[0282] D. Core-Shell Preparations

[0283]

[0280] In some embodiments, the present disclosure provides core-shell preparations as a means of controlling the release of one or more food components from a formulated composition. For example, in some embodiments, formulated compositions are or comprise core- shell preparations. For example, core- shell preparations may comprise a core component (e.g., interior component) and / or a shell component (e.g., coating, exterior component), each of which are essentially comprised of one or more food components, as described herein. In some embodiments, a core component is comprised of one or more food components and / or one or more release modulators. In some embodiments, a shell component is comprised of one or more food components and / or one or more release modulators.

[0284]

[0281] In some embodiments, a core-shell preparation may comprise a formulated composition comprising one or more food components and one or more release modulators arranged as a core component and one or more food components and / or one or more release modulators arranged as a shell component. In some embodiments, the one or more food components and one or more release modulators comprising a core component are additionally the one or more food components and / or one or more release modulators comprising a shell component. In some embodiments, one or more food components and one or more release modulators comprising a core component are different from the one or more food components and / or one or more release modulators comprising a shell component.

[0285]

[0282] In some embodiments, a core-shell preparation may comprise a formulated composition comprising one or more food components, one or more release modulators, and one or more additional components (e.g., one or more excipients, and / or one or more probiotics, prebiotics, or postbiotics) arranged as a core component and one or more food components, one or more release modulators, and / or one or more additional components (e.g., one or more excipients, and / or one or more probiotics, prebiotics, or postbiotics) arranged as a shell component.

[0286]

[0283] In some embodiments, one or more food components and one or more release modulators may be described as being dispersed within (e.g., embedded within) at least one shell component. In some embodiments, at least one shell component may be described as encapsulating a core component comprising one or more food components and one or more release modulators.

[0287]

[0284] In some embodiments, a core component and / or one or more shell components may be further characterized as a matrix preparation. In some embodiments, a core component and / or one or more shell components comprise a matrix preparation.

[0288]

[0285] In some embodiments, a core-shell preparation may comprise a formulated composition comprising multiple layers of one or more food components and one or more release modulators arranged as a core component and one or more food components and / or one or more release modulators arranged as at least one shell component.

[0289]

[0286] In some embodiments, a core-shell preparation may be described as being dispersed within (e.g., embedded within) one or more additional shell component. In some embodiments, one or more shell components may be described as encapsulating a core-shell preparation and / or matrix preparation.

[0290]

[0287] In some embodiments, a core component is encapsulated in 1 to 15, 3 to 15, 5 to 15, 7 to 15, 9 to 15, 11 to 15, 13 to 15, 1 to 13, 3 to 13, 5 to 13, 7 to 13, 9 to 13, 11 to 13, 1 to 11, 3 to 11, 5 to 11, 7 to 11, 9 to 11, 1 to 9, 3 to 9, 5 to 9, 7 to 9, 1 to 7, 3 to 7, 5 to 7, 1 to 5, 3 to 5, or 1 to 3 shell components. In some embodiments, one or more shell components are homogeneously blended.

[0291]

[0288] In some embodiments, a core component is characterized as being a solid. In some embodiments, a core component is characterized as being a liquid. In some embodiments, one or more shell components are characterized as being solids. In some embodiments, one or more shell components are characterized as being liquids.

[0292]

[0289] In some embodiments, a core-shell preparation may be characterized as a particle (e.g., particle preparation), an emulsion, a suspension, a powder (e.g., a protein powder), a bar, a gel, a capsule, a tablet, a fiber, an extrudate, a hard candy, a chip, and / or a mesh.

[0293]

[0290] In some embodiments, a core-shell preparation may be further characterized as an emulsion. In some embodiments, one or more emulsions are characterized as having low solubility (e.g., miscibility) in water. Additionally, or alternatively, one or more emulsions comprise a core component, one or more shell components, or both a core component and one or more shell components characterized as being amphiphilic. In some embodiments, a core-shell preparation characterized as an emulsion may be described as having a core component having low solubility (e.g., miscibility) in water and one or more shell components characterized as being amphiphilic. In some embodiments, a core-shell preparation characterized as an emulsion may be described as having a core component having high solubility (e.g., miscibility) in water and one or more shell components characterized as being amphiphilic. In some embodiments, a core-shell preparation characterized as an emulsion is prepared prior to ingestion by a subject. In some embodiments, a core-shell preparation characterized as an emulsion spontaneously forms upon addition to one or more dissolution solvents. In some embodiments, a core-shell preparation characterized as an emulsion spontaneously forms upon exposure to one or more triggers. For example, in some embodiments, an emulsion spontaneously forms in response to one or more cross-linkers, pH, bile salts, surfactants, reducing and / or oxidizing agents, osmotic pressure, proteases, amylases, lipases, bacteria, yeast, transglutaminases, thrombin, temperature, time, mechanical forces, or combination thereof.

[0294]

[0291] In some embodiments, one or more shell components controls the release of one or more food components from a core component. In some embodiments, a core component controls the release of one or more food components from a shell component. In some embodiments, control of the release of one more food components from a core component is achieved by one or more shell components providing a physical barrier to a dissolution solvent, a physical barrier to access of a digestive enzyme to one or more food components, controlling the diffusivity of one or more core components, controlling the chemical properties of one or more core components, controlling residence time of one or more core components in a dissolution medium, being responsive to one or more triggers described herein, or a combination thereof. In some embodiments, control of the release of one more food components from one or more shell components is achieved by a core component providing a physical barrier to a dissolution solvent, a physical barrier to access of a digestive enzyme to one or more food components, controlling the diffusivity of one or more shell components, controlling the chemical properties of one or more shell components, controlling residence time of one or more shell components in a dissolution medium, being responsive to one or more triggers described herein, or a combination thereof.

[0292] In some embodiments, one or more shell components provides a physical barrier between a dissolution solvent and a core component. For example, in some embodiments, one or more shell components may be characterized as insoluble in aqueous media (e.g., water, phosphate buffered saline solution, simulated intestinal fluid, simulated gastric fluid, simulated tear fluid, simulated urine, HEPES buffered saline solution, Dulbecco’s Modified Eagle Medium, Hank’s balanced salt solution, biological intestinal fluid, biological gastric fluid, plasma, saliva, urine, feces, sweat, tear fluid, and / or Kreb’s buffer). For example, in some embodiments, one or more shell components may be characterized by slow and / or zero-order solubilization in aqueous media. Without wishing to be bound by any particular theory, it is contemplated that one or more shell components characterized by insolubility, slow, and / or zero-order solubilization in aqueous media prevent access of such aqueous media to a core component, thus preventing dissolution (e.g., release) of one or more food components from the core component.

[0295]

[0293] In some embodiments, one or more shell components controls the chemical properties of a core component. In some embodiments, a core component controls the chemical properties of one or more shell components. For example, in some embodiments, one or more shell components may be ionically and / or covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer and / or a crystal) and / or a core component. Additionally, or alternatively, a core component may be ionically and / or covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer and / or a crystal) and / or one or more shell components. Without wishing to be bound by any particular theory, it is contemplated that ionic and / or covalent bonding of a core component with itself and / or one or more shell components may reduce preparation solubility, increase hydrophobicity, and / or increase molecular weight of the core component, thereby reducing diffusivity and release. Without wishing to be bound by any particular theory, it is contemplated that ionic and / or covalent bonding of one or more shell components and / or a core component may reduce preparation solubility, increase hydrophobicity, and / or increase molecular weight of the one or more shell components, thereby reducing diffusivity and release. In some embodiments, one or more shell components performs a chemical reaction on a core component to change its molecular weight and / or introduce a new chemical functionality. In some embodiments, a core component performs a chemical reaction on one or more shell components to change their molecular weight and / or introduce a new chemical functionality. Without wishing to be bound by any particular theory, it is contemplated that one or more components performing chemical reactions to reduce the molecular weight of a core component or one or more shell components may increase the release of one or more food components from a coreshell preparation.

[0296]

[0294] In some embodiments, one or more shell components controls the chemical properties of a core component. In some embodiments, a core component controls the chemical properties of one or more shell components. For example, in some embodiments, one or more shell components may be non-covalently bonded (e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.) to each other (e.g., a polymer and / or a crystal) and / or a core component. Additionally, or alternatively, a core component may be non- covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer and / or a crystal) and / or one or more shell components. Without wishing to be bound by any particular theory, it is contemplated that non-covalent bonding of a core component with itself and / or one or more shell components may reduce its solubility, increase hydrophobicity, and / or increase molecular weight of the core component, thereby reducing diffusivity and release. Without wishing to be bound by any particular theory, it is contemplated that non-covalent bonding of one or more shell components with each other and / or a core component may reduce their solubility, increase hydrophobicity, and / or increase molecular weight of the one or more shell components, thereby reducing diffusivity and release. In some embodiments, one or more shell components perform a chemical reaction on a core component to change its molecular weight and / or introduce a new chemical functionality. In some embodiments, a core component performs a chemical reaction on one or more shell components to change their molecular weight and / or introduce a new chemical functionality. Without wishing to be bound by any particular theory, it is contemplated that chemical reactions to reduce the molecular weight of a core component or one or more shell components may increase the release of one or more food components from a core-shell preparation.

[0297]

[0295] In some embodiments, one or more shell components control the residence time of a core component in a biological compartment. In some embodiments, a core-shell preparation, as provided herein, is characterized by retention in a biological compartment. In some embodiments, a core-shell preparation, as provided herein, is characterized by a lack of retention in a biological compartment. In some embodiments, one or more shell components is or are characterized as being mucoadhesive (e.g., having affinity and / or adhesion to one or more mucosal interfaces through interaction with the mucus, glycocalyx, extracellular matrix, cell membrane proteins, and / or cell membranes). In some embodiments, one or more shell components is or are characterized as being mucopenetrative (e.g., having a lack of interaction with the mucus, glycocalyx, extracellular matrix, cell membrane proteins, and / or cell membranes).

[0298]

[0296] In some embodiments, a mucoadhesive shell component may comprise pH- responsive carbohydrates, as described herein. In some embodiments, pH-responsive carbohydrates are characterized by having water solubility at a predetermined pH. In some embodiments, pH-responsive carbohydrates are characterized as having water solubility at low pH (e.g., pH < about 5, pH < about 4, pH < about 3, pH < about 2, pH < about 1). In some embodiments, pH-responsive carbohydrates exhibit low water solubility at low pH and higher water solubility at moderate pH (e.g., pH of about 5.5, about 6, about 6.5, about 7, about 7.5, about 8) to high pH (e.g., pH >8, pH > 9, pH > 10, pH > 11, pH > 12). In some embodiments, pH-responsive carbohydrates exhibit higher water solubility at low pH and lower water solubility at moderate to high pH.

[0299]

[0297] For example, in some embodiments, pH-responsive carbohydrates may comprise sodium alginate, potassium alginate, calcium alginate, magnesium alginate, zinc alginate, sodium pectinate, potassium pectinate, calcium pectinate, zinc pectinate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, magnesium hyaluronate, zinc hyaluronate, cellulose acetate succinate, cellulose acetate butyrate, cellulose acetate phthalate, hydroxypropyl methylcellulose acetate succinate, heparin sodium, sodium carboxymethylcellulose, chitosan, or a combination thereof.

[0300]

[0298] In some embodiments, a mucoadhesive shell component comprises a mucoadhesive carbohydrate. In some embodiments, a mucoadhesive carbohydrate is characterized by its ability to interact with the mucosal interface (e.g., mucus, mucins, glycocalyx, proteoglycans, cell membrane, phospholipids). Without wishing to be bound by any particular theory, mucoadhesive carbohydrates may utilize a combination of hydrogen bonding, charge-charge interaction, and hydrophobic effect to prolong residence time of core-shell preparations on a mucosal surface.

[0299] For example, in some embodiments, mucoadhesive carbohydrates may comprise sodium alginate, potassium alginate, calcium alginate, magnesium alginate, zinc alginate, sodium pectinate, potassium pectinate, calcium pectinate, zinc pectinate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, magnesium hyaluronate, zinc hyaluronate, sodium carboxymethylcellulose, chitosan, or a combination thereof.

[0301]

[0300] In some embodiments, a mucoadhesive shell component may comprise mucoadhesive proteins. In some embodiments, mucoadhesive proteins are characterized by their ability to interact with the mucosal interface (e.g., mucus, mucins, glycocalyx, proteoglycans, cell membrane, phospholipids). Without wishing to be bound by any particular theory, mucoadhesive proteins may utilize a combination of hydrogen bonding, charge-charge interaction, and hydrophobic effect to prolong residence time of formulations (e.g., particle preparations) on a mucosal surface.

[0302]

[0301] For example, in some embodiments, mucoadhesive proteins may comprise Lycopersicon esculentum agglutinin, wheat germ agglutinin, urtica dioica agglutinin, or a combination thereof.

[0303]

[0302] In some embodiments, a mucoadhesive shell component comprises a catechol. In some embodiments, mucoadhesive catechols are polyphenols (e.g., as described herein) that are characterized by their ability to interact with the mucosal interface (e.g., mucus, mucins, glycocalyx, proteoglycans, cell membrane, phospholipids). Without wishing to be bound by any particular theory, mucoadhesive catechols may utilize a combination of hydrogen bonding, 7t- stacking, chemical cross-linking, and hydrophobic effect to prolong residence time of formulations (e.g., particle preparations) on a mucosal surface.

[0304]

[0303] For example, in some embodiments, mucoadhesive catechols may comprise L- dopamine, poly(L-dopamine), hydroxytyrosol, catechol, caffeic acid, vanillin, veratraldehyde, eugenol, tannic acid, syringaldehyde, and / or protocatechuic aldehyde.

[0305]

[0304] In some embodiments, a mucoadhesive shell component(s) may comprise charged polymers (e.g., polymers exhibiting charge depending on the pH of a dissolution solvent). In some embodiments, a charged polymer may be an anionic mucoadhesive polymer (e.g., polymers exhibiting a negative charge depending on pH of a dissolution solvent). In some embodiments, a charged polymer may be cationic mucoadhesive polymer (e.g., polymers exhibiting a positive charge depending on pH of a dissolution solvent). Without wishing to be bound by any particular theory, it is contemplated that charged polymers facilitate interaction with the mucosal interface (e.g., mucus, mucins, glycocalyx, proteoglycans, cell membrane, phospholipids) thereby enabling greater retention time of one or more core-shell preparation(s).

[0306]

[0305] For example, in some embodiments, anionic mucoadhesive polymers may comprise poly(acrylic acid), poly (methacrylic acid), and / or poly(glycerol citrate). In alternative embodiments cationic mucoadhesive polymers may comprise poly(ethyleneimine), trimethylchitosan, and / or poly(L-arginine).

[0307]

[0306] In some embodiments, a mucopenetrative shell component is characterized by a lack of interaction with the mucus, glycocalyx, extracellular matrix, cell membrane proteins, and / or cell membranes. Without wishing to be bound by any particular theory, one or more mucopenetrative shell components are contemplated to increase the diffusion of a core-shell preparation at a mucosal interface. For example, in some embodiments, a mucopenetrative shell component may comprise poly(ethylene glycol), poly(propylene glycol), poly(vinyl alcohol), and / or poly (ethylene oxide-co-propylene oxide).

[0308]

[0307] In some embodiments, one or more shell components controls the release of one or more food components from a core component by responding to a trigger. In some embodiments, a core component controls the release of one or more food components from one or more shell components by responding to a trigger. In some embodiments, a trigger is characterized as a chemical trigger, enzymatic trigger, and / or a physical trigger. For example, a chemical trigger may be further characterized as a cross-linker, pH, bile salt, reducing and / or oxidizing agent, and / or osmotic pressure. For example, an enzymatic trigger may be further characterized as exposure to proteases, amylases, lipases, bacteria, transglutaminases, and / or thrombin. For example, a physical trigger may be further characterized as temperature, time, and / or mechanical forces. Without wishing to be bound by any particular theory, it is contemplated that one or more triggers may act to alter the physical and / or chemical properties of a core component and / or one or more shell components. It is further contemplated that alteration of one or more physical properties (e.g., increasing porosity, reducing molecular weight) acts to increase the release rate of one or more food components from a core-shell preparation. It is further contemplated that alteration of one or more chemical properties (e.g., increasing charge, increasing polarity) acts to increase the release rate of one or more food components from a corc-shcll preparation.

[0309] E. Matrix Preparations

[0310]

[0308] In some embodiments, the present disclosure provides matrix preparations as a means of controlling the release of one or more food components from a formulated composition. For example, in some embodiments, a formulated composition is or comprises a matrix preparation. For example, matrix preparations may comprise a solute component and / or a matrix component, each of which are essentially comprised of one or more food components and / or one or more release modulators. In some embodiments, a solute component comprises one or more food components and / or one or more release modulators. In some embodiments, a matrix component comprises one or more food components and / or one or more release modulators. In some embodiments, a solute component comprises one or more food components, one or more release modulators, and / or one or more excipients. In some embodiments, a matrix component comprises one or more food components, one or more release modulators, and / or one or more excipients.

[0311]

[0309] In some embodiments, a matrix preparation comprises one or more food components and / or one release modulators arranged as a solute component and one or more food components and / or one or more release modulators arranged as a matrix component. In some embodiments, the one or more food components and / or one or more release modulators comprising a solute component are additionally the one or more food components and / or one or more release modulators components comprising a matrix component. In some embodiments, the one or more food components and / or one or more release modulators comprising a solute component are different than the one or more food components and / or one or more release modulators components comprising a matrix component. In some embodiments, one or more solute components are distributed homogeneously within a matrix preparation. In some embodiments, one or more solute components are distributed heterogeneously within a matrix preparation.

[0312]

[0310] In some embodiments, a matrix component holds one or more food components and / or one or more release modulators in place at a pre-defined spatial distribution. In some embodiments, both a matrix component and a solute component are comprised of food components and release modulators. Tn some embodiments, a matrix preparation may also include an outer shell (c.g., coating).

[0313]

[0311] In some embodiments, one or more food components and / or one or more release modulators may be described as being dispersed within (e.g., embedded within) one or more matrix components.

[0314]

[0312] In some embodiments, one or more matrix components may be described as encapsulating one or more food components, and / or one or more release modulators.

[0315]

[0313] In some embodiments, one or more food components, one or more release modulators, one or more matrix components, or a combination thereof, may be characterized as being dispersed within (c.g., encapsulated in) one or more matrix components (for example, radially contained within an outer shell).

[0316]

[0314] In some embodiments, a matrix component and / or a solute component is characterized as being a liquid. In some embodiments, a matrix component and / or a solute component is characterized as being a solid.

[0317]

[0315] In some embodiments, a provided matrix preparations may be characterized as a particle (e.g., particle preparation), a bar, a gel, a capsule, a tablet, a fiber, an extrudate, a hard candy, a chip, and / or a mesh.

[0318]

[0316] In certain embodiments, a matrix preparation is characterized as having controlled release of one or more food components. In some embodiments, one or more matrix components controls the release of one or more food components from one or more solute components. In some embodiments, one or more solute components controls the release of one or more food components form one or more matrix components. In some embodiments, controlled release of one or more food components from one more solute components is achieved by one or more matrix components providing a physical barrier to a dissolution solvent, thereby controlling the diffusivity of one or more solute components, controlling the chemical properties of one or more solute components, controlling residence time of one or more solute components in a dissolution medium, and / or having responsiveness to one or more triggers, as described herein. In some embodiments, controlled release of one or more food components from one or more matrix components is achieved by one or more solute components controlling the chemical properties of one or more matrix components, and / or having responsiveness to one or more triggers, as described herein.

[0319]

[0317] In some embodiments, one or more matrix components controls the diffusivity of one or more solute components. In some embodiments, one or more solute components controls the diffusivity of one or more matrix components. For example, in some embodiments, one or more matrix components and / or one or more solute components may be characterized by at least one of porosity, chain length, and / or electric charge. Without wishing to be bound by any particular theory, it is contemplated that one or more matrix components characterized as having reduced porosity and / or increased chain length and / or complementary charge to one or more solute components reduces free movement (e.g., diffusivity) of one or more solute components by presenting a physical obstruction and / or an electric field, thus preventing dissolution (e.g., release) of one or more food components from one or more solute components. Without wishing to be bound by any particular theory, it is contemplated that one or more solute components characterized as having increased chain length and / or complementary charge to one or more matrix components reduce free movement (e.g., diffusivity) of one or more matrix components by presenting a physical obstruction and / or an electric field, thus preventing dissolution (e.g., release) of one or more food components from one or more matrix components.

[0320]

[0318] In certain embodiments, one or more matrix components controls the chemical properties of one or more solute components. In some embodiments, one or more solute components controls the chemical properties of one or more matrix components. For example, in some embodiments, one or more matrix components may be ionically and / or covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer) and / or one or more solute components. Additionally, or alternatively, one or more solute components may be ionically and / or covalently bonded (i.e., associated, complexed) to itself (e.g., a polymer) and / or one or more matrix components. Without wishing to be bound by any particular theory, it is contemplated that ionic and / or covalent bonding of one or more solute components with itself and / or one or more matrix components may reduce its solubility, increase hydrophobicity, and / or increase molecular weight of the solute component, thereby reducing diffusivity and release of one or more food components. Without wishing to be bound by any particular theory, it is contemplated that ionic and / or covalent bonding of one or more matrix components with itself and / or one or more solute components may reduce its solubility, increase hydrophobicity, and / or increase molecular weight of the one or more matrix components, thereby reducing diffusivity and release of one of more food components. In some embodiments, one or more matrix components performs a chemical reaction on one or more solute components to change its molecular weight and / or introduce a new chemical functionality. In some embodiments, one or more solute components performs a chemical reaction on one or more matrix components to change its molecular weight and / or introduce a new chemical functionality. Without wishing to be bound by any particular' theory, it is contemplated that one or more components performing chemical reactions to reduce the molecular' weight of one or more solute components or one or more matrix components may increase the release of one or more food components from a matrix preparation.

[0321]

[0319] In some embodiments, one or more matrix components controls the chemical properties of one or more solute components. In some embodiments, one or more solute components controls the chemical properties of one or more matrix components. For example, in some embodiments, one or more matrix components may be non-covalently bonded (e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.) to itself (e.g., a polymer) and / or one or more solute components. Additionally, or alternatively, one or more solute components may be non-covalently bonded (e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.) to itself (e.g., a polymer) and / or one or more matrix components. Without wishing to be bound by any particular theory, it is contemplated that non-covalent bonds (e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.) of one or more solute components with itself and / or one or more matrix components may reduce its solubility, increase hydrophobicity, and / or increase molecular weight of the one or more solute components, thereby reducing diffusivity and release of one or more food components. Without wishing to be bound by any particular theory, it is contemplated that non-covalent bonds (e.g., hydrogen bonding, Van der Waals forces, electrostatic interactions, hydrophobic interactions, etc.) of one or more matrix components with itself and / or one or more solute components may reduce its solubility, increase hydrophobicity, and / or increase molecular weight of the matrix component, thereby reducing diffusivity and release of one or more food components. In some embodiments, one or more matrix components performs a chemical reaction on one or more solute components to change its molecular weight and / or introduce a new chemical functionality. In some embodiments, one or more solute components performs a chemical reaction on one or more matrix components to change its molecular weight and / or introduce a new chemical functionality. Without wishing to be bound by any particular theory, it is contemplated that one or more components performing chemical reactions to reduce the molecular weight of a solute component or a matrix component may increase the release of one or more food components from a matrix preparation.

[0322]

[0320] In some embodiments, one or more matrix components controls the release of one or more food components from one or more solute components by responding to a trigger. In some embodiments, one or more solute components controls the release of one or more food components from one or more matrix components by responding to a trigger. In certain embodiments, a trigger is characterized as a chemical trigger, enzymatic trigger, and / or a physical trigger. For example, in some embodiments, a chemical trigger may be further characterized as a cross-linker, pH, bile salts, reducing and / or oxidizing agents, and / or osmotic pressure. For example, in some embodiments, an enzymatic trigger may be further characterized as exposure to proteases, amylases, lipases, bacteria, transglutaminases, and / or thrombin. For example, in some embodiments, a physical trigger may be further characterized as temperature, time, and / or mechanical forces. Without wishing to be bound by any particular theory, it is contemplated that one or more triggers may act to alter the physical and / or chemical properties of one or more solute components and / or one or more matrix components. It is further contemplated that alteration of one or more physical properties (e.g., increasing porosity, reducing molecular weight) acts to increase the release rate of one or more food components. It is further contemplated that alteration of one or more chemical properties (e.g., increasing charge, increasing polarity) acts to increase the release rate of one or more food components.

[0323] II. Formulated preparations

[0324]

[0321] In some embodiments, the present disclosure provides a formulated preparation comprising two or more formulated compositions. In some embodiments, the two or more formulated compositions are the same or substantially the same. In some embodiments, a formulated preparation comprises two or more formulated compositions that are different. 1. Excipients

[0325]

[0322] In some embodiments, a formulated preparation of the present disclosure comprises 1 or more excipients. In some embodiments, a formulated preparation of the present disclosure comprises 1 to 25, 5 to 25, 10 to 25, 15 to 25, 20 to 25, 1 to 20, 5 to 20, 10 to 20, 15 to 20, 1 to 15, 5 to 15, 10 to 15, 1 to 10, 5 to 10, or 1 to 5 components in addition to one or more food component and one or more release modulators. For example, in some embodiments, a formulated preparation of the present disclosure comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 components in addition to one or more food component and one or more release modulators.

[0326]

[0323] In some embodiments, one or more excipients comprise processing aids in the production and / or manufacture of a formulated composition of the present disclosure. In some embodiments, one or more excipients comprise an anti-caking processing aid (e.g., anti-caking agent). In some embodiments, an anti-caking processing aid comprises one or more of SIPERNAT 22S, SIPERNAT 50S, SIPERNAT 380, Wacker HDK N20, bamboo fiber, carrot fiber, rice hull powder, and calcium carbonate. In some embodiments, one or more excipients comprise an anti-sticking processing aid (e.g., anti-sticking agent). In some embodiments, an anti-sticking processing aid (e.g., an anti-sticking agent) comprises one or more of sunflower lecithin, soybean lecithin, and aquafaba. In some embodiments, one or more excipients comprise a sequestering processing aid (e.g., a sequestrant). In some embodiments, a sequestrant comprises one or more of sodium hexametaphosphate, sodium tripolyphosphate, potassium hexametaphosphate, potassium tripolyphosphate, calcium hexametaphosphate, calcium tripolyphosphate, sodium polyglutamate, potassium polyglutamate, or chitosan. In some embodiments, one or more excipients comprise an anti-foaming processing aid (e.g., an antifoaming agent). In some embodiments, an anti-foaming processing aid comprises one or more of monoglycerides, diglycerides, propylene glycol, and acetone. In some embodiments, one or more excipients comprise an anti-tack processing aid. In some embodiments, an anti-tack processing aid (e.g., an anti-tack agent) comprises one or more of talc, zinc oxide, magnesium oxide, and microcrystalline cellulose. In some embodiments, one or more excipients comprise an emulsion-stabilizing processing aid (e.g., a stabilizer). In some embodiments, an emulsionstabilizing processing aid comprises one or more of xanthan gum, guar gum, modified cellulose gum, and locust bean gum. In some embodiments, one or more excipients comprise an anti- caking (e.g., anti-agglomerating, anti-clumping, anti-aggregating) component, a surfactant component, a plasticizing component, an acid scavenger (e.g., buffering agent), a moisture scavenger, a water scavenger, an oxygen scavenger, a desiccant, a polymer, a preservative, a colorant, a flavoring, an anti-oxidant, a humectant, a solvent, or a combination thereof.

[0327]

[0324] In some embodiments, a formulated preparation of the present disclosure comprises about 0.01% to 10% (w / w), 0.1% to 10% (w / w), 0.2% to 10% (w / w), 0.3% to 10% (w / w), 0.4% to 10% (w / w), 0.5% to 10% (w / w), 0.7% to 10% (w / w), 0.8% to 10% (w / w), 0.9% to 10% (w / w), 1% to 10% (w / w), 1.5% to 10% (w / w), 2% to 10% (w / w), 2.5% to 10% (w / w), 3% to 10% (w / w), 3.5% to 10% (w / w), 4% to 10% (w / w), 4.5% to 10% (w / w), 5% to 10% (w / w), 5.5% to 10% (w / w), 6% to 10% (w / w), 6.5% to 10% (w / w), 7% to 10% (w / w), 7.5% to 10% (w / w), 8% to 10% (w / w), 8.5% to 10% (w / w), 9% to 10% (w / w), 9.5% to 10% (w / w), 0.01% to 5% (w / w), 0.1% to 5% (w / w), 0.2% to 5% (w / w), 0.3% to 5% (w / w), 0.4% to 5% (w / w), 0.5% to 5% (w / w), 0.7% to 5% (w / w), 0.8% to 5% (w / w), 0.9% to 5% (w / w), 1% to 5% (w / w), 1.5% to 5% (w / w), 2% to 5% (w / w), 2.5% to 5% (w / w), 3% to 5% (w / w), 3.5% to 5% (w / w), 4% to 5% (w / w), 4.5% to 5% (w / w), 0.01% to 1% (w / w), 0.1% to 1% (w / w), 0.2% to 1% (w / w), 0.3% to 1% (w / w), 0.4% to 1% (w / w), 0.5% to 1% (w / w), 0.7% to 1% (w / w), 0.8% to 1% (w / w), 0.9% to 1% (w / w), 0.01% to 0.5% (w / w), 0.1% to 0.5% (w / w), 0.2% to 0.5% (w / w), 0.3% to 0.5% (w / w), 0.4% to 0.5% (w / w), or 0.01% to 0.1% (w / w) of one or more excipients.

[0328]

[0325] In some embodiments, a formulated preparation of the present disclosure comprises about 0.01% to 10% (w / w), 0.1% to 10% (w / w), 0.2% to 10% (w / w), 0.3% to 10% (w / w), 0.4% to 10% (w / w), 0.5% to 10% (w / w), 0.7% to 10% (w / w), 0.8% to 10% (w / w), 0.9% to 10% (w / w), 1% to 10% (w / w), 1.5% to 10% (w / w), 2% to 10% (w / w), 2.5% to 10% (w / w), 3% to 10% (w / w), 3.5% to 10% (w / w), 4% to 10% (w / w), 4.5% to 10% (w / w), 5% to 10% (w / w), 5.5% to 10% (w / w), 6% to 10% (w / w), 6.5% to 10% (w / w), 7% to 10% (w / w), 7.5% to 10% (w / w), 8% to 10% (w / w), 8.5% to 10% (w / w), 9% to 10% (w / w), 9.5% to 10% (w / w), 0.01% to 5% (w / w), 0.1% to 5% (w / w), 0.2% to 5% (w / w), 0.3% to 5% (w / w), 0.4% to 5% (w / w), 0.5% to 5% (w / w), 0.7% to 5% (w / w), 0.8% to 5% (w / w), 0.9% to 5% (w / w), 1% to 5% (w / w), 1.5% to 5% (w / w), 2% to 5% (w / w), 2.5% to 5% (w / w), 3% to 5% (w / w), 3.5% to 5% (w / w), 4% to 5% (w / w), 4.5% to 5% (w / w), 0.01% to 1% (w / w), 0.1% to 1% (w / w), 0.2% to 1% (w / w), 0.3% to 1% (w / w), 0.4% to 1% (w / w), 0.5% to 1% (w / w), 0.7% to 1% (w / w), 0.8% to 1% (w / w), 0.9% to 1 % (w / w), 0.01 % to 0.5% (w / w), 0.1 % to 0.5% (w / w), 0.2% to 0.5% (w / w), 0.3% to 0.5% (w / w), 0.4% to 0.5% (w / w), or 0.01% to 0.1% (w / w) silica.

[0329]

[0326] In some embodiments, a formulated preparation of the present disclosure comprises about 0.01% to 10% (w / w), 0.1% to 10% (w / w), 0.2% to 10% (w / w), 0.3% to 10% (w / w), 0.4% to 10% (w / w), 0.5% to 10% (w / w), 0.7% to 10% (w / w), 0.8% to 10% (w / w), 0.9% to 10% (w / w), 1% to 10% (w / w), 1.5% to 10% (w / w), 2% to 10% (w / w), 2.5% to 10% (w / w), 3% to 10% (w / w), 3.5% to 10% (w / w), 4% to 10% (w / w), 4.5% to 10% (w / w), 5% to 10% (w / w), 5.5% to 10% (w / w), 6% to 10% (w / w), 6.5% to 10% (w / w), 7% to 10% (w / w), 7.5% to 10% (w / w), 8% to 10% (w / w), 8.5% to 10% (w / w), 9% to 10% (w / w), 9.5% to 10% (w / w), 0.01 % to 5% (w / w), 0.1 % to 5% (w / w), 0.2% to 5% (w / w), 0.3% to 5% (w / w), 0.4% to 5% (w / w), 0.5% to 5% (w / w), 0.7% to 5% (w / w), 0.8% to 5% (w / w), 0.9% to 5% (w / w), 1% to 5% (w / w), 1.5% to 5% (w / w), 2% to 5% (w / w), 2.5% to 5% (w / w), 3% to 5% (w / w), 3.5% to 5% (w / w), 4% to 5% (w / w), 4.5% to 5% (w / w), 0.01% to 1% (w / w), 0.1% to 1% (w / w), 0.2% to 1% (w / w), 0.3% to 1% (w / w), 0.4% to 1% (w / w), 0.5% to 1% (w / w), 0.7% to 1% (w / w), 0.8% to 1% (w / w), 0.9% to 1% (w / w), 0.01% to 0.5% (w / w), 0.1% to 0.5% (w / w), 0.2% to 0.5% (w / w), 0.3% to 0.5% (w / w), 0.4% to 0.5% (w / w), or 0.01% to 0.1% (w / w) sodium hexametaphosphate.

[0330]

[0327] In some embodiments, a formulated preparation of the present disclosure comprises about 0.01% to 10% (w / w), 0.1% to 10% (w / w), 0.2% to 10% (w / w), 0.3% to 10% (w / w), 0.4% to 10% (w / w), 0.5% to 10% (w / w), 0.7% to 10% (w / w), 0.8% to 10% (w / w), 0.9% to 10% (w / w), 1% to 10% (w / w), 1.5% to 10% (w / w), 2% to 10% (w / w), 2.5% to 10% (w / w), 3% to 10% (w / w), 3.5% to 10% (w / w), 4% to 10% (w / w), 4.5% to 10% (w / w), 5% to 10% (w / w), 5.5% to 10% (w / w), 6% to 10% (w / w), 6.5% to 10% (w / w), 7% to 10% (w / w), 7.5% to 10% (w / w), 8% to 10% (w / w), 8.5% to 10% (w / w), 9% to 10% (w / w), 9.5% to 10% (w / w), 0.01% to 5% (w / w), 0.1% to 5% (w / w), 0.2% to 5% (w / w), 0.3% to 5% (w / w), 0.4% to 5% (w / w), 0.5% to 5% (w / w), 0.7% to 5% (w / w), 0.8% to 5% (w / w), 0.9% to 5% (w / w), 1% to 5% (w / w), 1.5% to 5% (w / w), 2% to 5% (w / w), 2.5% to 5% (w / w), 3% to 5% (w / w), 3.5% to 5% (w / w), 4% to 5% (w / w), 4.5% to 5% (w / w), 0.01% to 1% (w / w), 0.1% to 1% (w / w), 0.2% to 1% (w / w), 0.3% to 1% (w / w), 0.4% to 1% (w / w), 0.5% to 1% (w / w), 0.7% to 1% (w / w), 0.8% to 1% (w / w), 0.9% to 1% (w / w), 0.01% to 0.5% (w / w), 0.1% to 0.5% (w / w), 0.2% to 0.5% (w / w), 0.3% to 0.5% (w / w), 0.4% to 0.5% (w / w), or 0.01% to 0.1% (w / w) chitosan.

[0328] In some embodiments, one or more excipients impart a benefit (e.g., reduced caking, increased stability, increased solubility, improved physical properties, improved taste, improved longevity, and / or increased biocompatibility) to a formulated composition and / or formulated preparation of the present disclosure. In some embodiments, one or more excipients impart a change to an environment of a formulated composition and / or formulated preparation. In some embodiments, one or more excipients impart a pH change, a color change, an oxygen concentration change, a water concentration change, or a combination thereof, within a formulated composition and / or formulated preparation. In some embodiments, one or more excipients impart a change (e.g., pH change, oxygen concentration change, flavor change, water concentration change, or combination thereof) to a local environment (e.g., gastrointestinal compartment, powder (e.g., protein powder) product, food product, beverage product) where a formulated composition and / or formulated preparation resides at a point in time. In some embodiments, one or more excipients increase and / or decrease the solubility of one or more food components in a formulated composition and / or formulated preparation of the present disclosure upon mixing in one or more dissolution solvents.

[0331]

[0329] In some embodiments, one or more excipients in a formulated composition and / or formulated preparation of the present disclosure is identified by one or more governing bodies as safe for animal consumption (e.g., generally regarded as safe and / or food additives). Without wishing to be bound by any particular theory, those skilled in the art will appreciate that one or more excipient components are or may be selected from excipients recognized as Generally Regarded as Safe (i.e., GRAS) by the U.S. Food and Drug Administration. In some embodiments, those skilled in the art will appreciate that one or more excipient components are or may be selected from excipients enumerated in 21 C.F.R. 184. In some embodiments, those skilled in the art will appreciate that one or more excipient components are or may be selected from those excipients enumerated in GB2760-2014 by the National Health and Family Planning Commission of the People’s Republic of China.

[0332]

[0330] In some embodiments, one or more excipients can lower the water activity of a formulated composition and / or formulated preparation of the present disclosure.

[0333]

[0331] In some embodiments, one or more excipients can lower the moisture content of a formulated composition and / or formulated preparation of the present disclosure.

[0332] In some embodiments, one or more excipients can lower the residual solvent content of a formulated composition and / or formulated preparation of the present disclosure.

[0334]

[0333] In some embodiments, one or more excipients can reduce the friability of a formulated composition and / or formulated preparation of the present disclosure.

[0335]

[0334] In some embodiments, one or more excipients can improve the flowability of a formulated composition and / or formulated preparation of the present disclosure.

[0336]

[0335] In some embodiments, one or more excipients can reduce clumping upon storage of a formulated composition and / or formulated preparation of the present disclosure.

[0337]

[0336] In some embodiments, one or more excipients can improve the solubility of one or more food components in a formulated composition and / or formulated preparation of the present disclosure.

[0338]

[0337] In some embodiments, one or more excipients can improve the mixing of one or more food components with one or more dissolution solvents. In some embodiments, one or more excipients can improve the mixing a formulated composition and / or formulated preparation with one or more dissolution solvents.

[0339]

[0338] In some embodiments, one or more excipients can improve the mixing of one or more food components in a powder (e.g., protein powder) product. In some embodiments, one or more excipients can improve the mixing of a formulated composition and / or formulated preparation in a powder product (e.g., protein powder).

[0340]

[0339] In some embodiments, one or more excipients can improve the mixing of one or more food components in a food product. In some embodiments, one or more excipients can improve the mixing of a formulated composition and / or formulated preparation in a food product.

[0341]

[0340] In some embodiments, one or more excipients can improve the mixing of one or more food components in a beverage product. In some embodiments, one or more excipients can improve the mixing of a formulated composition and / or formulated preparation in a beverage product.

[0341] In some embodiments, one or more excipients can improve the mixing of one or more food components in a supplement product. In some embodiments, one or more excipients can improve the mixing of a formulated composition and / or formulated preparation in a supplement product.

[0342]

[0342] In some embodiments, one or more excipients can improve the mixing of one or more food components with one or more other food components in a formulated composition and / or formulated preparation of the present disclosure.

[0343]

[0343] In some embodiments, one or more excipients can raise or lower the elastic modulus of a formulated composition and / or formulated preparation of the present disclosure. Without wishing to be bound by any particular theory, raising or lowering the elastic modulus may enable or facilitate methods of formulating or manufacturing a formulated composition and / or formulated preparation of the present disclosure.

[0344]

[0344] In some embodiments, one or more excipients can raise or lower the crystallinity of a formulated composition and / or formulated preparation of the present disclosure.

[0345]

[0345] In some embodiments, one or more excipients can alter and / or maintain the pH of a formulated composition of the present disclosure. In some embodiments, one or more excipients that maintain pH may additionally be used as a means of gas generation. Without wishing to be bound by any particular theory, generation of gas within a formulated composition and / or formulated preparation of the present disclosure may reduce the density of the formulation and increase buoyancy. Without wishing to be bound by any particular theory, increased buoyancy may contribute to increased residence time of a formulation and / or formulated preparation in one or more gastrointestinal compartments.

[0346]

[0346] In some embodiments, one or more excipients can react with environmental molecular- oxygen or introduce molecular oxygen in a formulated composition and / or formulated preparation of the present disclosure.

[0347]

[0347] In some embodiments, one or more excipients triggers release of one or more food components from a formulated composition and / or formulated preparation of the present disclosure.

[0348] In some embodiments, one or more excipient component can alter the pH within a microenvironment (c.g., stomach, powder (c.g., protein powder) product, food product, beverage product) where a formulated composition and / or formulated preparation of the present disclosure resides.

[0348]

[0349] In some embodiments, one or more excipients affects a response of a formulated composition and / or formulated preparation of the present disclosure to heat.

[0349]

[0350] In some embodiments, one or more excipients affects a response of a formulated composition and / or formulated preparation of the present disclosure to shear forces.

[0350]

[0351] In some embodiments, one or more excipients affects a response of a formulated composition and / or formulated preparation of the present disclosure to elevated pressure.

[0351]

[0352] In some embodiments, one or more excipients prevents fouling (e.g., microbial growth) of a formulated composition and / or formulated preparation of the present disclosure over a period of at least 4 weeks, at least 12 weeks, at least 6 months, at least 1 year, at least 2 years, at least 5 years, and / or at least 10 years.

[0352]

[0353] In some embodiments, one or more excipients improves the taste and / or fragrance of a formulated composition and / or formulated preparation of the present disclosure.

[0353]

[0354] In some embodiments, one or more excipients maintain the water activity a formulated composition and / or formulated preparation of the present disclosure.

[0354]

[0355] In some embodiments, one or more excipients provides a visually pleasing appearance to a formulated composition and / or formulated preparation of the present disclosure.

[0355]

[0356] In some embodiments, one or more excipients affect the stability of a formulated composition and / or formulated preparation of the present disclosure in light, heat, pressure, shear enzymes, bacteria, and / or one or more dissolution solvents.

[0356]

[0357] In some embodiments, one or more excipients are added to one or more food components and / or one or more release modulators during a manufacturing process of a formulated composition and / or formulated preparation. In some embodiments, one or more excipients are added to one or more food components and / or one or more release modulators after a manufacturing process of a formulated composition and / or formulated preparation and / or before ingestion of said formulation and / or formulated preparation by a subject.

[0357] 2. Probiotics, Prebiotics and / or Postbiotics

[0358]

[0358] In some embodiments, a formulated preparation of the present disclosure comprises 1 or more probiotics. In some embodiments, a formulated preparation of the present disclosure comprises 1 to 25, 5 to 25, 10 to 25, 15 to 25, 20 to 25, 1 to 20, 5 to 20, 10 to 20, 15 to 20, 1 to 15, 5 to 15, 10 to 15, 1 to 10, 5 to 10, or 1 to 5 probiotics. For example, in some embodiments, a formulated preparation of the present disclosure comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 probiotics.

[0359]

[0359] In some embodiments, a formulated preparation of the present disclosure comprises Bacillus coagulans, Bacillus licheniformis, Bacillus subtilis, Bifidobacterium angulatum, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Enterococcus faecium, Enterococcus faecalis, Lactobacillus acidophilus, Lactobacillus amylovorus, Lactobacillus alimentarius, Lactobacillus bulgaricus, Lactobacillus casei subsp., Lactobacillus casei shirota, Lactobacillus curvatus, Lactobacillus delbrueckii subsp lactis, Lactobacillus femientum, Lactobacillus farciminis, Lactobacillus gasseri, Lactobacillus helveticus, Lactobacillus johnsonii, Lactobacillus lacti, Lactobacillus paracasei, Lactobacillus pentosaceus, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus rhamnosus (Lactobacillus GG), Lactobacillus sake, Lactobacillus salivarius, Lactococcus lactis, Micrococcus varians, Pediococcus acidilactici Pediococcus pentosaceus, Pediococcus acidilactici, Pediococcus halophilus, Streptococcus faecalis, Streptococcus thermophilus, Staphylococcus camosus, or Staphylococcus xylosus Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus rhamnosus, Lactobacillus reuteri, Streptococcus thermophilus, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium lactis, Bacillus subtilis, Bacteroides fragilis, Akkermansia muciniphila, Faecalibacterium prausnitzii, or a combination thereof.

[0360]

[0360] In some embodiments, a formulated preparation of the present disclosure comprises about 1 x 104CFU to about 1 x 1011CFU, about 1 x 105CFU to about 1 x 1011CFU, about 1 x 106CFU to about 1 x 1011CFU, about 1 x 107CFU to about 1 x 1011CFU, about 1 x 108CFU to about 1 x 1011CFU, about 1 x 109CFU to about 1 x 1011CFU, about 1 x 1010CFU to about 1 x 1011CFU, about 1 x 104CFU to about 1 x IO10CFU, about 1 x 105CFU to about 1 x IO10CFU, about 1 x 106CFU to about 1 x IO10CFU, about 1 x 107CFU to about 1 x IO10CFU, about 1 x 108CFU to about 1 x IO10CFU, about 1 x 109CFU to about 1 x IO10CFU, about 1 x 104CFU to about 1 x 109CFU, about 1 x 105CFU to about 1 x 109CFU, about 1 x 106CFU to about 1 x 109CFU, about 1 x 107CFU to about 1 x 109CFU, about 1 x 108CFU to about 1 x 109CFU, about 1 x 104CFU to about 1 x 108CFU, about 1 x 105CFU to about 1 x 108CFU, about 1 x 106CFU to about 1 x 108CFU, about 1 x 107CFU to about 1 x 108CFU, about 1 x 104CFU to about 1 x 107CFU, about 1 x 105CFU to about 1 x 107CFU, about 1 x 106CFU to about 1 x 107CFU, about 1 x 104CFU to about 1 x 106CFU, about 1 x 105CFU to about 1 x 106CFU, or about 1 x 104CFU to about 1 x 105CFU, of one or more probiotics per gram of the preparation.

[0361]

[0361] In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a water activity less than 0.2. Without wishing to be bound by any particular theory, a water activity less than 0.2 supports the stability and / or longevity of one or more probiotic in a formulated preparation of the present disclosure.

[0362]

[0362] In some embodiments, a formulated preparation of the present disclosure comprises one or more prebiotic. In some embodiments, a formulated preparation of the present disclosure comprises galactooligosaccharides, inulin, fructan, 0-glucan, xylan, pectin, and or a combination thereof.

[0363]

[0363] In some embodiments, a formulated preparation of the present disclosure comprises one or more postbiotic. In some embodiments, a formulated preparation of the present disclosure comprises lactic acid, butyrate, propionate, acetate, or a combination thereof.

[0364] 3. Dietary Fiber

[0365]

[0364] In some embodiments, a formulated preparation of the present disclosure comprises 1 or more dietary fibers. In some embodiments, a formulated preparation of the present disclosure comprises 1 to 25, 5 to 25, 10 to 25, 15 to 25, 20 to 25, 1 to 20, 5 to 20, 10 to 20, 15 to 20, 1 to 15, 5 to 15, 10 to 15, 1 to 10, 5 to 10, or 1 to 5 dietary fibers. For example, in some embodiments, a formulated preparation of the present disclosure comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 fibers.

[0365] In some embodiments, a formulated preparation of the present disclosure comprises at least 0.1 parts of dietary fiber to at least 1 part of food component (c.g., protein) by dry weight, at least 0.15 parts of dietary fiber to at least 1 part of food component (e.g., protein) by dry weight, at least 0.2 parts of dietary fiber to at least 1 part of food component (e.g., protein) by dry weight, or at least 0.25 parts of dietary fiber to at least 1 part of food component (e.g., protein) by dry weight.

[0366]

[0366] In some embodiments, a formulated preparation of the present disclosure may comprise cellulose, dextrin, amylose, amylopectin, pectin, inulin, lignin, chitin, xanthan gum, sodium alginate, potassium alginate, calcium alginate, ammonium alginate, propylene glycol alginate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, agar, agarose, carrageenan, raffinose, cellulose acetate, methyl cellulose, ethyl cellulose, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, naturally occurring fiber (e.g., vegetable fiber, whole grain fiber, fruit fiber, cereal bran fiber, flaked cereal fiber, flour fiber), P-glucan soluble fiber, psyllium husk, guar gum, locust bean gum, mixed plant cell wall fibers (e.g., sugar cane fiber, apple fiber), arabinoxylan, alginate, inulin-type fructans, high amylose starch, galactooligosaccharide, polydextrose, maltodextrin, cross-linked phosphorylated RS4, glucomannan, acacia (gum arabic), or a combination thereof.

[0367] B. Controlled / Extended-release

[0368]

[0367] In some embodiments, the present disclosure provides a formulated composition and / or formulated preparation that is characterized as providing controlled release of one or more food components as compared to one or more food components that are not formulated (e.g., do not comprise one or more release modulators). Without wishing to be bound by any particular theory, controlled release may be characterized as the amount of one or more food components released from a formulated composition and / or formulated preparation in the presence of one or more dissolution solvents. In some embodiments, controlled release may be characterized as a predetermined release rate of one or more food components from a formulated composition and / or formulated preparation. In some embodiments, controlled release is characterized as a combination of the amount of one or more food components released from a formulated composition and / or formulated preparation and the rate at which one or more food components is released from the formulated composition.

[0369]

[0368] In some embodiments, controlled release of one or more food components from a formulated composition and / or formulated preparation is characterized by at least one of: a total amount (e.g., mass and / or weight) of one or more food components released; a total amount (e.g., mass and / or weight) of one or more food components released relative to initial loading (e.g., percent release); a total amount of energy provided (e.g., calories released); the location of release in a given incubation period in one or more dissolution solvents; or a combination thereof.

[0370]

[0369] Without wishing to be bound by any particular theory, those skilled in the art will appreciate that one or more food components may be characterized by solubility. Those skilled in the art will further appreciate that one or more food components may be characterized as slightly soluble, partially soluble, and / or completely soluble in one or more dissolution solvents. Those skilled in the art will further appreciate that solubility of one or more food components may be achieved by physical and / or chemical dispersal of one more food components within one or more dissolution solvents. Those skilled in the art will further appreciate that the dispersal (e.g., dissolution) of one or more food components in one or more dissolution solvents may be characterized as release of said one or more food components from a formulated composition and / or formulated preparation.

[0371]

[0370] Without wishing to be bound by any particular theory, it is contemplated that the solubility of one more food components is an important factor determining the gastrointestinal absorption of said one or more food components. Without wishing to be bound by any particular theory, controlling the solubility of one or more food components influences the gastrointestinal absorption and / or bioavailability of the one or more food components in a subject that has ingested a formulation. In some embodiments, controlling the solubility of one or more food components may be characterized as a means of controlling the release of one or more food components.

[0372]

[0371] In some embodiments, controlled release of one or more food components from a formulated composition and / or formulated preparation comprises regulating access of one or more dissolution solvents to the one or more food components, regulating access of one or more enzymes (e.g., digestive enzymes) to the one or more food components, regulating the diffusivity of the one or more food components, or a combination thereof.

[0373]

[0372] In some embodiments, the release of one or more food components is characterized by the amount (e.g., concentration) of the one or more food components solubilized in one or more dissolution solvents over a predetermined period of time (e.g., incubation period).

[0374]

[0373] In some embodiments, the present disclosure provides a formulated composition and / or formulated preparation that is characterized as providing a delayed release of one or more food components as compared to one or more food components that are not formulated (e.g., do not comprise one or more release modulators). In some embodiments, two or more food components in a formulated composition and / or formulated preparation are characterized as having the same delayed release profile. In some embodiments, two or more food components in a formulated composition and / or formulated preparation are characterized as having different delayed release profiles.

[0375]

[0374] In some embodiments, the present disclosure provides a formulated composition and / or formulated preparation that is characterized as providing an extended duration of release of one or more food components as compared to one or more food components that are not formulated (e.g., do not comprise one or more release modulators). In some embodiments, two or more food components in a formulated composition and / or formulated preparation are characterized as having the same extended durations of release. In some embodiments, two or more food components in a formulated composition and / or formulated preparation are characterized as having different extended durations of release.

[0376]

[0375] In some embodiments, a formulated composition and / or formulated preparation is characterized as providing controlled release of one or more food components in a gastrointestinal compartment (e.g., stomach, small intestine, large intestine) of a subject that has ingested said formulation. In some embodiments, a formulated composition and / or formulated preparation is characterized as providing a delayed release of one or more food components in a gastrointestinal compartment (e.g., stomach, small intestine, large intestine) of a subject that has ingested said formulation. In some embodiments, a formulated composition and / or formulated preparation is characterized as providing an extended duration of release of one or more food components in a gastrointestinal compartment (e.g., stomach, small intestine, large intestine) of a subject that has ingested said formulation.

[0377]

[0376] In some embodiments, a formulated composition is characterized as providing controlled release of one or more food components at a gastrointestinal epithelial surface of a subject that has ingested said formulation. In some embodiments, a formulated composition is characterized as providing a delayed release of one or more food components at a gastrointestinal epithelial surface of a subject that has ingested said formulation. In some embodiments, a formulated composition is characterized as providing an extended duration of release of one or more food components at a gastrointestinal epithelial surface of a subject that has ingested said formulation.

[0378]

[0377] In some embodiments, a formulated composition is characterized as providing controlled release of one or more food components at a gastrointestinal mucosal surface of a subject that has ingested said formulation. In some embodiments, a formulated composition is characterized as providing a delayed release of one or more food components at a gastrointestinal mucosal surface of a subject that has ingested said formulation. In some embodiments, a formulated composition is characterized as providing an extended duration of release of one or more food components at a gastrointestinal mucosal surface of a subject that has ingested said formulation.

[0379]

[0378] In some embodiments, a formulated composition of the present disclosure is characterized as providing a controlled time of residence of one or more released food components in one or more gastrointestinal compartments (e.g., stomach, small intestine, large intestine) of a subject that has ingested said formulation. In some embodiments, a formulated composition of the present disclosure is characterized as providing a delayed residence of one or more released food components in one or more gastrointestinal compartments of a subject that has ingested said formulation. In some embodiments, a formulated composition of the present disclosure is characterized as providing an extended duration of residence of one or more released food components in one or more gastrointestinal compartments of a subject that has ingested said formulation.

[0380]

[0379] In some embodiments, controlled release of one or more food components is characterized as being targeted to a gastrointestinal location. In some embodiments, a formulated composition releases one or more food components in the buccal cavity, stomach, duodenum, jejunum, ileum, colon, rectum, or combination thereof of a subject ingesting said formulation.

[0381]

[0380] In some embodiments, release of one or more food components from a formulated composition and / or formulated preparation into the buccal cavity, stomach, duodenum, jejunum, ileum, colon, rectum, or combination thereof of a subject ingesting said formulation is triggered by a change in pH. In some embodiments, a pH of about 1-2, about 2-3, about 3-4, about 4-5, about 5-6, about 6-7, about 7-8, about 8-9, or about 9-10, triggers release of one of more food components from a formulated composition and / or formulated preparation.

[0382]

[0381] In some embodiments, release of one or more food components from a formulated composition and / or formulated preparation into the buccal cavity, stomach, duodenum, jejunum, ileum, colon, rectum, or combination thereof of a subject ingesting said formulation is triggered by the presence of one or more enzymes. In some embodiments, the presence of one or more amylases, one or more lipases, one or more proteases, one or more bacteria, or combination thereof, triggers release of one of more food components from a formulated composition and / or formulated preparation.

[0383]

[0382] In some embodiments, release of one or more food components from a formulated composition and / or formulated preparation into the buccal cavity, stomach, duodenum, jejunum, ileum, colon, rectum, or combination thereof of a subject ingesting said formulation is triggered by the application of a physical force to said formulation. In some embodiments, the application of physical pressure and / or shear forces, triggers the release of one of more food components from a formulated composition and / or formulated preparation.

[0384]

[0383] In some embodiments, release of one or more food components from a formulated composition and / or formulated preparation into the buccal cavity, stomach, duodenum, jejunum, ileum, colon, rectum, or combination thereof of a subject ingesting said formulation is triggered by a change in temperature. In some embodiments, a temperature of about 20 °C, about 25 °C, about 28 °C, about 30 °C, about 35 °C, about 37 °C, about 40 °C, about 45 °C, or about 50 °C triggers the release of one of more food components from a formulated composition and / or formulated preparation.

[0384] In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as providing a controlled time of absorption of one or more released food components in one or more gastrointestinal compartments (e.g., stomach, small intestine, large intestine) of a subject that has ingested said formulation. In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as providing delayed absorption of one or more released food components in one or more gastrointestinal compartments of a subject that has ingested said formulation. In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as providing an extended duration of absorption of one or more released food components in one or more gastrointestinal compartments of a subject that has ingested said formulation.

[0385]

[0385] Without wishing to be bound by any particular theory, it is contemplated that controlled and / or an extended duration of release of one or more food components in one or more gastrointestinal compartments (e.g., stomach, small intestine, large intestine) of a subject that has ingested said formulation increases the bioavailability of the one or more food components to the subject.

[0386]

[0386] In some embodiments, a formulated composition and / or formulated preparation is characterized as providing controlled energy (e.g., caloric) release to a subject that has ingested said formulation. In some embodiments, a formulated composition and / or formulated preparation is characterized as providing delayed energy (e.g., caloric) release to a subject that has ingested said formulation. In some embodiments, a formulated composition and / or formulated preparation is characterized as providing an extended duration of energy (e.g., caloric) release to a subject that has ingested said formulation.

[0387]

[0387] In some embodiments, the release of one or more food components from a formulated composition and / or formulated preparation of the present disclosure may be held at a constant rate for about 0.5 hours to 72 hours, 1 hour to 72 hours, 2 hours to 72 hours, 4 hours to 72 hours, 6 hours to 72 hours, 8 hours to 72 hours, 10 hours to 72 hours, 12 hours to 72 hours, 18 hours to 72 hours, 24 hours to 72 hours, 30 hours to 72 hours, 36 hours to 72 hours, 42 hours to 72 hours, 48 hours to 72 hours, 54 hours to 72 hours, 60 hours to 72 hours, 66 hours to 72 hours, 0.5 hours to 66 hours, 1 hour to 66 hours, 2 hours to 66 hours, 4 hours to 66 hours, 6 hours to 66 hours, 8 hours to 66 hours, 10 hours to 66 hours, 12 hours to 66 hours, 18 hours to 66 hours, 24 hours to 66 hours, 30 hours to 66 hours, 36 hours to 66 hours, 42 hours to 66 hours, 48 hours to 66 hours, 54 hours to 66 hours, 60 hours to 66 hours, 0.5 hours to 60 hours, 1 hour to 60 hours, 2 hours to 60 hours, 4 hours to 60 hours, 6 hours to 60 hours, 8 hours to 60 hours, 10 hours to 60 hours, 12 hours to 60 hours, 18 hours to 60 hours, 24 hours to 60 hours, 30 hours to 60 hours, 36 hours to 60 hours, 42 hours to 60 hours, 48 hours to 60 hours, 54 hours to 60 hours, 0.5 hours to 54 hours, 1 hour to 54 hours, 2 hours to 54 hours, 4 hours to 54 hours, 6 hours to 54 hours, 8 hours to 54 hours, 10 hours to 54 hours, 12 hours to 54 hours, 18 hours to 54 hours, 24 hours to 54 hours, 30 hours to 54 hours, 36 hours to 54 hours, 42 hours to 54 hours, 48 hours to 54 hours, 0.5 hours to 48 hours, 1 hour to 48 hours, 2 hours to 48 hours, 4 hours to 48 hours, 6 hours to 48 hours, 8 hours to 48 hours, 10 hours to 48 hours, 12 hours to 48 hours, 18 hours to 48 hours, 24 hours to 48 hours, 30 hours to 48 hours, 36 hours to 48 hours, 42 hours to 48 hours, 0.5 hours to 42 hours, 1 hour to 42 hours, 2 hours to 42 hours, 4 hours to 42 hours, 6 hours to 42 hours, 8 hours to 42 hours, 10 hours to 42 hours, 12 hours to 42 hours, 18 hours to 42 hours, 24 hours to 42 hours, 30 hours to 42 hours, 36 hours to 42 hours, 0.5 hours to 36 hours, 1 hour to 36 hours, 2 hours to 36 hours, 4 hours to 36 hours, 6 hours to 36 hours, 8 hours to 36 hours, 10 hours to 36 hours, 12 hours to 36 hours, 18 hours to 36 hours, 24 hours to 36 hours, 30 hours to 36 hours, 0.5 hours to 30 hours, 1 hour to 30 hours, 2 hours to 30 hours, 4 hours to 30 hours, 6 hours to 30 hours, 8 hours to 30 hours, 10 hours to 30 hours, 12 hours to 30 hours, 18 hours to 30 hours, 24 hours to 30 hours, 0.5 hours to 24 hours, 1 hour to 24 hours, 2 hours to 24 hours, 4 hours to 24 hours, 6 hours to 24 hours, 8 hours to 24 hours, 10 hours to 24 hours, 12 hours to 24 hours, 18 hours to 24 hours, 0.5 hours to 18 hours, 1 hour to 18 hours, 2 hours to 18 hours, 4 hours to 18 hours, 6 hours to 18 hours, 8 hours to 18 hours, 10 hours to 18 hours, 12 hours to 18 hours, 0.5 hours to 12 hours, 1 hour to 12 hours, 2 hours to 12 hours, 4 hours to 12 hours, 6 hours to 12 hours, 8 hours to 12 hours, 10 hours to 12 hours, 0.5 hours to 10 hours, 1 hour to 10 hours, 2 hours to 10 hours, 4 hours to 10 hours, 6 hours to 10 hours, 8 hours to 10 hours, 0.5 hours to 8 hours, 1 hour to 8 hours, 2 hours to 8 hours, 4 hours to 8 hours, 6 hours to 8 hours, 0.5 hours to 6 hours, 1 hour to 6 hours, 2 hours to 6 hours, 4 hours to 6 hours, 0.5 hours to 4 hours, 1 hour to 4 hours, 2 hours to 4 hours, 0.5 hours to 2 hours, 1 hour to 2 hours, or 0.5 hours to 1.5 hours.

[0388]

[0388] In some embodiments, controlled release of one or more food components from a formulated composition and / or formulated preparation is characterized by the percent release of the one or more food components (based on dry weight) in a given time period (e.g., incubation period) in one or more dissolution solvents.

[0389]

[0389] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 1 hour.

[0390]

[0390] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 1.5 hours.

[0391]

[0391] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 2 hours.

[0392]

[0392] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 2.5 hours.

[0393]

[0393] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 3 hours.

[0394]

[0394] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 4 hours.

[0395]

[0395] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 6 hours.

[0396]

[0396] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 12 hours.

[0397]

[0397] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 24 hours.

[0398]

[0398] In some embodiments, about 5% to 80% (w / w), 10% to 80% (w / w), 15% to 80% (w / w), 20% to 80% (w / w), 25% to 80% (w / w), 30% to 80% (w / w), 35% to 80% (w / w), 40% to 80% (w / w), 45% to 80% (w / w), 50% to 80% (w / w), 55% to 80% (w / w), 60% to 80% (w / w), 65% to 80% (w / w), 70% to 80% (w / w), 75% to 80% (w / w), 5% to 70% (w / w), 10% to 70% (w / w), 15% to 70% (w / w), 20% to 70% (w / w), 25% to 70% (w / w), 30% to 70% (w / w), 35% to 70% (w / w), 40% to 70% (w / w), 45% to 70% (w / w), 50% to 70% (w / w), 55% to 70% (w / w), 60% to 70% (w / w), 65% to 70% (w / w), 5% to 60% (w / w), 10% to 60% (w / w), 15% to 60% (w / w), 20% to 60% (w / w), 25% to 60% (w / w), 30% to 60% (w / w), 35% to 60% (w / w), 40% to 60% (w / w), 45% to 60% (w / w), 50% to 60% (w / w), 55% to 60% (w / w), 5% to 50% (w / w), 10% to 50% (w / w), 15% to 50% (w / w), 20% to 50% (w / w), 25% to 50% (w / w), 30% to 50% (w / w), 35% to 50% (w / w), 40% to 50% (w / w), 45% to 50% (w / w), 5% to 40% (w / w), 10% to 40% (w / w), 15% to 40% (w / w), 20% to 40% (w / w), 25% to 40% (w / w), 30% to 40% (w / w), 35% to 40% (w / w), 5% to 30% (w / w), 10% to 30% (w / w), 15% to 30% (w / w), 20% to 30% (w / w), 25% to 30% (w / w), 5% to 20% (w / w), 10% to 20% (w / w), 15% to 20% (w / w), or 5% to 10% (w / w) of one or more food component is released from a formulated composition and / or formulated preparation into one or more dissolution solvents over a duration of about 48 hours.

[0399]

[0399] In some embodiments, the release of one or more food components from a formulated composition and / or formulated preparation of the present disclosure may occur in intervals (e.g., bolus doses) once every about 30 minutes to 24 hours, 60 minutes to 24 hours, 1.5 hours to 24 hours, 2 hours to 24 hours, 4 hours to 24 hours, 6 hours to 24 hours, 8 hours to 24 hours, 12 hours to 24 hours, 18 hours to 24 hours, 30 minutes to 18 hours, 60 minutes to 18 hours, 1.5 hours to 18 hours, 2 hours to 18 hours, 4 hours to 18 hours, 6 hours to 18 hours, 8 hours to 18 hours, 12 hours to 18 hours, 30 minutes to 12 hours, 60 minutes to 12 hours, 1.5 hours to 12 hours, 2 hours to 12 hours, 4 hours to 12 hours, 6 hours to 12 hours, 8 hours to 12 hours, 30 minutes to 6 hours, 60 minutes to 6 hours, 1.5 hours to 6 hours, 2 hours to 6 hours, 4 hours to 6 hours, 30 minutes to 4 hours, 60 minutes to 4 hours, 1.5 hours to 4 hours, 2 hours to 4 hours, 30 minutes to 2 hours, 60 minutes to 2 hours, 1.5 hours to 2 hours, 30 minutes to 1.5 hours, 60 minutes to 1.5 hours, or 30 minutes to 1 hour.

[0400]

[0400] In some embodiments, the release rate of one or more food components from a formulated composition and / or formulated preparation of the present disclosure may increase one or more times after about 1 hour to 48 hours, 2 hours to 48 hours, 4 hours to 48 hours, 6 hours to 48 hours, 8 hours to 48 hours, 12 hours to 48 hours, 18 hours to 48 hours, 24 hours to 48 hours, 30 hours to 48 hours, 36 hours to 48 hours, 42 hours to 48 hours, 1 hour to 42 hours, 2 hours to 42 hours, 4 hours to 42 hours, 6 hours to 42 hours, 8 hours to 42 hours, 12 hours to 42 hours, 18 hours to 42 hours, 24 hours to 42 hours, 30 hours to 42 hours, 36 hours to 42 hours, 1 hour to 36 hours, 2 hours to 36 hours, 4 hours to 36 hours, 6 hours to 36 hours, 8 hours to 36 hours, 12 hours to 36 hours, 18 hours to 36 hours, 24 hours to 36 hours, 30 hours to 36 hours, 1 hour to 30 hours, 2 hours to 30 hours, 4 hours to 30 hours, 6 hours to 30 hours, 8 hours to 30 hours, 12 hours to 30 hours, 18 hours to 30 hours, 24 hours to 30 hours, 1 hour to 24 hours, 2 hours to 24 hours, 4 hours to 24 hours, 6 hours to 24 hours, 8 hours to 24 hours, 12 hours to 24 hours, 18 hours to 24 hours, 1 hour to 18 hours, 2 hours to 18 hours, 4 hours to 18 hours, 6 hours to 18 hours, 8 hours to 18 hours, 12 hours to 18 hours, 1 hour to 12 hours, 2 hours to 12 hours, 4 hours to 12 hours, 6 hours to 12 hours, 8 hours to 12 hours, 1 hour to 8 hours, 2 hours to 8 hours, 4 hours to 8 hours, 6 hours to 8 hours, 1 hour to 6 hours, 2 hours to 6 hours, 4 hours to 6 hours, 1 hour to 4 hours, 2 hours to 4 hours, or 1 hour to 2 hours, following ingestion of said formulation by a subject.

[0401]

[0401] In some embodiments, the release rate of one or more food components from a formulated composition and / or formulated preparation of the present disclosure may increase one or more times after about 1 hour to 48 hours, 2 hours to 48 hours, 4 hours to 48 hours, 6 hours to 48 hours, 8 hours to 48 hours, 12 hours to 48 hours, 18 hours to 48 hours, 24 hours to 48 hours, 30 hours to 48 hours, 36 hours to 48 hours, 42 hours to 48 hours, 1 hour to 42 hours, 2 hours to 42 hours, 4 hours to 42 hours, 6 hours to 42 hours, 8 hours to 42 hours, 12 hours to 42 hours, 18 hours to 42 hours, 24 hours to 42 hours, 30 hours to 42 hours, 36 hours to 42 hours, 1 hour to 36 hours, 2 hours to 36 hours, 4 hours to 36 hours, 6 hours to 36 hours, 8 hours to 36 hours, 12 hours to 36 hours, 18 hours to 36 hours, 24 hours to 36 hours, 30 hours to 36 hours, 1 hour to 30 hours, 2 hours to 30 hours, 4 hours to 30 hours, 6 hours to 30 hours, 8 hours to 30 hours, 12 hours to 30 hours, 18 hours to 30 hours, 24 hours to 30 hours, 1 hour to 24 hours, 2 hours to 24 hours, 4 hours to 24 hours, 6 hours to 24 hours, 8 hours to 24 hours, 12 hours to 24 hours, 18 hours to 24 hours, 1 hour to 18 hours, 2 hours to 18 hours, 4 hours to 18 hours, 6 hours to 18 hours, 8 hours to 18 hours, 12 hours to 18 hours, 1 hour to 12 hours, 2 hours to 12 hours, 4 hours to 12 hours, 6 hours to 12 hours, 8 hours to 12 hours, 1 hour to 8 hours, 2 hours to 8 hours, 4 hours to 8 hours, 6 hours to 8 hours, 1 hour to 6 hours, 2 hours to 6 hours, 4 hours to 6 hours, 1 hour to 4 hours, 2 hours to 4 hours, or 1 hour to 2 hours, following placement of said formulation in one or more dissolution solvents.

[0402] In some embodiments, the release rate of one or more food components from a formulated composition and / or formulated preparation of the present disclosure may decrease one or more times after about 1 hour to 48 hours, 2 hours to 48 hours, 4 hours to 48 hours, 6 hours to 48 hours, 8 hours to 48 hours, 12 hours to 48 hours, 18 hours to 48 hours, 24 hours to 48 hours, 30 hours to 48 hours, 36 hours to 48 hours, 42 hours to 48 hours, 1 hour to 42 hours, 2 hours to 42 hours, 4 hours to 42 hours, 6 hours to 42 hours, 8 hours to 42 hours, 12 hours to 42 hours, 18 hours to 42 hours, 24 hours to 42 hours, 30 hours to 42 hours, 36 hours to 42 hours, 1 hour to 36 hours, 2 hours to 36 hours, 4 hours to 36 hours, 6 hours to 36 hours, 8 hours to 36 hours, 12 hours to 36 hours, 18 hours to 36 hours, 24 hours to 36 hours, 30 hours to 36 hours, 1 hour to 30 hours, 2 hours to 30 hours, 4 hours to 30 hours, 6 hours to 30 hours, 8 hours to 30 hours, 12 hours to 30 hours, 18 hours to 30 hours, 24 hours to 30 hours, 1 hour to 24 hours, 2 hours to 24 hours, 4 hours to 24 hours, 6 hours to 24 hours, 8 hours to 24 hours, 12 hours to 24 hours, 18 hours to 24 hours, 1 hour to 18 hours, 2 hours to 18 hours, 4 hours to 18 hours, 6 hours to 18 hours, 8 hours to 18 hours, 12 hours to 18 hours, 1 hour to 12 hours, 2 hours to 12 hours, 4 hours to 12 hours, 6 hours to 12 hours, 8 hours to 12 hours, 1 hour to 8 hours, 2 hours to 8 hours, 4 hours to 8 hours, 6 hours to 8 hours, 1 hour to 6 hours, 2 hours to 6 hours, 4 hours to 6 hours, 1 hour to 4 hours, 2 hours to 4 hours, or 1 hour to 2 hours, following ingestion of said formulation by a subject.

[0402]

[0403] In some embodiments, the release rate of one or more food components from a formulated composition and / or formulated preparation of the present disclosure may decrease one or more times after about 1 hour to 48 hours, 2 hours to 48 hours, 4 hours to 48 hours, 6 hours to 48 hours, 8 hours to 48 hours, 12 hours to 48 hours, 18 hours to 48 hours, 24 hours to 48 hours, 30 hours to 48 hours, 36 hours to 48 hours, 42 hours to 48 hours, 1 hour to 42 hours, 2 hours to 42 hours, 4 hours to 42 hours, 6 hours to 42 hours, 8 hours to 42 hours, 12 hours to 42 hours, 18 hours to 42 hours, 24 hours to 42 hours, 30 hours to 42 hours, 36 hours to 42 hours, 1 hour to 36 hours, 2 hours to 36 hours, 4 hours to 36 hours, 6 hours to 36 hours, 8 hours to 36 hours, 12 hours to 36 hours, 18 hours to 36 hours, 24 hours to 36 hours, 30 hours to 36 hours, 1 hour to 30 hours, 2 hours to 30 hours, 4 hours to 30 hours, 6 hours to 30 hours, 8 hours to 30 hours, 12 hours to 30 hours, 18 hours to 30 hours, 24 hours to 30 hours, 1 hour to 24 hours, 2 hours to 24 hours, 4 hours to 24 hours, 6 hours to 24 hours, 8 hours to 24 hours, 12 hours to 24 hours, 18 hours to 24 hours, 1 hour to 18 hours, 2 hours to 18 hours, 4 hours to 18 hours, 6 hours to 18 hours, 8 hours to 18 hours, 12 hours to 18 hours, 1 hour to 12 hours, 2 hours to 12 hours, 4 hours to 12 hours, 6 hours to 12 hours, 8 hours to 12 hours, 1 hour to 8 hours, 2 hours to 8 hours, 4 hours to 8 hours, 6 hours to 8 hours, 1 hour to 6 hours, 2 hours to 6 hours, 4 hours to 6 hours, 1 hour to 4 hours, 2 hours to 4 hours, or 1 hour to 2 hours, following placement of said formulation in one or more dissolution solvents.

[0403] 1. Measuring Release

[0404]

[0404] In some embodiments, the release of one or more food components from a formulated composition and / or formulated preparation is characterized by quantification of solubilization of the one or more food components in one or more dissolution solvents.

[0405]

[0405] In some embodiments, a dissolution solvent may be characterized by its miscibility with water. In some embodiments, one or more dissolution solvents is characterized as being miscible with water. In some embodiments, a dissolution solvent may comprise water, phosphate buffered saline (PBS), simulated gastric fluid (SGF), fasted state simulated gastric fluid (FaSSGF), simulated intestinal fluid, simulated tear fluid, simulated urine, HEPES buffered saline, Dulbecco’s Modified Eagle Medium (DMEM), Hank’s balanced salt solution, cyrene, glycofurol, furfural, Kreb’s buffer, acetone, tetrahydrofuran, ethanol, methanol, dimethylformamide, dimethyl sulfoxide, or a combination thereof.

[0406]

[0406] In some embodiments, one or more dissolution solvents is characterized as being immiscible with water. In some embodiments, a dissolution solvent may comprise n-octanol, n- nonanol, n-decanol, n-dodecanol, n-tetradecanol, n-hexadecanol, n-octadecanol, n-icosanol, fatty alcohol monoglyceride ethers, fatty acid monoglyceride esters, fatty alcohol diglyceride ethers, fatty acid diglyceride esters, fatty alcohol triglyceride ethers, fatty acid triglyceride esters, fatty alcohol glycol monoether, fatty acid glycol monoesters, fatty alcohol glycol diethers, fatty acid glycol diesters, coconut oil, com oil, cottonseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil, sunflower oil, almond oil, pine nut oil, cashew oil, fully hydrogenated palm oil, partially hydrogenated palm oil, fully hydrogenated sunflower oil, partially hydrogenated sunflower oil, fully hydrogenated soybean oil, partially hydrogenated soybean oil, fully hydrogenated vegetable oil, partially hydrogenated vegetable oil, fully hydrogenated cottonseed oil, partially hydrogenated cottonseed oil, dichloromethane, hexanes, toluene, 2-methyltetrahydrofuran, ethyl acetate, or a combination thereof.

[0407] In some embodiments, a dissolution solvent may be characterized by its salinity. In some embodiments, a dissolution solvent may comprise water, PBS, simulated intestinal fluid, SGF, FaSSGF, simulated tear fluid, simulated urine, HEPES buffered saline, DMEM, Hank’s balanced salt solution, biological intestinal fluid, biological gastric fluid, plasma, saliva, urine, feces, sweat, tear fluid, Kreb’s buffer, or a combination thereof.

[0407]

[0408] In some embodiments, a dissolution solvent may be characterized by its pH. In some embodiments, a dissolution solvent may comprise water, PBS, simulated intestinal fluid, SGF, FaSSGF, simulated tear fluid, simulated urine, HEPES buffered saline, DMEM, Hank’s balanced salt solution, biological intestinal fluid, biological gastric fluid, plasma, saliva, urine, feces, sweat, tear fluid, and / or Kreb’s buffer.

[0408]

[0409] In some embodiments, a dissolution solvent may be characterized as a native biological fluid (i.e., a fluid characterized as essential to a living organism). In some embodiments, a dissolution solvent may comprise water, biological intestinal fluid, biological gastric fluid, plasma, saliva, urine, feces, sweat, oral fluid, cecum fluid, bile, and / or tear fluid.

[0409]

[0410] In some embodiments, a dissolution solvent may be characterized as a surrogate of a native biological fluid (i.e., a surrogate of a fluid characterized as essential to a living organism). In some embodiments, a dissolution solvent may comprise water, PBS, simulated intestinal fluid, SGF, FaSSGF, simulated tear fluid, simulated urine, HEPES buffered saline, DMEM, Hank’s balanced salt solution, and / or Kreb’s buffer.

[0410]

[0411] In some embodiments, a dissolution solvent may be characterized by its miscibility with water, by its pH, by its salinity, as being a native biological fluid, as being a surrogate of a native biological fluid, or a combination thereof.

[0411]

[0412] In some embodiments, to determine release of one or more food components from a formulated composition and / or formulated preparation, a preparation of a formulated composition and / or formulated preparation is added to an excess quantity, by weight, of one or more dissolution solvents. In some embodiments, a preparation of a formulated composition and / or formulated preparation is added to at least about 5 fold, at least about 10 fold, at least about 20 fold, at least about 50 fold, at least about 100 fold, at least about 200 fold, at least about 1000 fold, at least about 5000 fold, or at least about 10000 fold, by weight, excess of one or more dissolution solvents.

[0413] In some embodiments, to determine release of one or more food components from a formulated composition and / or formulated preparation, a preparation of a formulated composition and / or formulated preparation is added to one or more dissolution solvents at a controlled temperature. In some embodiments, a preparation of a formulated composition and / or formulated preparation is added to one or more dissolution solvents held at least at about -20 °C, at least at about 0 °C, at least at about 4 °C, at least at about 20 °C, at least at about 37 °C, and / or at least at about 50 °C.

[0412]

[0414] In some embodiments, to determine release of one or more food components from a formulated composition and / or formulated preparation, a preparation of a formulated composition and / or formulated preparation is added to one or more dissolution solvents for a predetermined period of time (e.g., incubation period). In some embodiments, a preparation of a formulated composition and / or formulated preparation is added to one or more dissolution solvents and incubated for about 0.5 min. to 1500 min., 1 min. to 1500 min., 5 min. to 1500 min., 10 min. to 1500 min., 15 min. to 1500 min., 30 min. to 1500 min., 45 min. to 1500 min., 60 min. to 1500 min., 90 min. to 1500 min., 120 min. to 1500 min., 150 min. to 1500 min., 200 min. to 1500 min., 250 min. to 1500 min., 300 min. to 1500 min., 400 min. to 1500 min., 500 min. to 1500 min., 600 min. to 1500 min., 700 min. to 1500 min., 800 min. to 1500 min., 900 min. to 1500 min., 1000 min. to 1500 min., 1100 min. to 1500 min., 1200 min. to 1500 min., 1300 min. to 1500 min., 1400 min. to 1500 min., 0.5 min. to 1250 min., 1 min. to 1250 min., 5 min. to 1250 min., 10 min. to 1250 min., 15 min. to 1250 min., 30 min. to 1250 min., 45 min. to 1250 min., 60 min. to 1250 min., 90 min. to 1250 min., 120 min. to 1250 min., 150 min. to 1250 min., 200 min. to 1250 min., 250 min. to 1250 min., 300 min. to 1250 min., 400 min. to 1250 min., 500 min. to 1250 min., 600 min. to 1250 min., 700 min. to 1250 min., 800 min. to 1250 min., 900 min. to 1250 min., 1000 min. to 1250 min., 1100 min. to 1250 min., 0.5 min. to 1000 min., 1 min. to 1000 min., 5 min. to 1000 min., 10 min. to 1000 min., 15 min. to 1000 min., 30 min. to 1000 min., 45 min. to 1000 min., 60 min. to 1000 min., 90 min. to 1000 min., 120 min. to 1000 min.,

[0413] 150 min. to 1000 min., 200 min. to 1000 min., 250 min. to 1000 min., 300 min. to 1000 min.,

[0414] 400 min. to 1000 min., 500 min. to 1000 min., 600 min. to 1000 min., 700 min. to 1000 min.,

[0415] 800 min. to 1000 min., 900 min. to 1000 min., 0.5 min. to 750 min., 1 min. to 750 min., 5 min. to

[0416] 750 min., 10 min. to 750 min., 15 min. to 750 min., 30 min. to 750 min., 45 min. to 750 min., 60 min. to 750 min., 90 min. to 750 min., 120 min. to 750 min., 150 min. to 750 min., 200 min. to 750 min., 250 min. to 750 min., 300 min. to 750 min., 400 min. to 750 min., 500 min. to 750 min., 600 min. to 750 min., 700 min. to 750 min., 0.5 min. to 500 min., 1 min. to 500 min., 5 min. to 500 min., 10 min. to 500 min., 15 min. to 500 min., 30 min. to 500 min., 45 min. to 500 min., 60 min. to 500 min., 90 min. to 500 min., 120 min. to 500 min., 150 min. to 500 min., 200 min. to 500 min., 250 min. to 500 min., 300 min. to 500 min., 400 min. to 500 min., 0.5 min. to 250 min., 1 min. to 250 min., 5 min. to 250 min., 10 min. to 250 min., 15 min. to 250 min., 30 min. to 250 min., 45 min. to 250 min., 60 min. to 250 min., 90 min. to 250 min., 120 min. to 250 min., 150 min. to 250 min., 200 min. to 250 min., 0.5 min. to 100 min., 1 min. to 100 min., 5 min. to 100 min., 10 min. to 100 min., 15 min. to 100 min., 30 min. to 100 min., 45 min. to 100 min., 60 min. to 100 min., 90 min. to 100 min., 0.5 min. to 60 min., 1 min. to 60 min., 5 min. to

[0417] 60 min., 10 min. to 60 min., 15 min. to 60 min., 30 min. to 60 min., 45 min. to 60 min., 0.5 min. to 30 min., 1 min. to 30 min., 5 min. to 30 min., 10 min. to 30 min., 15 min. to 30 min., 0.5 min. to 15 min., 1 min. to 15 min., 5 min. to 15 min., 10 min. to 15 min., 0.5 min. to 10 min., 1 min. to

[0418] 10 min., 5 min. to 10 min., 0.5 min. to 5 min., 1 min. to 5 min., or 0.5 min to 1 min.

[0419]

[0415] For example, in some embodiments, to determine release of one or more food components from a formulated composition and / or formulated preparation, a preparation of a formulated composition and / or formulated preparation is added to one or more dissolution solvents and incubated for at least about 30 seconds, at least about 1 minute, at least about 5 minutes, at least about 10 minutes, at least about 30 minutes, at least about 60 minutes, at least about 120 minutes, at least about 6 hours, at least about 12 hours, or at least about 24 hours.

[0420] C. Additional Features

[0421] 1. Low Water Content / Water Activity

[0422]

[0416] In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having low moisture content. Without wishing to be bound by any particular theory, formulated compositions having low moisture content are characterized as having improved stability (e.g., reduced degradation, delayed degradation, etc.) of one or more food components as compared to food components and / or formulations having higher moisture content.

[0423]

[0417] In some embodiments, a formulated composition and / or formulated preparation is characterized as having a moisture content of less than about 0.5 wt% to 10 wt%, 1 wt% to 10 wt%, 2 wt% to 10 wt%, 4 wt% to 10 wt%, 6 wt% to 10 wt%, 8 wt% to 10 wt%, 0.5 wt% to 8 wt%, 1 wt% to 8 wt%, 2 wt% to 8 wt%, 4 wt% to 8 wt%, 6 wt% to 8 wt%, 0.5 wt% to 6 wt%, 1 wt% to 6 wt%, 2 wt% to 6 wt%, 4 wt% to 6 wt%, 0.5 wt% to 4 wt%, 1 wt% to 4 wt%, 2 wt% to 4 wt%, 0.5 wt% to 2 wt%, or 0.5% wt% to 1 wt%. For example, in some embodiments a formulated composition and / or formulated preparation is characterized as having a moisture content of less than about 0.5 wt%, 1 wt%, 2 wt%, 4 wt%, 6 wt%, 8 wt%, or 10 wt%.

[0424]

[0418] In some embodiments, a formulated composition and / or formulated preparation is characterized by resistance or mitigation of water / moisture absorption when exposed to high humidity or moisture content. In some embodiments, a formulated composition and / or formulated preparation does not absorb more than about 0.25% (w / w) to 5% (w / w), 0.5% (w / w) to 5% (w / w), 0.75% (w / w) to 5% (w / w), 1% (w / w) to 5% (w / w), 1.5% (w / w) to 5% (w / w), 2% (w / w) to 5% (w / w), 2.5% (w / w) to 5% (w / w), 3% (w / w) to 5% (w / w), 3.5% (w / w) to 5% (w / w), 4% (w / w) to 5% (w / w), 4.5% (w / w) to 5% (w / w), 0.25% (w / w) to 4% (w / w), 0.5% (w / w) to 4% (w / w), 0.75% (w / w) to 4% (w / w), 1% (w / w) to 4% (w / w), 1.5% (w / w) to 4% (w / w), 2% (w / w) to 4% (w / w), 2.5% (w / w) to 4% (w / w), 3% (w / w) to 4% (w / w), 3.5% (w / w) to 4% (w / w), 0.25% (w / w) to 3% (w / w), 0.5% (w / w) to 3% (w / w), 0.75% (w / w) to 3% (w / w), 1% (w / w) to 3% (w / w), 1.5% (w / w) to 3% (w / w), 2% (w / w) to 3% (w / w), 2.5% (w / w) to 3% (w / w), 0.25% (w / w) to 2% (w / w), 0.5% (w / w) to 2% (w / w), 0.75% (w / w) to 2% (w / w), 1% (w / w) to 2% (w / w), 1.5% (w / w) to 2% (w / w), 0.25% (w / w) to 1% (w / w), 0.5% (w / w) to 1% (w / w), 0.75% (w / w) to 1% (w / w), or 0.25% (w / w) to 0.5% (w / w) when exposed to an environment having a relative humidity of about 33% to 75%, 53% to 75%, or 33% to 53%.

[0425]

[0419] In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having low water activity. Without wishing to be bound by any particular theory, formulated compositions having low water activity are characterized as having improved stability (e.g., reduced degradation, delayed degradation, etc.) of one or more food components as compared to food components and / or formulations having higher water activity. In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a water of activity of less than 0.1 to 0.5, 0.15 to 0.5, 0.2 to 0.5, 0.25 to 0.5, 0.3 to 0.5, 0.35 to 0.5, 0.4 to 0.5, 0.45 to 0.5, 0.1 to 0.4, 0.15 to 0.4, 0.2 to 0.4, 0.25 to 0.4, 0.3 to 0.4, 0.35 to 0.4, 0.1 to 0.3, 0.15 to 0.3, 0.2 to 0.3, 0.25 to 0.3, 0.1 to 0.2, 0.15 to 0.2, or 0.1 to 0.15. For example, in some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a water of activity of less than 0.1. In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a water of activity of less than 0.2. In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a water of activity of less than 0.3. In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a water of activity of less than 0.4. In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a water of activity of less than 0.5.

[0426]

[0420] In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a water activity less than 0.2. Without wishing to be bound by any particular theory, a water activity less than 0.2 supports the stability and / or longevity of one or more probiotic in a formulated preparation of the present disclosure.

[0427] 2. Particle Size

[0428]

[0421] In some embodiments, a preparation of a formulated composition and / or formulated preparation of the present disclosure comprises one or more particles of the formulated composition. In some embodiments, a preparation comprising one or more particles of a formulated composition and / or formulated preparation has a particular shape or form. In some embodiments, a preparation comprising one or more particles of a formulated composition and / or formulated preparation has an irregular shape or a cross-sectional shape of a circle, an oval, a triangle, a square, or a hexagon. In some embodiments, a preparation comprising one or more particles of a formulated composition and / or formulated preparation includes two or more particles having different shapes or forms. In some embodiments, a preparation comprises particles where substantially all or all the particles have a common shape.

[0429]

[0422] In some embodiments, a preparation of a formulated composition and / or formulated preparation of the present disclosure is characterized as comprising particles having a distribution of diameters (e.g., Dv(10), Dv(20), Dv(30), Dv(40), Dv(50), Dv(60), Dv(70), Dv(80), Dv(90), Dv(99), etc.). In some embodiments, a preparation of a formulated composition and / or formulated preparation of the present disclosure is characterized as comprising particles having an average diameter (e.g., D[3,2], D[4,3], etc.). Regardless of the shape of a particle, the “diameter” (i.c., size) of a particle is the longest distance from one end of the particle to another end of the particle.

[0430]

[0423] In some embodiments, a preparation of a formulated composition and / or formulated preparation of the present disclosure is characterized as comprising particles having a distribution of diameters (e.g., Dv(10), Dv(20), Dv(30), Dv(40), Dv(50), Dv(60), Dv(70), Dv(80), Dv(90), Dv(99), etc.) of about 5 pm to 10,000 pm, 10 pm to 10,000 pm, 20 pm to 10,000 pm, 30 pm to 10,000 pm, 40 pm to 10,000 pm, 50 pm to 10,000 pm, 100 pm to 10,000 pm, 200 pm to 10,000 pm, 400 pm to 10,000 pm, 800 pm to 10,000 pm, 1000 pm to 10,000 pm, 1250 pm to 10,000 pm, 1500 pm to 10,000 pm, 2000 pm to 10,000 pm, 2500 pm to 10,000 pm, 5000 pm to 10,000 pm, 7500 pm to 10,000 pm, 5 pm to 5000 pm, 10 pm to 5000 pm, 20 pm to 5000 pm, 30 pm to 5000 pm, 40 pm to 5000 pm, 50 pm to 5000 pm, 100 pm to 5000 pm, 200 pm to 5000 pm, 400 pm to 5000 pm, 800 pm to 5000 pm, 1000 pm to 5000 pm, 1250 pm to 5000 pm, 1500 pm to 5000 pm, 2000 pm to 5000 pm, 2500 pm to 5000 pm, 5 pm to 2500 pm, 10 pm to 2500 pm, 20 pm to 2500 pm, 30 pm to 2500 pm, 40 pm to 2500 pm, 50 pm to 2500 pm, 100 pm to 2500 pm, 200 pm to 2500 pm, 400 pm to 2500 pm, 800 pm to 2500 pm, 1000 pm to 2500 pm, 1250 pm to 2500 pm, 1500 pm to 2500 pm, 2000 pm to 2500 pm, 5 pm to 1250 pm, 10 pm to 1250 pm, 20 pm to 1250 pm, 30 pm to 1250 pm, 40 pm to 1250 pm, 50 pm to 1250 pm, 100 pm to 1250 pm, 200 pm to 1250 pm, 400 pm to 1250 pm, 800 pm to 1250 pm, 1000 pm to 1250 pm, 5 pm to 625 pm, 10 pm to 625 pm, 20 pm to 625 pm, 30 pm to 625 pm, 40 pm to 625 pm, 50 pm to 625 pm, 100 pm to 625 pm, 200 pm to 625 pm, 400 pm to 625 pm, 5 pm to 300 pm, 10 pm to 300 pm, 20 pm to 300 pm, 30 pm to 300 pm, 40 pm to 300 pm, 50 pm to 300 pm, 100 pm to 300 pm, 200 pm to 300 pm, 5 pm to 150 pm, 10 pm to 150 pm, 20 pm to 150 pm, 30 pm to 150 pm, 40 pm to 150 pm, 50 pm to 150 pm, 100 pm to 150 pm, 5 pm to 100 pm, 10 pm to 100 pm, 20 pm to 100 pm, 30 pm to 100 pm, 40 pm to 100 pm, 50 pm to 100 pm, 5 pm to 50 pm, 10 pm to 50 pm, 20 pm to 50 pm, 30 pm to 50 pm, 40 pm to 50 pm, 5 pm to 20 pm, 10 pm to 20 pm, or 5 pm to 10 pm. For example, in some embodiments, a preparation of a formulated composition and / or formulated preparation of the present disclosure is characterized as comprising particles having a distribution of diameters of up to about 5 pm, 10 pm, 20 pm, 30 pm, 40 pm, 50 pm, 100 pm, 200 pm, 400 pm, 800 pm, 1250 pm, 2500 pm, or 5000 pm.

[0424] Without wishing to be bound to any particular theory, a preparation of a formulated composition and / or formulated preparation of the present disclosure comprising particles having substantially uniform shapes and small particle diameters may be characterized as being amenable for incorporating into a food and or beverage product (e.g., a powder (e.g., protein powder), bar, food, beverage, or supplement). In some embodiments, a preparation of a formulated composition and / or formulated preparation of the present disclosure comprising particles having substantially uniform shapes and small particle diameters may be characterized as having an appealing mouth-feel when ingested by a subject.

[0431] 3. Density

[0432]

[0425] In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a bulk density of about 0.15 g / mL, about 0.2 g / mL, about 0.25 g / mL, about 0.3 g / mL, about 0.35 g / mL, about 0.4 g / mL, about 0.45 g / mL, about 0.5 g / mL, about 0.55 g / mL, about 0.6 g / mL, about 0.65 g / mL, about 0.7 g / mL, about 0.75 g / mL, about 0.8 g / mL, about 0.85 g / mL, about 0.9 g / mL, about 0.95 g / mL, about 1.0 g / mL, about 1.05 g / mL, about 1.1 g / mL, about 1.15 g / mL, about 1.2 g / mL, about 1.25 g / mL, about 1.3 g / mL, about 1.35 g / mL, about 1.4 g / mL, about 1.45 g / mL, about 1.5 g / mL, about 1.55 g / mL, about 1.6 g / mL, about 1.65 g / mL, about 1.7 g / mL, about 1.75 g / mL, about 1.8 g / mL, about 1.85 g / mL, about 1.9 g / mL, about 1.95 g / mL, or about 2 g / mL. In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a tap density of about 0.15 g / mL, about 0.2 g / mL, about 0.25 g / mL, about 0.3 g / mL, about 0.35 g / mL, about 0.4 g / mL, about 0.45 g / mL, about 0.5 g / mL, about 0.55 g / mL, about 0.6 g / mL, about 0.65 g / mL, about 0.7 g / mL, about 0.75 g / mL, about 0.8 g / mL, about 0.85 g / mL, about 0.9 g / mL, about 0.95 g / mL, about 1.0 g / mL, about 1.05 g / mL, about 1.1 g / mL, about 1.15 g / mL, about 1.2 g / mL, about 1.25 g / mL, about 1.3 g / mL, about 1.35 g / mL, about 1.4 g / mL, about 1.45 g / mL, about 1.5 g / mL, about 1.55 g / mL, about 1.6 g / mL, about 1.65 g / mL, about 1.7 g / mL, about 1.75 g / mL, about 1.8 g / mL, about 1.85 g / mL, about 1.9 g / mL, about 1.95 g / mL, or about 2 g / mL. In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized by a Hausner ratio of less than about 0.7, less than about 0.8, less than about 0.9, less than about 1.0, less than about 1.1, less than about 1.2, less than about 1.3, less than about 1.4, less than about 1.5, less than about 1.6, less than about 1.7, less than about 1 .8, less than about 1 .9, less than about 2.0, less than about 2.1 , less than about 2.2, less than about 2.3, or less than about 2.4,

[0433] 4. Low Viscosity

[0434]

[0426] In some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a viscosity of about 1 cP to about 150 cP, about 25 cP to about 150 cP, about 50 cP to about 150 cP, about 75 cP to about 150 cP, about 100 cP to about 150 cP, about 125 cP to about 150 cP, about 1 cP to about 125 cP, about 25 cP to about 125 cP, about 50 cP to about 125 cP, about 75 cP to about 125 cP, about 100 cP to about 125 cP, about 1 cP to about 100 cP, about 25 cP to about 100 cP, about 50 cP to about 100 cP, about 75 cP to about 100 cP, about 1 cP to about 75 cP, about 25 cP to about 75 cP, about 50 cP to about 75 cP, about 1 cP to about 50 cP, about 25 cP to about 50 cP, or about 1 cP to about 25 cP. For example, in some embodiments, a formulated composition and / or formulated preparation of the present disclosure is characterized as having a viscosity of about 1 cP, 25 cP, about 50 cP, about 75 cP, about 100 cP, about 125 cP, or about 150 cP.

[0435]

[0427] In some embodiments, viscosity of a formulated preparation may be measured using a rotating disk (e.g., 20 mm).

[0436]

[0428] In some embodiments, the presence of one or more excipients (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 excipients) in a formulated preparation reduces the viscosity of the preparation.

[0437]

[0429] Without wishing to be bound by any particular theory, it is contemplated that formulated preparations characterized as having low viscosities (e.g., about 25 cP to about 150 cP) can be more homogeneously incorporated into food and / or beverage products. In some embodiments, formulated preparations characterized as having low viscosities (e.g., about 25 cP to about 150 cP) may improve mouth-feel when said preparation is incorporated into food and / or beverage products.

[0438] D. Additional Benefits

[0439] 1. Incorporation into foods / beverage products

[0440]

[0430] In some embodiments, the present disclosure provides for the incorporation of a formulated composition and / or formulated preparation into a food and / or beverage product.

[0431] In some embodiments, a formulated composition and / or formulation preparation may be incorporated into a food and / or beverage product including, but not limited to, protein powder, whey powder, baby formula, dry food powder, protein bar, snack bar, yogurt, supplements, bread, candy, cake, cereal, chip, chocolate, confectionary, cookie, food additive, gummy, ice cream, kefir, rice, pasta, dry food, nutrition supplement, packaged food, pet feed, pet food, protein powder, sachet, salad dressing, salty snack, seed, smoothie, spice, Meal Ready-to- Eat (MRE), frozen food, medical food, fermented food, protein shakes, drink mix powders, dairy milk, oat milk, almond milk, soy milk, coffee grinds, Meal Ready-to-Drink (RTD), ready-to- drink low phenylalanine medical food, electrolyte beverages, sports beverages, water, hard seltzers, alcoholic seltzers, beer, wine, soda, coffee, tea, fermented beverages, carbonated beverage, Gatorade™, Truly™ , Ensure™, PKU Sphere ™ Liquid.

[0441]

[0432] In some embodiments, a formulated composition and / or formulated preparation is characterized as having physical and / or chemical properties that allow said formulation to have sufficient mixability to incorporate with a food and / or beverage product. In some embodiments, a formulated composition and / or formulated preparation is characterized as having physical and / or chemical properties that allow said formulation to have sufficient flowability to incorporate with a food and / or beverage product.

[0442]

[0433] In some embodiments, a formulated composition and / or formulated preparation, may be incorporated into a food and / or beverage product during the manufacturing process of said food and / or beverage product. In some embodiments, a formulated composition and / or formulated preparation, may be incorporated into a food and / or beverage product during the packaging of said food and / or beverage product. In some embodiments, a formulated composition and / or formulated preparation, may be incorporated into a food and / or beverage product during the pasteurization of said food and / or beverage product. In some embodiments, a formulated composition and / or formulated preparation, may be incorporated into a food and / or beverage product prior to mixing of said food and / or beverage product. In some embodiments, a formulated composition and / or formulated preparation, may be incorporated into a finished food and / or beverage product. For example, in some embodiments, a formulated composition and / or formulated preparation may be provided as a ready-to-mix powder for incorporation into a finished food and / or beverage product.

[0434] In some embodiments, a formulated composition and / or formulated preparation, may be incorporated into a food and / or beverage product immediately before ingestion of said food and / or beverage product. In some embodiments, a formulated composition and / or formulated preparation, may be incorporated into a food and / or beverage product before sterilization of said food and / or beverage product. In some embodiments, a formulated composition and / or formulated preparation, may be incorporated into a food and / or beverage product after sterilization of said food and / or beverage product.

[0443]

[0435] In some embodiments, incorporation of a formulated composition and / or formulated preparation into a food and / or beverage product comprises one or more size reduction steps. In some embodiments, a size reduction step may be performed on a formulated composition and / or formulated preparation prior to incorporation into a food and / or beverage product. In some embodiments, a size reduction step may be performed concurrently with the incorporation of a formulated composition and / or formulated preparation with a food and / or beverage product. In some embodiments, a size reduction step may be performed after the incorporation of a formulated composition and / or formulated preparation with a food and / or beverage product.

[0444]

[0436] In some embodiments, a size reduction step may comprise planetary milling, ball milling, burr milling, roller milling, media milling, impact milling, jet milling, high-pressure homogenization, cryo-milling, hammer milling, conical milling, hand screening, granulation / extrusion, extrusion, spray drying, lyophilization / milling, fluid bed agglomeration, spray congealing, high-shear granulation, tableting, pouring, roller compaction, crosslinking, prilling, spinning disc atomization, or a combination thereof.

[0445]

[0437] In some embodiments, incorporation of a formulated composition and / or formulated preparation into a food and / or beverage product comprises one or more homogenization steps.

[0446]

[0438] In some embodiments, a homogenization step is applied to a formulated composition and / or formulated preparation after incorporation of said formulation into a food and / or beverage product. In some embodiments, a homogenization step may comprise use of an overhead stirrer, manual stirring, stir bar, high pressure homogenization, low pressure homogenization, sonication, ultrasonication, vortexing, or a combination thereof.

[0439] In some embodiments, incorporation of a formulated composition and / or formulated preparation into a food and / or beverage product significantly affects the visual appearance of said food and / or beverage product. In some embodiments, incorporation of a formulated composition and / or formulated preparation into a food and / or beverage product minimally affects the visual appearance of said food and / or beverage product. In some embodiments, incorporation of a formulated composition and / or formulated preparation into a food and / or beverage product improves the visual appearance of said food and / or beverage product.

[0447]

[0440] In some embodiments, incorporation of a formulated composition and / or formulated preparation into a food and / or beverage product significantly affects the taste of said food and / or beverage product. In some embodiments, incorporation of a formulated composition and / or formulated preparation into a food and / or beverage product minimally affects the taste of said food and / or beverage product. In some embodiments, incorporation of a formulated composition and / or formulated preparation into a food and / or beverage product improves the taste of said food and / or beverage product.

[0448]

[0441] In some embodiments, a formulated composition and / or formulated preparation is incorporated into a food product including, but not limited to, protein powder, whey powder, baby formula, dry food powder, protein bar, snack bar, yogurt, supplements, bread, candy, cake, cereal, chip, chocolate, confectionary, cookie, food additive, gummy, ice cream, kefir, rice, pasta, dry food, nutrition supplement, packaged food, pet feed, pet food, protein powder, sachet, salad dressing, salty snack, seed, smoothie, spice, Meal Ready-to-Eat (MRE), frozen food, medical food, or fermented food.

[0449]

[0442] In some embodiments, a formulated composition and / or formulated preparation is incorp...

Claims

CLAIMSLISTING OF THE CLAIMSWHAT IS CLAIMED IS:

1. A preparation comprising an extended-release composition comprising:(i) a protein payload; and(ii) a release modulator, wherein the release modulator interacts with the protein payload to prevent access of water molecules and / or one or more enzymes to the protein payload in the preparation, and wherein the protein payload is released in a subject over an extended period following ingestion of the preparation by the subject as compared to ingestion of the protein payload alone.

2. The preparation of claim 1, wherein the protein pay load is heat-treated.

3. The preparation of claim 1 or 2, wherein the protein pay load is heat-treated at about 72 °C to about 112 °C for about 60 minutes to about 120 minutes.

4. The preparation of any one of claims 1 to 3, wherein the protein payload is heat-treated at about 77 °C to about 107 °C for about 75 minutes to about 105 minutes.

5. The preparation of any one of claims 1 to 4, wherein the protein pay load is heat-treated at about 92 °C for about 90 minutes.

6. The preparation of any one of claims 1 to 5, wherein the protein payload is heat-treated at a pH of about 4 to about 8.

7. The preparation of any one of claims 1 to 6, wherein the protein pay load is heat-treated at a pH of about 4.5 to about 7.5.

8. The preparation of any one of claims 1 to 7, wherein the protein payload is heat-treated at a pH of about 5 to about 7.

9. The preparation of any one of claims 1 to 8, wherein the extended-release composition comprises 60% (w / w) to 85% (w / w) of the protein pay load.

10. The preparation of any one of claims 1 to 9, wherein the protein payload comprises whey protein isolate, whey protein concentrate, pea protein isolate, pea protein concentrate, oat protein isolate, oat protein concentrate, soy protein isolate, soy protein concentrate, wheat protein isolate, wheat protein concentrate, egg protein isolate, egg protein concentrate, dairy protein, plant-based protein, casein, bovine serum albumin, ovalbumin, a-lactalbumin, P-lactoglobulin, collagen, glutanin, gliadin, kefirin, avenin, zein, silk, gelatin, hordein, or a combination thereof.

11. The preparation of claim 10, wherein the protein pay load comprises whey protein isolate, whey protein concentrate, casein, lactalbumin, P-lactoglobulin, or a combination thereof.

12. The preparation of claim 10, wherein the protein payload comprises whey protein isolate, whey protein concentrate, pea protein isolate, oat protein isolate, soy protein isolate, wheat protein isolate, plant-based protein, or a combination thereof.

13. The preparation of any one of claims 1 to 12, wherein the extended-release composition comprises 15% (w / w) to 40% (w / w) of the release modulator.

14. The preparation of any one of claims 1 to 13, wherein the release modulator comprises a hydrocolloid.

15. The preparation of claim 14, wherein the hydrocolloid comprises pectin, alginate, carrageenan, or a combination thereof.

16. The preparation of claim 15, wherein the extended-release composition comprises 10% (w / w) to 40% (w / w) of pectin.

17. The preparation of claim 15 or 16, wherein the extended-release composition comprises 0.75% (w / w) to 1.25% (w / w) alginate.

18. The preparation of any one of claims 14 to 17, wherein the release modulator further comprises a gelator.

19. The preparation of claim 18, wherein the gelator comprises dicalcium phosphate, gluconolactonc, calcium carbonate, or a combination thereof.

20. The preparation of claim 18 or 19, wherein the release modulator comprises 7.5 parts or less of hydrocolloid by dry weight for every 1 part of gelator by dry weight.

21. The preparation of any one of claims 1 to 20, wherein the release modulator comprises a carbohydrate.

22. The preparation of claim 21, wherein the carbohydrate comprises hypromellose acetate succinate, rice starch, corn starch, inulin, oat fiber, glucose, tapioca polydextrose, maltodextrin, chitosan, sucrose palmitate, or a combination thereof.

23. The preparation of any one of claims 1 to 22, wherein the release modulator comprises a surfactant.

24. The preparation of claim 23, wherein the surfactant comprises Pluronic F68, Tween 85, triacetin, or Span 60.

25. The preparation of any one of claims 1 to 24, wherein the release modulator comprises shellac.

26. The preparation of any one of claims 1 to 25, wherein the release modulator comprises gum ar bic.

27. The preparation of claim 1, wherein the extended-release composition comprises:75% (w / w) to 85% (w / w) protein payload;10% (w / w) to 20% (w / w) hydrocolloid; and2% (w / w) to 10% (w / w) gelator.

28. The preparation of claim 27, wherein the extended-release composition comprises:75% (w / w) to 85% (w / w) heat-treated whey protein;10% (w / w) to 20% (w / w) alginate;0.5% (w / w) to 2% (w / w) gluconolactone; and0.5% (w / w) to 2% (w / w) dicalcium phosphate.

29. The preparation of claim 27, wherein the extended-release composition comprises:75% (w / w) to 85% (w / w) heat-treated whey protein;10% (w / w) to 20% (w / w) pectin or carrageenan;0.5% (w / w) to 1.5% (w / w) alginate;0.5% (w / w) to 2% (w / w) gluconolactone;0.5% (w / w) to 2% (w / w) dicalcium phosphate; and1.5% (w / w) to 6% (w / w) chitosan.

30. The preparation of any one of claims 1 to 29, wherein the preparation further comprises one or more excipients.

31. The preparation of claim 30, wherein the preparation comprises 0.01% (w / w) to 10% (w / w) of the one or more excipients.

32. The preparation of claim 30 or 31, wherein the one or more excipients comprises an anticaking aid.

33. The preparation of claim 32, wherein the anti-caking aid comprises silica.

34. The preparation of claim 33, wherein the preparation comprises 0.5% (w / w) to 5% (w / w) silica.

35. The preparation of any one of claims 30 to 34, wherein the one or more excipients comprises a sequestrant.

36. The preparation of claim 35, wherein the sequestrant comprises sodium hcxamctaphosphatc.

37. The preparation of claim 36, wherein the preparation comprises 1% (w / w) to 4% (w / w) of sodium hexametaphosphate.

38. The preparation of any one of claims 30 to 37, wherein the one or more excipients comprises chitosan.

39. The preparation of claim 38, wherein the preparation comprises 2.5% (w / w) to 7.5% (w / w) of chitosan.

40. The preparation of any one of claims 30 to 39, wherein the one or more excipients comprises a stabilizer.

41. The preparation of claim 40, wherein the stabilizer comprises xanthan gum.

42. The preparation of claim 41, wherein the preparation comprises 0.01% (w / w) to 0.1% (w / w) of chitosan.

43. The preparation of any one of claims 1 to 42, wherein the preparation further comprises one or more coatings.

44. The preparation of claim 43, wherein the one or more coatings encapsulate the extended- release composition.

45. The preparation of claim 43 or 44, wherein the one or more coatings comprise a hydrophobic coat.

46. The preparation of claim 45, wherein the hydrophobic coat comprises ethyl cellulose, a basic methacrylic copolymer, aqueous latex, or methylcellulose acetate succinate.

47. The preparation of claim 43 or 44, wherein the one or more coatings comprise a hydrophilic coat encapsulating the hydrophobic coat.

48. The preparation of claim 47, wherein the hydrophilic coat comprises hydroxypropyl mcthylccllulosc or sodium alginate.

49. The preparation of any one of claims 1 to 48, wherein the preparation further comprises one or more probiotics.

50. The preparation of claim 49, wherein the preparation comprises 1 x 107to 1 x IO10CFUs of the one or more probiotics per gram of the preparation.

51. The preparation of any one of claims 1 to 50, wherein the preparation further comprises one or more additional components.

52. The preparation of claim 51, wherein the preparation comprises 0.01% (w / w) to 20% (w / w) of the one or more additional components.

53. The preparation of claim 51 or 52, wherein the one or more additional components comprise a protein, a polypeptide, a peptide, an amino acid, a carbohydrate, a sugar, a monosaccharide, a polysaccharide, a dietary fiber, a fat, a fatty acid, a lipid, a nutrient, a nutraceutical, a macronutrient, a micronutrient, a vitamin, a mineral, a polypeptide, a carotenoid, an element, a ketone body, a prebiotic (e.g., a prebiotic fiber), a flavonoid, an antioxidant, an electrolyte, a salt, a circadian rhythm modulator, a supplement, a nootropic, an energy source, or a combination thereof.

54. The preparation of any one of claims 50 to 53, wherein the one or more additional components comprise inulin, arabino xylans, beta glucans, fructooligosaccharides, galactooligosaccharides, xyloglucans, psyllium, cellulose, guar gum, pectin, locust bean gum, hydroxypropylmethyl cellulose, alginate, resistant starch, polydextrose, resistant maltodextrin, mixed plant cell wall fibers, or a combination thereof.

55. The preparation of any one of claims 1 to 54, wherein the preparation is characterized as having a Dvso less than 100 pm.

56. The preparation of any one of claims 1 to 55, wherein the preparation is characterized as having a water activity of less than 0.2.

57. The preparation of any one of claims 1 to 56, wherein a 100 mg / mL solution of the preparation in water at 20 °C is characterized as having a viscosity of 1 to 100 cP.

58. The preparation of claim 57, wherein the viscosity of the 100 mg / mL solution is measured using a 20 mm rotating disk.

59. The preparation of any one of claims 1 to 58, wherein the preparation is characterized as having a Hausner ratio of less than 1.5.

60. The preparation of any one of claims 1 to 59, wherein the extended-release composition is characterized as having an extended duration of release.

61. The preparation of claim 60, wherein the extended duration of release is at least 2 hours, at least 4 hours, at least 6 hours, at least 12 hours, or at least 24 hours.

62. The preparation of any one of claims 1 to 61, wherein the extended-release composition does not release a maximum amount of releasable protein payload into a solution of simulated gastric fluid containing 60 units / ml of pepsin at 37 °C until after 2 hours of incubation in the solution.

63. The preparation of any one of claims 1 to 61, wherein the extended-release composition does not release a maximum amount of releasable protein payload into a solution of simulated gastric fluid containing 60 units / ml of pepsin at 37 °C until after 4 hours of incubation in the solution.

64. The preparation of any one of claims 1 to 61, wherein the extended- release composition does not release a maximum amount of releasable protein payload into a solution of simulated gastric fluid containing 60 units / ml of pepsin at 37 °C until after 6 hours of incubation in the solution.

65. A food or beverage product comprising a preparation of any one of claims 1 to 64 incorporated therein.

66. The food or beverage product of claim 65, wherein the food or beverage product is a protein powder, snack bar, carbonated beverage, salty snack, confectionary, sports drink, yogurt, or gummy.

67. A method of preparing a preparation of any one of claims 1 to 66.

68. The method of claim 67, wherein the method comprises:(i) hydrating a protein payload to form a solubilized protein solution;(ii) hydrating a release modulator to form a solubilized release modulator solution;(iii) mixing the solubilized protein solution and the solubilized release modulator solution to form a mixed solution;(iv) incubating the mixed solution for 4 hours to 24 hours at 2 °C to 30 °C;(v) heat-treating the mixed solution to form a heat-treated solution;(vi) diluting the heat-treated solution with an acid to form a diluted heat-treated solution;(vii) homogenizing the diluted heat-treated solution to from a homogenate;(viii) filtering the homogenate form a fdtered homogenate;(ix) spray drying the filtered homogenate to form a spray-dried preparation; lyophilizing the filtered homogenate to form a lyophilized preparation; or oven-drying the filtered homogenate to form a oven-dried preparation; and(x) milling the spray-dried preparation, lyophilized preparation, or oven-dried preparation to form an extended-release product.

69. The method of claim 68, wherein the solubilized protein solution comprises 2% (w / v) to 35% (w / v) of protein payload.

70. The method of claim 68 or 69, wherein the solubilized protein solution is pH adjusted to pH 3 to pH 10.71 . The method of any one of claims 68 to 70, wherein the solubilized release modulator solution comprises 1% (w / v) to 10% (w / v) of release modulator.

72. The method of any one of claims 68 to 71, wherein 0.01% (w / v) to 5% (w / v) dicalcium phosphate is added to the mixed solution.

73. The method of any one of claims 68 to 72, wherein 0.01% (w / v) to 5% (w / v) gluconolactone is added to the mixed solution.

74. The method of any one of claims 68 to 73, wherein the mixed solution is heated for 0.5 hrs. to 5 hrs. at 85 °C to 100 °C.

75. The method of any one of claims 68 to 74, wherein the heat-treated solution is diluted with 5% (v / v) to 200% (v / v) of 0.01% (w / v) to 2% (w / v) acetic acid.

76. The method of any one of claims 68 to 75, wherein 0.01% (w / v) to 3% (w / v) chitosan is added to the heat-treated solution.

77. The method of any one of claims 68 to 76, wherein the diluted heat-treated solution is homogenized at 3000 rpm to 20000 rpm for 1. min to 20 min.

78. The method of any one of claims 68 to 77, wherein the homogenate is passed through a 200 pm to 2000 pm screen filter.

79. The method of any one of claims 68 to 78, wherein 0.01% (w / v) to 0.5% (w / v) of one or more excipients is added to the filtered homogenate.

80. The method of any one of claims 68 to 79, wherein the spray drying is performed with an inlet temperature of 110 °C to 275 °C, an outlet temperature of 60 °C to 95 °C, an atomization pressure of 0.75 bar to 4 bar, or a combination thereof.

81. The method of any one of claims 68 to 80, wherein the extended-release product is characterized as having a moisture content under 6% (w / w).

82. The method of any one of claims 68 to 81 , further comprising (xi) milling the extended- release product using a 100 pm to 1000 pm screen filter to form a milled extended-release product.

Images