Sprinkle preparation and method of manufacturing a sprinkle preparation
Patent Information
- Application Number
- PCT/US2025/010941
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-03
- Filing Date
- 2025-01-09
- Publication Date
- 2025-08-28
AI Technical Summary
Conventional confectionary sprinkles have limited nutritional value and often contain non-natural dyes and colorants that can have adverse health effects when consumed in large quantities.
Develop sprinkle preparations incorporating prebiotic dietary fiber, protein, and binder, with optional anti-adherent and natural colorants, using a manufacturing process involving mixing, wet granulating, cold extruding, and drying to create core particles, which can be coated for enhanced nutritional and health benefits.
The sprinkle preparations provide improved nutritional benefits, such as balanced intestinal flora and reduced health risks from non-natural additives, while maintaining aesthetic appeal.
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Figure US2025010941_28082025_PF_FP_ABST
Abstract
Description
SPRINKLE PREPARATIONSCROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 619,696, filed January 10, 2024; U.S. Provisional Patent Application No. 63 / 632,879, filed April 11, 2024; and U.S. Provisional Patent Application No. 63 / 655,108, filed June 3, 2024; the title of each of which is “Sprinkle Preparations” and the content of each of which is incorporated herein by reference in its entirety.BACKGROUND
[0002] Conventional confectionary sprinkles have limited nutritional value and frequently contain non-natural dyes and colorants that may have deleterious health effects when consumed in large quantities by humans. The present disclosure provides sprinkle preparations having improved nutritional and health benefits, and methods of producing the same.SUMMARY
[0003] The present disclosure provides sprinkle preparations including a prebiotic dietary fiber and a protein. Exemplary preparations of the present disclosure provide improved nutritional and health benefits to conventional confectionary sprinkles familiar to persons of ordinary skill in the art.
[0004] In one aspect, the present disclosure is directed to a sprinkle preparation including a core particle, the core particle includes: (i) a prebiotic dietary fiber; (ii) an anti-adherent; (iii) a protein; and (iv) a binder. In some embodiments, the core particle includes 1% w / w to 70% w / w, 30% w / w to 60% w / w, 40% w / w to 45% w / w, 45% w / w to about 60% w / w, or 55% w / w to 60% w / w of the prebiotic dietary fiber.
[0005] In some embodiments, the prebiotic dietary fiber includes inulin, multi-functional com fiber, soluble corn fiber, multi-functional oat hull fiber, wheat bran, beta glucans, cellulose, chitin, chitosan, xanthan gum, guar gum, konjac gum, psyllium, raffinose, polydextrose, pectin,human milk oligosaccharide, or combinations thereof. In some embodiments, the dietary fiber includes inulin that includes dahlia tuber inulin, chicory root inulin, blue agave inulin, Jerusalem artichoke inulin, enzymatically synthesized inulin, or a combination thereof. In some embodiments, the inulin includes a number average molecular weight of at least 1 kDa.
[0006] In some embodiments, the core particle includes 5% w / w to 20% w / w, 8% w / w to 12% w / w, about 8% w / w to about 10% w / w, about 10% w / w, or about 8% w / w of the antiadherent. In some embodiments, the anti-adherent includes magnesium stearate, zinc stearate, calcium stearate, magnesium palmitate, zinc palmitate, calcium palmitate, glyceryl monostearate, glyceryl dibehenate, glyceryl monooleate, lecithin, calcium phosphate, magnesium phosphate, calcium carbonate, magnesium carbonate, silicon dioxide, sodium silicates, magnesium silicates, zinc silicates, calcium silicates, monoglyceride fatty acids, diglyceride fatty acids, or a combination thereof.
[0007] In some embodiments, the core particle includes 1% w / w to 90% w / w, 15% w / w to 90% w / w, 1% w / w to 70% w / w, about 20% w / w to about 25% w / w, about 25% w / w, or about 20% w / w of the protein. In some embodiments, the protein includes calcium caseinate, (e.g., micellar) casein, pea protein, oat protein, or a combination thereof.
[0008] In some embodiments, the core particle includes 1% w / w to 35% w / w, about 5% w / w to about 15% w / w, about 15% w / w, about 10% w / w, or about 5% w / w of the binder. In some embodiments, the binder includes a directly compressible-grade binder. In some embodiments, the binder includes a directly compressible starch, corn starch, isomalt, sodium alginate, a phytosterol, or a combination thereof. In some embodiments, the core particle includes: (i) 1% w / w to 70% w / w of the prebiotic dietary fiber; (ii) 5% w / w to 20% w / w of the anti-adherent; (iii) 15% w / w to 90% w / w of the protein; and (iv) 1% w / w to 35% w / w of the binder.
[0009] In some embodiments, the core particle includes: (i) about 45% w / w of the prebiotic dietary fiber that includes inulin; (ii) about 10% w / w of the anti-adherent that includes magnesium stearate; (iii) about 25% w / w of the protein that includes casein; and (iv) about 15% w / w of the binder, the binder includes about 10% w / w com starch and about 5% w / w isomalt.
[0010] In some embodiments, the core particle includes: (i) 1% w / w to 70% w / w of the prebiotic dietary fiber; (ii) 5% w / w to 20% w / w of the anti-adherent; (iii) 15% w / w to 90% w / wof the protein; and (iv) 1 % w / w to 10% w / w of the binder. Tn some embodiments, the core particle includes: (i) about 60% w / w of the probiotic dietary fiber that includes inulin; (ii) about 10% w / w of the anti-adherent that includes magnesium stearate; (iii) about 25% w / w of the protein that includes casein; and (iv) about 5% w / w of the binder that includes isomalt.
[0011] In some embodiments, the core particle includes: (i) 1% w / w to 70% w / w of the prebiotic dietary fiber; (ii) 5% w / w to 20% w / w of the anti-adherent; (iii) 1% w / w to 70% w / w of the protein; and (iv) 1% w / w to 20% w / w of the binder. In some embodiments, the core particle includes: (i) about 60% w / w of the prebiotic dietary fiber that includes inulin; (ii) about 8% w / w of the anti-adherent that includes magnesium stearate; (iii) about 20% w / w of the protein that includes a pea protein isolate; and (iv) about 10% w / w of the binder that includes 5% w / w sodium alginate and 5% w / w isomalt.
[0012] In some embodiments, the core particle further includes 1% w / w to 20% w / w of a natural colorant. In some embodiments, the natural colorant includes spirulina extract, rutin, quercetin, chlorophyll, curcumin, cyanidin, phloretin, astaxanthin, lutein, zeaxanthin, bixin, norbixin, capsanthin, lycopene, canthaxanthin, alpha carotene, beta carotene, gamma carotene, rubixanthin, violaxanthin, rhodoxanthin, citranaxanthin, betalain, betanin, orcein, cobalamin, cyanocobalamin, or a combination thereof. In some embodiments, the preparation includes 2% w / w of the natural colorant that includes spirulina extract. In some embodiments, the natural colorant is encapsulated. In some embodiments, the natural colorant is encapsulated in a basic methacrylic copolymer. In some embodiments, the encapsulated natural colorant includes: (i) 0.5% w / w to 40% w / w natural colorant; and (ii) 60% w / w to 95.5% w / w basic methacrylic copolymer. In some embodiments, the encapsulated natural colorant includes: (i) about 31% w / w natural colorant that includes about 26% lutein and about 5% zeaxanthin; and (ii) about 69% of basic methacrylic copolymer that includes w / w Eudraguard® protect.
[0013] In some embodiments, the preparation further includes a coating. In some embodiments, the preparation includes 10% w / w to 30% w / w or about 20% w / w of the coating. In some embodiments, the coating includes: (i) a polish; (ii) a glaze; (iii) a sealant, or (iv) a combination thereof. In some embodiments, (i) the polish includes Capol® 127C; (ii) the glaze includes Capol® 11-143A; (iii) the sealant includes Capol® 155C; or (iv) a combination thereof. In some embodiments, the coating includes: (i) 30% w / w to 33.3% w / w of Capol® 127C; (ii)30% w / w to 33.3 % w / w of Capol® 11 -143A; and (iii) 30% w / w to 33.3% w / w of Capol® 155C.In some embodiments, the coating further includes 0.1% w / w to 10% w / w of a natural colorant.
[0014] In some embodiments, the sparkle preparation includes an elongated geometry having a length in a range from about 1 mm to about 15 mm; a width in a range from about 0.5 mm to about 3.0 mm; and a height in a range from about 0.5 mm to about 3.0 mm. In some embodiments, the elongated geometry includes a length in a range from about 2.0 mm to about 10.0 mm (for example, from about 2.5 mm to about 10 mm, from about 3.0 mm to about 10 mm, from about 3.5 mm to about 10 mm, from about 2.0 mm to about 9 mm, from about 2.5 mm to about 9 mm, from about 2.5 mm to about 8 mm, from about 3.0 mm to about 8 mm, and / or from about 3.5 mm to about 7.0 mm). In some embodiments, the elongated geometry includes a width in a range from about 1.0 mm to about 2.0 mm (for example, from about 1.5 mm to about 2.0 mm, from about 1.6 mm to about 1.9 mm, from about 1.5 mm to about 1.9 mm; from about 1.6 mm to about 2.0 mm; from about 1.6 mm to about 1.8 mm, from about 1.65 mm to about 1.85 mm; and / or from about 1.65 mm to about 1.75 mm). In some embodiments, the elongated geometry includes a height in a range from about 1.0 mm to about 2.0 mm (for example, from about 1.5 mm to about 2.0 mm, from about 1.6 mm to about 1.9 mm, from about 1.5 mm to about 1.9 mm; from about 1.6 mm to about 2.0 mm; from about 1.6 mm to about 1.8 mm, from about 1.65 mm to about 1.85 mm; and / or from about 1.65 mm to about 1.75 mm). In some embodiments, the sparkle preparation includes a nonpareil geometry having a length, a width, and a height in a range from about 0.5 mm to about 3.0 mm. In some embodiments, the nonpareil geometry includes a length, a width, and a height in a range from about 1.0 mm to about 2.0 mm (for example, from about 1.5 mm to about 2.0 mm, from about 1.6 mm to about 1.9 mm, from about 1.5 mm to about 1.9 mm; from about 1.6 mm to about 2.0 mm; from about 1.6 mm to about 1.8 mm, from about 1.65 mm to about 1.85 mm; and / or from about 1.65 mm to about 1.75 mm).
[0015] In some embodiments, the sparkle preparation has a density in a range from about 0.7 mg / dL to about 1.0 mg / dL or in a range from about 0.75 mg / dL to about 0.95 mg / dL (for example, from about 0.8 mg / dL to about 0.95 mg / dL, from about 0.85 mg / dL to about 0.95 mg / dL, from about 0.8 mg / dL to about 0.9 mg / dL, from about 0.8 mg / dL to about 0.9 mg / dL, and / or from about 0.85 mg / dl to about 0.9 mg / dL).
[0016] In some embodiments, the sparkle preparation has a moisture content in a range from about 0.5% to about 10.0% or in a range from about 1% to about 8% (for example, from about 2% to 8%, from about 3% to 8%, from about 4% to 8%, from about 5% to 8%, from about6% to 8%, from about 1% to about 6%, from about 2% to 6%, from about 3% to 6%, from about4% to 6%, from about 1% to about 4%, from about 2% to 4%, from about 3% to 4%, and / or from about 1% to about 2%).
[0017] In some embodiments, the preparation includes a Shore hardness of 65 to 75 or about 70, as measured by a durometer. In some embodiments, the preparation includes a compressive force hardness of 10 N to 25 N or about 20 N, as measured by a texture analyzer.
[0018] In another aspect, the present disclosure is directed to a method of manufacturing a sprinkle preparation including: (i) mixing dry ingredients including: a prebiotic dietary fiber, an anti-adherent, a protein, and a binder, to form a mixture; (ii) wet granulating the mixture from step (!) to form a granulate; (iii) cold extruding the granulate from step (ii) to form an extrudate; and (iv) drying the extrudate resulting from step (iii).
[0019] In some embodiments, step (i) mixing dry ingredients further includes mixing: a natural colorant.
[0020] In some embodiments, step (ii) wet granulating includes granulating water with the mixture at a ratio of 1 to 10 ml of water to 1 to 20 g of the mixture or about 3.5 ml of water to about 10 g of the mixture.
[0021] In some embodiments, step (iii) cold extruding is performed at 50 to 150 RPM or about 100 RPM. In some embodiments, step (iii) cold extruding is performed at 20 °C to 25 °C or at about 22 °C.
[0022] In some embodiments, step (iv) drying is performed at 20 °C to 80 °C, at about 60 °C, or at about 20 °C to about 25 °C. In some embodiments, step (iv) drying is performed for 1 hour to 5 hours or about 3 hours.
[0023] In some embodiments, the method further includes: (v) blade milling. In some embodiments, step (v) blade milling is performed at 3500 rpm to 7500 rpm or at about 5500 rpm.
[0024] In some embodiments, the extrudate is spheronized before step (iv) drying. In some embodiments, spheronizing is performed at 1500 rpm to 2500 rpm or at about 2000 rpm.
[0025] In some embodiments, the method further includes: (vi) fluidized bed coating to form the sprinkle preparation. In some embodiments, step (vi) fluidized bed coating includes: (i) applying a polish; (ii) applying a glaze; and (iii) applying a sealant, to form a coating.
[0026] In some embodiments, the coating includes a natural colorant. In some embodiments, step (vi) fluidized bed coating includes the use of an inlet nozzle set at 50 °C to 70 °C or at about 60 °C. In some embodiments, step (vi) fluidized bed coating is performed at 100 to 200 LPM or at about 150 LPM. In some embodiments, step (vi) fluidized bed coating is performed at an on rate of 0.5 minutes to 0.7 minutes and an off rate of 0.3 minutes to 0.5 minutes or at an on rate of 0.6 minutes and an off rate of 0.4 minutes. In some embodiments, step (vi) fluidized bed coating is performed until the coating is 10% w / w to 30% w / w or about 20% w / w of the sprinkle preparation.
[0027] In some embodiments, the method further includes: (vi) pan coating to form the sprinkle preparation. In some embodiments, step (vi) pan coating includes the use of an inlet nozzle set at 70 °C to 90 °C or at about 80 °C. In some embodiments, step (vi) pan coating is performed at 40 to 80 RPM or at about 60 RPM. In some embodiments, step (vi) pan coating is performed at an on rate of 0.6 minutes to 1.0 minute and an off rate of 0.1 minutes to 0.3 minutes or at an on rate of 0.8 minutes and an off rate of 0.2 minutes. In some embodiments, step (vi) pan coating is performed until a coating applied by the pan coating is 10% w / w to 30% w / w or about 20% w / w of the sprinkle preparation.
[0028] In another aspect, the present disclosure is directed to a food product including the sprinkle preparation according to the present disclosure and a food base. In some embodiments, the food base is a dairy food base. In some embodiments, the dairy food base is yogurt, or ice cream. In some embodiments, the food base is a prepared food base. In some embodiments, the prepared food base is a cupcake, a cake, a cookie, or a doughnut. In some embodiments, the food base is a beverage. In some embodiments, the beverage is milk, oat milk, almond milk, a milkshake, coffee, tea, kefir, a drinkable yogurt, a cocktail, mate, or hot cocoa.
[0029] In another aspect, the present disclosure is directed to a sprinkle preparation including: (i) one or more core particles comprising a functional payload; and (ii) a matrix. In some embodiments, a functional payload comprises vitamin B12, pyrroloquinoline quinone (PQQ), vitamin D, caffeine, creatine, lutein, zeaxanthin, lycopene, zeaxanthin, lycopene,carotene, curcumin, taurine, citicoline, alpha glycerophosphocholine, diindolylmethane, cicosapcntacnoic acid, docosapcntacnoic acid, lauric acid, tryptophan, arginine, leucine, or any combination thereof. In some embodiments, a matrix comprises a basic methacrylic copolymer (e.g., EUDRAGUARD® Protect), corn starch, shellac, carnauba wax, rice bran wax, tristearin, glyceryl dibehenate, pea starch, rice starch hydroxypropyl starch, starch sodium octenyl succinate, soluble com fiber, hydroxypropyl beta cyclodextrin, gamma cyclodextrin, beta cyclodextrin, stearic acid, palmitic acid, polyvinylpyrrolidone, polyethylene glycol, sucrose palmitate, sucrose stearate, sorbitan tristearate, sorbitan monostearate, sorbitan monopalmitate, hydroxypropyl cellulose grade SSL, hydroxypropyl cellulose grade L, methyl cellulose 15cP viscosity, methyl cellulose 4000 cP viscosity, pullulan, curdlan, hydroxypropyl methylcellulose 50 cP viscosity, hydroxypropyl methylcellulose 100 cP viscosity, ethyl cellulose 10 cP viscosity, ethyl cellulose 100 cP viscosity, agarose, carboxymethylcellulose 300 cP viscosity, carboxymethylcellulose 250 cP viscosity, lambda carrageenan, iota carrageenan, kappa carrageenan, chitosan, basic methacrylic copolymer, acidic methacrylic copolymer, neutral methacrylic copolymer, tannic acid, ellagitannin, metatartaric acid, adipic acid, high methoxyl pectin, low methoxyl pectin, amidated low methoxyl pectin, gelatin type A, gelatin type B, glycerol esters of wood resins, behenic acid, arachidic acid, mono- and diglycerides of fatty acids, citric acid esters of mono- and diglycerides of fatty acids, sucroglycerides, stearyl tartrate, polyoxypropylene-polyoxyethylene polymers, gum benzoic, spermaceti wax, montan acid esters, hydroxypropyl distarch phosphate, acetylated distarch phosphate, acetylated distarch adipate, phosphate distarch phosphate, cocoa butter, shea butter, coconut oil, whey protein, native whey protein, casein, pea protein isolate, oat protein isolate, soy protein isolate, zein, agar, agarose, ethyl cellulose 300 cP viscosity, sucrose oleate, sodium alginate, oat starch, xanthan gum, gellan gum, guar gum, gum Arabic, beeswax, or any combination thereof.BRIEF DESCRIPTION OF THE DRAWINGS
[0030] Drawings 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, in which:
[0031] FIG. 1A shows an image of an exemplary plain (i.e., non-colored) nonpareil sprinkle preparation of the present disclosure.
[0032] FIG. IB shows an image of an exemplary coated nonpareil sprinkle preparation of the present disclosure.
[0033] FIG. 1C shows an image of an exemplary plain (i.e., non-colored) elongated sprinkle preparation of the present disclosure.
[0034] FIG. ID shows an image of an exemplary colored elongated sprinkle preparation of the present disclosure.
[0035] FIG. 2A shows an image of a micellar casein granulate (100% w / w) following wet-granulating with approximately 0.35 mL / g of water.
[0036] FIG. 2B shows an image of a micellar casein extrudate (100% w / w) following wet-granulating with approximately 0.35 mL / g of water and cold extrusion.
[0037] FIG. 2C shows an image of a micellar casein granulate (100% w / w) following wet-granulating with approximately 0.35 mL / g of water that is unsuitable for cold extrusion using a single screw extruder.
[0038] FIG. 2D shows an image of a micellar casein granulate (10% w / w micellar casein, 20% w / w magnesium stearate, 10% w / w isomalt, and 60% w / w inulin) following wetgranulating with approximately 0.35 mL / g of water.
[0039] FIG. 2E shows an image of a micellar casein extrudate (10% w / w micellar casein, 20% w / w magnesium stearate, 10% w / w isomalt, and 60% w / w inulin) following wetgranulating with approximately 0.35 mL / g of water and cold extrusion.
[0040] FIG. 2F shows an image of a micellar casein spheronized extrudate (10% w / w micellar casein, 20% w / w magnesium stearate, 10% w / w isomalt, and 60% w / w inulin) following wet-granulating with approximately 0.35 mL / g of water, cold extrusion, and spheronization.
[0041] FIG. 2G shows an image of an inulin granulate (80% w / w inulin, 10% w / w magnesium stearate, and 10% w / w isomalt) following wet-granulating with approximately 0.35 mL / g of water.
[0042] FIG. 2H shows an image of an inulin extrudate (80% w / w inulin, 10% w / w magnesium stearate, and 10% w / w isomalt) following wet-granulating with approximately 0.35 mL / g of water, and cold extrusion.
[0043] FIG. 21 shows an image of an inulin granulate (75% w / w inulin and 25% w / w magnesium stearate) following wet-granulating with approximately 0.35 mL / g of water.
[0044] FIG. 2J shows an image of an inulin extrudate (75% w / w inulin and 25% w / w magnesium stearate) following wet-granulating with approximately 0.35 mL / g of water and cold extrusion.
[0045] FIG. 2K shows an image of a micellar casein granulate (90% w / w micellar casein, 8% w / w inulin, 1% w / w magnesium stearate, and 1% w / w isomalt) following wetgranulating with approximately 0.35 mL / g of water.
[0046] FIG. 2L shows an image of a micellar casein extrudate (90% w / w micellar casein, 8% w / w inulin, 1% w / w magnesium stearate, and 1% w / w isomalt) following wetgranulating with approximately 0.35 mL / g of water and cold extrusion.
[0047] FIG. 2M shows an image of an inulin granulate (75% w / w inulin and 25% w / w isomalt) following wet-granulating with approximately 0.35 mL / g of water.
[0048] FIG. 2N shows an image of an inulin granulate (100% w / w inulin) following wetgranulating with 0.35 mL / g of water.
[0049] FIG. 3 shows images of micellar casein granulates and extrudates (60% w / w inulin, 25% w / w micellar casein, 10% w / w magnesium stearate and 5% w / w isomalt) under different processing parameters: FIG. 3, panel A, is an image of a micellar casein granulate following wet-granulating with approximately 0.15 ml / g water at 35 rpm for 2 minutes. FIG. 3, panel B, is an image of a micellar casein granulate following wet- granulating with approximately 0.5 ml / g water at 35 rpm for 2 minutes. FIG. 3, panel C, is an image of a micellar casein granulate after wet-granulating with approximately 0.35 mg / g of water at 15 rpm for 2 minutes. FIG. 3, panel D, is a micrograph of the granulate depicted in FIG. 3, panel C. FIG. 3, panel E, is an image of a micellar casein granulate following wet-granulating with approximately 0.35 ml / g water at 75 rpm for a duration of 2 minutes. FIG. 3, panel F, shows an image of a micellarcasein extrudate where the single screw extruder was set to 25 rpm. FIG. 3, panel G, shows an image of a micellar casein extrudate where the single screw extruder was set to 150 rpm.
[0050] FIG. 4 shows a flow diagram for an exemplary manufacturing method for producing an internally colored elongated sprinkle preparation of the present disclosure.
[0051] FIG. 5 shows a flow diagram for an exemplary manufacturing method for producing an internally colored nonpareil sprinkle preparation of the present disclosure.
[0052] FIG. 6 shows a flow diagram for an exemplary manufacturing method for producing a fluidized bed coated elongated sprinkle preparation of the present disclosure.
[0053] FIG. 7 shows a flow diagram for an exemplary manufacturing method for producing a fluidized bed coated nonpareil sprinkle preparation of the present disclosure.
[0054] FIG. 8 shows a flow diagram for an exemplary manufacturing method for producing a pan coated elongated sprinkle preparation of the present disclosure.
[0055] FIG. 9 shows a flow diagram for an exemplary manufacturing method for producing a pan coated nonpareil sprinkle preparation of the present disclosure.
[0056] FIG. 10A shows a bar graph of length, width, and height measurements of conventional confectionary sprinkles (Betty Crocker®; Elongated sprinkles = closed squares, Nonpareil sprinkles= open circles) and exemplary sprinkle preparations of the present disclosure (Prep. 1 blue elongated = grey squares, Prep. 2 yellow elongated = open squares, and Prep. 3 yellow nonpareils = closed circles) measured by electronic caliper.
[0057] FIG 10B shows a schematic illustration of representative dimensions (length, width, and height) for exemplary elongated and nonpareil sprinkle preparations.
[0058] FIG. 11A shows a bar graph of densities of conventional confectionary sprinkles (Betty Crocker®; Elongated sprinkles = closed squares, Nonpareil sprinkles = open circles) and exemplary sprinkle preparations of the present disclosure (Prep. 1 blue elongated = grey squares. Prep. 2 yellow elongated = open squares, and Prep. 3 yellow nonpareils = closed circles).
[0059] FIG. 11B shows an image of two sprinkle preparations of the present disclosure upon addition to the surface of water. Left - White Elongated; extruded with 1mm x 1mm die;density approximately 0.81 ± 0.13 g / mL. Right - White Elongated; extruded with 0.5mm x 0.5mm die; density approximately 1.04 ± 0.21 g / mL.
[0060] FIG. 11C shows an image of two sprinkle preparations of the present disclosure 5 minutes after addition to the surface of water. Left - White Elongated; extruded with 1mm x 1mm die; density approximately 0.81 ± 0.13 g / mL. Right - White Elongated; extruded with 0.5mm x 0.5mm die; density approximately 1.04 ± 0.21 g / mL.
[0061] FIG. 12 shows a bar graph of moisture content of conventional confectionary sprinkles (Betty Crocker®; Elongated sprinkles = closed squares, Nonpareil sprinkles = open circles) and exemplary sprinkle preparations of the present disclosure (Prep. Iblue elongated = grey squares, Prep. 2 yellow elongated = open squares, and Prep. 3 yellow nonpareils = closed circles).
[0062] FIG. 13A shows a 4X magnification microscopy image of a conventional confectionary sprinkle (Betty Crocker® yellow nonpareil).
[0063] FIG. 13B shows a 4X magnification microscopy image of a conventional confectionary sprinkle (Betty Crocker® blue nonpareil).
[0064] FIG. 13C shows a 4X magnification microscopy image of a conventional confectionary sprinkle (Betty Crocker® blue elongated).
[0065] FIG. 13D shows a 4X magnification microscopy image of an exemplary sprinkle preparation of the present disclosure (yellow nonpareil).
[0066] FIG. 13E shows a 4X magnification microscopy image of an exemplary sprinkle preparation of the present disclosure (blue nonpareil).
[0067] FIG. 13F shows a 4X magnification microscopy image of an exemplary sprinkle preparation of the present disclosure (blue nonpareil).
[0068] FIG. 13G shows a 4X magnification microscopy image of an exemplary sprinkle preparation of the present disclosure (blue elongated).
[0069] FIG. 13H shows a 4X magnification microscopy image of an exemplary sprinkle preparation of the present disclosure (purple elongated).
[0070] FIG. 131 shows a 4X magnification microscopy image of an exemplary sprinkle preparation of the present disclosure (yellow elongated).
[0071] FIG. 13J shows a 4X magnification microscopy image of an exemplary sprinkle preparation of the present disclosure (yellow elongated).
[0072] FIG. 14A shows a schematic illustration for obtaining a hardness measurement using a Shore durometer.
[0073] FIG. 14B shows a schematic illustration for obtaining a hardness measurement using a texture analyzer.
[0074] FIG. 15A shows an image of an exemplary sprinkle preparation of the present disclosure (incorporating 20% w / w oat protein and 2% w / w spirulina extract) on a Ben and Jerry’s® vanilla bean ice cream cone.
[0075] FIG. 15B shows an image of a sprinkle preparation of the present disclosure (incorporating 20% w / w pea protein and 2% w / w spirulina extract) on a Ben and Jerry’s® vanilla bean ice cream cone.
[0076] FIG. 16A shows an image of plain Chobani® vanilla blended Greek yogurt.
[0077] FIG. 16B shows an image of 12 g of Chobani® vanilla blended Greek yogurt fortified with 1.14 g of an exemplary sprinkle preparation of the present disclosure (60% w / w inulin) after 15 minutes of occasional stirring.
[0078] FIG. 17A shows an image of conventional confectionary sprinkles (Betty Crocker® elongated).
[0079] FIG. 17B shows an image of an exemplary mixed-color sprinkle preparation of the present disclosure (elongated).
[0080] FIG. 17C shows an image of conventional confectionary sprinkles (Betty Crocker® nonpareils).
[0081] FIG. 17D shows an image of an exemplary mixed-color sprinkle preparation of the present disclosure (nonpareils).
[0082] FIG. 18A shows an image of an exemplary mixed-color sprinkle preparation of the present disclosure (elongated).
[0083] FIG. 18B shows an image of an exemplary elongated sprinkle preparation of the present disclosure incorporating <1% w / w rutin and quercetin colorant.
[0084] FIG. 18C shows an image of an exemplary elongated sprinkle preparation of the present disclosure incorporating <1% w / w spirulina extract colorant.
[0085] FIG. 19A shows an image of Ben and Jeny’s® vanilla bean ice cream fortified with an exemplary mixed-color elongated sprinkle preparation of the present disclosure incorporating inulin and polyphenol.
[0086] FIG. 19B shows an image of Ben and Jerry’s® vanilla bean ice cream fortified with an exemplary mixed-color nonpareil sprinkle preparation of the present disclosure incorporating inulin and polyphenol.
[0087] FIG. 19C shows an image of Ben and Jerry’s® vanilla bean ice cream with conventional confectionary sprinkles (Betty Crocker® elongated) added.
[0088] FIG. 19D shows an image of Ben and Jeny’s® vanilla bean ice cream with conventional confectionary sprinkles (Betty Crocker® nonpareils) added.
[0089] FIG. 20A shows a flow diagram of a method for producing an exemplary vitamin B12 preparation of the present disclosure.
[0090] FIG. 20B shows a macroscopic image of an exemplary vitamin B 12 preparation producing using the method described in FIG. 20A.
[0091] FIG. 20C shows a microscopic image of an exemplary vitamin B12 preparation producing using the method described in FIG. 20A.
[0092] FIG. 20D shows a macroscopic image of an exemplary vitamin B12 preparation added to Breyer’s natural vanilla ice cream.
[0093] FIG. 20E shows a line graph comparing the release of vitamin B12 into a neutral aqueous solution (phosphate buffered saline) from an exemplary vitamin B12 preparation of the present disclosure (Meal Booster B 12), free vitamin B12 (Unformulated Bl 2), and vitamin B12 formulated in basic methacrylic copolymer, sucrose palmitate, and calcium phosphate (Formulated B12).
[0094] FIG. 20F shows a line graph comparing the release of vitamin B12 into simulated gastric fluid (pH 1.2) from an exemplary vitamin B12 preparation of the present disclosure (Meal Booster B 12), free vitamin B12 (Unformulated B 12), and vitamin B12 formulated in basic methacrylic copolymer, sucrose palmitate, and calcium phosphate (Formulated B12).
[0095] FIG. 21A shows a flow diagram of a method for producing an exemplary whey protein preparation of the present disclosure.
[0096] FIG. 21B shows a macroscopic image of an exemplary whey protein preparation produced using the method described in FIG. 21A.
[0097] FIG. 22A shows a flow diagram of an additional method for producing an exemplary whey protein preparation of the present disclosure.
[0098] FIG. 22B shows a macroscopic image of an exemplary whey protein preparation produced using the method described in FIG. 22A.
[0099] FIG. 23A shows a flow diagram of a method for producing an exemplary pyrroloquinoline quinone (PQQ) preparation of the present disclosure.
[0100] FIG. 23B shows a macroscopic image of an exemplary PQQ preparation producing using the method described in FIG. 23A.
[0101] FIG. 23C shows a microscopic image of an exemplary PQQ preparation producing using the method described in FIG. 23A.
[0102] FIG. 23D shows a macroscopic image of an exemplary PQQ preparation added to a salad.
[0103] FIG. 23E shows a line graph comparing the release of PQQ into a neutral aqueous solution (phosphate buffered saline) from an exemplary PQQ preparation of the present disclosure (Meal Booster PQQ), free PQQ (Unformulated PQQ), and PQQ formulated in poly(3- Hydroxybutyrate-co-3-Hydroxyvalerate) (PHBV), poly(vinyl pyrrolidone) (PVP), and triethyl citrate alone (Formulated PQQ).
[0104] FIG. 23F shows a line graph comparing the release of PQQ into simulated gastric fluid (pH 1.2) from an exemplary PQQ preparation of the present disclosure (Meal BoosterPQQ), free PQQ (Unformulated PQQ), and PQQ formulated in PHBV, PVP, and triethyl citrate alone (Formulated PQQ).
[0105] FIG. 24A shows line graphs comparing the release of inulin into fasted state simulated gastric fluid (FaSSGF) at pH 1.6 from un-formulated Jerusalem artichoke inulin and exemplary inulin preparations of the present disclosure: (i) 50% (w / w) guar gum and 50% (w / w) inulin; and (ii) 60% (w / w) guar gum, 40% (w / w) inulin.
[0106] FIG. 24B shows line graphs comparing the release of inulin into fasted state simulated gastric fluid (FaSSGF) at pH 1.6 from un-formulated Jerusalem artichoke inulin and exemplary inulin preparations of the present disclosure: (i) 50% (w / w) Sistema SP30™ and 50% (w / w) inulin; and (ii) 50% (w / w) sucrose palmitate and 50% (w / w) inulin.
[0107] FIG. 24C shows line graphs comparing the release of inulin into fasted state simulated gastric fluid (FaSSGF) at pH 1.6 from un-formulated Jerusalem artichoke inulin and exemplary inulin preparations of the present disclosure: (i) 35% (w / w) guar gum, 15% Sisterna SP30™, and 50% (w / w) inulin; and (ii) 35% (w / w) guar gum, 30% (w / w) sucrose palmitate, and 35% (w / w) inulin.
[0108] FIG. 24D shows line graphs comparing the release of inulin into fasted state simulated gastric fluid (FaSSGF) at pH 1.6 from un-formulated Jerusalem artichoke inulin and exemplary inulin preparations of the present disclosure: (i) 50% (w / w) sucrose palmitate, and 50% (w / w) inulin; (ii) 60% (w / w) guar gum, and 40% (w / w) inulin; and (iii) 50% (w / w) Sisterna SP30™ and 50% (w / w) inulin.DEFINITIONS
[0109] As described in the present disclosure, the following terms will be employed, and are defined as indicated below.
[0110] 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.
[0111] 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. Itmust 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.
[0112] 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 are for convenience only and do not interpret the scope or meaning of the claimed invention.
[0113] 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.
[0114] 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.
[0115] Adherent: As used herein, the term “adherent” means a substance or composition capable of sticking or binding to itself, a surface, or another substance. Similarly, the term “anti- adherent” as used herein refers to a substance or composition that mitigates the sticking or binding capability of a substance.
[0116] 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 someembodiments, 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%.
[0117] Binder: As used herein, the term “binder” is used to refer to a substance capable of making other substances, materials, or ingredients mix or otherwise stick together. In some embodiments, a substance is a “binder” if it facilitates the bonding of particles during granulation.
[0118] 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 some 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 some 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.
[0119] Colorant: As used herein, the term “colorant” refers to a substance that is capable of giving a particular color. A colorant may be used to add a color to a substance, a composition, a formulation, or other entity.
[0120] 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 ait will appreciate that conclusions may reasonably be drawn based on differences or similarities observed. In some embodiments, comparable sets of conditions, circumstances, individuals, orpopulations 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.
[0121] 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.
[0122] Diameter: As used herein, the term “diameter” is used to refer to the longest distance from one end of a particle to another end of the particle. Those skilled in the art will appreciate that a variety of techniques are available for use in characterizing particle diameters (i.e., particle sizes). In some instances, for example, size of particles (e.g., diameter of particles) can be measured by a Coulter Counter. In some instances, 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.).
[0123] 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 instances, for example, size of particles (e.g., diameter of particles) can be measured by a Coulter Counter. In some instances, 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 instances, the dispersity of a population of particles refers to double (e.g., 2-fold) the ratio of standard deviation (e.g., o) to average particle diameter (e.g., Dv50).
[0124] Elongated: As used herein, the term “elongated” refers to a shape having a length and a width, where the length is greater in relation to the width. An “elongated” shape may have a length of a greater measurement than the width of the shape.
[0125] 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 component of a sprinkle preparation (e.g., a natural colorant) is described as being encapsulated by a polymer component.
[0126] Hardness: The term “hardness” as used herein refers to the quality of being hard as measurable by a durometer or a texture analyzer.
[0127] Homogenous: As used herein, the term “homogenous” means of substantially uniform structure and / or composition throughout.
[0128] 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 instances, a material characterized as being hydrophobic is biologically derived and / or synthetically derived. In some instances, a material characterized as being hydrophobic is a lipid, protein, and / or carbohydrate. In some instances, a material characterized as being hydrophobic is a polymer and / or small molecule. Alternatively, or additionally, in some embodiments, composites, mixtures, blends, or super- structures of several materials are collectively referred to as hydrophobic based on their observed propensity to reject association, chemically and / or physically, with water.
[0129] Hydrophilic: As used herein, the term “hydrophilic” is used to refer to the propensity of a material to associate, chemically and / or physically, with water. In some instances, a material characterized as being hydrophilic is biologically derived and / or synthetically derived. In some instances, a material characterized as being hydrophilic is a protein, and / or carbohydrate. In some instances, a material characterized as being hydrophilic isa polymer and / or small molecule. Alternatively, or additionally, in some embodiments, composites, mixtures, blends, or super- structures of several materials arc collectively referred to as hydrophilic based on their observed propensity to associate, chemically and / or physically, with water.
[0130] 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 component).
[0131] 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., sprinkle 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 does not wholly encapsulate a material below. In some embodiments, at least one layer of a layered preparation is or comprises a coating.
[0132] Matrix: As used herein, the term “matrix” refers to one or more material interspersed between two or more core particles, compositions, or materials that are different than the matrix. In some embodiments, a matrix is characterized as having cohesive properties that facilitate the physical association of two or more core particles, compositions or materials that are different than the matrix.
[0133] Moisture Content: As used herein, the term “moisture content” means the quantity of water contained in a material, which can be expressed as a numerical value or ratio related to the composition of the material.
[0134] Natural: The term “natural” as used herein refers to an entity or substance that occurs in nature and is not solely made or caused by humankind.
[0135] Nonpareil: The term “nonpareil” as used herein refers to a small, rounded shape, such as a pellet or particle, that may be substantially spherical in shape.
[0136] 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 0.1 mm to 10 mm, about 0.1 mm to 9 mm, about 0.1 mm to 8 mm, about 0.1 mm to 7 mm, about 0.1 mm to 6 mm, about 0.1 mm to 5 mm, about 0.1 mm to 4 mm, about 0.1 mm to 3 mm, about 0.1 mm to 2 mm, about 0.1 mm to 1 mm, about 0.1 mm to 0.5 mm, about 0.5 mm to 10 mm, about 0.5 mm to 9 mm, about 0.5 mm to 8 mm, about 0.5 mm to 7 mm, about 0.5 mm to 6 mm, about 0.5 mm to 5 mm, about 0.5 mm to 4 mm, about 0.5 mm to 3 mm, about 0.5 mm to 2 mm, about 0.5 mm to 1 mm, about 1 mm to 10 mm, about 1 mm to 9 mm, about 1 mm to 8 mm, about 1 mm to 7 mm, about 1 mm to 6 mm, about 1 mm to 5 mm, about 1 mm to 4 mm, about 1 mm to 3 mm, about 1 mm to 2 mm, about 2 mm to 10 mm, about 2 mm to 9 mm, about 2 mm to 8 mm, about 2 mm to 7 mm, about 2 mm to 6 mm, about 2 mm to 5 mm, about 2 mm to 4 mm, about 2 mm to 3 mm, about 3 mm to 10 mm, about 3 mm to 9 mm, about 3 mm to 8 mm, about 3 mm to 7 mm, about 3 mm to 6 mm, about 3 mm to 5 mm, about 3 mm to 4 mm, about 4 mm to 10 mm, about 4 mm to 9 mm, about 4 mm to 8 mm, about 4 mm to 7 mm, about 4 mm to 6 mm, about 4 mm to 5 mm, about 5 mm to 10 mm, about 5 mm to 9 mm, about 5 mm to 8 mm, about 5 mm to 7 mm, about 5 mm to 6 mm, about 6 mm to 10 mm, about 6 mm to 9 mm, about 6 mm to 8 mm, about 6 mm to 7 mm, about 7 mm to 10 mm, about 7 mm to 9 mm, about 7 mm to 8 mm, about 8 mm to 10 mm, about 8 mm to 9 mm, or about 9 mm to 10 mm. A “particle” is not limited to a particular shape or form, for example, having a cross-sectional shape of a sphere, an oval, a triangle, a square, a hexagon, or an irregular shape. In some embodiments, particles can be solid particles. In some embodiments, particles can be liquid particles. In some embodiments, particles can be gel or gel-like particles. In some embodiments, 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). A “core particle” as used herein may refer to a particle that can be encapsulated or coated by another substance.
[0137] Parts per million (ppm): As used herein, 1 ppm (“parts per million”) is equivalent, when working with aqueous solutions, to 1 milligram per liter (mg / L) or 1 milligram per kilogram (mg / kg).
[0138] Prebiotic: As used herein, the term “prebiotic” refers to a non-digestible food ingredient that stimulates the growth and / or activity of one or more bacteria in the colon. A prebiotic may enhance the nutritional or health benefits of a food product.
[0139] 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 ail, a reference or control is determined or characterized under comparable conditions or circumstances to those under assessment. Those skilled in the art will appreciate when sufficient similarities are present to justify reliance on and / or comparison to a particular possible reference or control.
[0140] Sprinkle: As used herein, the term “sprinkle” refers to a particulate composition that can be added to a food item to enhance the nutritional benefits, health benefits, and / or aesthetic quality of a food product.
[0141] Stable: The term “stable,” when applied to compositions herein, means that the compositions maintain (e.g., as determined by one or more analytical assessments) one or more aspects of their physical structure and / or performance characteristic(s) (e.g., activity) over a period of time and / or under a designated set of conditions. 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 particlesizes (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.DETAILED DESCRIPTION OF SOME EMBODIMENTS
[0142] It is contemplated that systems, devices, methods, and processes of the disclosure encompass variations and adaptations developed using information from the embodiments described herein. Adaptation and / or modification of the systems, devices, methods, and processes described herein may be performed by those of ordinary skill in the relevant art.
[0143] Throughout the description, where articles, devices, and systems arc described as having, including, or comprising specific components, or where processes and methods are described as having, including, or comprising specific steps, it is contemplated that, additionally, there are articles, devices, and systems according to some embodiments of the present disclosure that consist essentially of, or consist of, the recited components, and that there are processes and methods according to some embodiments of the present disclosure that consist essentially of, or consist of, the recited processing steps.
[0144] It should be understood that the order of steps or order for performing certain action is immaterial so long as operability is not lost. Moreover, two or more steps or actions may be conducted simultaneously. As is understood by those skilled in the art, the terms “over”, “under”, “above”, “below”, “beneath”, and “on” are relative terms and can be interchanged in reference to different orientations of the layers, elements, and substrates included in the present disclosure. For example, a first layer on a second layer, in some embodiments means a first layer directly on and in contact with a second layer. In other embodiments, a first layer on a second layer can include another layer there between.
[0145] Headers are provided for the convenience of the reader and are not intended to be limiting with respect to the claimed subject matter.Sprinkle Preparations
[0146] In some embodiments, the present disclosure provides technologies that arise from and / or incorporate certain insights relating to nutritional form factors, such as for example,sprinkle preparations as described herein and / or other sprinkle compositions / preparations. See, for example, Examples 1, 2, and 4.Core Particles
[0147] The present disclosure provides preparations of one or more sprinkles wherein the one or more sprinkles include a core particle wherein the core particle incorporates one or more of a prebiotic dietary fiber, an anti-adherent, a protein, and a binder. In some embodiments, one or more components of the core particle provide a nutritional and / or health benefit to a subject when the sprinkle preparation is consumed by the subject.
[0148] The present disclosure provides preparations of one or more sprinkles wherein the one or more sprinkles include a core particle wherein the core particle incorporates a prebiotic dietary fiber, an anti-adherent, a protein, and a binder. In some embodiments, one or more components of the core particle provide a nutritional and / or health benefit to a subject when the sprinkle preparation is consumed by the subject.
[0149] In some embodiments, preparations of the present disclosure include one or more sprinkles, each sprinkle including one or more core particles. In some embodiments, a payload component is inulin, multi-functional corn fiber, soluble corn fiber, multi-functional oat hull fiber, wheat bran, beta glucans, cellulose, chitin, chitosan, xanthan gum, psyllium, raffinose, resistant polydextrose, pectin, human milk oligosaccharide, inulin from enzymatic synthesis, inulin from dahlia tuber, inulin from chicory root, inulin from blue agave, inulin from Jerusalem artichoke, casein, whey protein, pea protein, oat protein, rice protein, lutein, zeaxanthin, lycopene, phycocyanin, curcumin, silybin, pyrroloquinoline quinone, eicosapentaenoic acid, docosahexaenoic acid, eicosapentaenoic acid ethyl ester, eicosapentaenoic acid monoacylglycerol, or combinations thereof. In some embodiments, one or more core particles incorporate a functional pay load including, but not limited to, vitamin B12, pyrroloquinoline quinone (PQQ), vitamin D, caffeine, creatine, lutein, zeaxanthin, lycopene, zeaxanthin, lycopene, carotene, curcumin, taurine, citicoline, alpha glycerophosphocholine, diindolylmethane, eicosapentaenoic acid, docosapentaenoic acid, lauric acid, tryptophan, arginine, leucine, or any combination thereof. In some embodiments, one or more core particles incorporate a prebiotic dietary fiber as a functional payload. For example, in some embodiments, one or more core particles incorporate inulin as a functional payload.
[0150] In some embodiments, a sprinkle formulation of the present disclosure comprises (i) one or more payload components, and (ii) one or more coating layer and / or cncapsulant components, as provided herein. In some embodiments, a sprinkle formulation of the present disclosure comprises about 0.1 wt% to 60 wt%, about 0.5 wt% to 60 wt%, about 1 wt% to 60 wt%, about 5 wt% to 60 wt%, about 10 wt% to 60 wt%, about 20 wt% to 60 wt%, about 30 wt% to 60 wt%, about 40 wt% to 60 wt%, about 50 wt% to 60 wt%, about 0.1 wt% to 50 wt%, about 0.5 wt% to 50 wt%, about 1 wt% to 50 wt%, about 5 wt% to 50 wt%, about 10 wt% to 50 wt%, about 20 wt% to 50 wt%, about 30 wt% to 50 wt%, about 40 wt% to 50 wt%, about 0.1 wt% to 35 wt%, about 0.5 wt% to 35 wt%, about 1 wt% to 35 wt%, about 5 wt% to 35 wt%, about 10 wt% to 35 wt%, about 20 wt% to 35 wt%, or about 30 wt% to 35 wt% of a payload component. In some embodiments, a sprinkle formulation of the present disclosure comprises about 0.1 wt% to 50 wt%, about 0.5 wt% to 50 wt%, about 1 wt% to 50 wt%, about 5 wt% to 50 wt%, about 10 wt% to 50 wt%, about 20 wt% to 50 wt%, about 30 wt% to 50 wt%, about 40 wt% to 50 wt%, about 0.1 wt% to 40 wt%, about 0.5 wt% to 40 wt%, about 1 wt% to 40 wt%, about 5 wt% to 40 wt%, about 10 wt% to 40 wt%, about 20 wt% to 40 wt%, about 30 wt% to 40 wt%, about 0.1 wt% to 30 wt%, about 0.5 wt% to 30 wt%, about 1 wt% to 30 wt%, about 5 wt% to 30 wt%, about 10 wt% to 30 wt%, or about 20 wt% to 30 wt% of a coating layer and / or encapsulant component.Prebiotic Dietary Fiber
[0151] In some embodiments, a prebiotic dietary fiber incorporated in a core particle of the present disclosure includes one or more of inulin, multi-functional corn fiber, soluble corn fiber, multi-functional oat hull fiber, wheat bran, beta glucans, cellulose, chitin, chitosan, xanthan gum, psyllium, raffinose, resistant polydextrose, pectin, human milk oligosaccharide, or combinations thereof.
[0152] In some embodiments, prebiotic dietary fiber incorporated in a core particle of the present disclosure includes inulin. In some embodiments, the inulin is enzymatically synthesized. In some embodiments, the inulin may originate from one or more of dahlia tuber, chicory root, blue agave, or Jerusalem artichoke.
[0153] In some embodiments, the prebiotic dietary fiber has a molecular weight of at least 0.1 kDa. In some embodiments, the prebiotic dietary fiber has a molecular weight of at least 0.5 kDa, at least 1 kDa, at least 1.5 kDa, at least 2 kDa, at least 3 kDa, or at least 5 kDa. In some embodiments, the prebiotic dietary fiber has a molecular weight of about 1 kDa, about 2 kDa, or about 3 kDa.
[0154] In some embodiments, a core particle of the present disclosure includes about 0.1 wt% to 90 wt% of a prebiotic dietary fiber. For example, in some embodiments, a core particle of the present disclosure includes about 0.1 wt% to 90 wt%, about 0.5 wt% to 90 wt%, about 1 wt% to 90 wt%, about 5 wt% to 90 wt%, about 10 wt% to 90 wt%, about 20 wt% to 90 wt%, about 30 wt% to 90 wt%, about 40 wt% to 90 wt%, about 50 wt% to 90 wt%, about 60 wt% to 90 wt%, about 70 wt% to 90 wt%, about 80 wt% to 90wt%, about 0.1 wt% to 80 wt%, about 0.5 wt% to 80 wt%, about 1 wt% to 80 wt%, about 5 wt% to 80 wt%, about 10 wt% to 80 wt%, about 20 wt% to 80 wt%, about 30 wt% to 80 wt%, about 40 wt% to 80 wt%, about 50 wt% to 80 wt%, about 60 wt% to 80 wt%, about 70 wt% to 80 wt%, about 0.1 wt% to 70 wt%, about 0.5 wt% to 70 wt%, about 1 wt% to 70 wt%, about 5 wt% to 70 wt%, about 10 wt% to 70 wt%, about 20 wt% to 70 wt%, about 30 wt% to 70 wt%, about 40 wt% to 70 wt%, about 50 wt% to 70 wt%, about 60 wt% to 70 wt%, about 0.1 wt% to 60 wt%, about 0.5 wt% to 60 wt%, about 1 wt% to 60 wt%, about 5 wt% to 60 wt%, about 10 wt% to 60 wt%, about 20 wt% to 60 wt%, about 30 wt% to 60 wt%, about 40 wt% to 60 wt%, about 50 wt% to 60 wt%, about 0.1 wt% to 50 wt%, about 0.5 wt% to 50 wt%, about 1 wt% to 50 wt%, about 5 wt% to 50 wt%, about 10 wt% to 50 wt%, about 20 wt% to 50 wt%, about 30 wt% to 50 wt%, or about 40 wt% to 50 wt% of a prebiotic dietary fiber. For example, in some embodiments, a core particle of the present disclosure includes about 15 wt% to 70 wt%, about 25 wt% to 70 wt%, about 35 wt% to 70 wt%, about 45 wt% to 70 wt%, about 55 wt% to 70 wt%, about 65 wt% to 70 wt% about 15 wt% to 60 wt%, about 25 wt% to 60 wt%, about 35 wt% to 60 wt%, about 45 wt% to 60 wt%, about 55 wt% to 60 wt%, about 15 wt% to 50 wt%, about 25 wt% to 50 wt%, about 35 wt% to 50 wt%, about 55 wt% to 60 wt%, about 1 wt%, about 5 wt%, about 10 wt%, about 20 wt%, about 30 wt%, about 40 wt%, about 50 wt%, about 60 wt%, about 70 wt%, about 90 wt%, about 15 wt%, about 25 wt%, about 35 wt%, about 45 wt%, about 55 wt%, or about 65 wt% of a prebiotic dietary fiber. In some embodiments, a core particle of the present disclosure includes about 1 wt% to 70 wt% of a prebiotic dietary fiber. In some embodiments, a core particle of the presentdisclosure includes about 30 wt% to 60 wt% of a prebiotic dietary fiber. In some embodiments, a core particle of the present disclosure includes about 45 wt% of a prebiotic dietary fiber. In some embodiments, a core particle of the present disclosure includes about 60 wt% of a prebiotic dietary fiber.
[0155] In some embodiments, a prebiotic dietary fiber provides improved nutritional and / or health benefits when consumed by a subject. For example, in some embodiments, a prebiotic dietary fiber provides improved balance of intestinal flora, increased calcium absorption, blood sugar management, anti-inflammatory properties, promotion of thyroid and liver health, promotion of bowel movement regularity, improvement of eczema symptoms, or a combination thereof.Anti-Adherent
[0156] In some embodiments, a core particle of the present disclosure includes an antiadherent. In some embodiments, the core particle includes an anti-adherent selected from, but not limited to, magnesium stearate, zinc stearate, calcium stearate, magnesium palmitate, zinc palmitate, calcium palmitate, glyceryl monostearate, glyceryl dibehenate, glyceryl monooleate, lecithin, calcium phosphate, magnesium phosphate, calcium carbonate, magnesium carbonate, silicon dioxide, sodium silicate, magnesium silicate, zinc silicates, calcium silicate, monoglycerides of fatty acids, diglycerides of fatty acids, or combinations thereof. In some embodiments, the anti-adherent provides for reduced sticking of a core particle of the present disclosure to an extraneous surface.
[0157] In some embodiments, a core particle of the present disclosure includes about 1 wt% to 30 wt% of an anti-adherent. For example, in some embodiments, a core particle of the present disclosure includes about 1 wt% to 30 wt%, about 5 wt% to 30 wt%, about 10 wt% to 30 wt%, about 15 wt% to 30 wt%, about 20 wt% to 30 wt%, about 25 wt% to 30 wt%, about 1 wt% to 25 wt%, about 5 wt% to 25 wt%, about 10 wt% to 25 wt%, about 15 wt% to 25 wt%, about 20 wt% to 25 wt%, about 1 wt% to 20 wt%, about 5 wt% to 20 wt%, about 10 wt% to 20 wt%, about 15 wt% to 20 wt%, about 1 wt% to 15 wt%, about 5 wt% to 15 wt%, about 10 wt% to 15 wt%, about 1 wt% to 10 wt%, about 5 wt% to 10 wt%, or about 1 wt% to 5 wt% of an antiadherent. In some embodiments, a core particle of the present disclosure includes about 4 wt% to 16 wt%, about 6 wt% to 16 wt%, about 8 wt% to 16 wt%, about 10 wt% to 16 wt%, about 12wt% to 16 wt%, about 14 wt% to 16 wt%, about 4 wt% to 14 wt%, about 6 wt% to 14 wt%, about 8 wt% to 14 wt%, about 10 wt% to 14 wt%, about 12 wt% to 14 wt%, about 4 wt% to 12 wt%, about 6 wt% to 12 wt%, about 8 wt% to 12 wt%, about 10 wt% to 12 wt%, about 4 wt% to 10 wt%, about 6 wt% to 10 wt%, about 8 wt% to 10 wt%, about 4 wt% to 8 wt%, or about 6 wt% to 8 wt% of an anti-adherent. In some embodiments, a core particle of the present disclosure includes about 1 wt%, about 5 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 4 wt%, about 8 wt%, about 12 wt%, about 14 wt%, or about 16 wt% of an anti-adherent.Protein
[0158] In some embodiments, a core particle of the present disclosure includes a protein. In some embodiments, the protein is selected from, but not limited to, calcium caseinate (e.g., calcium caseinate Al or calcium caseinate A2), micellar casein (e.g., micellar casein Al or micellar casein A2), pea protein, oat protein corn protein, lentil protein, chickpea protein, wheat protein, faba bean protein isolate, gelatin, whey protein isolate, milk protein concentrate, egg protein isolate, soy protein isolate, collagen, albumin, or combinations thereof. In some embodiments, the gelatin is Type A gelatin. In some embodiments, the gelatin is Type B gelatin. In some embodiments, the whey protein isolate is native whey protein isolate, sweet whey protein isolate, or acid whey protein isolate. For example, in some embodiments, a core particle of the present disclosure includes calcium caseinate, micellar casein, pea protein, oat protein, or a combination thereof.
[0159] In some embodiments, a core particle of the present disclosure includes about 1 wt% to about 90 wt% of a protein. For example, in some embodiments, a core particle of the present disclosure includes about 1 wt% to 90 wt%, about 5 wt% to 90 wt%, about 10 wt% to 90 wt%, about 15 wt% to 90 wt%, about 20 wt% to 90 wt%, about 30 wt% to 90 wt%, about 40 wt% to 90 wt%, about 50 wt% to 90 wt%, about 60 wt% to 90 wt%, about 70 wt% to 90 wt%, about 80 wt% to 90wt%, about 1 wt% to 80 wt%, about 5 wt% to 80 wt%, about 10 wt% to 80 wt%, about 15 wt% to 80 wt%, about 20 wt% to 80 wt%, about 30 wt% to 80 wt%, about 40 wt% to 80 wt%, about 50 wt% to 80 wt%, about 60 wt% to 80 wt%, about 70 wt% to 80 wt%, about 1 wt% to 70 wt%, about 5 wt% to 70 wt%, about 10 wt% to 70 wt%, about 15 wt% to 70 wt%, about 20 wt% to 70 wt%, about 30 wt% to 70 wt%, about 40 wt% to 70 wt%, about 50wt% to 70 wt%, about 60 wt% to 70 wt%, about 1 wt% to 60 wt%, about 5 wt% to 60 wt%, about 10 wt% to 60 wt%, about 15 wt% to 60 wt%, about 20 wt% to 60 wt%, about 30 wt% to 60 wt%, about 40 wt% to 60 wt%, about 50 wt% to 60 wt%, about 1 wt% to 50 wt%, about 5 wt% to 50 wt%, about 10 wt% to 50 wt%, about 15 wt% to 50 wt%, about 20 wt% to 50 wt%, about 30 wt% to 50 wt%, or about 40 wt% to 50 wt% of a protein. For example, in some embodiments, a core particle of the present disclosure includes about 5 wt% to 60 wt%, about 15 wt% to 60 wt%, about 25 wt% to 60 wt%, about 35 wt% to 60 wt%, about 45 wt% to 60 wt%, about 55 wt% to 60 wt%, about 5 wt% to 50 wt%, about 15 wt% to 50 wt%, about 25 wt% to 50 wt%, about 35 wt% to 50 wt%, about 45 wt% to 50 wt%, about 5 wt% to 40 wt%, about 15 wt% to 40 wt%, about 25 wt% to 40 wt%, about 35 wt% to 40 wt%, about 5 wt% to 30 wt%, about 15 wt% to 30 wt%, about 25 wt% to 30 wt%, about 5 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 70 wt%, about 80 wt%, or about 90 wt% of a protein.
[0160] In some embodiments, a protein provides improved nutritional and / or health benefits when consumed by a subject. For example, in some embodiments, a protein provides improved glutamic acid levels, improved memory and focus, immune system support, prevention of hypoglycemia, improvement of muscular dystrophy symptoms, or a combination thereof.Binder
[0161] In some embodiments, a core particle of the present disclosure includes a binder. In some embodiments, a binder promotes encapsulation of one or more core particles of the present disclosure. In some embodiments, a core particle of the present disclosure includes a binder selected from, but not limited to, compressible starch, isomalt, sodium alginate, microcrystalline cellulose, aluminum hydroxide, hydroxypropyl cellulose, ethyl cellulose, lactose, phytosterols, cholesterol, or a combination thereof. In some embodiments, the compressible starch is a directly compressible-grade binder. For example, in some embodiments, a core particle of the present disclosure includes a directly compressible starch, isomalt, sodium alginate, a phytosterol, or a combination thereof.
[0162] In some embodiments, a core particle of the present disclosure includes about 1 wt% to 45 wt% of a binder. For example, in some embodiments, a core particle of the present disclosure includes about 1 wt% to 45 wt%, about 5 wt% to 45 wt%, about 10 wt% to 45 wt%,about 15 wt% to 45 wt%, about 20 wt% to 45 wt%, about 25 wt% to 45 wt%, about 30 wt% to 45 wt%, about 35 wt% to 45 wt%, about 40 wt% to 45 wt%, about 1 wt% to 40 wt%, about 5 wt% to 40 wt%, about 10 wt% to 40 wt%, about 15 wt% to 40 wt%, about 20 wt% to 40 wt%, about 25 wt% to 40 wt%, about 30 wt% to 40 wt%, about 35 wt% to 40 wt%, about 1 wt% to 35 wt%, about 5 wt% to 35 wt%, about 10 wt% to 35 wt%, about 15 wt% to 35 wt%, about 20 wt% to 35 wt%, about 25 wt% to 35 wt%, about 30 wt% to 35 wt%, about 1 wt% to 30 wt%, about 5 wt% to 30 wt%, about 10 wt% to 30 wt%, about 15 wt% to 30 wt%, about 20 wt% to 30 wt%, about 25 wt% to 30 wt%, about 1 wt% to 25 wt%, about 5 wt% to 25 wt%, about 10 wt% to 25 wt%, about 15 wt% to 25 wt%, or about 20 wt% to 25 wt% of a binder. In some embodiments, a core particle of the present disclosure includes about 1 wt%, about 5 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, or about 45 wt% of a binder.Colorant
[0163] In some embodiments, a core particle of the present disclosure includes a colorant or encapsulated colorant. In some embodiments, the colorant or encapsulated colorant includes a natural colorant. In some embodiments, a core particle of the present disclosure includes a colorant selected from, but not limited to, spirulina extract, rutin, quercetin, chlorophyll, curcumin, cyanidin, astaxanthin, lutein, zeaxanthin, bixin, norbixin, capsanthin, lycopene, canthaxanthin, carotene, rubixanthin, violaxanthin, rhodoxanthin, citranaxanthin, betalain, betanin, orcein, cobalamin, cyanocobalamin, or a combination thereof. In some embodiments, the carotene includes an alpha, beta, or gamma carotene. In some embodiments, the colorant includes spirulina extract. In some embodiments, the colorant includes lutein, zeaxanthin, or a combination thereof.
[0164] In some embodiments, a colorant of the present disclosure is encapsulated in a polymer. In some embodiments, a colorant is encapsulated in a polymer selected from, but not limited to, a basic methacrylic copolymer (e.g., EUDRAGUARD® Protect), corn starch, shellac, carnauba wax, rice bran wax, tristearin, glyceryl dibehenate, pea starch, rice starch hydroxypropyl starch, starch sodium octenyl succinate, soluble com fiber, hydroxypropyl beta cyclodextrin, gamma cyclodextrin, beta cyclodextrin, stearic acid, palmitic acid, polyvinylpyrrolidone, polyethylene glycol, sucrose palmitate, sucrose stearate, sorbitantristearate, sorbitan monostearate, sorbitan monopalmitate, hydroxypropyl cellulose grade SSL, hydroxypropyl cellulose grade L, methyl cellulose 15cP viscosity, methyl cellulose 4000 cP viscosity, pullulan, curdlan, hydroxypropyl methylcellulose 50 cP viscosity, hydroxypropyl methylcellulose 100 cP viscosity, ethyl cellulose 10 cP viscosity, ethyl cellulose 100 cP viscosity, agarose, carboxymethylcellulose 300 cP viscosity, carboxymethylcellulose 250 cP viscosity, lambda carrageenan, iota carrageenan, kappa carrageenan, chitosan, basic methacrylic copolymer, acidic methacrylic copolymer, neutral methacrylic copolymer, tannic acid, ellagitannin, metatartaric acid, adipic acid, high methoxyl pectin, low methoxyl pectin, amidated low methoxyl pectin, gelatin type A, gelatin type B, glycerol esters of wood resins, behenic acid, arachidic acid, mono- and diglycerides of fatty acids, citric acid esters of mono- and diglycerides of fatty acids, sucroglycerides, stearyl tailrate, polyoxypropylene-polyoxyethylene polymers, gum benzoic, spermaceti wax, montan acid esters, hydroxypropyl distarch phosphate, acetylated distarch phosphate, acetylated distarch adipate, phosphate distarch phosphate, cocoa butter, shea butter, coconut oil, whey protein, native whey protein, casein, pea protein isolate, oat protein isolate, soy protein isolate, zein, agar, agarose, ethyl cellulose 300 cP viscosity, sucrose oleate, sodium alginate, oat starch, xanthan gum, gellan gum, guar gum, gum Arabic, beeswax, or any combination thereof. In some embodiments, the polyvinylpyrrolidone is 10 kDa Mn, 40 kDa Mn, or 1300 kDa Mu. In some embodiments, the polyethylene glycol is 1.5 kDa Mu, 2.0 kDa Mu, 3.35 kDa Mn, 4 kDa Mn, 6 kDa Mn, 8 kDa Mn, or 12 kDa Mn. In some embodiments, the chitosan includes low molecular weight chitosan or high molecular weight chitosan. For example, in some embodiments, a colorant is encapsulated in a basic methacrylic copolymer (e.g., EUDRAGUARD® Protect).
[0165] In some embodiments, an encapsulated colorant includes about 0.5% w / w to 40% w / w of a colorant and about 60% w / w to 99.5% w / w of a polymer. For example, in some embodiments, an encapsulated colorant includes about 0.5% w / w to 30% w / w, about 0.5% w / w to 20% w / w, about 0.5% w / w to 15% w / w, about 0.5% w / w to 10% w / w, about 0.5% w / w to 5% w / w, about 0.5% w / w to 1% w / w, about 1% w / w to 40% w / w, about 1% w / w to 30% w / w, about 1% w / w to 20% w / w, about 1% w / w to 15% w / w, about 1% w / w to 10% w / w, about 1% w / w to 5% w / w, about 5% w / w to 40% w / w, about 5% w / w to 30% w / w, about 5% w / w to 20% w / w, about 5% w / w to 15% w / w, about 5% w / w to 10% w / w, about 10% w / w to 40% w / w, about 10% w / w to 30% w / w, about 10% w / w to 20% w / w, about 10% w / w to 15% w / w, about 15% w / w to40% w / w, about 15% w / w to 30% w / w, about 15% w / w to 20% w / w, about 15% w / w to 40% w / w, about 15% w / w to 30% w / w, about 20% w / w to 40% w / w, about 20% w / w to 30% w / w, or about 30% w / w to 40% w / w of a colorant. In some embodiments, an encapsulated colorant includes about 60% w / w to 99.5% w / w, about 60% w / w to 98% w / w, about 60% w / w to 95% w / w, about 60% w / w to 90% w / w, about 60% w / w to 85% w / w, about 60% w / w to 80% w / w, about 60% w / w to 70% w / w, about 70% w / w to 99.5% w / w, about 70% w / w to 98% w / w, about 70% w / w to 95% w / w, about 70% w / w to 90% w / w, about 70% w / w to 85% w / w, about 70% w / w to 80% w / w, about 80% w / w to 99.5% w / w, about 80% w / w to 98% w / w, about 80% w / w to 95% w / w, about 80% w / w to 90% w / w, about 80% w / w to 85% w / w, about 85% w / w to 99.5% w / w, about 85% w / w to 98% w / w, about 85% w / w to 95% w / w, about 85% w / w to 90% w / w, about 90% w / w to 99.5% w / w, about 90% w / w to 98% w / w, about 90% w / w to 95% w / w, about 95% w / w to 99.5% w / w, about 95% w / w to 98% w / w, or about 98% w / w to 99.5% w / w of a polymer.
[0166] In some embodiments, a core particle or a coating of the present disclosure includes about I wt% to 20 wt% of a colorant or an encapsulated colorant. For example, in some embodiments, a core particle of the present disclosure includes about 1 wt% to 20 wt%, about 5 wt% to 20 wt%, about 10 wt% to 20 wt%, about 15 wt% to 20 wt%, about 1 wt% to 15 wt%, about 5 wt% to 15 wt%, about 10 wt% to 15 wt%, about 1 wt% to 10 wt%, about 5 wt% to 10 wt%, or about 1 wt% to 5 wt% of a colorant or encapsulated colorant. In some embodiments, a core particle of the present disclosure includes about 2 wt% to 16 wt%, about 4 wt% to 16 wt%, about 6 wt% to 16 wt%, about 8 wt% to 16 wt%, about 10 wt% to 16 wt%, about 12 wt% to 16 wt%, about 14 wt% to 16 wt%, about 2 wt% to 14 wt%, about 4 wt% to 14 wt%, about 6 wt% to 14 wt%, about 8 wt% to 14 wt%, about 10 wt% to 14 wt%, about 12 wt% to 14 wt%, about 2 wt% to 12 wt%, about 4 wt% to 12 wt%, about 6 wt% to 12 wt%, about 8 wt% to 12 wt%, about 10 wt% to 12 wt%, about 2 wt% to 10 wt%, about 4 wt% to 10 wt%, about 6 wt% to 10 wt%, about 8 wt% to 10 wt%, about 2 wt% to 8 wt%, about 4 wt% to 8 wt%, or about 6 wt% to 8 wt% of a colorant or an encapsulated colorant. In some embodiments, a core particle of the present disclosure includes about 1 wt%, about 5 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 2 wt%, about 4 wt%, about 8 wt%, about 12 wt%, about 14 wt%, or about 16 wt% of a colorant or an encapsulated colorant. In some embodiments, a core particle of the present disclosure includes about 2 wt% of a colorant or an encapsulated colorant.
[0167] In some embodiments, a sprinkle preparation of the present disclosure includes a coating incorporating a colorant and / or an encapsulated colorant. In some embodiments, the coating incorporates about 0.05-10% w / w of colorant or an encapsulated colorant. For example, in some embodiments, the coating incorporates about 0.05-7.5% w / w, about 0.05-5.0% w / w, about 0.05-2.5% w / w, about 0.05-2.0% w / w, about 0.05-1.0% w / w, about 0.05-0.5% w / w, about 0.05-0.1% w / w, about 0.1-10% w / w, about 0.1-7.5% w / w, about 0.1-5.0% w / w, about 0.1-2.5% w / w, about 0.1-2.0% w / w, about 0.1-1.0% w / w, about 0.1-0.5% w / w, about 0.5-10% w / w, about 0.5-7.5% w / w, about 0.5-5.0% w / w, about 0.5-2.5% w / w, about 0.5-2.0% w / w, about 0.5-1.0% w / w, about 1.0-10% w / w, about 1.0-7.5% w / w, about 1.0-5.0% w / w, about 1.0-2.5% w / w, about 1.0-2.0% w / w, about 2.0-10% w / w, about 2.0-7.5% w / w, about 2.0-5% w / w, about 2.0-2.5% w / w, about 2.5-10% w / w, about 2.5-7.5% w / w, about 2.5-5.0% w / w, about 5.0-10% w / w, about 5.0-7.5% w / w, about 7.5-10% w / w, about 0.05% w / w, about 0.1% w / w, about 0.5% w / w, about 1.0% w / w, about 2.0% w / w, about 2.5% w / w, about 5.0% w / w, about 7.5% w / w, or about 10% w / w of a colorant or an encapsulated colorant.
[0168] In some embodiments, a sprinkle preparation of the present disclosure includes 0.01-2% w / w of colorant. For example, in some embodiments, a sprinkle preparation includes about 0.01-1.75% w / w, about 0.01-1.5% w / w, about 0.01-1.25% w / w, about 0.01-1.0% w / w, about 0.01-0.75% w / w, about 0.01-0.5% w / w, about 0.01-0.25% w / w, about 0.01-0.1% w / w, about 0.01-0.05% w / w, about 0.05-2% w / w, about 0.05-1.75% w / w, about 0.05-1.5% w / w, about 0.05-1.25% w / w, about 0.05-1.0% w / w, about 0.05-0.75% w / w, about 0.05-0.5% w / w, about 0.05-0.25% w / w, about 0.05-0.1% w / w, about 0.1-2% w / w, about 0.1-1.75% w / w, about 0.1- 1.5% w / w, about 0.1-1.25% w / w, about 0.1-1.0% w / w, about 0.1-0.75% w / w, about 0.1-0.5% w / w, about 0.1-0.25% w / w, about 0.25-2% w / w, about 0.25-1.75% w / w, about 0.25-1.5% w / w, about 0.25-1.25% w / w, about 0.25-1.0% w / w, about 0.25-0.75% w / w, about 0.25-0.5% w / w, about 0.5-2% w / w, about 0.5-1.75% w / w, about 0.5-1.5% w / w, about 0.5-1.25% w / w, about 0.5- 1.0% w / w, about 0.5-0.75% w / w, about 0.75-2% w / w, about 0.75-1.75% w / w, about 0.75-1.5% w / w, about 0.75-1.25% w / w, about 0.75-1.0% w / w, about 1-2% w / w, about 1-1.75% w / w, about 1-1.5% w / w, about 1-1.25% w / w, about 1.25-2% w / w, about 1.25-1.75% w / w, about 1.25-1.5% w / w, about 1 .5-2% w / w, about 1 .5-1 .75% w / w, about 1 .75-2% w / w, about 0.01 % w / w, about 0.05% w / w, about 0.1% w / w, about 0.25% w / w, about 0.5% w / w, about 0.75% w / w, about 1.0% w / w, about 1.25% w / w, about 1.5% w / w, about 1.75% w / w, or about 2% w / w of a colorant.
[0169] In some embodiments, a colorant provides improved nutritional and / or health benefits when consumed by a subject. For example, in some embodiments, a colorant provides antioxidant activity; antihypertensive properties; protection against neurodegenerative and cardiovascular diseases; anti-insulin resistance; improved levels of thiamine (Bl), riboflavin (B2), niacin (B3), copper, iron, or magnesium; increased protein consumption, anti-inflammatory properties, cholesterol regulation, prevention of cardiovascular disease, or a combination thereof.Coating
[0170] In some embodiments, a sprinkle preparation of the present disclosure can include at least one coating layer. A coating may encompass an outer surface of a core particle. A coating may include a polish, a glaze, a sealant, a colorant, or combinations thereof. In some embodiments, a coating may include, but is not limited to, Capol® 127C, Capol® 11-143 A, Capol® 155C, a polyphenol, water, ethanol, or combinations thereof.
[0171] In some embodiments, a coating may include about 30-33.3% w / w of a polish. In some embodiments, a coating may include about 30-33.3% w / w of a glaze. In some embodiments, a coating may include about 30-33.3% w / w of a sealant. In some embodiments, a coating includes a polish, a glaze, and a sealant at a ratio of 1 : 1 : 1. In some embodiments, a coating includes 30-33.3% w / w of a polish, 30-33.3% w / w of a glaze, and 30-33.3% w / w of a sealant. For example, in some embodiments, a coating includes 30-33.3% w / w of Capol® 127C, 30-33.3% w / w of Capol® 11-143A, and 30-33.3% w / w of Capol® 155C.
[0172] In some embodiments, a coating is applied to a core particle in at least three layers, where the layers are sequentially: (i) a polish, (ii) a glaze, and (iii) a sealant. For example, a sprinkle preparation of the present disclosure includes a core particle coated by a polish, where the polish is coated by glaze, and where the glaze is coated by a sealant.
[0173] In some embodiments, a coating of the present disclosure incorporates a colorant and / or an encapsulated colorant. In some embodiments, the coating incorporates about 0.05- 10% w / w of colorant or an encapsulated colorant. For example, in some embodiments, the coating incorporates about 0.05-7.5% w / w, about 0.05-5.0% w / w, about 0.05-2.5% w / w, about 0.05-2.0% w / w, about 0.05-1.0% w / w, about 0.05-0.5% w / w, about 0.05-0.1% w / w, about 0.1- 10% w / w, about 0.1-7.5% w / w, about 0.1-5.0% w / w, about 0.1-2.5% w / w, about 0.1-2.0% w / w, about O.1 -1.0% w / w, about 0.1-0.5% w / w, about 0.5-10% w / w, about 0.5-7.5% w / w, about 0.5-5.0% w / w, about 0.5-2.5% w / w, about 0.5-2.0% w / w, about 0.5-1 .0% w / w, about 1 .0-10% w / w, about 1.0-7.5% w / w, about 1.0-5.0% w / w, about 1.0-2.5% w / w, about 1.0-2.0% w / w, about 2.0- 10% w / w, about 2.0-7.5% w / w, about 2.0-5% w / w, about 2.0-2.5% w / w, about 2.5-10% w / w, about 2.5-7.5% w / w, about 2.5-5.0% w / w, about 5.0-10% w / w, about 5.0-7.5% w / w, about 7.5- 10% w / w, about 0.05% w / w, about 0.1% w / w, about 0.5% w / w, about 1.0% w / w, about 2.0% w / w, about 2.5% w / w, about 5.0% w / w, about 7.5% w / w, or about 10% w / w of a colorant or an encapsulated colorant. In some embodiments, a colorant or encapsulated colorant is applied with the polish, the glaze, the sealant, or any combination thereof.
[0174] In some embodiments, a sprinkle preparation of the present disclosure can include about 10% w / w to about 30% w / w (e.g., 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 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 10% w / w to about 20% w / w, about 15% w / w to about 20% w / w, or about 10% w / w to about 15% w / w) of the coating.
[0175] In some embodiments, a sprinkle preparation of the present disclosure includes a coating that encapsulates one or more core particles containing a functional payload. In some embodiments, a coating can include com starch, shellac, carnauba wax, rice bran wax, tristearin, glyceryl dibehenate, pea starch, rice starch hydroxypropyl starch, starch sodium octenyl succinate, soluble com fiber, hydroxypropyl beta cyclodextrin, gamma cyclodextrin, beta cyclodextrin, stearic acid, palmitic acid, polyvinylpyrrolidone, polyethylene glycol, sucrose palmitate, sucrose stearate, sorbitan tristearate, sorbitan monostearate, sorbitan monopalmitate, hydroxypropyl cellulose grade SSL, hydroxypropyl cellulose grade L, methyl cellulose 15cP viscosity, methyl cellulose 4000 cP viscosity, pullulan, curdlan, hydroxypropyl methylcellulose 50 cP viscosity, hydroxypropyl methylcellulose 100 cP viscosity, ethyl cellulose 10 cP viscosity, ethyl cellulose 100 cP viscosity, agarose, carboxymethylcellulose 300 cP viscosity, carboxymethylcellulose 250 cP viscosity, lambda carrageenan, iota carrageenan, kappa carrageenan, chitosan, basic methacrylic copolymer, acidic methacrylic copolymer, neutral methacrylic copolymer, tannic acid, ellagitannin, metatartaric acid, adipic acid, high methoxyl pectin, low methoxyl pectin, amidated low methoxyl pectin, gelatin type A, gelatin type B, glycerol esters of wood resins, behenic acid, arachidic acid, mono- and diglycerides of fattyacids, citric acid esters of mono- and diglycerides of fatty acids, sucroglycerides, stearyl tartrate, polyoxypropylcnc-polyoxycthylcnc polymers, gum benzoic, spermaceti wax, montan acid esters, hydroxypropyl distarch phosphate, acetylated distarch phosphate, acetylated distarch adipate, phosphate distarch phosphate, cocoa butter, shea butter, coconut oil, whey protein, native whey protein, casein, pea protein isolate, oat protein isolate, soy protein isolate, zein, agar, agarose, ethyl cellulose 300 cP viscosity, sucrose oleate, sodium alginate, oat starch, xanthan gum, gellan gum, guar gum, gum Arabic, beeswax, or any combination thereof.Exemplary Sprinkle Preparations
[0176] In some embodiments, an exemplary sprinkle preparation includes 1% w / w to 70% w / w of a prebiotic dietary fiber, 5% w / w to 20% w / w of an anti- adherent, 15% w / w to 90% w / w of a protein, and 1 % w / w o 35% w / w of a binder. In some embodiments, an exemplary sprinkle preparation includes about 45% w / w of a prebiotic dietary fiber, wherein the prebiotic dietary fiber includes inulin; about 10% w / w of an anti-adherent, wherein the anti-adherent includes magnesium stearate; about 25% w / w of a protein, wherein the protein includes casein; and about 15% w / w of a binder, wherein the binder includes about 10% w / w corn starch and about 5% w / w isomalt.
[0177] In some embodiments, an exemplary sprinkle preparation includes 1% w / w to 70% w / w of a prebiotic dietary fiber, 5% w / w to 20% w / w of an anti- adherent, 15% w / w to 90% w / w of a protein, and 1% w / w to 10% w / w of a binder. In some embodiments, an exemplary sprinkle preparation includes about 60% w / w of a prebiotic dietary fiber, wherein the prebiotic dietary fiber includes inulin; about 10% w / w of an anti-adherent, wherein the anti-adherent includes magnesium stearate; about 25% w / w of a protein, wherein the protein includes casein, and about 5% of a binder, wherein the binder includes isomalt.
[0178] In some embodiments, an exemplary sprinkle preparation includes 1% w / w to 70% w / w of a prebiotic dietary fiber, 5% w / w to 20% w / w of an anti- adherent, 1% w / w to 70% w / w of a protein, and 1% w / w to 20% w / w of a binder. In some embodiments, an exemplary sprinkle preparation includes about 60% w / w of a prebiotic dietary fiber, wherein the prebiotic dietary fiber includes inulin; about 8% w / w of an anti-adherent, wherein the anti-adherent includes magnesium stearate; about 20% w / w of a protein, wherein the protein includes peaprotein isolate, and about 10% of a binder, wherein the binder includes about 5% w / w sodium alginate and about 5% w / w isomalt.
[0179] In some embodiments, an exemplary sprinkle preparation includes the following components.
[0180] In some embodiments, an exemplary sprinkle preparation includes the following components.
[0181] In some embodiments, an exemplary sprinkle preparation includes the following components.
[0182] In some embodiments, an exemplary sprinkle preparation includes about 0.1% w / w to about 20% w / w of a functional payload. For example, in some embodiments, an exemplary sprinkle preparation includes about 0.1% w / w to about 20% w / w, about 0.5% w / w to about 20% w / w, about 1% w / w to about 20% w / w, about 1.5% w / w to about 20% w / w, about 2% w / w to about 20% w / w, about 2.5% w / w to about 20% w / w, about 5% w / w to about 20% w / w, about 7.5% w / w to about 20% w / w, about 10% w / w to about 20% w / w, about 12.5% w / w to about 20% w / w, about 15% w / w to about 20% w / w, about 17.5% w / w to about 20% w / w, about 0.1% w / w to about 17.5% w / w, about 0.5% w / w to about 17.5% w / w, about 1% w / w to about 17.5% w / w, about 1 .5% w / w to about 17.5% w / w, about 2% w / w to about 17.5% w / w, about 2.5% w / w to about 17.5% w / w, about 5% w / w to about 17.5% w / w, about 7.5% w / w to about 17.5% w / w, about 10% w / w to about 17.5% w / w, about 12.5% w / w to about 17.5% w / w, about 15% w / w to about 17.5% w / w, about 0.1% w / w to about 15% w / w, about 0.5% w / w to about 15% w / w, about 1% w / w to about 15% w / w, about 1.5% w / w to about 15% w / w, about 2% w / w to about 15% w / w, about 2.5% w / w to about 15% w / w, about 5% w / w to about 15% w / w, about 7.5% w / w to about 15% w / w, about 10% w / w to about 15% w / w, about 12.5% w / w to about 15% w / w, about 0.1% w / w to about 12.5% w / w, about 0.5% w / w to about 12.5% w / w, about 1% w / w to about 12.5% w / w, about 1.5% w / w to about 12.5% w / w, about 2% w / w to about 12.5% w / w, about 2.5% w / w to about 12.5% w / w, about 5% w / w to about 12.5% w / w, about 7.5% w / w to about 12.5% w / w, about 10% w / w to about 12.5% w / w, about 0.1% w / w to about 10% w / w, about 0.5% w / w to about 10% w / w, about 1% w / w to about 10% w / w, about 1.5% w / w to about 10% w / w, about 2% w / w to about 10% w / w, about 2.5% w / w to about 10% w / w, about 5% w / w to about 10% w / w, about 7.5% w / w to about 10% w / w, about 0.1% w / w to about 7.5% w / w, about 0.5% w / w to about 7.5% w / w, about 1% w / w to about 7.5% w / w, about 1.5% w / w to about 7.5% w / w, about 2% w / w to about 7.5% w / w, about 2.5% w / w to about 7.5% w / w, about 5% w / w to about 7.5% w / w, about 0.1% w / w to about 5% w / w, about 0.5% w / w to about 5% w / w, about 1% w / w to about 5% w / w, about 1.5% w / w to about 5% w / w, about 2% w / w to about 5% w / w, about 2.5% w / w to about 5% w / w, about 0.1% w / w to about 2.5% w / w, about 0.5% w / w to about 2.5% w / w, about 1 % w / w to about 2.5% w / w, about 1 .5% w / w to about 2.5% w / w, about 2% w / w to about 2.5% w / w, about 0.1% w / w to about 2% w / w, about 0.5% w / w to about 2% w / w, about 1% w / w to about 2% w / w, about 1.5% w / w to about 2% w / w, about 0.1% w / w toabout 1 .5% w / w, about 0.5% w / w to about 1 .5% w / w, about 1 % w / w to about 1 .5% w / w, about 0.1% w / w to about 1% w / w, about 0.5% w / w to about 1% w / w, or about 0.1% w / w to about 0.5% w / w of a functional pay load.
[0183] In some embodiments, a sprinkle preparation disclosed herein incorporates a functional payload including, but not limited to, vitamin B12, pyrroloquinoline quinone (PQQ), vitamin D, caffeine, creatine, lutein, zeaxanthin, lycopene, zeaxanthin, lycopene, carotene, curcumin, taurine, citicoline, alpha glycerophosphocholine, diindolylmethane, eicosapentaenoic acid, docosapentaenoic acid, lauric acid, tryptophan, arginine, leucine, or any combination thereof.
[0184] In some embodiments, an exemplary sprinkle preparation includes the following components.
[0185] In some embodiments, an exemplary sprinkle preparation includes the following components.
[0186] In some embodiments, an exemplary sprinkle preparation includes the following components.
[0187] In some embodiments, an exemplary sprinkle preparation includes the following components.Characteristics of Exemplary Sprinkle Preparations
[0188] In some embodiments, a sprinkle preparation of the present disclosure may have a substantially cylindrical geometry. In some embodiments, a sprinkle preparation of the present disclosure may have a nonpareil (i.e. , substantially spherical) geometry. In some embodiments, a sprinkle preparation of the present disclosure may have a width from about 0.5 mm to 3 mm.For example, a sprinkle of the present disclosure may have a diameter from about 0.5 mm to 2.8 mm, 0.5 mm to 2.6 mm, about 0.5 to 2.4 mm, about 0.5 mm to 2.2 mm, about 0.5 mm to 2 mm, about 0.5 mm to 1.8 mm, about 0.5 mm to 1.6 mm, about 0.5 mm to 1.4 mm, about 0.5 mm to1.2 mm, about 0.5 mm to 1 mm, about 0.5 mm to 0.8 mm, about 0.5 mm to 0.6 mm, about 1 mm to 3 mm, about 1 mm to 2.8 mm, about 1 mm to 2.6 mm, about 1 mm to 2.4 mm, about 1 mm to2.2 mm, about 1 mm to 2 mm, about 1 mm to 1.8 mm, about 1 mm to 1.6 mm, about 1 mm to 1.4 mm, about 1 mm to 1.2 mm, about 1.5 mm to 3 mm, about 1.5 mm to 2.8 mm, about 1.5 mm to 2.6 mm, about 1.5 mm to 2.4 mm, about 1.5 mm to 2.2 mm, about 1.5 mm to 2 mm, about 1.5 mm to 1.8 mm, about 1.5 mm to 1.6 mm, about 2 mm to 3 mm, about 2 mm to 2.8 mm, about 2 mm to 2.6 mm, about 2 mm to 2.4 mm, or about 2 mm to 2.2 mm. In some embodiments, asprinkle preparation may have a diameter from about 1 .6 mm to 1 .9 mm, about 1 .5 to about 1 .9 mm, about 1.6 to 2 mm, about 1.6 to 1.8 mm, about 1.65 mm to 1.85 mm, about 0.95 mm to about 1.25 mm, or about 1.65 mm to 1.75 mm.
[0189] In some embodiments, a sprinkle preparation of the present disclosure may have a length from about 1 mm to about 15 mm. For example, a sprinkle preparation may have a length from 1 mm to 14 mm, about 1 mm to 13 mm, about 1 mm to 12 mm, about 1 mm to 11 mm, about 1 mm to 10 mm, about 1 mm to 9 mm, about 1 mm to 9 mm, about 1 mm to 8 mm, about 1 mm to 7 mm, about 1 mm to 6 mm, about 1 mm to 5 mm, about 1 mm to 4 mm, about 1 mm to 3 mm, about 1 mm to 2 mm, about 2 mm to 14 mm, about 2 mm to 13 mm, about 2 mm to 12 mm, about 2 mm to 1 1 mm, about 2 mm to 10 mm, about 2 mm to 9 mm, about 2 mm to 9 mm, about2 mm to 8 mm, about 2 mm to 7 mm, about 2 mm to 6 mm, about 2 mm to 5 mm, about 2 mm to 4 mm, about 2 mm to 3 mm, about 3 mm to 14 mm, about 3 mm to 13 mm, about 3 mm to 12 mm, about 3 mm to 11 mm, about 3 mm to 10 mm, about 3 mm to 9 mm, about 3 mm to 9 mm, about 3 mm to 8 mm, about 3 mm to 7 mm, about 3 mm to 6 mm, about 3 mm to 5 mm, or about3 mm to 4 mm. In some embodiments, a sprinkle preparation may have a length from about 2.5 mm to 10 mm, about 3.5 mm to 10 mm, about 2.5 mm to 9 mm, about 3 mm to 9 mm, about 3.5 mm to 9 mm, about 2.5 mm to 8 mm, about 3 mm to 8 mm, about 3.5 mm to 8 mm, about 2.5 mm to 7 mm, about 3 mm to 7 mm, or about 3.5 mm to 7 mm.
[0190] In some embodiments, a sprinkle preparation of the present disclosure may have a height from about 0.5 mm to 3.0 mm. For example, in some embodiments, a sprinkle preparation has a height from about 0.5 mm to 3 mm. For example, a sprinkle of the present disclosure may have a diameter from about 0.5 mm to 2.8 mm, 0.5 mm to 2.6 mm, about 0.5 to2.4 mm, about 0.5 mm to 2.2 mm, about 0.5 mm to 2 mm, about 0.5 mm to 1.8 mm, about 0.5 mm to 1.6 mm, about 0.5 mm to 1.4 mm, about 0.5 mm to 1.2 mm, about 0.5 mm to 1 mm, about 0.5 mm to 0.8 mm, about 0.5 mm to 0.6 mm, about 1 mm to 3 mm, about 1 mm to 2.8 mm, about 1 mm to 2.6 mm, about 1 mm to 2.4 mm, about 1 mm to 2.2 mm, about 1 mm to 2 mm, about 1 mm to 1.8 mm, about 1 mm to 1.6 mm, about 1 mm to 1.4 mm, about 1 mm to 1.2 mm, about 1.5 mm to 3 mm, about 1.5 mm to 2.8 mm, about 1.5 mm to 2.6 mm, about 1.5 mm to 2.4 mm, about1.5 mm to 2.2 mm, about 1.5 mm to 2 mm, about 1.5 mm to 1.8 mm, about 1.5 mm to 1.6 mm, about 2 mm to 3 mm, about 2 mm to 2.8 mm, about 2 mm to 2.6 mm, about 2 mm to 2.4 mm, orabout 2 mm to 2.2 mm. In some embodiments, a sprinkle preparation may have a diameter from about 1.6 mm to 1.9 mm, about 1.5 to about 1.9 mm, about 1.6 to 2 mm, about 1.6 to 1.8 mm, about 1.65 mm to 1.85 mm, about 0.95 mm to about 1.25 mm, or about 1.65 mm to 1.75 mm.
[0191] In other embodiments, a sprinkle preparation of the present disclosure has a maximum dimension of about 1 mm to about 25 mm. In some embodiments, a sprinkle preparation of the present disclosure has a maximum dimension of about 1 mm to about 25 mm, about 1.5 mm to about 25 mm, about 2 mm to about 25 mm, about 2.5 mm to about 25 mm, about 5 mm to about 25 mm, about 7.5 mm to about 25 mm, about 10 mm to about 25 mm, about12.5 mm to about 25 mm, about 15 mm to about 25 mm, about 17.5 mm to about 25 mm, about 20 mm to about 25 mm, about 22.5 mm to about 25 mm, about 1 mm to about 22.5 mm, about1.5 mm to about 22.5 mm, about 2 mm to about 22.5 mm, about 2.5 mm to about 22.5 mm, about 5 mm to about 22.5 mm, about 7.5 mm to about 22.5 mm, about 10 mm to about 22.5 mm, about12.5 mm to about 22.5 mm, about 15 mm to about 22.5 mm, about 17.5 mm to about 22.5 mm, about 20 mm to about 22.5 mm, about 1 mm to about 20 mm, about 1.5 mm to about 20 mm, about 2 mm to about 20 mm, about 2.5 mm to about 20 mm, about 5 mm to about 20 mm, about7.5 mm to about 20 mm, about 10 mm to about 20 mm, about 12.5 mm to about 20 mm, about 15 mm to about 20 mm, about 17.5 mm to about 20 mm, about 1 mm to about 17.5 mm, about 1.5 mm to about 17.5 mm, about 2 mm to about 17.5 mm, about 2.5 mm to about 17.5 mm, about 5 mm to about 17.5 mm, about 7.5 mm to about 17.5 mm, about 10 mm to about 17.5 mm, about12.5 mm to about 17.5 mm, about 15 mm to about 17.5 mm, about 1 mm to about 15 mm, about1.5 mm to about 15 mm, about 2 mm to about 15 mm, about 2.5 mm to about 15 mm, about 5 mm to about 15 mm, about 7.5 mm to about 15 mm, about 10 mm to about 15 mm, about 12.5 mm to about 15 mm, about 1 mm to about 12.5 mm, about 1.5 mm to about 12.5 mm, about 2 mm to about 12.5 mm, about 2.5 mm to about 12.5 mm, about 5 mm to about 12.5 mm, about 7.5 mm to about 12.5 mm, about 10 mm to about 12.5 mm, about 1 mm to about 10 mm, about 1.5 mm to about 10 mm, about 2 mm to about 10 mm, about 2.5 mm to about 10 mm, about 5 mm to about 10 mm, about 7.5 mm to about 10 mm, about 1 mm to about 7.5 mm, about 1.5 mm to about 7.5 mm, about 2 mm to about 7.5 mm, about 2.5 mm to about 7.5 mm, about 5 mm to about 7.5 mm, about 1 mm to about 5 mm, about 1 .5 mm to about 5 mm, about 2 mm to about 5 mm, about 2.5 mm to about 5 mm, about 1 mm to about 2.5 mm, about 1.5 mm to about 2.5 mm,about 2 mm to about 2.5 mm, about 1 mm to about 2 mm, about 1 .5 mm to about 2 mm, or about 1 mm to about 1.5 mm.
[0192] In some embodiments, a sprinkle preparation of the present disclosure has a density of about 0.75 mg / dL to 1.10 mg / dL. For example, in some embodiments, a sprinkle preparation has a density of about 0.75 mg / dL to 1.05 mg / dL, about 0.75 mg / dL to 1.0 mg / dL, about 0.75 mg / dL to 0.95 mg / dL, about 0.75 mg / dL to 0.9 mg / dL, about 0.75 mg / dL to 0.85 mg / dL, about 0.75 mg / dL to 0.8 mg / dL, about 0.8 mg / dL to 1.10 mg / dL, about 0.8 mg / dL to 1.05 mg / dL, about 0.8 mg / dL to 1.0 mg / dL, about 0.8 mg / dL to 0.95 mg / dL, about 0.8 mg / dL to 0.9 mg / dL, about 0.8 mg / dL to 0.85 mg / dL, about 0.85 mg / dL to 1.10 mg / dL, about 0.85 mg / dL to 1 .05 mg / dL, about 0.85 mg / dL to 1 .0 mg / dL, about 0.85 mg / dL to 0.95 mg / dL, about 0.85 mg / dL to 0.9 mg / dL, about 0.9 mg / dL to 1.10 mg / dL, about 0.9 mg / dL to 1.05 mg / dL, about 0.9 mg / dL to 1.0 mg / dL, about 0.9 mg / dL to 0.95 mg / dL, about 0.95 mg / dL to 1.10 mg / dL, about 0.95 mg / dL to 1.05 mg / dL, about 0.95 mg / dL to 1.0 mg / dL, about 1.0 mg / dL to 1.1 mg / dL, or about 1.05 mg / dL to about 1.1 mg / dL. In some embodiments, a sprinkle preparation has a density of about 0.79 mg / dL, about 0.8 mg / dL, about 0.81 mg / dL, about 0.82 mg / dL, about 0.83 mg / dL, about 0.84 mg / dL, about 0.85 mg / dL, about 0.86 mg / dL, about 0.87 mg / dL, about 0.88 mg / dL, about 0.89 mg / dL, about 0.9 mg / dL, about 0.91 mg / dL, about 0.92 mg / dL, about 0.93 mg / dL, about 0.94 mg / dL, about 0.95 mg / dL, about 0.96 mg / dL, about 0.97 mg / dL, about 0.98 mg / dL, about 0.99 mg / dL, about 1.0 mg / dL, about 1.01 mg / dL, about 1.02 mg / dL, about 1.03 mg / dL, about 1.04 mg / dL, or about 1.05 mg / dL. In some embodiments, the average density of a plurality of sprinkles is about 0.75 mg / dL to 1.05 mg / dL, about 0.75 mg / dL to 1.0 mg / dL, about 0.75 mg / dL to 0.95 mg / dL, about 0.75 mg / dL to 0.9 mg / dL, about 0.75 mg / dL to 0.85 mg / dL, about 0.75 mg / dL to 0.8 mg / dL, about 0.8 mg / dL to 1.10 mg / dL, about 0.8 mg / dL to 1.05 mg / dL, about 0.8 mg / dL to 1.0 mg / dL, about 0.8 mg / dL to 0.95 mg / dL, about 0.8 mg / dL to 0.9 mg / dL, about 0.8 mg / dL to 0.85 mg / dL, about 0.85 mg / dL to 1.10 mg / dL, about 0.85 mg / dL to 1.05 mg / dL, about 0.85 mg / dL to 1.0 mg / dL, about 0.85 mg / dL to 0.95 mg / dL, about 0.85 mg / dL to 0.9 mg / dL, about 0.9 mg / dL to 1.10 mg / dL, about 0.9 mg / dL to 1.05 mg / dL, about 0.9 mg / dL to 1.0 mg / dL, about 0.9 mg / dL to 0.95 mg / dL, about 0.95 mg / dL to 1.10 mg / dL, about 0.95 mg / dL to 1 .05 mg / dL, about 0.95 mg / dL to 1 .0 mg / dL, about 1 .0 mg / dL to 1.1 mg / dL, or about 1 .05 mg / dL to about 1.1 mg / dL.
[0193] In some embodiments, a sprinkle preparation of the present disclosure includes a moisture content in a range from about 0.5% to about 10%. For example, in some embodiments, a sprinkle preparation includes a moisture content from about 0.5% to about 8%, about 0.5 % to about 6%, about 0.5% to about 5%, about 0.5% to about 4%, about 0.5% to about 3%, about 0.5% to about 2%, about 0.5% to about 1%, about 1% to about 10%, about 1% to about 8%, about 1 % to about 6%, about 1% to about 5%, about 1% to about 4%, about 1% to about 3%, about 1% to about 2%, about 2% to about 10%, about 2% to about 8%, about 2 % to about 6%, about 2% to about 5%, about 2% to about 4%, about 2% to about 3%, about 3% to about 10%, about 3% to about 8%, about 3 % to about 6%, about 3% to about 5%, about 3% to about 4%, about 4% to about 10%, about 4% to about 8%, about 4 % to about 6%, about 4% to about 5%, about 5% to about 10%, about 5% to about 8%, about 5 % to about 6%, about 6% to about 10%, about 6% to about 8%, or about 8% to about 10%.
[0194] In some embodiments, a sprinkle preparation of the present disclosure includes a Shore hardness measurable by a durometer. In some embodiments, a sprinkle preparation includes a Shore hardness of about 65 to 75, about 65 to 72.5, about 65 to 70, about 65 to 67.5, about 67.5 to 75, about 67.5 to 72.5, about 67.5 to 70, about 70 to 75, about 70 to 72.5, or about 72.5 to 75.
[0195] In some embodiments, a sprinkle preparation of the present disclosure includes a compressive force hardness measurable by a texture analyzer. In some embodiments, a sprinkle preparation includes a compressive force hardness of about 10 N to 25 N, about 10 N to 22.5 N, about 10 N to 20 N, about 10 N to 17.5 N, about 10 N to 15 N, about 10 N to 12.5 N, about 12.5 N to 25 N, about 12.5 N to 22.5 N, about 12.5 N to 20 N, about 12.5 N to 17.5 N, about 12.5 N to 15 N, about 15 N to 25 N, about 15 N to 22.5 N, about 15 N to 20 N, about 15 N to 17.5 N, about 17.5 N to 25 N, about 17.5 N to 22.5 N, about 17.5 N to 20 N, about 20 N to 25 N, about 20 N to 22.5 N, or about 22.5 N to 25 N.
[0196] In some embodiments, release of a payload component from a sprinkle preparation described herein into a solution is delayed as compared to an appropriate reference (e.g., as compared to free payload component and / or as compared to non-encapsulated payload component).
[0197] In some embodiments, a sprinkle preparation of the present disclosure is characterized by delayed release of a payload component into one or more gastrointestinal compartments of a subject that has ingested the sprinkle preparation as compared to release of the pay load component upon ingestion of an appropriate reference (e.g., of free payload component and / or of non-encapsulated pay load component). For example, in some embodiments, release of a payload component from a sprinkle preparation of the present disclosure is delayed until the sprinkle preparation reaches the large intestine, the small intestine, the gastrointestinal epithelium, and / or the gastrointestinal mucus of a subject that has ingested the sprinkle formulation. In some embodiments, release of a payload component from a sprinkle preparation of the present disclosure is delayed until the sprinkle preparation reaches the small intestine of a subject that has ingested the sprinkle formulation.
[0198] In some embodiments, a sprinkle preparation of the present disclosure is characterized in that release of a payload component is responsive to the presence of one or more digestive enzymes in a gastrointestinal compartment of a subject that has ingested the sprinkle formulation. In some embodiments, a sprinkle preparation of the present disclosure is characterized in that release of a payload component is responsive to the presence of one or more digestive enzymes in an oral cavity of a subject that has ingested the sprinkle formulation. In some embodiments, a sprinkle preparation of the present disclosure is characterized in that release of a payload component is responsive to the presence of one or more digestive enzymes in a gastric cavity of a subject that has ingested the sprinkle formulation. In some embodiments, a sprinkle preparation of the present disclosure is characterized in that release of a payload component is responsive to the presence of one or more digestive enzymes in a small intestine of a subject that has ingested the sprinkle formulation. In some embodiments, a sprinkle preparation of the present disclosure is characterized in that release of a payload component is responsive to the presence of one or more digestive enzymes in a large intestine of a subject that has ingested the sprinkle formulation. In some embodiments, a sprinkle preparation of the present disclosure is characterized in that release of a payload component is responsive to the presence of one or more digestive enzymes in a colon of a subject that has ingested the sprinkle formulation.
[0199] For example, in some embodiments, release of payload component from a sprinkle preparation described herein is reduced and / or delayed relative to an appropriate reference (e.g., as compared to free pay load component and / or as compared to non-encapsulated payload component) unless and / or until the sprinkle preparation encounters one or more digestive enzymes. When one or more relevant digestive enzymes are encountered, release may, in some embodiments, be rapid as compared to one or more other formulations comprising the same payload component.
[0200] In some embodiments, a sprinkle preparation of the present disclosure releases a payload component at a predictable rate upon ingestion of the sprinkle preparation by a subject. In some embodiments, a sprinkle preparation of the present disclosure releases a payload component upon ingestion of the sprinkle preparation by a subject at a rate that prolongs a pharmacologic, nutritive, and / or cognitive benefit of a payload component as compared to the benefit achieved by an appropriate reference (e.g., by free payload and / or by non-encapsulated pay load component).
[0201] In some embodiments, a sprinkle preparation of the present disclosure releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%, about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a pay load component incorporated therein within 12 hours of ingestion of the sprinkle preparation by a subject.
[0202] In some embodiments, a sprinkle preparation of the present disclosure that has been stored in a food and / or beverage product (for example, in a beverage, yogurt, food, or solid formulation, e.g., coconut water, sparkling water, fermented non-alcoholic beverages, alcoholic beverages, an energy beverage, water, nutrient-fortified water, a carbonated drink, coffee, tea, juice, milk, a milk alternative, a protein bar, a protein powder, an ice cream, an energy bar, a granola bar, or baby formula) for at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days, at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 12 weeks, at least 16 weeks, at least 6 months, at least 8 months, at least 10 months, at least 12 months, at least 16 months, at least 20 months, or at least 24 months, releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%, about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a payload component incorporated therein within 12 hours of ingestion of the sprinkle preparation by a subject.
[0203] In some embodiments, a sprinkle preparation of the present disclosure releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about80%, about 60% to about 80%, about 70% to about 80%, about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a pay load component incorporated therein within 2 hours of ingestion of the sprinkle preparation by a subject.
[0204] In some embodiments, a sprinkle preparation of the present disclosure stored in a food and / or beverage product (for example, in a beverage, yogurt, food, or solid formulation, e.g., coconut water, sparkling water, fermented non-alcoholic beverages, alcoholic beverages, an energy beverage, water, nutrient-fortified water, a carbonated drink, coffee, tea, juice, milk, a milk alternative, a protein bar, a protein powder, an ice cream, an energy bar, a granola bar, or baby formula) for at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days, at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 12 weeks, at least 16 weeks, at least 6 months, at least 8 months, at least 10 months, at least 12 months, at least 16 months, at least 20 months, or at least 24 months, releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%, about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a payload component incorporated therein within 2 hours of ingestion of the sprinkle preparation by a subject.
[0205] In some embodiments, a sprinkle preparation of the present disclosure releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%, about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a pay load component incorporated therein within 4 hours of ingestion of the sprinkle preparation by a subject.
[0206] In some embodiments, a sprinkle preparation of the present disclosure stored in a food and / or beverage product (for example, a beverage, yogurt, food, or solid formulation, e.g., coconut water, sparkling water, fermented non-alcoholic beverages, alcoholic beverages, an energy beverage, water, nutrient-fortified water, a carbonated drink, coffee, tea, juice, milk, a milk alternative, a protein bar, a protein powder, an ice cream, an energy bar, a granola bar, or baby formula) for at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days, at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 12 weeks, at least 16 weeks, at least 6 months, at least 8 months, at least 10 months, at least 12 months, at least 16 months, at least 20 months, or at least 24 months, releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%,about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a payload component incorporated therein within 4 hours of ingestion of the sprinkle preparation by a subject.
[0207] In some embodiments, a sprinkle preparation of the present disclosure releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%, about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a pay load component incorporated therein within 6 hours of ingestion of the sprinkle preparation by a subject.
[0208] In some embodiments, a sprinkle preparation of the present disclosure stored in a food and / or beverage product (for example, in a beverage, yogurt, food, or solid formulation, e.g., coconut water, sparkling water, fermented non-alcoholic beverages, alcoholic beverages, an energy beverage, water, nutrient- fortified water, a carbonated drink, coffee, tea, juice, milk, a milk alternative, a protein bar, a protein powder, an ice cream, an energy bar, a granola bar, or baby formula) for at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days, at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 12 weeks, at least 16 weeks, at least 6months, at least 8 months, at least 10 months, at least 12 months, at least 16 months, at least 20 months, or at least 24 months, releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%, about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a payload component incorporated therein within 6 hours of ingestion of the sprinkle preparation by a subject.
[0209] In some embodiments, a sprinkle preparation of the present disclosure releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%, about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a payload component incorporated therein within 8 hours of ingestion of the sprinkle preparation by a subject.
[0210] In some embodiments, a sprinkle preparation of the present disclosure stored in a food and / or beverage product (for example, in a beverage, yogurt, food, or solid formulation, e.g., coconut water, sparkling water, fermented non-alcoholic beverages, alcoholic beverages, an energy beverage, water, nutrient-fortified water, a carbonated drink, coffee, tea, juice, milk, a milk alternative, a protein bar, a protein powder, an ice cream, an energy bar, a granola bar, or baby formula) for a period of at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days, at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 12 weeks, at least 16 weeks, at least 6 months, at least 8 months, at least 10 months, at least 12 months, at least 16 months, at least 20 months, or at least 24 months, releases about 10% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 10% to about 90%, about 20% to about 90%, about 30% to about 90%, about 40% to about 90%, about 50% to about 90%, about 60% to about 90%, about 70% to about 90%, about 80% to about 90%, about 10% to about 80%, about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%, about 10% to about 70%, about 20% to about 70%, about 30% to about 70%, about 40% to about 70%, about 50% to about 70%, about 60% to about 70%, about 10% to about 60%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, about 10% to about 50%, about 20% to about 50%, about 30% to about 50%, about 40% to about 50%, about 10% to about 40%, about 20% to about 40%, about 30% to about 40%, about 10% to about 30%, about 20% to about 30%, or about 10% to about 20% of a payload component incorporated therein within 8 hours of ingestion of the sprinkle preparation by a subject.Fortified Food Products
[0211] The present disclosure additionally provides for food products that have been fortified with one or more sprinkle preparations incorporating a prebiotic dietary fiber, an antiadherent, a protein, and a binder.
[0212] In some embodiments, a sprinkle preparation of the present disclosure is added to a base food product to produce a fortified food product. In some embodiments, a base food product is selected from, but not limited to, a beverage (e.g., an energy drink, water, nutrient- fortified water, carbonated drink, coffee, tea, juice, milk, milk alternative, or baby formula), a dairy food base (e.g. yogurt, ice cream, etc.), or a prepared food base (e.g., a cupcake, a cake, a pizza, a hamburger, a salad, French fries, a cookie, a doughnut, etc.). In some embodiments, the dairy food base is a yogurt, an ice cream, a milkshake, or a dairy beverage.
[0213] In some embodiments a fortified food product includes about 0.01-10% w / v of a sprinkle formulation wherein the one or more lipid particles incorporate a prebiotic dietary fiber, an anti-adherent, a protein, and a binder. In some embodiments, a fortified food product of the present disclosure includes about 0.01-9% w / v, about 0.01-8% w / v, about 0.01-7% w / v, about 0.01-6% w / v, about 0.01-5% w / v, about 0.01-4% w / v, about 0.01-3% w / v, about 0.01-2% w / v, about 0.01-1% w / v, about 0.01-0.5% w / v, about 0.01-0.1% w / v, about 0.01-0.05% w / v, about 0.05-10% w / v, about 0.05-9% w / v, about 0.05-8% w / v, about 0.05-7% w / v, about 0.05-6% w / v, about 0.05-5% w / v, about 0.05-4% w / v, about 0.05-3% w / v, about 0.05-2% w / v, about 0.05-1% w / v, about 0.05-0.5% w / v, about 0.05-0.1% w / v, about 0.1-10% w / v, about 0.1-9% w / v, about 0.1-8% w / v, about 0.1-7% w / v, about 0.1-6% w / v, about 0.1-5% w / v, about 0.1-4% w / v, about 0.1-3% w / v, about 0.1-2% w / v, about 0.1-1% w / v, about 0.1-0.5% w / v, about 0.5-10% w / v, about 0.5-9% w / v, about 0.5-8% w / v, about 0.5-7% w / v, about 0.5-6% w / v, about 0.5-5% w / v, about 0.5-4% w / v, about 0.5-3% w / v, about 0.5-2% w / v, about 0.5-1% w / v, about 1-10% w / v, about 1-9% w / v, about 1-8% w / v, about 1-7% w / v, about 1-6% w / v, about 1-5% w / v, about 1- 4% w / v, about 1-3% w / v, about 1-2% w / v, about 2-10% w / v, about 2-9% w / v, about 2-8% w / v, about 2-7% w / v, about 2-6% w / v, about 2-5% w / v, about 2-4% w / v, about 2-3% w / v, about 3- 10% w / v, about 3-9% w / v, about 3-8% w / v, about 3-7% w / v, about 3-6% w / v, about 3-5% w / v, about 3-4% w / v, about 4-10% w / v, about 4-9% w / v, about 4-8% w / v, about 4-7% w / v, about 4- 6% w / v, about 4-5% w / v, about 5-10% w / v, about 5-9% w / v, about 5-8% w / v, about 5-7% w / v, about 5-6% w / v, about 6-10% w / v, about 6-9% w / v, about 6-8% w / v, about 6-7% w / v, about 7- 10% w / v, about 7-9% w / v, about 7-8% w / v, about 8-10% w / v, about 8-9% w / v, or about 8-9% w / v of a sprinkle formulation.
[0214] In some embodiments, a sprinkle preparation of the present disclosure exhibits favorable properties when incorporated into a food base. For example, a sprinkle preparation may have prolonged stability of shape and composition when incorporated into a food base. In some embodiments, a sprinkle preparation may retain texture (e.g., crunch) for a prolonged period of time when incorporated into a food base. In some embodiments, a sprinkle preparation may improve aesthetic appearance of a food base. In some embodiments, a sprinkle preparation may retain colorant without loss of color (e.g., leeching) into the food base.
[0215] In some embodiments, a sprinkle preparation of the present disclosure modulates a flavor of a food base to which it is added and / or incorporated. In some embodiments, a sprinkle preparation of the present disclosure is substantially tasteless and does not modulate a flavor of a food base to which it is added and / or incorporated.Methods of Preparation
[0216] The present disclosure additionally provides methods of preparing sprinkle preparations described herein that incorporate a prebiotic dietary fiber, an anti-adherent, a protein, and a binder.
[0217] In some embodiments, a sprinkle preparation of the present disclosure is prepared by: i) mixing dry ingredients, including a prebiotic dietary fiber, an anti-adherent, a protein, and a binder; ii) wet granulating the mixture formed in step (i) to form a granulate; iii) cold extruding the granulate formed in step (ii) to form an extrudate; and iv) drying the extrusion formed in step (iii).
[0218] In some embodiments, the prebiotic dietary fiber is selected from, but not limited to, inulin, multi-functional com fiber, soluble corn fiber, multi-functional oat hull fiber, wheat bran, beta glucans, cellulose, chitin, chitosan, xanthan gum, psyllium, raffinose, resistant polydextrose, pectin, human milk oligosaccharide, or combinations thereof. In someembodiments, the inulin is enzymatically synthesized. In some embodiments, the inulin may originate from one or more of dahlia tuber, chicory root, blue agave, or Jerusalem artichoke.
[0219] In some embodiments, the anti-adherent is selected from, but not limited to, , magnesium stearate, zinc stearate, calcium stearate, magnesium palmitate, zinc palmitate, calcium palmitate, glyceryl monostearate, glyceryl dibehenate, glyceryl monooleate, lecithin, calcium phosphate, magnesium phosphate, calcium carbonate, magnesium carbonate, silicon dioxide, sodium silicate, magnesium silicate, zinc silicates, calcium silicate, monoglycerides of fatty acids, diglycerides of fatty acids, or combinations thereof.
[0220] In some embodiments, the protein is selected from, but not limited to, calcium caseinate (e.g., calcium caseinate Al or calcium caseinate Al), micellar casein (e.g., micellar casein Al or micellar casein A2), pea protein, oat protein com protein, lentil protein, chickpea protein, wheat protein, faba bean protein isolate, gelatin, whey protein isolate, milk protein concentrate, egg protein isolate, soy protein isolate, collagen, albumin, or combinations thereof.
[0221] In some embodiments, the binder is selected from, but not limited to, compressible starch, isomalt, sodium alginate, microcrystalline cellulose, aluminum hydroxide, hydroxypropyl cellulose, ethyl cellulose, lactose, phytosterols, cholesterol, or a combination thereof. In some embodiments, the compressible starch is a directly compressible-grade binder. For example, in some embodiments, a core particle of the present disclosure includes a directly compressible starch, isomalt, sodium alginate, a phytosterol, or a combination thereof.
[0222] In some embodiments, the dry ingredients further include a colorant. In some embodiments, the colorant includes a natural colorant. In some embodiments, the colorant may be selected from, but not limited to, spirulina extract, rutin, quercetin, chlorophyll, curcumin, cyanidin, phloretin, astaxanthin, lutein, zeaxanthin, bixin, norbixin, capsanthin, lycopene, canthaxanthin, carotene, rubixanthin, violaxanthin, rhodoxanthin, citranaxanthin, betalain, betanin, orcein, cobalamin, cyanocobalamin, or a combination thereof. In some embodiments, the carotene includes an alpha, beta, or gamma carotene.Mixing
[0223] In some embodiments, the dry ingredients are mixed at ambient temperature. In some embodiments, the dry ingredients are mixed at a temperature of about 15 degrees to 30 degrees Celsius, about 15 degrees to 25 degrees Celsius, or about 20 to 25 degrees Celsius.
[0224] In some embodiments, the dry ingredients are mixed at a mixing rate of about 30- 40 rotations per minute (rpm), about 30-35 rpm, about 35-40 rpm, about 30 rpm, about 35 rpm, or about 40 rpm.
[0225] In some embodiments, the dry ingredients are mixed for about 1 to 10 minutes, about 1 to 5 minutes, about 1 to 4 minutes, about 1 to 3 minutes, about 1 to 2 minutes, about 2 to 5 minutes, about 2 to 4 minutes, about 2 to 3 minutes, about 3 to 5 minutes, about 4 to 5 minutes, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, or about 5 minutes.
[0226] In some embodiments, dry ingredients are mixed using a Caleva Multi Lab instrument (Caleva Process Solutions Ltd. Dorcet, UK) or similar instrument familiar to persons of skill in the art.Wet Granulating
[0227] In some embodiments, wet granulating includes granulating the dry ingredient mixture from step (i) with water. In some embodiments, the ratio of water to dry ingredient mixture is about 1 to 10 ml of water to 1 to 20 g of dry ingredient mixture. In some embodiments, the ratio is about 2-8 ml of water to 2-18 g of dry ingredient mixture, about 2-6 ml of water to 2-16 g of dry ingredient mixture, about 2-4 ml of water to 2-14 g of dry ingredient mixture, about 3-8 ml of water to 3-18 g of dry ingredient mixture, about 3-6 ml of water to 3-16 g of dry ingredient mixture, about 3-4 ml of water to 3-14 g of dry ingredient mixture, about 4-8 ml of water to 4- 18 g of dry ingredient mixture, or about 4-6 ml of water to about 4- 16 g of dry ingredient mixture. In some embodiments, the ratio is about 3.5 ml of water to 10 g of dry ingredient mixture.
[0228] In some embodiments, wet granulating is temporarily halted if clumping of the granulate occurs. In some embodiments, clumps of the granulate are broken up by spatula before wet granulating is resumed. In some embodiments, wet granulating is performed at about 30-40 rpm, about 30-35 rpm, about 35-40 rpm, about 30 rpm, about 35 rpm, or about 40 rpm.
[0229] In some embodiments, the ratio of water to dry ingredient mixture, the speed of granulating (i.c., rpm), or a combination thereof, is optimized to result in a granulate suitable for cold extrusion. For example, in some embodiments, the granulate is not rubbery, tacky, polydisperse, soft, sticky, brittle, or a combination thereof.Cold Extruding
[0230] In some embodiments, the granulate resulting from step (ii) is cold extruded to form an extrudate. In some embodiments, the granulate from step (ii) is cold extruded using a Caleva Multi Lab instrument (Caleva Process Solutions Ltd. Dorcet, UK) fitted with a single screw extrusion assembly, or similar instrument familiar to persons of skill in the art. In some embodiments, the granulate is extruded through a 1 mm x 1 mm circular die, a 1 mm x 4 mm circular die, a 0.5 mm x 0.5 mm circular die, a 0.5 mm x 1 mm circular die, a 0.5 mm x 4 mm circular die, a 1 mm x 1 mm trilobe die, a 1 mm x 1 mm quadlobe die, a 3mm x 3mm circular die, or a 3mm x 12mm circular die.
[0231] In some embodiments, cold extrusion of a granulate of step (ii) is performed at a rate of about 50 rpm to 150 rpm. In some embodiments, the rate is about 50 rpm to 125 rpm, about 50 rpm to 100 rpm, about 50 to 75 rpm, about 75 rpm to 150 rpm, about 75 rpm to 125 rpm, about 75 rpm to 100 rpm, about 100 rpm to 150 pm, about 100 rpm to 125 rpm, about 125 rpm to 150 rpm, about 50 rpm, about 75 rpm, about 100 rpm, about 125 rpm, or about 150 rpm.
[0232] In some embodiments, cold extruding is performed at a temperature of about 15 degrees to 25 degrees Celsius, about 20 to 25 degrees Celsius, about 20 degrees Celsius, about 21 degrees Celsius, about 22 degrees Celsius, about 23 degrees Celsius, about 24 degrees Celsius, or about 25 degrees Celsius.
[0233] In some embodiments, the choice of extruding die, the speed of cold extrusion (i.e., rpm), the temperature, or a combination thereof, is optimized to result in an extrudate suitable for milling (e.g., blade milling) and / or spheronization. For example, in some embodiments, the extrudate is not rubbery, tacky, polydisperse, soft, sticky, brittle, or a combination thereof.Drying
[0234] In some embodiments, drying of an extrudate formed in step (iii) is performed at a temperature of about 20 degrees Celsius to 80 degrees Celsius. In some embodiments, the drying temperature is about 20 degrees Celsius to 80 degrees Celsius, about 25 degrees Celsius to 80 degrees Celsius, about 30 degrees Celsius to 80 degrees Celsius, about 35 degrees Celsius to 80 degrees Celsius, about 40 degrees Celsius to 80 degrees Celsius, about 45 degrees Celsius to 80 degrees Celsius, about 50 degrees Celsius to 80 degrees Celsius, about 55 degrees Celsius to 80 degrees Celsius, about 60 degrees Celsius to 80 degrees Celsius, about 65 degrees Celsius to 80 degrees Celsius, about 70 degrees Celsius to 80 degrees Celsius, about 75 degrees Celsius to 80 degrees Celsius, about 20 degrees Celsius to 75 degrees Celsius, about 25 degrees Celsius to 75 degrees Celsius, about 30 degrees Celsius to 75 degrees Celsius, about 35 degrees Celsius to 75 degrees Celsius, about 40 degrees Celsius to 75 degrees Celsius, about 45 degrees Celsius to 75 degrees Celsius, about 50 degrees Celsius to 75 degrees Celsius, about 55 degrees Celsius to 75 degrees Celsius, about 60 degrees Celsius to 75 degrees Celsius, about 65 degrees Celsius to 75 degrees Celsius, about 70 degrees Celsius to 75 degrees Celsius, about 20 degrees Celsius to 70 degrees Celsius, about 25 degrees Celsius to 70 degrees Celsius, about 30 degrees Celsius to 70 degrees Celsius, about 35 degrees Celsius to 70 degrees Celsius, about 40 degrees Celsius to 70 degrees Celsius, about 45 degrees Celsius to 70 degrees Celsius, about 50 degrees Celsius to 70 degrees Celsius, about 55 degrees Celsius to 70 degrees Celsius, about 60 degrees Celsius to 70 degrees Celsius, about 65 degrees Celsius to 70 degrees Celsius, about 20 degrees Celsius to 65 degrees Celsius, about 25 degrees Celsius to 65 degrees Celsius, about 30 degrees Celsius to 65 degrees Celsius, about 35 degrees Celsius to 65 degrees Celsius, about 40 degrees Celsius to 65 degrees Celsius, about 45 degrees Celsius to 65 degrees Celsius, about 50 degrees Celsius to 65 degrees Celsius, about 55 degrees Celsius to 65 degrees Celsius, about 60 degrees Celsius to 65 degrees Celsius, about 20 degrees Celsius to 60 degrees Celsius, about 25 degrees Celsius to 60 degrees Celsius, about 30 degrees Celsius to 60 degrees Celsius, about 35 degrees Celsius to 60 degrees Celsius, about 40 degrees Celsius to 60 degrees Celsius, about 45 degrees Celsius to 60 degrees Celsius, about 50 degrees Celsius to 60 degrees Celsius, about 55 degrees Celsius to 60 degrees Celsius, about 20 degrees Celsius to 55 degrees Celsius, about 25 degrees Celsius to 55 degrees Celsius, about 30 degrees Celsius to 55 degrees Celsius, about 35 degrees Celsius to 55 degrees Celsius, about 40 degrees Celsius to 55 degrees Celsius, about 45 degrees Celsiusto 55 degrees Celsius, about 50 degrees Celsius to 55 degrees Celsius, about 20 degrees Celsius to 50 degrees Celsius, about 25 degrees Celsius to 50 degrees Celsius, about 30 degrees Celsius to 50 degrees Celsius, about 35 degrees Celsius to 50 degrees Celsius, about 40 degrees Celsius to 50 degrees Celsius, about 45 degrees Celsius to 50 degrees Celsius, about 20 degrees Celsius to 45 degrees Celsius, about 25 degrees Celsius to 45 degrees Celsius, about 30 degrees Celsius to 45 degrees Celsius, about 35 degrees Celsius to 45 degrees Celsius, about 40 degrees Celsius to 45 degrees Celsius, about 20 degrees Celsius to 40 degrees Celsius, about 25 degrees Celsius to 40 degrees Celsius, about 30 degrees Celsius to 40 degrees Celsius, about 35 degrees Celsius to 40 degrees Celsius, about 20 degrees Celsius to 35 degrees Celsius, about 25 degrees Celsius to 35 degrees Celsius, about 30 degrees Celsius to 35 degrees Celsius, about 20 degrees Celsius to 30 degrees Celsius, about 25 degrees Celsius to 30 degrees Celsius, or about 20 degrees Celsius to 25 degrees Celsius. In some embodiments, step (iv) drying is performed at about 60 °C. In some embodiments, drying is performed at about 20 °C to about 25 °C.
[0235] In some embodiments, drying of an extrudate of step (iii) occurs for a duration of about 1 hour to 5 hours. In some embodiments, the drying occurs for about 1 hour to 4 hours, about 1 hour to 3 hours, about 1 hour to 2 hours, about 2 hours to 5 hours, about 2 hours to 4 hours, about 2 hours to 3 hours, about 3 hours to 5 hours, about 3 hours to 4 hours, about 4 hours to 5 hours, about 1 hour, about 2 hours, about 3 hours, about 4 hours, or about 5 hours.Milling
[0236] In some embodiments, methods of the present disclosure further include the step of milling the dried extrudate resulting from step (iv). In some embodiments, milling includes blade milling, burr milling, hammer milling, planetary milling, ball milling, roller milling, impact milling, jet milling, cryo milling, conical milling, or a combination thereof.
[0237] In some embodiments, methods of the present disclosure further include the step of: (v) blade milling.
[0238] In some embodiments, blade milling a dried extrudate from step (iv) is performed at a rate of about 3500 rpm to 7500 rpm. In some embodiments, the rate is about 3500 rpm to 6500 rpm, about 3500 rpm to 5500 rpm, about 3500 rpm to 4500 rpm, about 4500 rpm to 7500 rpm, about 4500 rpm to 6500 rpm, about 4500 rpm to 5500 rpm, about 5500 rpm to 7500 rpm,about 5500 rpm to 6500 rpm, about 3500 rpm, about 4500 rpm, about 5500 rpm, about 6500 rpm, or about 7500 rpm.Spheronizing
[0239] In some embodiments, methods of the present disclosure further include spheronizing the extrudate resulting from step (iii) before step (iv) drying.
[0240] In some embodiments, spheronizing an extrudate from step (iv) is performed at a rate of about 1500 rpm to about 2500 rpm. In some embodiments, the rate is about 1500 rpm to 2000 rpm, about 2000 rpm to about 2500 rpm, about 1500 rpm, about 200 rpm, or about 2500 rpm.
[0241] In some embodiments, spheronizing is performed for about 1 min to 10 min, about 2 min to 10 min, about 3 min to 10 min, about 4 min to 10 min, about 5 min to 10 min, about 6 min to 10 min, about 7 min to 10 min, about 8 min to 10 min, about 9 min to 10 min, about 1 min, about 2 min, about 3 min, about 4 min, about 5 min, about 6 min, about 7 min, about 8 min, about 9 min, or about 10 min.
[0242] In some embodiments, spheronizing is performed at a temperature of about 15 degrees to 25 degrees Celsius, about 20 to 25 degrees Celsius, about 20 degrees Celsius, about 21 degrees Celsius, about 22 degrees Celsius, about 23 degrees Celsius, about 24 degrees Celsius, or about 25 degrees Celsius.
[0243] In some embodiments, an anti-caking starch may be added to the spheronized extrudate. In some embodiments, about 5% w / w to about 15% w / w (e.g., about 5% w / w to about 15% w / w, about 7.5% w / w to about 15% w / w, about 10% w / w to about 15% w / w, about 12.5% w / w to about 15% w / w, about 5% w / w to about 12.5% w / w, about 7.5% w / w to about 12.5% w / w, about 10% w / w to about 12.5% w / w, about 5% w / w to about 10% w / w, about 7.5% w / w to about 10% w / w, or about 5% w / w to about 7.5% w / w) of anti-caking starch (relative to the mass of the spheronized extrudate) is added to the spheronized extrudate.
[0244] In some embodiments, extrudate is spheronized using a Caleva Multi Lab instrument (Caleva Process Solutions Ltd. Dorcet, UK) or similar instrument familiar to persons of skill in the ait.Fluidized Bed Coating
[0245] In some embodiments, methods of the present disclosure further include the step of: (vi) fluidized bed coating. In some embodiments, fluidized bed coating may be performed on a spheronized extrudate to form a nonpareil (e.g., substantially spherical) sprinkle preparation. In some embodiments, fluidized bed coating may be performed on a blade-milled extrudate to form an elongated (e.g., cylindrical) sprinkle preparation.
[0246] In some embodiments, step (vi) fluidized bed coating includes sequential application of one or more coating layers. In some embodiments, step (vi) fluidized bed coating includes applying a polish, applying a glaze, and applying a sealant, or a combination thereof. In some embodiments, step (vi) fluidized bed coating includes sequentially applying a polish, applying a glaze, and applying a sealant to form a coating on the outer surface of a core particle. In some embodiments, the polish includes Capol® 127C. In some embodiments, the glaze includes Capol® 11-143A. In some embodiments, the sealant includes Capol® 155C. In some embodiments, the polish, the glaze, the sealant, or combination thereof, further includes a colorant (e.g., a natural colorant). In some embodiments, fluidized bed coating is performed to apply a final ratio of Capol® 127C to Capol® 11-143A to Capol® 155C to the final sprinkle preparation of 1:1:1.
[0247] In some embodiments, step (vi) fluidized bed coating is performed to achieve a final % w / w of coating in the sprinkle preparation of about 10% w / w to about 30% w / w (e.g., 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 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 10% w / w to about 20% w / w, about 15% w / w to about 20% w / w, or about 10% w / w to about 15% w / w). For example, in some embodiments, step (vi) fluidized bed coating is performed to achieve a final % w / w of coating in the sprinkle preparation of about 20% w / w.
[0248] In some embodiments, step vi) fluidized bed coating includes the use of an inlet nozzle. In some embodiments, the inlet nozzle is set to a temperature of about 50 degrees Celsius to 70 degrees Celsius. In some embodiments, the temperature is about 50 degrees Celsius, about 60 degrees Celsius, or about 70 degrees Celsius.
[0249] In some embodiments, fluidized bed coating is performed at a rate of about 100 to 200 lines per minute (LPM). In some embodiments, the fluidized bed coating rate is about 100 LPM to 175 LPM, about 100 LPM to 150 LPM, about 100 LPM to 125 LPM, about 125 LPM to200 LPM, about 125 LPM to 175 LPM, about 125 LPM to 150 LPM, about 150 LPM to 200 LPM, about 150 LPM to 175 LPM, about 175 LPM to about 200 LPM, about 100 LPM, about 125 LPM, about 150 LPM, about 175 LPM, or about 200 LPM.
[0250] In some embodiments, fluidized bed coating is performed at an on rate of about 0.5 minutes to 0.7 minutes and an off rate of about 0.3 minutes to 0.5 minutes. For example, in some embodiments, the on rate is about 0.5 minutes, about 0.6 minutes, or about 0.7 minutes and the off rate is about 0.3 minutes, about 0.4 minutes, or about 0.5 minutes. In some embodiments, the on rate is about 0.6 minutes and the off rate is about 0.4 minutes, the on rate is about 0.5 minutes and the off rate is about 0.5 minutes, or the on rate is about 0.7 minutes and the off rate is about 0.3 minutes.
[0251] In some embodiments, fluidized bed coating may be formed using a Freund Vector VFC-Micro fluid bed equipped with a Wurster insert and spray nozzle, or similar instrument familial- to persons of skill in the ail.Pan Coating
[0252] In some embodiments, methods of the present disclosure further include the step of: (vi) pan coating. In some embodiments, pan coating may be performed on a spheronized extrudate to form a nonpareil (e.g., substantially spherical) sprinkle preparation. In some embodiments, pan coating may be performed on a blade-milled extrudate to form an elongated (e.g., cylindrical) sprinkle preparation.
[0253] In some embodiments, step (vi) pan coating includes sequential application of one or more coating layers. In some embodiments, step (vi) pan coating includes applying a polish, applying a glaze, and applying a sealant, or a combination thereof. In some embodiments, step (vi) pan coating includes sequentially applying a polish, applying a glaze, and applying a sealant to form a coating on the outer surface of a core particle. In some embodiments, the polish includes Capol® 127C. In some embodiments, the glaze includes Capol® 11-143A. In some embodiments, the sealant includes Capol® 155C. In some embodiments, the polish, the glaze, the sealant, or combination thereof, further includes a colorant (e.g., a natural colorant). In someembodiments, fluidized bed coating is performed to apply a final ratio of Capol® 127C to Capol® 11-143A to Capol® 155C to the final sprinkle preparation of 1:1:1.
[0254] In some embodiments, step (vi) pan coating is performed to achieve a final % w / w of coating in the sprinkle preparation of about 10% w / w to about 30% w / w (e.g., 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 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 10% w / w to about 20% w / w, about 15% w / w to about 20% w / w, or about 10% w / w to about 15% w / w). For example, in some embodiments, step (vi) pan coating is performed to achieve a final % w / w of coating in the sprinkle preparation of about 20% w / w.
[0255] In some embodiments, step vi) pan coating includes the use of an inlet nozzle. In some embodiments, the inlet nozzle is set to a temperature of about 70 degrees Celsius to 90 degrees Celsius. In some embodiments, the temperature is about 70 degrees Celsius, about 80 degrees Celsius, or about 90 degrees Celsius. In some embodiments, fluidized bed coating is performed at a rate of about 40 to 80 rpm. In some embodiments, the fluidized bed coating rate is about 40 rpm to 70 rpm, about 40 rpm to 60 rpm, about 40 rpm to 50 rpm, about 50 rpm to 80 rpm, about 50 rpm to 70 rpm, about 50 rpm to 60 rpm, about 60 rpm to 80 rpm, about 60 rpm to 70 rpm, about 70 rpm to 80 rpm, about 40 rpm, about 50 rpm, about 60 rpm, about 70 rpm, or about 80 rpm.
[0256] In some embodiments, pan coating is performed at an on rate of about 0.6 minutes to 1.0 minutes and an off rate of about 0.1 minutes to 0.3 minutes. For example, in some embodiments, the on rate is about 0.6 minutes, about 0.7 minutes, about 0.8 minutes, about 0.9 minutes, or about 1.0 minutes, and the off rate is about 0.1 minutes, about 0.2 minutes, or about 0.3 minutes. In some embodiments, the on rate is about 0.8 minutes and the off rate is about 0.2 minutes, or the on rate is about 0.9 minutes and the off rate is about 0.1 minutes.EXAMPLES
[0257] The following examples are provided as illustrations and are not intended to be limiting with respect to any subject matter disclosed herein.Example 1: Exemplary Sprinkle Preparations
[0258] The present example describes the manufacture of certain exemplary sprinkle preparations of the present disclosure including: a prebiotic dietary fiber, an anti-adherent, a protein; and a binder.Nonpareils Sprinkle Preparations
[0259] FIG. 1A and FIG. IB show exemplary uncoated and coated, respectively, nonpareils (i.e., substantially spherical) sprinkle preparations of the present disclosure. To produce these preparations, a dry mixture of 45% w / w inulin, 25% w / w micellar casein, 10% w / w magnesium stearate, 10% w / w StarTab™ directly compressible starch, 5% w / w plant phytosterols, and 5% w / w isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument.
[0260] The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl. Approximately 0.35 mL / g water was added via a blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while the mixture continued to mix / granulate at 35 rpm.
[0261] If clumps appeared, wet granulating was temporarily halted, and material was manually broken up with a spatula before resuming wet granulating. Once the entirety of wetting agent was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl.
[0262] Following wet granulation, the Caleva Multi Lab instrument was fitted with an extrusion assembly, including a 1 mm by 1 mm circular extrusion die. The single screw extruder of the instrument was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min.
[0263] Extrudate (e.g., in the form of noodles) was collected and placed inside a spheronizing chamber of the Caleva instrument. For extrudate noodles that adhered to one another, individual noodles were manually separated and placed in the spheronizing chamber. Once all the extrudate was placed inside the chamber, the instrument was secured and the spheronizing disc was set to 2000 rpm. The extrudate was spheronized for 3-10 minutes atambient conditions. The instrument was briefly halted to break up noodle clumps at the beginning of the spheronization process, as necessary. When uniform spherical pellets were observed by visual inspection, an amount of Dry Flo anti-caking starch (Ingredion Inc, Westchester, IL), approximately equal to 10% w / w of the spheronized extrudate mass, was added to the spheronization chamber through the port located atop the chamber while the disc continued to spin. After allowing 3-5 seconds for the spherical pellets to become coated with the anti-caking starch, the spheronizing disc was shut off and the spheronizing chamber was opened.
[0264] The spheronized extrudate was collected and dried for 3h in a drying oven set to 60-65 °C. Dried, spheronized extrudate (FIG. 1A) was collected in sealed sachets with desiccant.
[0265] For coated sprinkle preparations (FIG. IB) three separate coatings were prepared for sequential application. Coating A, a polishing solution, was prepared by mixing 47 mL water, 10 g Capol® 127C (Capol LLC, Chicago, IL), and 200 mg spirulina extract at room temperature. Coating B, a glaze solution, was prepared by mixing 32 mL of pure ethanol, 47 mL of water, and 5 g Capol® 11-143A at room temperature. Coating C, a sealant solution, was prepared by mixing 5 g Capol® 155C with 25 mL of pure ethanol at room temperature. A Freund Vector VFC-Micro fluid bed equipped with a Wurster insert and spray nozzle was preheated to approximately 20-30 °C. Dried, spheronized extrudate was added to the instrument and airflow, set at 150 L / min, was fluidized prior to spraying. The spray nozzle air was initiated and each coating solution was metered in using a peristaltic pump set to on / off of 0.6 / 0.4. The coated material was fluidized for an additional 10-60 minutes to ensure complete drying or curing. Coated sprinkle preparations (FIG. IB) were collected and sealed in sachets with desiccant.Elongated Sprinkle Preparations
[0266] FIG. 1C and FIG. ID show exemplary uncoated and coated, respectively, elongated (i.e., substantially cylindrical) sprinkle preparations of the present disclosure. To produce these preparations, a dry mixture of 60% w / w inulin, 25% w / w calcium caseinate, 10% w / w magnesium stearate, and 5% w / w isomalt (for the preparations shown in FIG. 1C) or 60% w / w inulin, 20% w / w pea protein isolate, 8% w / w magnesium stearate, 5% w / w sodium alginate, 5% w / w isomalt, and 2% w / w spirulina extract (for the preparations shown in FIG. ID) wasadded to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument. The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of wetting agent (e.g., water).
[0267] Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl. Approximately 0.35 mL / g water was added via a blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while the mixture continued to mix / granulate at 35 rpm.
[0268] If clumps appeared, wet granulating was temporarily halted, and material was manually broken up with a spatula before resuming wet granulating. Once the entirety of wetting agent was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl.
[0269] Following wet granulation, the Caleva Multi Lab instrument was fitted with an extrusion assembly, including a 1 mm by 4 mm circular extrusion die. The single screw extruder of the instrument was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min.
[0270] Extrudate (e.g., in the form of noodles) was collected and set aside for drying. Cold extrudate noodles were collected in an oven- safe container and dried in an oven for 3 hours at 60-65 °C. Dried extrudate noodles were transferred to a blade mill and milled at 5500 rpm for 1-10 seconds at ambient conditions until milled particles were approximately 2-8 mm in length and 1 mm in diameter. Milled, dried, extrudate was collected and sealed with desiccant sachets.Internally Colored Elongated Sprinkle Preparations
[0271] FIG. 4 shows a manufacturing flow chart for the preparation of an exemplary internally-colored elongated (i.e., substantially cylindrical) sprinkle preparation of the present disclosure. To produce this preparation, a dry mixture of 60% w / w inulin, 20% w / w pea protein isolate, 8% w / w magnesium stearate, 5% w / w sodium alginate, 5% w / w isomalt, and 2% w / w spirulina extract were added to the mixing bowl (401, 402) of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument. The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl (403). Approximately 0.35 mL / g water was added via blunt needle syringe directly to the mixing bowl at rate of 2 mL / min while continuing to granulate at 35 rpm. If clumps appeared, wet-granulating was temporarily halted, and granulated clumps were broken up manually with a spatula before resuming granulating. Once the entirety of water was added and the mixture became a cohesive blend of granular texture, the material is removed from the mixing bowl. Following wet granulation, the Caleva Multi Lab instrument was fitted with an extrusion assembly (404), including 1 mm by 1 mm circular extrusion die. The single screw extruder was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min. Extrudate (e.g., in the form of noodles) was collected and set aside for drying. Cold extrudate noodles were collected in an oven-safe container and dried (405) in air at 20-25 °C for 3 hours. Following drying, dry extrudate (e.g., dried extrudate noodles) was transferred to a blade mill (406) and milled at 5500 rpm for 1-10 seconds at ambient conditions until milled extrudate was approximately 2-8 mm in length and 1 mm in diameter. The milled extrudate (407) was collected and sealed in sachets with desiccant.Internally Colored Nonpareil Sprinkle Preparations
[0272] FIG. 5 shows a manufacturing flow chart for the preparation of an exemplary internally-colored nonpareil (i.e., substantially spherical) sprinkle preparation of the present disclosure. To produce this preparation, a dry mixture of 45% w / w inulin, 25% w / w micellar casein, 10% w / w magnesium stearate, 5-10% w / w StarTab™ directly compressible starch, 1-5% w / w plant phytosterols, 1-5% w / w isomalt and 1-5% w / w coloring agent (e.g., lutein) was added to the mixing bowl (501, 502) of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument. The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl (503). Approximately 0.35 mL / g of water was added via blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while continuing to granulate at 35 rpm. If clumps appeared, granulating was temporarily halted, and clumped granulate was broken up manually with a spatula before resuming granulating. Once the entirety of water was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl. Following wet granulation, the Caleva Multi Lab instrument was fitted with extrusion assembly (504), including a 1 mm by 1 mm circular extrusion die. The single screw extruder was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min.
[0273] Extrudate (e.g., in the form of noodles) was collected and placed inside a sphcronizing chamber of the Calcva instrument. For extrudate noodles that adhered to one another, individual noodles were manually separated and placed in the sphcronizing chamber. Once all the extrudate was placed inside the chamber, the instrument was secured and the spheronizing disc was set to 2000 rpm (505). The extrudate was spheronized for 3-10 minutes at ambient conditions. The instrument was briefly halted to break up noodle clumps at the beginning of the spheronization process, as necessary. When uniform spherical pellets were observed by visual inspection, an amount of Dry Flo anti-caking starch (Ingredion Inc, Westchester, IL), approximately equal to 10% w / w of the spheronized extrudate mass, was added to the spheronization chamber through the port located atop the chamber while the disc continued to spin. After allowing 3-5 seconds for the spherical pellets to become coated with the anti-caking starch, the spheronizing disc was shut off and the spheronizing chamber was opened.
[0274] The spheronized extrudate was collected and dried at room temperature for 3 hours at 25 °C (506). Dried, spheronized extrudate (507) was collected in sealed sachets with desiccant.Fluidized Bed Coated Elongated Sprinkle Preparations
[0275] FIG. 6 shows a manufacturing flow chart for the preparation of an exemplary fluidized bed coated elongated (i.e., substantially cylindrical) sprinkle preparation of the present disclosure. To produce this preparation, a dry mixture of 60% w / w inulin, 25% w / w calcium caseinate, 10% w / w magnesium stearate, and 5% w / w isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument (601).
[0276] The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl (602). Approximately 0.35 mL / g water was added via a blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while the mixture continued to mix / granulate at 35 rpm.
[0277] If clumps appeared, wet granulating was temporarily halted, and material was manually broken up with a spatula before resuming wet granulating. Once the entirety ofwetting agent was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl.
[0278] Following wet granulation, the Caleva Multi Lab instrument was fitted with an extrusion assembly, including a 1 mm by 4 mm circular extrusion die (603). The single screw extruder of the instrument was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min.
[0279] Extrudate (e.g., in the form of noodles) was collected and set aside for drying. Cold extrudate noodles were collected in an oven-safe container and dried in an oven for 3 hours at 60-65 °C (604). Dried extrudate noodles were transferred to a blade mill and milled at 5500 rpm for 1-10 seconds at ambient conditions until milled particles were approximately 2-8 mm in length and 1 mm in diameter (605).
[0280] Milled extrudate was then coated using a fluidized bed coater (606). Three separate coatings were prepared. Coating A, a polishing solution, was prepared by mixing 32 mL pure ethanol, 47 mL water, 5 g Capol® 127C (Capol LLC, Chicago, IL), and 50 mg cyanidin chloride for color, at room temperature. Coating B, a glaze solution, was prepared by mixing 32 mL of pure ethanol, 47 mL of water, 5 g Capol® 11-143 A and 50 mg cyanidin chloride for color, at room temperature. Coating C, a sealant solution, was prepared by mixing 5 g Capol® 155C with 30 mL pure ethanol at room temperature. A Freund Vector VFC-Micro fluid bed equipped with a Wurster insert and spray nozzle was preheated to approximately 30-60 °C. Milled extrudate was then added and airflow, set at 150 L / min, was started prior to spraying. The spray nozzle air was initiated and each coating solution was metered in using a peristaltic pump set to on / off of 0.6 / 0.4. The coated material was fluidized for an additional 10-60 minutes to ensure complete drying or curing. Coated sprinkle preparations (607) were collected and sealed in sachets with desiccant.Fluidized Bed Coated Nonpareil Sprinkle Preparations
[0281] FIG. 7 shows a manufacturing flow chart for the preparation of an exemplary fluidized bed coated nonpareil (i.e., substantially spherical) sprinkle preparation of the present disclosure. To produce this preparation, a dry mixture of 45% (w / w) inulin, 25% (w / w) micellar casein, 10% (w / w) magnesium stearate, 10% (w / w) StarTab™ directly compressible starch, 5%(w / w) plant phytosterols, and 5% (w / w) isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument (701).
[0282] The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl (702). Approximately 0.35 mL / g of water was added via blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while continuing to granulate at 35 rpm. If clumps appeared, granulating was temporarily halted, and clumped granulate was broken up manually with a spatula before resuming granulating. Once the entirety of water was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl. Following wet granulation, the Caleva Multi Lab instrument was fitted with extrusion assembly (703), including a 1 mm by 1 mm circular extrusion die. The single screw extruder was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min.
[0283] Extrudate (e.g., in the form of noodles) was collected and placed inside a spheronizing chamber of the Caleva instrument. For extrudate noodles that adhered to one another, individual noodles were manually separated and placed in the spheronizing chamber. Once all the extrudate was placed inside the chamber, the instrument was secured and the spheronizing disc was set to 2000 rpm (704). The extrudate was spheronized for 3-10 minutes at ambient conditions. The instrument was briefly halted to break up noodle clumps at the beginning of the spheronization process, as necessary. When uniform spherical pellets were observed by visual inspection, an amount of Dry Flo anti-caking starch (Ingredion Inc, Westchester, IL), approximately equal to 10% w / w of the spheronized extrudate mass, was added to the spheronization chamber through the port located atop the chamber while the disc continued to spin. After allowing 3-5 seconds for the spherical pellets to become coated with the anti-caking starch, the spheronizing disc was shut off and the spheronizing chamber was opened.
[0284] Spheronized extrudate was dried for 3 hours in an oven set to 60 to 65 °C (705). Dried, spheronized extrudate was then coated using a fluidized bed coater (706). Three separate coatings were prepared. Coating A, a polishing solution, was prepared by mixing 32 mL pure ethanol, 47 mL water, 5 g Capol® 127C (Capol LLC, Chicago, IL), and 50 mg of polyphenol for color, at room temperature. Coating B, a glaze solution, was prepared by mixing 32 mL of pureethanol, 47 mL of water, 5 g Capol® 11- 143 A and 50 mg of polyphenol for color, at room temperature. Coating C, a sealant solution, was prepared by mixing 5 g Capol® 155C with 30 mL pure ethanol at room temperature. A Freund Vector VFC-Micro fluid bed equipped with a Wurster insert and spray nozzle was preheated to approximately 30-60 °C. Milled extrudate was then added and airflow, set at 150 L / min, was started prior to spraying. The spray nozzle air was initiated and each coating solution was metered in using a peristaltic pump set to on / off of 0.6 / 0.4. The coated material was fluidized for an additional 10-60 minutes to ensure complete drying or curing. Coated sprinkle preparations (707) were collected and sealed in sachets with desiccant.Pan Coated Elongated Sprinkle Preparations
[0285] FIG. 8 shows a manufacturing flow chart for the preparation of an exemplary pan coated elongated (i.e., substantially cylindrical) sprinkle preparation of the present disclosure.To produce this preparation, a dry mixture of 60% w / w inulin, 25% w / w calcium caseinate, 10% w / w magnesium stearate, and 5% w / w isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument (801).
[0286] The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl (802). Approximately 0.35 mL / g water was added via a blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while the mixture continued to mix / granulate at 35 rpm.
[0287] If clumps appeared, wet granulating was temporarily halted, and material was manually broken up with a spatula before resuming wet granulating. Once the entirety of wetting agent was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl.
[0288] Following wet granulation, the Caleva Multi Lab instrument was fitted with an extrusion assembly, including a 1 mm by 4 mm circular extrusion die (803). The single screw extruder of the instrument was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min.
[0289] Extrudate (e.g., in the form of noodles) was collected and set aside for drying. Cold extrudate noodles were collected in an oven- safe container and dried in an oven for 3 hours at 60-65 °C (804). Dried extrudate noodles were transferred to a blade mill and milled at 5500rpm for 1 -10 seconds at ambient conditions until milled particles were approximately 2-8 mm in length and 1 mm in diameter (805).
[0290] Milled extrudate was then coated using a pan coating instrument (806). Three separate coatings were prepared. Coating A, a polishing solution, was prepared by mixing 32 mL pure ethanol, 47 mL water, 5 g Capol® 127C (Capol LLC, Chicago, IL), and 50 mg cyanidin chloride for color, at room temperature. Coating B, a glaze solution, was prepared by mixing 32 mL of pure ethanol, 47 mL of water, 5 g Capol® 11-143A and 50 mg cyanidin chloride for color, at room temperature. Coating C, a sealant solution, was prepared by mixing 5 g Capol® 155C with 30 mL pure ethanol at room temperature. A KitchenAid™ stand mixer (KitchenAid, Benton Harbor, MI) was set up in the upright position and a large double mixing bowl, with approximate 16-inch diameter cut to mimic a commercial drum-style pan coater, was affixed to the stand mixer. The milled extrudate was placed inside the mixing bowl and a heat gun was mounted to a benchtop stand and held in position 12 inches off the table, pointed toward the inside of the mixing bowl. The KitchenAid mixer was turned on and set to mixing speed number “4”. The mixing bowl rotated counterclockwise at approximately 100 rpm. The heat gun was adjusted to an outlet temperature of 65 °C and switched on. The first Coating A was applied in intervals every 1-3 minutes, to achieve a total coating mass of 1-10% (w / w) of preparation. In the event of clumping, the heat gun and mixer were switched off clumps were broken up manually with a spatula. Preparation was allowed to dry for an additional 10-15 minutes under applied heat while the mixer continued to rotate. Following drying, the application of the next Coating B was initiated, followed by Coating C. Once each sequential coating had been applied and dried, the pan coated elongated sprinkle preparation (807) was collected and sealed within sachets including desiccant.Pan Coated Nonpareil Sprinkle Preparations
[0291] FIG. 9 shows a manufacturing flow chart for the preparation of an exemplary pan coated nonpareil (i.e., substantially spherical) sprinkle preparation of the present disclosure. To produce this preparation, a dry mixture of 45% (w / w) inulin, 25% (w / w) micellar casein, 10% (w / w) magnesium stearate, 10% (w / w) StarTab™ directly compressible starch, 5% (w / w) plantphytosterols, and 5% (w / w) isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument (901).
[0292] The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl (902). Approximately 0.35 mL / g of water was added via blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while continuing to granulate at 35 rpm. If clumps appeared, granulating was temporarily halted, and clumped granulate was broken up manually with a spatula before resuming granulating. Once the entirety of water was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl. Following wet granulation, the Caleva Multi Lab instrument was fitted with extrusion assembly (903), including a 1 mm by 1 mm circular extrusion die. The single screw extruder was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min.
[0293] Extrudate (e.g., in the form of noodles) was collected and placed inside a spheronizing chamber of the Caleva instrument. For extrudate noodles that adhered to one another, individual noodles were manually separated and placed in the spheronizing chamber. Once all the extrudate was placed inside the chamber, the instrument was secured and the spheronizing disc was set to 2000 rpm (904). The extrudate was spheronized for 3-10 minutes at ambient conditions. The instrument was briefly halted to break up noodle clumps at the beginning of the spheronization process, as necessary. When uniform spherical pellets were observed by visual inspection, an amount of Dry Flo anti-caking starch (Ingredion Inc, Westchester, IL), approximately equal to 10% w / w of the spheronized extrudate mass, was added to the spheronization chamber through the port located atop the chamber while the disc continued to spin. After allowing 3-5 seconds for the spherical pellets to become coated with the anti-caking starch, the spheronizing disc was shut off and the spheronizing chamber was opened.
[0294] Spheronized extrudate was collected and dried in an oven for 3 hours at 60-65 °C(905).
[0295] Dried, spheronized extrudate was then coated using a pan coating instrument(906). Three separate coatings were prepared. Coating A, a polishing solution, was prepared by mixing 32 mL pure ethanol, 47 mL water, 5 g Capol® 127C (Capol LLC, Chicago, IL), and 50mg polyphenol for color, at room temperature. Coating B, a glaze solution, was prepared by mixing 32 mL of pure ethanol, 47 mL of water, 5 g Capol® 11-143A and 50 mg polyphenol for color, at room temperature. Coating C, a sealant solution, was prepared by mixing 5 g Capol® 155C with 30 mL pure ethanol at room temperature. A KitchenAid® stand mixer (KitchenAid®, Benton Harbor, MI) was set up in the upright position and a large double mixing bowl, with approximate 16-inch diameter cut to mimic a commercial drum-style pan coater, was affixed to the stand mixer. The milled extrudate was placed inside the mixing bowl and a heat gun was mounted to a benchtop stand and held in position 12 inches off the table, pointed toward the inside of the mixing bowl. The KitchenAid® mixer was turned on and set to mixing speed number “4”. The mixing bowl rotated counterclockwise at approximately 100 rpm. The heat gun was adjusted to an outlet temperature of 65 °C and switched on. The first Coating A was applied in intervals every 1-3 minutes, to achieve a total coating mass of 1-10% (w / w) of preparation. In the event of clumping, the heat gun and mixer were switched off clumps were broken up manually with a spatula. Preparation was allowed to dry for an additional 10-15 minutes under applied heat while the mixer continued to rotate. Following drying, the application of the next Coating B was initiated, followed by Coating C. Once each sequential coating had been applied and dried, the pan coated elongated sprinkle preparation was collected and sealed within sachets including desiccant.Characterizing Exemplary Sprinkle Preparations
[0296] FIG. 10A and corresponding measurements in TABLE 1, show the dimensions (as described in FIG. 10B) of conventional commercial sprinkles (Betty Crocker® Elongated and Betty Crocker® Nonpareil) and exemplary sprinkle preparations of the present disclosure (Prep.1, Blue Elongated; Prep. 2 Yellow Elongated; and Prep. 3 Yellow Nonpareil) as measured by an electronic caliper. Each bar represents the average, + / - standard deviation of 3 individually measured sprinkles.TABLE 1: Dimensions of Exemplary Sprinkle Preparations.
[0297] FIG. 11A and corresponding measurements in TABLE 2, show the densities of conventional commercial sprinkles (Betty Crocker® Elongated and Betty Crocker® Nonpareil) and exemplary sprinkle preparations of the present disclosure (Prep. 1, Blue Elongated; Prep. 2 Yellow Elongated; and Prep. 3 Yellow Nonpareil). Each bar represents the average, + / - standard deviation of 3 individually measured sprinkle preparations. Sprinkle preparations using a larger die diameter exhibited an average density of -0.81 g / mL, while sprinkle preparations prepared using a smaller die diameter exhibited an average density of -1.04 g / mL. When added to a beverage, both sprinkle preparations remained suspended on the surface initially (e.g., at elapsed time of 0 minutes) (FIG. 4B), however, upon standing for 5 minutes (FIG. 4C), the sprinkle preparations having a greater density sank to the bottom of the beverage.TABLE 2: Densities of Exemplary Sprinkle Preparations.
[0298] FIG. 12 and corresponding measurements in TABLE 3, show the moisture content of conventional commercial sprinkles (Betty Crocker® Elongated and Betty Crocker® Nonpareil) and exemplary sprinkle preparations of the present disclosure (Prep. 1, Blue Elongated; Prep. 2 Yellow Elongated; and Prep. 3 Yellow Nonpareil) as measured using a Mettler Toledo HE53 Moisture Analyzer. Each bar represents the average, + / - standard deviation of 3 individually measured sprinkle preparations.TABLE 3: Moisture Content of Exemplary Sprinkle Preparations.
[0299] FIGs. 13A-13C are 4X magnification microscopic images of commercial (BettyCrocker® sprinkles: Yellow Nonpareil (FIG. 13A), Blue Nonpareil (FIG. 13B), and BlueElongated (FIG. 13C)) and exemplary sprinkle preparations of the present disclosure: yellow nonpareil (FIG. 13D), blue nonpareils (FIG. 13E, FIG. 13F), blue elongated (FIG. 13G), purple elongated (FIG. 13H), and yellow elongated (FIG. 131, FIG. 13J).
[0300] FIG. 14A shows an illustration of a method for testing the hardness of exemplary sprinkle preparations of the present disclosure using a Shore durometer. An exemplary sprinkle preparation is indented with the durometer which applies a known force (having a known geometry) over a 15 second period. The indentation depth is correlated to the hardness of the exemplary sprinkle preparation. FIG. 14B shows an illustration of an alternative method for testing the hardness of exemplary sprinkle preparations of the present disclosure using a texture analyzer. The analyzer measure the compression force required to form a first fracture of a sprinkle preparation of the present disclosure.Example 2: Exemplary Sprinkle Preparation Optimization
[0301] The present example describes component and process optimization for the manufacture of certain exemplary sprinkle preparations of the present disclosure.Protein Optimization
[0302] For the granulates and extrudates shown in FIGs. 2A-2C, a dry aliquot of 10 grams of 100% w / w micellar casein was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument and granulated, cold extruded, and dried using similar methods as previously described for Example 1: Elongated Sprinkle Preparations.
[0303] As shown in FIGs. 2A-2C, granulates and extrudates including 100% w / w casein were rubbery and dense. These extrudates were not a suitable texture for subsequent spheronization and / or milling.
[0304] For the granulates, extrudates, and spheronized extrudates shown in FIGs. 2D-2F, A dry mixture of 10 grams of 10% w / w micellar casein, 20% w / w magnesium stearate, 10% w / w isomalt, and 60% w / w inulin was added to the mixing bowl of a Caleva Multi Lab (CalevaProcess Solutions Ltd, Dorset, UK) instrument and granulated, cold extruded, and spheronized using similar methods as previously described for Example 1 : Nonpareils Sprinkle Preparations.
[0305] As shown in FIGs. 2D and FIG. 2E, granulates and extrudates including 10% w / w casein resulted in sticky / tacky spheronized extrudate that were soft and had inconsistent diameters (FIG. 2F).
[0306] For the granulates and extrudates shown in FIG. 2G and FIG. 2H, a dry mixture of 80% w / w inulin, 10% w / w magnesium stearate, and 10% w / w isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument and granulated, cold extruded, and dried using similar methods as previously described for Example 1: Nonpareils Sprinkle Preparations.
[0307] As shown in FIG. 2G and FIG. 2H, granulates and extrudates including 0% w / w protein were very stick / tacky and were not a suitable texture for subsequent spheronization or milling.Anti-Adherent and Binder Optimization
[0308] For the granulates and extrudates shown in FIG. 21 and FIG. 2J, a dry mixture of 75% w / w inulin and 25% w / w magnesium stearate was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument and granulated, cold extruded, and dried using similar methods as previously described for Example 1: Nonpareils Sprinkle Preparations.
[0309] As shown in FIG. 21 and FIG. 2J, granulates and extrudates including an excess of anti-adherent and prebiotic dietary fiber were very brittle extrudate that was very tacky and flaky. These extrudates were not a suitable texture for subsequent spheronization and / or milling.
[0310] For the granulates and extrudates shown in FIG. 2K and FIG. 2L, a dry mixture of 90% w / w micellar casein, 8% w / w inulin, 1% w / w magnesium stearate, and 1% w / w isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument and granulated, cold extruded, and dried using similar methods as previously described for Example 1: Nonpareils Sprinkle Preparations.
[0311] As shown in FIG. 2K and FIG. 2L, granulates and extrudates incorporating 90% w / w micellar casein, 8% w / w inulin, 1% w / w magnesium stearate, and 1% w / w isomalt werevery rubbery and sticky. These extrudates had a rippled texture and were not suitable for subsequent sphcronization.
[0312] For the granulate shown in FIG. 2M, a dry mixture of 75% w / w inulin and 25% w / w isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument and granulated using similar methods as previously described for Example 1: Nonpareils Sprinkle Preparations.
[0313] As shown in FIG. 2M, the dry ingredients immediately became solubilized by the addition of wetting agent (e.g., water) and resulted in a sticky, viscous granulate that was unsuitable for subsequent processing.Prebiotic Dietary Fiber Optimization
[0314] For the granulate shown in FIG. 2N, an aliquot of 100% w / w inulin was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument and granulated using similar methods as previously described for Example 1 : Nonpareils Sprinkle Preparations.
[0315] As shown in FIG. 2N, the dry ingredients immediately became solubilized by the addition of wetting agent (e.g., water) and resulted in a sticky, viscous granulate that was unsuitable for subsequent processing.Wetting Agent Optimization
[0316] For the granulates shown in FIG. 3, panel A, and FIG. 3, panel B, a mixture of dry ingredients including 60% w / w inulin, 25% w / w micellar casein, 10% w / w magnesium stearate and 5% w / w isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK). The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl. Approximately 0.15 mL / g water (FIG. 3, panel A) or 0.5 mL / g water (FIG. 3, panel B) was added via a blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while the mixture continued to mix / granulate at 35 rpm.
[0317] As shown in FIG. 3, panel A, adding too little wetting agent (e.g., 0.15 mL / g) during the wet granulation step resulted in a dry, powdery granulate that was unsuitable forfurther processing, whereas adding too much wetting agent (e.g., 0.5 mL / g) resulted in a viscous, sticky formulation that may be too soft for extrusion (FIG. 3, panel B).Wet Granulating Speed Optimization
[0318] For the granulates shown in FIG. 3, panel C, and FIG. 3, panel E, a mixture of dry ingredients including 60% w / w inulin, 25% w / w micellar casein, 10% w / w magnesium stearate and 5% w / w isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK). The dry ingredients were mixed at 5 rpm (FIG. 3, panel C) or 75 rpm (FIG. 3, panel E) in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl. Approximately 0.35 mL / g water was added via a blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while the mixture continued to mix / granulate at 5 rpm (FIG. 3, panel C) or 75 rpm (FIG. 3, panel E).
[0319] When the granulation speed was set too low (e.g., 5 RPM), there is not enough sheer to effectively mix the ingredients with the wetting agent, resulting in a heterogenous granulate (FIG. 3, panel C, and FIG. 3, panel D). Similarly, when the granulation speed being was set too high (e.g., 75 RPM), the resulting granulate (FIG. 3, panel E) was heterogenous due to the centrifugal forces holding the formulation together during mixing and preventing adequate mingling amongst all the components following the addition of wetting agent.Extrusion Optimization
[0320] For the granulates shown in FIG. 3, panel F, and FIG. 3, panel G, a mixture of dry ingredients including 60% w / w inulin, 25% w / w micellar casein, 10% w / w magnesium stearate and 5% w / w isomalt was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK). The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl. Approximately 0.35 mL / g water was added via a blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while the mixture continued to mix / granulate at 35 rpm.
[0321] If clumps appeared, wet granulating was temporarily halted, and material was manually broken up with a spatula before resuming wet granulating. Once the entirety ofwetting agent was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl. Following wet granulation, the Calcva Multi Lab instrument was fitted with an extrusion assembly, including a 1 mm by 1 mm circular extrusion die.
[0322] As shown in FIG. 3, panel F, when the single screw extruder was set to 25 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min, the resulting extrudate had a rippled texture and the extruded noodles were more likely to stick to one another. Furthermore, the processing time required for slow extrusion speeds limited output.
[0323] As shown in FIG. 3, panel G, when the single screw extruder was set to 150 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 5 g / min, the resulting extrudate lacked form and rigidity. This extrudate tended to fold over itself and clump making subsequent processing (e.g., milling and / or spheronization) difficult.Example 3: Incorporation of Exemplary Sprinkle Preparations into Food Bases
[0324] The present example describes the incorporation of exemplary sprinkle preparations of the present disclosure in various food bases.
[0325] FIG. 15A and FIG. 15B are images showing exemplary sprinkle preparation of the present disclosure incorporating 20% w / w oat protein and 2% w / w spirulina extract (FIG. 15A) or 20% w / w pea protein and 2% w / w spirulina extract (FIG. 15B) added to Ben and Jerry’s® vanilla bean ice cream.
[0326] FIG. 16A shows an image of plain Chobani® vanilla blended Greek yogurt and yogurt fortified with an exemplary sprinkle preparation of the present disclosure incorporating 60% w / w inulin (FIG. 16B). 1.14g of exemplary sprinkle preparation was added to 12g of yogurt (pH 4.4) to increase the amount of dietary fiber per serving by 10g. Following 15 minutes of incorporating in yogurt, with occasional stirring, the exemplary sprinkle preparation appeared to maintain structure with little to no color leaching.
[0327] FIG. 17A and FIG. 17C show images of conventional commercial sprinkles (FIG. 17A, Betty Crocker® Elongated; and FIG. 17C Betty Crocker® Nonpareil). As shown in FIG. 17B (elongated) and FIG. 17D (nonpareil), exemplary sprinkle preparation of the presentdisclosure are pastel in coloring and are comparable in size, shape and uniformity to conventional commercial sprinkles.
[0328] FIG. 18A, FIG. 18B, and FIG. 18C, show images of exemplary sprinkle preparations of the present disclosure. FIG. 18A shows a mixed color product of exemplary sprinkle preparations of the present disclosure. FIG. 18B shows a yellow-colored product of an exemplary sprinkle preparation of the present disclosure incorporating <1% w / w rutin and quercitin natural colorants. FIG. 18C shows a blue-colored product of an exemplary sprinkle preparation of the present disclosure incorporating <1% w / w spirulina extract natural colorant.
[0329] FIG. 19A and FIG. 19B show images of exemplary elongated (FIG. 19A) and nonpareil (FIG. 19B) sprinkle preparations of the present disclosure incorporating inulin and colored with polyphenol added to Ben and Jerry’s® vanilla bean ice cream. Addition of exemplary sprinkles of the present disclosure increased dietary fiber content of the serving by 14g. FIG. 19C (elongated) and FIG. 19D (nonpareil) show images of corresponding conventional Betty Crocker® commercial sprinkles. Exemplary sprinkle preparations of the present disclosure appeared to maintain structure with little to no color leaching into the food base.Example 4: Exemplary Preparations Including Functional Payloads
[0330] The present example describes exemplary preparations of the present disclosure including various functional payloads.Vitamin Bl 2 Preparations
[0331] As shown in the flow diagram of FIG. 20A, a dry mixture of 70% (w / w) basic methacrylic copolymer, 20% (w / w) sucrose palmitate, 9.9% (w / w) calcium phosphate and 0.1% (w / w) vitamin B12 were blended together via blade milling at 5500 rpm for 30 seconds until a homogenous, consistent texture and color (e.g., bright pink) was achieved. The combined dry ingredients were fed into a Thermo Fisher Scientific (USA) Mini Lab 3 hot melt extruder with twin screws operating at 30 rpm and 50 °C inlet and outlet temperatures. Approximately 0.5 g / min of material was fed into the feed chamber resulting in a bright magenta extrudate. Following extrusion, the extrudate was promptly cooled at 25 °C for a minimum of 5 minutes then blade milled at 5500 rpm for 2-5 minutes until consistent pink particles were formed.0.05% (w / w) of vitamin Bl 2 particles were then combined with 45% (w / w) inulin, 20% (w / w) oat protein, 15% (w / w) micellar casein, 5% (w / w) magnesium stearate, 5% (w / w) compressible starch, and 5% (w / w) sodium alginate. The dry ingredients were measured into and combined in a mixing bowl of a Caleva Multi Lab instrument fitted with a wet granulation attachment at 35 rpm for 2 minutes. Wet granulation was then performed using 0.35 mL wetting agent (water) per gram of material for approximately 5 minutes until a homogenous, granular material was formed and withdrawn from the mixing bowl. The granulated material was cold extruded using an extrusion attachment at 100 rpm through a 1 mm by 4 mm circular cast die, feeding material at a rate of 1 g / min. The extrudate was collected and dried in drying oven at 65 °C for a minimum 3 hours before shaping using a blade mill operating at 5500 rpm for 1-3 seconds to form elongated shapes (shown macroscopically in FIG. 20B, microscopically in FIG. 20C, and added to Breyer’s natural vanilla ice cream in FIG. 20D).
[0332] A resulting vitamin B12 preparation comprised 45% (w / w) inulin, 20% (w / w) oat protein, 15% (w / w) micellar casein, 5% (w / w) magnesium stearate, 5% (w / w) compressible starch, 5% (w / w) sodium alginate, 3.5% (w / w) basic methacrylic copolymer, 1% (w / w) sucrose palmitate, 0.495% (w / w) calcium carbonate, and 0.005% (w / w) vitamin B12.
[0333] To characterize the vitamin B12 release profile of an exemplary preparation in neutral buffer (e.g., phosphate buffered saline), 600 mg of unformulated vitamin B 12 (1% (w / w) vitamin B12 final), 1500 mg of formulated vitamin B12 (0.4% w / w vitamin B12 final), or 3000 mg of exemplary vitamin B12 preparation (0.2% (w / w) vitamin B12 final; “Meal Booster B 12”) were added to 12 mL of phosphate buffered saline (pH 7.4) prewarmed to 37 °C. 200 pL sample aliquots were collected at 0, 15, 30, 60, 225, 285, and 345 minutes following initial dosing and centrifuged to remove particulate matter. The supernatant was transferred to a clear 96-well polystyrene plate for spectrophotometric analysis using a wavelength of 361 nm. Percent release was calculated as the ratio of calculated concentration of vitamin B12 relative to the initially dosed concentration of vitamin B 12. Error bars were calculated as standard deviation of 3 independent experiments.
[0334] As shown in FIG. 20E, exemplary vitamin B12 formulation (“Meal Booster B12”) was characterized as having lower, sustained release of vitamin B12 into neutral aqueous solution (e.g., phosphate buffered saline) relative to unformulated Bl 2. As compared to vitaminBl 2 formulated in basic methacrylic copolymer, sucrose palmitate, and calcium phosphate (“Formulated B 12”), exemplary vitamin B12 formulation (“Meal Booster B 12”) was characterized as having a higher, sustained release of vitamin B12.
[0335] To characterize the vitamin B12 release profile of an exemplary preparation in simulated gastric conditions, 600 mg of unformulated vitamin B12 (1% (w / w) vitamin B12), 1500 mg of formulated vitamin B 12 (0.4% w / w vitamin B12; formulated in basic methacrylic copolymer, sucrose palmitate, and calcium phosphate), or 3000 mg of exemplary vitamin B12 preparation (0.2% (w / w) vitamin B12; “Meal Booster B12”) were added to 12 mL of simulated gastric fluid with 60 U / mL pepsin (pH 1.2) prewarmed to 37 °C. 200 pL sample aliquots were collected at 0, 15, 30, 60, 225, 285, and 345 minutes following initial dosing and centrifuged to remove particulate matter. The supernatant was transferred to a clear 96-well polystyrene plate for spectrophotometric analysis using a wavelength of 361 nm. Percent release was calculated as the ratio of calculated concentration of vitamin B12 relative to the initially dosed concentration of vitamin B12. Error bars were calculated as standard deviation of 3 independent experiments.
[0336] As shown in FIG. 20F, exemplary vitamin B12 formulation (“Meal Booster B12”) was characterized as having lower, sustained release of vitamin B12 in simulated gastric conditions relative to unformulated B 12 and vitamin B12 formulated in basic methacrylic copolymer, sucrose palmitate, and calcium phosphate (“Formulated Bl 2”) alone.
[0337] These data suggest that exemplary vitamin B12 formulations of the present disclosure achieve modulated release of certain payloads (e.g., vitamin B12) under different environmental conditions (e.g., pH).Whey Protein Preparations
[0338] As shown in the flow diagram of FIG. 21A, a dry mixture of 60% (w / w) micellar casein, 30% (w / w) hydrolyzed whey protein isolate, 5% (w / w) compressible starch, 3% (w / w) lactose, and 2% (w / w) magnesium stearate was added to the mixing bowl of a Caleva Multi Lab (Caleva Process Solutions Ltd, Dorset, UK) instrument.
[0339] The dry ingredients were mixed at 35 rpm in ambient conditions for a duration of 2 minutes prior to addition of the wetting agent (e.g., water). Once the dry ingredients were thoroughly mixed, water was added to the mixing bowl. Approximately 0.35 mL / g water wasadded via a blunt needle syringe directly to the mixing bowl at a rate of 2 mL / min while the mixture continued to mix / granulatc at 35 rpm.
[0340] If clumps appeared, wet granulating was temporarily halted, and material was manually broken up with a spatula before resuming wet granulating. Once the entirety of wetting agent was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl. Once the entirety of wetting agent was added and the mixture became a cohesive blend of granular texture, the granulate was removed from the mixing bowl.
[0341] Following wet granulation, the Caleva Multi Lab instrument was fitted with an extrusion assembly, including a 1 mm by 1 mm circular extrusion die. The single screw extruder of the instrument was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min.
[0342] Following wet granulation, the Caleva Multi Lab instrument was fitted with an extrusion assembly, including a 1 mm by 1 mm circular extrusion die. The single screw extruder of the instrument was set to 100-110 rpm and the granulate was fed into the extrusion chamber at a rate of approximately 3 g / min.
[0343] Extrudate (e.g., in the form of noodles) was collected and placed inside a spheronizing chamber of the Caleva instrument. Cold extrudate noodles were collected in and oven-safe container and dried in oven at 60-65 °C for 3 hours. Following drying, dry extrudate (noodles) were transferred to blade mill and milled at 5500 rpm for 1-3 seconds at ambient conditions until preparation particles approximately 2-8 mm in length and 1 mm diameter were achieved. Preparation particles were then collected and sealed in sachets with desiccant. An exemplary elongated whey protein preparation is shown in FIG. 21B.
[0344] In an alternative preparation, the exemplary manufacture of which is shown in the flow diagram of FIG. 22A, A dry combination of 50% (w / w) whey protein isolate, 30% (w / w) ethyl cellulose, and 20% (w / w) beeswax was prepared and then dry blade milled at 5500 rpm for 30 seconds to produce a fine powder of homogenous texture, color, and consistency. The powder mixture was then fed at a rate of 0.5 g / min to a Thermo Fisher Scientific (USA) Mini Lab 3 hot melt extruder set to 150 °C and twin screws operating at 25 rpm. The extrudate was collected and cooled at room temperature for 1-5 minutes. Once cool, the strips were broken into *4” to W sections. The extruded broken preparation were stored in a mylar or metal sachet withdesiccant at 25 °C. An exemplary extruded broken whey protein preparation is shown in FIG.22B.Pyrroloquinoline Quinone Preparations
[0345] As shown in the flow diagram of FIG. 23A, a dry blend of 64% (w / w) poly(3- Hydroxybutyrate-co-3-Hydroxyvalerate), 13.5% (w / w) poly(vinyl pyrrolidone), 13.5% (w / w) triethyl citrate, and 9% (w / w) pyrroloquinoline quinone (PQQ) were measured and dry blended together via blade mill at 5500 r m for 30 seconds to form a homogenous powder of consistent texture and soft red-brown color. Next, this mixture was fed at a rate of 1 g / min into a Thermo Fisher Scientific (USA) Mini Lab 3 twin screw hot melt extruder operating at 200 rpm and 180 °C. The extrudate was cooled at 25 °C for 5 minutes promptly following collection from the extruder, allowing the formulation to harden. Once cool, the PQQ formulation was hammer milled at 5500 rpm for 5 minutes with a 0.5 mm sieve in place to collect resultant particles.Once particles of D < 0.5mm were collected, 5% (w / w) PQQ particles were combined into a dry mixture containing 50% (w / w) whey protein, 25% (w / w) ethyl cellulose, and 20% (w / w) beeswax, to yield a final composition of 50% (w / w) whey protein, 25% (w / w) ethyl cellulose, 20% (w / w) beeswax, 3.2% (w / w) poly(3-Hydroxybutyrate-co-3-Hydroxyvalerate) (“PHBV”), 0.675% (w / w) poly(vinyl pyrrolidone) (“PVP”), 0.675% (w / w) triethyl citrate, and 0.45% (w / w) pyrroloquinoline quinone (PQQ). The dry blend of ingredients was blade milled at 5500 rpm for 30 seconds to obtain a homogenous, even texture and color. The dry mixture was reintroduced to the hot melt extrusion instrument at a rate of 0.5 g / min, at a temperature of 150 °C, and at a screw speed 25 rpm. The extruded material was collected and immediately cooled at 25 °C for 5 minutes until hardened. The resultant material was brown-red in color with apparent darker red specs, being the PQQ particles, which remained intact and during the second extrusion step. The resultant extrudate product was broken into !4”- Yi” sections following cooling (shown macroscopically in FIG. 23B, microscopically in FIG. 23C, and added to a salad in FIG. 23D).
[0346] To characterize the PQQ release profile of an exemplary preparation in neutral buffer (e.g., phosphate buffered saline), 12 mg of unformulated PQQ (100% PQQ (w / w)), 131.8 mg of formulated PQQ (9.1% PQQ (w / w); formulated in PHBV, PVP, and triethyl citrate), or 1318 mg of exemplary PQQ preparation (0.455% (w / w) PQQ; “Meal Booster PQQ”) were added to 12 mL of phosphate buffered saline (pH 7.4) prewarmed to 37 °C in triplicate. 200 pL samplealiquots were collected at 0, 15, 30, 60, 225, 285, and 345 minutes following initial dosing and centrifuged to remove particulate matter. The supernatant was transferred to a clear 96-wcll polystyrene plate for spectrophotometric analysis using a wavelength of 351 nm. Percent release was calculated as the ratio of calculated concentration of PQQ relative to the initially dosed concentration of PQQ. Error bars were calculated as standard deviation of 3 independent experiments.
[0347] As shown in FIG. 23E, exemplary PQQ formulation (“Meal Booster PQQ”) was characterized as having improved PQQ release in neutral aqueous solution (e.g., phosphate buffered saline) relative to unformulated PQQ and PQQ formulated in PHBV, PVP, and triethyl citrate alone (“Formulated PQQ”).
[0348] To characterize the PQQ release profile of an exemplary preparation in simulated gastric conditions, 12 mg of unformulated PQQ (100% PQQ (w / w)), 131.8 mg of formulated PQQ (9.1% PQQ (w / w); formulated in PHBV, PVP, and triethyl citrate), or 1318 mg of exemplary PQQ preparation (0.455% (w / w) PQQ; “Meal Booster PQQ”) were added to 12 mL of simulated gastric fluid with 60 U / mL pepsin (pH 1.2) prewarmed to 37 °C prewarmed to 37 °C in triplicate. 200 pL sample aliquots were collected at 0, 15, 30, 60, 225, 285, and 345 minutes following initial dosing and centrifuged to remove particulate matter. The supernatant was transferred to a clear 96-well polystyrene plate for spectrophotometric analysis using a wavelength of 351 nm. Percent release was calculated as the ratio of calculated concentration of PQQ relative to the initially dosed concentration of PQQ. Error bars were calculated as standard deviation of 3 independent experiments.
[0349] As shown in FIG. 23F, exemplary PQQ formulation (“Meal Booster PQQ”) was characterized as having improved PQQ release in simulated gastric conditions relative to unformulated PQQ and PQQ formulated in PHBV, PVP, and triethyl citrate alone (“Formulated PQQ”).
[0350] These data suggest that exemplary vitamin B12 formulations of the present disclosure achieve modulated release of certain payloads (e.g., PQQ) under different environmental conditions (e.g., pH).
[0351] Some embodiments of the present disclosure were described above. It is, however, expressly noted that the present disclosure is not limited to those embodiments, but rather the intention is that additions and modifications to what was expressly described in the present disclosure are also included within the scope of the disclosure. Moreover, it is to be understood that the features of the various embodiments described in the present disclosure were not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations were not made express, without departing from the spirit and scope of the disclosure. The disclosure has been described in detail with particular reference to some embodiments thereof, but it will be understood that variations and modifications can be effected within the spirit and scope of the claimed invention.Example 5: Exemplary Preparations Characterized by Delayed Release of Functional Payloads
[0352] The present example describes exemplary preparations of the present disclosure having delayed release of functional pay loads.Preparation of Exemplary Delayed Release Sprinkle Preparations
[0353] In the present example, sprinkle preparations comprising inulin were prepared by a hot melt extrusion and milling method. In brief, a mixture of 50% (w / w) inulin with 50% (w / w) guar gum, was extruded at 125 °C and 50 rpm with a Thermo Fisher Scientific (USA) Mini Lab 3 extruder fitted with twin screws. The extrudate was hammer milled using a Fitzpatrick mill operating at 5500 rpm fitted with 0.5 mm sieve to produce fine, flowable microparticles. In a separate exemplary embodiment, a mixture of 60% (w / w) guar gum and 40% (w / w) inulin was extruded and milled using the same processing protocol. In a third exemplary embodiment, a mixture of 50% (w / w) sucrose palmitate (HLB = 16) and 50% (w / w) inulin was processed at 125°C and 50 rpm with a Thermo Fisher Scientific (USA) Mini Lab 3 extruder fitted with twin screws. The extrudate was hammer milled using a Fitzpatrick mill operating at 5500 rpm fitted with 0.5 mm sieve to produce fine, flowable microparticles. In a fourth exemplary embodiment, a lower-HLB alternative sucrose ester, Sistema SP30 (HLB = 6), containing a mixture of sucrose palmitate and sucrose stearate (30% (w / w) distearate content), was mixed at 50% (w / w) relative to 50% (w / w) inulin powder and extruded and milled under the same processing conditions. In a fifth exemplary embodiment, 50% (w / w) guar gum and 50% (w / w) inulin were hot melt extrudedtogether at 125°C and 50 rpm, then milled using a Fitzpatrick mill at 5500 rpm with a 0.5 mm sieve attachment to create microparticles with a high melting point. These particles were then used for a second hot melt extruded formulation and combined with a mixture of 70% (w / w) guar gum / inulin particles and 30% (w / w) sucrose palmitate at a temperature of 60°C and 50 rpm. The preparation was then milled as described above to form microparticles of preparation having 35% (w / w) guar gum, 30% (w / w) sucrose palmitate and 35% (w / w) inulin. This preparation was further tailored by introducing a lower-HLB sucrose ester, Sisterna SP30 (HLB = 6) into the mixture in place of sucrose palmitate (HLB =16), to increase the hydrophobicity of the formulation. This mixture was processed at 110°C and 50 rpm with a Thermo Fisher Scientific (USA) Mini Lab 3 extruder fitted with twin screws. The extrudate was hammer milled using a Fitzpatrick mill operating at 5500 rpm fitted with 0.5 mm sieve to produce fine, flowable microparticles.Analysis of Delayed Release Sprinkle Preparations
[0354] The release profiles of exemplary sprinkle preparations of the present disclosure were evaluated using a USP dissolution method on a Distek 2500 instrument (Distek, USA) fitted with paddle attachments. Dissolution was performed by adding exemplary sprinkle preparations to 500 mL fasted state simulated gastric fluid (FaSSGF) pH 1.6 at 37°C, stirred at 50 rpm, in triplicate. Sample aliquots were collected from the dissolution apparatus up to 21 hours following initial sample introduction. The release of payload component(s) was compared to an appropriate reference (e.g., compared to free payload component and / or to nonencapsulated payload component) added in tandem to the USP dissolution apparatus.
[0355] As shown in FIGs. 24A - 24D, exemplary sprinkle preparations of the present disclosure delayed inulin release into solution as compared to the free diffusion of un-formulated inulin in solution. For example, while 100% of inulin is released after 15 minutes for unformulated inulin in solution, the 60% (w / w) guar gum and 40% (w / w) inulin preparation released about 25% and 75% of the inulin after 15 and 300 minutes respectively (as shown in FIG 24A), and the 35% (w / w) guar gum, 15% (w / w) SP30, and 50% (w / w) inulin preparation with released about 50% and 75% of the inulin after 1 and 6 hours respectively (as shown in FIG 24C). These data indicate that exemplary sprinkle formulations of the present disclosure can delay payload component release to achieve sustained payload component bioavailabilityfollowing ingestion of a sprinkle preparation by a subject. Moreover, by selecting specific sprinkle preparations, one or more specific release profiles can be achieved (c.g., 4-hour release, 8-hour release, or 12-hour release) (as shown in FIG 24D).
Claims
CLAIMSWhat is claimed is:
1. A sprinkle preparation comprising a core particle, wherein the core particle comprises:(i) 1% w / w to 70% w / w of a prebiotic dietary fiber;(ii) 5% w / w to 20% w / w of an anti- adherent;(iii) 1% w / w to 90% w / w of a protein; and(iv) 1% w / w to 35% w / w of a binder.
2. The preparation of claim 1, wherein the core particle comprises:(i) about 45% w / w to about 60% w / w of the prebiotic dietary fiber, wherein the prebiotic dietary fiber comprises inulin;(ii) about 8% w / w to about 10% w / w of the anti-adherent, wherein the anti-adherent comprises magnesium stearate;(iii) about 20% w / w to about 25% w / w of the protein, wherein the protein comprises at least one of casein and a pea protein isolate; and(iv) about 5% w / w to about 15% w / w of the binder, wherein the binder comprises corn starch, isomalt and / or sodium alginate.
3. The preparation of claim 1, wherein the core particle comprises 30% w / w to 60% w / w of the prebiotic dietary fiber.
4. The preparation of any one of claims 1 to 3, wherein the core particle comprises about 40% w / w to 45% w / w of the prebiotic dietary fiber.
5. The preparation of any one of claims 1 to 3, wherein the core particle comprises about 55% w / w to 60% w / w of the prebiotic dietary fiber.
6. The preparation of any one of claims 1 to 5, wherein the prebiotic dietary fiber comprises inulin, multi-functional corn fiber, soluble com fiber, multi-functional oat hull fiber, wheatbran, beta glucans, cellulose, chitin, chitosan, xanthan gum, guar gum, konjac gum, psyllium, raffinose, polydcxtrosc, pectin, human milk oligosaccharide, or combinations thereof.
7. The preparation of claim 6, wherein the dietary fiber comprises inulin and wherein the inulin comprises dahlia tuber inulin, chicory root inulin, blue agave inulin, Jerusalem artichoke inulin, enzymatically synthesized inulin, or a combination thereof.
8. The preparation of claim 6 or claim 7, wherein the inulin comprises a number average molecular weight of at least 1 kDa.
9. The preparation of any one of claims 1 to 8, wherein the core particle comprises 5% w / w to 20% w / w of the anti-adherent.
10. The preparation of any one of claims 1 to 9, wherein the core particle comprises 8% w / w to 12% w / w of the anti-adherent.
11. The preparation of any one of claims 1 to 10, wherein the core particle comprises about 10% w / w of the anti-adherent.
12. The preparation of any one of claims 1 to 10, wherein the core particle comprises about 8% w / w of the anti-adherent.
13. The preparation of any one of claims 1 to 12, wherein the anti-adherent comprises magnesium stearate, zinc stearate, calcium stearate, magnesium palmitate, zinc palmitate, calcium palmitate, glyceryl monostearate, glyceryl dibehenate, glyceryl monooleate, lecithin, calcium phosphate, magnesium phosphate, calcium carbonate, magnesium carbonate, silicon dioxide, sodium silicates, magnesium silicates, zinc silicates, calcium silicates, monoglyceride fatty acids, diglyceride fatty acids, or a combination thereof.
14. The preparation of any one of claims 1 to 13, wherein the core particle comprises 1% w / w to 90% w / w of the protein.
15. The preparation of any one of claims 1 to 14, wherein the core particle comprises 15% w / w to 90% w / w of the protein.
16. The preparation of any one of claims 1 to 14, wherein the core particle comprises 1% w / w to 70% w / w of the protein.
17. The preparation of any one of claims 1 to 16, wherein the core particle comprises about 25% w / w of the protein.
18. The preparation of any one of claims 1 to 16, wherein the core particle comprises about 20% w / w of the protein.
19. The preparation of any one of claims 1 to 18, wherein the protein comprises calcium caseinate, micellar casein, pea protein, oat protein, or a combination thereof.
20. The preparation of any one of claims 1 to 19, wherein the core particle comprises 1% w / w to 35% w / w of the binder.
21. The preparation of any one of claims 1 to 20, wherein the core particle comprises about 15% w / w of the binder.
22. The preparation of any one of claims 1 to 20, wherein the core particle comprises about 10% w / w of the binder.
23. The preparation of any one of claims 1 to 20, wherein the core particle comprises about 5% w / w of the binder.
24. The preparation of any one of claims 1 to 23, wherein the binder comprises a directly compressible- grade binder.
25. The preparation of any one of claims 1 to 24, wherein the binder comprises a directly compressible starch, isomalt, sodium alginate, a phytosterol, or a combination thereof.
26. The preparation of claim 1, wherein the core particle comprises:15% w / w to 90% w / w of the protein.
27. The preparation of claim 26, wherein the core particle comprises:(i) about 45% w / w of the prebiotic dietary fiber, wherein the prebiotic dietary fiber comprises inulin;(ii) about 10% w / w of the anti- adherent; wherein the anti-adherent comprises magnesium stearate;(iii) about 25% w / w of the protein, wherein the protein comprises casein; and(iv) about 15% w / w of the binder, wherein the binder comprises about 10% w / w corn starch and about 5% w / w isomalt.
28. The preparation of claim 1, wherein the core particle comprises:15% w / w to 90% w / w of the protein; and1% w / w to 10% w / w of the binder.
29. The preparation of claim 28, wherein the core particle comprises:(i) about 60% w / w of the prebiotic dietary fiber, wherein the prebiotic dietary fiber comprises inulin;(ii) about 10% w / w of the anti-adherent, wherein the anti-adherent comprises magnesium stearate;(iii) about 25% w / w of the protein, wherein the protein comprises casein; and(iv) about 5% w / w of the binder, wherein the binder comprises isomalt.
30. The preparation of claim 1, wherein the core particle comprises:1% w / w to 70% w / w of the protein; and1% w / w to 20% w / w of the binder.31 . The preparation of claim 30, wherein the core particle comprises:(i) about 60% w / w of the prcbiotic dietary fiber, wherein the probiotic dietary fiber comprises inulin;(ii) about 8% w / w of the anti-adherent, wherein the anti-adherent comprises magnesium stearate;(iii) about 20% w / w of the protein, wherein the protein comprises a pea protein isolate; and(iv) about 10% w / w of the binder, wherein the binder comprises 5% w / w sodium alginate and 5% w / w isomalt.
32. The preparation of any one of claims 1 to 31, wherein the core particle further comprises 1% w / w to 20% w / w of a natural colorant.
33. The preparation of claim 32, wherein the natural colorant comprises spirulina extract, rutin, quercetin, chlorophyll, curcumin, cyanidin, phloretin, astaxanthin, lutein, zeaxanthin, bixin, norbixin, capsanthin, lycopene, canthaxanthin, alpha carotene, beta carotene, gamma carotene, rubixanthin, violaxanthin, rhodoxanthin, citranaxanthin, betalain, betanin, orcein, cobalamin, cyanocobalamin, or a combination thereof.
34. The preparation of claim 32 or claim 33, wherein the preparation comprises 2% w / w of the natural colorant, and wherein the natural colorant comprises spirulina extract.
35. The preparation of any one of claims 32 to 34, wherein the natural colorant is encapsulated.
36. The preparation of claim 35, wherein the natural colorant is encapsulated in a basic methacrylic copolymer.
37. The preparation of claim 36, wherein the encapsulated natural colorant comprises:(i) 0.5% w / w to 40% w / w natural colorant; and(ii) 60% w / w to 95.5% w / w basic methacrylic copolymer.
38. The preparation of claim 36 or claim 37, wherein the encapsulated natural colorant comprises:(i) about 31% w / w natural colorant, wherein the natural colorant comprises about 26% lutein and about 5% zeaxanthin; and(ii) about 69% of basic methacrylic copolymer, wherein the basic methacrylic copolymer comprises w / w Eudraguard® protect.
39. The preparation of any one of claims 1 to 31, wherein the preparation further comprises a coating.
40. The preparation of claim 39, wherein the preparation comprises 10% w / w to 30% w / w of the coating.
41. The preparation of claim 40, wherein the preparation comprises about 20% w / w of the coating.
42. The preparation of any one of claims 39 to 41, wherein the coating comprises:(i) a polish;(ii) a glaze;(iii) a sealant, or(iv) a combination thereof.
43. The preparation of claim 42, wherein:(i) the polish comprises Capol® 127C;(ii) the glaze comprises Capol® 11-143A;(iii) the sealant comprises Capol® 155C; or(iv) a combination thereof.
44. The preparation of claim 43, wherein the coating comprises:(i) 30% w / w to 33.3% w / w of Capol® 127C;(ii) 30% w / w to 33.3 % w / w of Capol® 11-143A; and(iii) 30% w / w to 33.3% w / w of Capol® 155C.
45. The preparation of any one of claims 42 to 44, wherein the coating further comprises 0.1% w / w to 10% w / w of a natural colorant.
46. The preparation of claim 45, wherein the natural colorant comprises spirulina extract, rutin, quercetin, chlorophyll, curcumin, cyanidin, phloretin, astaxanthin, lutein, zeaxanthin, bixin, norbixin, capsanthin, lycopene, canthaxanthin, alpha carotene, beta carotene, gamma carotene, rubixanthin, violaxanthin, rhodoxanthin, citranaxanthin, betalain, betanin, orcein, cobalamin, cyanocobalamin, or a combination thereof.
47. The preparation of claim 45 or claim 46, wherein the preparation comprises 2% w / w of the natural colorant, and wherein the natural colorant comprises spirulina extract.
48. The preparation of any one of claims 45 to 47, wherein the natural colorant is encapsulated.
49. The preparation of claim 48, wherein the natural colorant is encapsulated in a basic methacrylic copolymer.
50. The preparation of claim 49, wherein the encapsulated natural colorant comprises:(i) 0.5% w / w to 40% w / w natural colorant; and(ii) 60% w / w to 95.5% w / w basic methacrylic copolymer.
51. The preparation of claim 49 or claim 50, wherein the encapsulated natural colorant comprises:(i) about 31% w / w natural colorant, wherein the natural colorant comprises about 26% lutein and about 5% zeaxanthin; and(ii) about 69% of basic methacrylic copolymer, wherein the basic methacrylic copolymer comprises w / w Eudraguard® protect.
52. The preparation of any one of claims 1 to 51, comprising an elongated geometry comprising:a length in a range from about 1 mm to about 15 mm; a width in a range from about 0.5 mm to about 3.0 mm; and a height in a range from about 0.5 mm to about 3.0 mm.
53. The preparation of claim 52, comprising a length in a range from about 2.0 mm to about 10.0 mm (for example, from about 2.5 mm to about 10 mm, from about 3.0 mm to about 10 mm, from about 3.5 mm to about 10 mm, from about 2.0 mm to about 9 mm, from about 2.5 mm to about 9 mm, from about 2.5 mm to about 8 mm, from about 3.0 mm to about 8 mm, and / or from about 3.5 mm to about 7.0 mm).
54. The preparation of claim 52 or claim 53, comprising a width in a range from about 1.0 mm to about 2.0 mm (for example, from about 1.5 mm to about 2.0 mm, from about 1.6 mm to about 1.9 mm, from about 1.5 mm to about 1.9 mm; from about 1.6 mm to about 2.0 mm; from about 1.6 mm to about 1.8 mm, from about 1.65 mm to about 1.85 mm, from about 0.95 mm to about 1.25 mm, and / or from about 1.65 mm to about 1.75 mm).
55. The preparation of any one of claims 52 to 54, comprising a height in a range from about 1.0 mm to about 2.0 mm (for example, from about 1.5 mm to about 2.0 mm, from about 1.6 mm to about 1.9 mm, from about 1.5 mm to about 1.9 mm; from about 1.6 mm to about 2.0 mm; from about 1.6 mm to about 1.8 mm, from about 1.65 mm to about 1.85 mm, from about 0.95 mm to about 1.25 mm, and / or from about 1.65 mm to about 1.75 mm).
56. The preparation of any one of claims 1 to 51, comprising a nonpareil geometry comprising a length, a width, and a height in a range from about 0.5 mm to about 3.0 mm.
57. The preparation of claim 56, comprising a length, a width, and a height in a range from about 1.0 mm to about 2.0 mm (for example, from about 1.5 mm to about 2.0 mm, from about 1.6 mm to about 1.9 mm, from about 1.5 mm to about 1.9 mm; from about 1.6 mm to about 2.0 mm; from about 1.6 mm to about 1.8 mm, from about 1.65 mm to about 1.85 mm; and / or from about 1.65 mm to about 1.75 mm).
58. The preparation of any one of claims 1 to 57, comprising a density in a range from about 0.7 mg / dL to about 1.0 mg / dL.
59. The preparation of claim 58, comprising a density in a range from about 0.75 mg / dL to about 0.95 mg / dL (for example, from about 0.8 mg / dL to about 0.95 mg / dL, from about 0.85 mg / dL to about 0.95 mg / dL, from about 0.8 mg / dL to about 0.9 mg / dL, from about 0.8 mg / dL to about 0.9 mg / dL, and / or from about 0.85 mg / dl to about 0.9 mg / dL).
60. The preparation of any one of claims 1 to 59, comprising a moisture content in a range from about 0.5% to about 10.0%.
61. The preparation of claim 60, comprising a moisture content in a range from about 1% to about 8% (for example, from about 2% to 8%, from about 3% to 8%, from about 4% to 8%, from about 5% to 8%, from about 6% to 8%, from about 1% to about 6%, from about 2% to 6%, from about 3% to 6%, from about 4% to 6%, from about 1% to about 4%, from about 2% to 4%, from about 3% to 4%, and / or from about 1% to about 2%).
62. The preparation of any one of claims 39 to 61, wherein the preparation comprises a Shore hardness of 65 to 75, as measured by a durometer.
63. The preparation of claim 62, wherein the preparation comprises a Shore hardness of about 70, as measured by the durometer.
64. The preparation of any one of claims 39 to 63, wherein the preparation comprises a compressive force hardness of 10 N to 25 N, as measured by a texture analyzer.
65. The preparation of claim 64, wherein the preparation comprises a compressive force hardness of about 20 N, as measured by the texture analyzer.
66. A method of manufacturing a sprinkle preparation comprising:(i) mixing dry ingredients comprising:a. a prebiotic dietary fiber, b. an anti- adherent, c. a protein, and d. a binder, to form a mixture;(ii) wet granulating the mixture from step (i) to form a granulate;(iii) cold extruding the granulate from step (ii) to form an extrudate; and(iv) drying the extrudate resulting from step (iii).
67. The method of claim 66, wherein step (i) mixing dry ingredients further comprises mixing: e. a natural colorant.
68. The method of claim 66 or claim 67, wherein step (ii) wet granulating comprises granulating water with the mixture at a ratio of 1 to 10 ml of water to 1 to 20 g of the mixture.
69. The method of any one of claims 66 to 68, wherein step (ii) wet granulating comprises granulating water with the mixture at a ratio of about 3.5 ml of water to about 10 g of the mixture.
70. The method of any one of claims 66 to 69, wherein step (iii) cold extruding is performed at 50 to 150 RPM.
71. The method of any one of claims 66 to 70, wherein step (iii) cold extruding is performed at about 100 RPM.
72. The method of any one of claims 66 to 71, wherein step (iii) cold extruding is performed at 20 °C to 25 °C.
73. The method of any one of claims 66 to 72, wherein step (iii) cold extruding is performed at about 22 °C.
74. The method of any one of claims 66 to 73, wherein step (iv) drying is performed at 20 °C to80 °C.
75. The method of any one of claims 66 to 74, wherein step (iv) drying is performed at about 60 °C.
76. The method of any one of claims 66 to 74, wherein step (iv) drying is performed at about 20 °C to about 25 °C.
77. The method of any one of claims 66 to 76, wherein step (iv) drying is performed for 1 hour to 5 hours.
78. The method of any one of claims 66 to 77, wherein step (iv) drying is performed for about 3 hours.
79. The method of any one of claims 66 to 78, wherein the method further comprises;(v) blade milling.
80. The method of claim 79, wherein step (v) blade milling is performed at 3500 rpm to 7500 rpm.
81. The method of claim 79 or claim 80, wherein step (v) blade milling is performed at about 5500 rpm.
82. The method of any one of claims 66 to 81, wherein the extrudate is spheronized before step (iv) drying.
83. The method of claim 82, wherein spheronizing is performed at 1500 rpm to 2500 rpm.
84. The method of claim 82 or claim 83, wherein spheronizing is performed at about 2000 rpm.
85. The method of any one of claims 79 to 84, wherein the method further comprises: (vi) fluidized bed coating to form the sprinkle preparation.
86. The method of claim 85, wherein step (vi) fluidized bed coating comprises:(i) applying a polish;(ii) applying a glaze; and(iii) applying a sealant, to form a coating.
87. The method of claim 86, wherein the coating comprises a natural colorant.
88. The method of any one of claims 85 to 87, wherein step (vi) fluidized bed coating comprises the use of an inlet nozzle set at 50 °C to 70 °C.
89. The method of any one of claims 85 to 88, wherein step (vi) fluidized bed coating comprises the use of an inlet nozzle set at about 60 °C.
90. The method of any one of claims 85 to 89, wherein step (vi) fluidized bed coating is performed at 100 to 200 LPM.
91. The method of any one of claims 85 to 90, wherein step (vi) fluidized bed coating is performed at about 150 LPM.
92. The method of any one of claims 85 to 91, wherein step (vi) fluidized bed coating is performed at an on rate of 0.5 minutes to 0.7 minutes and an off rate of 0.3 minutes to 0.5 minutes.
93. The method of any one of claims 85 to 92, wherein step (vi) fluidized bed coating is performed at an on rate of 0.6 minutes and an off rate of 0.4 minutes.
94. The method of any one of claims 86 to 93, wherein step (vi) fluidized bed coating is performed until the coating is 10% w / w to 30% w / w of the sprinkle preparation.
95. The method of any one of claims 86 to 94, wherein step (vi) fluidized bed coating is performed until the coating is about 20% w / w of the sprinkle preparation.
96. The method of any one of claims 79 to 84, wherein the method further comprises: (vi) pan coating to form the sprinkle preparation.
97. The method of claim 96, wherein step (vi) pan coating comprises the use of an inlet nozzle set at 70 °C to 90 °C.
98. The method of claim 96 or claim 97, wherein step (vi) pan coating comprises the use of an inlet nozzle set at about 80 °C.
99. The method of any one of claims 96 to 98, wherein step (vi) pan coating is performed at 40 to 80 RPM.
100. The method of any one of claims 96 to 99, wherein step (vi) pan coating is performed at about 60 RPM.
101. The method of any one of claims 96 to 100, wherein step (vi) pan coating is performed at an on rate of 0.6 minutes to 1.0 minute and an off rate of 0.1 minutes to 0.3 minutes.
102. The method of any one of claims 96 to 101, wherein step (vi) pan coating is performed at an on rate of 0.8 minutes and an off rate of 0.2 minutes.
103. The method of any one of claims 96 to 102, wherein step (vi) pan coating is performed until a coating applied by the pan coating is 10% w / w to 30% w / w of the sprinkle preparation.
104. The method of any one of claims 96 to 103, wherein step (vi) pan coating is performed until a coating applied by the pan coating is about 20% w / w of the sprinkle preparation.
105. A food product comprising the sprinkle preparation of any one of claims 1 to 65 and a food base.
106. The food product of claim 105, wherein the food base is a dairy food base.
107. The food product of claim 106, wherein the dairy food base is yogurt, or ice cream.
108. The food product of claim 105, wherein the food base is a prepared food base.
109. The food product of claim 108, wherein the prepared food base is a cupcake, a cake, a cookie, or a doughnut.
110. The food product of claim 105, wherein the food base is a beverage.
111. The food product of claim 110, wherein the beverage is milk, oat milk, almond milk, milkshake, coffee, tea, kefir, drinkable yogurt, cocktail, mate, or hot cocoa.
112. A sprinkle preparation comprising:(i) one or more core particles comprising a functional payload; and(ii) a matrix.
113. The sprinkle preparation of claim 112, wherein the functional payload comprises vitamin B12, pyrroloquinoline quinone (PQQ), vitamin D, caffeine, creatine, lutein, zeaxanthin, lycopene, zeaxanthin, lycopene, carotene, curcumin, taurine, citicoline, alpha glycerophosphocholine, diindolylmethane, eicosapentaenoic acid, docosapentaenoic acid, lauric acid, tryptophan, arginine, leucine, or any combination thereof.
14. The sprinkle preparation of claim 112 or 1 13, wherein the matrix comprises a basic methacrylic copolymer (c.g., EUDRAGUARD® Protect), com starch, shellac, carnauba wax, rice bran wax, tristearin, glyceryl dibehenate, pea starch, rice starch hydroxypropyl starch, starch sodium octenyl succinate, soluble corn fiber, hydroxypropyl beta cyclodextrin, gamma cyclodextrin, beta cyclodextrin, stearic acid, palmitic acid, polyvinylpyrrolidone, polyethylene glycol, sucrose palmitate, sucrose stearate, sorbitan tristearate, sorbitan monostearate, sorbitan monopalmitate, hydroxypropyl cellulose grade SSL, hydroxypropyl cellulose grade L, methyl cellulose 15cP viscosity, methyl cellulose 4000 cP viscosity, pullulan, curdlan, hydroxypropyl methylcellulose 50 cP viscosity, hydroxypropyl methylcellulose 100 cP viscosity, ethyl cellulose 10 cP viscosity, ethyl cellulose 100 cP viscosity, agarose, carboxymethylcellulose 300 cP viscosity, carboxymethylcellulose 250 cP viscosity, lambda carrageenan, iota carrageenan, kappa carrageenan, chitosan, basic methacrylic copolymer, acidic methacrylic copolymer, neutral methacrylic copolymer, tannic acid, ellagitannin, metatartaric acid, adipic acid, high methoxyl pectin, low methoxyl pectin, amidated low methoxyl pectin, gelatin type A, gelatin type B, glycerol esters of wood resins, behenic acid, arachidic acid, mono- and diglycerides of fatty acids, citric acid esters of mono- and diglycerides of fatty acids, sucroglycerides, stearyl tartrate, polyoxypropylenepolyoxyethylene polymers, gum benzoic, spermaceti wax, montan acid esters, hydroxypropyl distarch phosphate, acetylated distarch phosphate, acetylated distarch adipate, phosphate distarch phosphate, cocoa butter, shea butter, coconut oil, whey protein, native whey protein, casein, pea protein isolate, oat protein isolate, soy protein isolate, zein, agar, agarose, ethyl cellulose 300 cP viscosity, sucrose oleate, sodium alginate, oat starch, xanthan gum, gellan gum, guar gum, gum Arabic, beeswax, or any combination thereof.
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