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US-20260124256-A1 - LIPID ENCAPSULATED PROBIOTIC COMPOSITIONS

US20260124256A1US 20260124256 A1US20260124256 A1US 20260124256A1US-20260124256-A1

Abstract

A probiotic composition includes microbes and one or more barrier materials including, on a dry weight basis: about 40% to about 99% (w/w) lipid, and about 0% to about 59% (w/w) of: a carbohydrate, a protein, a polymer, and/or combinations thereof.

Inventors

  • Aaron C. Anselmo
  • Andrea Stamp
  • Ana Jaklenec
  • Catherine B. Reynolds
  • Robert S. Langer
  • Megan V. FRISBEE
  • Shannon M. TOFFTON
  • James D. SIEVERT
  • Kevin M. LUO
  • Anant Shankar Balijepalli
  • Tiffany B. HENDLEY
  • Cheyenne N. ROTH
  • Andrew D. CHRISTENSON
  • Joseph Collins

Assignees

  • VITAKEY INC.

Dates

Publication Date
20260507
Application Date
20231003

Claims (20)

  1. 1 . A probiotic composition comprising one or more microbes and one or more barrier materials wherein the barrier materials comprise, on a dry weight basis: about 1% to about 99% (w/w) lipid, the lipid comprising at least one of a wax, a plant oil, and a fatty acid; and about 0% to about 98% (w/w) of: a carbohydrate; a protein; a polymer; or combinations thereof, wherein the microbes comprise probiotic bacteria.
  2. 2 . A particle comprising the composition of claim 1 , wherein the particle comprises a diameter in a range from about 10 μm to about 300 μm.
  3. 3 . The particle of claim 176 , wherein the particle comprises a diameter in a range from about 100 μm to about 250 μm.
  4. 4 . The particle comprising the composition of claim 1 , wherein the particle comprises a diameter in a range from about 10 m to about 100 m.
  5. 5 . The particle comprising the composition of claim 1 , wherein the particle comprises a diameter in a range from about 10 μm to about 50 μm.
  6. 6 . The particle comprising the composition of claim 1 , wherein the particle comprises a diameter in a range from about 10 μm to about 25 μm.
  7. 7 . The composition of claim 1 , wherein the probiotic bacteria comprises at least one of Bacillus coagulans, Bacillus licheniformis, Bacillus subtilis, Bifidobacterium angulatum, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium Bifidobacterium longum, Enterococcus faecium, Enterococcus faecalis, Lactobacillus acidophilus, Lactobacillus amylovorus, Lactobacillus alimentarius, Lactobacillus bulgaricus, Lactobacillus casei subsp. casei, Lactobacillus casei Sinrota, Lactobacillus curvatus, Lactobacillus delbrueckii subsp lactis, Lactobacillus fermentum, Lactobacillus farciminis, Lactobacillus gasseri, Lactobacillus helveticus, Lactobacillus johnsonii, Lactobacillus lacti, Lactobacillus paracasei, Lactobacillus pentosaceus, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus rhamnosus ( Lactobacillus GG), Lactobacillus sake, Lactobacillus salivarius, Lactococcus lactis, Micrococcus varians, Pediococcus acidilactici Pediococcus pentosaceus, Pediococcus acidilactici, Pediococcus halophilus, Streptococcus faecalis, Streptococcus thermophilus, Staphylococcus camosus , and Staphylococcus xylosus.
  8. 8 . The composition of claim 7 , wherein the carbohydrate comprises amylose, amylopectin, cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl ethyl cellulose, cellulose triacetate, cellulose acetate succinate, cellulose acetate butyrate, cellulose acetate phthalate, hydroxypropyl methylcellulose acetate succinate, sodium alginate, potassium alginate, calcium alginate, magnesium alginate, zinc alginate, sodium pectinate, potassium pectinate, calcium pectinate, zinc pectinate, sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, magnesium hyaluronate, zinc hyaluronate, or a combination thereof.
  9. 9 . The composition of claim 7 , wherein the protein comprises whey protein, β-lactoglobulin, α-lactalbumin, casein, bovine serum albumin, ovalbumin, zein, hordein, gliadin, secalin, kafirin, avenin, or a combination thereof.
  10. 10 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 2, less than about 1, or less than about 0.5, when mixed and stored in a food and/or beverage product having a pH less than about 5.0 for at least 1 week.
  11. 11 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 2, less than about 1, or less than about 0.5, when mixed and stored in a food and/or beverage product having a pH less than about 5.0 for at least 2 weeks.
  12. 12 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 2, less than about 1, or less than about 0.5, when mixed and stored in a food and/or beverage product having a pH less than about 5.0 for at least 4 weeks.
  13. 13 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 8, less than about 7, less than bout 6 , less than about 5, or less than about 4, when mixed and in a food and/or beverage product and exposed to a temperature about 100° C. for 30 minutes.
  14. 14 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 2, less than about 1, or less than about 0.5, when mixed and stored in a food and/or beverage product having a fat content of about 1% to about 5% for at least 1 week.
  15. 15 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 2, less than about 1, or less than about 0.5, when mixed and stored in a food and/or beverage product having a fat content of about 1% to about 5% for at least 2 weeks.
  16. 16 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 2, less than about 1, or less than about 0.5, when mixed and stored in a food and/or beverage product having a fat content of about 1% to about 5% for at least 4 weeks.
  17. 17 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 2, less than about 1, or less than about 0.5, when mixed and stored in a liquid food and/or beverage product at about 25° C. for at least 1 week.
  18. 18 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 2, less than about 1, or less than about 0.5, when mixed and stored in a food and/or beverage product at about 25° C. for at least 2 weeks.
  19. 19 . The composition of claim 1 , wherein loss of log(CFU) of the probiotic bacteria in the probiotic composition is less than about 2, less than about 1, or less than about 0.5, when mixed and stored in a food and/or beverage product at about 25° C. for at least 4 weeks.
  20. 19 . The composition of claim 1 , wherein the probiotic composition does not significantly alter the pH of a food and/or beverage product when mixed and stored in the food and/or beverage product at about 25° C. for at least 1 week.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63/520,344, filed on Aug. 17, 2023: U.S. Provisional Application No. 63/515,063, filed on Jul. 21, 2023; U.S. Provisional Application No. 63/505,882, filed on Jun. 2, 2023; U.S. Provisional Application No. 63/468,505, filed on May 23, 2023; U.S. Provisional Application No. 63/440,903, filed on Jan. 24, 2023; U.S. Provisional Application No. 63/477,016, filed on Dec. 23, 2022; and U.S. Provisional Application No. 63/412,848, filed on Oct. 3, 2022. The text of each of the above-referenced applications is incorporated herein by reference. TECHNICAL FIELD The present disclosure is generally related to probiotic compositions (e.g., probiotic particle preparations) and technologies (e.g., methods of preparation, use, etc.) relating thereto. BACKGROUND The health benefits of probiotics to mammals such as humans have been studied for several decades. However, in many cases, the challenges associated with the delivery and viability of probiotic microbes (among other challenges) remain unsolved. As such, probiotics have yet to realize their full potential. SUMMARY A probiotic preparation (e.g., a probiotic composition, e.g., a probiotic particle preparation) can be included in a supplement, a food, a supplemented (i.e., fortified) food product, a beverage, a supplemented (i.e., fortified) beverage product, a powder, a gummy product (e.g., gummy bear, gummy worm, gelatin-based gummy product, pectin-based gummy product, etc.), or a supplemented (i.e., fortified) powder product intended to confer health benefits. Popular nutraceuticals include probiotics, prebiotics, microbes, microbial metabolites, bacteria, yeast, phage for example, Lactobacillus, Bifidobacterium, Bacillus, Saccharomyces, Streptococcus. Enterococcus, Escherichia, oligo polysaccharides, polysaccharides, lactic acid, prebiotics, short-chain fatty acids, etc. In some embodiments, the present disclosure provides technologies that involve utilizing microbes (e.g., probiotics) to confer health benefits. In some embodiments, the present disclosure provides technologies in which probiotics are provided as a preparation that is compatible, for example, with an ingestible source such as a supplement, and/or a food or nutrient source, and/or a drinking source, consumed by a human or an animal (e.g., a chicken, a cow, a dog, etc.). In some embodiments, provided particle preparations (e.g., probiotic compositions) achieve one or more advantages such as stability, extended shelf-life, controlled release, improved survival after ingestion, and compatibility with other materials. Disclosed herein, among other things, are compositions and methods for manufacture, maintenance (e.g., storage) and/or use (e.g., administration or delivery) of probiotic compositions (e.g., particle preparations comprising microbes comprising at least one of Lactobacillus rhamnosus, Lacticaseibacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium animalis. Bifidobacterium animalis subsp. Lactis, and/or mineral such as calcium carbonate). In some embodiments, the nutraceutical is or comprises, for example, one or more antioxidants, macronutrients, micronutrients, minerals, prebiotics, probiotics, vitamins, or combinations thereof. In some embodiments, a nutraceutical is or comprises a probiotic such as Lactobacillus rhamnosus, Lacticaseiobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium animalis. Bifidobacterium animalis subsp. Lactis. In some embodiments, a nutraceutical is or comprises a mineral such as calcium carbonate. In some embodiments, provided probiotic preparations (e.g., probiotic compositions) are characterized by one or more of the following advantages: (i) encapsulation and protection of probiotics within a hydrophobic or lipid material; (ii) improved shelf-life and resistance to degradation and resistance to viability or colony forming unit (CFU) losses at decreased temperatures (e.g., −80° C., −20° C., and/or 4° C.), elevated temperatures (e.g., 22° C., 25° C., 30° C., 35° C., and/or 40° C.), in food and/or food products, in beverages and/or beverage products, in supplements, in dry powders, in the presence of high relative humidity (e.g., up to 100%) or moisture, or a combination thereof; (iii) stability enhancement for payload component (e.g., microbes, probiotics) in supplements, foods, beverages, physiological fluids, the host's body; (iv) encapsulation and protection of probiotics within a hydrophobic or lipid material; (v) improved shelf-life in food or beverage matrices (e.g., protein bars, dry powders, milk powders, whey powders, yogurt, drinkable yogurt, water, etc.); (vi) improved compatibility with other components of nutraceutical products and/or compositions that include them (e.g., supplements, foods, drinks, or other edible materials), specifically compatibility with: high water activi