# US 11,433,107 B2 · Bacterial compositions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,433,107 B2 - Document ID: US11433107B2 - Status: Granted - Kind: B2 - Application number: 16/804,458 - Filed: 2020-02-28 - Published: 2020-06-25 - Granted: 2022-09-06 - Earliest claimed: 2015-01-02 - Assignees: Melaleuca, Inc. - Applicants: Melaleuca, Inc. - Inventors: Subhendu Nayak - Web page: https://patentgrep.com/patent/US11433107B2 ## CPC - A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis - A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} - A61K 9/4866: {Organic macromolecular compounds} - A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages - A61K 35/745: Bifidobacteria - A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract This document provides bacterial compositions. For example, bacterial compositions having a combination of different bacterial strains formulated in a manner to maintain the stability of the bacteria are provided. ## Claims ### Claim 1 A bacterial composition comprising Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis, wherein said bacterial composition is effective to release said Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis, within an intestine of a mammal following oral administration to said mammal; wherein said composition comprises microcrystalline cellulose (MCC) and has a water activity of about 0.125 to about 0.3; and wherein said bacterial composition comprises a uniform silicon dioxide coating that reduces moisture absorption by said Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis prior to oral administration to said mammal. ### Claim 2 (depends on 1) The composition of claim 1, wherein for every gram of the composition said composition comprises between about 4×109 colony forming units and about 50×109 colony forming units of Lactobacillus acidophilus. ### Claim 3 (depends on 1) The composition of claim 1, wherein for every gram of the composition said composition comprises between about 5×109 colony forming units and about 60×109 colony forming units of Lactobacillus plantarum. ### Claim 4 (depends on 1) The composition of claim 1, wherein for every gram of the composition said composition comprises between about 4×109 colony forming units and about 50×109 colony forming units of Lactobacillus casei. ### Claim 5 (depends on 1) The composition of claim 1, wherein for every gram of the composition said composition comprises between about 4×109 colony forming units and about 50×109 colony forming units of Lactobacillus rhamnosus. ### Claim 6 (depends on 1) The composition of claim 1, wherein for every gram of the composition said composition comprises at least about 1×109 colony forming units of Lactobacillus paracasei. ### Claim 7 (depends on 1) The composition of claim 1, wherein for every gram of the composition said composition comprises between about 4×109 colony forming units and about 50×109 colony forming units of Bifidobacterium lactis. ### Claim 8 (depends on 1) The composition of claim 1, wherein said MCC is MCC grade 112. ### Claim 9 (depends on 1) The composition of claim 1, wherein said composition comprises fructooligosaccharides. ### Claim 10 (depends on 8) The composition of claim 8, wherein for every gram of the composition said composition comprises between about 0.5 mg and about 50 mg of fructooligosaccharides. ### Claim 11 (depends on 1) The composition of claim 1, wherein for every gram of composition said composition comprises between about 5 mg and about 20 mg of silicon dioxide. ### Claim 12 (depends on 1) The composition of claim 1, wherein said composition comprises magnesium stearate. ### Claim 13 (depends on 1) The composition of claim 1, wherein for every gram of composition, said composition comprises between about 10 mg and about 20 mg of magnesium stearate. ### Claim 14 (depends on 1) The composition of claim 1, wherein for every gram of the composition said composition comprises more than 8×109 CFUs of bacteria. ### Claim 15 (depends on 1) The composition of claim 1, wherein for every gram of the composition said composition comprises more than 10×109 CFUs of bacteria. ### Claim 16 (depends on 1) The composition of claim 1, wherein for every gram of the composition said composition comprises more than 15×109 CFUs of bacteria. ### Claim 17 (depends on 16) The composition of claim 16, wherein for every gram of the composition more than 10×109 CFUs of bacteria of said composition remain viable after about 12 months of storage at room temperature and environmental humidity. ### Claim 18 (depends on 16) The composition of claim 16, wherein for every gram of the composition more than 10×109 CFUs of bacteria of said composition remain viable after about 12 months of storage at room temperature and environmental humidity. ### Claim 19 (depends on 1) The composition of claim 1, wherein said mammal is a human. ### Claim 20 (depends on 1) The composition of claim 1, wherein said composition has a water activity of about 0.13 to about 0.3. ### Claim 21 (depends on 1) The composition of claim 1, wherein said composition includes the MCC in an amount of about 300 mg to about 700 mg for every gram of the composition. ### Claim 22 (depends on 1) The composition of claim 1, wherein said composition is effective to release its contents when the composition reaches a location of the intestines having a pH above about 6.8. ### Claim 23 A method for making a bacterial composition, wherein said method comprises: (a) coating lyophilized bacteria to form coated lyophilized bacteria having a uniform silicon dioxide coating, wherein the bacteria comprise Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis, (b) adding MCC having a water activity of less than 0.3 and fructooligosaccharides to said coated lyophilized bacteria to form a mixture, wherein said mixture has a water activity of about 0.125 to about 0.3, and (c) encapsulating said mixture into a capsule, thereby forming said bacterial composition, wherein said capsule is effective to release said Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis within an intestine of a mammal following oral administration to said mammal. ### Claim 24 (depends on 23) The method of claim 23, wherein said MCC is MCC grade 112. ### Claim 25 A bacterial composition comprising lyophilized bacteria having a uniform silicon dioxide coating, wherein said lyophilized bacteria is a mixture of lyophilized Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis; wherein said bacterial composition is in the form of a capsule effective to release said Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis within an intestine of a mammal following oral administration to said mammal; wherein said composition has a water activity of about 0.125 to about 0.3, and wherein said the bacterial composition comprises MCC. ### Claim 26 (depends on 25) The composition of claim 25, wherein said silicon dioxide coating is configured to reduce moisture absorption by said Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis prior to oral administration to said mammal. ### Claim 27 (depends on 25) The composition of claim 25, wherein said MCC is MCC grade 112. ### Claim 28 A bacterial composition comprising: (a) lyophilized Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis, (b) fructooligosaccharides, and (c) MCC in an amount of about 300 mg to about 700 mg for every gram of the composition; wherein said bacterial composition is in the form of a capsule effective to, following oral administration to a mammal, release said Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis within an intestine of said mammal when the composition reaches a location of the intestine having a pH above about 6.8; wherein said composition has a water activity of about 0.13 to about 0.3; and wherein said bacterial composition comprises a uniform silicon dioxide coating that reduces moisture absorption by said Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus paracasei, and Bifidobacterium lactis prior to oral administration to said mammal. ### Claim 29 (depends on 28) The composition of claim 28, wherein said MCC is MCC grade 112.