# US 8,540,980 B2 · Delivery system for biological component > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,540,980 B2 - Document ID: US8540980B2 - Status: Granted - Kind: B2 - Application number: 13/686,147 - Filed: 2012-11-27 - Published: 2013-04-04 - Granted: 2013-09-24 - Earliest claimed: 2001-09-28 - Assignees: Tntgamble, Inc. - Applicants: TNTGamble, Inc. - Inventors: Christopher London; Stephen J. Turner; Tanya Borek; Catherine Federici; Michael P. Hite - Web page: https://patentgrep.com/patent/US8540980B2 ## CPC - A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite - A61K 9/2009: {Inorganic compounds} - A61K 9/2031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers} - A61K 9/205: {Polysaccharides, e.g. alginate, gums; Cyclodextrin} - A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose} - A61K 9/2063: {Proteins, e.g. gelatin} - A61K 9/485: {Inorganic compounds} - A61K 9/4866: {Organic macromolecular compounds} - A61K 35/744: Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs - A61M 5/00: Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests (tube connectors, tube couplings, valves or branch units, specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00) - A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) - 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) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A controlled release delivery system composition and method applied to humans and animals, for oral, anal or vaginal administration of a biological component is disclosed. Preferably, a bacterium is delivered, and more preferably the bacterium is probiotic in nature, however, the biological component is not limited to the bacterium. ## Claims ### Claim 1 A controlled release formulation for oral delivery to an intestinal system, the formulation comprising: about 5% to 40% by total weight of hydroxypropyl methylcellulose; about 5% to 40% by total weight of pectin; about 1% to 40% by total weight of at least one electrolytic agent selected from the group consisting of sodium carbonate and sodium bicarbonate; and a probiotic. ### Claim 2 (depends on 1) The controlled release formulation of claim 1 wherein the hydroxypropyl methylcellulose and the pectin are present in a ratio of about 1:1. ### Claim 3 (depends on 1) The controlled release formulation of claim 1 having a total weight of approximately 343 mg and consisting of the following components, each in the approximate amount of: 50 mg of hydroxypropyl methylcellulose; 50 mg of pectin; 50 mg of sodium bicarbonate; 100 mg of microcrystalline cellulose; 8 mg of stearic acid; 8 mg of silica; 2 mg of a turmeric; and 75 mg of a lactic acid bacteria pre-blend comprising a lyophilized powder including the probiotic and starch. ### Claim 4 (depends on 1) The controlled release formulation of claim 1 wherein the probiotic is non-viable. ### Claim 5 (depends on 1) The controlled release formulation of claim 1 having a total weight of approximately 532 mg and consisting of the following components, each in the approximate amount of: 150 mg of hydroxypropyl methylcellulose; 100 mg of pectin; 100 mg of sodium bicarbonate; 16 mg of stearic acid; 16 mg of silica; and 150 mg of a bifidobacterium bacteria pre-blend comprising a lyophilized powder including the probiotic and starch. ### Claim 6 (depends on 1) The formulation of claim 1 wherein the probiotic is a lactic acid bacteria. ### Claim 7 (depends on 1) The formulation of claim 1 wherein the probiotic comprises one or more of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus plantarum, Streptococcus thermophilus, Bifidobacterium infantis, Bifidobacterium bifidum, or Bifidobacterium longum. ### Claim 8 (depends on 1) The formulation of claim 1 wherein the electrolytic agent is sodium bicarbonate. ### Claim 9 (depends on 1) The formulation of claim 1 wherein said formulation is a directly compressed monolithic tablet. ### Claim 10 A controlled release formulation for oral delivery to an intestinal system, the formulation comprising: about 5% to 40% by total weight of hydroxypropyl methylcellulose; about 5% to 40% by total weight of pectin; about 1% to 40% by total weight of sodium bicarbonate; and a probiotic; wherein said formulation is a monolithic tablet without an enteric coating. ### Claim 11 (depends on 10) The controlled release formulation of claim 10 wherein the hydroxypropyl methylcellulose and the pectin are present in a ratio of about 1:1. ### Claim 12 (depends on 10) The controlled release formulation of claim 10 having a total weight of approximately 343 mg and consisting of the following components, each in the approximate amount of: 50 mg of hydroxypropyl methylcellulose; 50 mg of pectin; 50 mg of sodium bicarbonate; 100 mg of microcrystalline cellulose; 8 mg of stearic acid; 8 mg of silica; 2 mg of a turmeric; and 75 mg of a lactic acid bacteria pre-blend comprising a lyophilized powder including the probiotic and starch. ### Claim 13 (depends on 10) The controlled release formulation of claim 10 wherein the probiotic is non-viable. ### Claim 14 (depends on 10) The controlled release formulation of claim 10 having a total weight of approximately 532 mg and consisting of the following components, each in the approximate amount of: 150 mg of hydroxypropyl methylcellulose; 100 mg of pectin; 100 mg of sodium carbonate bicarbonate; 16 mg of stearic acid; 16 mg of silica; and 150 mg of a bifidobacterium bacteria pre-blend comprising a lyophilized powder including the probiotic and starch. ### Claim 15 (depends on 10) The formulation of claim 10 wherein the probiotic is a lactic acid bacteria. ### Claim 16 (depends on 10) The formulation of claim 10 wherein the probiotic comprises one or more of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus plantarum, Streptococcus thermophilus, Bifidobacterium infantis, Bifidobacterium bifidum, or Bifidobacterium longum. ### Claim 17 (depends on 10) The formulation of claim 10 wherein said formulation is a directly compressed monolithic tablet. ### Claim 18 A controlled release formulation for oral delivery to an intestinal system, the formulation comprising: about 5% to 40% by total weight of hydroxypropyl methylcellulose; about 5% to 40% by total weight of pectin; about 1% to 40% by total weight of sodium carbonate; and a probiotic; wherein said formulation is a monolithic tablet without an enteric coating.