# US 9,433,575 B1 · Method of administering hyaluronan formulation for preventing and ameliorating osteoarthritis > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,575 B1 - Document ID: US9433575B1 - Status: Granted - Kind: B1 - Application number: 14/054,102 - Filed: 2013-10-15 - Granted: 2016-09-06 - Earliest claimed: 2005-11-10 - Assignees: Reyn Pharma, LLC - Applicants: Reyn Pharma, LLC - Inventors: James D. Smith - Web page: https://patentgrep.com/patent/US9433575B1 ## CPC - A61K 31/728: Hyaluronic acid - A23L 33/10: using additives (addition of substantially indigestible substances A23L33/21) - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 47/02: Inorganic compounds - A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs - 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) - A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B) - A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION ## Abstract Disclosed is a method for mitigating or ameliorating osteoarthritis in vertebrate subjects including administering to a subject a therapeutically effective amount of an exogenous hyaluronan formulation. Also disclosed is an oral or parenteral hyaluronan composition comprising a polydisperse hyaluronan and a pharmaceutically acceptable carrier, and a method of manufacturing the composition. ## Claims ### Claim 1 A method for slowing, attenuating, mitigating, and/or ameliorating the loss of articular cartilage in a vertebrate subject, the method comprising orally administering a liquid composition comprising a therapeutically effective amount of exogenous polydisperse hyaluronan composition comprising a blend of hyaluronan polymers having different molecular masses from about 500,000 to about 2,500,000 Daltons and a pharmaceutically acceptable carrier to the subject, wherein the pH of the composition is between about 2.5 and about 4.5. ### Claim 2 (depends on 1) The method of claim 1, wherein the composition comprises from about 0.2 to about 5 mg hyaluronan per kg body weight of the subject. ### Claim 3 (depends on 2) The method of claim 2, wherein the composition comprises from about 0.4 to about 4 mg hyaluronan per kg body weight of the subject. ### Claim 4 (depends on 3) The method of claim 3, wherein the composition comprises from about 0.6 to about 3 mg hyaluronan per kg body weight of the subject. ### Claim 5 (depends on 4) The method of claim 4, wherein the composition comprises from about 0.8 to about 2 mg hyaluronan per kg body weight of the subject. ### Claim 6 (depends on 5) The method of claim 5, wherein the composition comprises about 1 mg hyaluronan per kg body weight of the subject. ### Claim 7 (depends on 1) The method of claim 1, wherein the pharmaceutically acceptable carrier comprises water. ### Claim 8 (depends on 1) The method of claim 1, wherein the composition further comprises at least one pharmaceutically acceptable excipient. ### Claim 9 (depends on 8) The method of claim 8, wherein the pharmaceutically acceptable excipient comprises sodium chloride. ### Claim 10 (depends on 1) The method of claim 1, wherein the composition comprises citric acid. ### Claim 11 (depends on 1) The method of claim 1, wherein the composition comprises an antimicrobial preservative. ### Claim 12 (depends on 11) The method of claim 11, wherein the preservative is at least one of potassium sorbate and sodium benzoate. ### Claim 13 (depends on 1) The method of claim 1, wherein the hyaluronan comprises molecular weights from about 750,000 to about 2,250,000 Daltons. ### Claim 14 (depends on 13) The method of claim 13, wherein the hyaluronan comprises molecular weights from about 1,000,000 to about 2,000,000 Daltons. ### Claim 15 (depends on 14) The method of claim 14, wherein the hyaluronan comprises molecular weights from about 1,250,000 to about 1,750,000 Daltons. ### Claim 16 (depends on 15) The method of claim 15, wherein the hyaluronan comprises molecular weights from about 1,375,000 to about 1,625,000 Daltons. ### Claim 17 (depends on 16) The method of claim 16, wherein the hyaluronan is of median molecular weight about 1,500,000 Daltons. ### Claim 18 A method for stimulating endogenous production of hyaluronic acid by synoviocytes in a vertebrate subject comprising administering a composition comprising a therapeutically effective amount of exogenous polydisperse hyaluronan composition comprising a blend of hyaluronan polymers having different molecular masses from about 500,000 to about 2,500,000 Daltons, wherein the pH of the composition is between about 2.5 and about 4.5. ### Claim 19 (depends on 18) The method of claim 18, wherein the composition comprises a pharmaceutically acceptable carrier. ### Claim 20 (depends on 19) The method of claim 19, wherein the composition comprises at least one pharmaceutically acceptable excipient. ### Claim 21 (depends on 18) The method of claim 18, wherein the composition comprises an antimicrobial preservative. ### Claim 22 (depends on 18) The method of claim 18, wherein the composition comprises citric acid. ### Claim 23 (depends on 18) The method of claim 18, wherein administering comprises oral administration. ### Claim 24 (depends on 18) The method of claim 18, wherein administering comprises parenterally administering by one of subcutaneous administration, or intramuscular administration, intravenous administration. ### Claim 25 (depends on 18) The method of claim 18, wherein the hyaluronan comprises molecular weights from about 750,000 to about 2,250,000 Daltons. ### Claim 26 (depends on 25) The method of claim 25, wherein the hyaluronan comprises molecular weights from about 1,000,000 to about 2,000,000 Daltons. ### Claim 27 (depends on 26) The method of claim 26, wherein the hyaluronan comprises molecular weights from about 1,250,000 to about 1,750,000 Daltons. ### Claim 28 (depends on 27) The method of claim 27, wherein the hyaluronan comprises molecular weights from about 1,375,000 to about 1,625,000 Daltons. ### Claim 29 (depends on 28) The method of claim 28, wherein the hyaluronan is of median molecular weight about 1,500,000 Daltons. ### Claim 30 A method for slowing, attenuating, mitigating, and/or ameliorating joint discomfort in a vertebrate subject in need thereof, the method comprising orally administering to the subject a composition comprising a therapeutically effective amount of polydisperse hyaluronan having an average molecular weight of from about 500,000 to about 2,500,000 Daltons and a pharmaceutically acceptable carrier, wherein the pH of the composition is between about 2.5 and about 4.5. ### Claim 31 (depends on 30) The method of claim 30, wherein the hyaluronan comprises an average molecular weight from about 750,000 to about 2,250,000 Daltons. ### Claim 32 (depends on 30) The method of claim 30, wherein the hyaluronan comprises an average molecular weight from about 1,000,000 to about 2,000,000 Daltons. ### Claim 33 A method for slowing, attenuating, mitigating, and/or ameliorating joint discomfort in a vertebrate subject in need thereof, the method comprising orally administering to the subject a dietary supplement comprising a therapeutically effective amount of polydisperse hyaluronan having an average molecular weight of from about 500,000 to about 2,500,000 Daltons and a pharmaceutically acceptable carrier, wherein the pH of the dietary supplement is between about 2.5 and about 4.5. ### Claim 34 (depends on 33) The method of claim 33, wherein the hyaluronan comprises an average molecular weight from about 750,000 to about 2,250,000 Daltons. ### Claim 35 (depends on 33) The method of claim 33, wherein the hyaluronan comprises an average molecular weight from about 1,000,000 to about 2,000,000 Daltons. ### Claim 36 A method for reducing joint pain in a vertebrate subject in need thereof, the method comprising orally administering to the subject a dietary supplement comprising a therapeutically effective amount of polydisperse hyaluronan having an average molecular weight of from about 500,000 to about 2,500,000 Daltons and a pharmaceutically acceptable carrier, wherein the pH of the dietary supplement is between about 2.5 and about 4.5. ### Claim 37 (depends on 36) The method of claim 36, wherein the hyaluronan comprises an average molecular weight from about 750,000 to about 2,250,000 Daltons. ### Claim 38 (depends on 36) The method of claim 36, wherein the hyaluronan comprises an average molecular weight from about 1,000,000 to about 2,000,000 Daltons. ### Claim 39 A method for supporting joint health in a vertebrate subject in need thereof, the method comprising orally administering to the subject a dietary supplement comprising a therapeutically effective amount of polydisperse hyaluronan having an average molecular weight from about 500,000 to about 2,500,000 Daltons and a pharmaceutically acceptable carrier, wherein the pH of the dietary supplement is between about 2.5 and about 4.5. ### Claim 40 (depends on 39) The method of claim 39, wherein the hyaluronan comprises an average molecular weight from about 750,000 to about 2,250,000 Daltons. ### Claim 41 (depends on 39) The method of claim 39, wherein the hyaluronan comprises an average molecular weight from about 1,000,000 to about 2,000,000 Daltons.