Method of administering hyaluronan formulation for preventing and ameliorating osteoarthritis

• US 9,492,381 B1
• Filed: 10/16/2013
• Issued: 11/15/2016
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: BI Investments LLC
• Original Assignee: Reyn Pharma, LLC
• Inventors: Smith, James D.
• Primary Examiner(s): McIntosh, III, Traviss C
• Application Number:
  US14/054,928
• Time in Patent Office: 1,126 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A23L 2/52 Adding ingredients adding preservatives A23L2/44
• CPC Class Codes: A23L 33/30 Dietetic or nutritional methods, e.g. for losing weight A23L33/10 takes precedence
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031

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

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 hyaluronan composition comprising hyaluronan polymer and a pharmaceutically acceptable carrier to the subject, wherein the pH of the composition is about 2.5 to about 4.5.

2. The method of claim 1, wherein the hyaluronan comprises an average molecular weight from about 750,000 to about 2,250,000 Daltons.

3. The method of claim 2, wherein the hyaluronan comprises an average molecular weight from about 1,000,000 to about 2,000,000 Daltons.

4. The method of claim 3, wherein the hyaluronan comprises an average molecular weight from about 1,250,000 to about 1,750,000 Daltons.

5. The method of claim 4, wherein the hyaluronan comprises an average molecular weight from about 1,375,000 to about 1,625,000 Daltons.

6. The method of claim 5, wherein the hyaluronan comprises an average molecular weight about 1,500,000 Daltons.

7. 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 liquid composition comprising a therapeutically effective amount of hyaluronan and a pharmaceutically acceptable carrier, wherein the pH of the composition is between about 2.5 and about 4.5.

8. The method of claim 7, wherein the hyaluronan comprises an average molecular weight from about 750,000 to about 2,250,000 Daltons.

9. The method of claim 8, wherein the hyaluronan comprises an average molecular weight from about 1,000,000 to about 2,000,000 Daltons.

10. The method of claim 9, wherein the hyaluronan comprises an average molecular weight from about 1,250,000 to about 1,750,000 Daltons.

11. The method of claim 10, wherein the hyaluronan comprises an average molecular weight from about 1,375,000 to about 1,625,000 Daltons.

12. The method of claim 11, wherein the hyaluronan comprises an average molecular weight about 1,500,000 Daltons.

13. 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 liquid dietary supplement comprising a therapeutically effective amount of hyaluronan and a pharmaceutically acceptable carrier, wherein the pH of the composition is between about 2.5 and about 4.5.

14. The method of claim 13, wherein the hyaluronan comprises an average molecular weight from about 750,000 to about 2,250,000 Daltons.

15. The method of claim 14, wherein the hyaluronan comprises an average molecular weight from about 1,000,000 to about 2,000,000 Daltons.

16. The method of claim 15, wherein the hyaluronan comprises an average molecular weight from about 1,250,000 to about 1,750,000 Daltons.

17. The method of claim 16, wherein the hyaluronan comprises an average molecular weight from about 1,375,000 to about 1,625,000 Daltons.

18. The method of claim 17, wherein the hyaluronan comprises an average molecular weight about 1,500,000 Daltons.

19. A method for reducing joint pain in a vertebrate subject in need thereof, the method comprising orally administering to the subject a liquid dietary supplement comprising a therapeutically effective amount of hyaluronan and a pharmaceutically acceptable carrier, wherein the pH of the dietary supplement is between about 2.5 and about 4.5.

20. The method of claim 19, wherein the hyaluronan comprises an average molecular weight from about 750,000 to about 2,250,000 Daltons.

21. The method of claim 20, wherein the hyaluronan comprises an average molecular weight from about 1,000,000 to about 2,000,000 Daltons.

22. The method of claim 21, wherein the hyaluronan comprises an average molecular weight from about 1,250,000 to about 1,750,000 Daltons.

23. The method of claim 22, wherein the hyaluronan comprises an average molecular weight from about 1,375,000 to about 1,625,000 Daltons.

24. The method of claim 23, wherein the hyaluronan comprises an average molecular weight about 1,500,000 Daltons.

25. A method for supporting joint health in a vertebrate subject in need thereof, the method comprising orally administering to the subject a liquid composition comprising a therapeutically effective amount of hyaluronan and a pharmaceutically acceptable carrier, wherein the pH of the liquid composition is between about 2.5 and about 4.5.

26. The method of claim 25, wherein the hyaluronan comprises an average molecular weight from about 750,000 to about 2,250,000 Daltons.

27. The method of claim 26, wherein the hyaluronan comprises an average molecular weight from about 1,000,000 to about 2,000,000 Daltons.

28. The method of claim 27, wherein the hyaluronan comprises an average molecular weight from about 1,250,000 to about 1,750,000 Daltons.

29. The method of claim 28, wherein the hyaluronan comprises an average molecular weight from about 1,375,000 to about 1,625,000 Daltons.

30. The method of claim 29, wherein the hyaluronan comprises an average molecular weight about 1,500,000 Daltons.