Compositions and methods for treating joints

• US 8,398,611 B2
• Filed: 12/28/2010
• Issued: 03/19/2013
• Est. Priority Date: 12/28/2010
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Hwang, Julia, Su, Dongling, Lopez, Julius
• Primary Examiner(s): Sirmons, Kevin C.
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US12/979,981
• Publication Number:
  US 20120165787A1
• Time in Patent Office: 812 Days
• Field of Search: 604/92, 604/500, 604/518, 623/11.11, 623/14.12
• US Class Current: 604/518
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/7008 Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 31/737 Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate A61K31/727 takes precedence
• 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: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Compositions and methods are provided for treating joint conditions, such as osteoarthritis and/or the pain associated therewith. The compositions and methods utilize a first component, namely hyaluraonic acid (“HA”), in combination with a lyophilized second component that is effective to at least temporarily reduce the viscosity of the HA. In an exemplary embodiment, the second component is one or more glycosaminoglycans (“GAG”), such as chondroitin sulfate (“CS”), including CS4 and/or CS6, dermatan sulfate, heparin, heparan sulfate, and keratan sulfate. The composition can optionally include other joint supplements, such as glucosamine (“GlcN”).

Claims

1. A kit for treating joints, comprising:

a first component comprising high molecular weight hyaluronic acid;

a second component comprising a lyophilized glycosaminoglycan, the second component being separate from the first component and effective to at least temporarily reduce the viscosity of the first component; and

a syringe for injecting a mixture of the first and second components.

2. The kit of claim 1, wherein the glycosaminoglycan comprises chondroitin sulfate.

3. The kit of claim 1, further comprising a third component comprising glucosamine.

4. The kit of claim 3, wherein the glucosamine is lyophilized.

5. The kit of claim 1, wherein, when the first and second components are combined to form a mixture, the first and second components are present within the mixture at a ratio of first component to second component in the range of about 1:

0.005 to 1;

100.

6. The kit of claim 1, wherein the syringe has a first chamber containing the first component, and a second container containing the second component, and wherein the syringe includes a plunger configured to inject the second component into the first chamber to mix the first and second components.

7. The kit of claim 1, wherein the second component is disposed within a container, and the syringe includes a first chamber containing the first component and a connector for removably coupling the container to the syringe such that a plunger slidably disposed within the first chamber of the syringe can inject the first component into the container to mix the first and second components.

8. The kit of claim 1, wherein the hyaluronic acid is lyophilized.

9. The kit of claim 1, wherein the hyaluronic acid has a molecular weight in the range of about 1 MDa to 4 MDa.

10. The kit of claim 1, wherein the hyaluronic acid has a concentration of at least about 7 mg/ml.

11. The kit of claim 1, further comprising a third component comprising a fluid configured to solubilize the first and second components.

12. The kit of claim 11, wherein the fluid is selected from the group consisting of water, saline, and a buffer.

13. A method for treating joints, comprising:

combining a first component comprising hyaluronic acid with a separate second component comprising a lyophilized glycosaminoglycan to form a mixture, wherein a viscosity of the mixture is at least temporarily less than a viscosity of the first component; and

injecting the mixture into a joint.

14. The method of claim 13, wherein the glycosaminoglycan comprises chondroitin sulfate.

15. The method of claim 13, further comprising a third component comprising glucosamine.

16. The method of claim 15, wherein the glucosamine is lyophilized.

17. The method of claim 13, wherein the hyaluronic acid is lyophilized, and wherein the first and second components are solubilized prior to or during combining the first and second components to form the mixture.

18. The method of claim 13, wherein the first and second components are combined in a vial and drawn into a syringe, and wherein the syringe is used to inject the mixture into a joint.

19. The method of claim 18, wherein the first and second components are drawn into the syringe within 30 minutes of formation of the mixture.

20. The method of claim 13, wherein the first component is disposed within a first chamber in a syringe, and the second component is disposed within a second chamber in the syringe, and wherein combining the first and second components comprises injecting the first component into the second chamber.

21. The method of claim 13, wherein combining the first and second components comprises coupling a container having the first component disposed therein to a syringe having the second component disposed therein, and injecting the second component from the syringe into the container.

22. The method of claim 13, wherein the first component has a molecular weight in the range of about 1 MDa to 4 MDa.

23. The method of claim 13, wherein the first component has a concentration of at least about 7 mg/ml.

24. The method of claim 13, wherein the first and second components are present within the mixture at a ratio of about 1:

0.005 to 1;

100.