Compositions and methods for treating joints

• US 10,532,069 B2
• Filed: 06/02/2017
• Issued: 01/14/2020
• Est. Priority Date: 01/20/2015
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Story, Brooks J., Wadsworth, Scott A., Parrish, William R., Herzberg, Uri, Torres, Donna, Byers, Benjamin A., Hwang, Julia, Su, Dongling
• Primary Examiner(s): Olson, Eric
• Application Number:
  US15/612,267
• Publication Number:
  US 20170266221A1
• Time in Patent Office: 956 Days
• Field of Search: None
• CPC Class Codes: A61K 31/7016 Disaccharides, e.g. lactose, lactulose lactobionic acid A61K31/7032
• CPC Class Codes: A61K 31/726 Glycosaminoglycans, i.e. mucopolysaccharides chondroitin sulfate, dermatan sulfate A61K31/737
• 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 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• 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: A61L 2300/236 Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/24 for joint reconstruction
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• 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 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C08B 37/0069 Chondroitin-4-sulfate, i.e. chondroitin sulfate A; Dermatan sulfate, i.e. chondroitin sulfate B or beta-heparin; Chondroitin-6-sulfate, i.e. chondroitin sulfate C; Derivatives thereof
• CPC Class Codes: C08B 37/0072 Hyaluronic acid, i.e. HA or hyaluronan; Derivatives thereof, e.g. crosslinked hyaluronic acid (hylan) or hyaluronates

Abstract

Compositions and methods are disclosed for the treatment of osteoarthritis. The compositions comprising combinations of hyaluronic acid, glucosamine, and chondroitin sulfate, can be useful for any synovial joint, including the knee, shoulder, hip, ankle, hands, spinal facet, or temporomandibular joint, both for the relief of pain and for slowing disease progression.

Claims

1. A composition for treating a joint, comprising:

an injectable formulation comprising hyaluronic acid (HA), glucosamine, and chondroitin sulfate, and the injectable formulation having a pH in the range of about 3-5.

2. The composition of claim 1, wherein glucosamine is present in a concentration of about 0.005-54 mg/mL.

3. The composition of claim 1, wherein chondroitin sulfate is present in a concentration of about 0.005-54 mg/mL.

4. The composition of claim 1, wherein HA is present in a concentration of about 3.6-36 mg/mL.

5. The composition of claim 1, wherein glucosamine and chondroitin sulfate are present in a ratio by weight of about 1:

1.

6. The composition of claim 1, further comprising trehalose.

7. The composition of claim 1, wherein

glucosamine is present in a concentration of about 18-20 mg/mL;

chondroitin sulfate is present in a concentration of about 18-20 mg/mL;

HA is present in a concentration of about 12-17.5 mg/mL;

the pH is in the range of about 3.5-4; and

the osmolality is in the range of about 600-650 mOSM.

8. A method of treating a joint, comprising:

injecting a therapeutically effective amount of a formulation into a joint of a subject,

wherein the formulation comprising hyaluronic acid (HA), glucosamine, and chondroitin sulfate, and having a pH of 3-5.

9. The method of claim 8, further comprising combining the HA with a mixture of the glucosamine and chondroitin sulfate to form the formulation less than about 30 minutes prior to injection.

10. The method of claim 8, wherein glucosamine is present in the formulation in the range of about 0.005-54 mg/mL.

11. The method of claim 8, wherein chondroitin sulfate is present in the formulation in the range of about 0.005-54 mg/mL.

12. The method of claim 8, wherein HA is present in the formulation in the range of about 3.6-36 mg/mL.

13. The method of claim 8, wherein glucosamine and chondroitin sulfate are present in the formulation in a ratio of about 1:

1.

14. The method of claim 8, wherein the formulation further comprises trehalose.

15. The method of claim 8, wherein

glucosamine is present in the formulation in the range of about 18-20 mg/mL;

chondroitin sulfate is present in the formulation in the range of about 18-20 mg/mL;

HA is present in the formulation in the range of about 12-17.5 mg/mL;

the pH is in the range of about 3.5-4; and

the osmolality is in the range of about 600-650 mOSM.

16. A kit for treating a joint, comprising:

hyaluronic acid (HA), and glucosamine and chondroitin sulfate separate from the HA, wherein combining the HA, glucosamine, and chondroitin sulfate forms a formulation having a pH in the range of about 3-5; and

a syringe for injecting the formulation into a joint.

17. The kit of claim 16, wherein the syringe comprises

a first chamber containing the HA;

a second chamber containing the glucosamine and chondroitin sulfate, and in fluid communication with the first chamber; and

a plunger configured to displace the glucosamine and chondroitin sulfate from the second container into the first container, to combine the HA, glucosamine, and chondroitin sulfate, and form the formulation.

18. The kit of claim 16, wherein glucosamine has a concentration of about 0.005-54 mg/mL.

19. The kit of claim 16, wherein chondroitin sulfate has a concentration of about 0.005-54 mg/mL.

20. The kit of claim 16, wherein HA has a concentration of about 3.6-36 mg/mL.