Compositions and methods for treating joints

• US 8,524,662 B2
• Filed: 12/28/2010
• Issued: 09/03/2013
• Est. Priority Date: 12/28/2010
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Mitek LLC (Johnson & Johnson)
• Inventors: Byers, Ben, Su, Dongling, Hwang, Julia
• Primary Examiner(s): KEMMERER, ELIZABETH
• Application Number:
  US12/979,972
• Publication Number:
  US 20120165731A1
• Time in Patent Office: 980 Days
• Field of Search: None
• US Class Current: 514/8.8
• 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 31/728 Hyaluronic acid
• CPC Class Codes: A61K 38/1875 Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis

Abstract

Methods and compositions are disclosed for an intra-articular injection for the treatment of osteoarthritis. The methods and compositions comprising combinations of hyaluronic acid and a bone morphogenetic protein, like rhGDF-5, 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 condition, comprising:

an injectable formulation comprising a precipitate of a bone morphogenetic protein (BMP) dispersed within a solution of hyaluronic acid (HA), the injectable formulation having a pH of at least about 3 and a concentration of BMP in the range of about 5 μ

g/mL to about 90 μ

g/mL, and the BMP being in a precipitated form and capable of becoming solubilized and biologically active after injection into an organism.

2. The composition of claim 1, wherein the BMP is a growth and differentiation factor (GDF) protein.

3. The composition of claim 2, wherein the GDF is a growth and differentiation factor 5 (GDF-5) protein.

4. The composition of claim 2, wherein the GDF is a growth and differentiation factor 6 (GDF-6) protein.

5. The composition of claim 2, wherein the GDF is a growth and differentiation factor 7 (GDF-7) protein.

6. The composition of claim 1, wherein the BMP is selected from the group consisting of BMP2 and BMP7.

7. The composition of claim 1, wherein the mixture has a pH in the range of about 5 to 7.5.

8. The composition of claim 1, wherein the HA has a molecular weight of at least about 500 kDa.

9. The composition of claim 1, wherein the HA is at a concentration of at least about 7 mg/ml.

10. The composition of claim 1, wherein the solution of HA comprises HA and water.

11. A kit, comprising:

a first component comprising a solution of hyaluronic acid (HA) having a pH in the range of about 3 to 8;

a second component comprising an amount of a bone morphogenetic protein (BMP) that is in precipitate form and capable of becoming solubilized and biologically active following delivery to an organism; and

a syringe for injecting a mixture of the first component and the second component, wherein the mixture has a concentration of BMP in the range of about 5 μ

g/mL to about 90 μ

g/mL.

12. The composition of claim 11, 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.

13. The composition of claim 11, wherein the BMP is a growth and differentiation factor (GDF) protein.

14. The composition of claim 13, wherein the GDF is selected from the group consisting of growth and differentiation factor 5 (GDF-5), growth and differentiation factor 6 (GDF-6), and growth and differentiation factor 7 (GDF-7).

15. The composition of claim 11, wherein the mixture has a pH in the range of about 5 to 7.5.

16. The composition of claim 11, wherein the HA has a molecular weight of at least about 500 kDa.

17. The composition of claim 11, wherein the HA is at a concentration of at least about 7 mg/ml.