Methods for forming compositions for treating joints comprising bone morphogenetic protein and hyaluronic acid

• US 8,927,491 B2
• Filed: 03/07/2013
• Issued: 01/06/2015
• Est. Priority Date: 12/28/2010
• Status: Active Grant

• Current Assignee: Depuy Mitek LLC (Johnson & Johnson)
• Original Assignee: Depuy Mitek LLC (Johnson & Johnson)
• Inventors: Su, Dongling, Hwang, Julia, Byers, Benjamin A.
• Primary Examiner(s): KEMMERER, ELIZABETH
• Application Number:
  US13/788,838
• Publication Number:
  US 20130172255A1
• Time in Patent Office: 670 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 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/1875 Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
• 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 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 39/223 Multiway valves
• 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 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/31 Details
• 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 method for forming a composition for treating a joint disorder, comprising:

combining a solution of hyaluronic acid (HA) and a bone morphogenetic protein (BMP); and

allowing the combination to form a mixture containing a precipitate of the BMP that is dispersed within the HA solution at a concentration in the range of about 5 μ

g/ml to about 90 μ

g/ml in the solution of HA, the mixture having a pH in the range of about 3 to 8, the BMP being in its precipitated form and capable of becoming solubilized and biologically active following delivery to an organism.

2. The method of claim 1, wherein the solution of HA is present in a syringe, and the BMP is present in the syringe.

3. The method of claim 2, wherein the syringe is a multi-chamber syringe and the HA solution and BMP are present in different chambers of the syringe.

4. The method of claim 2, wherein the solution of HA and the BMP are combined in a single chamber of the syringe.

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

6. The method of claim 5, 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).

7. The method of claim 1, wherein the BMP is in a liquid state prior to combining with the solution of HA.

8. The method of claim 1, wherein the BMP is in a lyophilized state prior to combining with the solution of HA.

9. The method of claim 2, wherein the mixture has a pH in the range of about 5 to 7.5.

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

11. The method of claim 1, wherein the HA is at a concentration of at least 7 mg/ml.

12. The method of claim 1, wherein the solution of HA comprises HA and water.

13. The method of claim 1, wherein the BMP is selected from the group of BMP2 and BMP7.

14. The method of claim 1, wherein the HA is at a concentration of about 5 mg/ml to about 60 mg/ml.