Biodegradable organic polymer delivery system for bone morphogenetic protein

• US 4,563,489 A
• Filed: 02/10/1984
• Issued: 01/07/1986
• Est. Priority Date: 02/10/1984
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: University of California
• Inventors: Urist, Marshall R.
• Primary Examiner(s): Kight, John
• Assistant Examiner(s): Nutter, Nathan M.
• Application Number:
  US06/579,034
• Time in Patent Office: 697 Days
• Field of Search: 524/17, 524/21, 523/113, 523/115, 523/116, 523/117, 424/177, 424/359, 424/78, 604/890, 604/891, 3/1.9
• US Class Current: 424/422
• CPC Class Codes: A61K 9/204 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: C08L 89/00 Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00
• CPC Class Codes: Y10S 623/915 Method or apparatus for preparing biological material

Abstract

Disclosed is a biodegradable polylactic acid polymer delivery system for delivery of bone morphogenic protein (BMP) to induce formation of new bone in viable tissue. The delivery composition is substantially pure BMP in combination with a biodegradable polylactic acid polymer and it is prepared by admixing the BMP with the biodegradable polymer. The composition is implanted in viable tissue where the BMP is slowly released and induces formation of new bone.

Claims

1. A composition comprising substantially pure BMP and physiologically acceptable, biodegradable polylactic acid polymer.

2. A composition comprising substantially pure BMP and a physiologically acceptable, biodegradable organic polymer selected from polylactic acid, polylactide, polyglycollic acid, polyglactin or polyglactic acid.

3. A delivery composition for delivering BMP to induce formation of new bone in viable tissue comprising substantially pure BMP and a physiologically acceptable, biodegradable polylactic acid polymer.

4. The delivery composition according to claim 3 to induce formation of new bone in viable tissue wherein the weight ratio of BMP to polymer is at least about 0.05 parts BMP to about 20 parts polymer.

5. The delivery composition according to claim 4 wherein the ratio is at least about 0.1 parts BMP to about 20 parts polymer.

6. The delivery composition of claim 5 wherein said weight ratio is in the range of up to 10 parts BMP to 20 parts polymer.

7. The delivery composition of claim 4 including in said composition a radioopacifying agent.

8. The delivery composition of claim 4 including in said composition an antibiotic.

9. A delivery composition for delivering BMP to induce formation of new bone in viable tissue comprising substantially pure BMP and a physiologically acceptable, biodegradable organic polymer selected from polylactic acid, polylactide, polyglycollic acid, polyglactin or polyglactic acid.

10. The method of preparing a delivery composition for delivering BMP to induce formation of new bone in viable tissue comprising the step of dissolving physiologically acceptable, biodegradable polylactic polymer in a solvent to form a solution, admixing the solution and BMP to form a dispersion, adding a second solvent to the dispersion which causes the precipitation of the polymer and forms a composite of said polymer and said BMP, and removing the solvents from said composite to form said composition, the weight ratio of BMP and polymer being at least 0.05 parts BMP to 20 parts polymer.

11. The method of inducing formation of new bone in viable tissue comprising implanting in said viable tissue a delivery composition comprising BMP and a physiologically acceptable, biodegradable polylactic acid polymer wherein the weight ratio is at least about 0.05 parts BMP to about 20 parts polymer.

12. A method according to claim 11 wherein the weight ratio is at least about 0.1 parts BMP to about 20 parts polymer.

13. A method according to claim 12 wherein the weight ratio is at least about 0.1 parts BMP to about 20 prts polymer.