Claims
- 1. A sustained release composition comprising a biologically active agent and a polymer paste comprising a biocompatible, biodegradable polymer having an inherent viscosity of about 0.12 dL/g or less and a viscosity reducing agent, wherein the biocompatible, biodegradable polymer is present in the polymer paste in at least 60% by weight and the viscosity of the composition is about 400 cP or less.
- 2. The sustained release composition of claim 1, wherein the biocompatible, biodegradable polymer is selected from the group consisting of: poly(lactide)s, poly(glycolide)s, poly(lactide-co-glycolide)s, poly(lactic acid)s, poly(glycolic acid)s, polycarbonates, polyesteramides, polyanhydrides, poly(amino acid)s, polyacetals, polycyanoacrylates, polyetheresters, polyorthoesters, polycaprolactone, poly(dioxanone)s, poly(alkylene alkylate)s, polyurethanes, and blends and copolymers thereof.
- 3. The sustained release composition of claim 2, wherein the biocompatible, biodegradable polymer is a poly(lactide-co-glycolide) polymer.
- 4. The sustained release composition of claim 3, wherein the poly(lactide-co-glycolide) polymer is selected from the group consisting of: TEGPLGA5050; ULMPLGA5050-L; ULMPLGA5050-LA; ULMPLGA7525-L; ULMPDLLA-L, and any combination thereof.
- 5. The sustained release composition of claim 1, wherein the viscosity reducing agent is selected from the group consisting of: polyethylene glycol polymers, surfactants, organic solvents, aqueous solvents, and combinations thereof.
- 6. The sustained release composition of claim 5, wherein the viscosity reducing agent is a polyethylene glycol polymer.
- 7. The sustained release composition of claim 6, wherein the polyethylene glycol polymer is PEG200.
- 8. The sustained release composition of claim 5, wherein the viscosity reducing agent is a polymer surfactant.
- 9. The sustained release composition of claim 8, wherein the polymer surfactant is a nonionic polymer surfactant selected from the group consisting of poloxamers and polysorbates.
- 10. The sustained release composition of claim 9, wherein the poloxamer is selected from the group consisting of: poloxamer 407, poloxamer 188, poloxamer 331, poloxamer 184, and combinations thereof.
- 11. The sustained release composition of claim 1, wherein the viscosity reducing agent is an organic solvent or an aqueous solvent.
- 12. The sustained release composition of claim 11, wherein the organic solvent is selected from the group consisting of: organic acids; DMSO; dimethylsulfone; tetrahydrofuran; N-methyl-2-pyrrolidone (NMP); 2-pyrrolidone; alcohols; dialkylamides; triacetiens; benzyl benzoate; methyl benzoate; ethyl acetate; ethyl lactate; and combinations thereof.
- 13. The sustained release composition of claim 12, wherein the dialkylamide is dimethylformamide, dimethylacetamide, or a combination thereof.
- 14. The sustained release composition of claim 12, wherein the alcohol is solketal, glycerol formal, glycofurol, benzyl alcohol, or a combination thereof.
- 15. The sustained release composition of claim 12, wherein the organic acid is lactic acid, acetic acid, or a combination thereof.
- 16. The sustained release composition of claim 5, wherein the viscosity reducing agent is a combination of a polyethylene glycol polymer and an organic solvent.
- 17. The sustained release composition of claim 5, wherein the viscosity reducing agent is a combination of a polyethylene glycol polymer and an organic acid.
- 18. The sustained release composition of claim 5, wherein the viscosity reducing agent is a combination of organic solvents.
- 19. The sustained release composition of claim 1, wherein the biologically active agent is present from about 0.5 g per 100 g polymer paste to about 75 g per 100 g polymer paste.
- 20. A method for the sustained delivery of a biologically active agent to a patient in need thereof comprising administering a therapeutically effective amount of a sustained release composition comprising a biologically active agent and a polymer paste comprising a biocompatible, biodegradable polymer having an inherent viscosity of about 0.12 dL/g or less and a viscosity reducing agent, wherein the biocompatible, biodegradable polymer is present in the polymer paste in at least 60% by weight and the viscosity of the composition is about 400 cP or less.
- 21. The method of claim 20, wherein the biocompatible, biodegradable polymer is selected from the group consisting of: poly(lactide)s, poly(glycolide)s, poly(lactide-co-glycolide)s, poly(lactic acid)s, poly(glycolic acid)s, polycarbonates, polyesteramides, polyanhydrides, poly(amino acid)s, polyacetals, polycyanoacrylates, polyetheresters, polyorthoesters, polycaprolactone, poly(dioxanone)s, poly(alkylene alkylate)s, polyurethanes, and blends and copolymers thereof.
- 22. The method of claim 21, wherein the biocompatible, biodegradable polymer is a poly(lactide-co-glycolide) polymer.
- 23. The method of claim 22, wherein the poly(lactide-co-glycolide) polymer is selected from the group consisting of: TEGPLGA5050; ULMPLGA5050-L; ULMPLGA5050-LA; ULMPLGA7525-L; ULMPDLLA-L, and combinations thereof.
- 24. The method of claim 20, wherein the viscosity reducing agent is selected from the group consisting of: polyethylene glycol polymers, surfactants, organic solvents, aqueous solvents, and combinations thereof.
- 25. The method of claim 24, wherein the viscosity reducing agent is a polyethylene glycol polymer.
- 26. The method of claim 25, wherein the polyethylene glycol polymer is PEG200.
- 27. The method of claim 24, wherein the viscosity reducing agent is a polymer surfactant.
- 28. The method of claim 27, wherein the polymer surfactant is a nonionic polymer surfactant selected from the group consisting of: poloxamers and polysorbates.
- 29. The method of claim 28 wherein the poloxamer is selected from the group consisting of: poloxamer 407, poloxamer 188, poloxamer 184, poloxamer 331, and combinations thereof.
- 30. The method of claim 20, wherein the viscosity reducing agent is an organic solvent.
- 31. The method of claim 30, wherein the organic solvent is selected from the group consisting of: organic acids; DMSO; dimethylsulfone; tetrahydrofuran; N-methyl-2-pyrrolidone (NMP); 2-pyrrolidone; alcohols; dialkylamides; triacetiens; benzyl benzoate; methyl benzoate; ethyl acetate; ethyl lactate; and combinations thereof.
- 32. The method of claim 31, wherein the dialkylamide is dimethylformamide, dimethylacetamide, or a combination thereof.
- 33. The method of claim 31, wherein the alcohol is solketal, glycerol formal, glycofurol, benzyl alcohol, or a combination thereof.
- 34. The method of claim 31, wherein the organic acid lactic acid, acetic acid, or a combination thereof.
- 35. The method of claim 24, wherein the viscosity reducing agent is a combination of a polyethylene glycol polymer and an organic solvent.
- 36. The method of claim 24, wherein the viscosity reducing agent is a combination of a polyethylene glycol polymer and an organic acid.
- 37. The method of claim 24, wherein the viscosity reducing agent is a combination of an organic solvent and an organic acid.
- 38. The method of claim 20 wherein the biologically active agent is present from about 0.5 g per 100 g polymer paste to about 75 g per 100 g polymer paste.
- 39. A polymer paste comprising a biocompatible, biodegradable polymer having an inherent viscosity of about 0.12 dL/g or less and a viscosity reducing agent, wherein the biocompatible, biodegradable polymer is present in the polymer paste in at least 60% by weight and the viscosity of the paste is about 400 cP or less.
- 40. The polymer paste of claim 39, wherein the biocompatible, biodegradable polymer is selected from the group consisting of: poly(lactide)s, poly(glycolide)s, poly(lactide-co-glycolide)s, poly(lactic acid)s, poly(glycolic acid)s, polycarbonates, polyesteramides, polyanhydrides, poly(amino acid)s, polyacetals, polycyanoacrylates, polyetheresters, polyorthoesters, polycaprolactone, poly(dioxanone)s, poly(alkylene alkylate)s, polyurethanes, and blends and copolymers thereof.
- 41. The polymer paste of claim 40, wherein the biocompatible, biodegradable polymer is a poly(lactide-co-glycolide) polymer.
- 42. The polymer paste of claim 41, wherein the poly(lactide-co-glycolide) polymer is selected from the group consisting of: TEGPLGA5050; ULMPLGA5050-L; ULMPLGA5050-LA; ULMPLGA7525-L; ULMPDLLA-L, and any combination thereof.
- 43. The polymer paste of claim 39, wherein the viscosity reducing agent is selected from the group consisting of: polyethylene glycol polymers, surfactants, organic solvents, aqueous solvents, and combinations thereof.
- 44. The polymer paste of claim 43, wherein the viscosity reducing agent is a polyethylene glycol polymer.
- 45. The polymer paste of claim 44, wherein the polyethylene glycol polymer is PEG200.
- 46. The polymer paste of claim 43, wherein the viscosity reducing agent is a polymer surfactant.
- 47. The polymer paste of claim 46, wherein the polymer surfactant is a nonionic polymer surfactant selected from the group consisting of: poloxamers and polysorbates.
- 48. The polymer paste of claim 47, wherein the poloxamer is selected from the group consisting of: poloxamer 407, poloxamer 188, poloxamer 331, poloxamer 184, and combinations thereof.
- 49. The polymer paste of claim 39, wherein the viscosity reducing agent is an organic solvent or an aqueous solvent.
- 50. The polymer paste of claim 49, wherein the organic solvent is selected from the group consisting of: organic acids; DMSO; dimethylsulfone; tetrahydrofuran; N-methyl-2-pyrrolidone (NMP); 2-pyrrolidone; alcohols; dialkylamides; triacetiens; benzyl benzoate; methyl benzoate; ethyl acetate; ethyl lactate; and combinations thereof
- 51. The polymer paste of claim 50, wherein the dialkylamide is dimethylformamide, dimethylacetamide, or a combination thereof.
- 52. The polymer paste of claim 50, wherein the alcohol is solketal, glycerol formal, glycofurol, benzyl alcohol, or a combination thereof.
- 53. The polymer paste of claim 50, wherein the organic acid is lactic acid, acetic acid, or a combination thereof.
- 54. The polymer paste of claim 43 wherein the viscosity reducing agent is a combination of a polyethylene glycol polymer and an organic solvent.
- 55. The polymer paste of claim 43, wherein the viscosity reducing agent is a combination of a polyethylene glycol polymer and an organic acid.
- 56. The polymer paste of claim 43, wherein the viscosity reducing agent is a combination of organic solvents.
RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional Patent Application No. 60/471,209, filed May 16, 2003, the entire teachings of which are incorporated herein by reference.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60471209 |
May 2003 |
US |