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Details for Patent: 6,500,448

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Details for Patent: 6,500,448

Title: Composition for sustained release of human growth hormone
Abstract:A pharmaceutical composition for the sustained release of human growth hormone from a polymer matrix is disclosed. The pharmaceutical composition comprises a biocompatible polymer, particles of metal cation-complexed human growth hormone wherein said particles are dispersed within the biocompatible polymer and an aqueous injection vehicle.
Inventor(s): Johnson; OluFunmi Lily (Cambridge, MA), Ganmukhi; Medha M. (Carlisle, MA), Bernstein; Howard (Cambridge, MA), Auer; Henry (Chicago, IL), Khan; M. Amin (Downingtown, PA)
Assignee: Alkermes Controlled Therapeutics, Inc. (Cambridge, MA)
Filing Date:Feb 17, 2000
Application Number:09/505,508
Claims:1. A pharmaceutical composition for the sustained release of human growth hormone from a polymer matrix, comprising: a) a biocompatible polymer; b) particles of metal cation-complexed human growth hormone, wherein said particles are dispersed within the biocompatible polymer; and c) an aqueous injection vehicle comprising about 3% weight/volume of sodium carboxymethyl cellulose wherein the sodium carboxymethyl cellulose is low viscosity.

2. A pharmaceutical composition for the sustained release of human growth hormone from a polymer matrix, comprising: a) a biocompatible polymer; b) particles of metal cation-complexed human growth hormone, wherein said particles are dispersed within the biocompatible polymer; and c) an aqueous injection vehicle comprising about 3% weight/volume of sodium carboxymethyl cellulose and polysorbate 20.

3. The pharmaceutical composition of claim 2 wherein the polysorbate 20 is present in the aqueous vehicle at a concentration of about 1% volume/volume.

4. The pharmaceutical composition of claim 1 wherein the aqueous injection vehicle further comprises sodium chloride.

5. The pharmaceutical composition of claim 4 wherein the sodium chloride is present at a concentration of about 0.9% weight/volume.

6. A pharmaceutical composition for the sustained release of human growth hormone from a polymer matrix, comprising: a) a biocompatible polymer; b) particles of metal cation-complexed human growth hormone, wherein said particles are dispersed within the biocompatible polymer; and c) an aqueous injection vehicle comprising about 3% weight/volume of sodium carboxymethyl cellulose, polysorbate 20 at a concentration of about 1% volume/volume and sodium chloride at a concentration of about 0.9% weight/volume.

7. The pharmaceutical composition of claim 1 wherein the biocompatible polymer is selected from the group consisting of poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amine acids), polyorthoesters, polycyanoacrylates, poly(dioxanone), poly(alkylene oxalate)s, biodegradable polyurethanes, blends and copolymers thereof.

8. The pharmaceutical composition of claim 7 wherein said polymer comprises poly(lactide-co-glycolide).

9. The pharmaceutical composition of claim 1 wherein the metal cation complexed human growth hormone contains a multivalent metal cation component.

10. The pharmaceutical composition of claim 9 wherein the metal cation component contains Zn.sup.+2.

11. The pharmaceutical composition of claim 1 further comprising a second metal cation component, wherein the second metal cation component is nor complexed to said human growth hormone, and wherein the second metal cation component is dispersed within the biocompatible polymer to modulate the release of human growth hormone from the polymer matrix.

12. A pharmaceutical composition for the sustained release of human growth hormone from a polymeric matrix, comprising: a) poly(lactide-co-glycolide); b) particles of zinc-complexed human growth hormone, with a zinc-to-human growth hormone molar ratio between 4:1 and 100:1, wherein said particles are dispersed within the poly(lactide-co-glycolide), and wherein the proportion of human growth hormone in the sustained release composition is between 10 and 30 weight percent; c) a second metal cation component, wherein the second metal cation component is not complexed to said human growth hormone, and wherein the second metal cation component is dispersed within the polymeric matrix at a concentration of at least about 1% by weight of polymer; and d) an aqueous injection vehicle comprising about 3% weight/volume of sodium carboxymethyl cellulose.

13. The pharmaceutical composition of claim 12 wherein the particles of zinc complexed human growth hormone also contain sodium bicarbonate.

14. The pharmaceutical composition of claim 12 wherein said second metal cation component is zinc carbonate.

15. The pharmaceutical composition of claim 12 wherein said zinc carbonate is dispersed within the polymeric matrix at a concentration of at least about 3% by weight of polymer.

16. The pharmaceutical composition of claim 12 wherein the sodium carboxymethyl cellulose is low viscosity.

17. The pharmaceutical composition of claim 12 wherein the aqueous injection vehicle further comprises polysorbate 20.

18. The pharmaceutical composition of claim 17 wherein the polysorbate 20 is present in the aqueous vehicle at a concentration of about 1% volume/volume.

19. The pharmaceutical composition of claim 12 wherein the aqueous injection vehicle further comprises sodium chloride.

20. The pharmaceutical composition of claim 19 wherein the sodium chloride is present at a concentration of about 0.9% weight/volume.

21. The pharmaceutical composition of claim 12 wherein the aqueous injection vehicle further comprises polysorbate 20 at a concentration of about 1% volume/volume and sodium chloride at a concentration of about 0.9% weight/volume.

22. A pharmaceutical composition for the sustained release of human growth hormone from a polymer matrix, comprising: a) a biocompatible polymer; b) particles of metal cation-complexed human growth hormone with a metal cation-to-human grow hormone molar ratio from about 4:1 to about 10:1, wherein said particles are dispersed within the biocompatible polymer; and c) an aqueous injection vehicle comprising about 3% weight/volume of sodium carboxymethyl cellulose, polysorbate 20 at a concentration of about 1% volume/volume and sodium chloride at a concentration of about 0.9% weight/volume.

23. The pharmaceutical composition of claim 2 wherein the biocompatible polymer is selected from the group consisting of poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amine acids), polyorthoesters, polycyanoacrylates, poly(p-dioxanone), poly(alkylene oxalate)s, biodegradable polyurethanes, blends and copolymers thereof.

24. The pharmaceutical composition of claim 23 wherein said polymer comprises poly(lactide-co-glycolide).

25. The pharmaceutical composition of claim 6 wherein the biocompatible polymer is selected from the group consisting of poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amine acids), polyorthoesters, polycyanoacrylates, poly(p-dioxanone), poly(alkylene oxalate)s, biodegradable polyurethanes, blends and copolymers thereof.

26. The pharmaceutical composition of claim 25 wherein said polymer comprises poly(lactide-co-glycolide).

27. The pharmaceutical composition of claim 22 wherein the biocompatible polymer is selected from the group consisting of poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amine acids), polyorthoesters, polycyanoacrylates, poly(p-dioxanone, poly(alkylene oxalate)s, biodegradable polyurethanes, blends and copolymers thereof.

28. The pharmaceutical composition of claim 27 wherein said polymer comprises poly(lactide-co-glycolide).

29. The pharmaceutical composition of claim 2 wherein the metal cation-complexed human growth hormone contains a multivalent metal cation component.

30. The pharmaceutical composition of claim 29 wherein the metal cation component contains Zn.sup.+2.

31. The pharmaceutical composition of claim 6 wherein the metal cation-complexed human growth hormone contains a multivalent metal cation component.

32. The pharmaceutical composition of claim 31 wherein the metal cation component contains Zn.sup.+2.

33. The pharmaceutical composition of claim 22 wherein the metal cation-complexed human growth hormone contains a multivalent metal cation component.

34. The pharmaceutical composition of claim 33 wherein the metal cation component contains Zn.sup.+2.

35. The pharmaceutical composition of claim 2 further comprising a second metal cation component, wherein the second metal cation component is not complexed to said human growth hormone, and wherein the second metal cation component is dispersed within the biocompatible polymer to modulate the release of human growth hormone from the polymer matrix.

36. The pharmaceutical composition of claim 6 further comprising a second metal cation component, wherein the second metal cation component is not complexed to said human growth hormone, and wherein the second metal cation component is dispersed within the biocompatible polymer to modulate the release of human growth hormone from the polymer matrix.

37. The pharmaceutical composition of claim 22 further comprising a second metal cation component, wherein the second metal cation component is not complexed to said human growth hormone, and wherein the second metal cation component is dispersed within the biocompatible polymer to modulate the release of human growth hormone from the polymer matrix.
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