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Claims for Patent: 6,124,261

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Claims for Patent: 6,124,261

Title: Non-aqueous polar aprotic peptide formulations
Abstract:This invention relates to stable non-aqueous polar aprotic formulations of peptide compounds. These stable formulations comprise peptide in non-aqueous polar aprotic solvent. They may be stored at elevated temperatures for long periods of time and are especially useful in implantable delivery devices for long term delivery of drug.
Inventor(s): Stevenson; Cynthia L. (Mountain View, CA), Prestrelski; Steven J. (Mountain View, CA)
Assignee: ALZA Corporation (Mt. View, CA)
Application Number:09/293,839
Patent Claims: 1. A stable non-aqueous formulation of a peptide compound comprising:

a) at least one peptide compound; and

b) at least one polar aprotic solvent, wherein said polar aprotic solvent is selected from the group consisting of DMSO and DMF.

2. A stable non-aqueous formulation of a peptide compound comprising:

a) at least one peptide compound; and

b) at least one polar aprotic solvent, which is stable after irradiation.

3. A stable non-aqueous formulation of a peptide compound comprising:

a) at least one peptide compound; and

b) at least one polar aprotic solvent, which does not contain components containing added water.

4. A stable non-aqueous formulation of a peptide compound comprising:

a) at least one peptide compound; and

b) at least one polar aprotic solvent, which exhibits bacteriostatic, bactericidal or sporicidal activity without the use of a conventional bacteriostatic, bactericidal or sporicidal agent, wherein said peptide compound is an LHRH-related compound.

5. The formulation of claim 1 which comprises at least about 10% (w/w) peptide compound.

6. The formulation of claim 1 which comprises at least about 30% (w/w) peptide compound.

7. The formulation of claim 1 of which is stable at 80.degree. C. for at least 2 months.

8. The formulation of claim 1 which is stable at 37.degree. C. for at least 3 months.

9. The formulation of claim 1 which is stable at 37.degree. C. for at least one year.

10. The formulation of claim 1 which is adapted for use in an implantable drug delivery device.

11. The formulation of claim 1 wherein said polar aprotic solvent provides an anti-gellant effect.

12. The formulation of claim 1 which is stable after irradiation.

13. The formulation of claim 1 wherein said peptide is an LHRH-related compound.

14. The formulation of claim 2 which comprises at least about 10% (w/w) peptide compound.

15. The formulation of claim 2 which comprises at least about 30% (w/w)

peptide compound.

16. The formulation of claim 2 of which is stable at 80.degree. C. for at least 2 months.

17. The formulation of claim 2 which is stable at 37.degree. C. for at least 3 months.

18. The formulation of claim 2 which is stable at 37.degree. C. for at least one year.

19. The formulation of claim 2 which is adapted for use in an implantable drug delivery device.

20. The formulation of claim 2 wherein said polar aprotic solvent is selected from the group consisting of DMSO and DMF.

21. The formulation of claim 2 wherein said polar aprotic solvent provides an anti-gellant effect.

22. The formulation of claim 2 wherein said peptide is an LHRH-related compound.

23. The formulation of claim 3 which comprises at least about 10% (w/w) peptide compound.

24. The formulation of claim 3 which comprises at least about 30% (w/w) peptide compound.

25. The formulation of claim 3 of which is stable at 80.degree. C. for at least 2 months.

26. The formulation of claim 3 which is stable at 37.degree. C. for at least 3 months.

27. The formulation of claim 3 which is stable at 37.degree. C. for at least one year.

28. The formulation of claim 3 which is adapted for use in an implantable drug delivery device.

29. The formulation of claim 3 wherein said polar aprotic solvent is selected from the group consisting of DMSO and DMF.

30. The formulation of claim 3 wherein said polar aprotic solvent provides an anti-gellant effect.

31. The formulation of claim 3 which is stable after irradiation.

32. The formulation of claim 3 wherein said peptide is an LHRH-related compound.

33. The formulation of claim 4 which comprises at least about 10% (w/w) peptide compound.

34. The formulation of claim 4 which comprises at least about 30% (w/w) peptide compound.

35. The formulation of claim 4 of which is stable at 80.degree. C. for at least 2 months.

36. The formulation of claim 4 which is stable at 37.degree. C. for at least 3 months.

37. The formulation of claim 4 which is stable at 37.degree. C. for at least one year.

38. The formulation of claim 4 which is adapted for use in an implantable drug delivery device.

39. The formulation of claim 4 wherein said polar aprotic solvent is selected from the group consisting of DMSO and DMF.

40. The formulation of claim 4 wherein said polar aprotic solvent provides an anti-gellant effect.

41. The formulation of claim 4 which is stable after irradiation.
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