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Claims for Patent: 5,932,547

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Claims for Patent: 5,932,547

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 (Palo Alto, CA)
Application Number:08/874,233
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 peptide compound is an LHRH-related compound.

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

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

4. The formulation of claim 1 wherein said peptide compound is selected from the group consisting of leuprolide, LHRH, nafarelin and goserelin.

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

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

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

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

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

a) at least one peptide compound;

b) at least one polar aprotic solvent; and

c) a non-aqueous protic solvent.

10. The formulation of claim 1 wherein said polar aprotic solvent is selected from the group consisting of DMSO and DMF.

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

12. The formulation of claim 1 which consists essentially of about 30% to about 50% (w/w) of the LHRH-related compound leuprolide acetate in DMSO.

13. The formulation of claim 1 which consists essentially of leuprolide and DMSO in the proportions of 370 mg leuprolide in 1 ml DMSO.

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

15. 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 peptide compound is selected from the group consisting of glucagon, glucagon like peptide-1 and glucagon like peptide-2.

16. The formulation of claim 9 which comprises at least about 10% (w/w) peptide compound.

17. The formulation of claim 9 which comprises at least about 30% (w/w) peptide compound.

18. The formulation of claim 9 of which is stable at 80.degree. C. for at least 2 months.

19. The formulation of claim 9 which is stable at 37.degree. C. for at least 3 months.

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

21. The formulation of claim 9 which is adapted for use in an implantable drug delivery device.

22. The formulation of claim 9 wherein said polar aprotic solvent is selected from the group consisting of DMSO and DMF.

23. The formulation of claim 9 wherein said polar aprotic solvent provides an anti-gellant effect.

24. The formulation of claim 9 which is stable after irradiation.

25. The formulation of claim 9 wherein said peptide is an LHRH-related compound.

26. The formulation of claim 15 which comprises at least about 10% (w/w) peptide compound.

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

28. The formulation of claim 15 of which is stable at 80.degree. C. for at least 2 months.

29. The formulation of claim 15 which is stable at 37.degree. C. for at least 3 months.

30. The formulation of claim 15 which is stable at 37.degree. C. for at least one year.

31. The formulation of claim 15 which is adapted for use in an implantable drug delivery device.

32. The formulation of claim 15 wherein said polar aprotic solvent is selected from the group consisting of DMSO and DMF.

33. The formulation of claim 15 wherein said polar aprotic solvent provides an anti-gellant effect.

34. The formulation of claim 15 which is stable after irradiation.
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