Details for Patent: 6,124,261
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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) |
Filing Date: | Apr 19, 1999 |
Application Number: | 09/293,839 |
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. |