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Claims for Patent: 7,879,828

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Claims for Patent: 7,879,828

Title:Tigecycline compositions and methods of preparation
Abstract:The present invention relates to novel tigecycline compositions with improved stability in both solid and solution states and processes for making these compositions. These compositions comprise tigecycline, a suitable carbohydrate, and an acid or buffer.
Inventor(s): Fawzi; Mahdi B. (Morristown, NJ), Zhu; Tianmin (Monroe, NY), Shah; Syed M. (East Hanover, NJ)
Assignee: Wyeth LLC (Madison, NJ)
Application Number:11/374,330
Patent Claims: 1. A composition comprising tigecycline, lactose, and an acid selected from hydrochloric acid and gentisic acid, wherein the molar ratio of tigecycline to lactose is between about 1:0.2 and about 1:5 and the pH of the composition in a solution is between about 3.0 and about 7.0.

2. The composition of claim 1 wherein the composition is lyophilized.

3. The composition of claim 1 wherein the composition is in solid form.

4. The composition of claim 1 wherein the pH of the composition in a solution is between about 4.0 and about 5.0.

5. The composition of claim 4 wherein the pH of the composition in a solution is between about 4.2 and about 4.8.

6. The composition of claim 1 wherein the acid is hydrochloric acid.

7. The composition of claim 2 wherein the acid is hydrochloric acid.

8. The composition of claim 3 wherein the acid is hydrochloric acid.

9. The composition of claim 1 wherein the molar ratio of tigecycline to lactose is between about 1:1.6 and about 1:3.3.

10. The composition of claim 1 wherein the pH of the composition in a solution is between about 4.5 and about 6.0.

11. The composition of claim 1 wherein the pH of the composition in a solution is between about 4.5 and about 5.5.

12. A composition comprising tigecycline, lactose, and hydrochloric acid, wherein the molar ratio of tigecycline to lactose is between about 1:0.2 and about 1:5 and the pH of the composition in a solution is between about 3.0 and about 7.0.

13. The composition of claim 12 wherein the molar ratio of tigecycline to lactose is between about 1:1.6 and about 1:3.3.

14. The composition of claim 12 wherein the pH of the composition in a solution is between about 4.0 and about 5.0.

15. The composition of claim 14 wherein the pH of the composition in a solution is between about 4.2 and about 4.8.

16. The composition of claim 12 wherein the pH of the composition in a solution is between about 4.5 and about 6.0.

17. The composition of claim 16 wherein the pH of the composition in a solution is between about 4.5 and about 5.5.

18. The composition of claim 12 wherein the composition is in solid form.

19. The composition of claim 13 wherein the composition is in solid form.

20. The composition of claim 14 wherein the composition is in solid form.

21. The composition of claim 15 wherein the composition is in solid form.

22. The composition of claim 16 wherein the composition is in solid form.

23. The composition of claim 17 wherein the composition is in solid form.
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