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Last Updated: May 17, 2024

Claims for Patent: 10,588,975


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Summary for Patent: 10,588,975
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. (Delray Beach, FL)
Assignee: Wyeth LLC (New York, NY)
Application Number:15/613,588
Patent Claims: 1. A composition comprising tigecycline, at least one suitable carbohydrate, and an acid or buffer wherein the suitable carbohydrate is lactose.

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

3. The composition according to claim 1 further comprising a pharmaceutically acceptable diluent.

4. The composition according to claim 3 wherein the pharmaceutically acceptable diluent is a saline, Lactated Ringer's Injection solution or dextrose solution.

5. The composition of claim 1 wherein the pH of the composition is between about 3.0 and 7.0.

6. The composition of claim 5 wherein the pH of the composition is between about 4.0 and 5.0.

7. The composition of claim 6 wherein the pH of the composition is between 4.2 and about 4.8.

8. The composition of claim 1 wherein the acid is 1.0N HCl or gentisic acid.

9. The composition of claim 3 wherein the acid is 1.0N HCl or gentisic acid.

10. The composition of claim 4 wherein the acid is 1.0N HCl or gentisic acid.

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