Tigecycline compositions and methods of preparation
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.
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.