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Claims for Patent: 9,138,456

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Claims for Patent: 9,138,456

Title:Lipopeptide compositions and related methods
Abstract: The present disclosure provides novel powder daptomycin formulations which have improved chemical stability and faster reconstitution times when in the solid state. Some examples of the compositions comprise daptomycin and sucrose.
Inventor(s): O'Connor; Sandra (Hudson, NH), Sun; Sophie (Lexington, MA), Naik; Gaauri (Cambridge, MA)
Assignee: Cubist Pharmaceuticals LLC (Kenilworth, NJ)
Application Number:14/096,346
Patent Claims: 1. A solid pharmaceutical daptomycin composition, wherein said composition is prepared by lyophilizing an aqueous daptomycin solution comprising daptomycin and sucrose.

2. The solid pharmaceutical daptomycin composition of claim 1, wherein the molar ratio of daptomycin to sucrose is about 1:1.12 to about 1:8.98.

3. The solid pharmaceutical daptomycin composition of claim 1, wherein the aqueous daptomycin solution further comprises a buffering agent.

4. The solid pharmaceutical daptomycin composition of claim 3, wherein the buffering agent is selected from the group consisting of phosphate, citrate, maleate, carbonate, or a combination thereof.

5. The solid pharmaceutical daptomycin composition of claim 3, wherein the buffering agent is selected from the group consisting of sodium phosphate dibasic, sodium citrate, sodium bicarbonate, histidine monohydrochloride, tris(hydroxymethyl)aminomethane, maleate, or a combination thereof.

6. The solid pharmaceutical daptomycin composition of claim 3, wherein the buffering agent is sodium phosphate dibasic.

7. The solid pharmaceutical daptomycin composition of claim 1, wherein the aqueous daptomycin solution has a pH of about 4.5 to about 8.0.

8. The solid pharmaceutical daptomycin composition of claim 7, wherein the aqueous daptomycin solution has a pH of about 6.5 to about 7.5.

9. The solid pharmaceutical daptomycin composition of claim 8, wherein the aqueous daptomycin solution has a pH of about 7.0.

10. A pharmaceutical product comprising the solid pharmaceutical daptomycin composition of claim 1 and a pharmaceutically acceptable diluent.

11. The pharmaceutical product according to claim 10, wherein the pharmaceutically acceptable diluent is selected from sterile water for injection, sterile sodium chloride for injection, or bacteriostatic water for injection.

12. A solid pharmaceutical daptomycin composition, wherein the solid pharmaceutical daptomycin composition is prepared by a process comprising: a. forming an aqueous solution comprising daptomycin, wherein the aqueous solution has a pH of about 4.5 to about 5.0; b. adding a buffering agent to the aqueous solution of daptomycin; c. dissolving sucrose in the aqueous solution of daptomycin to form a buffered daptomycin sucrose formulation; d. adjusting the pH of the buffered daptomycin sucrose formulation to about 6.5 to about 7.5; and e. converting the buffered daptomycin sugar formulation to the solid pharmaceutical daptomycin composition.

13. The solid pharmaceutical daptomycin composition of claim 12, wherein the buffering agent is selected from the group consisting of phosphate, citrate, maleate, carbonate, or a combination thereof.

14. The solid pharmaceutical daptomycin composition of claim 12, wherein the buffering agent is selected from the group consisting of sodium phosphate dibasic, sodium citrate, sodium bicarbonate, histidine monohydrochloride, tris(hydroxymethyl)aminomethane, maleate, or a combination thereof.

15. A solid pharmaceutical daptomycin composition, wherein the solid pharmaceutical daptomycin composition is prepared by a process comprising: a. dissolving sucrose in an aqueous solution comprising daptomycin to form a daptomycin sucrose formulation; b. adjusting the pH of the daptomycin sucrose formulation to about 6.5 to about 7.5; and c. converting the daptomycin sugar formulation to the solid pharmaceutical daptomycin composition.
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