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Details for Patent: 8,835,382

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Details for Patent: 8,835,382

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, Inc. (Lexington, MA)
Filing Date:Nov 23, 2010
Application Number:13/511,246
Claims:1. A method of manufacturing a pharmaceutical daptomycin preparation, the method comprising: a. forming an aqueous daptomycin solution comprising daptomycin and sucrose at a pH of about 6.5-7.5, and b. converting the aqueous daptomycin solution to a solid pharmaceutical daptomycin preparation.

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

3. The method of claim 1, wherein the aqueous daptomycin solution further comprises sodium hydroxide.

4. The method of claim 1, wherein the aqueous daptomycin solution further comprises phosphate.

5. The method of claim 1, wherein the aqueous daptomycin solution has a pH of about 7.

6. The method of claim 1, wherein step b comprises converting the aqueous daptomycin solution to the solid pharmaceutical daptomycin preparation by lyophilization, or spray drying.

7. The method of claim 1, wherein the method further comprises the step of reconstituting the solid pharmaceutical daptomycin preparation in a pharmaceutically acceptable diluent to obtain a reconstituted pharmaceutical daptomycin composition for parenteral administration.

8. The method of claim 7, wherein the reconstituted pharmaceutical daptomycin composition comprises 25-200 mg/mL daptomycin.

9. The method of claim 7, wherein the pharmaceutically acceptable diluent is selected from the group consisting of 0.9% aqueous sterile sodium chloride, water for injection, Ringer's solution, and any combination thereof.

10. The method of claim 1, wherein step a comprises forming an aqueous daptomycin solution comprising about 105 mg/mL daptomycin and about 2.5-20.0% w/v sucrose at a pH of about 6.5-7.5; and step b comprises converting the aqueous daptomycin solution to the solid pharmaceutical daptomycin preparation by lyophilization or spray drying.

11. The method of claim 10, wherein the method further comprises the step of reconstituting the solid pharmaceutical daptomycin preparation in a pharmaceutically acceptable diluent to obtain a reconstituted pharmaceutical daptomycin composition, and wherein the reconstituted pharmaceutical daptomycin composition comprises about 25-200 mg/mL daptomycin, and wherein the pharmaceutically acceptable diluent is selected from the group consisting of 0.9% aqueous sterile sodium chloride, water for injection, Ringer's solution, and any combination thereof.

12. A method of manufacturing a solid pharmaceutical daptomycin composition, the method comprising the steps of: a. forming an aqueous daptomycin solution comprising about 105 mg/mL daptomycin and about 2.5-20.0% w/v sucrose at a pH of about 6.5-7.5, and b. lyophilizing or spray drying the aqueous daptomycin solution to form the solid pharmaceutical daptomycin composition, wherein an amount of the solid pharmaceutical daptomycin composition comprising 500 mg of daptomycin dissolves in 10 mL of 0.9% aqueous sodium chloride in less than 2 minutes at 25 degrees C.

13. A method of manufacturing a pharmaceutical daptomycin composition, the method comprising the steps of: a. forming an aqueous daptomycin solution comprising about 10.5% w/v daptomycin and about 15% w/v sucrose at a pH of about 6.5-7.5; b. lyophilizing or spray drying the aqueous daptomycin solution to form the solid pharmaceutical daptomycin composition; and c. reconstituting the solid pharmaceutical daptomycin composition in a pharmaceutically acceptable diluent to obtain a reconstituted pharmaceutical daptomycin composition, wherein the reconstituted pharmaceutical daptomycin composition comprises about 25-200 mg/mL daptomycin.

14. The method of claim 13, wherein the pharmaceutically acceptable diluent is selected from the group consisting of 0.9% aqueous sterile sodium chloride, water for injection, Ringer's solution, and any combination thereof.

15. A method of manufacturing a solid pharmaceutical daptomycin composition, the method comprising: a. forming an aqueous daptomycin solution comprising daptomycin and sucrose at a pH of about 6.5-7.5, wherein the molar ratio of daptomycin to sucrose is about 1:1.12 to about 1:8.98; and b. converting the aqueous daptomycin solution to a solid pharmaceutical daptomycin composition.

16. The method of claim 15, wherein the aqueous daptomycin solution further comprises a buffering agent.

17. The method of claim 15, wherein step b comprises converting the aqueous daptomycin solution to a solid pharmaceutical composition by lyophilization, spray-drying or fluid bed drying.

18. A method of manufacturing a solid pharmaceutical daptomycin composition, the method comprising: a. forming an aqueous daptomycin solution comprising daptomycin and sucrose at a pH of about 6.5-7.5, wherein the molar ratio of daptomycin to sucrose is about 1:1.12 to about 1:8.98; and b. converting the aqueous daptomycin solution to a solid pharmaceutical daptomycin composition; wherein an amount of the solid pharmaceutical daptomycin composition comprising 500 mg of daptomycin dissolves in 10 mL of 0.9% aqueous sodium chloride in less than 2 minutes at 25 degrees C.
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