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Claims for Patent: 8,968,753

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Claims for Patent: 8,968,753

Title:Ceftolozane-tazobactam pharmaceutical compositions
Abstract: Pharmaceutical compositions can include ceftolozane lyophilized in the absence of tazobactam.
Inventor(s): Terracciano; Joseph (Concord, MA), Damour; Nicole Miller (Belmont, MA), Jiang; Chun (Hillsborough, CA), Fogliato; Giovanni (Barzana, IT), Donadelli; Giuseppe Alessandro (Casalpusterlengo, IT), Resemini; Dario (Milan, IT)
Assignee: Calixa Therapeutics, Inc. (Lexington, MA)
Application Number:14/285,185
Patent Claims: 1. A method of treating an infection selected from the group consisting of a complicated intra-abdominal infection and a complicated urinary tract infection in a patient comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising (a) ceftolozane lyophilized in the absence of tazobactam and (b) a tazobactam composition, in a ratio of 1,000 mg ceftolozane active per 500 mg of tazobactam active.

2. The method of claim 1, wherein the infection is a complicated urinary tract infection.

3. The method of claim 1, wherein the pharmaceutical composition is intravenously administered to the patient as an infusion after combining the ceftolozane lyophilized in the absence of tazobactam and the tazobactam composition with a pharmaceutically acceptable carrier.

4. The method of claim 1, wherein the pharmaceutical composition comprises an amount of a pharmaceutically acceptable salt of ceftolozane providing a total of 1,000 mg of ceftolozane active, blended with the tazobactam composition to form the pharmaceutical composition.

5. The method of claim 1, wherein the tazobactam in the tazobactam composition is tazobactam sodium.

6. The method of claim 1, wherein the tazobactam in the tazobactam composition is a crystalline tazobactam.

7. The method of claim 1, wherein the ceftolozane is ceftolozane sulfate.

8. The method of claim 1, wherein the pharmaceutical composition does not contain a compound of formula (III) ##STR00006##

9. A method of treating an infection in a patient selected from the group consisting of a complicated intra-abdominal infection and a complicated urinary tract infection, the method comprising intravenously administering to the patient a therapeutically effective amount of ceftolozane obtained by lyophilizing a solution comprising ceftolozane without tazobactam to obtain a ceftolozane composition, and tazobactam in a ratio of 1,000 mg ceftolozane active per 500 mg of tazobactam active.

10. The method of claim 9, wherein the ceftolozane and the tazobactam are administered in a pharmaceutical composition comprising an amount of a pharmaceutically acceptable salt of ceftolozane providing a total of 1,000 mg of ceftolozane active.

11. The method of claim 10, wherein the pharmaceutical composition is obtained by a process comprising the step of combining tazobactam lyophilized in the absence of ceftolozane with the lyophilized ceftolozane composition.

12. The method of claim 9, wherein the tazobactam is tazobactam sodium.

13. The method of claim 9, wherein the tazobactam is a crystalline tazobactam.

14. The method of claim 9, wherein the ceftolozane is ceftolozane sulfate.

15. The method of claim 10, wherein the pharmaceutical composition does not contain a compound of formula (III) ##STR00007##

16. The method of claim 10, wherein the ceftolozane and the tazobactam are lyophilized in separate solutions prior to forming the pharmaceutical composition.

17. The method of claim 9, wherein the ceftolozane composition is obtained by dissolving a compound of formula (I): ##STR00008## in the solution, adjusting the pH of the solution to about 5-7 prior to lyophilization, and lyophilizing the solution to obtain the lyophilized ceftolozane composition.

18. A method of treating an infection selected from the group consisting of a complicated intra-abdominal infection and a complicated urinary tract infection in a patient comprising: dissolving in a pharmaceutically acceptable carrier a composition comprising tazobactam and ceftolozane prepared in the absence of tazobactam to obtain a pharmaceutical composition comprising ceftolozane active and tazobactam active in a 2:1 weight ratio; and administering to the patient a therapeutically effective amount of the pharmaceutical composition.

19. The method of claim 18, wherein the infection is a complicated urinary tract infection.

20. The method of claim 18, wherein the pharmaceutical composition is intravenously administered to the patient as an infusion.

21. The method of claim 20, wherein the pharmaceutical composition comprises an amount of a pharmaceutically acceptable salt of ceftolozane providing a total of 1,000 mg of ceftolozane active.

22. The method of claim 18, wherein the ceftolozane is obtained by a process comprising the step of lyophilizing a solution comprising ceftolozane sulfate in the absence of tazobactam.

23. The method of claim 20, wherein the pharmaceutical composition is obtained by a process comprising the step of combining tazobactam with the lyophilized ceftolozane composition.

24. The method of claim 18, wherein the tazobactam is tazobactam sodium.

25. The method of claim 18, wherein the pharmaceutical composition does not contain a compound of formula (III) ##STR00009##

26. The method of claim 18, wherein the ceftolozane and the tazobactam are lyophilized in separate solutions prior to administering to the patient.

27. The method of claim 18, wherein the ceftolozane is lyophilized in the absence of tazobactam and is prepared by lyophilizing a solution of ceftolozane of formula (I) in the absence of tazobactam, adjusted to a pH to about 5-7 prior to lyophilization: ##STR00010##

28. A method of treating an infection selected from the group consisting of a complicated intra-abdominal infection and a complicated urinary tract infection in a patient comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising: (a) tazobactam or a pharmaceutically acceptable salt thereof and (b) a lyophilized ceftolozane composition, wherein prior to lyophilization the ceftolozane composition does not contain tazobactam or salts thereof.

29. The method of claim 28, wherein the pharmaceutical composition comprises the ceftolozane and the tazobactam in a weight ratio of about 2:1 between the ceftolozane active and the tazobactam active.

30. The method of claim 29, wherein the lyophilized ceftolozane is lyophilized in a solution comprising ceftolozane of formula (I) in the absence of tazobactam: ##STR00011## adjusted to a pH of about 5-7 prior to lyophilization.
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