Ceftolozane-tazobactam pharmaceutical compositions

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)

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)

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):

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)

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:

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:

adjusted to a pH of about 5-7 prior to lyophilization.