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Claims for Patent: 9,320,740

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Claims for Patent: 9,320,740

Title:Ceftolozane-tazobactam pharmaceutical compositions
Abstract: Pharmaceutical compositions are provided in unit dosage forms comprising ceftolozane and tazobactam in separate unit dosage form containers, ceftolozane prepared in the absence of tazobactam, tazobactam prepared in the absence of ceftolozane, and/or compositions where ceftolozane and tazobactam are first combined within a unit dosage form container.
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: MERCK SHARP & DOHME CORP. (Rahway, NJ)
Application Number:14/214,221
Patent Claims: 1. A sterile pharmaceutical composition comprising tazobactam, or a pharmaceutically acceptable salt thereof, and ceftolozane, or a pharmaceutically acceptable salt thereof, in a sealed unit dosage form container, wherein the ceftolozane, or a pharmaceutically acceptable salt thereof, and the tazobactam, or a pharmaceutically acceptable salt thereof, provide ceftolozane active and tazobactam active in a ratio of 2:1 by weight, and wherein said ceftolozane, or a pharmaceutically acceptable salt thereof, and the tazobactam, or a pharmaceutically acceptable salt thereof, were not in physical contact prior to filling the composition into said unit dose form container.

2. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable salt of ceftolozane is ceftolozane sulfate.

3. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable salt of tazobactam is tazobactam sodium or tazobactam arginine.

4. The pharmaceutical composition of claim 3, wherein the pharmaceutically acceptable salt of tazobactam is tazobactam sodium.

5. The pharmaceutical composition of claim 1, wherein the amount of ceftolozane active is 1,000 mg and the amount of tazobactam active is 500 mg.

6. The pharmaceutical composition of claim 1, wherein the amount of ceftolozane active is 2,000 mg and the amount of tazobactam active is 1,000 mg.

7. The pharmaceutical composition of claim 1, wherein the tazobactam, or a pharmaceutically acceptable salt thereof, and the ceftolozane, or a pharmaceutically salt thereof, were individually lyophilized prior to filling.

8. The pharmaceutical composition of claim 1, wherein the unit dosage form container includes a means for injecting a liquid into the container.

9. An injectable composition for intravenous administration comprising the pharmaceutical composition of claim 1 dissolved in a pharmaceutically acceptable carrier.

10. A pharmaceutical composition comprising tazobactam, or a pharmaceutically acceptable salt thereof, and ceftolozane, or a pharmaceutically salt thereof, prepared by aseptically filling the tazobactam, or a pharmaceutically acceptable salt thereof, and the ceftolozane, or a pharmaceutically salt thereof, in a unit dosage form container and then sealing the unit dosage form container, wherein the ceftolozane, or a pharmaceutically acceptable salt thereof, and tazobactam, or a pharmaceutically acceptable salt thereof, provide ceftolozane active and tazobactam active in a ratio of 2:1 by weight.

11. The pharmaceutical composition of claim 10, wherein the unit dosage form container is blanketed with an inert gas prior to sealing.

12. The pharmaceutical composition of claim 10, wherein the ceftolozane, or a pharmaceutically acceptable salt, thereof and the tazobactam, or a pharmaceutically acceptable salt thereof, were not in physical contact prior to filling the composition into said unit dose form container.

13. The pharmaceutical composition of claim 10, wherein the tazobactam, or a pharmaceutically acceptable salt thereof, and the ceftolozane, or a pharmaceutically acceptable salt thereof, are co-filled into the unit dosage form container.

14. The pharmaceutical composition of claim 10, wherein the pharmaceutically acceptable salt of ceftolozane is ceftolozane sulfate.

15. The pharmaceutical composition of claim 10, wherein the pharmaceutically acceptable salt of tazobactam is tazobactam sodium or tazobactam arginine.

16. The pharmaceutical composition of claim 15, wherein the pharmaceutically acceptable salt of tazobactam is tazobactam sodium.

17. The pharmaceutical composition of claim 10, wherein the amount of ceftolozane active is 1,000 mg and the amount of tazobactam active is 500 mg.

18. The pharmaceutical composition of claim 10, wherein the amount of ceftolozane active is 2,000 mg and the amount of tazobactam active is 1,000 mg.

19. The pharmaceutical composition of claim 10, wherein the tazobactam, or a pharmaceutically acceptable salt thereof, and the ceftolozane, or a pharmaceutically acceptable salt thereof, were individually lyophilized prior to filling.

20. The pharmaceutical composition of claim 10, wherein the unit dosage form container includes a means for injecting a liquid into the container.

21. An injectable composition for intravenous administration comprising a pharmaceutical composition of claim 10 dissolved in a pharmaceutically acceptable carrier.
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