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Claims for Patent: 8,133,883

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Claims for Patent: 8,133,883

Title:Compositions containing piperacillin and tazobactam useful for injection
Abstract: An aminocarboxylic acid chelating agent, preferably EDTA, or a salt thereof has been found to be useful for inhibiting particulate formation in piperacillin/tazobactam parenteral combinations. The composition may also contain a buffer, preferably citrate, and optionally an aminoglycoside. The product may be in the form of a frozen composition that can be thawed for use. The product may also be in the form of a cryodesiccated powder that can be reconstituted by addition of an aqueous vehicle to reform a solution.
Inventor(s): Cohen; Jonathan M. (Monroe, NY), Shah; Syed M (East Hanover, NJ), Ofslager; Christian L. (Newburgh, NY), Fawzi; Mahdi B. (Morristown, NJ)
Assignee: Pfizer Inc. (New York, NY)
Application Number:13/033,861
Patent Claims: 1. A pharmaceutical composition useful for the treatment or control of bacterial infections by parenteral administration, the composition comprising effective amounts of (a) piperacillin or a pharmaceutically acceptable salt thereof, (b) tazobactam or a pharmaceutically acceptable salt thereof and c) ethylenediaminetetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof.

2. A pharmaceutical composition according to claim 1 further comprising a buffer adapted to maintain a pH within the range of 6.0 to 7.5.

3. A pharmaceutical composition according to claim 2 wherein the buffer is adapted to maintain a pH of substantially 6.5.

4. A pharmaceutical composition according to claim 2 wherein the buffer is citrate.

5. A pharmaceutical composition according to claim 1 containing piperacillin sodium, tazobactam sodium and a sodium salt of the EDTA.

6. A pharmaceutical composition according to claim 5 further comprising sodium citrate as buffer.

7. A pharmaceutical composition according to claim 1 further comprising an aminoglycoside.

8. A pharmaceutical composition according to claim 7 wherein the aminoglycoside is selected from amikacin and tobramycin.

9. A pharmaceutical composition according to claim 1, the pharmaceutical composition being in the form of a powder that can be reconstituted by addition of a compatible reconstitution diluent prior to parenteral administration.

10. A pharmaceutical composition according to claim 1 in the form of a frozen composition adapted to be thawed and, if desired, diluted with a compatible diluent prior to parenteral administration.

11. A pharmaceutical composition according to claim 1 in a form ready to use for parenteral administration.

12. A pharmaceutical composition according to claim 1 in the form of a solution.

13. A method for the treatment or control of bacterial infections in a mammal wherein the method comprises parenteral administration of a therapeutically effective amount of the pharmaceutical composition of claim 1 to said mammal.

14. A method for the treatment or control of bacterial infections in a mammal wherein the method comprises parenteral co-administration of a therapeutically effective amount of the pharmaceutical composition of claim 1 and an aminoglycoside to said mammal.

15. The method according to claim 14 wherein the aminoglycoside is selected from amikacin and tobramycin.
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