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Claims for Patent: 7,915,229

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Claims for Patent: 7,915,229

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 Marc (Monroe, NY), Shah; Syed Muzafar (East Hanover, NJ), Ofslager; Christian Luther (Newburgh, NY), Fawzi; Mahdi Bakir (Morristown, NJ)
Assignee: Wyeth Holdings Corporation (Madison, NJ)
Application Number:12/370,794
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) as a particulate formation inhibitor, an aminocarboxylic acid chelating agent or a pharmaceutically acceptable salt thereof, wherein the ratio of particulate formation inhibitor to piperacillin is within the range of about 0.01 to about 40 mg particulate formation inhibitor per gram of piperacillin.

2. A pharmaceutical composition according to claim 1, wherein the ratio of particulate formation inhibitor to piperacillin is within the range of about 0.1 to about 0.5 mg particulate formation inhibitor per gram of pipericillin.

3. A pharmaceutical composition according to claim 2, wherein the ratio of particulate formation inhibitor to piperacillin is about 0.25 mg particulate formation inhibitor per gram of piperacillin.

4. A pharmaceutical composition useful for the treatment or control of bacterial infections by parenteral administration, the composition comprising about 40 mg/ml piperacillin sodium, about 5 mg/ml tazobactam sodium, about 20 mg/ml dextrose hydrous USP, about 2 mg/ml sodium citrate dihydrate, and, as a particulate formation inhibitor, an aminocarboxylic acid chelating agent or a pharmaceutically acceptable salt thereof, wherein said composition is a solution and is a unit dose contained in an IV bag or IV bottle for intravenous administration, in which the pH of said solution is about 6.5.

5. A pharmaceutical composition according to claim 4 comprising, as the particulate formation inhibitor, 1 mg EDTA.

6. A pharmaceutical composition useful for the treatment or control of bacterial infections by parenteral administration, the composition comprising about 4000 mg piperacillin sodium, about 500 mg tazobactam sodium, about 200 mg sodium citrate and about 1 mg EDTA.

7. A pharmaceutical composition useful for the treatment or control of bacterial infections by parenteral administration, wherein said composition is a dose concentrate in a sealed container, and wherein said composition comprises about 2000 mg piperacillin sodium, about 250 mg tazobactam sodium, about 100 mg sodium citrate and about 0.5 mg EDTA.

8. A lyophilized pharmaceutical composition, wherein said composition comprises about 40.5 g piperacillin sodium, about 4.5 g tazobactam sodium, about 1.8 g sodium citrate and about 9 mg EDTA.

9. A pharmaceutical composition that is a solution comprising piperacillin sodium in an amount from about 12 to about 300 mg/ml, tazobactam sodium in an amount from about 1.5 to about 75 mg/ml, a sodium citrate buffer in an amount from about 0.6 to about 15 mg/ml and EDTA in an amount from about 0.003 to about 1.0 mg/ml.

10. 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) as a particulate formation inhibitor, an aminocarboxylic acid chelating agent or a pharmaceutically acceptable salt thereof, wherein said composition is a solution and is a unit dose contained in an IV bag or IV bottle for intravenous administration, for which a light obscuration test, performed 24 hours after creation of said solution using a method according to USP 788, yields a particulate count per ml in the 25 micrometer category no greater than 3.

11. A pharmaceutical composition according to claim 10, wherein the particulate formation inhibitor is EDTA.

12. A pharmaceutical composition according to claim 11, further comprising an aminoglycoside.

13. 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) as a particulate formation inhibitor, an aminocarboxylic acid chelating agent or a pharmaceutically acceptable salt thereof, wherein said composition is a solution and is a unit dose contained in an IV bag or IV bottle for intravenous administration, and wherein said solution comprises about 8.0 to about 90 mg/ml piperacillin sodium and about 0.1 to about 25 mg/ml tazobactam sodium.

14. A pharmaceutical composition according to claim 13, wherein said solution comprises about 25 to about 80 mg/ml piperacillin sodium and about 1.0 to about 22 mg/ml tazobactam sodium.

15. A pharmaceutical composition according to claim 14, wherein said solution comprises about 30 to about 80 mg/ml piperacillin sodium and about 3.0 to about 20 mg/ml tazobactam sodium.

16. 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) as a particulate formation inhibitor, an aminocarboxylic acid chelating agent or a pharmaceutically acceptable salt thereof, and further comprising a buffer adapted to maintain the pH with the range of about 6.0 to about 7.5, wherein the total concentration of piperacillin sodium, tazobactam sodium, particulate formation inhibitor and citrate as buffer is about 9 to about 125 mg/ml.

17. A pharmaceutical composition according to claim 16, wherein the total concentration of piperacillin sodium, tazobactam sodium, particulate formation inhibitor and citrate as buffer is about 14 to about 115 mg/ml.

18. A pharmaceutical composition according to claim 17, wherein the total concentration of piperacillin sodium, tazobactam sodium, particulate formation inhibitor and citrate as buffer is about 20 to about 105 mg/ml.
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