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Details for Patent: 7,498,312

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Details for Patent: 7,498,312

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)
Filing Date:Apr 07, 2004
Application Number:10/553,139
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) an aminocarboxylic acid chelating agent or a pharmaceutically acceptable salt thereof, wherein the aminocarboxylic acid chelating agent is at least one compound selected from the group consisting of O,O'-bis(2-aminoethyl)ethyleneglycol-N,N,N',N'-tetraacetic acid (EGTA) and trans-1,2-diaminocyclohexane-N,N,N',N'-tetraacetic acid (CyDTA).

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 aminocarboxylic acid chelating agent.

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

7. A pharmaceutical composition according to claim 2 further comprising amikacin.

8. A pharmaceutical composition according to claim 6 further comprising amikacin.

9. A pharmaceutical composition according to claim 1, wherein the composition is 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 6, wherein the composition is in the form of a powder that can be reconstituted by addition of a compatible reconstitution diluent prior to parenteral administration.

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

12. A pharmaceutical composition according to claim 6, wherein the composition is in the form of a frozen composition adapted to be thawed and, if desired, diluted with a compatible diluent prior to parenteral administration.

13. A pharmaceutical composition according to claim 1, wherein the composition is in a form ready to use for parenteral administration.

14. A pharmaceutical composition according to claim 6, wherein the composition is in a form ready to use for parenteral administration.

15. A pharmaceutical composition according to claim 1, wherein the composition is in the form of a solution and the piperacillin is present in an amount from about 8 mg/ml to about 500 mg/ml.

16. A pharmaceutical composition according to claim 6, wherein the composition is in the form of a solution and the piperacillin is present in an amount from about 8 mg/ml to about 500 mg/ml.

17. A pharmaceutical composition according to claim 1, wherein the composition is in the form of a solution and the tazobactam is present in an amount from about 0.1 mg/ml to about 125 mg/ml.

18. A pharmaceutical composition according to claim 6, wherein the composition is in the form of a solution and the tazobactam is present in an amount from about 0.1 mg/ml to about 125 mg/ml.

19. A pharmaceutical composition of claim 6, wherein the composition is in the form of a solution and the citrate buffer is present in an amount from about 0.25 mg/ml to about 25 mg/ml.

20. A pharmaceutical composition according to claim 1, wherein the composition is in the form of a solution, said composition further comprising an effective amount of dextrose to render the composition physiologically isosmotic.

21. A pharmaceutical composition according to claim 20, wherein the effective amount of dextrose is from about 5 mg/ml to about 100 mg/ml.

22. A pharmaceutical composition according to claim 8, wherein the composition is in the form of a solution and the amikacin is present in an amount from about 0.1 mg/ml to about 75 mg/ml.

23. A pharmaceutical composition according to claim 1, wherein the composition is in the form of a solution, and wherein the aminocarboxylic acid chelating agent is present in an amount of about 0.002 mg/ml to about 10 mg/ml.

24. A pharmaceutical composition according to claim 23, wherein the aminocarboxylic acid chelating agent is present in an amount of about 0.003 mg/ml to about 1 mg/ml.

25. A pharmaceutical composition according to claim 1, wherein said pharmaceutical composition is a dose concentrate in a sealed container wherein said container has a space sufficient for introduction of a volume of aqueous solvent sufficient to form a concentrated solution of said pharmaceutical composition.

26. A pharmaceutical composition according to claim 6, wherein said pharmaceutical composition is a dose concentrate in a sealed container wherein said container has a space sufficient for introduction of a volume of aqueous solvent sufficient to form a concentrated solution of said pharmaceutical composition.

27. A pharmaceutical composition according to claim 1, wherein said pharmaceutical composition is in the form of a solution and is a unit dose contained in an IV bag or IV bottle for intravenous administration.

28. A process for the manufacture of a reconstitutable pharmaceutical composition in the form of a powder which process comprises the steps of: (a) dissolving effective amounts of piperacillin or a pharmaceutically acceptable salt thereof, tazobactam or a pharmaceutically acceptable salt thereof, and an aminocarboxylic acid chelating agent or a pharmaceutically acceptable salt thereof in an aqueous solvent to form a solution, wherein the aminocarboxylic acid chelating agent is at least one compound selected from the group consisting of O,O'-bis(2-aminoethyl)ethyleneglycol-N,N,N',N'-tetraacetic acid (EGTA) and trans-1,2-diaminocyclohexane-N,N,N',N'-tetraacetic acid (CyDTA); (b) adjusting the pH of said solution in the range of about 6.0 to about 7.5; and (c) freeze drying said solution to form a reconstitutable powder.

29. The process according to claim 28 further comprising in step (a) dissolving an aminoglycoside selected from amikacin with said piperacillin, tazobactam and aminocarboxylic acid chelating agent; and in step (b) wherein an effective amount of buffer is used to adjust the pH.

30. The process according to claim 29, wherein the amikacin is present in an amount of about 0.1 mg/ml to about 75 mg/ml.

31. The process according to claim 28 further comprising in step (b) the pH is adjusted to about 6.5 with an effective amount of a buffer.

32. The process according to claim 31, wherein the buffer is citrate.

33. The process according to claim 31, wherein the buffer is sodium citrate.

34. A method for the treatment or control of bacterial infections in a mammal, said infections being caused by piperacillin/tazobactam susceptible bacteria wherein the method comprises parenteral administration of a therapeutically effective amount of the pharmaceutical composition of claim 1 to said mammal.

35. A method for the treatment or control of bacterial infections in a mammal, said infections being caused by piperacillin/tazobactam susceptible bacteria wherein the method comprises parenteral administration of a therapeutically effective amount of the pharmaceutical composition of claim 6 to said mammal.

36. A method for the treatment or control of bacterial infections in a mammal, said infections being caused by piperacillin/tazobactam susceptible bacteria wherein the method comprises parenteral co-administration of a therapeutically effective amount of the pharmaceutical composition of claim 2 and amikacin to said mammal.

37. A method for the treatment or control of bacterial infections in a mammal, said infections being caused by piperacillin/tazobactam susceptible bacteria wherein the method comprises parenteral co-administration of a therapeutically effective amount of the pharmaceutical composition of claim 6 and amikacin to said mammal.
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