Compositions containing piperacillin and tazobactam useful for injection
AssigneeWyeth Holdings Corporation
InventorsJonathan Cohen, Syed Shah, Christian Ofslager, Mahdi Fawzi
Life of this patent
Estimating the term…
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.
Claims45
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).
7-37. (canceled)
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.
Dependencies are inferred from the claim text.