This invention is concerned with a low bulk density lyophilized pharmaceutical parenteral dosage unit of Sodium Piperacillin and method of making same.
This is a division of application, Ser. No. 379,378, filed May 17, 1982, U.S. Pat. No. 4,477,452, which is a continuation-in-part of application Ser. No. 247,586, filed Mar. 26, 1981, abandoned.
The invention pertains to pharmaceutical compositions of Zosyn.RTM. piperacillin with tazobactam in the presence of a buffer, preferably citrate, a particulate formation inhibitor, preferably EDTA optionally an aminoglycoside which when frozen and thawed or lyophilized and reconstituted reform a solution which has decreased particulate formation.
The present invention provides a premixed form of a buffered piperacillin product having a near neutral pH and capable of a shelf life of at least nine months, with freezer storage (-20.degree. C. or lower), or a refrigerated shelf life of up to 14 days at about 5.degree. C. The piperacillin may additionally contain a tazobactam component to inactivate beta-lactamases that commonly cause resistance to penicillins, allowing the piperacillin component to destroy susceptible bacteria. With the addition of dextrose, the premixed composition is physiologically isosmotic.
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.
