Do Formulation Differences between the Reference Listed Drug and Generic Piperacillin-Tazobactam Impact Reconstitution? | Zendy

HaiAn Zheng | Zendy; James Truong | Zendy; F Carroll | Zendy; Manjunath P. Pai | Zendy

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Do Formulation Differences between the Reference Listed Drug and Generic Piperacillin-Tazobactam Impact Reconstitution?

Author(s) -

HaiAn Zheng,

James Truong,

F Carroll,

Manjunath P. Pai

Publication year - 2014

Publication title -

antimicrobial agents and chemotherapy

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.07

H-Index - 259

eISSN - 1070-6283

pISSN - 0066-4804

DOI - 10.1128/aac.04563-14

Subject(s) - piperacillin/tazobactam , piperacillin , tazobactam , medicine , drug , pharmacology , mathematics , biology , bacteria , genetics , pseudomonas aeruginosa

Pharmaceutical differences between the reference listed drug (RLD) and generic formulations of piperacillin-tazobactam may impact the reconstitution process for intravenous administration. This study evaluated the RLD against three generic formulations and measured their reconstitution times using a standardized process. The mean (standard deviation [SD]) reconstitution time for one generic formulation was 5.57 (1.49) min, which was 35% to 42% longer (P < 0.002) than that for the RLD and two other formulations. Observable microscopic differences in powder particle morphology may explain these findings.

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