Expanded studies of piperacillin/tazobactam formulations: variations among branded product lots and assessment of 46 generic lots

Expanded studies of piperacillin/tazobactam formulations: variations among branded product lots and assessment of 46 generic lots

Author Moet, Gary J. Google Scholar
Watters, Amy A. Google Scholar
Sader, Helio S. Autor UNIFESP Google Scholar
Jones, Ronald N. Google Scholar
Institution JMI Labs
Universidade Federal de São Paulo (UNIFESP)
Tufts Univ
Abstract The experience with analyzing the potency of piperacillin/tazobactam generic formulations by a precise multiorganism in vitro assay was expanded to 46 lots (29 manufacturers, 17 countries). Across all generic lots, the range of activity compared with a reference branded lot (RLOT; Zosyn (R); Wyeth Pharmaceuticals, Philadelphia, PA) was +10% to -42% (average, -16%). Eight lots of Zosyn (R) were also tested with a range of +7 to -19 (average, only -6%), and the reproducibility (13 replicates) of the RLOT assay was confirmed (+/- 3%). This ongoing quality assurance project demonstrated wide activity variations in piperacillin/tazobactam generic lots with a consistent trend toward subpotent performance (-16%) compared with the branded product. Generic substitutions within hospital formularies should consider parameters of in vitro activity, in addition to applied chemical analyses and measures of bioavailability to avoid potential adverse clinical consequences. (C) 2009 Elsevier Inc. All rights reserved.
Keywords Piperacillin/tazobactam
Generic potencies
MIC assays
Zosyn (R)
Language English
Sponsor Wyeth Pharmaceuticals (Collegeville, PA)
Date 2009-11-01
Published in Diagnostic Microbiology and Infectious Disease. New York: Elsevier B.V., v. 65, n. 3, p. 319-322, 2009.
ISSN 0732-8893 (Sherpa/Romeo, impact factor)
Publisher Elsevier B.V.
Extent 319-322
Origin http://dx.doi.org/10.1016/j.diagmicrobio.2009.06.012
Access rights Closed access
Type Article
Web of Science ID WOS:000271296800014
URI http://repositorio.unifesp.br/handle/11600/31925

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