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1
Do formulation differences between the reference listed drug and generic piperacillin-tazobactam impact reconstitution?参比制剂与哌拉西林-他唑巴坦仿制药之间的制剂差异会影响复溶吗？
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Expanded studies of piperacillin/tazobactam formulations: variations among branded product lots and assessment of 46 generic lots.哌拉西林/他唑巴坦制剂的扩展研究：品牌产品批次之间的差异以及对 46 个仿制药批次的评估。
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本文引用的文献

1
Even apparently insignificant chemical deviations among bioequivalent generic antibiotics can lead to therapeutic nonequivalence: the case of meropenem.即使生物等效的仿制抗生素之间看似微不足道的化学差异也可能导致治疗等效性的丧失：以美罗培南为例。
Antimicrob Agents Chemother. 2014;58(2):1005-18. doi: 10.1128/AAC.00350-13. Epub 2013 Nov 25.
2
Expanded studies of piperacillin/tazobactam formulations: variations among branded product lots and assessment of 46 generic lots.哌拉西林/他唑巴坦制剂的扩展研究：品牌产品批次之间的差异以及对 46 个仿制药批次的评估。
Diagn Microbiol Infect Dis. 2009 Nov;65(3):319-22. doi: 10.1016/j.diagmicrobio.2009.06.012.
3
Zosyn (piperacillin/tazobactam) reformulation: Expanded compatibility and coadministration with lactated Ringer's solutions and selected aminoglycosides.复方哌拉西林钠他唑巴坦钠（Zosyn）新剂型：与乳酸林格氏液和某些氨基糖苷类药物的配伍禁忌扩大，可联合用药。
Ther Clin Risk Manag. 2008 Apr;4(2):303-14. doi: 10.2147/tcrm.s2564.
4
Pore structure and surface area of mannitol powder, granules and tablets determined with mercury porosimetry and nitrogen adsorption.用压汞法和氮吸附法测定甘露醇粉末、颗粒剂和片剂的孔隙结构和表面积。
Eur J Pharm Biopharm. 1998 Jul;46(1):61-8. doi: 10.1016/s0939-6411(97)00169-0.

参比制剂与哌拉西林-他唑巴坦仿制药之间的制剂差异会影响复溶吗？

Do formulation differences between the reference listed drug and generic piperacillin-tazobactam impact reconstitution?

作者信息

Zheng HaiAn, Truong James, Carroll Fred, Pai Manjunath P

机构信息

Albany College of Pharmacy and Health Sciences, Albany, New York, USA

Albany College of Pharmacy and Health Sciences, Albany, New York, USA.

出版信息

Antimicrob Agents Chemother. 2015 Mar;59(3):1767-9. doi: 10.1128/AAC.04563-14. Epub 2014 Dec 15.

DOI:10.1128/AAC.04563-14
PMID:25512410
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4325799/
Abstract

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.

摘要

哌拉西林-他唑巴坦的参比制剂（RLD）与仿制药制剂之间的药学差异可能会影响静脉给药的复溶过程。本研究将RLD与三种仿制药制剂进行了比较，并采用标准化流程测定了它们的复溶时间。一种仿制药制剂的平均（标准差[SD]）复溶时间为5.57（1.49）分钟，比RLD和其他两种制剂长35%至42%（P<0.002）。粉末颗粒形态在显微镜下的明显差异或许可以解释这些结果。