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.
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.
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。
Zotero 插件