Klin Farmakol Farm. 2011;25(1):11-17

Comparison of branded and generic lots of carbapenem antibiotics

Karel Urbánek, Michal Šiller, Rostislav Večeřa, Alice Zachařová, Zuzana Matušková

Ústav farmakologie Lékařské fakulty Univerzity Palackého v Olomouci

Background: Carbapenem antibiotics are used in severe nosocomial infections, so the quality of their different preparations has been

emphasized.

Aim: A comparison of the quality of generic imipenem/cilastatin and meropenem produced by Fresenius Kabi with the branded preparations.

Methods: 3 commercially available lots of generic preparations (Imipenem/cilastatin Kabi® and Meropenem Kabi®) were compared with

one branded lot of each carbapenem (Tienam® and Meronem®). Concentrations of active agents were measured by HPLC analysis with

spectrophotometric detection. Impurity or degradation product content, concentration of active agent in preparation dissolved for use,

stability of dissolved preparation and plasma concentrations following intraperitoneal administration to laboratory rats were measured.

Results: Concentrations of the active agents in all tested lots have not significantly varied. Impurities or degradation products were not

found in any of the tested lots. All tested preparations were sufficiently stable at temperatures up to 26 °C in 6-hour interval. Plasma

concentrations in experimental rats in 20, 60, 120, 180 and 240 min. following intraperitoneal administration have not varied significantly,

as well as the AUC in 0–4 hours.

Conclusions: Conformity of the tested generic lots with branded preparations was proved in all assessed parameters.

Keywords: imipenem, meropenem, high-performance liquid chromatography, pharmacokinetics, stability, purity

Published: March 18, 2011  Show citation