Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics

Abstract

This study aimed to provide comparative information of pharmaceutical properties, including particle morphology and distribution uniformity, solubility, presence of residual solvent and insoluble particles, and antimicrobial activities, between brand-name meropenem (Mepem®, BNM) and its six generic products (GPs A-F) marketed in China. Particles of GP-A and -C in dry powder had similar diameters of BNM, while other GPs were larger. Only BNM and GP-A were completely dissolved within 100 s in the lab condition. No insoluble particles >25 μm in diameter were detected in BNM and GP-E. Regarding stability of GPs solutions evaluated by concentration of open-ring metabolites at 6 h and 8 h, BNM showed the lowest open-ringed metabolite concentrates. Residual solvent of acetone detected in one GP showed the maximum value, while ethanol and ethyl acetate were detected both in product E and product F. The concordance rates (%) of minimum inhibitory concentration (MIC) of each generic compared to BNM were 89.5, 85, 87.5, 88, 88.5, and 86.5, respectively, although no significant difference was reached in MIC. Pharmaceutical characteristic differences between the BNM and GPs identified in this study could provide insights into understanding the deviations in the drug manufacturing processes of generic drugs.

Comparative Efficacy and Safety of Generic vs Brand-Name Meropenem for Anti-infective Use in Real-world

“…The differences in e cacy between generic and brand-name formulations are partially controversial, and whether drug equivalence and bioequivalence between generic and brand-name formulations translate into equivalent clinical outcomes remains to be studied [7][8][9][10] . A researcher 11 reported the drug characterization of meropenem originator and six major generics and found that no signi cant differences were observed in High Performance Liquid Chromatography (HPLC) quanti cation and antimicrobial activity assays; however, the studied meropenem generics differed from the originator in some drug characteristics (e.g., stability, dissolution time, and morphology). Whether this difference leads to differences in clinical effectiveness is unclear.…”