AI Article Synopsis
- This study compared various pharmaceutical properties of brand-name meropenem (BNM) and six generic versions (GPs A-F) marketed in China, focusing on aspects like particle size, solubility, and antimicrobial activity.
- GPs A and C had similar particle sizes as BNM, but the other GPs were larger; only BNM and GP-A dissolved completely in under 100 seconds, and no large insoluble particles were found in BNM and GP-E.
- The study revealed differences in the stability and residual solvents of the products, with BNM showing better stability, suggesting variations in the manufacturing processes of generics which could affect their performance.
Article 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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8469160 | PMC |
| http://dx.doi.org/10.3390/antibiotics10091096 | DOI Listing |
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