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Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics
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 generi...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8469160/ https://www.ncbi.nlm.nih.gov/pubmed/34572677 http://dx.doi.org/10.3390/antibiotics10091096 |
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author | Yang, Ping Fujimura, Shigeru Du, Yawei Zhang, Bei Yang, Li Kawamura, Masato Zhang, Zhenhua Zhai, Suodi |
author_facet | Yang, Ping Fujimura, Shigeru Du, Yawei Zhang, Bei Yang, Li Kawamura, Masato Zhang, Zhenhua Zhai, Suodi |
author_sort | Yang, Ping |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8469160 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-84691602021-09-27 Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics Yang, Ping Fujimura, Shigeru Du, Yawei Zhang, Bei Yang, Li Kawamura, Masato Zhang, Zhenhua Zhai, Suodi Antibiotics (Basel) Article 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. MDPI 2021-09-10 /pmc/articles/PMC8469160/ /pubmed/34572677 http://dx.doi.org/10.3390/antibiotics10091096 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Yang, Ping Fujimura, Shigeru Du, Yawei Zhang, Bei Yang, Li Kawamura, Masato Zhang, Zhenhua Zhai, Suodi Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics |
title | Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics |
title_full | Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics |
title_fullStr | Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics |
title_full_unstemmed | Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics |
title_short | Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics |
title_sort | comparison of pharmaceutical characteristics between brand-name meropenem and its generics |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8469160/ https://www.ncbi.nlm.nih.gov/pubmed/34572677 http://dx.doi.org/10.3390/antibiotics10091096 |
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