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<sup>®</sup>, BN...
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-09-01
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| Series: | Antibiotics |
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| Online Access: | https://www.mdpi.com/2079-6382/10/9/1096 |
| _version_ | 1797520460890505216 |
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| author | Ping Yang Shigeru Fujimura Yawei Du Bei Zhang Li Yang Masato Kawamura Zhenhua Zhang Suodi Zhai |
| author_facet | Ping Yang Shigeru Fujimura Yawei Du Bei Zhang Li Yang Masato Kawamura Zhenhua Zhang Suodi Zhai |
| author_sort | Ping Yang |
| collection | DOAJ |
| 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<sup>®</sup>, 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. |
| first_indexed | 2024-03-10T07:57:05Z |
| format | Article |
| id | doaj.art-6db52b4d3759460081d7af24e4ab860b |
| institution | Directory Open Access Journal |
| issn | 2079-6382 |
| language | English |
| last_indexed | 2024-03-10T07:57:05Z |
| publishDate | 2021-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Antibiotics |
| spelling | doaj.art-6db52b4d3759460081d7af24e4ab860b2023-11-22T11:46:12ZengMDPI AGAntibiotics2079-63822021-09-01109109610.3390/antibiotics10091096Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its GenericsPing Yang0Shigeru Fujimura1Yawei Du2Bei Zhang3Li Yang4Masato Kawamura5Zhenhua Zhang6Suodi Zhai7Department of Pharmacy, Peking University Third Hospital, Beijing 100191, ChinaDivision of Clinical Infectious Diseases & Chemotherapy, Tohoku Medical and Pharmaceutical University, Sendai 981-8558, JapanDepartment of Pharmacy, Peking University Third Hospital, Beijing 100191, ChinaDepartment of Pharmacy, Peking University Third Hospital, Beijing 100191, ChinaDepartment of Pharmacy, Peking University Third Hospital, Beijing 100191, ChinaDivision of Clinical Infectious Diseases & Chemotherapy, Tohoku Medical and Pharmaceutical University, Sendai 981-8558, JapanDepartment of Medical Affairs, Sumitomo Pharmaceuticals (Suzhou) Co. Ltd., Shanghai 200025, ChinaDepartment of Pharmacy, Peking University Third Hospital, Beijing 100191, ChinaThis 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<sup>®</sup>, 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.https://www.mdpi.com/2079-6382/10/9/1096meropenemdissolution timestabilitymorphology of particlesantimicrobial susceptibility patterns |
| spellingShingle | Ping Yang Shigeru Fujimura Yawei Du Bei Zhang Li Yang Masato Kawamura Zhenhua Zhang Suodi Zhai Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics Antibiotics meropenem dissolution time stability morphology of particles antimicrobial susceptibility patterns |
| 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 | meropenem dissolution time stability morphology of particles antimicrobial susceptibility patterns |
| url | https://www.mdpi.com/2079-6382/10/9/1096 |
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