Capsule Commentary on Romanelli et al., Predictors of Statin Compliance after Switching from Branded to Generic Agents Among Managed-Care Beneficiaries

Pathak, Himanshu

doi:10.1007/s11606-014-2974-y

Cited by 1 publication

(1 citation statement)

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“…Generic drugs must contain the same quantitative and qualitative composition of active ingredients compared to their brand-name counterparts [1][2][3][4]. The prescription of generic drugs is an effective approach for reducing the cost [5,6] and increasing global access to first-line medication for the treatment of diverse diseases. In 2010, generic antibiotics represented more than two-thirds of the global consumption of medications [7].…”

Section: Introductionmentioning

confidence: 99%

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

Yang

Fujimura

et al. 2021

Antibiotics

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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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