Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6115429 | Diagnostic Microbiology and Infectious Disease | 2016 | 5 Pages |
Abstract
Generic agents play a crucial role in reducing the cost of medical care in many countries. However, the therapeutic equivalence remains a great concern. Our study aims to assess the in vitro antimicrobial activity and bioequivalence between generic and brand-name levofloxacin. Enantiomeric purity test, dissolution test, and in vitro antimicrobial susceptibility against seven clinically important pathogens by the agar dilution method were employed to assess the similarity between four generic products and brand-name levofloxacin (Daiichi Sankyo). All the generic and brand-name levofloxacin passed enantiomeric purity test. The results of dissolution tests were not similar among the generic products and the brand-name levofloxacin. Compared with the generic products, the brand-name levofloxacin had the smallest mean variations (â25% to 13%) with reference standard (United States Pharmacopeia levofloxacin Reference Standards). Variations were observed particularly in dissolution profiles and in vitro activity between generic products and brand-name levofloxacin.
Keywords
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Applied Microbiology and Biotechnology
Authors
Hsin-Yun Sun, Hsiao-Wei Liao, Meng-Huei Sheng, Hui-Min Tai, Ching-Hua Kuo, Wang-Huei Sheng,