title: Bioequivalence and in vitro antimicrobial activity between generic and brand-name levofloxacin.
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 (-25% 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.
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Hsin-Yun
authors.initials: HY
authors.lastname: Sun
authors.affiliation: School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Hsiao-Wei
authors.initials: HW
authors.lastname: Liao
authors.affiliation: Jia-Nan University of Pharmacy and Science, Tainan, Taiwan.
authors.forename: Meng-Huei
authors.initials: MH
authors.lastname: Sheng
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Hui-Min
authors.initials: HM
authors.lastname: Tai
authors.affiliation: School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Ching-Hua
authors.initials: CH
authors.lastname: Kuo
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: whsheng@ntu.edu.tw.
authors.forename: Wang-Huei
authors.initials: WH
authors.lastname: Sheng
mesh_terms: D000900:Anti-Bacterial Agents / Q000494:pharmacology*; D016568:Drugs, Generic / Q000737:chemistry* / Q000494:pharmacology*; D006801:Humans; D064704:Levofloxacin / Q000494:pharmacology*; D008826:Microbial Sensitivity Tests; D013810:Therapeutic Equivalency; D014481:United States
chemical_list: D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D064704:Levofloxacin
keywords: Bioequivalence; Brand-name; Generic; Levofloxacin