Quality attributes of twenty-nine brands of ciprofloxacin: post-marketing in vitro analyses, microbiological assay and in vivo simulation

Abstract

Ciprofloxacin is a fluoroquinolone antibiotic employed to treat infections. There are over three hundred registered generic brands of ciprofloxacin in Nigeria. There has been an observed marked variation in therapeutic or clinical outcome with change in brands by health professionals and patients. In a previous study of six (6) brands we had reported a high degree of inequivalence. In this study, twenty-nine (29) brands of ciprofloxacin were extensively evaluated against compendia requirements. Microbial sensitivity against two test organisms was conducted. In-vitro drug release and in-vivo simulation were established. Analysis of the data generated indicated that all brands passed qualitative test using TLC and disintegration test, six failed hardness test, one failed friability, nine failed antimicrobial assay and six failed percentage content assay. Conclusions drawn from the study for evidence-based clinical decisionwould include the fact that three brands only were found to be bioequivalent to the innovator brand, Ciproxin; while eight brands were bio-inequivalent using the three models of similarity factor (f2), and difference factor (f1) in two media and dissolution efficiency (DE) in pH 4.5. The three brands (Cipro-All, Cifran And Ciprogem) may confidently be used interchangeably with the innovator brand
 Keywords: Bioequivalence; Ciprofloxacin Drug quality; Generic substitution; Post-marketing surveillance

Occurrence profiling, risk assessment, and correlations of antimicrobials in surface water and groundwater systems in Southwest Nigeria

“…There are over 300 registered ciprooxacin brands in Nigeria. 35 In same vein, metronidazole is commonly used to treat a wide range of bacterial and parasitic infections including bacterial vaginosis treatment in women and diarrhoea in children 36 and as combination therapy with Ciprooxacin for disease treatment. 29 3.4 Global comparison of antibiotics and parabens in water 3.4.1 Ciprooxacin.…”