Abstract:
Background: Circulation of poor-quality drugs has dire consequences on the health of consumers. Introduction of branded generics to ensure availability and affordability has shown potential for spread of poor-quality drugs. In this study, quality assessment of some commonly marketed ciprofloxacin (500 mg) and levofloxacin (500 mg) tablet brands in Karu Local Government Area (LGA) of Nasarawa
State, Nigeria was evaluated.
Methods: Five tablet brands including an innovator, of either drug were sourced from 5 different Pharmacies in the LGA. Tablets were coded A1-A5 and B1-B5 for ciprofloxacin and levofloxacin brands respectively. Physical assessment of the tablets was done. Physico-mechanical properties, uniformity of weight, friability and disintegration time were also evaluated using pharmacopeia
methods. In vitro dissolution was carried out and the profiles statistically analyzed using the similarity and difference factors in comparison with the innovator products.
Results: All the tablets had uniform weights within official specification, diameter was between 16.37 and 19.44 mm. Friability values were between 0.01 and 0.06 %; within specification. Disintegration time for ciprofloxacin and levofloxacin tablets was within 1.23 - 7.20 min and 3.19 - 12.90 min respectively; all met the specification. All (100 %) the ciprofloxacin brands met pharmacopeia requirement for drug release while only 60 % of the levofloxacin brands met this requirement. Comparatively A4 with f2 value of 41.62 % may not be interchangeable with the innovator brand while brands B2 and B4 with f2 values of 53.40 and 53.03 % respectively may be interchanged with the innovator brand or with each other.
Conclusion: All the tablet brands were found to have good mechanical properties but only 75 % of the ciprofloxacin and 50 % of the levofloxacin tablet brands were found to be interchangeable with the innovator drug brands. This calls for concern as it brings to question the possible interchangeability of these brands with the innovator.
