Quality and In Vitro Pharmaceutical Equivalence of Ciprofloxacin Tablets Brands in Kenya

Abstract

The quality and in vitro pharmaceutical equivalence of nineteen generic products of ciprofloxacin tablets with marketing authorization in Kenya are reported. The tablets were assessed for compliance with pharmacopoeial specifications for identity, uniformity of weight, disintegration, drug content and dissolution. All the evaluated generic brands complied with the compendial specifications for identity, uniformity of weight, disintegration and drug content. However, five (26.3%) of the evaluated generic brands were non-compliant in the dissolution test at pH 1.2. In vitro pharmaceutical equivalence analysis showed that ten (52.6%) generic ciprofloxacin tablets brands exhibited similar dissolution profiles as the innovator Cipro^® brand at pH 1.2 and pH 4.5, while the other nine (47.4%) had significantly variable dissolution profiles. Therefore only 10 of the 19 generic ciprofloxacin tablets brands evaluated in this study may be regarded as pharmaceutically equivalent to the innovator Cipro^® brand.

Key words: Ciprofloxacin tablets, quality parameters, pharmaceutical equivalence