Quality control and comparative in vitro dissolution profile of ciprofloxacin hydrochloride 500 mg tablets marketed in Burkina Faso, West Africa

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Résumé

Counterfeit and substandard medicines pose a threat to public health. In Burkina Faso in West Africa, essential medicines are regularly sampled and subjected to pharmaceutical quality control. The aim of this study was to assess the quality of the leading brands of 500 mg ciprofloxacin hydrochloride tablets on the market in this country. Five samples were selected from a list of imported brands in 2025. All samples underwent macroscopic, pharmacotechnical (uniformity of mass, disintegration, dissolution), and physicochemical tests (identification and dosage of the active ingredient) testing in accordance with USP/NF 43. Additionally, the dissolution profiles of ciprofloxacin from samples obtained in acetate buffer at pH 4.5, phosphate buffer at pH 6.8 and hydrochloric acid at pH 1.2 were compared with those of the TYFLOX® 500 mg reference tablet. The results showed that all the tablets complied with the prescribed specifications. However, comparative dissolution tests revealed that, at pH 4.5, one of the samples had a dissolution profile that was not similar.
Also, at pH 6.8, the release profiles of two samples were different. These differences in release appeared to be more related to the disintegration time of the dosage form than to the solubility of ciprofloxacin. These results suggest differences in bioavailability between the different drugs. Therefore, stricter post-marketing controls are necessary to ensure the interchangeability of ciprofloxacin tablets approved in Burkina Faso

Mots-clés

Ciprofloxacin, tablet, pharmaceutical quality, dissolution, similarity