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Post-Marketing Quality Assessment and Comparative Dissolution Study of Some Ciprofloxacin Tablets Marketed in Mongolia

Azjargal Ganbat, Gereltuya Dorj*, Bruce Sunderland, Tsetsegmaa Sanjjav, Anudari Tompurev, Tserendulam Luvsandorj, Battulga Borbaatar, Gantuya Dorj, Daariimaa Khurelbat

Variable quality of dosage forms of a wide range of drugs has often been reported, prompting the WHO to set standards for generic products. This study aimed to assess the quality and dissolution characteristics of generic ciprofloxacin 500 mg products available on the market, by comparison with a leading brand as well as to establish dissolution profiles in order to inform manufacturers and decision makers. A post-marketing quality assessment and comparative dissolution study of five generic ciprofloxacin products from different manufacturers available in Mongolia were completed. USP buffer at pH=1.2 (hydrochloric acid solution) and pH=4.5 (phosphate buffer solution) were dissolution media. In addition, weight variation, hardness, friability, disintegration time and assay were determined according to established methods. All five sampled products complied with the official specifications for uniformity of weight, friability and disintegration time. All five samples contained >99% (w/w) of labeled chemical content. However, significant inter and intra-brand variabilities in terms of dissolution rate were detected. As only two generic ciprofloxacin tablets included in this investigation were similar with the chosen comparator bioequivalence.