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

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 genericciprofloxacin tablets included in this investigation were similar with the chosen comparator bioequivalence.

Keywords: Quality control; ciprofloxacin hydrochloride; dissolution; interchangeability; Mongolia

CONCLUSION

This study has shown significant variations occurred between commercially available ciprofloxacin tablets in Mongolia. Ciprofloxacin is a BCS IV drug and in vivo BE studies are required to confirm the interchangeability. Due to financial constraints and lack of resources BE studies are yet to be performed in Mongolia. However, in selected cases dissolution rates are recognized to be useful in developing an in vitro/in vivo correlation to reduce costs. Moreover, it is useful to establish the similarity of dissolution profiles pre and post-change products for SUPAC and allow approval of BE. This study was a pilot approach and further in vivo investigations are required in order to establish the interchangeability of generic products in Mongolia.

Full article: https://www.longdom.org/open-access/postmarketing-quality-assessment-and-comparative-dissolution-study-of-some-ciprofloxacin-tablets-marketed-in-mongolia.pdf

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Nancy Ella
Editor Board
Drug Designing: Open Access
drugdesign@eclinicalsci.org