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Original Article

J App Pharm Sci. 2016; 6(9): 063-068


In-vitro bioequivalence, physicochemical and economic benefits study for marketed innovator and generic ciprofloxacin hydrochloride tablets in Saudi Arabia

Ahmed F. Hanafy.

Abstract
The objective of the present study was to compare and evaluate the economic benefits and in-vitro bioequivalence of different marketed generic ciprofloxacin tablets against the innovator tablet formulation that are present in the local market of Saudi Arabia. The comparative bioequivalence and physicochemical study of five ciprofloxacin marketed tablets were performed through the assessment of the uniformity of weight, hardness, disintegration, dissolution, and content assay of the products. In order to compare the dissolution profiles of all generic tablet formulations and the innovator, a model independent approach of similarity factor (f2) and difference factor (f2) was employed in the in vitro dissolution studies. Deviations in were noted in two generic products, these deviations caused significant differences in disintegration time and in dissolution profile in only one of the generic products. All tested generic products passed USP monograph dissolution testing except one product which failed to pass both similarity factor (f2) and difference factor (f1) tests required by FDA bioequivalence testing. The majority of generic products in Saudi Arabia which had lower prices showed comparable quality to innovator.

Key words: Ciprofloxacin tablets, comparative dissolution profile, difference factor, similarity factor, physicochemical parameters.



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