Equivalencia farmacéutica “in vitro” de ciprofloxacino frente a Ciproval.

Abstract

The purpose of this study was to determine pharmaceutical equivalence in vitro between "Generic Drugs" in the dosage form of tablets, containing 500 mg ciprofloxacin hydrochloride, in front of Ciproval, using experimental, comparative, and quality control methods. All the tablets tested, according to the Pharmacopoeia of the United States of America, USP 35 NF 30, comply with the quality control tests. However, after comparing the dissolution profiles by factors of difference f1 and similarity f2, it must be because the results obtained from f2 (below 50), no tablet from the different laboratories presents similarity to Ciproval, likewise; once the values of the difference factor have been calculated, there is a difference between the dissolution profiles, because the values of f1 are above the reference value that is less than or equal to 15. According to USP NF 30, all tested tablets comply with the reference values for tests of a) friability, b) content uniformity, given that in no case is 15% exceeded and c) disintegration time. Within the linear models the laboratories J, L and the reference I conform to the Korsmeyer-Pepas model, which presents linearity for values of F <0.6, when drug release and dissolution occurs from inside the tablets, while laboratories K and M conform to the kinetic model of Weibull, empirical model adapted to processes of dissolution and liberation. The bioexención, is a term that makes reference to the exemption of studies of bioavailability in vivo to demonstrate the bioequivalencia of different oral formulations of immediate liberation of a same active principle by means of a comparative study of the profiles of dissolution in vitro.