Evaluación de la equivalencia farmacéutica in vitro de metformina clorhidrato (500 mg) en fármacos genéricos frente a Glucofage

Abstract

This study evaluated the in vitro pharmaceutical equivalence of Metformin Hydrochloride (500 mg) in generic drugs versus Glucofage®. The research had an analytical, comparative and cross-sectional experimental approach. The batches used were from the following laboratories: Labovida (L), Nifa (N), BKF (B) and the commercial drug Glucofage (G), being the latter the innovative drug, selected by the probabilistic cluster sampling method. Each tablet was subjected to: quality control, evaluation of organoleptic and geometric characteristics, disaggregation test, content uniformity, hardness, dissolution and construction of dissolution profiles. Microsoft Excel was used for the statistical analysis and the DD-solver complement for the application of the dependent and independent model, all the results were compared with the regulations of the United States Pharmacopeia (USP). A total of 120 tablets were studied, of which 100% of batches presented a regular appearance, sui generis smell (N, G, B), all presented an optimal general appearance, only batch G had inscription, all had a regular appearance, 100% met the geometric characteristics established in the USP, only batches L and N met hardness criteria, G and B met content uniformity criteria, and 100% met disintegration time criteria. The dissolution profiles had a quite similar behavior unlike batch L. The comparison of dissolution profiles through the dependent model showed that it fits the Korsmeyer-Peppas model, while the dependent model indicated that the profile of the 500mg metformin tablets are similar to the innovator. It is concluded that the 3 groups of generic drugs analyzed of 500 mg metformin hydrochloride tablets are pharmaceutical equivalents with their innovator. It is recommended to cover a greater number of commercial brands in later studies.