Equivalencia farmacéutica in vitro de metformina clorhidrato frente a Glucofage®

Abstract

The pharmaceutical equivalence in vitro is a study that allows to know if a generic drug is or not similar to its innovator based on different tests that guarantee the quality of the drugs. This study was focused on demonstrate the in vitro pharmaceutical equivalence of generic medicines of metformin hydrochloride of 850mg against Glucofage® (innovator). The methodology used was experimental, comparative and analytical design, performing the relevant quality control tests and comparing the dissolution profiles through the difference and similarity factors f1 and f2 respectively and through the dependent mathematical models: zero order, first order, Hixson and Crowell, Korsmeyer and Peppas and Higuchi. With the results obtained, it was demonstrated that the generic tablets of 4 commercial houses (B, C, D, E) are pharmaceutical equivalents to the innovator based on f2. But it was found that the F tablets are not similar to the innovator as their f2 was <50 in the comparison of dissolution profiles, in addition they did not comply with the organoleptic characteristics and the hardness parameters; while the B tablets did not meet the content uniformity criterion. The other tablets met the parameters of quality control satisfactorily. Finally, regarding the release kinetics, it was determined that all the tablets conform to the Korsmeyer and Peppas model