Evaluación de la equivalencia farmacéutica in vitro de atenolol 100 mg de fármacos genéricos frente a tenormin®

Abstract

In Ecuador, the high cost of commercial drugs, their limited availability in the public sector, and the low perception of generic medicines about their quality influence adherence to treatment. Therefore, this study aimed to evaluate the in vitro pharmaceutical equivalence of atenolol 100 mg in generic drugs against the trademark Tenormin®. The methodology used had a quantitative and quantitative approach of comparative type, carried out through various tests described in the pharmacopeia of the United States. Considering the method specified in USP 44 NF 39, the pharmaceutical equivalence of generics to the reference determines through compliance with the following tests: organoleptic characteristics, a geometric test of hardness, friability, disintegration, and dissolution, in the last test, the dissolution profiles elaborates at 3, 5, 10, 20, and 30 minutes, time in which they must reach 80% of dissolved active ingredient according to the monograph of atenolol, which indicates that all generics present a rapid dissolution, It should note that there was a variation in the percentage of the dissolved amount of each laboratory and the values of the similarity factor, F2 for K (f2 = 66.215), M (f2 = 40.961), and MK (f2 = 56.026), concluding that the generic M, does not present pharmaceutical equivalence since it does not meet specific quality parameters however the generics K and MK to meet all quality parameters are considered pharmaceutical equivalents, having the ability to be therapeutically interchangeable with the reference Tenormin®.