Estudio de equivalencia farmacéutica In Vitro sobre comprimidos de atenolol 50 mg provenientes de tres diferentes laboratorios de Ecuador

Abstract

The main objective of this research study was to determine the in vitro therapeutic equivalence against the atenolol 50 mg tablets, from three different pharmaceutical laboratories in Ecuador. The development of this study had an analytical, transversal, and comparative approach due to the fact that a relationship that was established between the variables proposed and the results obtained. Batches from the laboratories were used: Ecuaquímica (A1, A2), LIFE (B1, B2), Bagó (C1, C2), and the innovative drug Tenormin (D) selected by probabilistic sampling by clusters. Each tablet underwent quality control, evaluation of organoleptic characteristics, disintegration test, hardness, weight, content uniformity, dissolution, and construction of dissolution profiles. Microsoft Excel and Minitab were used for the execution of the dependent and independent variables. All the results were compared with the United States Pharmacopeia (USP). A total of 140 tablets were studied, of which 100% presented a regular appearance, and suigeneris odor (A, B), all of them presented an optimal appearance in general. Grooves and inscriptions were observed in batches B, C, and D, 100% of the batches met the hardness criteria. All batches met the parameters of content uniformity and disintegration time. The dissolution profiles of all the batches of generic drugs behaved similarly to those of the innovated drug. The confrontation of dissolution profiles through the dependent model showed that it fits better to the Cubic Root model, while the dependent model showed that Atenolol 50 mg tablets are similar to the innovative drug. Thus, it is concluded that each laboratory's 2 batches of Atenolol 50 mg generic drugs are pharmaceutical equivalents of its innovator. It is recommended that a larger number of generic brands be covered in future studies.