Evaluación de la equivalencia farmacéutica in vitro de meloxicam (15 mg) de fármacos genéricos frente a Mobic®

Abstract

The objective of the study was to evaluate the pharmaceutical equivalence in vitro of Meloxicam 15 mg of generic drugs against Mobic®. The applied methodology presented a quantitative, cross-sectional and comparative approach, solid oral pharmaceutical forms marketed in pharmacies in the city of Riobamba were analyzed, for the analysis of the tablets physicochemical tests of color, smell, taste, appearance, surface, diameter, thickness, resistance to rupture, friability, content uniformity, disintegration and dissolution according to the regulations of the United States Pharmacopeia 44 National Form 39, in addition, the comparison of dissolution profiles was performed through the similarity factor (f2) and the difference factor (f1), finally, to define the drug release kinetics, five dependent mathematical models were applied. The results obtained for the quality control tests applied to the Meloxicam tablet at a concentration of 15 mg from the four pharmaceutical companies under study complied with the specifications described in USP 44, except for the MG1 tablets, since the average value in the hardness test was below the permitted acceptance range. Likewise, the mathematical model with the best fit for the four drugs was the Weibull function. The comparison made to the generic medication against the innovator was acceptable for both factors f1 and f2, concluding that the three generic brands are pharmaceutical equivalents and similar to the innovator medication.