Calidad biofarmacéutica de comprimidos genéricos de ibuprofeno 400 mg en relación al medicamento de referencia

Abstract

The overall objective of this study was to evaluate biopharmaceutical aspects of generic ibuprofen tablets 400 mg compared to their reference drug, using quality parameters to demonstrate their pharmaceutical bioequivalence. The research was framed in an observational, descriptive and correlational study, without intervening in the administration or manufacturing process of the drugs. The study population consisted of ibuprofen tablets purchased in the city of Machala, while the sample included three generics of different brands and one reference drug. Processing methods included evaluation of organoleptic characteristics, average weight, friability, hardness, disintegration, titration and dissolution profile of the tablets. Microsoft Excel 2021 and Jamovi 2.4.14.0 software were used to compare the measured variables and detect significant differences between the groups. The results showed uniformity in the sensory characteristics of the tablets, but significant variations in physicochemical parameters between the brands evaluated. Dissolution profiles also showed significant variations, which may influence the bioavailability and therapeutic efficacy of the drugs. In conclusion, some evaluated brands meet the acceptable ranges, and in terms of bioequivalence only a generic brand is bioequivalent to the reference drug, continuous monitoring of quality parameters is important to ensure the consistency and safety of pharmaceutical products.