Calidad biofarmacéutica de tabletas de paracetamol de 500 mg genéricos con respecto a un comercial como medicamento de referencia

Abstract

The widespread trade involving the over-the-counter sale of acetaminophen tablets carries with it an ethical and legal responsibility on the part of the pharmaceutical industry to ensure their quality, safety and efficacy. However, concern arises as to whether generic tablets retain the same quality standards as commercial ones, highlighting the importance of investigating biopharmaceutical quality to ensure therapeutic equivalence between generic and commercial tablets. The research examined organoleptic (appearance, color, odor, texture) and physicochemical (friability, disintegration, hardness, average weight, dissolution, titration) parameters through quality controls in different assays on 500 mg paracetamol tablets taken from a single batch from five different pharmaceutical companies. It was observed that all tablets complied with the organoleptic parameters, although variations in hardness and disintegration were observed between formulations. Dissolution profiles showed differences, with some formulations dissolving faster than others. Formulations A, B and D were observed to dissolve faster compared to the reference profile X, while formulation C showed slower dissolution. When compared to standards established by USP 41, all formulations met the dissolution criteria. However, formulation C was found not to be bioequivalent to reference brand X. These findings suggest the need for more rigorous biopharmaceutical quality control to ensure the therapeutic efficacy of acetaminophen.