Estudio de bioequivalencia de los medicamentos antibióticos genéricos comparado con el innovador para la demostración de su equivalencia terapéutica.

Abstract

Bioequivalence compares the bioavailability between a generic and an innovative drug, if they have similarity they are considered bioequivalent. Antibiotics are drugs that help fight infectious bacterial diseases. This research aims to determine the bioequivalence of multi-source antibiotic drugs with those of reference to demonstrate the therapeutic equivalence. The methodology used was the search for bibliographic research, where the scientific articles from databases of high impact journals were analyzed, in which the information on the study of the in vitro and in vivo bioequivalence of multi-source antibiotics was extracted. As results we have that dissolution profiles and relative bioavailability were compared. It was determined according to the dissolution profile of multi-source amoxicillin, doxycycline, cefadroxil and ciprofloxacin, which had therapeutic equivalence with the innovator because their f2 was in the established range, and according to the relative bioavailability of sulfamethoxazole and multi-source rifaximin, only rifaximin resulted not be bioequivalent with the innovator because it is not in the established range of bioavailability. Therefore, it is concluded that most of the generic drugs compared in this study do have therapeutic equivalence, thus demonstrating that they are interchangeable with the reference drug.