Estudio de bioequivalencia de los medicamentos antihipertensivos multifuentes comparados con el medicamento innovador para la demostración de su equivalencia terapéutica

Abstract

Hypertension is a prevalent pathology worldwide that especially affects older adults, for which the use of antihypertensive drugs has been used as treatment, which must be safe and effective for their prescription and dispensing. Generic antihypertensive drugs are widely marketed due to their inexpensive price compared to an innovative one. Because the demand of patients who need to acquire them constantly places them among one of the first in dispensation. However, generic drugs have the same active ingredient as commercial drugs, but only some are exempt from in-vivo studies that demonstrate their therapeutic action. The present work aims to determine the bioequivalence of multi-source antihypertensive drugs in comparison with the innovative ones to demonstrate their therapeutic equivalence, using a correlational descriptive methodology, through bibliographic review. Different authors have determined the bioequivalence of antihypertensive drugs, demonstrating through dissolution and similarity factor tests that generic atenolol has behaviors similar to its commercial ones. On the other hand, in-vivo analyzes have been performed for the drugs amlodipine and carvedilol, where both tablets were correctly tolerated by the volunteers who participated in the studies. Meanwhile, in the analyzes carried out on enalapril tablets, it can be observed that the dissolution profiles varied, and therefore, their f2 was <50. In conclusion, the generic and commercial drugs atenolol, amlodipine, and carvedilol were shown to be bioequivalent. Whereas, multi-source enalapril was not bioequivalent with its innovative Enalten.