Estudio de bioequivalencia “in vitro” de los medicamentos genéricos de mayor demanda comercial.

Abstract

Generic drugs are those created with the same composition as a brand-name drug, being bioequivalent when its bioavailability is studied or replaced by it by "in vitro" studies such as the dissolution profile, thereby guaranteeing its quality, safety, efficacy and efficiency. These drugs are in high demand because they are more accessible to consumers due to their variety and price, mainly in the public health systems of a country. The objective of this research work will be to evaluate in vitro bioequivalence studies of generic drugs by dissolution profile tests, using a bibliographic research methodology where several scientific articles were analyzed. Several authors have determined that the analysis of the bioequivalence parameters in different studies makes it possible to know if generic and innovative drugs are interchangeable with each other, through in vitro tests such as the dissolution profile of enalapril, ibuprofen, propranolol and loratadine, which if they had equivalence therapy with the innovator, because the factor (f1) and (f2) was within the established range. Likewise, dissolution tests were analyzed where their values are within the permissible parameter, presenting good bioavailability. Finally, it is concluded that of the 6 active ingredients studied, 4 of them do not meet the bioequivalence, that is, there are generics that do not have a difference factor or a similarity factor in the established ranges, therefore, if they have therapeutic equivalence it is It is necessary to continue with these studies to obtain safe drugs presenting therapeutic exchange.