Evaluación de los factores que influyen en la biodisponibilidad de los medicamentos y su bioequivalencia farmacéutica.

Abstract

Bioavailability is the amount and fraction in which a drug enters the bloodstream and becomes available at its site of action. There are differences in bioavailability between drugs with the same active principle that are of great importance in the clinical part, for this reason, it is considered essential to know whether two drugs are equivalent or not. The objective was to evaluate the factors that influence the bioavailability of a drug by means of a bibliographic research of scientific articles for the knowledge of its therapeutic bioequivalence. In the present work, bioavailability studies were compiled, based on the Biopharmaceutical Classification System (BPS), which indicates which drugs have bioexemption criteria, to which in vitro studies are carried out by dissolution profiles and those that do not meet this criterion are subjected to in vivo studies evaluating the pharmacokinetic parameters that demonstrate the interchangeability between a similar drug and its innovator. Based on the studies analyzed, it is concluded that the factors that have influenced the bioavailability of Class I and Class III drugs are the characteristics of the active substance, excipients and also the manufacturing process, since there are conditions such as temperature or humidity that directly affect the active ingredient, thus affecting its therapeutic effect, while the drugs in in vivo studies present factors such as interactions with food, physiological and pathological factors, which do not allow complete absorption, thus decreasing bioavailability.