Estudio comparativo de bioequivalencia de la amoxicilina genérica con su innovador para la demostración de su equivalencia farmacéutica.

Abstract

Bioequivalence is a very important study to demonstrate that generic drugs compared to reference drugs are pharmaceutically equivalent, therefore, they are therapeutic equivalents. The following investigative work aims to determine the bioequivalence of generic amoxicillin compared to its innovator to demonstrate its pharmaceutical equivalence, the methodology used was the bibliographic review, where scientific articles from database journals such as Scielo, Redalyc were analyzed. , PUBMED, among others, from which information was obtained on bioequivalence studies of amoxicillin both in vivo and in vitro. As results we have that, in the different studies reviewed, they showed that the in vitro tests by analyzing the dissolution profiles of amoxicillin, the majority if they were bioequivalent with the innovator, because the value of both the difference factor (f1) and the similarity factor (f2) were within the allowed range, which is 0 - 15 and 50 - 100, respectively. On the other hand, in the in vivo tests, not all the drugs evaluated were able to comply with the pharmaceutical parameters compared to the reference drug, and they were not interchangeable with each other. Concluding that most of the generic amoxicillin drugs that are marketed, if they comply with the in vitro and in vivo bioequivalence studies, that is, if they are therapeutically similar and interchangeable with the reference drug, thus guaranteeing their safety and efficacy .