Estudio de bioequivalencia in vitro de comprimidos génericos de metformina en comparación con el medicamento innovador.

Abstract

The in vitro bioequivalence of drugs is one of the most important studies that guarantee the quality and safety of generic drugs sold in the pharmaceutical market. The dissolution profile compares whether the test drug is similar to the innovative drug by quantifying the dissolved amount of drugs, where the calculation of the similarity factor (f2) determines this property. On the other hand, one of the most prevalent diseases in the world is diabetes, and metformin is widely used as a first-choice drug. For this reason, it is important to carry out these studies in the multisource of metformin to guarantee the community access to safe, effective and low-cost medicines. The objective of the bibliographic research is to determine the bioequivalence of metformin tablets in their different concentrations, for this, a search of scientific articles was carried out to know the fulfillment of these studies. The results obtained were that of the five investigations, four presented generic drugs that were not in the range of the allowed f2 that is 50 -100, therefore, they were not bioequivalent. Likewise, quality controls such as hardness, friability, content uniformity, disintegration and quantification of the active principle were analyzed, where the majority met these parameters. In conclusion, there were studies of generic drugs of metformin that did not meet bioequivalence in vitro, therefore, it will be necessary to continue these studies to obtain effective and safe drugs to demonstrate their therapeutic interchangeability.