Pharmaceutical equivalence and similarity studies of glibenclamide tablets

Abstract

The in vitro dissolution is the physicochemical test most used to estimate the release of the drug from the pharmaceutical form. Due to the close relationship between the dissolution rate of the drug in vitro and the absorption in vivo, the dissolution study is considered as the necessary and sufficient criterion to allow the commercialization of a pharmaceutical product. In this study, the similarity of the dissolution profiles of different products containing glibenclamide used in the Mexican Health Sector was compared. The dissolution profiles of 7 generic products were constructed and analyzed and compared with the innovative drug. The quality control carried out showed that one generic product did not comply with the specifications. Two products showed no difference in the percentage dissolved compared to the reference product; however, none of the products presented a parallel behavior to the innovator. Only one of the seven pharmaceutical products used in the Health Sector met the interchangeability criteria. Properly controlled bio-equivalence studies are strongly recommended to further investigate the potential inequivalence of the tested products.