Evaluation of in vitro dissolution similarity of bisoprolol film-coated tablets based on Weibull modelling using MATLABTM simulation software

Abstract

The aim of this study was to compare the in vitro dissolution behaviour of reference (R) and generic-test (T) medicinal products with non-linear effects model. Mathematical function Weibull, was employed as basis for the non-linear effects model, coupled with MATLABTM simulation software to describe the release profile of the active substance. Medicinal products selected for the presented study include immediate-release tablets Concor 10 mg and Bisoprolol 10 mg, which belongs to BCS class 1 of biopharmaceutics classification system. The result from the study indicated that Weibull distribution function coupled with computer-based program is more useful for comparison of the dissolution profiles. This combined approach provides robust and informative results, with accurate estimation on the in vitro performance for the medicinal products and it’s the most suitable tool for prediction of in vivo behaviour of the medicinal product. In summary, we have employed Simulink graphical programming to design our system in a simulation environment.</jats:p>