Revista Cubana de Farmacia
versão On-line ISSN 1561-2988
Dissolution is the most important step in the global release process of a drug, since it is closely related to the absorption processes, which are determinant in the bioavailability of a drug administered by oral route. The dissolution profiles of two batches of Daonil® (Hoechst Farma SA Barcelona), a leading drug of the glibenclamide active principle (DCI), and of 3 batches of glibenclamide 5 mg of national production were studied. The percentage data of the active principle released against time were subjected to a study of adjustment of 4 models to common dissolution profiles by the CurveExpert program, and the statistical comparison of dissolution profiles was made by using a mathematical independent model (f2: similarity factor). All the batches studied do not fulfill the criteria of the Food and Drug Administration (FDA) for the in vitro equivalence studies and showed significant differences in their dissolution profiles.
Palavras-chave : Glibenclamide; Daonil®,; dissolution; dissolution profile comparison.