Abstract

MARTINEZ MIRANDA, Lisette et al. ZantacÒ150 and ranitidine of national production: in vitro release. Rev Cubana Farm [online]. 2004, vol.38, n.2, pp.1-1. ISSN 0034-7515.

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 3 batches of ZantacÒ (Glaxo Wellcome), a leading drug of the ranitidine active principle (DCI), and of 3 batches of ranitidine 150 mg of national production were performed. The method described in the USP 23 was used for the dissolution test. The percentage data of the active principle released against time were subjected to a study of adjustment of 4 models to common disssolution profiles by the CurveExpert program. All the studied batches fulfilled the criteria of the Food and Drug Administration (FDA) for the in vitro bioequivalence studies.

Keywords : Ranitidine; Zantac; dissolution; dissolution profiles; in vitro bioequivalence.