Abstract

PEREDA RODRIGUEZ, Diana; PEREZ SOUTO, Néstor; MARTINEZ MIRANDA, Lisette  and  CHANG VALDES, Aleyda. Evaluación comparativa de la liberación in vitro de Metildopa de producción nacional contra Aldomet^®. Rev Cubana Farm [online]. 2001, vol.35, n.1, pp.13-17. ISSN 0034-7515.

A comparative study was made between the dissolution profiles of 3 lots of Aldometâ (Merck, Sharp & Dohme), a leading drug of the methyldopa active principle (DCI), and of 3 batches of methyldopa 250 mg of national production. The spectrophotometric method was used for the quantification of the active principle in the different batches, which fulfilled the criteria of the Food and Drug Administration (FDA) for the in vitro equivalency studies. The best adjustment to common models for dissolution profiles was determined among the data obtained by using the CurveExpert program.

Keywords : COMPARATIVE STUDY; DRUG SCREENING; METHYILDOPA [pharmacokinetics]; CHEMISTRY, PHARMACEUTICAL [methods]; TECHNOLOGY, PHARMACEUTICAL; SPECTROPHOTOMETRY [methods]; THERAPEUTIC EQUIVALENCY.