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Revista Cubana de Farmacia

versión impresa ISSN 0034-7515versión On-line ISSN 1561-2988

Resumen

GARCIA PENA, Caridad Margarita; IRAIZOZ BARRIOS, Antonio  y  MARTINEZ ESPINOSA, Vivian. Comparative assessment of in vitro release of 3 mg Risperidone produced in Cuba versus Risperidal®. Rev Cubana Farm [online]. 2010, vol.44, n.2, pp.189-195. ISSN 0034-7515.

The 3 mg Risperidone tablets dissolution profiles, a generic drug produced in Cuba and the Risperidal® (Janssen-Cilag S.A. Labs) were compared to demonstrate its similarity. Also, we compared some dissolution means at different pH to assess a potential bio-exoneration. To quantify the active principle, a previously validated high-performance liquid chromatography was used. The comparison was conducted on the base of differentiation and similarity factors. Results demonstrated that there weren't differences en release profiles for tablets produced in Cuba and of innovative product, as well as for the different dissolution means at pH used.

Palabras clave : Dissolution profiles; Risperidone; exchange.

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