Abstract

MEDINA LOPEZ, José Raúl; GARCIA LUGO, Carlos Abner; HURTADO Y DE LA PENA, Marcela  and  DOMINGUEZ-RAMIREZ, Adriana Miriam. In vitro release study of ibuprofen dragees: dose and dissolution apparatus influence. Rev. mex. cienc. farm [online]. 2015, vol.46, n.2, pp.24-32. ISSN 1870-0195.

In order to evaluate the effect of the dose and the dissolution apparatus on the release of ibuprofen from immediate- release dosage forms, the dissolution profiles of reference product Motrin® (400 and 600 mg, dragees) in USP Apparatus 2 and 4 at different pHs, were obtained. Using USP Apparatus 2 at pH 6.8 only the 400 mg drug product reached the 85 % dissolved at 30 min. Significant differences in dissolution efficiency, related to dose and apparatus used, were found (p< 0.05). The results suggest the need to reconsider biowaiver criteria for ibuprofen drug products.

Keywords : ibuprofen; dose; flow-through cell method; reference product.