Abstract

MEDINA LOPEZ, José Raúl; HURTADO Y DE LA PENA, Marcela; CORTES ARROYO, Alma Rosa  and  DOMINGUEZ RAMIREZ, Adriana Miriam. Comparative dissolution of indomethacin capsules using the USP Apparatus 1 and 4. Rev. mex. cienc. farm [online]. 2012, vol.43, n.3, pp.72-80. ISSN 1870-0195.

Dissolution profiles of four indomethacin generic products (capsules) and the reference product were compared under pharmacopeial specifications with the USP Apparatus 1 (baskets) and the USP Apparatus 4 (flow-through cell system). All products met the dissolution criteria (Q=80 % in 20 min) with the USP Apparatus 1, but dissolution profiles of generic products differed significantly from the reference product (f₂<50), as well as mean dissolution time and dissolution efficiency (p<0.05). Only one of the generic products and the reference reached dissolution criteria and their dissolution profiles were similar (f₂>50) in the USP Apparatus 4. USP Apparatus 4 had more discriminative capacity to evaluate differences in both, rate and extent of indomethacin dissolution process from capsules.

Keywords : indomethacin; capsules; flow-through cell; USP Apparatus 4.