Statistical optimization of tamsulosin hydrochloride controlled release pellets coated with the blend of HPMCP and HPMC

Abstract

The objective of the present study was to evaluate three coating parameters for the application of a blend of HPMCP and HPMC in ethylcellulose aqueous dispersions (Surelease®) in order to obtain controlled release of tamsulosin hydrochloride. The selected independent variables, HPMCP content (X 1), HPMC content (X2) and coating level (X3), were optimized with a three-factor, three-level Box-Behnken design. The selected dependent variables were the cumulative percentage values of tamsulosin hydrochloride that had dissolved after 2, 3 and 5 h. Various dissolution profiles of the drug from controlled release pellets were obtained. Optimization was performed for X1, X2 and X3 using the following target ranges; 15%≤Y1≤30%; 50%≤Y 2≤65%; 80%≤Y3≤95%. Results of the optimization procedure indicated that the optimized levels of HPMCP content (X1), HPMC content (X2) and coating level (X3) were 30%, 15% and 25%, respectively. Controlled release pellets coated with the optimized formulation provided a release profile that was close to predicted values. In addition, the dissolution profiles of the controlled release pellets coated with the optimized formulation were similar to those of the commercial product Harunal® capsule (f1=4.6, f2=78.7). © 2007 Pharmaceutical Society of Japan.