Formulation and in vitro Evaluation of Alfuzosin Extended Release Tablets Using Directly Compressible Eudragit

摘要

The aim of the present study was the determination of formulation factors and the in vitro evaluation of an extended release dosage form of a freely soluble weakly basic drug (alfuzosin hydrochloride). Binary mixer of one hydrophilic polymer (hydroxypropylmethylcellulose) and one directly compressible Eudragit (RS PO) was used in tablets prepared by direct compression. The amounts of both polymers were taken as independent variables for the 32 Factorial design. The percent drug releases at 1, 6, 12 and 20 h were selected as responses. The main effect and interaction terms were quantitatively evaluated using mathematical model. Dissolution data were fitted to zero order, first order, and Higuchi's release kinetics to evaluate kinetic data. Both the diffusion and erosion mechanisms were responsible for drug release as shown by the power law. The release of Alfuzosin was prolonged for 20 h by binary mixer indicating the usefulness of the formulations for once daily dosage forms.