Formulation and Evaluation of Controlled-Release Tablet of Zolpidem Tartrate by Melt Granulation Technique

Abstract

The present investigation describes the influence of the concentration of PEG 6000 as a melt binder and ratio of HPMC K4M : PVP on Zolpidem tartrate controlled-release tablet formulations using 3 2 full factorial design. The ratio of HPMC K4M and PVP K30 () and the concentration of melt binder () were selected as independent variables, and drug release at 1 hr (), 4 hr (), 8 hr (), diffusion coefficient (), and release rate constant () were selected as a dependent variable. Tablets were prepared by melt granulation technique and evaluated for various evaluation parameters. It was observed that concentration of melt binder had significant effect on , , , and Binder concentration 25% w/w was found optimum. Optimized formulation () showed good similarity with theoretical profile of drug. The variable had a significant effect on dependent variables, and the variable had no significant effect on dependent variables.