Formulation and Evaluation of Sustained Release Matrix Tablet of a Model Drug

ABOUT AUTHOR
Ravi kumar Misal^*_, Atish Waghmare, Dr. Dinesh Sakarkar
Department of Pharmaceutics, S. N. Institute of Pharmacy, Pusad- 445204, Yavatmal. M. S. India.
*E-mail: [email protected]

Abstract
The purpose of this work was to prepare oral sustained release matrix tablet of highly water soluble drug and to evaluate the effect of concentration of lipophilic binderand effect of type of lipophilic binder and effect of release enhancers such as lactose. Based on Preformulation studies the concentrations of the hydrophobic polymers to be used in the formulation were optimized. The compatibility between the pure drug and excipients used in design of the formulations were confirmed by IR studies. Diltiazem hydrochloride tablets were prepared by melt granulation technique using hydrophobic polymers namely Stearic acid and Stearyl alcohol to formulate six different formulations. The tablets were then evaluated for their hardness, thickness, friability, weight variation, drug content and In-vitro dissolution studies. Drug release is inversely proportion to the level of rate retarding polymers present in matrix system i.e extent of drug release decrease with increase in wax content of the matrix. In-vitro drug release profile of formulation F2 resembles with that of marketed formulation hence considered as satisfactory formulation. Stearic acid was found to be a good retardant science it forms thin coating on surface of drug particle. Drug release increases with increase in concentration of release enhancers such as lactose. Optimized formulation F2 was subjected to accelerated stability study was found to be stable.
Keywords: Melt granulation, sustained release, Diltiazem hydrochloride, Stearic acid and Stearyl alcohol