Abstract

EFFECT OF SINTERING ON SUSTAINED RELEASE PROFILE OF Î’- BLOCKER TABLET PREPARED BY DIRECT COMPRESSION METHOD

Pentewar R. S.*, Sayyed Sarfaraz Ali Riyasat Ali, Thonte S. S., Nasheer Shaikh

Abstract

Exploration of sintering concept in the pharmaceutical science is relatively recent. The objective of this study was to investigate the release characteristic of matrix tablet consisting of a different concentration of various retarding polymers and Sotalol Hcl for sustain release formulation using different sintering techniques. The Sotalol tablet was prepared by using different polymers by direct compression method and formulation was sintered at various temperatures and time point. The sintering of tablet is done by using different techniques like thermal sintering and microwave sintering. The sintered tablets were tested for weight variation, hardness, friability, content uniformity and in-vitro dissolution study. The sintered tablet showed more strength and drug was also retarded than unsintered tablet. Formulation Fs3 and Fs6 showed 96.31% and 95.41 % release profile in 18 hr when subjected to thermal sintering at 80C for 5 hr. whereas, Formulation Fm3 and Fm6 provided 97.21 % and 97.68 % release profile in 18 hr when subjected to microwave sintering at 100 watt for 6 min. Sintering i.e. Application of heat, causes the bonding of adjacent particle surfaces in a mass of powder or in a compact leading to the retardation of drug release. FTIR, Differential Scanning Calorimetry studies ruled out the occurrence of drug interaction after sintering condition. The drug release followed Peppas kinetics. The mean diffusional exponent values (n) ranged from 0.2987 to 0.4972 indicating that all these formulations presented a dissolution behavior controlled by Fickian Diffusion. The stability study conducted as per the ICH Guidelines for optimized formulation was found to be stable.

Keywords: Sotalol Hcl, sintering technique, direct compression, Eudragit RS100 sustained release, FTIR.