DEVELOPMENT AND CHARACTERIZATION OF GASTRO RETENTIVE TABLETS OF CLARITHROMYCIN FOR ANTIULCER EFFECT

Abstract

Gastroretentive floating drug delivery system (GFDDS) is used to prolong the gastric residence time after oral administration, at a particular site and controlled or modified the release of drug from the formulation.The purpose of the present study is to develop a gastro retentive floating drug delivery system to achieving controlled release so that is improves bioavailability of the formulation, Structure activity relationship based on Biopharmaceutical Properties of Clarithromycin indicates good biopharmaceutical Properties. Floating dosage form of Clarithromycin was designed for the treatment of gastric ulcer caused by Helicobacter pylori. The granules were prepared by wet granulation method and evaluated for flow property, Carrs' index, bulk density, tapped density and Hausner ratio. The dosage form was designed by using polymers of different viscosity as gelling agents, sodium bicarbonate as gas generating agent and other excipients. The granules were further subjected to tablet preparation and the prepared tablets were subjected for evaluated on the basis of different evaluation parameters like hardness, in vitro buoyancy, in vitro drug release. Incorporation of gas generating agent together with polymer improved drug release Optimized formulation (F7) containing Clarithromycin, HPMC, 90 SH , HPMC K4M , sodium bicarbonate, released approximately 86.6% drug in 10 hrs. and the floating lag time was found to be 25 sec. KEYWORDS: GFDDS, Helicobacter pylori, gelling agents, in vitro buoyancy, HPMC, wet granulation.