FORMULATION DEVELOPMENT AND OPTIMIZATION OF DELAYED RELEASE CAPSULE CONTAINING PROTON PUMP INHIBITOR

Abstract

The aim of the present work was to develop a delayed release multi particulate drug delivery system of Drug X (Proton Pump Inhibitor) to overcome the problem associate with the gastric disorders like Dyspepsia, GERD, Helicobacter Pylori. The formulation consisted of enteric coated pellets coated using enteric coating polymer (Eudragit L30D55) used for achieving desired drug release at target site (Duodenum). The inert pellets consist of three main layers; Drug Loading, Seal Coating, Enteric Coating, which were optimized by modifying the Solid Content, Percentage coating and Process Variables. The Optimized batch is mainly Consists of 25%W/W Barrier coating followed by 70% W/W Enteric Coating of EudragitL30D55 which has good acid resistance properties. Percentage drug release in the basic environment was found to be within the limits which is 99.0 ± 3.00 within 30minutes. In case of Inadequate coating less than 25%W/W in barrier coating and 70%W/W enteric coating resulted into drug release in the acidic stage. In case of excessive coating, drug release was retarded due to higher polymer contents. The similarity factor f2 was found to be >50 when compare to that of the innovator. Hence, it can be concluded that between marketed product and optimized batch there is no significant differences regarding dissolution profile and the developed delayed release multi particulate drug delivery system of proton pump inhibitor gave similar site specific release to the small intestine as marketed product.