Abstract

FORMULATION AND EVALUATION OF “GASTRORETENTIVE - CYTOPROTECTIVE ORAL DELIVERY SYSTEM” OF DICLOFENAC SODIUM

Nishi Prakash Jain* and Chandra Prakash Jain

Abstract

The purpose of present study was to develop and design an oral controlled drug delivery system for controlled release of Diclofenac sodium (DNa) and cytoprotective drug as well mucoadhesive agent sucralfate (SFT). A Gastroretentive-cytoprotective drug delivery system (GR-CDDS), of Diclofenac sodium tablet was developed by using wet granulation technique, in which sucralfate granules were prepared by different concentration of pregelatinised starch, with drying in microwave oven for 1 minute and 10 seconds and two types Diclofenac sodium granules prepared using HPMC as binding and mucoadhesive agent with coating H.E.C. Formulation prepared with coated and uncoated granules of Diclofenac sodium were evaluated for release of DS. For the period of 8hr. in simulated Gastric fluid (without enzyme) using United States Pharmacopoeia (USP) type II dissolution apparatus. Along with other physical properties, hardness, friability was also evaluated. The in-vitro release study revealed that, there was a significant difference in drug release between uncoated and coated granules. Gastroretention by Sucralfate (SFT) was successfully control the drug release which was more efficient in coated granules of DNa, However each of component was capable of interacting to some extent with each other to control drug release with cytoprotection. The best fit release kinetics with the highest correlation coefficient was achieved with the Higuchi equation p1 of followed by first order and zero order equation over 8 hrs. Compare to conventional sustained release of DNa 75 mg. GR-CDDS tablet was started releasing drug immediately and for prolonged time. Stability studies as per norms suggested that formulation were not significantly affected coated granules of DNa was more stable.

Keywords: Diclofenac Sodium (DNa), Gastroretentive – cytoprotective drug delivery system (GR-CDDS), sucralfate (SFT).