FORMULATION DEVELOPMENT OF CONTROLLED RELEASE FORMULATION OF ESOMEPRAZOLE SODIUM TABLETS

Abstract: The main aim of this work is Esomeprazole sodium is formulated as controlled release tablets to provide desired effect at certain ti me in maintained drug concentration without any unwanted effect with patient compliance also to improve it bioavailability by decreasing its expose to gastric acid. A controlled release dosage form is designed to release the drug from the dosage form at a time other than promptly after administration. UV Spectrophotometric method has been developed for the estimation of Esomeprazole in pharmaceutical formulations. Then the tablets were prepared by dry granulation method rather than direct compression becaus e of cohesive property of the drug. Optimized core tablet then subjected for enteric coating by selected base coat polymer cellulose derivative for preventing core tablet from moisture. The coated formulations were compared with marketed sample (ESOZ) for optimization. Dissolution results of tablets with enteric coating have shown release of Esomeprazole in simulated gastrointestinal fluid pH 1.2, but most of the drug released in pH 6.8 Phosphate buffer. At the end it was found that prepared formulation gav e satisfactory results compared with marketed sample dissolution profile. Hence prepared formulation by - pass the degradation of Esomeprazole by enteric coating approach and can be used as single unit dosage for the treatment of acid - related diseases. Thus a pharmaceutically equivalent, robust formulation of Esomeprazole controlled release tablet was developed. Keywords: Esomeprazole, UV spectrophotometric method, Enteric coating, Controlled release tablets, In vitro drug release.