Formulation Development and Evaluation of Enteric Coated Tablets of Rabeprazole Sodium

Abstract

Rabeprazole sodium is highly acid-labile and presents many formulation challenges and to protect it from acidic environment of the stomach an enteric coated tablet formulation is tried in the present study. This study is aimed to develop pharmaceutically equivalent and stable enteric-coated tablets of Rabeprazole sodium comparable to innovator product. Different Formulations of Rabeprazole core tablets were developed using mannitol as diluent and croscarmellose as super disintegrant in different proportions. Further optimized formulation was coated with varying the compositions of sub coating and enteric coating using opadry white and enteric yellow. Compatibility studies were performed for drug, physical mixture tablet which shows no interaction. From the dissolution the formulation F6 shows highest percentage of drug release. The kinetics of drug release for F6 & Innovator followed first order and ‘n’ value ( 0.5>n<1) shows that the mechanism may be erosion control rate release. The f1 and f2 were found to be 3.03 and 72.01 respectively for formulation F6 and innovator product. Hence these two products were considered similar and comparable. In the accelerated stability testing carried out at 40°c and 75% RH for three months, no significant change in the physical properties, drug content, and dissolution rate of formulation F6 was observed. From this it can be concluded that formulation F6 developed is found to be an efficient delayed release formulations of Rabeprazole comparable to the innovator product. Thus the study fulfilled the objective of developing efficient Rabeprazole delayed release tablets.