Formulation, Optimization, and Characterization of Rabeprazole Sodium Pellets for Sustained and Targeted Intestinal Drug Release

The present study focuses on the formulation and evaluation of sustained release pellets of Rabeprazole Sodium using the extrusion-spheronization technique. Rabeprazole, a proton pump inhibitor, is acid-labile and requires protection from gastric degradation. To address this, a multiparticulate sustained release dosage form was developed using various polymers such as microcrystalline cellulose (MCC), hydroxypropyl methylcellulose (HPMC K4M and E5), ethyl cellulose, and polyvinylpyrrolidone (PVP K30). The pellets were prepared by wet massing the drug and excipients, extruding through a suitable die, and spheronizing under optimized conditions. Enteric coating was applied using suitable pH-dependent polymers to ensure drug release in the intestinal environment. The prepared pellets were evaluated for micromeritic properties, drug content, in vitro drug release, and stability. Drug release data were fitted to various kinetic models to understand the release mechanism. The optimized batch showed a controlled drug release profile over 12 hours with good stability. The extrusion-spheronization technique proved to be effective in achieving sustained release and uniform pellet size, providing a promising approach for improved patient compliance and therapeutic efficacy.