Abstract

FORMULATION AND EVALUATION OF GASTRORETENTIVE FLOATING BEADS OF SIMVASTATIN BY IONOTROPIC GELATION METHOD

*Riya Singh, Dr. Arun Patel, Shailendra Patel

ABSTRACT

The present study aimed to develop and evaluate gastroretentive floating beads of Simvastatin using ionotropic gelation technique for prolonged gastric retention and sustained drug release. Floating drug delivery systems (FDDS) enhance gastric residence time and improve bioavailability of drugs absorbed mainly in the upper gastrointestinal tract. Simvastatin-loaded floating beads were prepared using sodium alginate along with polymers such as HPMC, ethyl cellulose, and PVP in different concentrations. Calcium chloride was used as the cross-linking agent, while calcium carbonate served as the gas-generating agent to impart buoyancy. The prepared formulations were evaluated for percentage yield, drug entrapment efficiency, buoyancy, floating lag time, particle size, zeta potential, scanning electron microscopy (SEM), and in-vitro drug release studies. The percentage yield ranged from63.3±0.2% to 76.1±0.4%, while drug entrapment efficiency ranged from 64.85±0.25% to 75.45±0.47%. Formulation F3 showed optimum performance with maximum percentage yield (76.1±0.4%), drug entrapment efficiency (75.45±0.47%), and buoyancy (74.4±0.4%). The optimized formulation exhibited a particle size of 322.2 nm and zeta potential of -23.4 mV, indicating good stability. In-vitro drug release studies demonstrated sustained release behavior over 12 hours. Drug release kinetics followed zero-order kinetics with an R² value of 0.990, indicating controlled drug release. Stability studies conducted according to ICH guidelines revealed no significant changes in appearance, drug content, or dissolution profile during storage.

Keywords: Simvastatin, Floating Drug Delivery System, Gastroretentive Beads, Ionotropic Gelation, Sodium Alginate, Sustained Release, Buoyancy, Drug Entrapment.