Preparation and Evaluation of Gastroretentive Microballoons of Dexlansoprazole Containing Natural and Synthetic Polymers

Research Article

Abstract

In oral drug delivery, multi-particulate systems hold greater significance than single-unit dosage forms. Among various multi-particulate drug delivery systems, floating microballoons stand out as an effective method to enhance gastric retention. These microballoons contribute to more reproducible drug absorption, mitigate the risk of local irritation, and enhance the bioavailability of the drug. This research focuses on Dexlansoprazole (DSP), a BCS class-II drug and proton pump inhibitor utilized in treating gastroesophageal reflux disease (GERD) and ulcer colitis. Dexlansoprazole acts by reducing stomach acid quantity and was formulated into non-effervescent floating microballoons using both natural and synthetic polymers. Sodium alginate and chitosan served as natural polymers, while ethyl cellulose and HPMC acted as synthetic polymers, with Span 80 employed as the surfactant. Pre-formulation studies encompassed solubility, partition coefficient, and micromeritics for the pure Dexlansoprazole drug. Additionally, drug-excipient compatibility studies were conducted using FTIR. Various formulations of floating microballoons were prepared via the solvent evaporation method. In-vitro drug release and kinetic studies were performed on all Dexlansoprazole microballoons, with results systematically analyzed. Formulation F7 exhibited favorable release characteristics up to 10 hours, leading to its identification as the optimized formulation. The Peppas n values for all formulations exceeded 0.5, indicating a non-Fickian diffusion mechanism for the drug release in all formulated Dexlansoprazole microballoons