Formulation and Evaluation of Enteric Coated Tablet of Dexlansoprazole

Abstract

Dexlansoprazole is a proton pump inhibitor requiring precise quantification and optimized formulation for effective therapeutic outcomes. This study aimed to develop a reliable analytical method and formulate enteric-coated capsules with enhanced dissolution and controlled release profiles. A UV-Visible spectrophotometric method was developed and validated using 6.8 phosphate buffer, measuring absorbance at 238 nm across 2 to 10 µg/ml concentrations. Solid dispersions of Dexlansoprazole with HP-β-cyclodextrin were prepared to improve solubility. Powder blends were evaluated for flow and compressibility prior to direct compression of enteric-coated capsules. Post-compression parameters and in vitro dissolution profiles were assessed. The spectrophotometric method showed excellent linearity and precision. Solid dispersions significantly increased dissolution rates, with over 90% drug release within an hour. The powder blends exhibited consistent flow properties suitable for manufacturing. Capsules met pharmacopeial standards concerning weight variation, thickness, friability, drug content, and hardness. In vitro dissolution demonstrated sustained and nearly complete drug release over 12 hours. Kinetic analyses indicated a diffusion-controlled release mechanism involving anomalous transport. The study successfully formulated robust Dexlansoprazole enteric-coated capsules with enhanced dissolution and controlled release characteristics, indicating potential for improved therapeutic efficacy and patient compliance.