Vol. 7, Issue 2, Part D (2025)

Osmotic controlled-release matrix (OCRM) tablets of Losartan Potassium and Amlodipine Besylate were formulated to achieve sustained drug delivery for effective hypertension management. Tablets were prepared by direct compression, followed by ethyl cellulose-PEG coating and micro-orifice drilling to enable osmotic release, using Mannitol as an osmogen and HPMC K15M as the matrix polymer. Optimized formulations, LP13C and AB13C, exhibited uniform physicochemical properties and reproducible drug release profiles. In vitro dissolution studies demonstrated zero-order release with non-Fickian diffusion, indicating prolonged and controlled drug delivery. FTIR, DSC, and SEM analyses confirmed drug-polymer compatibility and well-formed osmotic pores. Stability studies conducted under ICH-recommended conditions showed no significant changes in drug content, hardness, or release characteristics. These findings suggest that the developed OCRM tablets can enhance patient compliance by reducing dosing frequency and maintaining steady therapeutic drug levels.