Design, Evaluation Optimization Of Oro Dispersible Film Of Felodipine Using Response Surface Method: In Vitro Characterization

Abstract

The present study aimed to formulate and evaluate Felodipine orodispersible films (ODFs) to enhance patient compliance and provide rapid onset of action. Orodispersible films were prepared using the solvent casting method with HPMC E15 as the film-forming polymer, SSG as a superdisintegrant, PEG 400 as a plasticizer, and aspartame as a sweetener. Drug-excipient compatibility was assessed by FTIR and DSC studies. Films were evaluated for physical appearance, weight uniformity, thickness, folding endurance, tensile strength, moisture absorption/loss, drug content, in vitro disintegration, and dissolution. In vitro drug release kinetics were analyzed using zero-order, first-order, Higuchi, and Korsmeyer–Peppa’s models. Stability studies were conducted under accelerated and room temperature conditions for 90 days. FTIR studies confirmed no significant interactions between Felodipine and excipients. All films demonstrated acceptable mechanical properties, rapid disintegration (F15: 11 sec), and uniform drug content (69.69–83.15%). The optimized formulation (F15) exhibited 80.10% drug release within 30 min, following a diffusion-controlled mechanism. Stability studies indicated no significant changes in physical or chemical properties over 90 days. Felodipine orodispersible films, particularly F15, were successfully developed with rapid disintegration, satisfactory mechanical strength, uniform drug content, and favourable drug release, making them a promising dosage form for improved oral delivery and patient compliance.