Development and Characterization of Amlodipine Oral Disintegrating Films Incorporating Natural–Synthetic Polymer Blends for Enhanced Antihypertensive Therapy

Abstract

This study aimed to create and characterise Amlodipine oral disintegrating films (ODFs) utilising mixes of natural and synthetic polymers to improve patient adherence and facilitate quick antihypertensive effects. ODFs were fabricated by the solvent casting technique, employing HPMC E15 as a synthetic film former and pectin as a natural biodegradable polymer. Six formulations (A1–A6) were developed by altering polymer ratios and assessed for physicomechanical properties, disintegration characteristics, drug content, in-vitro dissolution, release kinetics, and stability. All films exhibited a consistent look, appropriate thickness (152–175 µm), elevated folding endurance (182–230), near-neutral surface pH (6.57–6.71), and acceptable drug content (96.8–100.2%). All formulations exhibited rapid disintegration (18.7–29.6 s) and swift drug release (>80% within 6 min). Formulation A6 exhibited optimal performance, attaining 98.61% drug release at 6 minutes and total release within 8 minutes. The release kinetics adhered to Higuchi diffusion, exhibiting Fickian to anomalous transport characteristics. Stability investigations validated the robustness of the formulation. The optimised Amlodipine ODF provides a quick, user-friendly option for managing hypertension.