Sublingual Delivery of Ivabradine Via Pullulan-Based Films: Formulation, Characterization, And Optimization

Abstract

Angina pectoris refers to chest pain or discomfort resulting from insufficient oxygen delivery to the heart muscle, commonly caused by coronary artery disease. Ivabradine (IVB) also known to be effective in managing angina and reducing myocardial ischemia. This study focuses on the development and assessment of sublingual films prepared using various film-forming polymers, including HPMC E5 LV, HPMC E15 LV, HPMC 3 cps, HPMC 5 cps, and pullulan, through the solvent casting technique. Experimental batches containing different concentrations of film-forming polymers were developed and analyzed based on several parameters, such as film thickness, surface area, elongation percentage, disintegration time (in vitro), folding endurance, tensile strength, drug content uniformity, dissolution profile (in vitro), and permeability studies (in vitro). A batch F10 with pullulan 100 mg was found to produce satisfactory results. With the help of minitab software the sublingual films batches were optimized by using 3² factorial designs. The 9 factorial batches were formulated, evaluated and validated to prepare the optimized batch. The optimized batch sublingual films found to release 99.5 ± 0.6% of drug within 10 minutes and satisfactory physicochemical properties.