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ACTA Pharmaceutica Sciencia 2025 , Vol 63 , Num 1
Formulation and characterization of lercanidipine HCl nanoparticles as fast-dissolving sublingual film
Zahraa A. ALSAFAR 1 Fatima J. JAWAD 1
1 Baghdad University, College of Pharmacy, Department of Pharmaceutics, Baghdad, Iraq
DOI : 10.23893/1307-2080.APS6303 Viewed : 3232 - Downloaded : 1788 Calcium channel blocker lercanidipine HCl treats hypertension and angina pectoris. It is a biopharmaceutical classification system (BCS) class II drug due to its poor water solubility. First-pass metabolism and low solubility reduce lercanidipine HCl oral bioavailability to 10%. This research aims to improve the dissolution rate of lercanidipine HCl by developing a nanosuspension and then transforming it into a sublingual fast-dissolving film with rapid disintegration, simple administration, and stability that will enhance patient adherence. The solvent-antisolvent precipitation technique produced lercanidipine HCl nanosuspension. Sublingual fast-dissolving films contain lercanidipine HCl nanoparticles produced by solvent casting. The dissolution rate increased significantly in nanosuspension. Film formulations using 50% polyvinyl alcohol and 30% glycerin produced excellent results. Formula F4 is optimal due to its 25-second disintegration and 99.8% in vitro drug release in 4 minutes. The study observed that lercanidipine HCl sublingual film offered an effective drug delivery system with improved disintegration and patient compliance. Keywords : lercanidipine HCl, nanoparticles, PVA, solvent casting, sublingual film

Istanbul Medipol University