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Abstract
Asthma is a chronic inflammatory airway disease requiring sustained pharmacological management. Montelukast sodium, a cysteinyl leukotriene receptor antagonist, is widely prescribed as an adjunctive agent. However, oral administration is hindered by erratic bioavailability, extensive hepatic first-pass metabolism, and suboptimal patient adherence, collectively compromising its therapeutic efficacy. The present study aimed to develop and evaluate a matrix-type transdermal patch of montelukast sodium to provide prolonged and controlled drug delivery while supporting improved asthma management. Transdermal patches were prepared by the solvent-casting method using HPMC E15 and Eudragit RL100 polymers with PEG 400 as plasticizer and oleic acid as a penetration enhancer. The prepared formulations (F1–F6) were evaluated for physicochemical properties, in vitro drug release, ex vivo permeation, release kinetics, skin irritation, and stability. The optimized formulation (F4) demonstrated satisfactory physicochemical characteristics and showed sustained drug release of approximately 85% over 48 h. The release data followed the Korsmeyer–Peppas model, indicating diffusion-controlled release behaviour. Ex vivo permeation studies showed enhanced drug flux of 13.6 µg/cm²/h compared with the control formulation (4.8 µg/cm²/h). The optimized patch exhibited no skin irritation and maintained acceptable stability under accelerated conditions. This study supports the development of a patient-centred transdermal delivery system for prolonged asthma management and contributes to United Nations Sustainable Development Goal 3 (SDG 3): Good Health and Well-Being by promoting improved access to safe, effective, and adherence-friendly therapeutic approaches for chronic respiratory disease management.