Optimization of Fast-Dissolving Lingual Films of Clonazepam Using Natural Polymers for Epilepsy Management

Abstract

Epilepsy is a chronic neurological disorder that demands rapid and effective therapeutic interventions to control seizures and improve patient quality of life. Clonazepam, a benzodiazepine derivative with strong anticonvulsant properties, is widely used in epilepsy management but is limited by poor compliance, delayed onset, and variability in gastrointestinal absorption when administered as conventional oral formulations. To address these challenges, the present study focused on developing and optimizing fast-dissolving lingual films of clonazepam using natural polymers such as pullulan, guar gum, and sodium alginate. The films were prepared through solvent casting and evaluated for thickness, weight variation, folding endurance, surface pH, disintegration time, and drug content uniformity. In vitro dissolution studies demonstrated rapid drug release, with pullulan-based films exhibiting the fastest disintegration and highest release efficiency, while sodium alginate contributed to controlled release. Statistical optimization using response surface methodology identified formulations with balanced mechanical strength and rapid disintegration, ensuring reliable therapeutic performance. Surface morphology studies confirmed smooth texture and uniform drug dispersion, supporting stability and reproducibility. Comparative analysis with synthetic polymers highlighted natural polymers as sustainable, biocompatible alternatives with favorable film-forming properties and patient acceptability. The findings indicate that natural polymer-based fast-dissolving clonazepam films can provide a rapid therapeutic onset, improved compliance, and environmental benefits, making them a promising alternative for effective epilepsy management..