Formulation Optimization & Evaluation of Oro-Dispersible Film of Levocetirizine & Montelukast Sodium

The main aim of research work was to design novel Oro-Dispersible film of Levocetrizine and Montelukast sodium as a drug delivery system for the effective management of allergic conditions. Oro-dispersible film of Levocetirizine dihydrochloride & Montelukast sodium was prepared using HPMC E5 and Doshion P542. A Central Composite Design was employed to study the effects of polymer concentration on drug release and disintegration time. The films were evaluated for various parameters like general appearance, weight variation, thickness, folding endurance, wetting time, surface pH, In-vitro dissolution, Uniformity Drug Content & disintegration time. Stability testing was conducted under ICH guidelines. The optimized formulation (LM 5) demonstrated excellent mechanical properties, uniform drug content, rapid disintegration (25.34 sec.), and enhanced % drug release of Levocetirizine Dihydrochloride (93.46%) & Montelukast Sodium (92.53%) within 10 minutes. Stability studies confirmed the robustness of the formulation under accelerated conditions. The developed ODF presents an effective, rapid-onset, and user-friendly alternative to conventional oral dosage forms for allergy treatment, especially suitable for pediatric & geriatric patients.