Formulation and Evaluation of Mouth Dissolving Films of Sumatriptan Succinate Using Super Disintegrating Agent

Abstract

Background: The purpose of this study was to formulate and evaluate Mouth-Dissolving Films (MDF) of Sumatriptan Succinate with super disintegrating agent Polacrilin Potassium, aimed at providing a fast and efficient delivery system for migraine relief. The patient can consume the formulation without water because the films are made to dissolve in few seconds when they come into touch with a wet surface, such the tongue. It results in increased patient compliance. Objectives: The present study aimed to formulate mouth dissolving film of Sumatriptan Succinate which is a widely used medication for acute migraine attacks but the bioavailability is very less in oral administration due to first pass metabolism and the mouth-dissolving film formulation provides the advantage of rapid onset of action. Materials and Methods: MDFs of Sumatriptan Succinate were prepared by the solvent casting method employing various film-forming polymers like HPMCE15, Glycerine as a plasticizer, and super disintegrating agents Polyacrylic Potassium, and the films are evaluated for their physical, mechanical, and drug release properties. The solvent casting method is most commonly used for preparing Mouth Dissolving Films (MDFs) that involves dissolving the Active Pharmaceutical Ingredient (API), film-forming polymers, plasticizer, and other additives in a suitable solvent to form a uniform solution, which is then cast into a film and dried. The results indicated that the films containing Polacrilin Potassium in optimum concentration and HPMC E15 in optimum concentration exhibited acceptable disintegration time, good folding endurance, drug release profiles, and mechanical properties. Formulation F9 containing HPMC E15 300 mg and Polacrilin Potassium 25 mg was the best formulation, having disintegration time lies between 9-17 sec, a higher dissolution rate and drug release was 100%. Conclusion: Mouth dissolving films formulated in this study can be used as an alternative for conventional dosage form effectively with rapid onset of action and with better patient compliance. The mouth dissolving film of Sumatriptan Succinate holds high translational potential due to its ability to be used with high efficacy, patient comfort, and rapid migraine pain relief. It is non-invasive, fast-acting, and user-friendly drug delivery systems. With continued research into in vivo performance, taste masking, and formulation optimization, this delivery platform could become a standard treatment modality for acute migraine attacks.