Fast-Dissolving Films of Sumatriptan Succinate: Factorial Design to Optimize In Vitro Dispersion Time

Sumatriptan succinate, a serotonin 5-HT agonist, commonly used for migraine has erratic absorption from the gastrointestinal tract following oral administration and undergoes first-pass metabolism, resulting in a low bioavailability. The present study was undertaken to formulate fast-dissolving films of sumatriptan succinate meant to be quickly dispersed in the mouth. Films were prepared by solvent casting method and characterized for thickness, folding endurance, elongation, surface pH, and content uniformity. A 32 factorial design was used to optimize the in vitro dispersion time of films, and in vitro dissolution study was studied to determine the drug release. Ex vivo buccal permeation study was carried out using goat buccal mucosa mounted on a modified Franz diffusion cell. The optimized in vitro dispersion time for both the type of films was ∼30 s. The in vitro drug dissolution was complete in 90 s for both types of films. Thirty-eight percent of the drug was permeated from the hydroxy propyl methyl cellulose (HPMC) film, and about 42 % was permeated from maltodextrin film in 30 min. Such fast-dissolving films of sumatriptan succinate would mediate the release of drug and would be potentially useful for the treatment of migraine where quick onset of action is required.