Formulation and Evaluation of Mouth Dissolving Sumatriptan Buccinate Films

Abstract

The aim of the study was to prepare the mouth dissolving films of sumatriptan succinate, which can useful in the acute attacks of migraine. The films were prepared by solvent casting technique. Mouth dissolving films were dissolved/disintegrated in the mouth with in a matter of few seconds without need of water. Various low viscous grades of hydroxy propyl methyl cellulose (HPMC) E15, E5, E6 and LVP K100 used as film forming polymers. Propylene glycol, sodium saccharine and sorbitol are used as plasticizer and sweetening agents respectively. The
prepared films were evaluated for thickness, content uniformity, folding endurance, invitro, in vivo disintegration time and in vitro release studies. In vitro and in vivo disintegrated studies of all films revealed that disintegrates with in 35-90 seconds. In vitro release studies showed 90% of drug release from all formulations within 15 minutes. The films were flexible at 20% of plasticizer concentration. Drug was uniformly distributed throughout the film and adequate thickness for handling. The formulation containing HPMC E5 (2.5%) showed better performance in terms of disintegration time and percent drug release profile. This finding suggests that the mouth dissolving films were likely to become one of the choices of sumatriptan succinate preparations for migraine therapy.