Preparation, optimization and in vivo evaluation of Eletriptan HBR fast dissolving oral films

The present investigation was aimed with the objective of developing fast dissolving oral films of Eletriptan HBr in order to attain quick onset of action for the better management of migraine attack. Twenty five formulations were prepared by solvent casting method using different polymer types, plasticizer types, surfactant concentrations and different ratio of hydroxypropyl methyl cellulose and maltodextrin. The prepared films were evaluated for folding endurance, thickness, drug content, in vitro/in vivo disintegration time, drug release and tensile test. The optimized formulation F17 containing HPMC 15cp and maltodextrin showed minimum in vitro disintegration time 11 seconds, highest dissolution rate i.e. 98.5% of drug within 10 min. The optimized film was further evaluated for bioavailability compared with a marketed product (Relpax-20mg). The pharmacokinetic results revealed that the fast dissolving oral films has higher peak blood concentration (Cmax, 0.455±0.1µg/ml) within shorter time (Tmax, 0.5 hours), indicating rapid absorption and faster onset of action with acceptable bioavailability value. Therefore, the oral fast dissolving film is considered to be potentially useful for the treatment of migraine disease where quick onset of action is desired, also improved patient compliance