Abstract
In the present research work, aimed to prepare and evaluate the fast dissolving oral films containing Rizatriptan Benzoate, an antimigraine drug using different ratios of polymers, Hydroxypropyl methylcellulose E15, Polyvinyl alcohol and Maltodextrin. The film was prepared by solvent casting technique using Propylene Glycol, Aspartame and Mannitol as plasticizer, sweetening and cooling agent respectively. The study examines the influence of polymers ratio on physicochemical properties and drug release potential of films. Rizatriptan Benzoate, a serotonin 5-HT1 receptor agonist is a new generation antimigraine drug which has oral bioavailability of 45% due to hepatic first pass metabolism. The present study investigated the possibility of developing Rizatriptan benzoate fast dissolving sublingual films allowing fast, reproducible drug dissolution in the oral cavity, thus bypassing first pass metabolism to provide rapid onset of action of the drug. The films were thin, smooth, flexible, and uniform in drug content, weight and thickness as observed from low SD values. The film formulation, (F11) consisting of 200mg of polyvinyl alcohol and 200mg of Maltodextrin was found to be suitable in the form of fast dissolving oral film based on in vitro evaluation studies. From the Ex vivo studies it was found that 82.93% drug was permeated through porcine oral mucosa. The optimized formulation, F11 showed less disintegration time and faster drug release. All the systems were found to be stable with respect to drug content as well as physical changes at 400C and 75% RH. The results suggest that polymer based fast dissolving films are potential means to achieve rapid drug release for effective therapy.
