Preparation and Evaluation of Fast Dissolving Oral Film Containing Naratriptan HCl

Recently, fast dissolving films are gaining interest as an alternative of fast dissolving tablets. The present study aimed at preparing fast dissolving oral films of Naratriptan hydrochloride as a model drug which is used for the migraine treatment. Fast dissolving dosage forms have acquired great importance in pharmaceutical industry because of their unique properties like dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the product without need for additional liquid. This convenience provides both a marketing advantage and increased patient compliance. In the present investigation various trials were carried out using two grades of HPMC (E3 and E6), Propylene glycol, PEG-400 and other polymers by solvent casting method.  The prepared films were evaluated for film thickness, folding endurance, surface pH, morphological properties, %drug content and content uniformity, tensile strength, percent elongation, in vitro disintegration time and in vitro dissolution studies. The optimized formulation S11 prepared using HPMC E6 showed minimum disintegration time (10 sec), highest dissolution rate i.e. 98.23% of drug within 6 min and satisfactory physicochemical properties. Results of DSC and FTIR data of optimized formulation (S11) revealed that there was no incompatibility observed between the drug and excipients used in the formulation. These findings suggest that the fast dissolving oral film containing Naratriptan hydrochloride is considered to be potentially useful for the treatment of migraine where quick onset of action is desirable when compared with reference standard Naratrax conventional tablet.