FORMULATION DEVELOPMENT AND IN VIVO EVALUATION OF ZOLMITRIPTAN ORAL DISSOLVING FILMS

Abstract

The present study aimed at preparing fast dissolving oral films of zolmitriptan 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. In the present research work various trials were carried out using different grades of HPMC E3, E6, and E15, maltodextrin DE6 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 F23 prepared using HPMC E15 showed minimum disintegration time (10 sec), highest dissolution rate i.e. 99% of drug within 8 min and satisfactory physicochemical properties. The optimized film was evaluated for its bioavailability compared with pure drug as reference standard. Statistical analysis revealed that no significant difference between the bioavailability parameters of the film and the reference standard indicated that they exhibited comparable plasma level-time profiles. These findings suggest that the fast dissolving film containing zolmitriptan is considered to be potentially useful for the treatment of migraine where quick onset of action is desirable.