DESIGN AND EVALUATION OF EBASTINE FAST DISSOLVING ORAL FILMS

The work was under taken as an attempt to prepare quick release films of ebastine with the purpose of developing a dosage form for very quickly on set of action, which will be beneficial in managing severe condition of allergies, aiding in enhancement of bioavailability. It is necessary to prepare ebastine as fast dissolving oral films to bypass the first pass metabolism. Ebastine was prepared as solid dispersion. Ebastine solid dispersion was incorporated in a different concentration of polymers such as pullulan, HPMC and PVP for the development of fast dissolving films. Propylene glycol was used as a plasticizer and aspartame as a sweetener. Films were prepared by a solvent casting method. The developed films were subjected for the physicochemical characterization such as uniformity of thickness, uniformity of weight, tensile strength and % elongation, folding endurance, surface pH, drug content uniformity, disintegration time, in-vitro drug release and ex-vivo permeation study. The formulations showed disintegration time within 25 sec. FB5 was found to be the best formulation, and has shown an ex-vivo permeation of 88.72% within 10 min. It was concluded that the films containing solid dispersion of ebastine showed improved solubility and bioavailability. Fast dissolving films can be a potential novel drug dosage form for paediatric, geriatric and also for general population.