Formulation and in-Vitro Evaluation of Ketotifen Fumarate Oral Strips

Fast dissolving film can be defined as a dosage form, which when placed in the oral cavity it rapidly disintegrates and dissolves to release the medication for oral mucosal absorption or allow for the gastrointestinal absorption to be achieved when swallowed. Ketotifen Fumarate (KF), antiasthmatic and antiallergic has oral bioavailability of 50% due to hepatic first pass metabolism. This study aims to formulate ketotifen fumarate as oral dissolving films, to improve the bioavailability by avoiding hepatic first-pass metabolism. Nineteen formulas were prepared using solvent-casting method, and the effect of different formulation variables on the physical and mechanical properties of the prepared films, besides to the drug release behavior was evaluated. The prepared oral film of ketotifen fumarate that contains HPMC (6cp) showed the fastest in- vivo/in- vitro disintegration time among other investigated polymers. The results also showed that as the concentration of HPMC decreased, both the disintegration and the drug release rates increased, it was also seen that the disintegration and the drug release rate increased significantly as the concentration of tween 80 is increased