DESIGN AND CHARACTERIZATION OF FAST DISSOLVING BUCCAL FILMS OF KETOTIFEN FUMARATE

Anitha K., S. T. Bhagawati* and K. Manjunath

ABSTRACT

Anti-histaminic drugs are Pharmacological agents that are used to treat Major Allergic Reactions. The aim of the present study is to Design and Characterization of Fast dissolving buccal films Ketotifen fumarate films were prepared by using different polymers like HPMC E15, PVA, PVP and Glycerol as Plasticizer and Saccharin as a Sweetening agent and Vanillin as a Flavoring agent. Buccal films were prepared using Solvent casting technique. The major problem with Ketotifen fumarate was it belongs to class Ⅱ in BCS classification and have low solubility in biological fluids. In order to enhance the solubility of Ketotifen fumarate Solid dispersion of Ketotifen fumarate were prepared by melting technique at different drug carrier (PEG 4000) weight ratios and evaluated. No interaction was found between the drug and the polymers by the FTIR studies. The buccal films were evaluated for Folding endurance, Weight variation, Drug content, Thickness, Permeation study and In-vitro drug release study. Dissolution profile as studied using stirrer + 250mL beaker using pH 6.8 Simulated Saliva. The influence of variable like polymer type, concentration, of Ketotifen fumarate release profile was studied. The formulation was optimized on the basis of various evaluation parameters like Drug content and In-vitro drug release. Formulation F3 successfully sustained the release of drug within 12min. Stability studies were as per ICH guidelines and result indicated that the selected formulation was stable.

Keywords: Ketotifen fumarate, HPMC E15, PVA, PVP, PEG 4000, Solvent casting method.