Formulation and Evaluation of Fast Dissolving Film of Imipramine Hcl

Abstract

This research work was aimed to provide faster onset of action of Imipramine Hcl (used for the treatment depression and bed wetting) by formulating its fast-dissolving film (FDF). Imipramine Hcl belongs to BCS I. The FDF of Imipramine Hcl was prepared by solvent casting method using HPMC (film forming agent), Glycerol (plasticizer), Citric acid (saliva stimulating agent), Mannitol (sweetening agent). The formulation was optimized by two factors, three levels (32) was used for the formulation optimization of fast dissolving film of Imipramine Hcl and experimental trials are performed on all 9 formulations. In which the amount of HPMC, Glycerol was selected as independent variables (factor) varied at three different level: low (-1), medium (0), and high (+1) levels. The drug release and disintegration time used as dependent variables (response). and formulation was evaluated for weight variation, thickness, folding endurance, drug content, in- vitro disintegration, in vitro dissolution study and stability study. Based on results it was concluded that FDF (F3) showed faster onset of action.