The objective of the present investigation was to formulate, evaluate and optimize the mouth dissolving film of escitalopram oxalate to achieve quick disintegration and fast release of the drug for depressant and anxiety patients. In the present study, HPMC E15 was used as film forming polymer that showed rapid disintegration time of film in saliva fluid. These formulations were evaluated for the parameters like drug excipient compatibility study, uniformity of weight, thickness, tensile strength, content uniformity, folding endurance, in-vitro drug release and accelerated stability studies. On the basis of preliminary results, the amount of HPMC E15 (X1) and the amount of propylene glycol (X2) were chosen as independent variables in 32 full factorial design, while disintegration time (DT), tensile strength (TS) and cumulative % drug release after 10 min (% CDR) were taken as dependent variables. Multiple linear regression analysis, ANOVA and graphical representation of the influence of factor by contour plots were performed using demo version of Design Expert. Check point batch was prepared to validate the evolved model. In the present study, the following constraints were arbitrarily used for the selection of an optimized batch: DT < 42 sec, TS between 1.0 to 1.2 kg/cm2 and % CDR > 98. Batches F1, F2, F4 and F7 met the selection criteria. Batch F1 showed lowest disintegrating time (40 sec) and more % cumulative drug release (99.58) after 10 min, hence Batch F1 was selected as an optimized batch. The optimized formulation was subjected to ex-vivo study model, histopathology study and accelerated stability study. Skin permeation study of the batch F1 exhibited 95.43% of drug permeation in 10 min. Histopathology study of selected batch film (Batch F1) for film compatibility showed encouraging results depicting no evidence of any inflammation, any foreign body granuloma or any necrosis or hemorrhage and even there were no minor changes in tissue configuration before and after implantation. The optimized batch F1 was found to be stable in the stability evaluation.
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