Abstract
In the present work, fast dissolving oral dispersible films of Sildenafil citrate were prepared by using water soluble polymers with the aim to improve drug delivery and patient compliance. A 2-factor, 3-level design used is appropriate for exploring quadratic response surfaces and creating polynomial models with 3 centre points per block Design Expert version 8.0.7.1. The 2 independent variables such as HPMC 15 cps (X1) and polypropylene glycol (X2) were chosen on the basis of preliminary trials which were carried before executing Design expert 8.0.7.1 Effect of independent variables like Concentration of HPMC 15 cps and propylene glycol on the dependent factors called response factors Y1 (% Drug Release) and Y2 (Disintegration time) of films were evaluated. Box-Behnkem statistical design was used for DOE which generated an optimized drug model for formulation of oral dispersible films. Optimum formulations were given and based on the desirability the optimum result was selected. The polynomial equation is generated based on Y1 and Y2 responses the independent variables like X1 and X2 in the formulation of the film was optimized. The Maximum desirability was found to be 0.831 for FF15 batch. Formulated films were evaluated for various parameters like thickness, folding endurance, weight variation, moisture content, disintegration time, percentage drug release and permeability studies, and it was found that all the results shown were found to be satisfactory.
