Formulation and Optimization of Fast Dissolving Buccal Films of Hydralazine HCl Using Design Expert Software

Aim and Objectives: This study aimed to design and optimize Fast-Dissolving Buccal Films (FDBF) containing Hydralazine HCl, with the goal of developing an effective treatment for hypertension. Materials and Methods: Solvent casting method was employed to prepare the films. Optimization focused on the effects of independent variables such as Pullulan, PVP and PG on the percentage of drug release and the disintegration time of the film, using a 23 factorial design. Polynomial equation analysis was used to derive equations from the results, effectively describing the influence of the independent variables on the selected responses. Three-dimensional surface plots are generated to depict the relationship between both variables and a design layout was developed for the optimized formulation using Design Expert software version 13.0 trial edition. Results: The Optimized Formulation (OF) exhibited a rapid disintegration time of 48 sec, cumulative drug permeation at 70.3%, and excellent physicochemical properties and ex vivo drug release through goat buccal mucosa was 69.4%. The short-term stability test of the optimized formulation OF, performed according to ICH, indicated stability test at 30°C±2°C and 65%±5% relative humidity for one month. Conclusion: These findings suggest that the developed formulation offers a novel dosage form that can enhance drug delivery, provide a quicker onset of action, and improve patient compliance significantly.