Innovative Approaches in Designing a Pregabalin Orodispersible Film for Epilepsy Treatment Download PDF

The study aimed to develop a fast-disintegrating Pregabalin film, targeting API bitterness suppression, reduced disintegration time, and improved drug release. With Pregabalin bioavailability range affected by first-pass metabolism, a mouth dissolving film was chosen to circumvent this issue, particularly beneficial for pediatric epilepsy treatment. The buccal route was preferred due to enhanced absorption resulting from drug ionization at gastric pH. The process involved preparing a solid dispersion using the kneading method, followed by solvent casting, and evaluating it for API bitterness, solubility, drug content, and release rate. In vitro drug release analysis demonstrated that the solid dispersion effectively suppressed API bitterness, increased solubility, and achieved faster drug release compared to the pure drug. Various parameters such as physical appearance, surface pH, thickness uniformity, disintegration duration, drug content uniformity, folding durability, and tensile strength were assessed. A 3² full factorial design, utilizing Design-Expert® software Version 13, optimized the mouth dissolving film (MDF). The optimized MDF underwent evaluation for palatability, in vitro dissolution, ex vivo permeation, and stability. It exhibited a disintegration time of 25 seconds and released 90% of the drug within 6 minutes for Pregabalin, confirming its efficacy. Rapid stability studies indicated stability across all formulations under extreme conditions.