DEVELOPMENT AND CHARACTERIZATION OF PULLULAN-BASED ORODISPERSIBLE FILMS OF ALMOTRIPTAN MALATE WITH SUPERDISINTEGRANT OPTIMIZATION

Abstract

Almotriptan Malate requires rapid systemic delivery for acute migraine management to overcome disease-induced gastric stasis and dysphagia. This study aimed to systematically develop and optimize pullulan-based orodispersible films (ODFs) enhanced with superdisintegrants. A 3-factor, 3-level Box-Behnken Design (BBD) was utilized to optimize the concentrations of pullulan, crospovidone, and glycerol. Films were prepared via the solvent casting method and evaluated for mechanical strength, disintegration time, and in vitro dissolution. Solid state characterization was conducted using FTIR, DSC, XRD, and SEM. The optimized formulation (4.2% w/v pullulan, 7.5% w/w crospovidone, 21.5% w/w glycerol) exhibited a rapid disintegration time of 19.25 seconds and excellent mechanical resilience (tensile strength: 3.72 MPa). In vitro studies demonstrated >91% drug release within 5 minutes, driven by Fickian diffusion. Solid-state analyses confirmed the complete amorphization and uniform molecular dispersion of the drug without any chemical incompatibilities. Furthermore, the formulation maintained robust physical and chemical integrity throughout 3 months of accelerated stability testing. In conclusion, the statistically optimized pullulan-crospovidone ODF presents a highly effective, patient-centric delivery platform for rapid therapeutic intervention in migraine therapy.