Study on dexamethasone-fast dissolving oral film based on pullulan-vitamin E succinic acid

Objective This study aimed to enhance the solubility and dispersion of poorly water-soluble dexamethasone (DEX) in oral films by developing a novel pullulan-vitamin E succinate (PUL-VES) coupling compound (designated PUVS3) as the film matrix. Methods The amphiphilic coupling compound PUVS3 was synthesized, characterized and evaluated. Using PUVS3 as a solubilizing/suspension agent, and PUL as the film-forming material, a dexamethasone-fast dissolving oral film (DEX-FDOF) was prepared by solvent casting method. The film was evaluated for appearance, microstructure, mechanical properties, weight variation, content uniformity, disintegration time and in vitro dissolution. Results The DEX-FDOF formulation exhibited a smooth surface with no observable drug precipitation and demonstrated excellent transparency. Both weight variation and content uniformity complied with the pharmacopoeial standards. The film displayed rapid disintegration (<15s) and favorable mechanical properties with an elastic modulus of 35–45 MPa and elongation at break of 17%–20%. Notably, in vitro dissolution reached approximately 47 % within 10 min, representing a significant improvement over the pure drug. This enhancement was achieved through the use of a self-synthesized PUL-VES coupling compound as the film matrix. This innovative approach enabled homogeneous dispersion of the poorly water-soluble DEX within the water-soluble oral film while simultaneously improving its solubility characteristics. Conclusion The DEX-FDOF, fabricated using the self-synthesized PUL-VES coupling compound as the matrix, exhibited excellent uniformity, mechanical strength, rapid disintegration (<15 s), and notably enhanced dissolution (47 % in 10 min), demonstrating its potential as an effective delivery system for poorly soluble drugs such as DEX.