Fabrication and characterization of prednisolone acetate-loaded electrospun mucoadhesive nanofibers for treatment of oral lichen planus
摘要
Oral lichen planus (OLP), a chronic inflammatory disease affecting the stratified squamous epithelium of oral mucosa (mucositis), presents treatment challenges due to rapid washout of conventional topical gels. This study developed prednisolone acetate-loaded mucoadhesive electrospun nanofibers using PVP K90/Eudragit RS100 via Super ES-3 technology to enhance drug retention and therapeutic efficacy. Nanofibers exhibited uniform morphology (diameter ranging from185 ± 0.3 nm to 704 ± 0.3 nm), neutral surface pH (7.4 ± 0.1), and superior mucoadhesion of 0.03N and bond strength of 0.455 Nmm2. FTIR confirmed polymer-drug compatibility and XRD studies revealed crystalline state of drug in nanofibers. In vitro release from prednisolone acetate-loaded nanofibers followed zero-order kinetics (r2 = 0.999, RMSE = 1.02%, 90.21% Q₁₂ₕ), ideal for sustained delivery vis a vis. prednisolone acetate dispersion that followed Korsmeyer-Peppas model (r2 = 0.962, RMSE = 3.99, 51.34% Q12h). In vivo evaluations using 4% SDS-induced mucosal irritation model in Wistar rats shown irritation score of 4.333 ± 0.58 in disease control, nanofibers achieved near-complete resolution (score 1.000 ± 0.58, equivalent to vehicle p = 0.7538), significantly outperforming marketed formulation (3.000 ± 0.58, p = 0.0015; using one-way ANOVA F = 45.2, p < 0.0001). Histopathology confirmed superiority with no signs of irritation or tissue damage of the oral mucosa showing normalized rete ridges and minimal inflammation. These findings demonstrate mucoadhesive nanofibers as a promising localized delivery system for OLP, providing sustained prednisolone acetate release, prolonged buccal retention of 7 h, and superior therapeutic outcomes while minimizing systemic corticosteroid exposure.