Development of a Nystatin-Loaded Oral Disintegrating Film Formulation: Characterization and Anticandidal Activity

vıı. INTERNATIONAL ENZYME&BIOPROCESS DAYS, Trabzon, Türkiye, 26 - 28 Ağustos 2026, ss.38-39, (Özet Bildiri)

Oral candidiasis is an opportunistic fungal infection that arises as a consequence of immunosuppression (1). The

therapeutic efficacy of nystatin, a widely used antifungal drug, primarily depends on its adequate residence time on the

oral mucosa. However, difficulty and inconvenience of application of currently available oral suspension formulations,

leads to significantly diminished therapeutic impact particularly in geriatric patients (2–4). In this study, nystatin-loaded

orodispersable thin films (ODF) capable of providing localized drug delivery from the intaglio surface of dental prostheses

were developed to improve patient adherence during denture use. Electrospinning (Inovenso®- NE300) was employed as

the fabrication technique, and Eudragit® was selected as the polymeric carrier. The formulations were characterized in

terms of the drug content, pH, and disintegration time. The nystatin:Eudragit® L100-55 system exhibited the most

favorable performance. To further characterize the nystatin ODF, surface morphology was evaluated using scanning

electron microscopy (SEM), compatibility between formulation components was assessed by differential scanning

calorimetry (DSC), changes in the crystalline structure of the active pharmaceutical ingredient were analysed by X-ray

diffraction (XRD), and folding endurance test was used to evaluate the structural integrity of the formulations. Moreover,

optimized formulation consisting of nystatin (10% w/w relative to polymer weight), Eudragit® L100-55 (1 g), and methanol

demonstrated in vitro anticandidal activity against Candida albicans and showed no cytotoxic effects on L929 murine

fibroblast cell line. In conclusion, we successfully developed a ODF form of nystatin for a potential future clinical use in

oral candidiasis infection in geriatric populations.