Development and Evaluation of Sublingual Films of Asenapine for Management of Post-Traumatic Stress Disorder

Pharmacy

Oral candidiasis is a common fungal infection, with Candida albicans being the causative agent in over 95% of cases. Fluconazole is commonly used to treat oral candidiasis, but conventional oral delivery can cause side effects. This study aimed to develop a fluconazole-loaded sesame oil nanotransfersome formulation (FS-NTF) embedded in hyaluronic acid hydrogel (HA-FS-NTF) to improve localized treatment. An optimal FS-NTF formulation was developed using a Box-Behnken design evaluating the effects of lecithin, fluconazole, and sesame oil amounts on vesicle size, entrapment efficiency, antifungal activity, and ulcer index. The optimized FS-NTF showed 140 nm vesicle size, 70% entrapment efficiency, 14.5 mm fungal inhibition zone, and ulcer index of 1. The HA-FS-NTF exhibited suitable rheological properties for oral delivery. In vitro release was 85% in 3 hours, significantly higher than fluconazole suspension (12%) and gel (43%). Ex vivo permeation across sheep buccal mucosa was also markedly enhanced for HA-FS-NTF (400 μg/cm2) versus gel (294 μg/cm2) and suspension (122 μg/cm2). HA-FS-NTF showed superior antifungal activity with 14.33 mm inhibition zone and ulcer index of 0.67 in rats versus other formulations. Overall, fluconazole delivery is enhanced using nanotransfersomes in hyaluronic acid hydrogel, representing a promising approach for localized oral candidiasis treatment.

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