Preparation and characterization of fluconazole-loaded sodium caseinate matrix films for oral candidiasis

Sodium caseinates (SCs), which are milk proteins, can form micelle structures by self-assembly and can be applied as film-forming agents. The aim of this study was to investigate the physicochemical properties of SC films loaded with fluconazole (FCZ) for use as a drug delivery system with anticandidal activity. A tablet filmcoating instrument was used for film production via the spraying method. FCZ molecules can interact with the SC micelles in films via hydrogen bond formation. The FCZ-loaded SC films with a 1:0.1 SC:FCZ ratio presented an amorphous form of FCZ and greater flexibility than films with higher loadings. The FCZ particles (in monohydrate form) can be embedded in the film matrix, resulting in changes in the thermal and mechanical properties. The film dissolution time and drug release rate increased with an increase in FCZ content. The released FCZ was efficient against Candida albicans and possessed mucoadhesive properties on porcine mucosa. In addition, the FCZ-loaded SC films still presented good stability under ambient conditions after 3-months of storage. This study indicates that FCZ-loaded SC films have strong potential for use in oral candidiasis treatment.