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System for release of antifungials complexed with beta-cyclodextrin through mucoadhesives aiming treatment of denture stomatitis

Abstract

Denture stomatitis (DS) is the most prevalent oral candidosis among users of removable dentures. Although conventional treatment with topical or systemic antifungal agents is effective in relieving its signs and symptoms, it has been commonly observed that the oral mucosa reinfection has been observed within two weeks after treatment. In recent decades, mucoadhesives with a drug delivery system have become a trend in pharmaceutical technology, as they enable faster absorption directly from the infected site, in addition to better adhesion in mucous tissues and drug bioavailability. Furthermore, inclusion complexes with cyclodextrins have been suggested to increase drug solubility and molecule stability. Therefore, the aim of this study will be to develop and characterize mucoadhesives containing nystatin (Nis) or chlorhexidine (Clx) pure or complexed with beta-cyclodextrin (beta-CD) for the treatment of DS. To determine the composition of the formulations, the characterization will involve mucoadhesion, residence time, spreadability, rheology, homogeneity and drug incorporation, in vitro release and permeation tests. After drug incorporation, the antifungal capacity to the growth of Candida albicans of mucoadhesives (Nis, Clx Nis:beta-CD and Clx:beta-CD) will be evaluated by means of the determination of minimum inhibitory concentrations (microdilution in broth) and minimum fungicidal concentrations (CFU/mL). The antifungal potential of the formulations will also be evaluated on the surface of a denture base acrylic resin by cell countings, metabolic activity according to the percentage reduction of XTT and quantification of biofilm mass by confocal laser scanning microscopy. Next, the mucoadhesive formulations will be evaluated according to their rheological properties in an oscillating rheometer, bioadhesive in a texturometer and cytotoxic through the MTT and Alamar Blue tests in 3D cell culture. The data obtained will be analyzed statistically (±=5%). (AU)

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