Development and Evaluation of Buccal Mucoadhesive Polymer Formulations Containing Antifungal Drugs of the Management of Denture-Stomatitis - Trial PACTR202210598505787

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Summary

Denture stomatitis commonly affects denture users mainly due to oral candidiasis (OC). Chronic erythematous candidiasis (CEC) commonly referred to as Candida-associated denture stomatitis, presents as a reddening of the mucosa beneath the fitting surface of a denture. CEC is the most prevalent form of oral candidiasis, with up to 75% of denture wearers having clinical signs, although the individual is often unaware of infection. Oral candidiasis (OC) can be treated using traditional formulations such as mouthwashes, lozenges, and oral gels. These formulations are often unable to maintain effective antifungal levels for an extended time; they suffer several drawbacks such as need for repeated applications, possibility of inaccurate dosing, easily washable by saliva, low adherence to denture and tissue surface and fast release of the active agent.Mucoadhesive drug delivery systems that attach to the buccal mucosa and stay in place for an extended period of time could offer better alternatives for treating CEC. Antifungal mucoadhesive films, in particular, offer fixed antifungal dose in each film, and cushioning effect under hard denture fitting surface which contributes to pain relief.The present study aimed to formulate and assess the effect of a denture-adhesive and palate-mucoadhesive buccal film in the management of upper denture stomatitis, caused by Candida albicans, in comparison to a marketed oral gel (Daktarin® Janssen Pharmaceutica N.V, Belgium). The developed antifungal mucoadhesive films present an attractive alternative avoiding gel drawbacks.

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