Nanosuspension-Loaded Oral Transmucosal Drug Delivery of Clotrimazole for Effective Management of Oral Candidiasis

Oral candidiasis is a widespread opportunistic fungal infection traditionally managed with topical antifungal agents. However, conventional formulations are often limited by poor drug solubility and inadequate mucosal retention, leading to suboptimal therapeutic outcomes. This study aimed to enhance the solubility, mucosal adherence, and antifungal efficacy of clotrimazole (CZ) through the development of a nanosuspension-loaded mucoadhesive film for oral transmucosal delivery. Clotrimazole nanosuspensions were prepared using the antisolvent precipitation method and optimized through a 3² factorial design. The optimized batch (NS-6) exhibited a particle size of 268 nm, a zeta potential of −15.9 mV, and a drug entrapment efficiency of 97.28%, indicating good stability and improved solubility. This nanosuspension was incorporated into a mucoadhesive film with a unidirectional backing layer to facilitate localized drug release. The resulting formulation demonstrated strong adhesion to the oral mucosa, sustained drug release, and enhanced antifungal activity, suggesting the potential for reduced dosing frequency and improved patient compliance. Overall, the clotrimazole nanosuspension-based mucoadhesive film represents a promising strategy for the effective management of oral candidiasis.