Abstract

Mucoadhesive buccal films of clotrimazole for local delivery of the drug to the oral cavity were formulated by the solvent casting technique. A number of different bioadhesive and film-forming polymers were evaluated. Propylene glycol was used as the plasticizer while the solvents depended on the type of polymer chosen. The films were evaluated on the basis of their physical characteristics, bioadhesive performance, release characteristics, surface pH, folding endurance and stretchability. A combination of Carbopol-934P and hydroxypropyl cellulose-M in the ratio of 1:5 and using ethanol (95%) as the solvent was found to give satisfactory results. The film exhibited an in vitro adhesion time of 4 hours and maintained the concentration of clotrimazole in the dissolution medium (isotonic phosphate buffer pH 6.6) above the MIC of Candida albicans (T>MIC, d) for upto 4 hours. A maximum concentration (Cmax, d) of 21.1 mg/ml was obtained in the dissolution medium after 2 hours (tmax, d). The drug released from the formulation was found to be microbiologically active.