MUCO-ADHESIVE BUCCAL TABLETS OF CLOTRIMAZOLE FOR ORAL CANDIDIASIS

Muco-adhesive erodible buccal tablets of clotrimazole were formulated using a combination of bio-adhesive polymers like Carbopol-974P (CP-97 4P) and hydroxypropylmethylcellulose-K4M (HPMC-K4M), and soluble excip ients like polyethylene glycol-6000 and mannitol. Increasing the conce ntration of CP-974P was found to increase the in vitro adhesion time a s well as the bio-adhesive strength of the formulations. A combination of 7.5% of CP-974P and 42.5% of HPMC-K4M along with the soluble excip ients in the erodible matrix, was found to release the drug for up to 3 hr, in vitro without getting dislodged. The drug released was found to be microbiologically active against Candida albicans. In vivo evalu ation of the buccal tablet in healthy human volunteers and its compari son with a marketed troche formulation revealed that the muco-adhesive tablet produced more uniform and effective salivary drug levels with adequate comfort, taste, and non-irritancy over a period of 6 hr.