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Abstract
Muco-adhesive erodible buccal tablets of clotrimazole were formulated using a combination of bio-adhesive polymers like Carbopol-974P (CP-974P) and hydroxypropylmethylcellulose-K4M (HPMC-K4M), and soluble excipients like polyethylene glycol-6000 and mannitol. Increasing the concentration of CP-974P was found to increase the in vitro adhesion time as 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 excipients 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 evaluation of the buccal tablet in healthy human volunteers and its comparison 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.