Formulation and characterisation of a buccoadhesive erodible tablet for the treatment of oral lesions.

Buccoadhesive erodible tablets of trimcinolone acetonide were prepared using different bioadhesive polymers along with excipients like mannitol and PEG-6000. In vitro release characteristics were evaluated using a 'flow-thru assembly' which simulated the conditions of the human buccal cavity. The bioadhesive performance and the surface pH of the tablets was satisfactory. The optimized formulation containing 8.0 mg of triamcinolone acetonide, 2.5 mg of mannitol, 7.5 mg of PEG-6000, 2.0 mg of magnesium stearate along with carbopol-934P (CP-934P) and sodium carboxy methyl cellulose-DVP (SCMC-DVP) in the ratio of 1:4 was found to release the drug for a period of over 8 h without getting dislodged. Maximum in vitro drug release was found to be 79.08% in 8 h study. In vivo evaluation of placebo buccoadhesive tablets revealed adequate comfort, taste, non-irritancy during the period of study. None of the volunteers reported severe dry mouth/severe salivation or heaviness at the place of attachment. A linear and positive correlation was found between in vitro and in vivo mean adhesion time. The buccoadhesive tablet eroded completely after 8 h leaving no exhausted device to be removed. This formulation has potential clinical usefulness for the treatment of oral lesions.