Buccoadhesive erodible disk for treatment of oro-dental infections: design and characterisation

Buccoadhesive erodible disks of cetylpyridinium chloride were prepared using different bioadhesive polymers along with excipients like mannitol. The purpose of designing the erodible disk was to obviate the need for removal of exhausted device. The optimized disk containing 5.0 mg of cetylpyridinium chloride, 2.0 mg of magnesium stearate and 6.0 mg of mannitol along with sodium carboxy methyl cellulose DVP and hydroxypropylmethylcellulose K4M in the ratio of 1:3 was found to release the drug for a period of over 6.0 h without getting dislodged. Maximum in vitro drug release was found to be 94.78% in 6.0-h study. In situ release characteristics were evaluated using a 'flow-through assembly', which simulated the conditions of the human buccal cavity. The drug concentrations in the in situ samples were found to be above minimum inhibitory concentration (MIC) of the drug. The bioadhesive performance and the surface pH of the disks were satisfactory. Cetylpyridinium chloride disks were tested against microorganisms commonly found in oro-dental infections namely Candida albicans, Staphylococcus aureus, Escherichia coli and Streptococcus mutans. The disk as well as the in situ samples showed inhibition of growth of microorganisms. Approval was taken from Jamia Hamdard Review Board (Ethical Board) to perform in vivo studies in healthy human volunteers. In vivo evaluation of buccoadhesive disks revealed adequate comfort, taste, and non-irritation and none of the volunteers reported severe dry mouth/severe salivation or heaviness at the place of attachment. Salivary concentrations were maintained above MIC for 8.0 h. Correlation was found between the drug concentration in situ and concentration of drug in saliva collected in healthy human volunteers. The correlation was found to be positive with a correlation coefficient of 0.9596. It was found to be statistically significant at 5% confidence level (P<0.05).