Formulation of mucoadhesive mouth paint for oral infections

Oral mucoadhesive mouth paint preparation was designed and prepared for the treatment of oral candidiasis, where prolonged drug release at the infected area is essential. Fluconazole, a recent triazole derivative having antifungal activity is chosen as the desired drug in this study to formulate mucoadhesive mouth paint. Oral candidiasis is a common infection in debilated patients, AIDS patients and in persons who administer immunosuppressive drugs. Mouth paints containing 1% fluconazole with hydrophilic polymer HPMC was prepared and compared with mouth paint prepared without the addition of hydrophilic polymer. The prepared mouth paint formulation was subjected to various evaluation parameters like pH determination, drug content, rheological behavior, mucoadhesive studies, spreadability and IR spectral analysis. In vitro drug release studies were carried out at salivary pH 6.4 using cellophane membrane as barrier. Stability studies were carried out at different temperature conditions like ambient temp (R. T.), 8 ± 1oC, 45 ± 2oC at 75% ± 5% R. H. (accelerated temperature) 3 months and analyzed at different time intervals for drug content, physical appearance, pH, mucoadhesive strength and spreadability and the prepared formulation was found to be stable. Antimicrobial studies were carried out to ascertain the antifungal activity of prepared mucoadhesive formulation against the pure drug. The test organism Candida albicans was a clinical isolate obtained from a diseased patient suffering from oral Candidiasis. In vitro antifungal activity was evaluated using standard Agar cup-plate method by zone inhibitions studies. Formulations, containing HPMC showed good zone inhibition. In vivo oral mucosal skin irritancy tests were carried out using mucoadhesive formulation on lab experimental animals (Rabbits and Guinea-pigs) and on healthy human volunteers. No edema, erythema, inflammation or redness in the mucosal cavity of both animals and human volunteers were observed.