Formulation of topical oral gel for the treatment of oral sub mucousfibrosis (OSMF)

摘要

In the present work oral mucoadhesive semi solid jels were prepared for the treatment of oral sub mucous fibrosis, which provide effect for extended periods of time. Stress was given for improvised local action of the drug with the addition of mucoadhesive polymer in the formulation. Curcumin was taken as a model drug as it exhibits profound antitumeric amp; antimutogenic activity. The semisolid preparations were comprising of stabilizer like sodium metabisulphite, muco retention / mucoadhesive polymer HEC and were subjected for various pysicochemical parameters like pH, spreadability, drug content uniformity, extrudability, viscosity amp; I.R. studies. In-vitro drug release studies were carried out in phosphate buffer (6.4 pH). Stability studies were also done at room temperature for a period of eight weeks. The formulation containing HEC as base showed good in-vitro release and good adhesion to oral mucosae. IR studies showed that there was no drug-excipient interaction. The in-vivo studies were carried out in two phases using 18 mice with the permission of ethical committee under the supervision and help of staff, Department of Pathology, M.R. Medical College, Gulbarga. In first phase oral sub mucous fibrosis was induced in mice using marketed Gutkha preparation and formulating into a mucoadhesive gel form and applying to mice oral mucosa with the help of cotton bud for a period of 6 months. In second phase, treatment was carried out following the above method using curcumin formulation. The tissue samples collected for 1, 3 amp; 6 months induction period amp; 1, 3 amp; 6 months of treatment period on 6 months oral sub mucous fibrosis induced mice. Histopathological observations reported that there was considerable induction of oral sub mucous fibrosis and excellent treatment results on curcumin usage. The results of the present study of mucoadhesive semi-solid drug design for the treatment of oral sub mucous fibrosis will be useful for drug industry for the benefit of patients suffering from oral sub mucous fibrosis.