Oral Submucous Fibrosis (OSMF) has been reported in 33% to 40% of Indian population due to an excessive usage of gutkha, tobacco, pan masalas and areca nut. Looking to the need of developing an oral formulation that would dissolve slowly in the oral cavity without causing any irritation, an attempt was made to formulate and evaluate Curcumin (Cu)-β-CD based medicated jelly and focus on improvement of its aqueous solubility. Inclusion complexes were prepared by common solvent evaporation method and were further evaluated for saturation, phase solubility, FTIR, DSC, in-vitro dissolution. Saturation solubility of Cu in DW and methanol (9:1) increased from (0.00027mg/ml) to (0.047mg/ml) respectively. At the end of 1 h, 9.2 ± 0.36 % and that for 7th h was 74.45±0.25% respectively. The inclusion complex was further formulated into Oral Medicated Jelly using 32 Factorial design pectin (X1) and propylene glycol (X2), selected as independent variables. (Y1) % drug release and (Y2) mucoadhesive strength were considered as dependent variables and were evaluated for Physical Appearance, pH, Viscosity, Consistency, Drug Content, Muchoadhesion, in-vitro Dissolution profiles and rheological studies. The optimized batch F6 exhibited 67.27% ±0.25 drug release in 7th h and mucoadhesive strength 14.81 ± 0.79g. Dynamic moduli can be used to measure gel strength and are significant for the interpretation of drug release. The results of stability studies of best formulation revealed no change in physical appearance, drug content, pH, viscosity thus indicating that formulation was stable.
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