Optimized formulation of Xiao'er Magan Orally Disintegrating Tablet by central composite design-response surface methodology

AIM:To optimize formulation of Xiao'er Magan Orally Disintegrating Tablet by central composite design-response surface methodology. METHODS:By two factors and five levels central composite design,independent variables were the proportion of optimized microcrystalline cellulose 50 and mannitol and the pressure,while disintegrating time and tensile strength were dependent variables. Binary linear and quadratic models were used to estimate the relationship between the dependent and the indepedent variables,and to delineate response surface method and overlay contour plots in order to select the optimal formulations. RESULTS:The binomial regression equation were TS =0. 096 88X1 + 0. 027 6X1X2(r = 0. 759),DT = 9. 845 4X1 -63. 196X2 + 40. 092 9X22 (r = 0. 838) which indicated the quantitative relationship between the factors and the evaluation indexes was characterized. The optimal formulation were the ratio of microcrystalline cellulose 50 and mannitol in the range of 0. 35 and 0. 6,and the pressure was in the range of 6 and 8 KN. CONCLUSION:The optimized formulation validation is close to the estimated value,indicating that the method has a good predictability and reliability.