Optimization of Cudrania extractum tablets formulation by central composite design-response surface methodology

Objective To optimize the formulation of Cudrania extractum tablets by the central composite design-response surface methodology.Methods In the formulation design using response surface methodology plus central composite design,independent variables included the amounts of microcrystalline cellulose(MCC),lactose,and the polyvinylpynolidone(PVP)content in 95% EtOH.Disintegration time of tablets and dissolution of three active components in the extractum at 45 minutes were taken as dependent variables.Multilinear and quadratic models were used to estimate the relationship between the dependent and the independent variables,and to delineate response surface method(RSM)and overlay contour plots in order to select the optimal formulations.Finally,predicted responses were verified.Results The quantitative relationships between three factors and four evaluation indexes were characterized.Optimal formulation was proposed to contain MCC 40 mg,lactose 70 mg,and 4 % PVP.Dissolution test of the selected optimal formulation indicated that there existed high approximation between the observed and estimated values.Conclusions The muti-objective simultaneous optimization of Cudrania extractum tablets formulation could be achieved by the central composite design and response surface methodology.