Formulation optimization of gliquidone double-layer osmotic pump tablets using central composite design-response surface methodology

Objective To prepare gliquidone double-layer osmotic pump tablets and optimize the formulation using central composite design-response surface methodology (RSM plus CCD). Methods In the formulation design, the amount of polyoxyethylene (X1, mg) and NaCl(X2, mg) in drug layer and the coating gain (X3, %) were taken as independent factors, while similarity factor (f2) between the dissolution profiles of the prepared formulation and the target dissolution profile was taken as dependent factor. Result An optimal formulation was obtained based on the optimal experimental conditions. The dissolution profiles of the self-made osmotic pump tablets were similar to that of the target profile. Conclusion The optimization of gliquidone double-layer osmotic pump tablets’ formulation can be achieved by the central composite design-response surface methodology, the models of which are proved to be predicable and feasible.