Optimization of the Formulation of Bezafibrate Osmotic Pump Tablets by Central Composite Design-response Surface Methodology

OBJECTIVE: To prepare bezafibrate osmotic pump tablets(BOPT) and optimize its formulation by central composite design-response surface methodology(CCDRSM).METHODS: The amount of polyoxyethylene(PEO) N80 which used as an adjuvant of Bezafibrate osmotic pump tablets(A),the amount of Na2CO3(B),and the coating weight increase(C) were used as 3 factors for investigation,and the cumulative release amount at 1 h and 6 h respectively,and the linear correlation coefficient(r) of the cumulative release amount versus time were taken as indexes.The formulation of BOPT was optimized by CCDRSM and the optimized formulation was verified.RESULTS: The optimized formulation obtained was as follows: A 40 mg,B 20 mg,and C 29 mg.The tablets prepared in optimized formulation demonstrated good release behavior,with the absolute value of deviation of each index being less than 5%.CONCLUSION: The CCDRSM can be applied to optimize the formulation of BOPT and the established model is of satisfactory predictive value.