Study of the BCS Classification and in vitro-in vivo Correlation Evaluation of Sodium Ferulate
Objective To determine the BCS classification properties of sodium ferulate by solubility experiments and permeability experiments,investigate the in vitro-in vivo correlation of sodium ferulate by in vitro dissolution experiments andin vivo data collected.Methods According to the guidelines of the US FDA 2015 version,The solubility of sodium ferulate(37 ℃,pH 1～7.5)was determined.The in vivo one-way in situ intestinal perfusion model was used to determine the permeability of sodium ferulate in different intestinal segments of rats,and to determine the BCS classification properties of sodium ferulate.The dissolution behavior of sodium ferulate tablets in different pH dissolution media was investigated by in vitro dissolution experiments,and the in vivo absorption of sodium ferulate was obtained according to the literature,DAS 3.2.7.The linear relationship is used to predict the in vitro-in vivo correlation.Results The D0 value of sodium ferulate was less than 1,sodium ferulate is a highly solubility drug;The Fa(human)value of sodium ferulate in the jejunum,colon and duodenum was greater than 85％,and the Fa(human)value in ileum was less than 85％,sodium ferulate was a highly permeable drug;The r value of sodium ferulate in pH 4.0 medium was greater than the critical value of 0.974 1 and theP＜0.001.Conclusion Sodium ferulate belongs to BCS I drug.Sodium ferulate has good IVIVC at pH 4.0.
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