Doses-Based BCS Solubility Classification of Dexamethasone

ABSTRACT

OBJECTIVE: To study the dose-based BCS (biopharmaceutical classification system) classification of dexamethasone for different indications. METHODS: Saturation shake-flask method was utilized with the conditions of shaking water bath at 37℃ and 120 r•min-1, somewhat excess solids added into saturate systems at pH 1.2, 4.5 and 6.8 buffers respectively. And high-performance liquid chromatography was used for saturation concentration measurement. In this study, the dosages of dexamethasone for both classic and new indications were collected, such as covid-19, which were divided into low-dose, intermediate-dose and high-dose. Then the dissolution volumes (DSVs) were calculated and the indication-based BCS classifications of dexamethasone was studied. RESULTS: At the low-dose, the BCS classification of dexamethasone was high solubility;at the high-dose, the BCS classification of dexamethasone was low;and at the intermediate-dose, the BCS classification of dexamethasone was on the edge of low solubility and high solubility. CONCLUSION: This study provides basic data for the BCS classification of dexamethasone;dose-related solubility classification has guiding significance for the BCS classification of dexamethasone for new indications, and provides refine reference for the rationality of the BE wavier for solid oral dosage forms in the consistency evaluation of generic drugs. Copyright 2021 by the Chinese Pharmaceutical Association.