Objective：To study biopharmaceutics character of warfarin sodium. To compare the dissolution behavior of warfarin sodium tablets, and investigate dissolution and absorption correlation of warfarin sodium tablets. Methods：Testing the solubility and permeability of warfarin sodium in different pH media, and the biopharmaceutical characteristics of warfarin sodium tablets were studied and analyzed. The dissolution curves of warfarin sodium tablets in different media were plotted. The dissolution behavior of warfarin sodium tablets was studied and compared. Based on the data of reference listed drug (RLD) dissolution curves in vitro, the correlation between dissolution and absorption of warfarin sodium tablets was studied by computer simulation. Results：The solubility of warfarin sodium increased with the increase of pH value. However, the permeability decreased with the increase of pH value. warfarin sodium was classified as BCS Ⅱ (low solubility and high permeability drugs). The dissolution of warfarin sodium RLD tablets was similar in four media. The dissolution behavior of generic A was similar to that of reference, and that of generic B was not similar to that of reference. The dissolution and absorption of warfarin sodium tablets in pH 6.8 showed a high correlation. Conclusion：The dissolution curves of warfarin sodium tablets in media of pH 1.2, pH 4.5 and pH 6.8 can be used as the characteristic dissolution curves of the preparation. This study can provide reference for drug formulation screening, biopharmaceuticals classification determination and bioequivalence risk assessment.
SUN Yi, FAN Bao-rui, FU Hui, HU Qin, ZHANG Zhe
. Dissolution behavior of warfarin sodium tablets based on solubility, permeability and computer simulation[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(8)
: 1454
-1460
.
DOI: 10.16155/j.0254-1793.2021.08.21
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