Prediction of Bioequivalence of Lenvatinib Mesilate Capsules Based on Parallel Artificial Membrane Permeability Analysis
10.13748/j.cnki.issn1007-7693.20230017
- VernacularTitle:基于平行人工膜渗透模型预测甲磺酸仑伐替尼胶囊生物等效性
- Author:
Hua ZHENG
1
;
Guizhou HAO
1
;
Pingping SHANG
1
;
Jipeng HOU
1
;
Qingxiao LIU
1
;
Xingkai GENG
1
;
Guimin ZHANG
1
Author Information
1. Lunan Pharmaceutical Group Co., Ltd., National Chiral Pharmaceuticals Engineering and Technology Research Center, Linyi 273400, China
- Publication Type:Journal Article
- Keywords:
lenvartinib mesylate capsules ；solubility； permeability；bioequivalence
- From:
Chinese Journal of Modern Applied Pharmacy
2024;41(13):1775-1780
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE :To predict the in vivo bioequivalence of lenvatinib mesilate capsules and reference preparation by using the parallel artificial membrane permeability analysis.
METHODS
Based on the biopharmaceutics classification system classification of lenvatinib mesilate and the parallel artificial membrane permeation model, the in vitro dissolution permeation rate test model of lenvatinib mesilate capsules was established, through real-time monitoring of the dissolution and penetration of lenvartinib mesylate capsules and reference preparations in fasting gastric juice, intestinal fluid and postprandial intestinal fluid, the flux and total penetration of drugs through the membrane were calculated.
RESULTS
In fasting state and fed state, the 90% confidence interval of geometric mean ratio of two key quality parameters (permeation flux and permeation amount) of the preparation A all were in the range of 80.00%−125.00%, the preparation B did not fall into this interval.
CONCLUSION
This research method can predict the bioequivalence of renvartinib mesylate capsule and reference preparation, and has a certain correlation in vivo and in vitro.
