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Bioequivalence of paclitaxel protein-bound particles in patients with breast cancer: determining total and unbound paclitaxel in plasma by rapid equilibrium dialysis and liquid chromatography-tandem mass spectrometry

文献类型：期刊论文

作者Li, Junling1; Li, Wei2; Dai, Xiaojian2; Zhong, Dafang2; Ding, Yaping1; Chen, Xiaoyan2
刊名DRUG DESIGN DEVELOPMENT AND THERAPY
出版日期2019
卷号13页码:1739-1749
关键词nab-paclitaxel bioequivalence rapid equilibrium dialysis unbound fraction pharmacokinetics
ISSN号1177-8881
DOI10.2147/DDDT.S200679
通讯作者Chen, Xiaoyan(xychen@simm.ac.cn)
英文摘要Background and objective: Paclitaxel protein-bound particles for injectable suspension (nab-paclitaxel) showed many advantages in safety, effectiveness, and convenience. Different from conventional formulations, the bioequivalence evaluation of nab-paclitaxel formulations requires to determine the total amount of paclitaxel in plasma and the unbound paclitaxel to reflect their in vivo disposition. This study aimed to develop an analytical method to quantify the total and unbound paclitaxel in plasma and evaluate the bioequivalence of two formulations of nab-paclitaxel in patients with breast cancer. Materials and methods: An open-label, randomized, two-period crossover study was completed among 24 Chinese patients with breast cancer. The patients were randomized to receive either the test formulation on cycle 1 day 1 and after 21 days in cycle 2 day 1 by the reference formulation (Abraxane (R)), or vice versa. Rapid equilibrium dialysis was adopted to separate the unbound paclitaxel in human plasma. Total and unbound paclitaxel concentrations were measured by the validated liquid chromatography-tandem mass spectrometry methods over the range of 5.00-15,000 and 0.200-200 ng/mL, respectively. The bioequivalence of the test formulation to the reference formulation was assessed using the Food and Drug Administration and European Medicines Agency guidelines. Results: All the 90% confidence intervals (CIs) of the geometric mean ratios fell within the predetermined acceptance range. The 90% CIs for the area under the concentration-time curve (AUC) from 0 h to 72 h (AUC(0 t)), AUC from time zero to infinity (AUC(0 infinity)), and peak plasma concentrations (C-max) for total paclitaxel were 92.03%-98.05%, 91.98%-99.37%, and 91.37%-99.36%, respectively. The 90% CIs of AUC(0 t), AUC(0 infinity) and C-max for unbound paclitaxel were 86.77%-97.88%, 86.81%-97.88%, and 87.70%-98.86%, respectively. Conclusion: Bioequivalence between the two nab-paclitaxel formulations was confirmed for total and unbound paclitaxel at the studied dose regimen.
WOS关键词QUANTITATIVE-DETERMINATION ; TAXOL ; ALBUMIN ; DOCETAXEL ; DRUG ; PHARMACOKINETICS ; FORMULATION ; VALIDATION ; THERAPY ; BINDING
WOS研究方向Pharmacology & Pharmacy
语种英语
WOS记录号WOS:000469123900001
出版者DOVE MEDICAL PRESS LTD
源URL[http://119.78.100.183/handle/2S10ELR8/289614]  
专题中国科学院上海药物研究所
通讯作者Chen, Xiaoyan
作者单位1.Shanghai Univ, Coll Sci, Shanghai, Peoples R China
2.Chinese Acad Sci, Shanghai Inst Mat Med, 501 Haike Rd, Shanghai 201203, Peoples R China
推荐引用方式
GB/T 7714		 Li, Junling,Li, Wei,Dai, Xiaojian,et al. Bioequivalence of paclitaxel protein-bound particles in patients with breast cancer: determining total and unbound paclitaxel in plasma by rapid equilibrium dialysis and liquid chromatography-tandem mass spectrometry[J]. DRUG DESIGN DEVELOPMENT AND THERAPY,2019,13:1739-1749.
APA Li, Junling,Li, Wei,Dai, Xiaojian,Zhong, Dafang,Ding, Yaping,&Chen, Xiaoyan.(2019).Bioequivalence of paclitaxel protein-bound particles in patients with breast cancer: determining total and unbound paclitaxel in plasma by rapid equilibrium dialysis and liquid chromatography-tandem mass spectrometry.DRUG DESIGN DEVELOPMENT AND THERAPY,13,1739-1749.
MLA Li, Junling,et al."Bioequivalence of paclitaxel protein-bound particles in patients with breast cancer: determining total and unbound paclitaxel in plasma by rapid equilibrium dialysis and liquid chromatography-tandem mass spectrometry".DRUG DESIGN DEVELOPMENT AND THERAPY 13(2019):1739-1749.

入库方式： OAI收割

来源：上海药物研究所

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