LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG2000 nanoformulation: What if traditional methods are not applicable?

LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG2000 nanoformulation: What if traditional methods are not applicable?

Endotoxin detection is an important step in drug characterization. Herein we found that a chemotherapeutic drug nanoformulation composed of irinotecan hydrochloride (CPT-11) and an amphiphilic molecule DSPE-mPEG2000 can interfere with the limulus amebocyte lysate assay (LAL). Furthermore, the rabbit...

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Main Authors: Yanan Jin, Juanjuan Jia, Chan Li, Jianqi Xue, Jiabei Sun, Kaiyuan Wang, Yaling Gan, Jing Xu, Yaqin Shi, Xingjie Liang
Format: Article
Language:English
Published: Elsevier 2018-05-01
Series:Asian Journal of Pharmaceutical Sciences
Online Access:http://www.sciencedirect.com/science/article/pii/S1818087617307286
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record_format Article
collection DOAJ
language English
format Article
sources DOAJ
author Yanan Jin
Juanjuan Jia
Chan Li
Jianqi Xue
Jiabei Sun
Kaiyuan Wang
Yaling Gan
Jing Xu
Yaqin Shi
Xingjie Liang
spellingShingle Yanan Jin
Juanjuan Jia
Chan Li
Jianqi Xue
Jiabei Sun
Kaiyuan Wang
Yaling Gan
Jing Xu
Yaqin Shi
Xingjie Liang
LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG2000 nanoformulation: What if traditional methods are not applicable?
Asian Journal of Pharmaceutical Sciences
author_facet Yanan Jin
Juanjuan Jia
Chan Li
Jianqi Xue
Jiabei Sun
Kaiyuan Wang
Yaling Gan
Jing Xu
Yaqin Shi
Xingjie Liang
author_sort Yanan Jin
title LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG2000 nanoformulation: What if traditional methods are not applicable?
title_short LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG2000 nanoformulation: What if traditional methods are not applicable?
title_full LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG2000 nanoformulation: What if traditional methods are not applicable?
title_fullStr LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG2000 nanoformulation: What if traditional methods are not applicable?
title_full_unstemmed LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG2000 nanoformulation: What if traditional methods are not applicable?
title_sort lal test and rpt for endotoxin detection of cpt-11/dspe-mpeg2000 nanoformulation: what if traditional methods are not applicable?
publisher Elsevier
series Asian Journal of Pharmaceutical Sciences
issn 1818-0876
publishDate 2018-05-01
description Endotoxin detection is an important step in drug characterization. Herein we found that a chemotherapeutic drug nanoformulation composed of irinotecan hydrochloride (CPT-11) and an amphiphilic molecule DSPE-mPEG2000 can interfere with the limulus amebocyte lysate assay (LAL). Furthermore, the rabbit pyrogen test (RPT) results indicated that at a relatively high dosage, the drug irinotecan hydrochloride can induce a hypothermia effect which may render the RPT results ambiguous in determination of the safety of the drug formulation.Our findings demonstrate limitations of endotoxin detection in micellar drugs, and call for the necessity of developing reliable endotoxin detection methods that can overcome the interference of nanomaterials in order to better ensure the drug safety of patients in future pharmaceutical drug development. Keywords: Irinotecan hydrochloride, Endotoxin detection, Micelle, DSPE-mPEG2000, Limulus amebocyte lysate assay, Rabbit pyrogen test
url http://www.sciencedirect.com/science/article/pii/S1818087617307286
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spelling doaj-a419ec5f85074deb9771d1761c02f0fa2020-11-25T00:12:21ZengElsevierAsian Journal of Pharmaceutical Sciences1818-08762018-05-01133289296LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG2000 nanoformulation: What if traditional methods are not applicable?Yanan Jin0Juanjuan Jia1Chan Li2Jianqi Xue3Jiabei Sun4Kaiyuan Wang5Yaling Gan6Jing Xu7Yaqin Shi8Xingjie Liang9College of Chemistry & Environmental Science, Key Laboratory of Medicinal Chemistry and Molecular Diagnosis of the Ministry of Education, Hebei University, Baoding 071002, ChinaNational Institutes for Food and Drug Control, No. 5, Huatuo Rd., Daxing District, Beijing 102629, ChinaLaboratory of Controllable Nanopharmaceuticals, Chinese Academy of Sciences (CAS) Center for Excellence in Nanoscience, No. 11, First North Road Zhongguancun, Beijing 100190, China; CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, National Center for Nanoscience and Technology of China, No. 11, First North Road Zhongguancun, Beijing 100190, ChinaLaboratory of Molecular Iron Metabolism, College of Life Science, Hebei Normal University, Shijiazhuang 050024, ChinaNational Institutes for Food and Drug Control, No. 5, Huatuo Rd., Daxing District, Beijing 102629, ChinaLaboratory of Controllable Nanopharmaceuticals, Chinese Academy of Sciences (CAS) Center for Excellence in Nanoscience, No. 11, First North Road Zhongguancun, Beijing 100190, China; CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, National Center for Nanoscience and Technology of China, No. 11, First North Road Zhongguancun, Beijing 100190, ChinaLaboratory of Controllable Nanopharmaceuticals, Chinese Academy of Sciences (CAS) Center for Excellence in Nanoscience, No. 11, First North Road Zhongguancun, Beijing 100190, China; CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, National Center for Nanoscience and Technology of China, No. 11, First North Road Zhongguancun, Beijing 100190, ChinaLaboratory of Controllable Nanopharmaceuticals, Chinese Academy of Sciences (CAS) Center for Excellence in Nanoscience, No. 11, First North Road Zhongguancun, Beijing 100190, China; CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, National Center for Nanoscience and Technology of China, No. 11, First North Road Zhongguancun, Beijing 100190, China; Corresponding author. National Center for Nanoscience and Technology of China, No. 11, First North Road Zhongguancun, Beijing 100190, China. Tel.: +86 10 82545530.National Institutes for Food and Drug Control, No. 5, Huatuo Rd., Daxing District, Beijing 102629, China; Corresponding author. National Institutes for Food and Drug Control, No. 5, Huatuo Rd., Daxing District, Beijing 102629, China. Tel.: +86 10 53851506.College of Chemistry & Environmental Science, Key Laboratory of Medicinal Chemistry and Molecular Diagnosis of the Ministry of Education, Hebei University, Baoding 071002, China; Laboratory of Controllable Nanopharmaceuticals, Chinese Academy of Sciences (CAS) Center for Excellence in Nanoscience, No. 11, First North Road Zhongguancun, Beijing 100190, China; CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, National Center for Nanoscience and Technology of China, No. 11, First North Road Zhongguancun, Beijing 100190, China; University of Chinese Academy of Sciences, Beijing 100049, China; Corresponding author. National Center for Nanoscience and Technology of China, No. 11, First North Road Zhongguancun, Beijing 100190, China. Tel.: +86 10 82545569.Endotoxin detection is an important step in drug characterization. Herein we found that a chemotherapeutic drug nanoformulation composed of irinotecan hydrochloride (CPT-11) and an amphiphilic molecule DSPE-mPEG2000 can interfere with the limulus amebocyte lysate assay (LAL). Furthermore, the rabbit pyrogen test (RPT) results indicated that at a relatively high dosage, the drug irinotecan hydrochloride can induce a hypothermia effect which may render the RPT results ambiguous in determination of the safety of the drug formulation.Our findings demonstrate limitations of endotoxin detection in micellar drugs, and call for the necessity of developing reliable endotoxin detection methods that can overcome the interference of nanomaterials in order to better ensure the drug safety of patients in future pharmaceutical drug development. Keywords: Irinotecan hydrochloride, Endotoxin detection, Micelle, DSPE-mPEG2000, Limulus amebocyte lysate assay, Rabbit pyrogen testhttp://www.sciencedirect.com/science/article/pii/S1818087617307286

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