Synchrotron Radiation Microcomputed Tomography Guided Chromatographic Analysis for Displaying the Material Distribution in Tablets

doi:10.1021/acs.analchem.7b04726

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	Synchrotron Radiation Microcomputed Tomography Guided Chromatographic Analysis for Displaying the Material Distribution in Tablets
	Zhang, Liu 1,6; Wu, Li 2,6; Wang, Caifen 6; Zhang, Guoqing 6; Yu, Lin 1,6; Li, Haiyan6 ; Maharjan, Abi 6; Tang, Yan 6; He, Dunwei 5; York, Peter 4,6
刊名	ANALYTICAL CHEMISTRY
	2018-03-06
卷号	90 期号:5 页码:3238-3244
ISSN号	0003-2700
DOI	10.1021/acs.analchem.7b04726
文献子类	Article
英文摘要	One unusual and challenging scientific field that has received only cursory attention to date is the threedimensional (3D) microstructure and spatial distribution of drug(s) and formulation materials in solid dosage forms. This study aims to provide deeper insight into the relationships between the microstructure of multiple-unit pellet system (MUPS) tablets and the spatial distribution of the active pharmaceutical ingredient (API) and excipients to facilitate the design of quantitative models for drug delivery systems. Synchrotron radiation X-ray microcomputed tomography (SR-pCT) was established as a 3D structure elucidation technique, which, in conjunction with liquid chromatography coupled to mass spectrometry (LC MS) or liquid chromatography with evaporative light-scattering detector (LC-ELSD) enables chemical analysis of tablets. On the basis of the specific interior construction of theophylline MUPS tablets, the spatial distribution of materials was acquired by quantifying microregion samples that had been validated by SR-pCT for their locations in the MUPS tablets. The 3D structure of the MUPS tablets was catalogued as three structural domains: a matrix layer (ML), a protective cushion layer (PCL), and pellets (PL). Compared with the components in the ML, components in the PL had a larger proportion of theophylline, sucrose, and diethyl phthalate and a smaller proportion of lactose and sodium lauryl sulfate, whereas glyceryl monostearate was found to account for a large portion of the PCL. Microstructural characterization-guided zonal chemical determination represents a new approach for quality assessment and the development of drug delivery systems with in-depth insight into their constituent layers on a new scale.
资助项目	National Natural Science Foundation of China[81573392] ; National Natural Science Foundation of China[81773645] ; National Natural Science Foundation of China[81430087] ; Intergovernment Key International Scientific and Technological Innovation Cooperation[2016YFE0125100] ; National Science and Technology Major Project[2017ZX09101001-006] ; China Postdoctoral Science Foundation[2017M610284]
WOS关键词	OSMOTIC PUMP TABLETS ; X-RAY MICROTOMOGRAPHY ; SPATIAL-DISTRIBUTION ; RELEASE ; MECHANISM ; KINETICS
WOS研究方向	Chemistry
语种	英语
出版者	AMER CHEMICAL SOC
WOS记录号	WOS:000427095700038
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/279857]
专题	药物制剂研究中心分子影像中心（筹）
通讯作者	Yin, Xianzhen; Zhang, Jiwen; Sun, Lixin
作者单位	1.Shenyang Pharmaceut Univ, Sch Pharm, Dept Pharmaceut Anal, Shenyang 110016, Liaoning, Peoples R China; 2.Yantai Univ, Minist Educ, Sch Pharm, Key Lab Mol Pharmacol & Drug Evaluat, Yantai 264005, Peoples R China; 3.Natl Inst Food & Drug Control, Beijing 100050, Peoples R China 4.Univ Bradford, Inst Pharmaceut Innovat, Bradford BD7 1DP, W Yorkshire, England; 5.Shandong Hiqual Pharmatech Co Ltd, Zibo 255035, Peoples R China; 6.Chinese Acad Sci, Shanghai Inst Mat Med, Ctr Drug Delivery Syst, Shanghai 201203, Peoples R China;
推荐引用方式 GB/T 7714	Zhang, Liu,Wu, Li,Wang, Caifen,et al. Synchrotron Radiation Microcomputed Tomography Guided Chromatographic Analysis for Displaying the Material Distribution in Tablets[J]. ANALYTICAL CHEMISTRY,2018,90(5):3238-3244.
APA	Zhang, Liu.,Wu, Li.,Wang, Caifen.,Zhang, Guoqing.,Yu, Lin.,...&Sun, Lixin.(2018).Synchrotron Radiation Microcomputed Tomography Guided Chromatographic Analysis for Displaying the Material Distribution in Tablets.ANALYTICAL CHEMISTRY,90(5),3238-3244.
MLA	Zhang, Liu,et al."Synchrotron Radiation Microcomputed Tomography Guided Chromatographic Analysis for Displaying the Material Distribution in Tablets".ANALYTICAL CHEMISTRY 90.5(2018):3238-3244.