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The structural diversity of ibuprofen sustained-release pellets on the same goal of bioequivalence consistency

文献类型：期刊论文

作者Cao, Zeying5,7; Sun, Ningyun6,8; Sun, Hongyu5; Liu, Jun5; Li, Jing5,7; Bi, Dezhong8; Wang, Caifen5; Wu, Li5; Yin, Xianzhen1,5; Xiao, Tiqiao2
刊名MATERIALS & DESIGN
出版日期2022-05-01
卷号217页码:11
ISSN号0264-1275
关键词Consistency evaluation Bioequivalence Three-dimensional structures Internal structure parameters Ibuprofen sustained-release pellets Micro-computed tomography
DOI10.1016/j.matdes.2022.110583
通讯作者Xu, Mingdi(xumingdi@nifdc.org.cn) ; Wu, Wei(wuwei@shmu.edu.cn) ; Zhang, Jiwen(jwzhang@simm.ac.cn)
英文摘要The consistency evaluation, which is largely unexplored is crucial in regulating the quality and efficacy of generic drugs. In this report, after generic ibuprofen (IBU) sustained-release pellets were developed and validated as bioequivalent to the reference list drug (RLD) in 48 healthy human volunteers (p < 0.001***), three-dimensional (3D) structures of generic IBU pellets from bioequivalence tests, along with RLD were investigated and compared for architecture using Micro-computed tomography (Micro-CT). The surface and internal architectures of the pellets, sphericity, pellet volume, core volume and gray value have been evaluated in both static and dynamic conditions. The material distribution and composition of IBU pellets were characterized using synchrotron radiation-FTIR mapping. Although the structures of RLD and the generic products were not similar dynamically, identical release profiles and bioequivalence were obtained. Overall, micro-CT could be very useful for characterization of internal structure, material design and development of new dosage form. (C) 2022 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
WOS关键词DRUG-RELEASE ; INFLAMMATION ; MICROSCOPY ; PARAMETERS ; EROSION
资助项目National Key R&D Program of China[2020YFE0201700] ; National Science and Technology Major Projects for Major New Drugs Innovation and Develop-ment[2017ZX09101001-005] ; National Natural Science Foun-dation of China[81803446] ; Youth Innovation Promotion Association of CAS[2018323]
WOS研究方向Materials Science
语种英语
出版者ELSEVIER SCI LTD
WOS记录号WOS:000919013200001
源URL[http://119.78.100.183/handle/2S10ELR8/303376]  
专题中国科学院上海药物研究所
通讯作者Xu, Mingdi; Wu, Wei; Zhang, Jiwen
作者单位1.Lingang Lab, Shanghai 201602, Peoples R China
2.Chinese Acad Sci, Shanghai Adv Res Inst, Shanghai Synchrotron Radiat Facil, Zhangjiang Lab, Shanghai 201204, Peoples R China
3.Natl Inst Food & Drug Control, NMPA Key Lab Qual Res & Evaluat Chem Drugs, Beijing 100050, Peoples R China
4.Natl Inst Food & Drug Control, NMPA Key Lab Qual Res & Evaluat Pharmaceut Excipi, Beijing 100050, Peoples R China
5.Chinese Acad Sci, Ctr Drug Delivery Syst, Shanghai Inst Mat Med, Shanghai 201203, Peoples R China
6.Fudan Univ, Sch Pharm, Key Lab Smart Drug Delivery MOE, Shanghai 201203, Peoples R China
7.Univ Chinese Acad Sci, Beijing 100049, Peoples R China
8.SPH Sine Pharmaceut Labs Co Ltd, Shanghai 201206, Peoples R China
推荐引用方式
GB/T 7714		 Cao, Zeying,Sun, Ningyun,Sun, Hongyu,et al. The structural diversity of ibuprofen sustained-release pellets on the same goal of bioequivalence consistency[J]. MATERIALS & DESIGN,2022,217:11.
APA Cao, Zeying.,Sun, Ningyun.,Sun, Hongyu.,Liu, Jun.,Li, Jing.,...&Zhang, Jiwen.(2022).The structural diversity of ibuprofen sustained-release pellets on the same goal of bioequivalence consistency.MATERIALS & DESIGN,217,11.
MLA Cao, Zeying,et al."The structural diversity of ibuprofen sustained-release pellets on the same goal of bioequivalence consistency".MATERIALS & DESIGN 217(2022):11.

入库方式： OAI收割

来源：上海药物研究所

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