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Structure based release kinetics analysis of doxazosin mesylate sustained-release tablets using micro-computed tomography

文献类型：期刊论文

作者Liu, Qian1; Zan, Mengqing1,2; Huang, Hanhan1,2; Su, Hai1,2; Zhang, Wenjing1,2; Ma, Lingyun1; Zhang, Guangchao1; Zhang, Zunjian2; Zhang, Jiwen3,4; Niu, Jianzhao1
刊名ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES
出版日期2024-12-01
卷号19期号:6页码:9
关键词Doxazosin mesylate sustained-release tablets Osmotic pump tablets Micro-computed tomography Three-dimensional structures Ethanol
ISSN号1818-0876
DOI10.1016/j.ajps.2024.100966
通讯作者Zhang, Jiwen(jwzhang@simm.ac.cn) ; Niu, Jianzhao(njz@nifdc.org.cn) ; Xu, Mingdi(xumingdi@nifdc.org.cn)
英文摘要The structures of solid dosage forms determine their release behaviors and are critical attributes for the design and evaluation of the solid dosage forms. Here, the 3D structures of doxazosin mesylate sustained-release tablets were parallelly assessed by micro- computed tomography (micro-CT). There were no significant differences observed in the release profiles between the RLD and the generic formulation in the conventional dissolution, but the generic preparation released slightly faster in media with ethanol during an alcohol-induced dose-dumping test. With their 3D structures obtained via micro-CT determination, the unique release behaviors of both RLD and the generic were investigated to reveal the effects of internal fine structure on the release kinetics. The structural parameters for both preparations were similar in conventional dissolution test, while the dissolutions in ethanol media showed some distinctions between RLD and generic preparations due to their static and dynamic structures. Furthermore, the findings revealed that the presence of ethanol accelerated dissolution and induced changes in internal structure of both RLD and generic preparations. Moreover, structure parameters like volume and area of outer contour, remaining solid volume and cavity volume were not equivalent between the two formulations in 40 % ethanol. In conclusion, the structure data obtained from this study provided valuable insights into the diverse release behaviors observed in various modified-release formulations in drug development and quality control. (c) 2024 Shenyang Pharmaceutical University. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
WOS关键词OSMOTIC PUMP TABLETS ; DISSOLUTION TESTS
资助项目Key Program for International Science and Technology Cooperation Projects of China[2020YFE0201700] ; State Drug Administration key laboratory project[2024HYZX04]
WOS研究方向Pharmacology & Pharmacy
语种英语
WOS记录号WOS:001363184500001
出版者SHENYANG PHARMACEUTICAL UNIV
源URL[http://119.78.100.183/handle/2S10ELR8/314674]  
专题中国科学院上海药物研究所
通讯作者Zhang, Jiwen; Niu, Jianzhao; Xu, Mingdi
作者单位1.Natl Inst Food & Drug Control, NMPA Key Lab Qual Res & Evaluat Chem Drugs, Beijing 100050, Peoples R China
2.China Pharmaceut Univ, Nanjing 210009, Peoples R China
3.Chinese Acad Sci, Ctr Drug Delivery Syst, Shanghai Inst Mat Med, Shanghai 201203, Peoples R China
4.Natl Inst Food & Drug Control, NMPA Key Lab Qual Res & Evaluat Pharmaceut Excipie, Beijing 100050, Peoples R China
推荐引用方式
GB/T 7714		 Liu, Qian,Zan, Mengqing,Huang, Hanhan,et al. Structure based release kinetics analysis of doxazosin mesylate sustained-release tablets using micro-computed tomography[J]. ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES,2024,19(6):9.
APA Liu, Qian.,Zan, Mengqing.,Huang, Hanhan.,Su, Hai.,Zhang, Wenjing.,...&Xu, Mingdi.(2024).Structure based release kinetics analysis of doxazosin mesylate sustained-release tablets using micro-computed tomography.ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES,19(6),9.
MLA Liu, Qian,et al."Structure based release kinetics analysis of doxazosin mesylate sustained-release tablets using micro-computed tomography".ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES 19.6(2024):9.

入库方式： OAI收割

来源：上海药物研究所

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