Superior Dissolution Behavior and Bioavailability of Pharmaceutical Cocrystals and Recent Regulatory Issues
文献类型:期刊论文
作者 | Xia, Meng Y.1,2; Zhu, Bing Q.2; Wang, Jian-R2; Yang, Ze E.2; Mei, Xue F.1,2 |
刊名 | ACS MEDICINAL CHEMISTRY LETTERS
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出版日期 | 2021-12-30 |
页码 | 9 |
关键词 | Pharmaceutical cocrystals solubility dissolution bioavailability IVIVC patentability |
ISSN号 | 1948-5875 |
DOI | 10.1021/acsmedchemlett.1c00478 |
通讯作者 | Mei, Xue F.(xuefengmei@simm.ac.cn) |
英文摘要 | Cocrystallization has been used extensively to optimize the physicochemical properties of active pharmaceutical ingredients (APIs), such as stability, dissolution, and bioavailability. This review summarizes the history and development of cocrystals, the differences between pharmaceutical cocrystals and salts, and the mechanism underlying the improvement of dissolution through cocrystallization. The correlation of in vitro dissolution and in vivo absorption data (IVIVC) of cocrystals has been discussed as well. Subsequently, guidelines for regulatory classification of cocrystals by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are introduced. Finally, D-alpha-tocopherol is used as an example to demonstrate the potential of cocrystals in patent generation. |
WOS关键词 | SOLUBILITY ; SALTS ; PHARMACOKINETICS ; SUPERSATURATION ; POLYMORPHS ; DRUG |
资助项目 | Shanghai Science and Technology Innovation Action Plan[20142201800] |
WOS研究方向 | Pharmacology & Pharmacy |
语种 | 英语 |
WOS记录号 | WOS:000739942800001 |
出版者 | AMER CHEMICAL SOC |
源URL | [http://119.78.100.183/handle/2S10ELR8/300682] ![]() |
专题 | 中国科学院上海药物研究所 |
通讯作者 | Mei, Xue F. |
作者单位 | 1.Univ Chinese Acad Sci, Beijing 100049, Peoples R China 2.Chinese Acad Sci, Pharmaceut Analyt & Solid State Chem Res Ctr, Shanghai Inst Mat Med, Shanghai 201203, Peoples R China |
推荐引用方式 GB/T 7714 | Xia, Meng Y.,Zhu, Bing Q.,Wang, Jian-R,et al. Superior Dissolution Behavior and Bioavailability of Pharmaceutical Cocrystals and Recent Regulatory Issues[J]. ACS MEDICINAL CHEMISTRY LETTERS,2021:9. |
APA | Xia, Meng Y.,Zhu, Bing Q.,Wang, Jian-R,Yang, Ze E.,&Mei, Xue F..(2021).Superior Dissolution Behavior and Bioavailability of Pharmaceutical Cocrystals and Recent Regulatory Issues.ACS MEDICINAL CHEMISTRY LETTERS,9. |
MLA | Xia, Meng Y.,et al."Superior Dissolution Behavior and Bioavailability of Pharmaceutical Cocrystals and Recent Regulatory Issues".ACS MEDICINAL CHEMISTRY LETTERS (2021):9. |
入库方式: OAI收割
来源:上海药物研究所
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