2022 Fiscal Year Final Research Report
Development and evaluation of drug substance evaluation method by X-ray absorption edge microstructure measurement
Project/Area Number |
20K07001
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Research Category |
Grant-in-Aid for Scientific Research (C)
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Allocation Type | Multi-year Fund |
Section | 一般 |
Review Section |
Basic Section 47020:Pharmaceutical analytical chemistry and physicochemistry-related
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Research Institution | Toho University |
Principal Investigator |
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Co-Investigator(Kenkyū-buntansha) |
鈴木 浩典 東邦大学, 薬学部, 講師 (20625694)
伊藤 雅隆 東邦大学, 薬学部, 講師 (30792410)
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Project Period (FY) |
2020-04-01 – 2023-03-31
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Keywords | X線吸収スペクトル測定法 |
Outline of Final Research Achievements |
In this study, we focused on the X-ray absorption fine structure (XAFS) method and evaluated its applicability to bulk pharmaceuticals and pharmaceutical formulations. X-ray structural analysis and XAFS spectroscopic measurements were performed on the crystal polymorphs of bulk pharmaceuticals, and the XAFS spectral shapes were compared with the interaction patterns formed by the X-ray-absorbing atoms in the crystals. The results demonstrated that the formation of non-covalent interactions such as hydrogen bonds, halogen bonds, and halogen-π interactions can be detected as differences in XAFS spectral shape. The XAFS method is expected to be useful not only for the evaluation of crystal form of API, but also for element-specific information on intermolecular interactions formed by API molecules in pharmaceutical formulations.
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Free Research Field |
製剤学
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Academic Significance and Societal Importance of the Research Achievements |
本研究は医薬品分子の形成する非共有結合性の弱い相互作用の形成をXAFSスペクトルにより検知できることを初めて明らかにした。XAFS法を用いることで医薬品製剤における原薬分子の分子レベルの状態をより詳細に評価できることが可能となり、医薬品製剤の設計あるいは品質評価をより高いレベルで遂行することを可能にすると期待できる。
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