2023 Fiscal Year Final Research Report
Elucidation of low-frequency Raman spectra and its application to precision control of drug manufacturing process
| Project/Area Number |
20K07002
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Review Section |
Basic Section 47020:Pharmaceutical analytical chemistry and physicochemistry-related
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| Research Institution | Meiji Pharmaceutical University |
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Principal Investigator |
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| Project Period (FY) |
2020-04-01 – 2024-03-31
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| Keywords | ラマン分光法 / 製剤化工程 / 結晶多形 / プロセス分析 |
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| Outline of Final Research Achievements |
In this study, the reporter conducted by utilizing low-wavenumber Raman spectroscopy, (i) in situ monitoring of the effect of disintegrant on drug substance crystals during the granulation process using a probe-type detector, (ii) chemical imaging enabling to visualize the internal structure and component distribution of orally disintegrating tablet using microscopic measurements, and (iii) measuring the content of the active pharmaceutical ingredient in tablets by transmission Raman measurement with influence of parameters during granulation process. Among these, (i) process analysis using probe measurements provides a new measurement option to the current standard method of near-infrared spectroscopy, and allows for the immediate evaluation of the crystalline state of the ingredients in the drug products. Because it is useful for the purpose of this research, it was able to contribute to precise control of the formulation process.
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| Free Research Field |
物理薬剤学
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| Academic Significance and Societal Importance of the Research Achievements |
本研究ではラマン分光法の多彩な測定モードに着目し，試料の状態を選ばず，非破壊的に測定する技術を確立したこと，すなわち各種の添加剤（崩壊剤）が結晶の転移速度に及ぼす影響を動的な製剤工程内で実証したことから，様々な医薬品の開発ステージにおいて，医薬品の品質向上ならびに製造プロセスの効率化が期待できるため，社会的に大きな意義を有している．また，医薬品の結晶性成分に特異的な低波数領域における散乱ピークが各々の格子振動に基づいており，それらの帰属や法則性についても一部を明らかにできたこと，ならびに医薬品製剤を構成する成分の特定にも有用であることを示せたことから，学術的にも大きな意義を有している．
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