Highly sensitive and specific measurement of pharmaceutical cocrystals based on the low-frequency Raman spectroscopy

2020 Fiscal Year Final Research Report

• Project/Area Number: 17K08253
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Physical pharmacy
• Research Institution: Meiji Pharmaceutical University
• Principal Investigator: Fukami Toshiro 明治薬科大学, 薬学部, 教授 (20366628)
• Co-Investigator(Kenkyū-buntansha): 大西 優 明治薬科大学, 薬学部, 助手 (60817021) ; 鈴木 直人 日本大学, 薬学部, 助教 (60756005)
• Project Period (FY): 2017-04-01 – 2021-03-31
• Keywords: ラマン分光 / 品質管理 / 結晶多形 / プロセス分析

Outline of Final Research Achievements

In this study, the reporters have established a technique using low-frequency Raman spectroscopy including (i) ultra-trace analysis of solid samples by microscopic measurement and exploring method for novel crystal forms, and (ii) in situ monitoring using a probe-type detector for evaluating the crystal form of active pharmaceutical ingredient and its transition process. (i) Ultra-trace analysis by microscopic measurement would be a useful technique even when the usable amount of drug substance is severely limited in the early stage of the new drug development, and has the potential to extend the applicability to new modality in drug discovery. (ii) Probe-type LF Raman monitoring could provide a new option for in situ measurement in addition to near-infrared spectroscopy, which is currently widely used for process analysis.

Free Research Field

製剤学

Academic Significance and Societal Importance of the Research Achievements

本研究では，ラマン分光法の低波数領域に着目し，その散乱ピークが医薬品の結晶性成分に特異的であり，結晶多形の識別や転移過程の解明に対する有用性を実証できたことから，学術的に大きな意義を有している．また，確立できた複数の技術は，新薬の様々な開発ステージにおいて実用的であり，医薬品の品質向上ならびに開発や生産プロセスの効率化に寄与できることから，本研究は社会的にも大きな意義がある．