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Primary Particle Imaging of Active Pharmaceutical Ingredient in Formulations by Raman Crystal Orientation Mapping

Research Project

Project/Area Number 16K08213
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Physical pharmacy
Research InstitutionShujitsu University

Principal Investigator

Moriyama Kei  就実大学, 薬学部, 准教授 (60345163)

Project Period (FY) 2016-04-01 – 2019-03-31
Project Status Completed (Fiscal Year 2018)
Budget Amount *help
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2018: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2017: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2016: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Keywordsラマン分光法 / 製剤 / 原薬 / 一次粒子 / イメージング / 溶出 / 粉砕 / 分級 / 結晶構造 / フェニトイン / 粒度分布 / 粒子径
Outline of Final Research Achievements

The aim of this study was to develop an imaging method of primary particles of active pharmaceutical ingredients (API) in formulations by Raman crystal orientation mapping (RCOM) method. Raman spectrum is determined based on the angle between the polarization direction of excitation laser and the crystal axes; therefore, the spectral transition is observed on the boundary of the primary particles of the API, which forms the concept of RCOM. We applied this technique to visualize the primary particles in the formulations using phenytoin and cilostazol as the model API. Also, we performed dissolution tests for model tablets of phenytoin and cilostazol and revealed the relationship between the primary particle morphology and the dissolution rate. We believe that the application of the RCOM method would facilitate visualization of the primary particles of various APIs in a formulation for the better understanding of the dissolution behavior of the formulation.

Academic Significance and Societal Importance of the Research Achievements

医薬品の研究・製造現場において、医薬品原薬の分散状態を簡便に可視化できるラマンイメージング法は極めて重要な分析ツールとなっている。ただし、ここで可視化できている原薬像はあくまでもその凝集塊のものであり、一次粒子の形態まで把握できるイメージング法は本研究開始当初には存在していなかった。近年開発されている医薬品原薬は難溶性のものが多く、一次粒子の粒子形態がその溶出挙動に極めて重要な要因となっている。本研究で開発した製剤中原薬の一次粒子イメージング法は、製剤からの原薬溶出挙動の予測および評価をより高次元で行うことを可能とするものであり、医薬品の品質安定化に大きく寄与するものと考えられる。

Report

(4 results)
  • 2018 Annual Research Report   Final Research Report ( PDF )
  • 2017 Research-status Report
  • 2016 Research-status Report
  • Research Products

    (16 results)

All 2019 2018 2017 2016 Other

All Journal Article (5 results) (of which Int'l Joint Research: 3 results,  Peer Reviewed: 4 results,  Open Access: 1 results,  Acknowledgement Compliant: 1 results) Presentation (8 results) (of which Int'l Joint Research: 3 results,  Invited: 2 results) Remarks (3 results)

  • [Journal Article] 医薬品の品質管理とラマン分光法2019

    • Author(s)
      森山 圭
    • Journal Title

      Farumashia

      Volume: 55 Issue: 4 Pages: 310-314

    • DOI

      10.14894/faruawpsj.55.4_310

    • NAID

      130007621946

    • ISSN
      0014-8601, 2189-7026
    • Related Report
      2018 Annual Research Report
  • [Journal Article] Applications of Raman Spectroscopy on Quality Control of Hospital Formulations2018

    • Author(s)
      Moriyama, K., Yakushige, A., Yamamoto, M., Ogura, Y., Fukushima, S., Kamei, T., Akagi, S., Tokuda, H., Takayanagi, K., Takami, Y.
    • Journal Title

      YAKUGAKU ZASSHI

      Volume: 138 Issue: 12 Pages: 1561-1568

    • DOI

      10.1248/yakushi.18-00103

    • NAID

      130007539081

    • ISSN
      0031-6903, 1347-5231
    • Year and Date
      2018-12-01
    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Fluorescence-Based High-Throughput Salt Screening.2018

    • Author(s)
      Kimura, K., Onishi, S., Moriyama, K.
    • Journal Title

      J. Pharm. Sci.

      Volume: 印刷中 Issue: 7 Pages: 1870-1878

    • DOI

      10.1016/j.xphs.2018.02.018

    • Related Report
      2018 Annual Research Report 2017 Research-status Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Visualization of Protonation/Deprotonation of Active Pharmaceutical Ingredient in Solid State by Vapor Phase Amine-Selective Alkyne Tagging and Raman Imaging2017

    • Author(s)
      Moriyama, K., Yasuhara, Y., Ota, H.
    • Journal Title

      Journal of Pharmaceutical Sciences

      Volume: 印刷中 Issue: 7 Pages: 1778-1785

    • DOI

      10.1016/j.xphs.2017.03.006

    • Related Report
      2017 Research-status Report 2016 Research-status Report
    • Peer Reviewed / Int'l Joint Research / Acknowledgement Compliant
  • [Journal Article] Advanced Applications of Raman Imaging for Deeper Understanding and Better Quality Control of Formulations2016

    • Author(s)
      Moriyama, K.
    • Journal Title

      Current Pharmaceutical Design

      Volume: 22 Issue: 32 Pages: 4912-4916

    • DOI

      10.2174/1381612822666160726093637

    • Related Report
      2016 Research-status Report
    • Peer Reviewed / Int'l Joint Research
  • [Presentation] 結晶配向性ラマンイメージングによる製剤中の原薬一次粒子径評価と溶出挙動との関連性調査:第2報2019

    • Author(s)
      矢野 遥子、大森 翔太、森山 圭
    • Organizer
      日本薬剤学会第34年会
    • Related Report
      2018 Annual Research Report
  • [Presentation] 結晶配向性ラマンイメージングによる製剤中の原薬一次粒子径評価と溶出挙動との関連性調査2018

    • Author(s)
      榎本 千夏、木村 和恵、森山 圭
    • Organizer
      日本薬剤学会第33年会
    • Related Report
      2018 Annual Research Report
  • [Presentation] Primary Particle Imaging of Active Pharmaceutical Ingredient in Formulations by Raman Crystal Orientation Mapping (RCOM)2018

    • Author(s)
      Chinatsu Enomoto, Kazue Kimura, Kei Moriyama
    • Organizer
      The 26th International Conference on Raman Spectroscopy (ICORS)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 医薬品の開発・製造過程におけるラマン分光法の応用2018

    • Author(s)
      森山 圭
    • Organizer
      日本分光学会夏期セミナー
    • Related Report
      2018 Annual Research Report
    • Invited
  • [Presentation] A Sound Medication in Sound Analyses: Advanced applications of Raman spectroscopy for formulation design and quality control2017

    • Author(s)
      Moriyama, K.
    • Organizer
      International symposium on Raman spectroscopy for biomedical applications
    • Related Report
      2017 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Raman Crystal Orientation Mapping: Visualization of Primary Particle of API in Formulations2016

    • Author(s)
      Moriyama, K.
    • Organizer
      The 1st Workshop for Japan-Korea Young Scientists on Pharmaceutics
    • Place of Presentation
      京都教育文化センター(京都府京都市左京区)
    • Year and Date
      2016-06-24
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research
  • [Presentation] 薬学分野におけるラマン分光法応用研究の最先端2016

    • Author(s)
      森山 圭
    • Organizer
      最先端光計測とライフサイエンスの近未来
    • Place of Presentation
      東北大学青葉山キャンパス(宮城県仙台市青葉区)
    • Year and Date
      2016-06-18
    • Related Report
      2016 Research-status Report
  • [Presentation] 結晶配向性ラマンイメージングによりメトホルミン製剤中の原薬一次粒子イメージングと粒子径評価2016

    • Author(s)
      大西 宏来,森山 圭
    • Organizer
      日本薬剤学会第31年会
    • Place of Presentation
      長良川国際会議場(岐阜県岐阜市)
    • Year and Date
      2016-05-19
    • Related Report
      2016 Research-status Report
  • [Remarks] 就実大学薬学部医薬品構造解析学講座ホームページ

    • URL

      http://moriyamalab.com/

    • Related Report
      2018 Annual Research Report 2017 Research-status Report
  • [Remarks] 就実大学薬学部製剤ラマンイメージングデータベース

    • URL

      https://info.shujitsu.ac.jp/raman/

    • Related Report
      2018 Annual Research Report 2017 Research-status Report
  • [Remarks] 就実大学薬学部医薬品構造解析学講座ホームページ

    • URL

      http://moriyamalab.com

    • Related Report
      2016 Research-status Report

URL: 

Published: 2016-04-21   Modified: 2020-03-30  

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