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Establishment of comprehensive photosafety evaluation system on the basis of pharmaceutical sciences

Research Project

Project/Area Number 19K07225
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 47060:Clinical pharmacy-related
Research InstitutionGihu University of Medical Science (2020-2022)
University of Shizuoka (2019)

Principal Investigator

Yoshiki Seto  岐阜医療科学大学, 薬学部, 准教授 (30744974)

Project Period (FY) 2019-04-01 – 2023-03-31
Project Status Completed (Fiscal Year 2022)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2021: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2020: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2019: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Keywords光安全性 / 皮膚曝露 / 活性酸素種 / Reactive oxygen species / ROS
Outline of Research at the Start

オゾン層の破壊により,太陽光からの紫外線曝露が近年問題となっており,これに伴い医薬品や化粧品による薬剤性光線過敏症が重要な副作用として注目を集めている.本研究では医薬品開発の初期段階にて本副作用を回避するため,化学物質の光化学的特性ならびに皮膚への曝露を指標とした光安全性評価のためのスクリーニングシステムを提示することを目的としている.さらに社会的に重要となっている動物福祉について本研究を通じて実験動物の犠牲を減らすことのできるよう,動物実験に依存しない光安全性評価システムの提案を目指し,研究を進めていく.

Outline of Final Research Achievements

This study aimed to develop a photosafety evaluation system based on the photoreactivity and skin deposition of chemical substances. In this study, in vitro skin permeability test using excised skin was employed as an alternative to animal testing for skin deposition. Combined use of the results of photoreactivity and skin exposure provided reliable photosafety information of tested chemicals, and in vitro skin permeability test could reduce the number of experimental animals compared with in vivo pharmacokinetic study. In addition, the use of an artificial membranes as an alternative to an excised skin in permeability test showed the feasibility of animal-independent evaluation of skin deposition. From these findings, proposed photosafety evaluation system would contribute to development of pharmaceuticals and cosmetics and animal welfare.

Academic Significance and Societal Importance of the Research Achievements

化粧品開発における動物実験の完全撤廃に代表される昨今の動物福祉に対する国際的な流れを鑑みると,光安全性評価においても in vivo 試験に頼らない試験系の構築が必要である.本研究で構築した光安全性評価系では皮膚内動態評価において摘出皮膚を用いるものの,動物福祉に貢献しうる成果を示すことができたと考える.また,人工膜を用いた系を導入した光安全性評価系の構築とその feasibility について継続的に検証していくことで,より動物福祉に貢献できる光安全性評価系の提供が可能になるであろう.

Report

(5 results)
  • 2022 Annual Research Report   Final Research Report ( PDF )
  • 2021 Research-status Report
  • 2020 Research-status Report
  • 2019 Research-status Report
  • Research Products

    (22 results)

All 2022 2021 2020 2019 2018

All Journal Article (10 results) (of which Peer Reviewed: 10 results,  Open Access: 1 results) Presentation (12 results) (of which Int'l Joint Research: 1 results,  Invited: 1 results)

  • [Journal Article] Reactive oxygen species (ROS) assay-based photosafety screening for complex ingredients: Modification of the ROS assay protocol2022

    • Author(s)
      Ohtake Hiroto、Tokuyoshi Yasuharu、Iyama Yosuke、Nukaga Takumi、Nishida Hayato、Ohtake Toshiyuki、Hirota Morihiko、Yamada Kohei、Seto Yoshiki、Sato Hideyuki、Kouzuki Hirokazu、Onoue Satomi
    • Journal Title

      The Journal of Toxicological Sciences

      Volume: 47 Issue: 11 Pages: 483-492

    • DOI

      10.2131/jts.47.483

    • ISSN
      0388-1350, 1880-3989
    • Related Report
      2022 Annual Research Report
    • Peer Reviewed
  • [Journal Article] In chemico sequential testing strategy for assessing the photoallegic potential2021

    • Author(s)
      Nishida Hayato、Ohtake Toshiyuki、Ashikaga Takao、Hirota Morihiko、Onoue Satomi、Seto Yoshiki、Tokura Yoshiki、Kouzuki Hirokazu
    • Journal Title

      Toxicology in Vitro

      Volume: 77 Pages: 105245-105245

    • DOI

      10.1016/j.tiv.2021.105245

    • Related Report
      2021 Research-status Report
    • Peer Reviewed
  • [Journal Article] An approach to evaluate metabolite-related phototoxicity with combined use of photochemical properties and skin deposition2021

    • Author(s)
      Seto Yoshiki、Tonami Ryo、Iyama Yosuke、Sato Hideyuki、Onoue Satomi
    • Journal Title

      Toxicology Letters

      Volume: 350 Pages: 91-97

    • DOI

      10.1016/j.toxlet.2021.07.007

    • Related Report
      2021 Research-status Report
    • Peer Reviewed
  • [Journal Article] Novel approach for attenuation of pirfenidone-induced digestive symptoms: a respirable powder formulation of pirfenidone2021

    • Author(s)
      Seto Yoshiki、Suzuki Gen、Aoki Asako、Kaneko Yuuki、Kato Masashi、Sato Hideyuki、Onoue Satomi
    • Journal Title

      Therapeutic Delivery

      Volume: 12 Issue: 7 Pages: 515-522

    • DOI

      10.4155/tde-2021-0027

    • Related Report
      2021 Research-status Report
    • Peer Reviewed
  • [Journal Article] Phototoxic risk assessment of dermally-applied chemicals with structural variety based on photoreactivity and skin deposition2020

    • Author(s)
      Seto Yoshiki、Ohtake Hiroto、Sato Hideyuki、Onoue Satomi
    • Journal Title

      Regulatory Toxicology and Pharmacology

      Volume: 113 Pages: 104619-104619

    • DOI

      10.1016/j.yrtph.2020.104619

    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Journal Article] Strategic photosafety screening system consisting of in chemico photoreactivity and in vitro skin exposure for quinolone derivatives.2020

    • Author(s)
      Iyama Y, Sato H, Seto Y, Onoue S
    • Journal Title

      Eur J Pharm Sci.

      Volume: 146 Pages: 105257-105257

    • DOI

      10.1016/j.ejps.2020.105257

    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Journal Article] Photochemmically Stabilized Formulation of Dacarbazine with Reduced Production of Algogenic Photodegradants2019

    • Author(s)
      A. Uchida, H. Ohtake, Y. Suzuki, H. Sato, Y. Seto, S. Onoue, T. Oguchi
    • Journal Title

      International Journal of Pharmaceutics

      Volume: 印刷中 Pages: 492-498

    • DOI

      10.1016/j.ijpharm.2019.04.063

    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Development of novel lutein nanocrystal formulation with improved oral bioavailability and ocular distribution2019

    • Author(s)
      Seto Yoshiki、Ueno Kodai、Suzuki Hiroki、Sato Hideyuki、Onoue Satomi
    • Journal Title

      Journal of Functional Foods

      Volume: 61 Pages: 103499-103499

    • DOI

      10.1016/j.jff.2019.103499

    • Related Report
      2019 Research-status Report
    • Peer Reviewed
  • [Journal Article] A new photosafety screening strategy based on in chemico photoreactivity and in vitro skin exposure for dermally-applied chemicals2019

    • Author(s)
      Iyama Y, Sato H, Seto Y, Onoue S
    • Journal Title

      Toxicol Lett.

      Volume: 317 Pages: 45-52

    • DOI

      10.1016/j.toxlet.2019.09.016

    • Related Report
      2019 Research-status Report
    • Peer Reviewed
  • [Journal Article] Photochemical and Pharmacokinetic Characterization of Orally Administered Chemicals to Evaluate Phototoxic Risk2018

    • Author(s)
      Yosuke Iyama, Hideyuki Sato, Yoshiki Seto, Satomi Onoue
    • Journal Title

      Journal of Pharmaceutical Sciences

      Volume: 108 Issue: 3 Pages: 1303-1308

    • DOI

      10.1016/j.xphs.2018.10.013

    • Related Report
      2019 Research-status Report
    • Peer Reviewed
  • [Presentation] 迅速かつ高効率な光毒性リスク予測を実現する光安全性評価手法の戦略的開発2022

    • Author(s)
      世戸孝樹,尾上誠良
    • Organizer
      第 12 回 レギュラトリーサイエンス学会学術大会
    • Related Report
      2022 Annual Research Report
    • Invited
  • [Presentation] 動物実験代替法としての化学物質の光安全性評価系の構築2021

    • Author(s)
      世戸孝樹、猪山陽輔、佐藤秀行、尾上誠良
    • Organizer
      日本病院薬剤師会東海ブロック・日本薬学会東海支部 合同学術大会 2021
    • Related Report
      2021 Research-status Report
  • [Presentation] St. John’s Wort エキスの光毒性リスク評価: 主要成分の光反応性および in vitro 皮膚蓄積性に基づく統合的解析2020

    • Author(s)
      林 勇寿、猪山 陽輔、世戸 孝樹、佐藤 秀行、尾上 誠良
    • Organizer
      日本薬学会 第 140 年会
    • Related Report
      2020 Research-status Report
  • [Presentation] ナノエマルション技術による fisetin の皮膚移行性および皮膚保護作用の向上2020

    • Author(s)
      望月 大吾、世戸 孝樹、佐藤 秀行、尾上 誠良
    • Organizer
      日本病院薬剤師会東海ブロック・日本薬学会東海支部合同学術大会 2020
    • Related Report
      2020 Research-status Report
  • [Presentation] in vivo 試験に依存しない光安全性予測:NSAIDs の光反応性および皮膚暴露量を指標として2019

    • Author(s)
      徳吉泰春、猪山洋輔、佐藤秀行、世戸孝樹、尾上誠良
    • Organizer
      日本薬剤学会第 34 年会
    • Related Report
      2019 Research-status Report
  • [Presentation] 光安全性評価における光毒性代謝物の皮膚曝露とその推移の重要性:imipramine をモデルとした検討2019

    • Author(s)
      世戸孝樹、當波諒、猪山陽輔、佐藤秀行、尾上誠良
    • Organizer
      第 46 回日本毒性学会学術年会
    • Related Report
      2019 Research-status Report
  • [Presentation] Reactive oxygen species assay および in vitro 皮膚透過性試験を用いたキノロン系抗菌薬の光安全性評価2019

    • Author(s)
      猪山陽輔、佐藤秀行、世戸孝樹、尾上誠良
    • Organizer
      第 5 回日本医薬品安全性学会学術大会
    • Related Report
      2019 Research-status Report
  • [Presentation] 光反応性および in vitro 皮膚蓄積性の統合的解析による光安全性評価2019

    • Author(s)
      猪山陽輔、佐藤秀行、世戸孝樹、尾上誠良
    • Organizer
      第 25 回創剤フォーラム若手研究会
    • Related Report
      2019 Research-status Report
  • [Presentation] Photosafety testing: the combination use of photoreactivity and skin deposition2019

    • Author(s)
      Yosuke Iyama, Hideyuki Sato, Yoshiki Seto, Satomi Onoue
    • Organizer
      4th AFPS
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research
  • [Presentation] 薬剤性光線過敏症リスク評価における代謝物の皮膚内動態評価の重要性2019

    • Author(s)
      世戸孝樹、當波諒、猪山陽輔、佐藤秀行、尾上誠良
    • Organizer
      日本病院薬剤師会東海ブロック・日本薬学会東海支部 合同学術大会 2019
    • Related Report
      2019 Research-status Report
  • [Presentation] Reactive oxygen species (ROS) assay による分子量不明素材における光反応性評価2019

    • Author(s)
      徳吉泰春、猪山陽輔、額賀巧、廣田衞彦、上月裕一、佐藤秀行、世戸孝樹、尾上誠良
    • Organizer
      日本動物実験代替法学会第 32 回大会
    • Related Report
      2019 Research-status Report
  • [Presentation] 動物実験を用いない光安全性評価系の開発:経皮適用時の光毒性リスク2019

    • Author(s)
      猪山陽輔、佐藤秀行、世戸孝樹、尾上誠良
    • Organizer
      日本動物実験代替法学会第 32 回大会
    • Related Report
      2019 Research-status Report

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Published: 2019-04-18   Modified: 2024-01-30  

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