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Design and pharmacokinetic evaluations of polymeric carrier-based nano formulations for inhalation

Research Project

Project/Area Number 20K07180
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 InstitutionUniversity of Shizuoka

Principal Investigator

Sato Hideyuki  静岡県立大学, 薬学部, 准教授 (70739242)

Project Period (FY) 2020-04-01 – 2024-03-31
Project Status Completed (Fiscal Year 2023)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2022: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2021: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2020: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Keywords高分子ナノキャリア / 吸入用微粒子 / 粘液透過性ナノ粒子 / 粘液付着性ナノ粒子 / 中分子医薬品 / 中分子医薬 / ナノ粒子 / 薬物動態制御 / 粉末吸入製剤 / 高分子ナノ粒子 / 吸入製剤 / 機能性ポリマー / プリンタ技術 / 経肺 DDS / 薬物動態学
Outline of Research at the Start

本研究は,近年極めて重要性が高くなっているが注射等の侵襲的投与経路以外に有効な投与経路が存在していないバイオ医薬品に対する有効かつ安全な新規経肺 DDS 製剤の戦略的開発を目的とする.粉末吸入製剤は,バイオ医薬品の新たな投与形態として期待されるが,肺内における複雑な異物排除機構のため,吸入した微粒子の肺内における粒子動態や薬物動態は未だ不明な点が多く,肺からの薬物吸収制御を極めて困難なものとしている.本研究課題では,最新のナノテクノロジーとイメージング技術を駆使し,肺内における微粒子動態および薬物動態を制御可能な革新的経肺 DDS プラットフォームの開発に挑戦するものである.

Outline of Final Research Achievements

The aim of present study was to develop strategic drug delivery system via respiratory system to achieve efficient delivery of biologics like antibody, protein, peptide, and nucleic acid which have been mainly administrated by parenteral administration. Environmental responsive fluorescent probe was selected as model drug to accurately evaluate the biodistribution/retention of drug-loaded nanoparticles after intratracheal administration. To control diffusiveness of inhalable particles within respiratory tracts, mucopenetrating and mucoadhesive nanoparticle-loaded inhalable particles were designed. These formulations enabled inner drug to control drug exposure at respiratory tracts. Based on these findings, the application of novel strategy for respiratory DDS could contribute to effective delivery of target compounds to not only respiratory tract but also systemic circulation.

Academic Significance and Societal Importance of the Research Achievements

粉末吸入製剤は,バイオ医薬品の新たな投与形態として期待されるが,肺内における複雑な異物排除機構のため,吸入した微粒子の肺内における粒子動態や薬物動態は未だ不明な点が多く,肺からの薬物吸収制御を極めて困難なものとしている.本研究成果は肺に対する薬物送達ならびに肺から全身への薬物送達を制御する製剤技術を提案するものであり,これまで注射でしか使用できなかった薬物をより簡便な投与により患者自身で安全に使用できる可能性を示すものである.創薬モダリティの多様化する昨今,中高分子を対象とするDDS製剤設計に有用な情報を提示可能と考える.

Report

(5 results)
  • 2023 Annual Research Report   Final Research Report ( PDF )
  • 2022 Research-status Report
  • 2021 Research-status Report
  • 2020 Research-status Report
  • Research Products

    (34 results)

All 2022 2021 2020 Other

All Int'l Joint Research (11 results) Journal Article (9 results) (of which Int'l Joint Research: 2 results,  Peer Reviewed: 8 results,  Open Access: 1 results) Presentation (13 results) Patent(Industrial Property Rights) (1 results)

  • [Int'l Joint Research] シドニー大学(オーストラリア)

    • Related Report
      2023 Annual Research Report
  • [Int'l Joint Research] プリンストン大学(米国)

    • Related Report
      2023 Annual Research Report
  • [Int'l Joint Research] フダン大学(中国)

    • Related Report
      2023 Annual Research Report
  • [Int'l Joint Research] プリンストン大学(米国)

    • Related Report
      2022 Research-status Report
  • [Int'l Joint Research] フダン大学(中国)

    • Related Report
      2022 Research-status Report
  • [Int'l Joint Research] シドニー大学(オーストラリア)

    • Related Report
      2021 Research-status Report
  • [Int'l Joint Research] プリンストン大学(米国)

    • Related Report
      2021 Research-status Report
  • [Int'l Joint Research] フダン大学(中国)

    • Related Report
      2021 Research-status Report
  • [Int'l Joint Research] The University of Sydney(オーストラリア)

    • Related Report
      2020 Research-status Report
  • [Int'l Joint Research] Princeton University(米国)

    • Related Report
      2020 Research-status Report
  • [Int'l Joint Research] Fudan Univercity(中国)

    • Related Report
      2020 Research-status Report
  • [Journal Article] Nanocrystal solid dispersion of fuzapladib free acid with improved oral bioavailability2022

    • Author(s)
      Yamada Kohei、Hayashi Yuto、Sasaki Kenta、Higuchi Koji、Shindo Takeshi、Shikama Hiroshi、Sato Hideyuki、Onoue Satomi
    • Journal Title

      Biopharmaceutics & Drug Disposition

      Volume: 43 Issue: 3 Pages: 89-97

    • DOI

      10.1002/bdd.2314

    • Related Report
      2022 Research-status Report
    • Peer Reviewed
  • [Journal Article] Development of Poly(lipoic acid) Nanoparticles with Improved Oral Bioavailability and Hepatoprotective Effects of Quercetin2022

    • Author(s)
      Banik Sujan、Yamada Kohei、Sato Hideyuki、Onoue Satomi
    • Journal Title

      Molecular Pharmaceutics

      Volume: 19 Issue: 5 Pages: 1468-1476

    • DOI

      10.1021/acs.molpharmaceut.2c00009

    • Related Report
      2022 Research-status Report
    • Peer Reviewed
  • [Journal Article] Flash Nanoprecipitation 法を基盤としたナノ粒子設計と薬物動態制御への応用 (2)2022

    • Author(s)
      佐藤 秀行,尾上 誠良
    • Journal Title

      製剤機械技術学会誌

      Volume: 154 Pages: 21-29

    • Related Report
      2022 Research-status Report
  • [Journal Article] Clofazimine-Loaded Mucoadhesive Nanoparticles Prepared by Flash Nanoprecipitation for Strategic Intestinal Delivery2021

    • Author(s)
      Yamada Kohei、Ristroph Kurt D.、Kaneko Yuki、Lu Hoang D.、Sato Hideyuki、Prud’homme Robert K.、Onoue Satomi
    • Journal Title

      Pharmaceutical Research

      Volume: 38 Issue: 12 Pages: 2109-2118

    • DOI

      10.1007/s11095-021-03144-3

    • Related Report
      2021 Research-status Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Self‐emulsifying drug delivery system of (R)‐α‐lipoic acid to improve its stability and oral absorption2021

    • Author(s)
      Banik Sujan、Halder Shimul、Sato Hideyuki、Onoue Satomi
    • Journal Title

      Biopharmaceutics & Drug Disposition

      Volume: 42 Issue: 5 Pages: 226-233

    • DOI

      10.1002/bdd.2277

    • Related Report
      2021 Research-status Report
    • Peer Reviewed
  • [Journal Article] Tranilast-loaded amorphous solid dispersion prepared with fine droplet drying process for improvement of oral absorption and anti-inflammatory effects on chemically-induced colitis2021

    • Author(s)
      Moritani Tatsuru、Kaneko Yuuki、Morinaga Tadahiko、Ohtake Hiroto、Seto Yoshiki、Sato Hideyuki、Onoue Satomi
    • Journal Title

      Journal of Drug Delivery Science and Technology

      Volume: 64 Pages: 102544-102544

    • DOI

      10.1016/j.jddst.2021.102544

    • Related Report
      2021 Research-status Report
    • Peer Reviewed
  • [Journal Article] Design and Biopharmaceutical Evaluations of Peptide-loaded Inhalable Formulation to Control Pharmacokinetic Behavior2020

    • Author(s)
      佐藤 秀行
    • Journal Title

      YAKUGAKU ZASSHI

      Volume: 140 Issue: 11 Pages: 1305-1312

    • DOI

      10.1248/yakushi.20-00144

    • NAID

      130007933493

    • ISSN
      0031-6903, 1347-5231
    • Year and Date
      2020-11-01
    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Journal Article] Polymeric Nanocarriers With Mucus-Diffusive and Mucus-Adhesive Properties to Control Pharmacokinetic Behavior of Orally Dosed Cyclosporine A2020

    • Author(s)
      Sato Hideyuki、Kaneko Yuuki、Yamada Kohei、Ristroph Kurt D.、Lu Hoang D.、Seto Yoshiki、Chan Hak-Kim、Prud’homme Robert K.、Onoue Satomi
    • Journal Title

      Journal of Pharmaceutical Sciences

      Volume: 109 Issue: 2 Pages: 1079-1085

    • DOI

      10.1016/j.xphs.2019.10.043

    • Related Report
      2020 Research-status Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Design and Characterizations of Inhalable Poly(lactic-co-glycolic acid) Microspheres Prepared by the Fine Droplet Drying Process for a Sustained Effect of Salmon Calcitonin2020

    • Author(s)
      Sato Hideyuki、Tabata Aiko、Moritani Tatsuru、Morinaga Tadahiko、Mizumoto Takahiro、Seto Yoshiki、Onoue Satomi
    • Journal Title

      Molecules

      Volume: 25 Issue: 6 Pages: 1311-1311

    • DOI

      10.3390/molecules25061311

    • Related Report
      2020 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] 薬物の経粘膜吸収制御と吸収予測2022

    • Author(s)
      山田幸平,Ristroph K. D., 上林敦,佐藤秀行,Wu W., Chan H-K., Prud’homme R. K., 尾上誠良
    • Organizer
      日本薬学会第 142 年会
    • Related Report
      2022 Research-status Report
  • [Presentation] 吸入剤の体内動態予測:Cyclosporine A 含有粉末吸入剤の開発と体内動態予測モデルの適用性検討2022

    • Author(s)
      山田幸平,上林敦,佐藤秀行,尾上誠良
    • Organizer
      日本薬剤学会第 37 年会
    • Related Report
      2022 Research-status Report
  • [Presentation] Polyethylene glycol 修飾脂質を用いた固体脂質ナノ粒子によるCyclosporine A の経口吸収性改善2022

    • Author(s)
      佐藤秀行,寺尾龍哉,中澤明日香,Robert K. Prud'homme,山田幸平,尾上誠良
    • Organizer
      日本薬剤学会第 37 年会
    • Related Report
      2022 Research-status Report
  • [Presentation] 大腸炎の炎症部位への薬物集積を指向した cyclosporine A 封入粘液透過性ナノ粒子2022

    • Author(s)
      井上侑樹,中澤明日香,安達大貴,水元隆博,Robert K. Prud’homme,山田幸平,佐藤秀行,尾上誠良
    • Organizer
      第 38 回日本 DDS 学会年会
    • Related Report
      2022 Research-status Report
  • [Presentation] Cyclosporine A の炎症性腸疾患への応用を指向した粘液透過性ナノ粒子の開発2022

    • Author(s)
      井上侑樹,中澤明日香,安達大貴,水元隆博,Robert K. Prud’homme,山田幸平,佐藤秀行,尾上誠良
    • Organizer
      日本薬学会東海支部
    • Related Report
      2022 Research-status Report
  • [Presentation] Polyethylene glycol 修飾脂質を用いた Solid lipid nanoparticle による Cyclosporine A の経口吸収性制御2021

    • Author(s)
      寺尾 龍哉,中澤 明日香,Robert K. Prud’homme,山田 幸平,佐藤 秀行,尾上 誠良
    • Organizer
      第 141 回日本薬学会
    • Related Report
      2021 Research-status Report
  • [Presentation] Mucosal drug delivery system を基盤とした Cyclosporine A の経粘膜吸収性制御2021

    • Author(s)
      山田 幸平,Ristroph K.D.,Lu H.D.,Wu W.,Chan H-K.,Prud’homme R.K.,佐藤 秀行,尾上 誠良
    • Organizer
      日本薬学会東海支部
    • Related Report
      2021 Research-status Report
  • [Presentation] Flash NanoPrecipitation 法を応用したナノ粒子設計による薬物動態制御2021

    • Author(s)
      佐藤 秀行
    • Organizer
      製剤機械技術学会 第 29 回 講演会
    • Related Report
      2021 Research-status Report
  • [Presentation] 印刷工学技術を応用した粒子設計による Tobramycin 多孔性吸入粉末製剤の開発2021

    • Author(s)
      奥村 逸希,森谷 樹,森永 匡彦,佐藤 祐一,小番 昭宏,山田 幸平,佐藤 秀行,尾上 誠良
    • Organizer
      第 29 回 DDS カンファレンス
    • Related Report
      2021 Research-status Report
  • [Presentation] Flash nanoprecipitation 法を基盤とする薬物の消化管吸収制御を指向した Mucosal drug delivery system の開発2020

    • Author(s)
      9.山田 幸平,Kurt D. Ristroph,Hoang D. Lu,世戸 孝樹,Wei Wu,Hak-Kim Chan,Robert. K. Prud’homme,佐藤 秀行,尾上 誠良
    • Organizer
      日本薬剤学会第 35 年会
    • Related Report
      2020 Research-status Report
  • [Presentation] Fine droplet drying 工法による cyclosporine A 含有ナノ粒子の吸入製剤設計2020

    • Author(s)
      11.中澤 明日香,森谷 樹,森永 匡彦,佐藤 祐一,小番 昭宏,世戸 孝樹,佐藤 秀行,尾上 誠良
    • Organizer
      日本薬剤学会第 35 年会
    • Related Report
      2020 Research-status Report
  • [Presentation] Fine droplet drying 工法による cyclosporine A 含有ナノ粒子の吸入製剤設計2020

    • Author(s)
      10.中澤 明日香,森谷 樹,森永 匡彦,佐藤 祐一,小番 昭宏,世戸 孝樹,佐藤 秀行,尾上 誠良
    • Organizer
      第 36 回 日本 DDS 学会学術集会
    • Related Report
      2020 Research-status Report
  • [Presentation] PHARMACOKINETIC CONTROL OF CYCLOSPORINE A EMPLOYING POLYMERIC NANOCARRIERS DESIGNED BY FLASH NANOPRECIPITATION2020

    • Author(s)
      11.Hideyuki Sato, Yuuki Kaneko, Kurt D Ristroph, Hoang D Lu, Hak-Kim Chan, Robert K Prud’homme, Kohei Yamada, Satomi Onoue
    • Organizer
      第 57 回 ペプチド討論会
    • Related Report
      2020 Research-status Report
  • [Patent(Industrial Property Rights)] 脂質ナノ粒子を含有する粒子及びその製造方法2020

    • Inventor(s)
      尾上誠良、佐藤秀行、森谷樹
    • Industrial Property Rights Holder
      静岡県公立大学法人,株式会社リコー
    • Industrial Property Rights Type
      特許
    • Industrial Property Number
      2020-088154
    • Filing Date
      2020
    • Related Report
      2020 Research-status Report

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Published: 2020-04-28   Modified: 2025-01-30  

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