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Development of novel prediction method for intestinal absorption of a drug from supersaturated state

Research Project

Project/Area Number 15K18946
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Medical pharmacy
Research InstitutionHiroshima International University

Principal Investigator

Tanaka Yusuke  広島国際大学, 薬学部, 助教 (10435068)

Project Period (FY) 2015-04-01 – 2018-03-31
Project Status Completed (Fiscal Year 2017)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2017: ¥390,000 (Direct Cost: ¥300,000、Indirect Cost: ¥90,000)
Fiscal Year 2016: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2015: ¥3,250,000 (Direct Cost: ¥2,500,000、Indirect Cost: ¥750,000)
Keywords過飽和溶解 / 消化管吸収 / 難溶解性薬物 / 消化管内薬物濃度 / 過飽和 / 塩 / 溶解
Outline of Final Research Achievements

The aim of this study is to clarify the key factors to determine oral absorption of supersaturated drugs, and applying the knowledge to in vitro predictive methodology and/or physiologically based pharmacokinetic model.
In the case of study using cinnarizine, it was clarified that the re-dissolution was key process for the intestinal absorption. Also, since cinnarizine rapidly precipitated in the duodenum, different supersaturation stabilities in different doses observed in in vitro precipitation experiment was not reflected to in vivo absorption. The study using pioglitazone revealed that the absorbed amount of a supersaturated drug is determined by the balance between the absorption and precipitation rate in the GI tract, and therefore there is possibility that precipitation process may be overestimated if evaluated in a closed dissolution system.
We believe that our findings are of significance in the development of an ideal PBPK model and in vitro predictive dissolution tool.

Report

(4 results)
  • 2017 Annual Research Report   Final Research Report ( PDF )
  • 2016 Research-status Report
  • 2015 Research-status Report
  • Research Products

    (6 results)

All 2017 2016

All Journal Article (3 results) (of which Peer Reviewed: 2 results,  Acknowledgement Compliant: 1 results) Presentation (3 results)

  • [Journal Article] In vivo analysis of supersaturation/precipitation/absorption behavior after oral administration of pioglitazone hydrochloride salt; determinant site of oral absorption.2017

    • Author(s)
      Tanaka Y, Sugihara M, Kawakami A, Imai S, Itou T, Murase H, Saiki K, Kasaoka S, Yoshikawa H.
    • Journal Title

      Eur J Pharm Sci.

      Volume: 106 Pages: 431-438

    • DOI

      10.1016/j.ejps.2017.06.011

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed
  • [Journal Article] 消化管内における難溶解性薬物の過飽和溶解挙動の評価2017

    • Author(s)
      田中佑典
    • Journal Title

      PHARMSTAGE

      Volume: 17 Pages: 25-28

    • Related Report
      2017 Annual Research Report
  • [Journal Article] In vivo evaluation of supersaturation/precipitation/re-dissolution behavior of cinnarizine, a lipophilic weak base, in the gastrointestinal tract: the key process of oral absorption.2017

    • Author(s)
      Tanaka Y, Kawakami A, Nanimatsu A, Horio M, Matsuoka J, Wada T, Kasaoka S, Yoshikawa H.
    • Journal Title

      Eur J Pharm Sci.

      Volume: 1 Pages: 464-471

    • Related Report
      2016 Research-status Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Presentation] 消化管内における難溶解性薬物の過飽和溶解挙動の評価2016

    • Author(s)
      田中佑典
    • Organizer
      日本薬剤学会第7回経口吸収FG合宿討論会
    • Place of Presentation
      KKRホテル熊本
    • Year and Date
      2016-12-15
    • Related Report
      2016 Research-status Report
  • [Presentation] 消化管におけるCinnarizineの過飽和/析出/再溶解挙動の評価:その吸収におけるKey Process2016

    • Author(s)
      田中佑典,川上彩花,何松亜美,堀尾実咲,松岡純平,和田貴美,笠岡敏,吉川広之
    • Organizer
      第22回創剤フォーラム若手研究会
    • Place of Presentation
      就実大学
    • Year and Date
      2016-11-26
    • Related Report
      2016 Research-status Report
  • [Presentation] 消化管内における弱塩基性薬物シンナリジンの過飽和/析出挙動2016

    • Author(s)
      田中佑典、川上彩花、何松亜美、堀尾実咲、和田貴美、笠岡敏、吉川広之
    • Organizer
      日本薬剤学会第31年会
    • Place of Presentation
      長良川国際会議場および岐阜都ホテル
    • Year and Date
      2016-05-18
    • Related Report
      2016 Research-status Report

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Published: 2015-04-16   Modified: 2019-03-29  

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