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Development of a mianserin suppository for patients with delirium and depression who cannot take it orally

Research Project

Project/Area Number 16K18958
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Medical pharmacy
Research InstitutionShowa University

Principal Investigator

Nawata Shuichi  昭和大学, 薬学部, 講師 (10744386)

Project Period (FY) 2016-04-01 – 2020-03-31
Project Status Completed (Fiscal Year 2019)
Budget Amount *help
¥2,340,000 (Direct Cost: ¥1,800,000、Indirect Cost: ¥540,000)
Fiscal Year 2018: ¥130,000 (Direct Cost: ¥100,000、Indirect Cost: ¥30,000)
Fiscal Year 2017: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2016: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Keywordsせん妄 / 抑うつ / 経口摂取困難 / ミアンセリン / 坐剤 / 薬物動態 / 高齢者 / ミアンセリン坐剤 / 薬物動態試験 / 臨床薬物動態 / 在宅医療
Outline of Final Research Achievements

There is a limited number of drugs available for patients with depression and delirium that are difficult to administer orally. Therefore, we developed a mianserin suppositories that is expected to be effective for both symptoms. Based on the pharmacokinetics of the suppositories in healthy adult males, we concluded that the suppository has the potential for clinical application.
Therefore, in the present study, we further investigated the pharmacokinetics of the suppository in the elderly, who are often used in practice. The pharmacokinetics were studied in three healthy elderly adult males. The results showed that a single 20 mg dose had a slow increase in blood concentration. Based on these results, it was concluded that the efficacy and safety of the drug should be ensured by starting at 20 mg, and increasing the dose as the clinical effect of the drug is monitored. It was suggested that it could be done.

Academic Significance and Societal Importance of the Research Achievements

経口投与が困難な患者に対して、服用していた錠剤を粉砕して基剤と混合し、坐剤として投与する方法は、従来より行われてきた。しかし、坐剤として投与した際の薬物動態の検討が行われるケースは少ない。また、吸収促進を目的に医薬品以外の基剤が使用されるケースも多く、日常臨床への応用が困難なケースが多く見受けられる。
今回、我々は、ミアンセリン錠を粉砕して医薬品の基剤と混合しただけの坐剤において、若年成人と高齢成人での薬物動態の違いを明らかにした。特に高齢成人での坐剤の薬物動態に関する研究報告は、ほとんどなく、今後の坐剤開発においても有益な情報を社会に発信できたと考えらる。

Report

(5 results)
  • 2019 Annual Research Report   Final Research Report ( PDF )
  • 2018 Research-status Report
  • 2017 Research-status Report
  • 2016 Research-status Report
  • Research Products

    (3 results)

All 2019 2017

All Journal Article (1 results) (of which Peer Reviewed: 1 results) Presentation (2 results)

  • [Journal Article] Clinical Pharmacokinetics of Mianserin Suppositories in Healthy Older Japanese Male Adults:A Pilot Study2019

    • Author(s)
      D.Ichikura, S.Nawata, N. Kohyama, M.Tokunaga, N.Hida, T.Yamazaki, S.Takenoshita, N.Uchida, A.Minemura, T.Sasaki
    • Journal Title

      Jpn J Clin Pharmacol ther.

      Volume: 52 Pages: 23-30

    • Related Report
      2018 Research-status Report
    • Peer Reviewed
  • [Presentation] 経口投与困難な患者対象のミアンセリン坐剤開発に向けた若年・高齢成人の薬物動態2019

    • Author(s)
      縄田 修一
    • Organizer
      第57回日本癌治療学会学術集会
    • Related Report
      2019 Annual Research Report
  • [Presentation] 日本人健康高齢男性におけるミアンセリン坐剤の臨床薬物動態試験2017

    • Author(s)
      縄田 修一、市倉 大輔
    • Organizer
      第27回日本医療薬学会年会
    • Related Report
      2017 Research-status Report

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Published: 2016-04-21   Modified: 2021-02-19  

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