Nonclinical Approaches to Determining the Acceptability of Breastfeeding in the Pharmacotherapy of Lactating Women

2023 Fiscal Year Final Research Report

• Project/Area Number: 21K12764
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 90140:Medical technology assessment-related
• Research Institution: Setsunan University
• Principal Investigator: Komori koji 摂南大学, 薬学部, 准教授 (60611598)
• Project Period (FY): 2021-04-01 – 2024-03-31
• Keywords: 乳汁移行性 / 周産期薬物治療 / 母乳育児 / ヒト乳腺上皮細胞

Outline of Final Research Achievements

In the field of perinatal pharmacotherapy, where clinical trials are challenging, information on the transfer of drugs into breast milk is insufficient. The aim of this study is to evaluate drugs using a non-clinical approach that combines In vivo tests with mice and In vitro tests with human mammary epithelial cells. During the grant period, we tested L-theanine, for which there was no information on milk transfer, and edoxaban, for which there was limited information on milk transfer in humans. The results suggested that the transfer of these two drugs into breast milk is likely to be low.

Free Research Field

医薬品評価学、臨床薬理学

Academic Significance and Societal Importance of the Research Achievements

トランスポーターの発現や乳汁の組成の違いから、マウスなどげっ歯類での乳汁移行性に関する情報は、ヒトでの移行性を評価するのに有用性が低いとされてきたが、ヒト乳腺上皮細胞の透過性と組み合わせて評価する本研究成果は、動物実験の結果に対する類似点や差異を明確に出来るなど学術的意義は大きい。また、本研究で得られた医薬品の乳汁移行性に関する結果は、授乳婦の薬物治療において、母乳育児と薬物治療の葛藤を解消できるため、社会的意義は極めて大きい。