Nano-technology base drug development for oral mucositis pain caused by anticancer therapy

2023 Fiscal Year Final Research Report

• Project/Area Number: 20K07186
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 47060:Clinical pharmacy-related
• Research Institution: Showa University
• Principal Investigator: Momo Kenji 昭和大学, 薬学部, 准教授 (30645552)
• Project Period (FY): 2020-04-01 – 2024-03-31
• Keywords: がん / 口腔粘膜炎 / 口内炎 / 副作用 / 院内製剤 / 製剤 / 医薬品開発 / 病院薬局製剤

Outline of Final Research Achievements

In Japan, there are no locally applicable medications for pain caused by oral mucositis (stomatitis). Therefore, this study conducted a clinical trial to evaluate the efficacy and safety of a 0.25% indomethacin spray, a topical formulation for oral application. We demonstrated that this formulation had a significant effect compared to a placebo. Additionally, a novel preparation method was devised using commercially available oral indomethacin products, enabling easy formulation of the mouth wash at hospital pharmacies. The stability of the formulation was assessed, and its efficacy and safety were evaluated through the application to patients. Furthermore, an epidemiological analysis using medical big data was conducted to identify the needs for the desired formulation and to clarify the background of patients who would benefit from this preparation.

Free Research Field

院内製剤

Academic Significance and Societal Importance of the Research Achievements

癌治療の副作用として発症する口腔粘膜炎は、激しい疼痛を伴い、その痛みのために癌治療自体を中止せざるを得ない状況となる。我が国にはこのような口腔粘膜炎の疼痛緩和のための医薬品は存在せず、課題であった。本研究では、湿布剤などで広く使用されている鎮痛薬であるインドメタシンを主成分として口腔内に局所適応する新規製剤を開発した。ヒトにおいて安全性試験においても安全性が確認され、重篤な口腔粘膜炎を有する患者に対しても適応が期待できる。