Chemiluminescence Method for Evaluation of Photooxidative Degradation of Dispensed Drugs: A Possible New Drug Information Item

2023 Fiscal Year Final Research Report

• Project/Area Number: 20K07182
• 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: Tohoku Medical and Pharmaceutical University
• Principal Investigator: Murai Yuriko 東北医科薬科大学, 薬学部, 教授 (70209998)
• Project Period (FY): 2020-04-01 – 2024-03-31
• Keywords: 医薬品の品質 / 医薬品の安定性 / 化学発光測定法 / 光酸化 / 酸化劣化 / 後発医薬品 / 調剤薬 / 一包化調剤

Outline of Final Research Achievements

Drug information about stability after dispensing is extremely limited. To obtain such information, the weak chemiluminescence (CL) measurement method that can detect oxidative degradation was investigated.
With the duration of storage exposed to light after one-dose packaging, the tablets and granules showed an increase in CL, which is thought to be due to photooxidation caused by light exposure. CL increased even when no changes in color were detected by naked eye examination. It was suggested that this method could be used to sensitively evaluate the degradation of drugs caused by photooxidation. CL was seen on the light-exposed surfaces of tablets. Using the CL method, it was possible to visually capture the photooxidation of the tablet surface for the first time.
It is worth continuing this research with CL method to explore the possibility that it can be applied in clinical settings as a new stability assessment index for drugs.

Free Research Field

医療薬学

Academic Significance and Societal Importance of the Research Achievements

従来、調剤後の薬剤の変化・変質を検出する手法は、主成分を中心に単独か2～3剤混合系での検討がほとんどだが、CL法は製剤丸ごとの酸化劣化を評価できる。迅速・簡便なCL測定法により調剤薬の安定性情報が得られれば、より安定な調剤薬を患者に届けることができ、変質による健康被害や廃棄、無駄な調剤行為を避けられるなど、この研究成果による医療への波及効果も考えられる。従来安定性データは文字情報中心だが、本法は画像情報を与えるもので、その点も新しい。また、CL発光プロファイルの比較から製剤への異物混入を検出できることが示唆される。医薬品や錠剤タイプの機能性表示食品等の新規評価法や品質管理への展開が期待される。