Usefulness of time-domain NMR as a monitoring tool for pharmaceutical process analytical technology

2022 Fiscal Year Final Research Report

• Project/Area Number: 20K06986
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 47020:Pharmaceutical analytical chemistry and physicochemistry-related
• Research Institution: University of Toyama
• Principal Investigator: Onuki Yoshinori 富山大学, 薬学部, 客員教授 (10350224)
• Project Period (FY): 2020-04-01 – 2023-03-31
• Keywords: 製剤 / 錠剤 / NMR緩和 / 結晶状態評価 / 水分量測定

Outline of Final Research Achievements

The main purpose of this research is to demonstrate the usefulness of TD-NMR for evaluating characteristics of pharmaceuticals. Time domain NMR (TD-NMR) is a promising NMR method to evaluate NMR relaxometry. It enables rapid and easy measurement of the T1 and T2 relaxation times, NMR parameters reflecting the molecular mobility of the substances. To achieve the research purpose, this research project performed the following TD-NMR studies: (1) to characterize the crystalline state of active pharmaceutical ingredients, and (2) to quantify the water content in pharmaceutical ingredients and wet granules. Consequently, it was confirmed that TD-NMR has a strong potential to be applied in the characterization of pharmaceuticals as a novel analytical method.

Free Research Field

製剤学

Academic Significance and Societal Importance of the Research Achievements

分子運動性という新たな視点で製剤物性を評価できるTD-NMRは、既存の技術とは一線を画す有望な分析技術である。本研究課題では、事例研究を通して、製剤物性評価における有用性を明らかにした。現時点では、製剤分野でのTD-NMRの応用例は極めて少ないものの、本課題の成果によって、錠剤の製造工程や最終製品の品質管理など、様々な場面での適用が期待され、製剤物性評価技術の更なる発展に寄与すると考えられる。