Formulating Ibuprofen Gargle for Longer Lasting Effect and Lower User Discomfort

2022 Fiscal Year Final Research Report

• Project/Area Number: 19K16413
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 47060:Clinical pharmacy-related
• Research Institution: Kobe University
• Principal Investigator: Ioroi Takeshi 神戸大学, 医学部附属病院, 薬剤師 (40789343)
• Project Period (FY): 2019-04-01 – 2023-03-31
• Keywords: イブプロフェン / 含嗽剤

Outline of Final Research Achievements

In the practical application of ibuprofen gargle, it's necessary to develop a formulation that extends its duration of action and reduces discomfort during use. Therefore, a reevaluation and reconsideration of the manufacturing process was undertaken. We considered strategies such as adding high molecular weight gelling agents or local anesthetics to extend the effect duration, but these were discarded due to challenges, including the sterilization process of the formulation. To reduce the sensation of use, we decided to make a gargle without preservatives, opting for a sterile preparation.
A placebo-controlled trial was conducted to evaluate the efficacy and safety of the ibuprofen gargle in patients undergoing lower third molar extraction. However, the primary endpoint of analgesia was not met.

Free Research Field

臨床薬理学

Academic Significance and Societal Importance of the Research Achievements

本研究では、イブプロフェン含嗽剤の作用時間延長と使用感の改善を目指した製剤化に取り組んだことにより、新たな製剤開発の視点を提供しています。しかし、一部の滅菌工程における問題が明らかになったことは、製剤化における課題について再考させられる結果となりました。一方、臨床試験において、主要評価項目である疼痛緩和効果が認められなかったことは、対象者の選定方針や評価方法を考慮する上での制約などを踏まえて、新規製剤開発の難しさを示す結果となりました。しかしながら、この結果は今後の研究の参考になると考えております。