Evaluation of acceptability and palatability of orally disintegrating tablets

2019 Fiscal Year Final Research Report

• Project/Area Number: 17K08454
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: University of Shizuoka
• Principal Investigator: Namiki Noriyuki 静岡県立大学, 薬学部, 教授 (90514563)
• Co-Investigator(Kenkyū-buntansha): 内田 信也 静岡県立大学, 薬学部, 准教授 (80372522) ; 柏倉 康治 静岡県立大学, 薬学部, 講師 (70746403) ; 田中 紫茉子 静岡県立大学, 薬学部, 助教 (10559925)
• Project Period (FY): 2017-04-01 – 2020-03-31
• Keywords: 口腔内崩壊錠 / 電子味覚システム / 味マスキング / アドヒアランス

Outline of Final Research Achievements

In this study, we aimed to develop the novel evaluation methods of palatability of orally disintegrating tablets (ODTs). We examined the in vitro short dissolution test methods for amlodipine ODTs with different levels of physical masking, and the results were compared to those obtained from in vivo study with in the human volunteers. oral cavity. Our results indicate that the Tricorptester method was the most preferable of all in vitro tests. In addition, this study showed that the combination methods of the in vitro short dissolution test methods and an electronic gustatory system (α-Astree e-Tongue) could be quantitatively predict the effect of taste masking on the palatability of amlodipine ODTs.

Free Research Field

臨床製剤学

Academic Significance and Societal Importance of the Research Achievements

本研究の成果により、in vitro溶出試験法であるトリコープテスタ法と電子味覚システムを組み合わせた新たな評価法を用い，OD錠の味マスキング効果評価する方法を開発することができた。さらに，本評価方法は様々な薬物のOD錠への適用の可能性も示唆された。本研究により効率的にOD錠の服用性を評価することが可能になり、製剤開発における応用が期待できる