Development of new formulations of thiamazole and levothyroxine as hospital preparation

2021 Fiscal Year Final Research Report

• Project/Area Number: 18K14952
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 47060:Clinical pharmacy-related
• Research Institution: University of Shizuoka
• Principal Investigator: KASHIWAGURA YASUHARU 静岡県立大学, 薬学部, 講師 (70746403)
• Project Period (FY): 2018-04-01 – 2022-03-31
• Keywords: レボチロキシン / 院内製剤 / クリーム製剤 / テープ製剤 / フォーム製剤

Outline of Final Research Achievements

In this study, we prepared cream and tape formulations containing levothyroxine with the aim of developing transdermal formulations for the treatment of hypothyroidism as alternatives to oral formulations. In addition, we aimed to develop a foam formulation of levothyroxine that would be easier to swallow for patients with dysphagia. Our results indicate that formulations of cream and tape containing levothyroxine could be prepared, and their in vitro skin permeability could be evaluated. A new dosage form, a foam formulation, was also developed. We were able to clarify the formulation characteristics of these new dosage forms.

Free Research Field

医療系薬学

Academic Significance and Societal Importance of the Research Achievements

レボチロキシン製剤は主に経口製剤（錠剤および散剤）を用いた薬物治療が行われているが、嚥下困難な高齢者や小児では服薬できないことで治療に支障をきたすことがある。近年発売された注射剤があるが、侵襲性による痛みを伴い、かつ自己投与できないために在宅で使用できないなどの問題点がある。本研究では甲状腺機能低下症患者のレボチロキシンによる在宅での治療を見据えた投与剤形の開発であり、患者の病態に合わせた治療薬の剤形選択の幅を広げることが期待できる。