Pharmaceutical Studies of Levothyroxine Sodium Hydrate Suppository Provided as a Hospital Preparation
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- Hamada Yuhei
- Department of Practical Pharmacy, Faculty of Pharmaceutical Sciences, Chiba University
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- Masuda Kazushi
- Department of Practical Pharmacy, Graduate School of Pharmaceutical Sciences, Chiba University Division of Pharmacy, University Hospital, Chiba University School of Medicine
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- Okubo Masato
- Department of Practical Pharmacy, Graduate School of Pharmaceutical Sciences, Chiba University Division of Pharmacy, University Hospital, Chiba University School of Medicine
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- Nakasa Hiromitsu
- Division of Pharmacy, University Hospital, Chiba University School of Medicine
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- Sekine Yuko
- Department of Practical Pharmacy, Graduate School of Pharmaceutical Sciences, Chiba University
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- Ishii Itsuko
- Division of Pharmacy, University Hospital, Chiba University School of Medicine Department of Clinical Pharmacology, Graduate School of Pharmaceutical Sciences, Chiba University
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Abstract
The levothyroxine sodium hydrate suppository (L-T4-suppository) is provided as a hospital preparation for the treatment of hypothyroid patients with dysphagia in Japan because only oral preparations of levothyroxine sodium (L-T4) are approved for the treatment of hypothyroidism. However, it has been found that serum thyroxine and triiodothyronine levels do not increase as expected with the hospital preparation, requiring a higher dosage of L-T4 in the L-T4-suppository than in the oral preparations. In this study, to determine an effective thyroid gland hormone-replacement therapy for patients with dysphagia, the pharmaceutical properties of the L-T4-suppository were investigated. Suppositories containing 300 µg L-T4 in a base of Witepsol H-15 and Witepsol E-75 (ratio of 1 : 1) were prepared according to Chiba University Hospital’s protocol. Content uniformity, stability, and suppository release were tested. The L-T4-suppository had uniform weight and content. The content and release property were stable over 90 d when the L-T4-suppository was stored at 4°C and protected from light. The release rate of L-T4 increased as pH increased. However, no L-T4 was released below pH 7.2. The release rate of L-T4 decreased as temperature decreased. These findings suggest that the low level of release of L-T4 in the rectum under physiological conditions may be the cause of the low serum thyroxine and triiodothyronine levels following L-T4-suppository administration.
Journal
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- Biological and Pharmaceutical Bulletin
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Biological and Pharmaceutical Bulletin 38 (4), 625-628, 2015
The Pharmaceutical Society of Japan
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Keywords
Details 詳細情報について
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- CRID
- 1390001204631854336
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- NII Article ID
- 130005062267
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- NII Book ID
- AA10885497
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- ISSN
- 13475215
- 09186158
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- NDL BIB ID
- 026283644
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- PubMed
- 25832643
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- Text Lang
- en
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- Data Source
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
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- Abstract License Flag
- Disallowed