Study of the pseudo-crystalline transformation from form 1 to form 2 of thiamine hydrochloride (vitamin B1)
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- Masuda Katsuhiko
- Department I, Medicinal Chemistry Research Laboratory I, Research Division, Mitsubishi Tanabe Pharma Corporation
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- Ishige Takayuki
- Department I, Medicinal Chemistry Research Laboratory I, Research Division, Mitsubishi Tanabe Pharma Corporation
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- Yamada Hiroyuki
- CMC Research Center, Mitsubishi Tanabe Pharma Corporation
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- Fujii Kotaro
- Department of Chemistry and Materials Science, Tokyo Institute of Technology
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- Uekusa Hidehiro
- Department of Chemistry and Materials Science, Tokyo Institute of Technology
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- Miura Keiko
- Industrial Application Division, Japan Synchrotron Radiation Research Institute
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- Yonemochi Etsuo
- School of Pharmaceutical Sciences, Toho University
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- Terada Katsuhide
- School of Pharmaceutical Sciences, Toho University
書誌事項
- タイトル別名
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- Study of the Pseudo-Crystalline Transformation from Form I to Form II of Thiamine Hydrochloride (Vitamin B1)
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The purpose of the current study was to evaluate the rate of the pseudo-crystalline transformation of thiamine hydrochloride form I to form II depending on the temperature and humidity. Changes in the appearance and weight of form I crystals were observed under humidified conditions using a water vapor sorption system equipped with a CCD camera. The form I crystals and tablets were stored under various temperature and humidity conditions (the saturation salt desiccator method), and the pseudo-crystalline transformation was observed using X-ray powder diffractometry with our laboratory equipment for drug substances and using synchrotron X-ray powder diffractometry for tablets. It was confirmed that the activation energy in the pseudo-crystalline transformation rate from form I to form II was dependent on humidity, and the calculated values were 121—155 kJ/mol at 70—90% relative humidity. Moreover, when thiamine hydrochloride was formulated as tablets, it was confirmed that the transformation rate was slower compared with the drug substances alone. The pseudo-crystalline transformation rate therefore declined after formulation in tablet form, perhaps due to the shielding effects of thiamine hydrochloride crystal from contact with water molecules by excipients, compaction, etc.
収録刊行物
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- CHEMICAL & PHARMACEUTICAL BULLETIN
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CHEMICAL & PHARMACEUTICAL BULLETIN 59 (1), 57-62, 2011
公益社団法人 日本薬学会
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詳細情報 詳細情報について
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- CRID
- 1390001204174099200
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- NII論文ID
- 130000405489
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- NII書誌ID
- AA00602100
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- ISSN
- 13475223
- 00092363
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- NDL書誌ID
- 10926956
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- NDL
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