Effect of Heat Transfer in the Packages on the Stability of Thiamine Nitrate under Uncontrolled Temperature Conditions

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  • Nakamura Toru
    Department of Pharmaceutics, Hoshi University Oral Liquid Formulation, R&D Laboratories, Self Medication Business, Taisho Pharmaceutical Company, Ltd.
  • Yamaji Takayuki
    Oral Liquid Formulation, R&D Laboratories, Self Medication Business, Taisho Pharmaceutical Company, Ltd.
  • Takayama Kozo
    Department of Pharmaceutics, Hoshi University

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Other Title
  • 非等温環境でのチアミン硝化物の安定性に及ぼす熱伝導と包装容器の影響
  • ヒトウオン カンキョウ デ ノ チアミンショウカブツ ノ アンテイセイ ニ オヨボス ネツ デンドウ ト ホウソウ ヨウキ ノ エイキョウ

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Abstract

  To accurately predict the stability of thiamine nitrate as a model drug in pharmaceutical products under uncontrolled temperature conditions, the average reaction rate constant was determined, taking into account the heat transfer from the atmosphere to the product. The stability tests of thiamine nitrate in the three packages with different heat transfers were performed under non-isothermal conditions. The stability data observed were compared with the predictions based on a newly developed method, showing that the stability was well predicted by the method involving the heat transfer. By contrast, there were some deviations observed from the predicted data, without considering heat transfer in the packages with low heat transfer. The above-mentioned result clearly shows that heat transfer should be considered to ensure accurate prediction of the stability of commercial pharmaceutical products under non-isothermal atmospheres.<br>

Journal

  • YAKUGAKU ZASSHI

    YAKUGAKU ZASSHI 133 (12), 1411-1415, 2013-12-01

    The Pharmaceutical Society of Japan

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