Stability of Nilvadipine Solid Dispersion Tablet with Non-Packaging Condition

  • HIRASAWA Noriyuki
    <i>Research and Development Center, Nichi-iko Pharmaceutical Co., Ltd.</i>
  • ISHISE Sayoko
    <i>Research and Development Center, Nichi-iko Pharmaceutical Co., Ltd.</i>
  • MIYATA Hitomi
    <i>Research and Development Center, Nichi-iko Pharmaceutical Co., Ltd.</i>

Bibliographic Information

Other Title
  • ニルバジピン固体分散体錠の無包装状態での安定性
  • ニルバジピン コタイ ブンサンタイジョウ ノ ムホウソウ ジョウタイ デ ノ アンテイセイ

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Description

  Nilvadipine (NIL) solid-dispersion tablets were stored counter to packaging instructions by exposing them to 40°C, 25°C, 75% relative humidity, and light. The dissolution, stability assay, and tablet properties (weight, thickness and hardness) were then examined. NIL dissolved more than 85% after all storage periods with exposure to high temperature and humidity. Powder X-ray diffraction analysis indicated that NIL was present in an amorphous state as in the initialstate. The stability assay of NIL showed that it was more than 99% stable during all storage periods when exposed to temperature, humidity, and light, indicating good stability. Tablet properties were influenced by humidity more than by temperature, and the hardness of tablets decreased with time to 42.9 N after storage of 3 months.

Journal

  • YAKUGAKU ZASSHI

    YAKUGAKU ZASSHI 124 (1), 19-23, 2004-01-01

    The Pharmaceutical Society of Japan

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