口腔内崩壊錠の無包装での安定性と使用性に関する評価法：アムロジピンベシル酸塩製剤を用いた検討

DOI Web Site Web Site 被引用文献5件 参考文献4件
  • 堀 雄史
    浜松医科大学がん教育研究センター 浜松医科大学医学部附属病院薬剤部
  • 吉田 直子
    浜松医科大学医学部附属病院薬剤部 金沢大学医薬保健研究域薬学系国際保健薬学
  • 奥村 友則
    沢井製薬株式会社製剤研究部
  • 岡村 康史
    沢井製薬株式会社製剤研究部
  • 川上 純一
    浜松医科大学医学部附属病院薬剤部

書誌事項

タイトル別名
  • Method for the Evaluation of the Stability and Usability after Opening Packages of Orally Disintegrating Tablets: Case of Amlodipine Besilate Products
  • コウクウ ナイ ホウカイジョウ ノ ムホウソウ デ ノ アンテイセイ ト シヨウセイ ニ カンスル ヒョウカホウ アムロジピンベシル サンエン セイザイ オ モチイタ ケントウ

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抄録

  Orally disintegrating (OD) tablets are widely used in clinical practice. However, drug information on the choice and dispensing based on their stability after opening packages and usability in patients and dispensaries is not sufficient. The aim of this study was to investigate possible evaluation methods of the stability and usability of amlodipine OD tablets. Additives of the brand were changed in April 2009, and therefore the previous and current forms and two generics, current and newly marketed (in November 2009) products of different firms, were used. OD tablets were stored at 25°C and 75% relative humidity for 3 months after opening the packages, and their physicochemical properties were evaluated. Their weight, diameter, thickness, and color difference increased slightly from the initial state. The extent of the change in their hardness, disintegration time, and friability was different among products. These physicochemical changes were acceptable in dispensary practice. Storage after opening the packages did not affect their dissolution rate. The dissolution rate at the initial state of the current brand was slower than that of the previous one. All products used were able to be dispensed by an automatic tablet-packing machine and applied to the so-called simple suspension method for intubational administration. Sensory evaluation tests revealed no major difference in the oral disintegration time, taste, impression, and preference among products. In conclusion, the stability and usability of amlodipine OD tablets used in this study were examined using several methods, and they can be used equivalently from the stability and usability viewpoints.<br>

収録刊行物

  • 薬学雑誌

    薬学雑誌 130 (8), 1029-1040, 2010-08-01

    公益社団法人 日本薬学会

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