Method for the Evaluation of the Stability and Usability after Opening Packages of Orally Disintegrating Tablets: Case of Amlodipine Besilate Products

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  • HORI Katsuhito
    Cancer Education and Research Center, Hamamatsu University School of Medicine Department of Hospital Pharmacy, Hamamatsu University School of Medicine
  • YOSHIDA Naoko
    Department of Hospital Pharmacy, Hamamatsu University School of Medicine Drug Management and Policy, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
  • OKUMURA Tomonori
    Pharmaceutical Development Department, Sawai Pharmaceutical Co., Ltd.
  • OKAMURA Yasufumi
    Pharmaceutical Development Department, Sawai Pharmaceutical Co., Ltd.
  • KAWAKAMI Junichi
    Department of Hospital Pharmacy, Hamamatsu University School of Medicine

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Other Title
  • 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
  • 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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Abstract

  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>

Journal

  • YAKUGAKU ZASSHI

    YAKUGAKU ZASSHI 130 (8), 1029-1040, 2010-08-01

    The Pharmaceutical Society of Japan

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