Stability and Evaluation of Sustained-release Isosorbide Dinitrate Preparations
スポンサーリンク
概要
- 論文の詳細を見る
The characteristics such as weight variations, hardness, drug content, release properties and the conservation stability of three commercial sustained-release formulations(Nitrol-R^<[O!R]>, NTR ; Frandol^<[O!R]>, FRD ; Nitrol^<[O!R]>, NT) of isosorbide dinitrate were determined. NTR and FRD showed the sustained-release properties with the release rate of NTR being higher than that of FRD. These preparations were maintained under five conditions that are based on the composite experimental design composing the temperature and the humidity. NTR was softened by humidity to a greater extent than FRD. The weight of NTR tended to increase under proportion to the humidity. The hardness of FRD was increased in the conditions of high temperature and low humidity. This phenomenon can be explained by the fact that the melted wax in the tablet penetrated the gaps and hardened after cooling. The contents of NTR remained constant against the rise in temperature and humidity ; it was assumed that the capsule worked to protect the inner granules. During the 14-day stability test, the residual rate of isosorbide dinitrate was predicted by multiple regression analysis and the results are illustrated three-dimensionally. The predicted residual rate of isosorbide dinitrate on NTR and FRD agreed well with the experimental data. The release profiles of these sustained-release preparations were influenced by both temperature and humidity. Guaranteed quality and efficacy of the preparations by hospital pharmacists is required for proper medical treatment.
- 日本医療薬学会の論文
- 1996-08-10
著者
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SHIROTAKE Shoichi
Department of Pharmacy, Yokohama City University Hospital
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SUZUKI YOSHITAKA
Department of Cardiovascular Surgery, Teikyo University School of Medicine
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Shirotake Shoichi
Department Of Pharmaceutics And Biopharmaceutics Showa Pharmaceutical University
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ICHISAWA MASAYUKI
Department of Pharmacy, Yokohama City University Hospital
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Ichisawa Masayuki
Department Of Pharmacy Yokohama City University Hospital
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Iwata Masanori
Department Of Obstetrics And Gynecology St. Marianna University School Of Medicine Tohyoko Hospitall
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Shiraishi Shuji
Department Of Pharmaceutics And Biopharmaceutics Showa Pharmaceutical University
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Suzuki Yoshitaka
Department Of Pharmacy Yokohama City University Hospital
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Suzuki Yoshitaka
Department Of Cardiovascular Surgery Teikyo University School Of Medicine
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