徐放性プロゲステロン膣坐剤<br/>─第3報：院内製剤の開発と臨床評価─

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タイトル別名
  • Sustained-Release Progesterone Vaginal Suppositories 3<br/>—Development and Clinical Feasibility Testing—
  • 徐放性プロゲステロン膣坐剤(第3報)院内製剤の開発と臨床評価
  • ジョホウセイ プロゲステロンチツザザイ(ダイ3ポウ)インナイ セイザイ ノ カイハツ ト リンショウ ヒョウカ

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抄録

  Although progesterone vaginal suppositories (hospital-formulated) are used for the treatment of infertility, their half-life is so short that multiple doses are required. In this study, we aimed to develop sustained-release vaginal suppositories suitable for clinical use which maintain an effective blood concentration by once-a-day treatment, and prepared 7 types of suppository containing the sustained-release progesterone tablets to characterize their sustained-release performance. We selected one candidate suppository among them, taking recovery rate, reproducibility, and hardness, as well as the sustained-release performance into consideration. The shell of the selected suppository is composed of VOSCO S-55 and progesterone for rapid release. The molded progesterone tablets for sustained release were embedded inside. The distribution of the weight and content of the suppository was limited, and the release rate of progesterone was significantly slower than that of a conventional progesterone suppository prepared in our hospital. The single-dose administration of the selected suppository to five healthy volunteers led to significant extension of the blood concentration. We also confirmed the rise of the basic value by multiple administration. The simulation comparison suggested that the blood progesterone concentration is controlled by once-a-day administration of the selected suppository better than twice-a-day administration of the conventional suppository. In conclusion, the sustained-release vaginal suppository prepared in this study was considered to be useful for clinical treatment.<br>

収録刊行物

  • 薬学雑誌

    薬学雑誌 133 (6), 727-736, 2013

    公益社団法人 日本薬学会

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