顶部尺寸对USP II帆船装置溶解档案的影响
Hiroyuki Yoshida1, Tokio Morita2, Yasuhiro Abe2
1Division of Drugs, National Institute of Health Sciences, 3-25-26, Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa, 210-9501, Japan. h.yoshida@nihs.go.jp.
AAPS PharmSciTech
|December 29, 2023
概括
顶级容器可以通过减少形来改善溶解测试,但它们的有效性取决于配方. 低的顶峰高度提供了解决效果,尽管溶解改进因配方特性而异.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 分析化学 分析化学
背景情况:
- 在溶解测试中,结合是常见的问题,可能会影响药物释放的准确性.
- 已经提出了顶级容器以减轻化,但它们对溶解概况的影响需要详细调查.
研究的目的:
- 为了研究不同顶部容器大小对容易结的配方溶解行为的影响.
- 确定使用顶峰船的最佳条件,以增强溶解测试的歧视力.
主要方法:
- 使用了五个高度和中心度不同的顶峰容器,以及综合性容器.
- 用不同密度的标准颗粒测量轮旋转速度,以获得圆分辨率.
- 在30-100rpm时对普得尼松,阿托瓦斯塔丁水合物和勒沃弗洛克萨辛配方进行溶解试验.
主要成果:
- 阿佩克斯容器以较低的速度解决了化,而不是综合性容器,颗粒集中在中心.
- 大多数配方的溶解速率随着顶峰高度的增加而增加,除了50rpm的阿托瓦斯塔丁.
- 降低速度 (30rpm) 改善了levofloxacin在综合容器中的溶解;顶部中心度变化的影响最小.
结论:
- 顶级容器,特别是低高度的容器,可以有效地解决溶解测试中的圆现象.
- 溶解改善的程度取决于配方,突出了需要量身定制的方法.
- 了解配方特征对于优化顶部容器使用和保持歧视性溶解测试至关重要.
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