在药物片的分解过程中对热量释放的热量测量研究
Jongmin Lee1, Daniel J Goodwin2, Ranjit M Dhenge3
1Department of Chemical Engineering and Biotechnology, University of Cambridge, Philippa Fawcett Drive, Cambridge CB3 0AS, UK.
International journal of pharmaceutics
|June 9, 2024
概括
这项研究引入了一种新的热量计方法来分析药片分解,超越了简单的通过/失败结果. 热量计揭示了平板电脑孔隙度和分解率之间的直接相关性,提供了更深入的配方见解.
科学领域:
- 制药科学 制药科学
- 物理化学 物理化学
- 材料科学 材料科学 材料科学
背景情况:
- USP701分解试验为即时释放片提供了二进制结果.
- 这种方法缺乏对解体过程的机械洞察力.
- 需要使用定量方法来评估药片分解动态.
研究的目的:
- 开发和验证一种新的热量计方法来分析药片分解.
- 为超越传统方法的局限性提供全面的工艺概况.
- 通过热量测量来研究平板电脑的孔隙性和分解动力学之间的关系.
主要方法:
- 开发一个定制的分解反应热量计.
- 在安慰剂片 (MCC,无水乳糖,CCS,MgSt) 的分解过程中监测热释放.
- 对度变化概况的分析和与平板电脑孔隙度的相关性.
主要成果:
- 热量计方法成功监测了分解过程中的热释放.
- 在较高的平板电脑孔隙度和较短的升温时间 (更快的分解) 之间观察到直接相关性.
- 与外热事件一起,确定了一种归因于无水乳糖溶解的内热过程.
结论:
- 热量测量分析提供了一种敏感的定量方法,用于评估药片分解.
- 该方法可以根据平板电脑的孔隙性来辨别分解速度的差异.
- 热量计显示了量化湿透性和优化药片配方的潜力.
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