药典仪器旋转盘的内在溶解率建模与流通道方法相比
Amelie M Mattusch1, Gerhard Schaldach1, Jens Bartsch1
1Department of Biochemical and Chemical Engineering, TU Dortmund University, Germany.
Pharmaceutical development and technology
|March 19, 2024
概括
旋转盘装置中的溶解测试错误是由不均的流量引起的. 使用流通道或纠正旋转盘数据可以提高药物开发的内在溶解率准确度.
科学领域:
- 制药科学 制药科学
- 化学工程是化学工程的重要组成部分.
- 物理化学 物理化学
背景情况:
- 精确的体外溶解速度测量对于了解药物特性至关重要.
- 水力动力学被认为是影响药物溶解的主要因素.
- 旋转盘装置是溶解测试的常见方法.
研究的目的:
- 为了研究旋转盘装置中的混合行为对内在溶解速率测量的影响.
- 为了识别和量化溶解速率计算中的系统错误,由于不均的流量场.
- 为更准确的溶解测试提出替代方法或纠正.
主要方法:
- 使用旋转盘装置和流通道进行实验.
- 执行计算流体动力学 (CFD) 模拟来分析流场.
- 分析实验时间和流体速度对溶解速率的影响.
- 开发用于旋转磁盘数据的校正方法.
主要成果:
- 旋转盘装置产生不均的流场,导致内部溶解率计算中的系统错误.
- 实验时间和流体速度都显著影响观察到的误差.
- 一个具有均溢出的流通道将这些错误最小化.
- 建议使用雷诺兹数和校正因子将旋转盘数据与流通道数据进行比较和调整的方法.
结论:
- 由于其水力动力学,标准的旋转盘装置可以在内在溶解率测量中引入重大错误.
- 对于更可靠的溶解行为调查,建议使用流通道装置.
- 调整后的旋转盘测量结果可以与流通道结果进行比较.
- 在各种温度下建模器件独立的内在溶解速率是可行的,使用适应的方程.
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