Particle diffusional layer thickness in a USP dissolution apparatus II: a combined function of particle size and paddle speed.
Particle diffusional layer thickness in a USP dissolution apparatus II: a combined function of particle size and paddle speed.
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USP 溶出度仪 II 中的颗粒扩散层厚度：颗粒尺寸和桨速度的组合函数。
DOI：
10.1002/jps.21345
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发表时间：
2008
影响因子：
3.8
通讯作者：
Amidon,GordonL
中科院分区：
文献类型：
--
作者：
Sheng,JenniferJ;Sirois,PaulJ;Dressman,JenniferB;Amidon,GordonL
本工作旨在研究USP溶出仪II中粒度和桨速对颗粒扩散层厚度h app的影响。通过对非诺贝特< 20、20-32、32-45、63-75和90-106 μm五种粒径的粉末溶出速率的测定，本工作表明，h app对粒径的依赖性随桨速的不同而遵循不同的函数。在50 rpm下，h app的函数最好通过h app= 9.91 d− 23.31（R 2= 0.98）的线性图来描述，在整个粒径d范围内，从6.8到106 µm。相比之下，在100 rpm时，存在23.7 µm的过渡颗粒半径r，在此情况下，出现线性关系h app= 1.59 r（R2 = 0.98），但在此之上，h app变为43.5 µm的常数。因此，h app不仅随粒径变化，而且还随标准USP配置下的流体力学变化，这在过去被忽视。此外，使用无量纲分析将粒度和桨速对h app的影响组合。在一定的流体速度/颗粒状态下，h app/d与雷诺数（d/v）1/2的平方根呈线性相关，即h app/d= 1.5207− 9.25× 10− 4（d/v）1/2（R2 = 0.9875）。
This work was to investigate the effects of particle size and paddle speed on the particle diffuisonal layer thickness h app in a USP dissolution apparatus II. After the determination of the powder dissolution rates of five size fractions of fenofibrate, including< 20, 20–32, 32–45, 63–75, and 90–106 µm, the present work shows that the dependence of h app on particle size follows different functions in accordance with the paddle speed. At 50 rpm, the function of h app is best described by a linear plot of h app= 9.91 d− 23.31 (R 2= 0.98) throughout the particle diameter, d, from 6.8 to 106 µm. In contrast, at 100 rpm a transitional particle radius, r, of 23.7 µm exists, under which linear relationship h app= 1.59r (R 2= 0.98) occurs, but above which h app becomes a constant of 43.5 µm. Thus, h app changes not only with particle size, but also with the hydrodynamics under standard USP configurations, which has been overlooked in the past. Further, the effects of particle size and paddle speed on h app were combined using dimensionless analysis. Within certain fluid velocity/particle regime, linear correlation of h app/d with the square‐root of Reynolds number (d ϖ/υ) 1/2, that is, h app/d= 1.5207− 9.25× 10− 4 (d ϖ/ν) 1/2 (R 2= 0.9875), was observed.