New Jersey Institute of Technology, Otto H. York Department of Chemical and Materials Engineering, Newark, NJ 07102-1982, USA.
United States Pharmacopeial Convention (USP), Dosage Form Performance Laboratory (DFPL), Rockville, MD 20852-1790, USA.
Int J Pharm. 2023 Nov 25;647:123492. doi: 10.1016/j.ijpharm.2023.123492. Epub 2023 Oct 6.
Changes to hydrodynamics arising from changes within dissolution testing systems, such as the fill volume level, can potentially cause variability in dissolution results. However, the literature on hydrodynamics in Apparatus 1 is quite limited and little information is available for vessels with different liquid volumes. Here, velocities in a USP Apparatus 1 vessel with a liquid fill volume of 500 mL, a common alternative to 900 mL, were experimentally measured using 2D-2C Particle Image Velocimetry (PIV) for different basket rotational speeds. Tangential velocities dominated the flow field, while axial and radial velocities were much lower and varied with location. The velocities distribution increased proportionately with the basket rotational speed almost everywhere in the vessel excepting for underneath the basket. A nearly horizontal radial liquid jet was found to originate close to the basket upper edge. Comparison of these results with those previously reported with 900-mL liquid volume (Sirasitthichoke et al., Intern. J. Pharmaceutics:X; 3 (2021) 100078) showed that the flow rate through the baskets was similar in both systems, implying that, at least initially, the amount of drug in solution would increase linearly with time. In other words, the flow rate through the baskets would be independent of the liquid volume. Velocity profiles were also found to be similar, except in the region above the basket, which was affected by the radial jet with an orientation significantly different between the 500-mL and the 900-mL systems.
由于溶解测试系统内部的变化(如填充体积水平)引起的流体动力学变化可能会导致溶解结果的变异性。然而,关于 1 号仪器中的流体动力学的文献相当有限,对于具有不同液体体积的容器,可用的信息很少。在这里,使用二维-二维粒子图像测速法(2D-2C PIV)实验测量了 USP 1 号仪器中填充体积为 500 毫升的容器中的速度,这是 900 毫升的常见替代方案,对于不同的篮筐旋转速度。切向速度主导流场,而轴向和径向速度较低,且随位置变化。除了篮筐下方,速度分布几乎在容器的各个位置都与篮筐的旋转速度成比例增加。发现一个几乎水平的径向液体射流起源于靠近篮筐上边缘。将这些结果与之前报道的 900 毫升液体体积(Sirasitthichoke 等人,国际制药杂志:X;3(2021)100078)进行比较表明,两个系统中的篮筐通过的流量相似,这意味着,至少在最初阶段,溶液中的药物量将随时间线性增加。换句话说,篮筐通过的流量将与液体体积无关。速度分布也被发现是相似的,除了在篮筐上方的区域,该区域受到径向射流的影响,而 500 毫升和 900 毫升系统之间的方向明显不同。