Sirasitthichoke Chadakarn, Perivilli Satish, Liddell Mark R, Armenante Piero M
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 X. 2021 May 4;3:100078. doi: 10.1016/j.ijpx.2021.100078. eCollection 2021 Dec.
The USP Apparatus 1 (basket apparatus) is commonly used to evaluate the dissolution performance of oral solid dosage forms. The hydrodynamics generated by the basket contributes, in general, to the dissolution rate and hence the dissolution results. Here, the hydrodynamics of Apparatus 1 was quantified in a vessel filled with 900-mL de-ionized water at room temperature by determining, via Particle Image Velocimetry (PIV), the velocity profiles on a vertical central plane and on 11 horizontal planes at different elevations at three different basket agitation speeds. The flow field was dominated by the tangential velocity component and was approximately symmetrical in all cases. Despite all precautions taken, small flow asymmetries were observed in the axial and radial directions. This appears to be an unavoidable characteristic of the flow in Apparatus 1. The magnitudes of the axial and radial velocity components varied with location but were always low. A small jet was seen emanating radially near the top edge of the basket. Velocities typically scaled well with increasing agitation speed in most regions of the vessel except for a region directly below the basket. The results of this work provide a major insight into the flow field inside the USP Apparatus 1.
美国药典装置1(篮式装置)通常用于评估口服固体剂型的溶出性能。一般来说,篮式装置产生的流体动力学对溶出速率有影响,进而影响溶出结果。在此,通过粒子图像测速技术(PIV)测定在室温下装有900 mL去离子水的容器中,篮式装置在三种不同搅拌速度下垂直中心平面以及11个不同高度水平面上的速度分布,对装置1的流体动力学进行了量化。流场以切向速度分量为主,在所有情况下大致对称。尽管采取了所有预防措施,但在轴向和径向上仍观察到小的流动不对称性。这似乎是装置1中流动不可避免的一个特征。轴向和径向速度分量的大小随位置而变化,但始终较低。在篮式装置顶部边缘附近可看到有一小股径向射流。除了篮式装置正下方的区域外,在容器的大多数区域,速度通常随搅拌速度的增加而良好地变化。这项工作的结果为深入了解美国药典装置1内部的流场提供了重要依据。