Abrahmsén-Alami Susanna, Körner Anna, Nilsson Ingvar, Larsson Anette
AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden.
Int J Pharm. 2007 Sep 5;342(1-2):105-14. doi: 10.1016/j.ijpharm.2007.05.005. Epub 2007 May 13.
A small release cell, in the form of a rotating disc, has been constructed to fit into the MRI equipment. The present work show that both qualitative and quantitative information of the swelling and erosion behavior of hydrophilic extended release (ER) matrix tablets may be obtained using this release cell and non-invasive magnetic resonance imaging (MRI) studies at different time-points during matrix dissolution. The tablet size, core size and the gel layer thickness of ER matrix formulations based on poly(ethylene oxide) have been determined. The dimensional changes as a function of time were found to correspond well to observations made with texture analysis (TA) methodology. Most importantly, the results of the present study show that both the erosion (displacement of the gel-dissolution media interface) and the swelling (decrease of dry tablet core size) proceed with a faster rate in radial than in axial direction using the rotating disk set-up. This behavior was attributed to the higher shear forces experienced in the radial direction. The results also indicate that front synchronization (constant gel layer thickness) is associated with the formation of an almost constant polymer concentration profile through the gel layer at different time-points.
一种呈旋转盘形式的小型释放池已被制造出来,以适配磁共振成像(MRI)设备。目前的研究表明,使用这种释放池以及在基质溶解过程中的不同时间点进行非侵入性磁共振成像(MRI)研究,可以获得亲水性缓释(ER)基质片剂溶胀和侵蚀行为的定性和定量信息。基于聚环氧乙烷的ER基质制剂的片剂尺寸、芯部尺寸和凝胶层厚度已被确定。发现尺寸随时间的变化与用质地分析(TA)方法所做的观察结果非常吻合。最重要的是,本研究结果表明,使用旋转盘装置时,侵蚀(凝胶 - 溶解介质界面的位移)和溶胀(干片剂芯部尺寸的减小)在径向方向上的进行速率比轴向方向更快。这种行为归因于在径向方向上经历的更高剪切力。结果还表明,前沿同步(恒定的凝胶层厚度)与在不同时间点通过凝胶层形成几乎恒定的聚合物浓度分布有关。