A New Approach to Dissolution Testing by UV Imaging and Finite Element Simulations
A New Approach to Dissolution Testing by UV Imaging and Finite Element Simulations
复制标题
DOI：
10.1007/s11095-013-0972-0
复制
发表时间：
2013-05-01
影响因子：
3.7
通讯作者：
Jensen, Henrik
中科院分区：
文献类型：
--
作者：
Boetker, Johan P.;Rantanen, Jukka;Jensen, Henrik
大多数溶解测试系统依赖于在时间分辨率较差的不同时间点从溶解样品表面远距离地分析样品，因此提供了关于溶解过程的相对未分辨的时间和空间信息。在这项研究中，一个灵活的数值模型与一种新型的紫外成像系统相结合，能够以亚秒级的分辨率监测溶出过程，通过收集流出物和对扑热息痛进行紫外成像来监测溶出过程。利用有限元模型对紫外光成像系统进行了分析，成功地建立了紫外光成像系统的有限元模型。用紫外成像法和流出物分析法研究了扑热息痛的溶出度。从收集的出水中得到的溶解速率与数值模型符合得很好。该数值模型可以评估紫外线成像仪测量溶解时间分布的能力。结合有限元、实验溶出数据和紫外成像，对有限元模型进行了实验验证，并对溶出过程进行了详细的描述。
Most dissolution testing systems rely on analyzing samples taken remotely from the dissolving sample surface at different time points with poor time resolution and therefore provide relatively unresolved temporally and spatially information on the dissolution process. In this study, a flexible numerical model was combined with a novel UV imaging system, allowing monitoring of the dissolution process with sub second time resolution.The dissolution process was monitored by both effluent collection and UV imaging of compacts of paracetamol. A finite element model (FEM) was used to characterize the UV imaging system.A finite element model of the UV imaging system was successfully built. The dissolution of paracetamol was studied by UV imaging and by analysis of the effluent. The dissolution rates obtained from the collected effluent were in good agreement with the numerical model. The numerical model allowed an assessment of the ability of the UV imager to measure dissolution-time profiles. The simulation was able to extend the experimental results to conditions not easily obtained experimentally.Combining FEM,experimental dissolution data and UV imaging provided experimental validation of the FEM model as well as a detailed description of the dissolution process.