Laksmana F L, Van Vliet L J, Hartman Kok P J A, Vromans H, Frijlink H W, Van der Voort Maarschalk K
Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, A. Deusinglaan 1, 9713 AV, Groningen, The Netherlands.
Pharm Res. 2009 Apr;26(4):965-76. doi: 10.1007/s11095-008-9805-y. Epub 2008 Dec 16.
This study aims to develop a characterization method for coating structure based on image analysis, which is particularly promising for the rational design of coated particles in the pharmaceutical industry.
The method applies the MATLAB image processing toolbox to images of coated particles taken with Confocal Laser Scanning Microscopy (CSLM). The coating thicknesses have been determined along the particle perimeter, from which a statistical analysis could be performed to obtain relevant thickness properties, e.g. the minimum coating thickness and the span of the thickness distribution. The characterization of the pore structure involved a proper segmentation of pores from the coating and a granulometry operation.
The presented method facilitates the quantification of porosity, thickness and pore size distribution of a coating. These parameters are considered the important coating properties, which are critical to coating functionality. Additionally, the effect of the coating process variations on coating quality can straight-forwardly be assessed.
Enabling a good characterization of the coating qualities, the presented method can be used as a fast and effective tool to predict coating functionality. This approach also enables the influence of different process conditions on coating properties to be effectively monitored, which latterly leads to process tailoring.
本研究旨在开发一种基于图像分析的包衣结构表征方法，该方法在制药行业包衣颗粒的合理设计方面具有特别广阔的前景。
该方法将MATLAB图像处理工具箱应用于通过共聚焦激光扫描显微镜（CSLM）拍摄的包衣颗粒图像。沿颗粒周长确定包衣厚度，据此可进行统计分析以获得相关厚度特性，例如最小包衣厚度和厚度分布范围。孔隙结构的表征涉及从包衣中正确分割孔隙以及粒度分析操作。
所提出的方法有助于对包衣的孔隙率、厚度和孔径分布进行量化。这些参数被视为重要的包衣特性，对包衣功能至关重要。此外，可直接评估包衣工艺变化对包衣质量的影响。
所提出的方法能够很好地表征包衣质量，可作为预测包衣功能的快速有效工具。这种方法还能够有效监测不同工艺条件对包衣性能的影响，进而实现工艺调整。
