Juuti Mikko, van Veen Bert, Peiponen Kai-Erik, Ketolainen Jarkko, Kalima Valtteri, Silvennoinen Raimo, Pakkanen Tuula T
Department of Physics, University of Joensuu, PO Box 111, FI-80101, Joensuu, Finland.
Orion Pharma R&D, Orion Corporation, PO Box 425, FI-20101, Turku, Finland.
AAPS PharmSciTech. 2006 Mar;7(1):E43-E48. doi: 10.1208/pt070107. Epub 2017 Mar 8.
The purpose of this study was to detect local gloss and surface structure changes of sodium chloride tablets. The changes in surface structure were reflected by gloss variation, which was measured using a diffractive optical element-based gloss-meter (DOG). By scanning a surface area, we constructed a 2-dimensional gloss map that characterized the tablet's surface structure. The gloss variation results were compared with scanning electron microscopy (SEM) images and average surface roughness values that were measured by conventional diamond stylus profilometry. The profilometry data showed a decrease in tablet surface roughness as a function of compression force. In general, a smoother surface contributes to higher average gloss values. The average gloss values for this material, in contrast, showed a decrease as a function of the compression force. The sequence of particle fragmentation and deformation together with crack formation in sodium chloride particles resulted in a loss of gloss for single sodium chloride particles at the tablet surfaces, which could be detected by the DOG. These results were supported by the SEM images. The results show that detailed information regarding tablets' surface structure changes can be obtained by detection of local gloss variation and average gloss.
本研究的目的是检测氯化钠片剂的局部光泽度和表面结构变化。表面结构的变化通过光泽度变化来反映，光泽度使用基于衍射光学元件的光泽度仪（DOG）进行测量。通过扫描一个表面积，我们构建了一个二维光泽度图，该图表征了片剂的表面结构。将光泽度变化结果与扫描电子显微镜（SEM）图像以及通过传统金刚石触针轮廓仪测量的平均表面粗糙度值进行比较。轮廓仪数据显示片剂表面粗糙度随压缩力的增加而降低。一般来说，表面越光滑，平均光泽度值越高。相比之下，这种材料的平均光泽度值随压缩力的增加而降低。氯化钠颗粒的颗粒破碎、变形以及裂纹形成的过程导致片剂表面单个氯化钠颗粒的光泽度丧失，这可以通过DOG检测到。SEM图像支持了这些结果。结果表明，通过检测局部光泽度变化和平均光泽度，可以获得有关片剂表面结构变化的详细信息。
