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Monitoring tablet surface roughness during the film coating process

机译:在薄膜包衣过程中监控药片表面粗糙度

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摘要

The purpose of this study was to evaluate the change of surface roughness and the development of the film during the film coating process using laser profilometer roughness measurements, SEM imaging, and energy dispersive X-ray (EDX) analysis. Surface roughness and texture changes developing during the process of film coating tablets were studied by noncontact laser profilometry and scanning electron microscopy (SEM). An EDX analysis was used to monitor the magnesium stearate and titanium dioxide of the tablets. The tablet cores were film coated with aqueous hydroxypropyl methylcellulose, and the film coating was performed using an instrumented pilot-scale side-vented drum coater. The SEM images of the film-coated tablets showed that within the first 30 minutes, the surface of the tablet cores was completely covered with a thin film. The magnesium signal that was monitored by SEM-EDX disappeared after ∼15 to 30 minutes, indicating that the tablet surface was homogeneously covered with film coating. The surface roughness started to increase from the beginning of the coating process, and the increase in the roughness broke off after 30 minutes of spraying. The results clearly showed that the surface roughness of the tablets increased until the film coating covered the whole surface area of the tablets, corresponding to a coating time period of 15 to 30 minutes (from the beginning of the spraying phase). Thereafter, the film only became thicker. The methods used in this study were applicable in the visualization of the changes caused by the film coating on the tablet surfaces.
机译:这项研究的目的是使用激光轮廓仪粗糙度测量,SEM成像和能量色散X射线(EDX)分析来评估涂膜过程中表面粗糙度的变化和膜的发展。通过非接触激光轮廓仪和扫描电子显微镜(SEM)研究了薄膜包衣片剂在加工过程中表面粗糙度和纹理变化。用EDX分析监测片剂的硬脂酸镁和二氧化钛。将片剂核心用羟丙基甲基纤维素水溶液进行薄膜包衣,并使用仪器化的中试侧通气式鼓包衣机进行薄膜包衣。薄膜包衣片剂的SEM图像显示,在最初的30分钟内,片剂核心的表面完全被薄膜覆盖。在约15至30分钟后,由SEM-EDX监测的镁信号消失,表明片剂表面被薄膜包衣均匀覆盖。从涂覆过程开始,表面粗糙度开始增加,并且在喷涂30分钟后,粗糙度的增加就停止了。结果清楚地表明,直到薄膜包衣覆盖片剂的整个表面积为止,片剂的表面粗糙度增加,这对应于15至30分钟的涂覆时间段(从喷雾阶段开始)。此后,膜仅变厚。本研究中使用的方法适用于可视化片剂表面上的薄膜包衣引起的变化。

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