Bechard S R, Down G R
Merck Frosst Centre for Therapeutic Research, Pharmaceutical R&D, Quebec, Canada.
Pharm Res. 1992 Apr;9(4):521-8. doi: 10.1023/a:1015896414765.
The goal of this study was to use infrared thermography as a new technique to investigate the heat released during compaction and consolidation of pharmaceutical powders and granules. Real-time temperature measurements without physical contact with tablets were provided by a highly sensitive (+/- 0.1 degrees C at 30 degrees C) infrared camera (Agema Infrared Systems, Model 470 with CM-SOFT software). High-resolution images were captured at the takeoff point, i.e., less than 1 sec after compaction, stored on floppy disks, and then analyzed on a regular PC equipped with a VGA color monitor. Thermal surface profiles of tablets were obtained with high geometric and temperature resolution. Reproducibility of the camera readouts was better than 3%. The model granulation used was a direct compression blend of microcrystalline cellulose, spray-dried lactose, and magnesium stearate. This blend was compressed using an instrumented Korsch PH106 rotary press fitted with 1 station of 19.1 x 7.9-mm (0.750 x 0.312-in.) capsule-shaped tools. The effects of compaction force (6-20 kN), rate (130- to 360-msec contact time), and lubricant level (0.5 and 1.0%) on postcompaction temperature rise, caused by heat released during compaction, were investigated. The presence and location of nonhomogeneous heat distribution were assessed as well. Results have shown that the heat released during compaction increases with compaction force. Tablet surface temperatures of 33.8 +/- 0.7 degrees C were observed at 20 kN compaction force in contrast to 29.5 +/- 0.3 degrees C at 6.7 kN.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究的目的是使用红外热成像技术作为一种新技术,来研究药物粉末和颗粒在压实和固结过程中释放的热量。一台高灵敏度(30℃时为±0.1℃)的红外热像仪(阿格玛红外系统公司,型号470,配备CM-SOFT软件)可在不与片剂进行物理接触的情况下进行实时温度测量。在片剂压实后不到1秒的起飞点采集高分辨率图像,存储在软盘上,然后在配备VGA彩色显示器的普通个人电脑上进行分析。以高几何分辨率和温度分辨率获得片剂的热表面轮廓。热像仪读数的重现性优于3%。所使用的模型颗粒是微晶纤维素、喷雾干燥乳糖和硬脂酸镁的直接压片混合物。使用配备了1个19.1×7.9毫米(0.750×0.312英寸)胶囊形工具工位的Korsch PH106型仪器化旋转压片机对该混合物进行压制。研究了压实力(6 - 20 kN)、速率(130至360毫秒接触时间)和润滑剂水平(0.5%和1.0%)对压实过程中释放的热量导致的压实后温度升高的影响。还评估了非均匀热分布的存在和位置。结果表明,压实过程中释放的热量随压实力增加。在20 kN压实力下观察到片剂表面温度为33.8±0.7℃,而在6.7 kN时为29.5±0.3℃。(摘要截选至250字)