Waimer F, Krumme M, Danz P, Tenter U, Schmidt P C
Department of Pharmaceutical Technology, Eberhard-Karls-University Tübingen, Germany.
Pharm Dev Technol. 1999 Aug;4(3):359-67. doi: 10.1081/pdt-100101371.
The purpose of this work was to develop an instrumented upper punch to measure the adhesion force which occurs when the punch detaches itself from the upper surface of the tablet after compression. A specially designed adhesion force sensor instrumented with semiconductor strain gauges was inserted into an upper punch with a 25-mm punch face diameter suitable for a Korsch EK II eccentric press. Sorbitol, microencapsulated acetylsalicylic acid (ASA), and a formulation of a new active ingredient resulted in characteristic pull-off signals, providing a quantitative measure of the adhesion force. With "sticking-free" substances such as microcrystalline cellulose, tension signals could not be obtained; only Starch 1500 showed small adhesion force signals that indicated a sticking tendency. The compression force had a specific influence on the extent of the adhesion force; increasing the compression force caused an increase (sorbitol) or a decrease (ASA) of the adhesion force signals due to the plastic and elastic behavior of the substances. Depending on running time, ASA showed an increase in the adhesion force, reaching a plateau after 150 tablets. The addition of lubricants such as magnesium stearate resulted in smaller adhesion forces. The instrumented upper punch is a new helpful tool for the quantification of sticking and a valuable instrument in the development of formulations.
这项工作的目的是开发一种带有仪器的上冲头，以测量在压片后冲头从片剂上表面分离时产生的粘附力。一个特别设计的、装有半导体应变片的粘附力传感器被插入到一个冲头面直径为25毫米、适用于科施EK II偏心压力机的上冲头中。山梨醇、微囊化乙酰水杨酸（ASA）以及一种新活性成分的制剂产生了特征性的剥离信号，提供了粘附力的定量测量。对于微晶纤维素等“无粘性”物质，无法获得张力信号；只有淀粉1500显示出小的粘附力信号，表明有粘附倾向。压缩力对粘附力的大小有特定影响；由于物质的塑性和弹性行为，增加压缩力会导致粘附力信号增加（山梨醇）或减少（ASA）。根据运行时间，ASA的粘附力会增加，在压制150片后达到平稳状态。添加硬脂酸镁等润滑剂会使粘附力变小。带有仪器的上冲头是用于量化粘附的一种新型有用工具，也是制剂开发中的一种有价值仪器。
