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):369-75. doi: 10.1081/pdt-100101372.
The purpose of this study was to investigate the influence of engravings on the sticking of tablets. Therefore, an instrumented upper punch capable of measuring the pull-off force, which occurs when the punch detaches itself from the upper surface of a tablet, was equipped with small cones of different angles between the punch face and the cones' lateral face. The cones could be screwed into a threaded hole at the center of the punch face. The adhesion forces of two formulations known to stick to engravings during production increased with a greater steepness of the cones' lateral face. With microencapsulated acetylsalicylic acid, no quantitative differences could be found between the adhesion forces obtained with plain and modified punch faces, indicating that the sticking behavior of the substance was not affected by shear forces. Starch 1500 showed higher adhesion force signals in comparison to those obtained with a plain punch face. Microcrystalline cellulose, which gave no adhesion force signals with a plain punch face and did not stick to the cones, showed distinct pull-off signals. The instrumented upper punch equipped with shear cones is a valuable instrument for detecting the adhesion caused by engravings and is therefore a helpful tool for tablet formulation development and the design optimization of tablet identification.
本研究的目的是调查刻痕对片剂黏附性的影响。因此,配备了一个能够测量冲头从片剂上表面分离时产生的拉脱力的仪器化上冲头,在冲头表面和圆锥体侧面之间设置了不同角度的小圆锥体。这些圆锥体可以拧入冲头表面中心的螺纹孔中。已知在生产过程中会黏附在刻痕上的两种制剂的黏附力随着圆锥体侧面坡度的增大而增加。对于微囊化乙酰水杨酸,在普通冲头表面和改良冲头表面获得的黏附力之间未发现定量差异,这表明该物质的黏附行为不受剪切力的影响。与普通冲头表面相比,淀粉1500显示出更高的黏附力信号。微晶纤维素在普通冲头表面未产生黏附力信号且不黏附在圆锥体上,但显示出明显的拉脱信号。配备剪切圆锥体的仪器化上冲头是检测由刻痕引起的黏附的有价值工具,因此是片剂配方开发和片剂标识设计优化的有用工具。