Konkel P, Mielck J B
Abteilung für Pharmazeutische Technologie, Institut für Pharmazie, Universität Hamburg, Germany.
Eur J Pharm Biopharm. 1998 Mar;45(2):137-48. doi: 10.1016/s0939-6411(98)00020-4.
A series of modern direct-compression excipients with differing mechanisms of deformation and densification, Karion Instant Pharma, Vivacel 200, Cellactose, Tablettose, and Parmcompress, after admixing magnesium stearate, have been tabletted (400 mg, 10 mm flat-faced punches) on an eccentric machine, Fette E XI at 43.6 rpm, and on a rotary machine, Fette PT 2090 at 20, 60, and 90 rpm, to graded maximum forces (3, 5, 10, 15 kN, respectively). Force/time (E XI and PT 2090) and displacement/time (E XI) curves were recorded. From the data on the E XI, parameters of a modified Weibull function, slopes of the Heckel function, quotients of partial areas under the curves, and the differences between times of maximum forces and the respective maximum densifications, t(diff), were calculated. From the data on the PT 2090, partial areas under the curves for the upper punch, various quotients of these areas, and the peak-offset times, t(off), the times of maximum force relative to the middle of the dwell time, t(dwell), were calculated. Close associations were found between the area A1 reI during the precompression phase (PT 2090) and the Heckel slope (E XI), between the quotient of partial areas before and after the middle of t(dwell) (PT 2090) and that of partial areas before and after maximum densification (E XI), and between t(off) (PT 2090) and t(diff) (E XI). However, certain materials (e.g. Karion Instant, Vivacel) showed marked deviations in behavior by particular parameters on the two machines. The results from both machines with respect to densification behavior complement one another.
一系列具有不同变形和致密化机制的现代直接压片辅料,即Karion Instant Pharma、Vivacel 200、Cellactose、Tablettose和Parmcompress,在与硬脂酸镁混合后,已在偏心式压片机(Fette E XI,转速43.6 rpm)和旋转式压片机(Fette PT 2090,转速分别为20、60和90 rpm)上压片(400 mg,10 mm平面冲头),达到分级的最大压力(分别为3、5、10、15 kN)。记录了力/时间(E XI和PT 2090)以及位移/时间(E XI)曲线。根据E XI的数据,计算了修正韦布尔函数的参数、赫克尔函数的斜率、曲线下部分面积的商以及最大力时间与相应最大致密化时间之间的差值t(diff)。根据PT 2090的数据,计算了上冲头曲线下的部分面积、这些面积的各种商以及峰偏移时间t(off),即相对于保压时间t(dwell)中间时刻的最大力时间。发现在预压阶段(PT 2090)的相对面积A1 reI与赫克尔斜率(E XI)之间、t(dwell)中间时刻前后的部分面积商(PT 2090)与最大致密化前后的部分面积商(E XI)之间以及t(off)(PT 2090)与t(diff)(E XI)之间存在密切关联。然而,某些物料(如Karion Instant、Vivacel)在两台机器上的特定参数表现出明显的行为偏差。两台机器关于致密化行为的结果相互补充。