Amidon G E, Smith D P, Hiestand E N
J Pharm Sci. 1981 Jun;70(6):613-7. doi: 10.1002/jps.2600700610.
A die with a flexible wall was constructed and evaluated on a specially modified instrumented rotary tablet press. The design permits an inward deflection of the die wall by a side punch, which rolls past a side compression roll during compression-decompression. The side compression roll is instrumented to monitor the applied side compression roll forces. On decompression, return of the die wall to its original position permits release of residual die wall pressure. The decreased residual die wall pressure can decrease fracture and capping of tablets for problem formulations. The performance was tested on three experimental formulations. For these formulations, tablets made in a conventional die exhibited severe capping problems. However, most tablets compressed in the special die were superior. With proper adjustment of punch and die wall compression forces, excellent tablets could be manufactured. The merits of the special die and modified tablet machine are substantiated, although this initial design did not provide adequate die wall pressure for all formulations. Further engineering efforts could result in practical production equipment.
制作了一种具有柔性壁的模具，并在一台经过特殊改装的装有仪器的旋转压片机上进行了评估。该设计允许侧冲头使模具壁向内偏转，在压缩-解压过程中，侧冲头会滚过一个侧压辊。侧压辊装有仪器，用于监测所施加的侧压辊力。在解压时，模具壁回到其原始位置，从而释放模具壁残余压力。降低的模具壁残余压力可以减少问题配方片剂的断裂和裂片。在三种实验配方上测试了该性能。对于这些配方，在传统模具中压制的片剂表现出严重的裂片问题。然而，在特殊模具中压制的大多数片剂性能更优。通过适当调整冲头和模具壁的压缩力，可以制造出优质的片剂。尽管这种初始设计并没有为所有配方提供足够的模具壁压力，但特殊模具和改装压片机的优点得到了证实。进一步的工程努力可能会带来实用的生产设备。
