Osamura Takashi, Takeuchi Yoshiko, Onodera Risako, Kitamura Masahiro, Takahashi Yoshiteru, Tahara Kohei, Takeuchi Hirofumi
Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-Nishi, Gifu 501-1196, Japan.
Pharmaceutical Technology Department, Sawai Pharmaceutical Co. Ltd, 12-34, Hiroshibacho, Suita-Shi, Osaka 564-0052, Japan.
Asian J Pharm Sci. 2017 Sep;12(5):412-417. doi: 10.1016/j.ajps.2017.05.001. Epub 2017 May 17.
We previously determined "Tableting properties" by using a multi-functional single-punch tablet press (GTP-1). We proposed plotting "Compactability" on the x-axis against "Manufacturability" on the y-axis to allow visual evaluation of "Tableting properties". Various types of tableting failure occur in commercial drug production and are influenced by the amount of lubricant used and the shape of the punch. We used the GTP-1 to measure "Tableting properties" with different amounts of lubricant and compared the results with those of tableting on a commercial rotary tableting machine. Tablets compressed with a small amount of lubricant showed bad "Manufacturability", leading to sticking of powder on punches. We also tested various punch shapes. The GTP-1 correctly predicted the actual tableting results for all punch shapes. With punches that were more likely to cause tableting failure, our system predicted the effects of lubricant quantity in the tablet formulation and the occurrence of sticking in the rotary tableting machine.
我们之前使用多功能单冲压片机（GTP - 1）测定“压片性能”。我们建议在x轴上绘制“可压性”，在y轴上绘制“可生产性”，以便直观评估“压片性能”。在商业药物生产中会出现各种类型的压片失败情况，并且受到所用润滑剂的量和冲头形状的影响。我们使用GTP - 1测量不同润滑剂用量下的“压片性能”，并将结果与在商业旋转压片机上的压片结果进行比较。用少量润滑剂压制的片剂显示出较差的“可生产性”，导致粉末粘在冲头上。我们还测试了各种冲头形状。GTP - 1正确预测了所有冲头形状的实际压片结果。对于更有可能导致压片失败的冲头，我们的系统预测了片剂配方中润滑剂用量的影响以及旋转压片机中粘片现象的发生。
