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. 2018 Mar;13(2):113-119. doi: 10.1016/j.ajps.2017.08.002. Epub 2017 Aug 10.
We previously determined "Tableting properties" by using a multi-functional single-punch tablet press (GTP-1). We plotted "Compactability" on the x-axis against "Manufacturability" on the y-axis to allow visual evaluation of "Tableting properties". Here, we examined whether this evaluation method can be used in the formulation design of tablets prepared by wet granulation. We used the GTP-1 to measure "Tableting properties" with different amounts of binder, disintegrant, and lubricant, and compared the results with those of tableting on a commercial rotary tableting machine. Tableting failures (capping and binding in particular) occurred when samples that had been evaluated as having poor "Compactability" or "Manufacturability" on the GTP-1 were compressed on the rotary tableting machine. Thus, our evaluation method predicted tableting failure at the commercial scale. The method will prove useful for scaling up production.
我们之前使用多功能单冲压片机(GTP - 1)测定了“压片性能”。我们将“可压性”绘制在x轴上,将“可制造性”绘制在y轴上,以便直观评估“压片性能”。在此,我们研究了这种评估方法是否可用于湿法制粒制备片剂的处方设计中。我们使用GTP - 1测量了不同粘合剂、崩解剂和润滑剂用量下的“压片性能”,并将结果与在商用旋转压片机上的压片结果进行比较。当在GTP - 1上被评估为“可压性”或“可制造性”较差的样品在旋转压片机上压制时,会出现压片失败(尤其是裂片和黏冲)的情况。因此,我们的评估方法能够预测商业规模下的压片失败。该方法将证明对扩大生产规模很有用。