Terashita Keijiro, Imamura Keisuke
Osaka Prefecture University, Department of Engineering, Sakai, Japan.
Chem Pharm Bull (Tokyo). 2002 Dec;50(12):1542-9. doi: 10.1248/cpb.50.1542.
Direct compression is able to produce tablets at a lower cost than wet granulation and tableting method, due to a fewer items of process validation. In this study, acetaminophen was used as a medicine with various granular diameters to formulate tablets by direct compression, thus evaluating their physical properties. Consequently, direct compression was found effective in formulating tablets with excellent physical properties, with the granular diameter taken into account. It was confirmed that tablets produced by direct compression were similar in physical properties in tablets produced by wet granulation and tableting method. Further, it was suggested that use of a dry-type binder would make it possible to provide a tablet having higher content of the medicine with excellent physical properties.
由于工艺验证项目较少，直接压片法能够以比湿法制粒压片法更低的成本生产片剂。在本研究中，对乙酰氨基酚被用作具有不同粒径的药物，通过直接压片法制备片剂，从而评估其物理性质。结果发现，考虑到粒径因素，直接压片法能有效地制备出具有优异物理性质的片剂。证实了直接压片法生产的片剂与湿法制粒压片法生产的片剂在物理性质上相似。此外，还表明使用干型粘合剂能够制备出药物含量更高且物理性质优异的片剂。
