Division of Pharmaceutical Technology, University of Helsinki, P.O. Box 56 (Viikinkaari 5E) 00014, Finland.
Int J Pharm. 2010 Sep 15;397(1-2):19-26. doi: 10.1016/j.ijpharm.2010.06.041. Epub 2010 Jun 30.
The aim of this study was to evaluate how different granule size distributions affect the tablet compression process. The emphasis was on developing new analytic methods for compression data for entire batch. In all, 18 batches of granules containing theophylline and lactose were tabletted, using an instrumented eccentric tabletting machine. During tablet compression, upper and lower punch forces were recorded. Mathematical methods were developed for analysing the compression data during tabletting. The results suggested two types of undulation in the tabletting data: (1) short-time scale variation or tablet-to-tablet changes in force data and (2) long-time scale undulation describing the changes occurring throughout the tabletting process, such as segregation. These undulation phenomena were analysed, using various mathematical methods. In addition the results suggest that smaller particles have better tabletting properties, to a certain limit. However particle size alone cannot explain the tabletability of granules.
本研究旨在评估不同粒度分布如何影响片剂压缩过程。重点是开发用于整个批次压缩数据的新分析方法。总共使用仪器偏心压片机压片了 18 批含有茶碱和乳糖的颗粒。在片剂压缩过程中，记录了上下冲头的力。为分析压片过程中的压缩数据，开发了数学方法。结果表明，压片数据中存在两种波动：（1）短时间尺度变化或力数据的片剂间变化，（2）长时间尺度波动，描述整个压片过程中发生的变化，如分离。使用各种数学方法分析了这些波动现象。此外，结果表明，在一定限度内，较小的颗粒具有更好的压片性能。然而，仅颗粒大小不能解释颗粒的可压性。
