Division of Pharmaceutical Technology, Department of Pharmacy, University of Helsinki, P.O. Box 56, 00014 Helsinki, Finland.
J Pharm Sci. 2010 Apr;99(4):2061-9. doi: 10.1002/jps.21945.
The purpose of this study was to determine the variation in the granule size distribution in a die of an eccentric tableting machine. Theophylline anhydrate and alpha-lactose monohydrate were granulated with an aqueous solution of polyvinylpyrrolidone, using an instrumented fluid bed granulator. The granules were tabletted, using an instrumented eccentric tableting machine. Punch forces were recorded and tablets were collected in order during the tableting process. Powder samples, which had the same mass as the tablets, were also collected from the die for particle size determination. The particle size distribution was measured, using a spatial filtering technique. In addition, the segregation of microcrystalline cellulose pellets during tableting was analyzed. The particle size distribution changed dramatically during the tableting process, due to a segregation phenomenon.
本研究旨在确定偏心压片机模具中颗粒大小分布的变化。使用仪器化流化床制粒机，用聚乙烯吡咯烷酮的水溶液对茶碱无水物和α-乳糖一水合物进行制粒。使用仪器化偏心压片机对颗粒进行压片。在压片过程中记录冲头力并收集片剂。还从模具中收集与片剂具有相同质量的粉末样品，以进行粒度测定。使用空间滤波技术测量粒度分布。此外，还分析了压片过程中小结晶纤维素颗粒的分离现象。由于分离现象，颗粒大小分布在压片过程中发生了显著变化。
