Miguélez-Morán Andres M, Wu Chuan-Yu, Dong Hanshan, Seville Jonathan P K
School of Chemical Engineering, University of Birmingham, Birmingham, UK.
Eur J Pharm Biopharm. 2009 May;72(1):173-82. doi: 10.1016/j.ejpb.2008.12.005. Epub 2008 Dec 24.
Roller compaction is one stage in a dry granulation process to produce free flowing granules. Its proper understanding is essential in optimising manufacturing efficiency and product quality. Roller compaction produces a compacted strip or "ribbon", which is then milled to produce granules. For a given milling condition, the density distribution in the ribbons determines the properties of the granules (particularly their size distribution and strength). Therefore, knowing the density distributions in the ribbons is very important in improving the effectiveness of the roller compaction process and the quality of the granules produced. In this paper, the density distribution in roller-compacted ribbons of microcrystalline cellulose (Avicel PH102) has been examined using three different techniques: (1) sectioning; (2) micro-indentation and (3) X-ray micro-computed tomography. It has been shown that with proper calibration all three techniques can essentially produce the same results, but with a different degree of resolution (scale of scrutiny). In addition, the influence of process conditions, such as roll gap, roll speed and the presence or absence of lubrication, on the ribbon density distributions has also been investigated. Flow into the press is often constrained by the presence of "cheek plates", which prevent lateral powder movement. In this type of arrangement, it is found that non-uniform powder feeding occurs in the compaction region, induced by the friction between the powder and the cheek plates; as a result, the densities in the middle of the ribbon width are generally higher than those close to the edges. It has also been shown that higher average ribbon densities are obtained when the roll gap, roll speed, or the friction between the powder and the side cheek plates is reduced.
滚压是干法制粒过程中的一个阶段,用于生产自由流动的颗粒。正确理解这一过程对于优化生产效率和产品质量至关重要。滚压会产生一条压实的条带或“薄条”,然后将其研磨以生产颗粒。对于给定的研磨条件,条带中的密度分布决定了颗粒的性质(特别是它们的尺寸分布和强度)。因此,了解条带中的密度分布对于提高滚压过程的效率和所生产颗粒的质量非常重要。在本文中,使用三种不同技术研究了微晶纤维素(Avicel PH102)滚压条带中的密度分布:(1)切片;(2)微压痕;(3)X射线微计算机断层扫描。结果表明,经过适当校准后,所有三种技术基本上都能产生相同的结果,但分辨率(审查尺度)不同。此外,还研究了工艺条件,如辊缝、辊速以及是否存在润滑,对条带密度分布的影响。进入压机的物料流动通常会受到“侧板”的限制,侧板会阻止粉末横向移动。在这种布置方式中,发现压实区域会出现不均匀的粉末进料,这是由粉末与侧板之间的摩擦引起的;结果,条带宽度中间的密度通常高于靠近边缘的密度。研究还表明,当辊缝、辊速或粉末与侧侧板之间的摩擦力减小时,条带的平均密度会更高。