Miguélez-Morán A M, Wu C-Y, Seville J P K
Department of Chemical Engineering, University of Birmingham, Birmingham, B15 2TT, UK.
Int J Pharm. 2008 Oct 1;362(1-2):52-9. doi: 10.1016/j.ijpharm.2008.06.009. Epub 2008 Jun 17.
Roller compaction is a continuous dry granulation process for producing free flowing granules in order to increase the bulk density and uniformity of pharmaceutical formulations. It is a complicated process due to the diversity of powder blends and processing parameters involved. The properties of the produced ribbon are dominated by a number of factors, such as the powder properties, friction, roll speed, roll gap, feeding mechanisms and feeding speed, which consequently determine the properties of the granules (size distribution, density and flow behaviour). It is hence important to understand the influence of these factors on the ribbon properties. In this study, an instrumented roller press developed at the University of Birmingham is used to investigate the effect of lubrication on the density distribution of the ribbons. Three different cases are considered: (1) no lubrication, (2) lubricated press, in which the side cheek plates of the roller press are lubricated, and (3) lubricated powder, for which a lubricant is mixed into the powder. In addition, how the powders are fed into the entry region of the roller press and its influence on ribbon properties are also investigated. It is found that the method of feeding the powder into the roller press plays a crucial role in determining the homogeneity of the ribbon density. For the roller press used in this study, a drag angle (i.e., the angle formed when the powder is dragged into the roller press) is introduced to characterise the powder flow pattern in the feeding hopper. It is shown that a sharper drag angle results in a more heterogeneous ribbon. In addition, the average ribbon density depends upon the peak pressure and nip angle. The higher the peak pressure and nip angle are, the higher the average ribbon density is. Furthermore, the densification behaviour of the powder during roller compaction is compared to that during die compaction. It has been shown that the densification behaviour during these two processes is similar if the ribbons and the tablets have the same thickness.
滚压是一种连续干法制粒工艺,用于生产流动性良好的颗粒,以提高药物制剂的堆密度和均匀性。由于涉及的粉末混合物和加工参数的多样性,这是一个复杂的过程。所生产的带状物的性质受多种因素支配,如粉末性质、摩擦力、辊速、辊隙、进料机制和进料速度,这些因素进而决定了颗粒的性质(粒度分布、密度和流动行为)。因此,了解这些因素对带状物性质的影响很重要。在本研究中,使用伯明翰大学开发的带仪表的辊压机来研究润滑对带状物密度分布的影响。考虑了三种不同情况:(1)无润滑,(2)润滑压机,其中辊压机的侧颊板进行了润滑,(3)润滑粉末,即将润滑剂混入粉末中。此外,还研究了粉末如何进料到辊压机的入口区域及其对带状物性质的影响。发现将粉末进料到辊压机的方法在确定带状物密度的均匀性方面起着关键作用。对于本研究中使用的辊压机,引入了一个拖曳角(即粉末被拖入辊压机时形成的角度)来表征进料斗中的粉末流动模式。结果表明,拖曳角越尖锐,带状物的不均匀性就越大。此外,带状物平均密度取决于峰值压力和咬入角。峰值压力和咬入角越高,带状物平均密度越高。此外,还比较了滚压过程中粉末的致密化行为与模压过程中的致密化行为。结果表明,如果带状物和片剂具有相同的厚度,这两个过程中的致密化行为是相似的。