Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Universitaetsstrasse 1, 40225, Duesseldorf, Germany.
AAPS PharmSciTech. 2010 Dec;11(4):1549-51. doi: 10.1208/s12249-010-9532-7. Epub 2010 Nov 2.
Pellet manufacturing by extrusion/spheronization is quite common in the pharmaceutical field because the obtained product is characterized by a high sphericity as well as a narrow particle size distribution. The established mechanisms only consider deformation of the initially fractured particles but do not account for mass transfer between the particles as a factor in achieving spherical particles. This study dealt with the visualization of mass transfer during spheronization. Therefore, two common pelletization aids, microcrystalline cellulose and kappa-carrageenan, were used alone as well as in combination with lactose as a filler. This study proves that mass transfer between particles must be considered in addition to plastic deformation in order to capture the spheronization mechanism. Moreover, it is evident that there are regional distinctions in the amount of mass transfer at the particle surface. Therefore, the commonly espoused pelletization mechanisms need to be extended to account for material transfer between pellet particles, which has not been considered before.
微丸造粒是制药领域常用的方法,因为所得到的产品具有高球形度和较窄的粒径分布。已建立的机制仅考虑最初断裂颗粒的变形,但不考虑颗粒间的质量传递作为实现球形颗粒的因素。本研究涉及到微丸造粒过程中质量传递的可视化。因此,使用了两种常用的制粒助剂,即微晶纤维素和卡拉胶,单独使用以及与乳糖作为填充剂一起使用。本研究证明,为了捕捉微丸造粒机制,除了塑性变形外,还必须考虑颗粒间的质量传递。此外,颗粒表面的质量传递存在明显的区域差异。因此,需要扩展常用的制粒机制,以考虑颗粒间的物质传递,这是以前没有考虑过的。