Heng P W, Koo O M
Department of Pharmacy, National University of Singapore, Singapore.
Pharm Res. 2001 Apr;18(4):480-7. doi: 10.1023/a:1011054310895.
Physical characterization and extrusion-spheronization profiles of 11 microcrystalline cellulose (MCC) grades were performed. Correlation between the physical characteristics and extrusion spheronization behavior and pellet quality was performed to determine critical MCC characteristics that influence the water requirement and spheronization water sensitivity for extrusion-spheronization.
Extrusion spheronization of MCC-lactose at varying water contents was performed to determine water requirement, spheronization water sensitivity, and the effect of increasing water content on some pellet qualities (pellet flow rate, friability, bulk, and tapped densities) of each MCC grade. MCC physical properties and tapping characteristics were assessed. Correlation between MCC physical properties and its spheronization behavior parameters was performed.
MCC characteristics, such as powder particle size, size distribution, and porosity, were found to have little influence on the extrusion-spheronization process. However, significant correlation was found between void volumes or packing properties of MCC and the water requirement for extrusion-spheronization and pellet qualities.
A new insight into the action of MCC as a spheronizing aid was discovered. MCC void volume and packing properties play an important role in determining water retention and release during extrusion-spheronization.
对11种微晶纤维素（MCC）等级进行物理特性及挤出滚圆特性分析。研究物理特性与挤出滚圆行为及微丸质量之间的相关性，以确定影响挤出滚圆所需水量及滚圆水敏感性的关键MCC特性。
对不同含水量的MCC -乳糖进行挤出滚圆，以确定每种MCC等级的需水量、滚圆水敏感性以及含水量增加对某些微丸质量（微丸流速、脆碎度、堆密度和振实密度）的影响。评估MCC的物理性质和振实特性。分析MCC物理性质与其滚圆行为参数之间的相关性。
发现MCC的特性，如粉末粒径、粒度分布和孔隙率，对挤出滚圆过程影响较小。然而，发现MCC的空隙体积或堆积性质与挤出滚圆所需水量及微丸质量之间存在显著相关性。
发现了对MCC作为滚圆助剂作用的新见解。MCC空隙体积和堆积性质在挤出滚圆过程中决定水分保留和释放方面起着重要作用。
