Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, United States.
Eur J Pharm Sci. 2011 May 18;43(1-2):50-6. doi: 10.1016/j.ejps.2011.03.009. Epub 2011 Apr 5.
The influence of massing during high shear wet granulation (HSWG) process on granule properties and performance was investigated using microcrystalline cellulose (MCC). Massing time varied from 0 to 40 min while other factors were fixed. Granule physical properties, including morphology, size, porosity, and specific surface area (SSA), were characterized. Changes in powder properties were profound in the first 10 min of massing but negligible beyond 10 min. With 10 min of massing, granule tabletability decreased by 75% while flowability increased by 75%. The significantly deteriorated tabletability and improved flowability resulted from dramatic changes in granule morphology, porosity, and SSA. The results confirm that massing time is a key process parameter in HSWG, and it must be carefully evaluated and controlled during process development, scale up, and manufacturing.
使用微晶纤维素 (MCC) 研究了高剪切湿法制粒 (HSWG) 过程中制粒过程中的团聚对颗粒性质和性能的影响。团聚时间从 0 分钟变化到 40 分钟，而其他因素保持不变。对颗粒物理性质，包括形态、大小、孔隙率和比表面积 (SSA) 进行了表征。在团聚的最初 10 分钟内，粉末性质发生了深刻的变化，但超过 10 分钟后则可以忽略不计。经过 10 分钟的团聚，颗粒可压性降低了 75%，而流动性增加了 75%。可压性的显著恶化和流动性的提高是由于颗粒形态、孔隙率和 SSA 的剧烈变化所致。结果证实，团聚时间是 HSWG 的一个关键工艺参数，在工艺开发、放大和制造过程中必须仔细评估和控制。
