GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive, Singapore, 117543, Singapore.
AAPS PharmSciTech. 2013 Sep;14(3):1267-77. doi: 10.1208/s12249-013-0022-6. Epub 2013 Aug 17.
This work explored the importance of packability of component particles in the different wet processing steps of extrusion-spheronization and investigated different processing and formulation approaches for enhancing packing of component particles during extrusion-spheronization to produce spherical pellets with high yield and narrow size distribution. Various cross-linked polyvinyl pyrrolidone (XPVP) and lactose grades with different particle sizes were used as pelletization aid and filler in 1:3 binary powder blends. Loosely packed extrudates obtained from coarse XPVP/lactose blends possessed low cohesive strength and produced irregular shaped pellets with low yield whereas tightly packed, rigid extrudates obtained from XPVP/fine lactose grades possessed high cohesive strength and produced elongated pellets. Adjustment of spheronization tip speed to provide sufficient forces generated by the rotating frictional base plate for facilitating packing by rearrangement of component particles improved pellet quality. Double extrusion, decreasing particle size of the formulation component(s), and/or widening particle size distribution of the powder blend are approaches applicable to improve cohesiveness of moistened mass by closer packing of component particles for production of good quality pellets.
这项工作探讨了在挤出滚圆的不同湿加工步骤中颗粒可填充性的重要性，并研究了不同的加工和配方方法，以增强挤出滚圆过程中颗粒的填充性，从而生产出收率高、粒径分布窄的球形颗粒。不同粒径的交联聚乙烯吡咯烷酮（XPVP）和乳糖级分被用作造粒助剂和填充剂，以 1:3 的比例混合在二元粉末中。由粗 XPVP/乳糖混合物得到的松散填充挤出物具有较低的内聚强度，并且产生具有低收率的不规则形状的颗粒，而由 XPVP/细乳糖级分得到的紧密填充、刚性挤出物具有较高的内聚强度，并且产生细长的颗粒。调整造粒尖端速度，以提供由旋转摩擦基板产生的足够的力，促进通过重新排列颗粒来实现填充，从而提高颗粒的质量。双挤出、减小制剂成分的粒径和/或拓宽粉末混合物的粒径分布是可用于通过更紧密地填充颗粒来提高湿物料的内聚性从而生产出高质量颗粒的方法。
