Oral Formulation Science, Preclinical Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Merck & Co., Inc., 126 E Lincoln Ave, Rahway, New Jersey, 07065, USA.
AAPS PharmSciTech. 2019 May 3;20(5):182. doi: 10.1208/s12249-019-1392-1.
A feasibility evaluation of the addition of fumed silica (SiO) into an agitated dryer to aid spray-dried solid dispersion intermediate (SDSDi) flow during secondary drying and discharge is described. The quantity of SiO to enhance the flow character of SDSDi was assessed by measuring particle size distribution, bulk density, and flow-through-an-orifice. Results indicate that the addition of the SiO did not alter the drying kinetics and did not impact the bulk particle size distribution of the SDSDi. While bulk density of SDSDi increased with the addition of SiO, the flow, and thus the recovery of the SDSDi-SiO batch from the secondary dryer, was significantly higher than that for the intermediate alone. Imaging indicated uniform distribution of SiO in the bulk powder and coating on intermediate particles. Premixing and co-sieving of the SiO with a portion of pre-dry SDSDi promotes the uniform distribution of SiO within the bulk powder bed.
描述了一种将气相法二氧化硅（SiO）添加到搅拌干燥器中以辅助二次干燥和卸料过程中喷雾干燥固体分散体中间体（SDSDi）流动的可行性评估。通过测量粒径分布、堆密度和通过孔口的流动来评估添加 SiO 以增强 SDSDi 流动特性的用量。结果表明，添加 SiO 不会改变干燥动力学，也不会影响 SDSDi 的散装颗粒尺寸分布。虽然 SDSDi 的堆密度随着 SiO 的添加而增加，但 SiO 的流动，因此 SDSDi-SiO 批料从二级干燥器中的回收，明显高于中间产物。成像表明 SiO 在散装粉末中的均匀分布以及中间产物颗粒上的涂层。SiO 与一部分预干燥 SDSDi 的预混合和共筛分促进了 SiO 在散装粉末床中的均匀分布。
