Gupta Abhay, Peck Garnet E, Miller Ronald W, Morris Kenneth R
Department of Industrial and Physical Pharmacy, Purdue University School of Pharmacy, 575 Stadium Mall Drive, West Lafayette, Indiana 47907-2091, USA.
J Pharm Sci. 2004 Apr;93(4):1047-53. doi: 10.1002/jps.20003.
Compact strength and the particle-size distribution of milled roller compacted compacts were correlated to the slope of the best-fit line through near-infrared spectra for samples prepared under different roll speeds and feed rates. The above correlations were found to hold for compacts prepared from microcrystalline cellulose powder as well as from a typical direct compression pharmaceutical powder blend containing tolmetin sodium dihydrate, microcrystalline cellulose, and dicalcium phosphate dihydrate. Near-infrared spectra were also collected real time for the compacts prepared from the tolmetin powder blend. The real-time slope values for the spectra showed good agreement with the off-line data. The strength of compacts was determined using three-point beam bending method and the particle-size distribution of the milled compacts was determined using sieve analysis. The results suggest that the real-time values of the slope of the best-fit line through the near-infrared spectrum offers a robust, yet simple and fast quality control tool to monitor/control manufacturing and scale-up processes involving dry granulation by roller compaction.
将不同轧辊速度和进料速率下制备的样品通过近红外光谱的最佳拟合线斜率与碾磨辊压实物的抗压强度及粒度分布相关联。发现上述相关性适用于由微晶纤维素粉末以及含有二水合托美汀钠、微晶纤维素和二水合磷酸氢钙的典型直接压片药用粉末混合物制备的压实物。还对由托美汀粉末混合物制备的压实物实时采集近红外光谱。光谱的实时斜率值与离线数据显示出良好的一致性。使用三点梁弯曲法测定压实物的强度，使用筛分分析测定碾磨压实物的粒度分布。结果表明，通过近红外光谱的最佳拟合线斜率的实时值提供了一种强大、简单且快速的质量控制工具，用于监测/控制涉及辊压干法制粒的制造和放大过程。
