Spectroscopic approach for on-line monitoring of particle size during the processing of pharmaceutical nanoparticles

被引:58
作者
Higgins, JP [1 ]
Arrivo, SM [1 ]
Thurau, G [1 ]
Green, RL [1 ]
Bowen, W [1 ]
Lange, A [1 ]
Templeton, AC [1 ]
Thomas, DL [1 ]
Reed, RA [1 ]
机构
[1] Merck & Co Inc, Merck Res Labs, West Point, PA 19486 USA
关键词
D O I
10.1021/ac0207980
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A novel application of near-infrared (near-IR) spectroscopy for the on-line determination of nanoparticle size of a drug compound in a high solids dispersion is described. The on-line spectroscopic technique provides real-time data for process monitoring and control and overcomes the limitations that are encountered using laboratory-based instrumentation for nanoparticle size determination. Near-IR spectroscopy is capable of providing an accuracy of 2.4 nm near the endpoint of particle production, where the volume-weighted D90 particle size is determined to be 200-220 nm. The accuracy is adequate for endpoint control, which minimizes excess processing and provides control over the particle size throughout nanoparticle production.
引用
收藏
页码:1777 / 1785
页数:9
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