Near-infrared spectroscopic method for real-time monitoring of pharmaceutical powders during voiding

被引:27
作者
Barajas, Martha J.
Cassiani, Alex Rodriguez
Vargas, Wandylis
Conde, Carlos
Ropero, Jorge
Figueroa, Jorge
Romanach, Rodolfo J.
机构
[1] Univ Puerto Rico, Dept Chem, Mayaguez, PR 00682 USA
[2] Wyeth Pharmaceut Co, Guayama, PR 00785 USA
关键词
in-line monitoring; near-infrared spectroscopy; NIR spectroscopy; diffuse reflectance; powder segregation;
D O I
10.1366/000370207780807713
中图分类号
TH7 [仪器、仪表];
学科分类号
0804 ; 080401 ; 081102 ;
摘要
A near-infrared (NIR) spectroscopic method has been developed to monitor flowing pharmaceutical powders during their voiding and detect post-blending segregation. The method is capable of providing both chemical and physical information (particle size differences) on the flowing pharmaceutical powders. Particle size differences are widely recognized as the predominant driver for segregation. Pharmaceutical powders may segregate following blending as they are voided down pipes to compressing machines, increasing the variability of the drug content and dissolution of the final product tablets because of segregation. NIR diffuse reflectance spectra of pharmaceutical powders were obtained following voiding through a six-foot pipe. Spectral subtraction was used to eliminate baseline differences but maintain particle size differences. The NIR spectra indicated differences in the particle size of the flowing powder. Particle size differences were also tracked throughout the voiding of pharmaceutical powders by plotting the absorbance at 1536 nm. The method was also applied to the voiding of two layers of lactose particles with different particle sizes. The system described in this report provides an approach to study post-blending segregation in pharmaceutical powders and other relevant materials.
引用
收藏
页码:490 / 496
页数:7
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