Application of Online Near Infrared for Process Understanding of Spray-Drying Solution Preparation

Solution preparation is the first unit operation of the manufacturing process for spray-dried solid dispersions. Visual inspection and offline high-performance liquid chromatography analysis are routinely used to assess the solution preparation end point as well as the final solution composition. Ho...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2019-03, Vol.108 (3), p.1203-1210
Hauptverfasser:	Lee, Yung-Chi, Zhou, George, Ikeda, Craig, Chouzouri, Georgia, Howell, Logan
Format:	Artikel
Sprache:	eng
Schlagworte:	amorphous solid dispersion Chemistry, Pharmaceutical - instrumentation Chemistry, Pharmaceutical - methods Chemistry, Pharmaceutical - standards Chromatography, High Pressure Liquid - instrumentation Chromatography, High Pressure Liquid - methods Desiccation - instrumentation Desiccation - methods dissolution Drug Compounding - instrumentation Drug Compounding - methods Drug Compounding - standards Feasibility Studies NIRs PAT Quality Control Solubility Solvents - chemistry Spectroscopy, Fourier Transform Infrared - instrumentation Spectroscopy, Fourier Transform Infrared - methods spray drying Water - chemistry
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