title: Use of near-infrared spectroscopy to quantify drug content on a continuous blending process: influence of mass flow and rotation speed variations.
abstract: The aim of this study was to develop a quantitative Near-Infrared (NIR) method which monitors the homogeneity of a pharmaceutical formulation coming out of a continuous blender. For this purpose, a NIR diode array spectrometer with fast data acquisition was selected. Additionally, the dynamic aspects of a continuous blending process were studied; the results showed a well-defined cluster for the steady state, and the paths for the start-up and emptying stages were clearly identified. The end point of the start-up phase was detected by moving block of standard deviation, relative standard deviation, and principal component analysis. A partial least square (PLS) model was generated for the quantification of the drug, with a standard error of prediction of 0.2% m/m. The PLS model was successfully applied for monitoring the drug level at the outlet of the continuous blender. Furthermore, the PLS model was tested under different flow and stirring rates. Flow and stirring rate variations caused different powder flow dynamics, which were reflected on the NIR measurements. Therefore, the PLS model was sensitive to changes in mass flow and rotation speeds.
authors: Department of Pharmaceutical Sciences, Pharmacenter, University of Basel, Basel, Switzerland. lizbeth.martinez@unibas.ch
authors: Lizbeth
authors: L
authors: Martínez
authors: Antonio
authors: A
authors: Peinado
authors: Lorenz
authors: L
authors: Liesum
authors: Gabriele
authors: G
authors: Betz
mesh_terms: D002138:Calibration; D004339:Drug Compounding / Q000379:methods*; D015195:Drug Design; D004867:Equipment Design; D016018:Least-Squares Analysis; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011208:Powders; D025341:Principal Component Analysis; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013678:Technology, Pharmaceutical / Q000379:methods*; D013997:Time Factors
chemical_list: D004364:Pharmaceutical Preparations; D011208:Powders