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Mechanistic approach in powder blending PAT: Bi-layer mixing and asymptotic end point prediction

Author:
Sibik, Juraj, Chalus, Pascal, Maurer, Lene, Murthy, Avinash, Krimmer, Siegfried
Source:
Powder technology 2017 v.308 pp. 306-317
ISSN:
0032-5910
Subject:
algorithms, drugs, ingredients, mixing, models, near-infrared spectroscopy, powders, prediction, process control
Abstract:
We derive a simple first order kinetics model for the powder mixing in a bin blender and adapt it to fit the NIR spectra obtained during the real-time mixing. The model is tested on a full drug product formulation mixing consisting of API and multiple excipients. It allows to extract a quantitative mixing rate for individual ingredients, which may be used in the drug development and production scale-up design. We further propose an algorithm for a calibration-free blending end-point determination from the NIR data, which allows for a robust and easily transferable blending process control.
Agid:
6096461