Mechanistic approach in powder blending PAT: Bi-layer mixing and asymptotic end point prediction
| Autor: | Pascal Chalus, Avinash Murthy, Lene Maurer, Siegfried Krimmer, Juraj Sibik |
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| Rok vydání: | 2017 |
| Předmět: |
Imagination
Chemical substance Chemistry General Chemical Engineering Process analytical technology media_common.quotation_subject Mechanical engineering 02 engineering and technology 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy Bin Quality by Design 03 medical and health sciences Search engine 0302 clinical medicine Process control 0210 nano-technology Biological system Mixing (physics) media_common |
| Zdroj: | Powder Technology. 308:306-317 |
| ISSN: | 0032-5910 |
| DOI: | 10.1016/j.powtec.2016.12.038 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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