A new PAT/QbD approach for the determination of blend homogeneity: combination of on-line NIRS analysis with PC Scores Distance Analysis (PC-SDA)
A novel and straightforward multivariate analytical tool for the qualitative determination of powder blend uniformity using on-line Near-Infrared Spectroscopy (NIRS) is presented. The approach combines current chemometric methods, e.g. spectral pre-processing and Principal Component Analysis (PCA),...
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| Hauptverfasser: | , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2011
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| In: |
European journal of pharmaceutics and biopharmaceutics
Year: 2011, Jahrgang: 78, Heft: 1, Pages: 173-182 |
| ISSN: | 1873-3441 |
| DOI: | 10.1016/j.ejpb.2010.12.015 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ejpb.2010.12.015
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| Verfasserangaben: | T. Puchert, C.-V. Holzhauer, J.C. Menezes, D. Lochmann, G. Reich |
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| 245 | 1 | 2 | |a A new PAT/QbD approach for the determination of blend homogeneity |b combination of on-line NIRS analysis with PC Scores Distance Analysis (PC-SDA) |c T. Puchert, C.-V. Holzhauer, J.C. Menezes, D. Lochmann, G. Reich |
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| 520 | |a A novel and straightforward multivariate analytical tool for the qualitative determination of powder blend uniformity using on-line Near-Infrared Spectroscopy (NIRS) is presented. The approach combines current chemometric methods, e.g. spectral pre-processing and Principal Component Analysis (PCA), with (1) a new approach of data analysis to determine the end-point of the blending process, (2) building a design space (DS) for blend homogeneity and (3) developing a solid statistical rationale to stop blending according to Quality-by-Design (QbD) principles of FDA's Process Analytical Technology (PAT) initiative. The new approach comprises calculation of Euclidean distances between PCA scores in a multidimensional space and determination of Moving Block Standard Deviations (MBSDs) of successive Principal Component (PC) scores distances to estimate a time-window during blending where spectral variability decreases to a preset minimum. Hotelling's T(2) statistics is then used to monitor and report blend homogeneity. This technique is called "Principal Component Scores Distance Analysis" (PC-SDA). A Central Composite Design resulting in 10 batches mixed in a bin-blender (same composition, different blender fill level, different number of revolutions) was executed. NIR Chemical Imaging (NIR-CI) in combination with Symmetry Parameter Image Analysis (SPIA) was used to verify the NIRS analyzer response and assess homogeneity of all NIR-active components. | ||
| 650 | 4 | |a Multivariate Analysis | |
| 650 | 4 | |a Principal Component Analysis | |
| 650 | 4 | |a Spectroscopy, Near-Infrared | |
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| 650 | 4 | |a United States Food and Drug Administration | |
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| 700 | 1 | |a Menezes, J. C. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Lochmann, D. |e VerfasserIn |4 aut | |
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