Dokument: Proof of a LOD prediction model with orthogonal PAT methods in continuous wet granulation and drying

Titel:	Proof of a LOD prediction model with orthogonal PAT methods in continuous wet granulation and drying
URL für Lesezeichen:	https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=68066
URN (NBN):	urn:nbn:de:hbz:061-20250108-130331-6
Kollektion:	Publikationen
Sprache:	Englisch
Dokumententyp:	Wissenschaftliche Texte » Artikel, Aufsatz
Medientyp:	Text
Autoren:	Kiricenko, Katharina [Autor] Klinken, Stefan [Autor] Kleinebudde, Peter [Autor]
Dateien:	[Dateien anzeigen] Adobe PDF [Details] 1,75 MB in einer Datei [ZIP-Datei erzeugen] Dateien vom 08.01.2025 / geändert 08.01.2025
Stichwörter:	PAT, LOD prediction, Continuous manufacturing, Vibrated fluidized bed dryer, Mass balance, NIR spectroscopy
Beschreibung:	Real-time monitoring of critical quality attributes, such as residual water in granules after drying which can be determined through loss-on-drying (LOD), during wet granulation and drying is essential in continuous manufacturing. Near-infrared (NIR) spectroscopy has been widely used as process analytical technology (PAT) for in-line LOD monitoring. This study aims to develop and apply a model for predicting the LOD based on process parameters. Additionally, the efficacy of an orthogonal PAT approach using NIR and mass balance (MB) for a vibrating fluidized bed dryer (VFBD) is demonstrated. An in-house-built, cost-effective NIR sensor was utilized for measurements and exhibited good correlation compared to standard method via infrared drying. The combination of NIR and MB, as independent methods, has demonstrated their applicability. A good correlation, with a Pearson r above 0.99, was observed for LOD up to 16 % (w/w). The use of an orthogonal PAT method mitigated the risk of false process adaption. In some experiments where the NIR sensor might have been covered by powder and therefore did not measure accurately, LOD monitoring via MB remained feasible. The developed model effectively predicted LOD or process parameters, resulting in an R2 of 0.882 and a RMSE of 0.475 between predicted and measured LOD using the standard method.
Rechtliche Vermerke:	Originalveröffentlichung: Kiricenko, K., Klinken, S., & Kleinebudde, P. (2024). Proof of a LOD prediction model with orthogonal PAT methods in continuous wet granulation and drying. Journal of Pharmaceutical Sciences, 114(1), 176–184. https://doi.org/10.1016/j.xphs.2024.07.008
Lizenz:	Dieses Werk ist lizenziert unter einer Creative Commons Namensnennung 4.0 International Lizenz
Fachbereich / Einrichtung:	Mathematisch- Naturwissenschaftliche Fakultät
Dokument erstellt am:	08.01.2025
Dateien geändert am:	08.01.2025