Dokument: Development of an in-line measuring tool for ribbon solid fraction during roll compaction
| Titel: | Development of an in-line measuring tool for ribbon solid fraction during roll compaction | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=48124 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20190116-112606-8 | |||||||
| Kollektion: | Dissertationen | |||||||
| Sprache: | Englisch | |||||||
| Dokumententyp: | Wissenschaftliche Abschlussarbeiten » Dissertation | |||||||
| Medientyp: | Text | |||||||
| Autor: | Wiedey, Raphael [Autor] | |||||||
| Dateien: |
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| Beitragende: | Prof. Dr. Kleinebudde, Peter [Gutachter] Prof. Dr. Breitkreutz, Jörg [Gutachter] | |||||||
| Stichwörter: | roll compaction, Walzenkompaktieren, process analytical technologies, Prozessanalytische Technologie | |||||||
| Dewey Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften » 610 Medizin und Gesundheit | |||||||
| Beschreibung: | Beim Walzenkompaktieren/Trockengranulieren werden Pulver zwischen gegenläufig rotierenden Walzen verpresst und die entstandenen Schülpen anschließend zu Granulaten gemahlen. Die Porosität dieser Schülpen ist dabei ein wichtiges Qualitätsmerkmal, weil sie die Partikelgrößenverteilung und die Wiederverpressbarkeit der Granulate bestimmt. Da trotz der Bedeutung dieser Eigenschaft bisher kein System zur in-line Überwachung dieser Größe allgemein akzeptiert ist, war das Ziel dieser Arbeit ein zuverlässiges und einfach zu bedienendes Messystem für diese Anwendung zu entwickeln. Um zu entscheiden ob die neue Technik so entwickelt werden soll, dass neben den Porosität der gesamten Schülpe auch die Porositätsverteilung detektiert werden kann, wurden in einem Teil der Arbeit zudem die Verteilungsmuster sowie deren Relevanz für Folgeprozesse untersucht.
In dieser Arbeit wurde die Porosität aus den thermischen Eigenschaften der Schülpe bestimmt. Die Schülpentemperatur wurden mit einer Infrarot-Kamera aufgezeichnet und anschließend analysiert. Dabei korrelierte die Schülpentemperatur negativ mit der Porosität. Dies war der Fall für eine Reihe von verschiedenen Füllstoffen. Die Reaktionszeiten war kurz, die Ergebnisse waren Robust gegen Variation der Prozessparameter und des Raumklimas, erlaubten präzise und akkurate Vorhersagen und enthielten Information über die Produkteigenschaften, die über das was aus der Überwachung der Prozessparameter geschlossen werden kann, hinausgeht. Die Temperaturverteilung konnte zudem zur Überwachung der Porositätsverteilung herangezogen werden, wie durch Abgleich mit Mikro-Computertomographischen Messungen gezeigt werden konnte. Da in einer weiteren Untersuchung allerdings keine Relevanz der Schülpenhomogenität nachgewiesen werden konnte, wurde dies nicht weiter untersucht. Das Messsignal war nicht robust gegenüber einer Erwärmung des Walzenkompaktors über die Prozesszeit. Um die Robustheit zu erhöhen, wurde versucht die Porosität aufgrund der Wärmeleitfähigkeit der Schülpen zu bestimmen (hohe Porosität bedingt niedrige Leitfähigkeit). Dazu wurde die Schülpe durch eine 450 nm Laserdiode punktuell erhitzt und die Ausbreitung der Wärme von diesem Punkt aus mittels IR-Kamera verfolgt. Dieser Ansatz zeigte ebenfalls Richtigkeit, Präzision und Robustheit gegen fluktuierende Prozessparameter in den Vorhersagen und war Robust gegen das Aufheizen des Walzenkompaktors über die Prozesszeit. Negative Einflüsse auf die Stabilität des Arzneistoffs, konnten in einer Modellstudie mit dem Wirkstoff Nifedipin nicht gefunden werden. | |||||||
| Quelle: | [1] E.L. Parrott, Densification of powders by concavo‐convex roller compactor, J. Pharm. Sci., 70 (1981) 288-291.
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| Lizenz: |  Urheberrechtsschutz | |||||||
| Bezug: | 01/2015-09/2018 | |||||||
| Fachbereich / Einrichtung: | Mathematisch- Naturwissenschaftliche Fakultät » WE Pharmazie » Pharmazeutische Technologie und Biopharmazie | |||||||
| Dokument erstellt am: | 16.01.2019 | |||||||
| Dateien geändert am: | 16.01.2019 | |||||||
| Promotionsantrag am: | 06.07.2018 | |||||||
| Datum der Promotion: | 04.09.2018 |
