Dokument: Systematic investigations for the development and manufacturing of pharmaceutical mini-tablets
| Titel: | Systematic investigations for the development and manufacturing of pharmaceutical mini-tablets | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=58751 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20220203-134950-8 | |||||||
| Kollektion: | Dissertationen | |||||||
| Sprache: | Englisch | |||||||
| Dokumententyp: | Wissenschaftliche Abschlussarbeiten » Dissertation | |||||||
| Medientyp: | Text | |||||||
| Autor: | Lura, Ard [Autor] | |||||||
| Dateien: |
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| Beitragende: | Prof. Dr. Breitkreutz, Jörg [Gutachter] Prof. Dr. Kleinebudde, Peter [Gutachter] | |||||||
| Dewey Dezimal-Klassifikation: | 500 Naturwissenschaften und Mathematik » 570 Biowissenschaften; Biologie 600 Technik, Medizin, angewandte Wissenschaften » 610 Medizin und Gesundheit | |||||||
| Beschreibung: | In recent years the interest in manufacturing mini-tablets increased due to a change of paradigm from liquid to solid dosage forms for children as well as to acceptance studies, which proved the administration of mini-tablets as a single- or multiparticulate dosage form. The manufacturing and development of mini-tables is still not fully understood, yet. Examples can be found in the literature where formulations have higher mechanical strength with smaller tablet diameters. However, the materials and hypotheses can not always be applied to mini-tablets and industry-related pharmaceutical manufacturing conditions.
In this work, the tableting behavior of pharmaceutical excipients is systematically investigated using a compaction simulator. In the study 1, 2 and 3 mm mini-tablets are compared with 8 and 11.28 mm conventionally sized tablets. In addition to tablet size, the influence of the punch tool used on mini- tableting is also investigated. It was shown that tablet size alone does not influence tablet properties, but that there is probably an influence of material properties and tablet size. A more industrial aspect of this work deals with a transfer and scale-up study of 2 mm orodispersible mini-tablets (ODMTs) from a compaction simulator to an industrial tablet press, following EMA and FDA guidelines. The effect of critical material attributes and process parameters on critical quality attributes (CQAs) of ODMTs is evaluated. It was proven that the definition of CMAs and monitoring of CPPs is mandatory, as with increasing batch size and longer process time CQAs of ODMTs could not be met anymore. Finally, formulation development of 2 mm ODMTs based on two ready-to-use excipients and the model drugs enalapril maleate and hydrochlorothiazide is conducted. The different formulations are compared and the effect of ambient and stress conditions on CQAs of the ODMTs is evaluated. | |||||||
| Lizenz: |  Urheberrechtsschutz | |||||||
| Fachbereich / Einrichtung: | Mathematisch- Naturwissenschaftliche Fakultät » WE Pharmazie » Pharmazeutische Technologie und Biopharmazie | |||||||
| Dokument erstellt am: | 03.02.2022 | |||||||
| Dateien geändert am: | 03.02.2022 | |||||||
| Promotionsantrag am: | 21.12.2021 | |||||||
| Datum der Promotion: | 26.01.2022 |
