Dokument: Manufacturing of solid dosage forms using pressure-assisted microsyringe 3D-printing
| Titel: | Manufacturing of solid dosage forms using pressure-assisted microsyringe 3D-printing | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=56050 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20210427-104835-3 | |||||||
| Kollektion: | Dissertationen | |||||||
| Sprache: | Englisch | |||||||
| Dokumententyp: | Wissenschaftliche Abschlussarbeiten » Dissertation | |||||||
| Medientyp: | Text | |||||||
| Autor: | El Aita, Ilias [Autor] | |||||||
| Dateien: |
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| Beitragende: | Prof. Dr. Breitkreutz, Jörg [Gutachter] Prof. Dr. Dr. Kleinebudde, Peter [Gutachter] | |||||||
| Stichwörter: | 3D-printing, solid dosage forms, individualized medicine | |||||||
| Dewey Dezimal-Klassifikation: | 500 Naturwissenschaften und Mathematik » 570 Biowissenschaften; Biologie | |||||||
| Beschreibung: | Over the past years 3D-printing has emerged as a promising manufacturing process for pharmaceutical dosage forms. The term 3D-printing covers several different printing technologies, which differ in the required starting material, the used printer as well as in the mode of solidification. For the present thesis, pressure-assisted microsyringe (PAM) printing was identified as a potential on-site manufacturing process of dosage forms in pharmacies and hospital pharmacies. Compared to further printing technologies, PAM printing requires semi-solid formulations as starting material. Further, the process can be conducted at room temperature enabling the processing of thermo-sensitive active pharmaceutical ingredients (API). Due to the nature of the printing process, a drying step has to be implemented into the overall manufacturing cascade. For the current thesis, levetiracetam, an antiepileptic drug, was used as API.
In the first phase of the thesis, a printing formulation consisting of the API, a polymer and water as solvent was developed successfully. Tablets were printed reproducible regarding the resulting mass and assay. Further, the drying process was characterized intensively in order to optimize the drying time. Printed tablets of this study were robust towards an applied mechanical stress and revealed an immediate drug release. Additionally, it could be demonstrated that changes of the printing formulation, for example by adding a further polymer, result in changes of the drug release behavior. The gained knowledge about the printing process as well as of the formulation development were transferred further to manufacture age-appropriate dosage forms using PAM printing based on a novel individualization concept. The implemented individualization concept enables the fast adaption of the required amount of levetiracetam based on the respective body weight of selected paediatric sub-populations. The success of the calibration model was displayed especially by the achieved acceptance value (AV). Beside the establishment of an individualization concept for the levetiracetam dose, the dependency of the drug release on the SA/V ratio of printed tablets was demonstrated. By increasing the SA/V ratio, the drug release rate of the dosage forms was also increased. This demonstrated the ability of adjusting the drug release behavior as needed. In order to reduce the production time as well as the production costs, a storable formulation was further developed successful. Storable printing formulations would enable manufacturer to manufacture a stock formulation, which might be used to print dosage forms when needed. It could be shown that the printability of storable printing formulation as well as the properties of printed tablets were not affected by the storage. Furthermore, the drug release rate of printed tablets could be manipulated successfully by varying the amount of incorporated HMPC as well as changing the infill design of printed tablets. | |||||||
| Lizenz: |  Urheberrechtsschutz | |||||||
| Fachbereich / Einrichtung: | Mathematisch- Naturwissenschaftliche Fakultät » WE Pharmazie » Pharmazeutische Technologie und Biopharmazie | |||||||
| Dokument erstellt am: | 27.04.2021 | |||||||
| Dateien geändert am: | 27.04.2021 | |||||||
| Promotionsantrag am: | 15.01.2021 | |||||||
| Datum der Promotion: | 26.03.2021 |
