Dokument: Individualised Medicines by Pharmaceutical Inkjet Printing onto Orodispersible Films

Titel:Individualised Medicines by Pharmaceutical Inkjet Printing onto Orodispersible Films
URL für Lesezeichen:https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=59374
URN (NBN):urn:nbn:de:hbz:061-20220504-080147-2
Kollektion:Dissertationen
Sprache:Englisch
Dokumententyp:Wissenschaftliche Abschlussarbeiten » Dissertation
Medientyp:Text
Autor: Kiefer, Olga [Autor]
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Dateien vom 03.05.2022 / geändert 03.05.2022
Beitragende:Prof. Dr. Breitkreutz, Jörg [Gutachter]
Prof. Dr. Seidlitz, Anne [Gutachter]
Stichwörter:inkjet printing, orodispersible films, individualised medicine
Dewey Dezimal-Klassifikation:600 Technik, Medizin, angewandte Wissenschaften » 610 Medizin und Gesundheit
Beschreibung:The aim of the present work was to use inkjet printing as liquid dosing technique to prepare customised orodispersible films on demand. By combining this innovative dosage form with the new flexible API loading technology, a prospective solution has been established that enables an individualised drug therapy. With the utilisation of metoprolol tartrate and L-thyroxine as APIs, a broad patient group range was intended to be addressed.

First, different pharmaceutical ink formulations were developed. It turned out that the choice of suitable excipients is limited. Drug-free inks were used to gain prior knowledge of printing behaviour and were used for comparison purposes.
Inks containing metoprolol tartrate and L-thyroxine were used to test different drug dosing strategies. It was found that an effective increase in dose of the final product by means of increased ink concentration is limited due to resulting significant change in physicochemical properties. Print resolution proves to be a useful parameter for dose control. Nozzle aging necessitates a calibration step prior to each batch manufacturing to ensure accurate dosing. The print head’s number of nozzles and their arrangement can limit the print resolution range and thus the possible dosages at a given ink concentration.
Confocal Raman microscopy, optical high shear viscosimetry based on microfluidic chip system and stroboscopic drop view were implemented as analytic methods for ink characterisation. Together with the quantification of the API content by HPLC, these provide a more tangible overview for pharmaceutical purposes than the dimensionless numbers commonly used to merely predict the printability of inks.

Two different industrial print heads, KM512SHX and Spectra SE-128 AA, were compared with regard to their suitability for pharmaceutical applications. A design of experiments was conducted to identify the key factors on resulted quantities and to evaluate the performance of the print heads. Print heads with lower native resolution but larger nozzle diameter are not disadvantageous per se, although it has been found that lower negative pressure is required to hold the ink meniscus.

Fundamental studies on the solvent casting process of orodispersible films were conducted generating new mechanistic insights. The chromatic confocal optical sensor proved to be a useful tool for monitoring film thickness not only during coating, as shown previously, but also during the drying process. In order to optimise orodispersible film formulations for inkjet applications in terms of absorption capacity, various additives and incorporation techniques were investigated. It was found that a particle enriched surface independent from the additive type is advantageous.

The acquired knowledge could be used to conceptualise a general workflow for the development of ink formulations and film substrates as well as pharmaceutical inkjet printing process.
In conclusion, inkjet printing for API deposition on orodispersible films was successfully examined in the present thesis. Deepening process understanding in the pharmaceutical field contributes to the advances in individualised medicines. Nevertheless, multi-disciplinary collaborations between pharmacists, pharmaceutical technologists, engineers and inkjet printing experts are crucial for the further progress and success of this innovative approach.
Lizenz:In Copyright
Urheberrechtsschutz
Fachbereich / Einrichtung:Mathematisch- Naturwissenschaftliche Fakultät » WE Pharmazie » Pharmazeutische Technologie und Biopharmazie
Dokument erstellt am:04.05.2022
Dateien geändert am:04.05.2022
Promotionsantrag am:06.01.2022
Datum der Promotion:03.03.2022
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