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Quality Control of 3D Printed Pharmaceuticals using Process Analytical Technologies

Trenfield, Sarah Jane; (2021) Quality Control of 3D Printed Pharmaceuticals using Process Analytical Technologies. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

Three-dimensional (3D) printing is forecast to cause a paradigm shift in pharmaceuticals, transitioning away from a ‘one-size-fits-all’ treatment approach towards personalised medicine. However, a major barrier to clinical integration lies in the inability to ensure the quality of the 3D printed tablets. Current quality control (QC) methods are inherently destructive, which would be unsuitable for the real-time release of printed medicines at the point-of-care. As such, this PhD thesis aims to evaluate the ability of process analytical technologies (PAT), including near infrared (NIR), Raman and terahertz spectroscopy, to act as alternative non-destructive QC methods for 3D printed medicines produced using selective laser sintering (SLS). The major findings were as follows: 1) NIR spectroscopy enabled the dose quantification of a single drug (paracetamol) and two distinct drugs (amlodipine and lisinopril) in a rapid, point-and-shoot process. Raman microscopy was found suitable to evaluate the drug distribution and solid-state characteristics across the dosage form surface and cross-section; 2) Amorphous solid dispersions of a BCS II drug (itraconazole) were produced using SLS 3D printing. Amorphous quantification was successful using NIR spectroscopy and Raman spectroscopy, which were comparable to reference x-ray powder diffraction (XRPD) analysis; 3) Laser scanning speed has a significant impact of 3D printed drug product density and drug release. Due to the different surface presentations of the dosage forms, preliminary data showed that FT-NIR spectroscopy may be a promising tool for the prediction of density and drug release. Overall, for the first time, this research demonstrates the potential for PAT technologies to undertake QC of 3D printed pharmaceuticals, overcoming a major barrier and hence supporting the integration of this technology into the clinic.

Type: Thesis (Doctoral)
Qualification: Ph.D
Title: Quality Control of 3D Printed Pharmaceuticals using Process Analytical Technologies
Event: UCL
Language: English
Additional information: Copyright © The Author 2021. Original content in this thesis is licensed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) Licence (https://creativecommons.org/licenses/by-nc/4.0/). Any third-party copyright material present remains the property of its respective owner(s) and is licensed under its existing terms. Access may initially be restricted at the author’s request.
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
URI: https://discovery.ucl.ac.uk/id/eprint/10126553
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