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dc.contributor.authorTrenfield, S.J.
dc.contributor.authorGoyanes, A.
dc.contributor.authorTelford, Richard
dc.contributor.authorWilsdon, D.
dc.contributor.authorRowland, M.
dc.contributor.authorGaisford, S.
dc.contributor.authorBasit, A.W.
dc.date.accessioned2018-08-28T13:32:15Z
dc.date.available2018-08-28T13:32:15Z
dc.date.issued2018-10-05
dc.identifier.citationTrenfield SJ, Goyanes A, Telford R (et al) 2018 3D printed drug products: Non-destructive dose verification using a rapid point-and-shoot approach. International Journal of Pharmaceutics. 549(1-2): 283-292.en_US
dc.identifier.urihttp://hdl.handle.net/10454/16553
dc.descriptionYesen_US
dc.description.abstractThree-dimensional printing (3DP) has the potential to cause a paradigm shift in the manufacture of pharmaceuticals, enabling personalised medicines to be produced on-demand. To facilitate integration into healthcare, non-destructive characterisation techniques are required to ensure final product quality. Here, the use of process analytical technologies (PAT), including near infrared spectroscopy (NIR) and Raman confocal microscopy, were evaluated on paracetamol-loaded 3D printed cylindrical tablets composed of an acrylic polymer (Eudragit L100-55). Using a portable NIR spectrometer, a calibration model was developed, which predicted successfully drug concentration across the range of 4–40% w/w. The model demonstrated excellent linearity (R2 = 0.996) and accuracy (RMSEP = 0.63%) and results were confirmed with conventional HPLC analysis. The model maintained high accuracy for tablets of a different geometry (torus shapes), a different formulation type (oral films) and when the polymer was changed from acrylic to cellulosic (hypromellose, HPMC). Raman confocal microscopy showed a homogenous drug distribution, with paracetamol predominantly present in the amorphous form as a solid dispersion. Overall, this article is the first to report the use of a rapid ‘point-and-shoot’ approach as a non-destructive quality control method, supporting the integration of 3DP for medicine production into clinical practice.en_US
dc.description.sponsorshipOpen Access funded by Engineering and Physical Sciences Research Council United Kingdom (EPSRC), UK for their financial support (EP/L01646X).en_US
dc.language.isoenen_US
dc.relation.isreferencedbyhttps://doi.org/10.1016/j.ijpharm.2018.08.002en_US
dc.rights© 2018 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/BY/4.0/).en_US
dc.subject3D printingen_US
dc.subjectAdditive manufacturingen_US
dc.subjectProcess analytical technology (PAT)en_US
dc.subjectOral drug delivery systemsen_US
dc.subjectPrintletsen_US
dc.subjectDigital healthcareen_US
dc.title3D printed drug products: Non-destructive dose verification using a rapid point-and-shoot approachen_US
dc.status.refereedYesen_US
dc.date.Accepted2018-08-01
dc.date.application2018-08-02
dc.typeArticleen_US
dc.type.versionpublished version paperen_US
refterms.dateFOA2018-08-28T13:32:18Z


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