3D printed drug products: Non-destructive dose verification using a rapid point-and-shoot approach

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Publication date
2018-10-05Keyword
3D printingAdditive manufacturing
Process analytical technology (PAT)
Oral drug delivery systems
Printlets
Digital healthcare
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© 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/).Peer-Reviewed
YesOpen Access status
openAccessAccepted for publication
2018-08-01
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Show full item recordAbstract
Three-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.Version
Published versionCitation
Trenfield 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.Link to Version of Record
https://doi.org/10.1016/j.ijpharm.2018.08.002Type
Articleae974a485f413a2113503eed53cd6c53
https://doi.org/10.1016/j.ijpharm.2018.08.002