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

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    Publication date
    2018-10-05
    Author
    Trenfield, S.J.
    Goyanes, A.
    Telford, Richard
    Wilsdon, D.
    Rowland, M.
    Gaisford, S.
    Basit, A.W.
    Keyword
    3D printing
    Additive manufacturing
    Process analytical technology (PAT)
    Oral drug delivery systems
    Printlets
    Digital healthcare
    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/).
    Peer-Reviewed
    Yes
    
    Metadata
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    Abstract
    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.
    URI
    http://hdl.handle.net/10454/16553
    Version
    published version paper
    Citation
    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 publisher’s version
    https://doi.org/10.1016/j.ijpharm.2018.08.002
    Type
    Article
    Collections
    Life Sciences Publications

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