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

Publication date: Available online 2 August 2018Source: International Journal of PharmaceuticsAuthor(s): Sarah J Trenfield, Alvaro Goyanes, Richard Telford, David Wilsdon, Martin Rowland, Simon Gaisford, Abdul W BasitAbstractThree-dimensional printing (3DP) has the potential to cause a paradigm shift in 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 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 dosage form type (oral films) and when the polymer composition 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-shootâ€...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research