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Open AccessArticle

Impact of Processing Parameters on the Quality of Pharmaceutical Solid Dosage Forms Produced by Fused Deposition Modeling (FDM)

by Muqdad Alhijjaj 1,2,†, Jehad Nasereddin 1,†, Peter Belton 3 and Sheng Qi 1,*
1
School of Pharmacy, University of East Anglia, Norwich, Norfolk NR4 7TJ, UK
2
College of Pharmacy, University of Basrah, Basrah 61004, Iraq
3
School of Chemistry, University of East Anglia, Norwich, Norfolk NR4 7TJ, UK
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Pharmaceutics 2019, 11(12), 633; https://doi.org/10.3390/pharmaceutics11120633
Received: 23 October 2019 / Revised: 18 November 2019 / Accepted: 25 November 2019 / Published: 27 November 2019
(This article belongs to the Special Issue 3D Printing of Pharmaceuticals and Drug Delivery Devices)
Fused deposition modeling (FDM) three-dimensional (3D) printing is being increasingly explored as a direct manufacturing method to product pharmaceutical solid dosage forms. Despite its many advantages as a pharmaceutical formulation tool, it remains restricted to proof-of-concept formulations. The optimization of the printing process in order to achieve adequate precision and printing quality remains to be investigated. Demonstrating a thorough understanding of the process parameters of FDM and their impact on the quality of printed dosage forms is undoubtedly necessary should FDM advance from a proof-of-concept stage to an adapted pharmaceutical manufacturing tool. This article describes the findings of an investigation into a number of critical process parameters of FDM and their impact on quantifiable, pharmaceutically-relevant measures of quality. Polycaprolactone, one of the few polymers which is both suitable for FDM and is a GRAS (generally regarded as safe) material, was used to print internally-exposed grids, allowing examination of both their macroscopic and microstructural reproducibility of FDM. Of the measured quality parameters, dimensional authenticity of the grids was found to poorly match the target dimensions. Weights of the grids were found to significantly vary upon altering printing speed. Printing temperature showed little effect on weight. Weight uniformity per batch was found to lie within acceptable pharmaceutical quality limits. Furthermore, we report observing a microstructural distortion relating to printing temperature which we dub The First Layer Effect (FLE). Principal Component Analysis (PCA) was used to study factor interactions and revealed, among others, the existence of an interaction between weight/dosing accuracy and dimensional authenticity dictating a compromise between the two quality parameters. The Summed Standard Deviation (SSD) is proposed as a method to extract the optimum printing parameters given all the perceived quality parameters and the necessary compromises among them. View Full-Text
Keywords: Fused Deposition Modeling 3D Printing; processing parameters; pharmaceutical quality control; hot-melt extrusion; solid dosage forms Fused Deposition Modeling 3D Printing; processing parameters; pharmaceutical quality control; hot-melt extrusion; solid dosage forms
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MDPI and ACS Style

Alhijjaj, M.; Nasereddin, J.; Belton, P.; Qi, S. Impact of Processing Parameters on the Quality of Pharmaceutical Solid Dosage Forms Produced by Fused Deposition Modeling (FDM). Pharmaceutics 2019, 11, 633.

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