Impact of processing parameters on the quality of pharmaceutical solid dosage forms produced by fused deposition modelling (FDM)

Alhijjaj, Muqdad, Nasereddin, Jehad, Belton, Peter and Qi, Sheng (2019) Impact of processing parameters on the quality of pharmaceutical solid dosage forms produced by fused deposition modelling (FDM). Pharmaceutics, 11 (12). ISSN 1999-4923

[img] PDF (pharmaceutics_636051_REVISED_SQ_1811) - Submitted Version
Restricted to Repository staff only until 31 December 2099.

Download (1MB) | Request a copy
[img]
Preview
PDF (pharmaceutics-11-00633) - Published Version
Available under License Creative Commons Attribution.

Download (2MB) | Preview

Abstract

Fused deposition modeling (FDM) 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.

Item Type: Article
Faculty \ School: Faculty of Science > School of Pharmacy
Faculty of Science > School of Chemistry
Depositing User: LivePure Connector
Date Deposited: 27 Nov 2019 02:02
Last Modified: 30 Jun 2020 00:04
URI: https://ueaeprints.uea.ac.uk/id/eprint/73141
DOI: 10.3390/pharmaceutics11120633

Actions (login required)

View Item View Item