3D printing; GMP; Hospital pharmacy; Legislation; Pharmaceutical technology; Quality assurance; Quality Control
Abstract :
[en] Three-dimensional (3D) printing technologies have been applied to manufacture a variety of medicinal products. This emerging technology holds significant potential in pharmaceutical applications, offering innovative solutions for both patients and pharmacies. In this paper, we describe the application of 3D printing in the hospital pharmacy setting. To describe the current and future role of 3D printing in hospital pharmacies, we start by discussing the relevant legislation of the three key European regulatory bodies: the European Medicines Agency (EMA, EU), the Swiss Agency for Therapeutic Products (Swissmedic, Switzerland), and the Medicines and Healthcare Products Regulatory Agency (MHRA, UK). Furthermore, we discuss critical elements of the printing process, such as quality assurance aspects of 3D printed tablets, focusing on quality management systems, process validation, and in-process controls. Additionally, we introduce three extrusion-based 3D printing techniques applicable in a clinical setting: fused deposition modelling (FDM), semi-solid extrusion (SSE), and direct powder extrusion (DPE). The different printing materials used for each technique are described, and examples of related GMP-compliant printers are given. We also address quality control measures and propose specifications for the final printed products. The information on the regulatory frameworks, quality assurance, printing techniques, and quality control is combined to develop a practical example of how extrusion-based 3D printing could be implemented in hospital pharmacy practice.
Research Center/Unit :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Ahmed, Aisha A ; Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center (LUMC), Albinusdreef 2, Leiden 2333 ZA, the Netherlands. Electronic address: a.a.ahmed@lumc.nl
Schimmel, Kirsten J M; Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center (LUMC), Albinusdreef 2, Leiden 2333 ZA, the Netherlands
Tubic-Grozdanis, Marija; University Medical Center of the Johannes Gutenberg University, Langenbeckstr.1, Mainz 55131, Germany
Tuleu, Catherine; UCL School of Pharmacy, University College London, United Kingdom
Soulairol, Ian; Department of Pharmacy, Nîmes University Hospital, Nîmes 30900, France, ICGM, CNRS, ENSCM, University of Montpellier, Montpellier 34000, France
Dadkhah, Adrin; Hospital Pharmacy and Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg 20246, Germany
Paulson, Mattias; Department of Women's and Children's Health, Uppsala University, Uppsala University Hospital Pharmacy, Uppsala 75185, Sweden
Lechanteur, Anna ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Carrez, Laurent; Pharmacy Department, Lausanne University Hospital, Switzerland
Schnor, Trine; Capital Region Pharmacy, Marielundvej 25, Herlev 2730, Denmark
Lagarce, Frederic; University Hospital of Angers - France, MINT UMR INSERM 1066/CNRS 6021 Health University, Pharmacy Department, France
Le Brun, Paul P H; Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center (LUMC), Albinusdreef 2, Leiden 2333 ZA, the Netherlands
Crauste-Manciet, Sylvie; University Hospital of Angers - France, MINT UMR INSERM 1066/CNRS 6021 Health University, Pharmacy Department, France
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