AccScience Publishing / IJB / Online First / DOI: 10.36922/ijb.4063
REVIEW
Early Access

The promising role of semi-solid extrusion technology in custom drug formulation for pediatric medicine

Thomas Cerveto1 Lucas Denis2, 3 Maxime Stoops2 Anna Lechanteur4 Christine Jérôme5 Julien Leenhardt6, 7, 8 Stephen Flynn9 Alvaro Goyanes10, 11, 12 Roseline Mazet6 * Maxime Annereau2 * Luc Choisnard1
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1 Univ. Grenoble Alpes, CNRS, DPM, UMR 5063, Grenoble 38000, France
2 Clinical Pharmacy Department, Gustave Roussy Cancer Campus, Villejuif 94800, France.
3 Univ. Paris Saclay, CNRS, Institut Galien Paris-Saclay, UMR 8612, 91400 Orsay, France.
4 Laboratory of Pharmaceutical Technology and Biopharmacy, Center for Interdisciplinary Research on Medicines (CIRM), Université de Liège, 4000 Liège, Belgium
5 CESAM Research Unit, Center for Education and Research on Macromolecules (CERM), University of Liège, B-4000 Liège, Belgium
6 Pharmacy Department, CHU Grenoble Alpes, Grenoble 38000, France
7 Nuclear Medicine Department, CHU Grenoble Alpes, Grenoble 38000, France
8 Univ. Grenoble Alpes, INSERM, LRB, UMR 1039, Grenoble 38000, France
9 Roquette Frères, Jumeauville, Île-de-France, France
10 Department of Pharmacology, Pharmacy and Pharmaceutical Technology, Paraquasil Group, Faculty of Pharmacy, University of Santiago de Compostela (USC), and Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela 15782, Spain
11 Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK
12 FabRx Ltd., 3 Romney Road, Ashford, Kent TN24 0RW, UK
Submitted: 27 June 2024 | Accepted: 7 August 2024 | Published: 29 August 2024
(This article belongs to the Special Issue Advanced Biomaterials for 3D Printing and Healthcare Application)
© 2024 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
Abstract

The long-standing issue of inadequate medicine formulations has been a focus of regulatory bodies and pharmaceutical research, particularly in adapting medicines for children’s unique requirements. The pediatric population presents diverse challenges in pharmacotherapy due to their varying age-related physiological differences, taste and dosage form preferences. Conventional formulations often fail to meet these needs, leading to high prevalence of off-label medication use and modifications by caregivers, which can compromise drug efficacy and safety. The well-known problems of managing children's medication are very similar to those encountered in geriatrics, which also require doses to be adapted to the patient's pathophysiological characteristics to avoid deglutination problems. This paper explores recent innovations in drug formulations, highlighting the shift from traditional liquid formulations to solid dosages through 3D printing technology. Recent advancements in 3D printing technology offer promising solutions to these challenges. Additive manufacturing (AM), or 3D printing, facilitates the creation of complex objects including drug formulations, directly from digital models, allowing for high precision and customization. 3D printed formulations have shown considerable promise in improving palatability, adherence, and dose accuracy for pediatric use. Innovations like chewable tablets and taste-masked formulations make medications more acceptable to children. Moreover, the ability of 3D printing to adjust drug release profiles and doses offers a personalized approach to pediatric and geriatric pharmacotherapy, essential for conditions requiring tight therapeutic control. The paper discusses several case studies based on the semi-solid extrusion (SSE) process that enables the production of personalized dosage forms and the various technical and regulatory challenges to implementing this process in hospitals for drug manufacturing.  In conclusion, while 3D printing in pediatric and geriatric pharmacotherapy addresses many challenges of traditional drug formulations, ongoing research and adaptation of regulatory frameworks are necessary to expand its application, ensuring safer, more effective, and more acceptable medication.

Keywords
Unlicensed preparation
3D printing
Pediatrics
Semi-solid extrusion
Hospital preparation
Personalized medicines
Funding
This work was partially supported by Agence Nationale de la Recherche through Labex ARCANE and CBH-EUR-GS (ANR-17-EURE-0003).
Conflict of interest
The authors declare they have no competing interests
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International Journal of Bioprinting, Electronic ISSN: 2424-8002 Print ISSN: 2424-7723, Published by AccScience Publishing