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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 Grenoble Alpes University and Centre National de la Recherche Scientifique (CNRS; French National Centre for Scientific Research), Département de Pharmacochimie Moléculaire (DPM; Department of Molecular Pharmacochemistry), Unité Mixte de Recherche (UMR; Mixed Research Unit), Grenoble, France
2 Clinical Pharmacy Department, Gustave Roussy Cancer Campus, Villejuif, France
3 Paris-Saclay University and CNRS, Institut Galien Paris-Saclay, UMR, Orsay, France
4 Laboratory of Pharmaceutical Technology and Biopharmacy, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, Liège, Belgium
5 CESAM Research Unit, Center for Education and Research on Macromolecules (CERM), University of Liège, Liège, Belgium
6 Pharmacy Department, Centre Hospitalier Universitaire (CHU; University Hospital Center) Grenoble Alpes, Grenoble, France
7 Nuclear Medicine Department, CHU Grenoble Alpes, Grenoble, France
8 Grenoble Alpes University, Institut National de la Santé et de la Recherche Médicale (INSERM; National Institute of Health and Medical Research), Laboratoire de Recherche sur les Maladies Cardiovasculaires (LRB; Cardiovascular Diseases Research Laboratory), UMR, Grenoble, France
9 Global Pharma Marketing service, Roquette Frères, Lestrem, France
10 Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Instituto de Materiales (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, Santiago de Compostela, Spain
11 Department of Pharmaceutics, UCL School of Pharmacy, University College London, Brunswick Square, London, UK
12 FABRX Ltd., Henwood House, Henwood, Ashford, Kent, UK
IJB 2024, 10(6), 4063 https://doi.org/10.36922/ijb.4063
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/ )
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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, and taste and dosage form preferences. Conventional formulations often fail to meet these needs, leading to a high prevalence of off-label medication use and modifications by caregivers, which can compromise drug efficacy and safety. The well-known challenges of managing children’s medication are similar to those in geriatrics, both of which require dose adjustments to accommodate the patient’s pathophysiological characteristics and prevent deglutination problems. This paper explores recent innovations in drug formulations, highlighting the shift from traditional liquid formulations to solid dosages through three-dimensional (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 (e.g., drug formulations) directly from digital models, allowing for high precision and customization. 3D-printed formulations have displayed 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, which is essential for managing conditions that require precise therapeutic control. The paper discusses several case studies using the semi-solid extrusion (SSE) process for producing personalized dosage forms, along with various technical and regulatory challenges associated with implementing this process in hospital-based 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.

 

Graphical abstract
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
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