Rodríguez-Pombo, Lucía;
Gallego-Fernández, Concepción;
Jørgensen, Anna Kirstine;
Parramon-Teixidó, Carlos Javier;
Cañete-Ramirez, Carme;
Cabañas-Poy, Maria Josep;
Basit, Abdul W;
... Goyanes, Alvaro; + view all
(2024)
3D printed personalized therapies for pediatric patients affected by adrenal insufficiency.
Expert Opinion on Drug Delivery
10.1080/17425247.2024.2399706.
(In press).
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Abstract
BACKGROUND: Adrenal insufficiency is usually diagnosed in children who will need lifelong hydrocortisone therapy. However, medicines for pediatrics, in terms of dosage and acceptability, are currently unavailable. RESEARCH DESIGN AND METHODS: Semi-solid extrusion (SSE) 3D printing (3DP) was utilized for manufacturing of personalized and chewable hydrocortisone formulations (printlets) for an upcoming clinical study in children at Vall d'Hebron University Hospital in Barcelona, Spain. The 3DP process was validated using a specific software for dynamic dose modulation. RESULTS: The printlets contained doses ranging from 1 to 6 mg hydrocortisone in three different flavor and color combinations to aid adherence among the pediatric patients. The pharma-ink (mixture of drugs and excipients) was assessed for its rheological behavior to ensure reproducibility of printlets through repeated printing cycles. The printlets showed immediate hydrocortisone release and were stable for 1 month of storage, adequate for prescribing instructions during the clinical trial. CONCLUSIONS: The results confirm the suitability and safety of the developed printlets for use in the clinical trial. The required technical information from The Spanish Medicines Agency for this clinical trial application was compiled to serve as guidelines for healthcare professionals seeking to apply for and conduct clinical trials on 3DP oral dosage forms.
| Type: | Article |
|---|---|
| Title: | 3D printed personalized therapies for pediatric patients affected by adrenal insufficiency |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1080/17425247.2024.2399706 |
| Publisher version: | http://dx.doi.org/10.1080/17425247.2024.2399706 |
| Language: | English |
| Additional information: | © 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent. |
| Keywords: | 3D printed medications, Direct ink writing 3D printing, additive manufacturing of medicines, chewable drug delivery systems, hydrocortisone formulations for children, oral drug products for paediatrics, patient acceptability of pharmaceuticals, personalised pharma-inks |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10197674 |
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