2026-04-13T03:39:31Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/122332025-10-24T10:29:44Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Rodríguez Pombo, Lucía
author
Gallego-Fernández, Concepción
author
Jørgensen, Anna Kirstine
author
Cañete Ramirez, Carme
author
Parramón-Teixidó, Carlos Javier
author
Cabañas Poy, Mª José
2025-10-24T10:29:44Z
2025-10-24T10:29:44Z
2024-11-19T08:17:13Z2024-11-19T08:17:13Z2024-09
http://hdl.handle.net/11351/12233
3D printed medications; Chewable drug; PaediatricsMedicaments impresos en 3D; Medicaments masticables; PediatriaMedicamentos impresos en 3D; Medicamentos masticables; PediatríaBackground
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.This paper was funded by the UK Research and Innovation, the Engineering and Physical Sciences Research Council [EP/S023054/1], and the Ministerio de Universidades [FPU20/01245].
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
Glàndules suprarenals - Malalties - Tractament
Hidrocortisona
Medicina personalitzada
Impressió 3D
DISEASES::Endocrine System Diseases::Adrenal Gland Diseases::Adrenal Insufficiency::Addison Disease
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Polycyclic Compounds::Fused-Ring Compounds::Steroids::Pregnanes::Pregnenes::Pregnenediones::Hydrocortisone
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Precision Medicine
TECHNOLOGY, INDUSTRY, AND AGRICULTURE::Technology, Industry, and Agriculture::Technology::Printing, Three-Dimensional
ENFERMEDADES::enfermedades del sistema endocrino::enfermedades de las glándulas suprarrenales::insuficiencia suprarrenal
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::compuestos policíclicos::compuestos con anillos de fusión::esteroides::pregnanos::pregnenos::pregnenodionas::hidrocortisona
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::medicina de precisión
TECNOLOGÍA, INDUSTRIA Y AGRICULTURA::tecnología, industria y agricultura::tecnología::impresión tridimensional
3D printed personalized therapies for pediatric patients affected by adrenal insufficiency
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion