Development of 3D printed mini-waffle shapes containing hydrocortisone for children's personalized medicine

[en] Hydrocortisone is mainly used in the substitution treatment of adrenal insufficiency which results in a dysregulation of cortisol. Compounding of hydrocortisone capsules remains the only low-dose oral treatment suitable for the pediatric population. However, capsules often show non-compliance in mass and content uniformity. Three-dimensional printing offers the prospect of practising personalized medicine for vulnerable patients like children. The goal of this work is to develop low-dose solid oral forms containing hydrocortisone by hot-melt extrusion coupled with fused deposition modeling for the pediatric population. Formulation, design and processes temperatures were optimized to produce printed forms with the desired characteristics. Red mini-waffle shapes containing drug loads of 2, 5 and 8 mg were successfully printed. This new 3D design allow to release more than 80% of the drug in 45 minutes indicating a conventional release like the one obtained with capsules. Mass and content uniformity, hardness and friability tests complied with European Pharmacopeia specifications, despite the considerable challenge of the small dimensions of the forms. This study demonstrates that FDM can be used to produce innovative pediatric-friendly printed shapes of an advanced pharmaceutical quality to practice personalize medicine.

Research Center/Unit :

CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège

Disciplines :

Pharmacy, pharmacology & toxicology

Author, co-author :

Parulski, Chloé ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)

Bya, Laure-Anne ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)

Goebel, Justine; Laboratory of Pharmaceutical Technology and Biopharmacy, Center for Interdisciplinary Research on Medicines (CIRM), Department of Pharmacy, University of Liege (ULiege), Avenue Hippocrate 15, 4000 Liege, Belgium

Servais, Anne-Catherine ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments

Lechanteur, Anna ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique

Evrard, Brigitte ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique

Language :

English

Title :

Development of 3D printed mini-waffle shapes containing hydrocortisone for children's personalized medicine

Alternative titles :

[fr] Développement de mini-formes de gaufres imprimées en 3D contenant de l'hydrocortisone pour la médecine personnalisée des enfants

Original title :

[en] Development of 3D printed mini-waffle shapes containing hydrocortisone for children's personalized medicine

Publication date :

13 June 2023

Journal title :

International Journal of Pharmaceutics

ISSN :

0378-5173

eISSN :

1873-3476

Publisher :

Elsevier BV, Netherlands

Volume :

642

Issue :

123131

Peer reviewed :

Peer Reviewed verified by ORBi

Additional URL :

https://api.elsevier.com/content/article/PII:S0378517323005513?httpAccept=text/xml

Name of the research project :

Development of new oral formulations produced by hot-melt extrusion technique coupled with fused deposition modeling 3D printing

Funders :

FEDER - Fonds Européen de Développement Régional

Funding number :

884148-329407

Available on ORBi :

since 19 June 2023

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