Regulations on excipients used in 3D printing of pediatric oral forms.

Autor: Monteil M; ICGM, Univ Montpellier, CNRS, ENSCM, Montpellier, France., M Sanchez-Ballester N; ICGM, Univ Montpellier, CNRS, ENSCM, Montpellier, France; Department of Pharmacy, Nîmes University Hospital, Nîmes, France., Devoisselle JM; ICGM, Univ Montpellier, CNRS, ENSCM, Montpellier, France., Begu S; ICGM, Univ Montpellier, CNRS, ENSCM, Montpellier, France. Electronic address: sylvie.begu@umontpellier.fr., Soulairol I; ICGM, Univ Montpellier, CNRS, ENSCM, Montpellier, France; Department of Pharmacy, Nîmes University Hospital, Nîmes, France. Electronic address: ian.soulairol@montpellier.fr.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2024 Sep 05; Vol. 662, pp. 124402. Date of Electronic Publication: 2024 Jul 01.
DOI: 10.1016/j.ijpharm.2024.124402
Abstrakt: A promising solution to customize oral drug formulations for the pediatric population has been found in the use of 3D printing, in particular Fused Deposition Modeling (FDM) and Semi-Solid Extrusion (SSE). Although formulation development is currently limited to research studies, the rapid advances in 3D printing warn of the need for regulation. Indeed, even if the developed formulations include pharmaceutical excipients used to produce traditional oral forms such as tablets, the quantities of excipients used must be adapted to the process. Therefore, the aim of this literature review is to provide a synthesis of the available safety data on excipients mainly used in extrusion-based 3D printing for the pediatric population. A total of 39 relevant articles were identified through two scientific databases (PubMed and Science Direct). Then, groups of the main excipients were listed including their general information (name, chemical structure and pharmaceutical use) and a synthesis of the available safety data extracted from several databases. Finally, the role of the excipients in 3D printing, the amount used in formulations and the oral dose administered per form are presented.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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