Evidence map›Paper›PMID 41599110›Full record

ReviewPharmaceutics2025

Three-Dimensionally Printed Paediatric Medicines: Formulation, Process, and Regulatory Considerations.

Krisztina Petrinca, Zsófia Németh, Ildikó Csóka, Rita Ambrus, Orsolya Jójárt-Laczkovich

Abstract readReview
In one paragraph

Review in Pharmaceutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Krisztina PetrincaInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös Street 6, 6720 Szeged, Hungary.
Zsófia NémethInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös Street 6, 6720 Szeged, Hungary.ORCID 0000-0003-3953-9831
Ildikó CsókaInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös Street 6, 6720 Szeged, Hungary.ORCID 0000-0003-0807-2781
Rita AmbrusInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös Street 6, 6720 Szeged, Hungary.ORCID 0000-0001-5496-1710
Orsolya Jójárt-LaczkovichInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös Street 6, 6720 Szeged, Hungary.ORCID 0000-0003-1846-5925

Funding

National Academy of Scientist Education Program of the National Biomedical Foundation under the sponsorship of the Hungarian Ministry of Culture and Innovation TKP2021-EGA-32
6 · The paper itself

Abstract

Paediatric formulations are pharmaceutical dosage forms specifically designed to meet the physiological, developmental, pharmacokinetic, and practical needs of patients from birth to adolescence. Developing safe, effective, and age-appropriate medicines for children remains a significant challenge due to their age-dependent variability in physiological development, pharmacokinetic profiles, and therapeutic needs. These differences, combined with practical barriers such as poor palatability, limited swallowability, inappropriate dosage form size, and instability, often lead to the modification of adult medicines-practices that can cause dosing inaccuracies, contamination risks, and reduced therapeutic efficacy. Three-dimensional printing has emerged as a promising solution to address these limitations by creating personalised paediatric dosage forms with adjustable strengths, multilayer structures for controlled release, and child-friendly shapes that may improve acceptability and adherence. This review offers an overview of the physiological, technological, and regulatory factors involved in developing 3D-printed paediatric medicines. The Critical Quality and Performance Attributes relevant to this field-including dose accuracy and flexibility, release kinetics, palatability, product dimensions, material choice, safety, stability, cost-effectiveness, production time, scalability, and reproducibility-are discussed in the article. Additionally, the review discusses the evolving Good Manufacturing Practice and regulatory landscape necessary to ensure the quality, safety, and consistency of 3D-printed medicinal products. Overall, these insights underline the transformative potential of 3D printing as a pathway towards safer, more effective, and truly personalised pharmacotherapy for paediatric patients.

Indexed as

3D-printed medicine3D printingindividualised therapypaediatric dosage formspaediatrics

Identifiers

PMID41599110
PMCPMC12844787

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.