Evidence map›Paper›PMID 34826120›Full record

ReviewTherapeutic innovation & regulatory science2022

Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design.

Julian Quodbach, Malte Bogdahn, Jörg Breitkreutz, Rebecca Chamberlain, Karin Eggenreich, Alessandro Giuseppe Elia, Nadine Gottschalk, Gesine Gunkel-Grabole, Lena Hoffmann, Dnyaneshwar Kapote and 7 more

Open access · hybridAbstract readReview
In one paragraph

Review in Therapeutic innovation & regulatory science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
5.3field-weighted citation impact, top 3% of its field
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

34 citing papers in PubMed, 78 citations in OpenAlex.

  1. Article
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  6. Nano-Based 3D Printed Scaffold for Bone Tissue Engineering.Bioengineering (Basel, Switzerland) · 2026
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  17. A case study on decentralized manufacturing of 3D printed medicines.International journal of pharmaceutics: X · 2023
    Article
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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

17 authors at 3 institutions in 1 country.

Julian QuodbachInstitute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany. julian.quodbach@hhu.de.ORCID http://orcid.org/0000-0003-2471-4502
Malte BogdahnMerck Healthcare KGaA, Frankfurter Str. 250, Darmstadt, Germany.
Jörg BreitkreutzInstitute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany.
Rebecca ChamberlainInstitute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany.
Karin EggenreichGen-Plus GmbH & Co. KG, Staffelseestr. 6, München, Germany.
Alessandro Giuseppe EliaMerck Life Science KGaA, Frankfurter Str. 250, Darmstadt, Germany.
Nadine GottschalkMerck Healthcare KGaA, Frankfurter Str. 250, Darmstadt, Germany.
Gesine Gunkel-GraboleMerck Life Science KGaA, Frankfurter Str. 250, Darmstadt, Germany.
Lena HoffmannInstitute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany.
Dnyaneshwar KapoteGen-Plus GmbH & Co. KG, Staffelseestr. 6, München, Germany.
Thomas KippingMerck Life Science KGaA, Frankfurter Str. 250, Darmstadt, Germany.
Stefan KlinkenInstitute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany.
Fabian LooseLaboratory for Manufacturing Systems, University of Applied Sciences Cologne, Betzdorfer Str. 2, 50679, Cologne, Germany.
Tristan MarquetantMerck Life Science KGaA, Frankfurter Str. 250, Darmstadt, Germany.
Hellen WindolfInstitute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225, Düsseldorf, Germany.
Simon GeißlerMerck Healthcare KGaA, Frankfurter Str. 250, Darmstadt, Germany.
Tilmann SpitzLaboratory for Manufacturing Systems, University of Applied Sciences Cologne, Betzdorfer Str. 2, 50679, Cologne, Germany.
Merck (Germany) · DEHeinrich Heine University Düsseldorf · DETH Köln - University of Applied Sciences · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

3d printing is capable of providing dose individualization for pediatric medicines and translating the precision medicine approach into practical application. In pediatrics, dose individualization and preparation of small dosage forms is a requirement for successful therapy, which is frequently not possible due to the lack of suitable dosage forms. For precision medicine, individual characteristics of patients are considered for the selection of the best possible API in the most suitable dose with the most effective release profile to improve therapeutic outcome. 3d printing is inherently suitable for manufacturing of individualized medicines with varying dosages, sizes, release profiles and drug combinations in small batch sizes, which cannot be manufactured with traditional technologies. However, understanding of critical quality attributes and process parameters still needs to be significantly improved for this new technology. To ensure health and safety of patients, cleaning and process validation needs to be established. Additionally, adequate analytical methods for the in-process control of intermediates, regarding their printability as well as control of the final 3d printed tablets considering any risk of this new technology will be required. The PolyPrint consortium is actively working on developing novel polymers for fused deposition modeling (FDM) 3d printing, filament formulation and manufacturing development as well as optimization of the printing process, and the design of a GMP-capable FDM 3d printer. In this manuscript, the consortium shares its views on quality aspects and measures for 3d printing from drug-loaded filaments, including formulation development, the printing process, and the printed dosage forms. Additionally, engineering approaches for quality assurance during the printing process and for the final dosage form will be presented together with considerations for a GMP-capable printer design.

Indexed as

PolymersPrinting, Three-DimensionalChildDrug CombinationsDrug LiberationHumansSolubilityDrug CombinationsPolymers

Identifiers

PMID34826120
PMCPMC9492703
OpenAlexW3215279303

What OpenQuestion 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 OpenQuestion graph.