Quodbach, Julian, Bogdahn, Malte, Breitkreutz, Joerg, Chamberlain, Rebecca, Eggenreich, Karin, Elia, Alessandro Giuseppe, Gottschalk, Nadine, Gunkel-Grabole, Gesine, Hoffmann, Lena, Kapote, Dnyaneshwar, Kipping, Thomas, Klinken, Stefan, Loose, Fabian, Marquetant, Tristan, Windolf, Hellen ORCID: 0000-0001-6157-011X, Geissler, Simon and Spitz, Tilmann . Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design. Ther. Innov. Regul. Sci.. HEIDELBERG: SPRINGER HEIDELBERG. ISSN 2168-4804

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Quodbach, JulianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bogdahn, MalteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Breitkreutz, JoergUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chamberlain, RebeccaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eggenreich, KarinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Elia, Alessandro GiuseppeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gottschalk, NadineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gunkel-Grabole, GesineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoffmann, LenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kapote, DnyaneshwarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kipping, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klinken, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loose, FabianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marquetant, TristanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Windolf, HellenUNSPECIFIEDorcid.org/0000-0001-6157-011XUNSPECIFIED
Geissler, SimonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spitz, TilmannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-581968
DOI: 10.1007/s43441-021-00354-0
Journal or Publication Title: Ther. Innov. Regul. Sci.
Publisher: SPRINGER HEIDELBERG
Place of Publication: HEIDELBERG
ISSN: 2168-4804
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
HOT-MELT EXTRUSION; AMORPHOUS SOLID DISPERSIONS; PHARMACEUTICAL EXCIPIENTS; MINI-TABLETS; DRUG-RELEASE; IN-VITRO; ACCEPTABILITY; SPECTROSCOPY; CHALLENGES; STABILITYMultiple languages
Medical Informatics; Pharmacology & PharmacyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/58196

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