TY  - JOUR
U1  - Zeitschriftenartikel, wissenschaftlich - begutachtet (reviewed)
A1  - Quodbach, Julian
A1  - Bogdahn, Malte
A1  - Breitkreutz, Jörg
A1  - Chamberlain, Rebecca
A1  - Eggenreich, Karin
A1  - Elia, Alessandro Giuseppe
A1  - Gottschalk, Nadine
A1  - Gunkel-Grabole, Gesine
A1  - Hoffmann, Lena
A1  - Kapote, Dnyaneshwar
A1  - Kipping, Thomas
A1  - Klinken, Stefan
A1  - Loose, Fabian
A1  - Marquetant, Tristan
A1  - Windolf, Hellen
A1  - Geißler, Simon
A1  - Spitz, Tilmann
T1  - Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design
JF  - Therapeutic Innovation & Regulatory Science
N2  - 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.
KW  - Pharmazie
KW  - Pharmacy
KW  - Drug Safety and Pharmacovigilance
KW  - Pharmacotherapy
Y1  - 2022
UN  - https://nbn-resolving.org/urn:nbn:de:hbz:832-epub4-21349
SN  - 2168-4790
SS  - 2168-4790
SN  - 2168-4804
SS  - 2168-4804
U6  - https://doi.org/10.1007/s43441-021-00354-0
DO  - https://doi.org/10.1007/s43441-021-00354-0
VL  - 56
IS  - 6
SP  - 910
EP  - 928
S1  - 19
PB  - Springer International Publishing
ER  -