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Open AccessArticle

Hot-Melt Extrusion Process Fluctuations and Their Impact on Critical Quality Attributes of Filaments and 3D-Printed Dosage Forms

1
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Duesseldorf, Germany
2
Drug Delivery Innovation Center (DDIC), INVITE GmbH, Chempark Building W 32, 51368 Leverkusen, Germany
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(6), 511; https://doi.org/10.3390/pharmaceutics12060511
Received: 4 May 2020 / Revised: 29 May 2020 / Accepted: 29 May 2020 / Published: 3 June 2020
(This article belongs to the Collection 3D Printing and Bioprinting Applications in Pharmaceutics)
Fused deposition modeling (FDMTM) is a 3D-printing technology of rising interest for the manufacturing of customizable solid dosage forms. The coupling of hot-melt extrusion with FDMTM is favored to allow the production of pharma-grade filaments for the printing of medicines. Filament diameter consistency is a quality of great importance to ensure printability and content uniformity of 3D-printed drug delivery systems. A systematical process analysis referring to filament diameter variations has not been described in the literature. The presented study aimed at a process setup optimization and rational process analysis for filament fabrication related to influencing parameters on diameter inhomogeneity. In addition, the impact of diameter variation on the critical quality attributes of filaments (mechanical properties) and uniformity of mass of printed drug-free dosage forms was investigated. Process optimization by implementing a winder with a special haul-off unit was necessary to obtain reliable filament diameters. Subsequently, the optimized setup was used for conduction of rational extrusion analysis. The results revealed that an increased screw speed led to diameter fluctuations with a decisive influence on the mechanical resilience of filaments and mass uniformity of printed dosage forms. The specific feed load was identified as a key parameter for filament diameter consistency. View Full-Text
Keywords: 3d printing; hot-melt extrusion; process analysis; fused deposition modeling; process optimization; filament fabrication 3d printing; hot-melt extrusion; process analysis; fused deposition modeling; process optimization; filament fabrication
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MDPI and ACS Style

Ponsar, H.; Wiedey, R.; Quodbach, J. Hot-Melt Extrusion Process Fluctuations and Their Impact on Critical Quality Attributes of Filaments and 3D-Printed Dosage Forms. Pharmaceutics 2020, 12, 511.

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