Fused deposition modeling (FDMTM) is a 3D-printing technology of rising interest for the\nmanufacturing of customizable solid dosage forms. The coupling of hot-melt extrusion with FDMTM\nis favored to allow the production of pharma-grade filaments for the printing of medicines. Filament\ndiameter consistency is a quality of great importance to ensure printability and content uniformity of\n3D-printed drug delivery systems. A systematical process analysis referring to filament diameter\nvariations has not been described in the literature. The presented study aimed at a process setup\noptimization and rational process analysis for filament fabrication related to influencing parameters\non diameter inhomogeneity. In addition, the impact of diameter variation on the critical quality\nattributes of filaments (mechanical properties) and uniformity of mass of printed drug-free dosage\nforms was investigated. Process optimization by implementing a winder with a special haul-off unit\nwas necessary to obtain reliable filament diameters. Subsequently, the optimized setup was used for\nconduction of rational extrusion analysis. The results revealed that an increased screw speed led to\ndiameter fluctuations with a decisive influence on the mechanical resilience of filaments and mass\nuniformity of printed dosage forms. The specific feed load was identified as a key parameter for\nfilament diameter consistency.
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