Ponsar Hanna, Wiedey Raphael, Quodbach Julian
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Duesseldorf, Germany.
Drug Delivery Innovation Center (DDIC), INVITE GmbH, Chempark Building W 32, 51368 Leverkusen, Germany.
Pharmaceutics. 2020 Jun 3;12(6):511. doi: 10.3390/pharmaceutics12060511.
Fused deposition modeling (FDM) is a 3D-printing technology of rising interest for the manufacturing of customizable solid dosage forms. The coupling of hot-melt extrusion with FDM 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.
熔融沉积建模（FDM）是一种在制造可定制固体剂型方面越来越受关注的3D打印技术。热熔挤出与FDM的结合有利于生产用于药物打印的医药级长丝。长丝直径的一致性对于确保3D打印药物递送系统的可打印性和内容均匀性至关重要。文献中尚未描述针对长丝直径变化的系统过程分析。本研究旨在对与直径不均匀性的影响参数相关的长丝制造进行工艺设置优化和合理的工艺分析。此外，还研究了直径变化对长丝关键质量属性（机械性能）和打印无药剂型质量均匀性的影响。通过使用带有特殊牵引单元的卷绕机进行工艺优化对于获得可靠的长丝直径是必要的。随后，将优化后的设置用于进行合理的挤出分析。结果表明，螺杆速度的增加会导致直径波动，这对长丝的机械弹性和打印剂型的质量均匀性具有决定性影响。特定的进料负荷被确定为长丝直径一致性的关键参数。
