Hot-melt extrusion process fluctuations and their impact on critical quality attributes of filaments and 3d-printed dosage forms

Hanna Ponsar; Raphael Wiedey; Julian Quodbach

doi:10.3390/pharmaceutics12060511

Hot-melt extrusion process fluctuations and their impact on critical quality attributes of filaments and 3d-printed dosage forms

Hanna Ponsar, Raphael Wiedey, Julian Quodbach^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Article number	511
Number of pages	15
Journal	Pharmaceutics
Volume	12
Issue number	6
DOIs	https://doi.org/10.3390/pharmaceutics12060511
Publication status	Published - Jun 2020
Externally published	Yes

Bibliographical note

Funding Information:
Acknowledgments: The authors thank the Drug Delivery Innovation Center (DDIC) for financial support and providing the scientific network. The authors thank Sharon von Harrach and Shadfar Mehrabani for their support in the conduction of extrusion and printing experiments.

Publisher Copyright:
© 2020 by the authors. Licensee MDPI, Basel, Switzerland.

Funding

Acknowledgments: The authors thank the Drug Delivery Innovation Center (DDIC) for financial support and providing the scientific network. The authors thank Sharon von Harrach and Shadfar Mehrabani for their support in the conduction of extrusion and printing experiments.

Keywords

3d printing
Filament fabrication
Fused deposition modeling
Hot-melt extrusion
Process analysis
Process optimization

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10.3390/pharmaceutics12060511

Cite this

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title = "Hot-melt extrusion process fluctuations and their impact on critical quality attributes of filaments and 3d-printed dosage forms",

abstract = "Fused deposition modeling (FDM{\texttrademark}) is a 3D-printing technology of rising interest for the manufacturing of customizable solid dosage forms. The coupling of hot-melt extrusion with FDM{\texttrademark} 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.",

keywords = "3d printing, Filament fabrication, Fused deposition modeling, Hot-melt extrusion, Process analysis, Process optimization",

author = "Hanna Ponsar and Raphael Wiedey and Julian Quodbach",

note = "Funding Information: Acknowledgments: The authors thank the Drug Delivery Innovation Center (DDIC) for financial support and providing the scientific network. The authors thank Sharon von Harrach and Shadfar Mehrabani for their support in the conduction of extrusion and printing experiments. Publisher Copyright: {\textcopyright} 2020 by the authors. Licensee MDPI, Basel, Switzerland.",

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AU - Wiedey, Raphael

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N1 - Funding Information: Acknowledgments: The authors thank the Drug Delivery Innovation Center (DDIC) for financial support and providing the scientific network. The authors thank Sharon von Harrach and Shadfar Mehrabani for their support in the conduction of extrusion and printing experiments. Publisher Copyright: © 2020 by the authors. Licensee MDPI, Basel, Switzerland.

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N2 - 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.

AB - 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.

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Hot-melt extrusion process fluctuations and their impact on critical quality attributes of filaments and 3d-printed dosage forms

Abstract

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Keywords

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