Material Considerations for Fused-Filament Fabrication of Solid Dosage Forms

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Additive Manufacturing

Background:

• Material selection is critical for solid dosage form design, impacting drug release and manufacturability.
• Pharmaceutical polymers must meet specific physical and bulk properties for successful manufacturing.
• Limited approved materials exist for solid dosage form production.

Purpose of the Study:

• To detail complications of using pharmaceutical polymers in fused-filament fabrication for oral tablets.
• To present strategies for overcoming these manufacturing challenges.
• To define the essential parameter profile for successful 3D printing of solid dosage forms.

Main Methods:

• Investigated fused-filament fabrication (a hot-melt extrusion-based 3D printing process).
• Employed formulation and melt-blending strategies to improve printability of Kollidon® VA64.
• Identified essential parameter profiles and pre-screening tools for material formulation.

Main Results:

• Identified specific issues encountered when using pharmaceutical grade polymers like Kollidon® VA64 in fused-filament fabrication.
• Demonstrated that formulation and melt-blending can enhance material printability.
• Established critical parameters for successful 3D printing of solid dosage forms.

Conclusions:

• Fused-filament fabrication presents unique challenges for pharmaceutical polymers.
• Strategic formulation and process optimization are key to successful 3D printing of oral tablets.
• Defined parameter profiles and pre-screening tools will guide future material development for 3D printed dosage forms.