Sustainable Design and DoE-Based Optimization of Polymeric Systems for FDM 3D-Printed Indomethacin Amorphous Solid...

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Sustainable Manufacturing

Background:

• Amorphous solid dispersions (ASDs) enhance poorly water-soluble drug performance.
• Hot-melt extrusion (HME) and fused deposition modeling (FDM) 3D printing are key manufacturing methods.
• Current processes are energy-intensive, lacking sustainability focus.

Purpose of the Study:

• To develop and optimize indomethacin (IND) ASDs using a Design of Experiments (DoE) framework.
• To integrate electrical energy consumption as a key performance metric alongside pharmaceutical attributes.
• To establish a sustainable workflow for 3D-printed ASD dosage forms.

Main Methods:

• Screening polymer-plasticizer miscibility using hot-stage microscopy.
• Filament preparation via HME and optimization using factorial DoE.
• 3D printing via FDM with a second DoE for process optimization.

Main Results:

• Achieved complete drug amorphization within a specific thermal window.
• Identified electrical energy demand influenced by thermal setpoints and process duration.
• Validated a dual-stage DoE approach for reduced energy consumption and maintained drug quality.

Conclusions:

• Electrical energy consumption can be a quantitative variable in pharmaceutical process optimization.
• A dual-stage DoE strategy enables development of efficient and stable 3D-printed ASDs.
• This framework balances drug performance with environmental efficiency in manufacturing.