Tailoring immediate release FDM 3D printed tablets using a quality by design (QbD) approach.

Area of Science:

• Pharmaceutical Technology
• 3D Printing in Medicine
• Drug Delivery Systems

Background:

• Fused Deposition Modeling (FDM) offers potential for personalized medicine.
• Optimizing pharmaceutical formulations for 3D printing requires understanding material properties and process parameters.
• Achieving desired drug release profiles from printed dosage forms is a key challenge.

Purpose of the Study:

• To produce immediate release printed tablets using FDM.
• To explore the effects of different compositions on drug release via a Quality by Design (QbD) approach.
• To establish critical material attributes (CMAs) and critical process parameters (CPPs) for FDM tablet printing.

Main Methods:

• Screening studies using hot melt extrusion and FDM printing to define CMA limits.
• Utilizing a D-optimal mixture design with 17 formulations.
• Investigating rheological properties and mechanical strength of filaments.
• Performing pharmaceutical characterizations and dissolution testing.

Main Results:

• Successful hot melt extrusion and FDM printing of theophylline tablets (10-60% w/w) using various polymers (HPC, Eudragit® EPO, Kollidon® VA 64) and sodium starch glycolate, without plasticizer.
• Hydroxy propyl cellulose (HPC) identified as a superior flexibility modifier for printable filaments.
• Dissolution profiles confirmed theophylline release, with QbD enabling prediction of an optimal formulation achieving 85% release at 30 minutes.

Conclusions:

• FDM printing is a viable technology for producing immediate release tablets.
• A QbD approach effectively guided formulation development and optimization.
• The developed platform holds promise for commercial development of patient-specific immediate release medications.