QbD guided development of immediate release FDM-3D printed tablets with customizable API doses.

Area of Science:

• Pharmaceutical Technology
• Additive Manufacturing
• Materials Science

Background:

• Developing personalized dosage forms with adjustable active pharmaceutical ingredient (API) content is crucial for tailored patient therapy.
• Fused Deposition Modeling (FDM) offers potential for fabricating customized 3D printed tablets, but ensuring consistent drug release and dose accuracy remains a challenge.

Purpose of the Study:

• To develop a 3D printed immediate release (IR) tablet using FDM with adjustable API dosage and stable drug release profiles.
• To investigate the influence of tablet design, size, and printing parameters on drug release and API content.

Main Methods:

• Polyvinyl alcohol-based filaments with 50% w/w API were prepared via hot melt extrusion (HME).
• Tablet fabrication utilized FDM 3D printing (3DP) under a Quality by Design (QbD) framework, incorporating risk management and Design of Experiments (DoE).
• Mechanical characterization assessed filament printability; drug release and API content were analyzed based on tablet design, size, and layer height.

Main Results:

• A honeycomb tablet architecture demonstrated suitability for IR dosage forms with easily modifiable API doses.
• The study identified tablet design, size, and layer height as significant factors influencing drug release and API content.
• A predictive model was developed to optimize FDM printing variables for tailored drug delivery.

Conclusions:

• FDM 3D printing provides a viable platform for creating IR tablets with customizable API doses and predictable release profiles.
• The honeycomb design and QbD approach facilitate the development of flexible and reliable 3D printed pharmaceutical dosage forms.
• Predictive modeling aids in optimizing the 3D printing process for personalized medicine applications.