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Structure-function correlation and personalized 3D printed tablets using a quality by design (QbD) approach.

Jiaxiang Zhang1, Rishi Thakkar1, Yu Zhang1

  • 1Pharmaceutical Engineering and 3D Printing (PharmE3D) Labs, Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, University of Texas at Austin, Austin, TX 78712, USA.

International Journal of Pharmaceutics
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Summary
This summary is machine-generated.

This study combined hot-melt extrusion (HME) and fused deposition modeling (FDM) 3D printing to create personalized tablets. Design of experiments optimized tablet properties, demonstrating a flexible platform for on-demand drug manufacturing.

Keywords:
3D printingBox-Behnken designDesign of experimentsFused deposition modelingHot-melt extrusionIbuprofenQuality by design

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Area of Science:

  • Pharmaceutical Technology
  • Additive Manufacturing
  • Materials Science

Background:

  • 3D printing offers potential for personalized medicine.
  • Hot-melt extrusion (HME) and fused deposition modeling (FDM) are key additive manufacturing (AM) techniques.
  • Understanding structure-function relationships is crucial for optimizing 3D printed pharmaceuticals.

Purpose of the Study:

  • To manufacture and evaluate 3D printed tablets using a combined HME and FDM approach.
  • To investigate the structure-function relationship of these 3D printed tablets.
  • To optimize tablet properties like drug loading, mechanical strength, and drug release performance.

Main Methods:

  • Utilized Design of Experiments (DoE) with Box-Behnken design for formulation optimization.
  • Selected key parameters: shell thickness, infill density, and layer height.
  • Evaluated responses including tablet weight, hardness, and in vitro drug release profiles.
  • Characterization included DSC, XRD, PLM, and texture analysis.

Main Results:

  • Confirmed amorphous solid-state conversion of the drug using DSC, XRD, and PLM.
  • Texture analysis demonstrated robust mechanical properties of the filaments.
  • Shell thickness and infill density significantly impacted tablet weight and mechanical properties (p < 0.05).
  • DoE studies revealed significant effects of variables on drug release kinetics.

Conclusions:

  • Conjugating HME with FDM provides a flexible platform for on-demand, personalized drug product development.
  • DoE offers robust guidance for optimizing patient-focused drug products.
  • This approach aligns with regulatory expectations for pharmaceutical manufacturing.