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Manufacturing and Process Scale-Up

Design-Controlled Co-Administration of Ibuprofen and Itraconazole via an HME-FDM 3D Printing Platform

Dimitrios Lamprou – Professor, Queen's University Belfast; Sune Andersen – Scientific Associate Director, Johnson & Johnson Innovative Medicine; Thomas Quinten – Senior Principal Scientist, Johnson & Johnson Innovative Medicine
Introduction: 3DP represents a rapidly growing field, allowing for the development of personalisable solid oral dosage forms (SODFs) in the pharma world. In particular, hot-melt extrusion (HME) combined with fused deposition modelling (FDM) has enabled the incorporation of poorly water-soluble drugs into amorphous solid dispersions (ASDs), in the form of FDM printable filaments (1). This study developed a robust single-screw HME–FDM platform, for the manufacture of Ibuprofen (IBU)-Itraconazole (ITZ) combination SODFs, two API with contrasting physico-chemical properties that have shown improved anti-fungal activity when co-delivered but have not been incorporated yet in a combination product (2).

Learning Objectives:

  • Understand the screening process used to identify HME and FDM processing parameters.
  • Understand the process of selection between monolithic and multilayer for multi-API SODFs.
  • Evaluate the impact of 3DP design on the drug release properties.