Pharmaceutical Hot-Melt Extrusion: A Comprehensive Guide


Explore the principles, process design, and applications of HME in modern drug development


Nearly 90% of new molecules and 40% of marketed oral drugs face solubility challenges. Hot-melt extrusion (HME) offers a scalable, solvent-free solution to:

  • Enhance bioavailability of poorly soluble APIs
  • Enable taste masking and abuse deterrence
  • Support controlled and sustained release formulations
  • Produce innovative dosage forms such as implants and films

What You’ll Learn Inside

  • Introduction to HME: principles, benefits, and comparison to spray drying
  • Formulation Characterization: glass transition, melting points, and rheology for process optimization
  • Process Design & Development: how screw speed, feed rate, temperature profile, and barrel setup influence product quality
  • Downstream Processing: creating tablets, pellets, oral films, injectable implants, and 3D-printable filaments
  • Case Studies & Examples: from co-extrusion methods to scale-up strategies

Who Should Read This Guide

  • Pharmaceutical scientists developing new solid oral and implantable formulations
  • Process engineers optimizing scale-up and manufacturing conditions
  • R&D managers seeking solvent-free, GMP-compliant solutions
  • Regulatory professionals evaluating manufacturing techniques and compliance

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