HME compendium: Twin-screw extrusion for pharmaceutical applications

For optimal effectiveness, solid oral drugs must not only be highly soluble to ensure good bioavailability, but they must also be palatable and manageable in size and dosage to maintain high patient compliance.

Image Credit: Thermo Fisher Scientific

As it stands, 90 % of new molecules and around 40 % of the leading solid oral drugs marketed across the US and Europe demonstrate low solubility.1

Hot-melt extrusion (HME) is a technique that not only enhances the efficacy of a drug but also addresses the bioavailability issues associated with an active pharmaceutical ingredient (API). Additionally, HME allows for the customization of various drug release profiles.

HME is a relatively simple technique for dispersing drug particles or molecules within a polymer matrix. The viability of different types of dispersions depends on various factors, including processing conditions and the chemical and physical properties of the polymers and APIs.

This 28-page compendium introduces Hot Melt Extrusion (HME) and demonstrates the method's versatility. It offers tips on designing a solvent-free HME process and outlines how to produce various dosage forms. Additionally, the guide answers key questions, such as what happens to materials when they are heated.

Download the compendium

Highlights include:

  • Introduction to pharmaceutical HME (hot-melt extrusion)
  • HME process design and development
  • HME process examples
  • Downstream processing and resulting dosage forms
  • Physical and thermal characterization of the formulation

References and further reading

  1. M. Rodriguez-Aller, D. Guillarme, J. L. Veuthey, and R. Gurny, “Strategies for formulating and delivering poorly water-soluble drugs,” J Drug Deliv Sci Technol, vol. 30, pp. 342–351, 2015, doi: 10.1016/j.jddst.2015.05.009.

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Last updated: Apr 23, 2024 at 8:39 AM

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