Melt Extrusion

Interest in melt extrusion techniques for pharmaceutical applications is continuing to grow rapidly. Melt extrusion has been a widely-applied technique in the plastics industry and has since emerged as a viable method to prepare several types of dosage forms and drug delivery systems. Melt extruded dosage forms are complex mixtures of active pharmaceutical ingredient (API), excipients, and polymer carrier which are blended using industry-standard equipment. This equipment includes single and twin-screw extruders, which are replacing traditional batch processes because of the consistent and repeatable nature of continuous extrusion.

Compared to solvent processes aiming at solid molecular dispersions, melt extrusion technology offers a promising alternative. The mixture is melted and extruded, which de-aggregates the API into small particles. The final product can be a tablet, capsule, skin patch, film, or tape. This technology is suitable for both high dose and potent compounds and has been proven to provide sustained, modified, and targeted drug delivery. Melt extrusion also offers several advantages over traditional pharmaceutical processing techniques which make in an attractive alternative to traditional processing methods. These advantages include cost and performance benefits such as a faster path to FDA approval for new compounds, possible re-indication for existing APIs, controllable bioavailability, possible lower doses, and probable lower production costs.