In designing a system for hot melt extrusion to formulate the solid dispersions of APIs in a polymer matrix, several parameters must be considered. Thermo Scientific extruders play an important role in formulation development from R&D to production-scale.
Extruders come in various sizes and determine throughput. For example our 11mm (screw diameter) twin-screw extruder is ideal in the experimental stage, where it's important to conserve APIs. Larger screw diameter extruders (16mm and 24mm) enable production piloting or small-scale continuous manufacturing.
In order to develop design for process scale-up to larger, production-oriented extruders, it's beneficial to apply the geometrically similar parameters throughout the process design.
Our new Executive Summary -- Continuous Manufacturing of Pharmaceuticals: Scale-up of a Hot Melt Extrusion Process outlines the process design for HME scale-up and reviews how factors such as screw speed, throughput and residence time can be used consistently from one extruder to the next level.
The paper will give you a good understanding the dependencies of process variables for a scientific approach to drug delivery scale-up, and show you how you can eliminate the need to redesign the project at each step from R&D to production.