Modelling of co-rotating twin-screw extruders in the pharmaceutical industry I : single component model

Twin-screw extruders are being increasingly applied in the pharmaceutical industry for the manufacture of solid dispersions. In particular, Hot Melt Extrusion (HME) is a viable manufacturing alternative for poorly soluble drugs that are difficult to process. This is due to the high shear stress applied in the process, which enhances mixing of the base polymer with the dispersed API. Delivery systems that can be obtained using this technology include pellets, granules, sustained release tablets and implants. Experiments for HME are typically very labour-intensive, involving the use of highly viscous polymers, high pressures, and require proper cleaning between runs. Identifying the critical experiments to perform based on model simulations would thus be highly desirable. Single-component modelling of twin-screw extrusion processes could be beneficial in the following areas: identifying optimal screw configurations, tracking the degree of melting and when identifying the area within the extruder where the polymer becomes completely melted