Scientific Area Leader Research Center Pharmaceutical Engineering GmbH Graz, Austria
The pharmaceutical industry is shifting from batch to continuous manufacturing, aiming to improve efficiency, reduce costs, and minimize material losses. Continuous manufacturing also enables real-time quality control, advanced monitoring, rapid parameter adjustments, and full automation. To support this transition, a continuous manufacturing line is being developed using itraconazole as the model API. The strategy involves processing itraconazole into an amorphous solid dispersion (ASD) via hot melt extrusion (HME), followed by direct compression (DC) in an integrated system. Small-scale experiments and 1D HME simulations have been conducted to identify and optimize critical process parameters for scale-up, ensuring tablets achieve suitable friability, disintegration, and dissolution. In the planned large-scale phase, ASD formation will be carried out using a ZSK18 extruder, followed by continuous pelletizing and milling to achieve a controlled particle size distribution (PSD). A vacuum transport system will then deliver the milled material to the DC line, which is designed to include feeders, a high-shear blender, and a rotary tablet press.
Learning Objectives:
The objective is to develop and integrate an ASD formulation using HME into a continuous direct compaction process, validating its scalability and efficiency for solid oral dosage production.
Explore critical process parameters relevant for ASD formation.
Understand factors influencing the disintegration and dissolution of the produced tablets.
