Continuous twin-screw granulation – What to consider in process design, development and scale-up

Twin-screw granulation (TSG) offers a significant advantage over traditional granulation methods: the possibility of continuous manufacturing. Due to the recognized advantages of continuous manufacturing, twin-screw granulation has drawn increased attention in recent years. This whitepaper summarizes the most important process parameters and their influence on product quality as well as crucial parameters for scale-up based on a recent study. The results show that it is possible to tailor particle size distribution of the granules, which enables scientists in pharmaceutical technology to influence final product quality right from the start. This whitepaper also provides a summary of useful recommendations to address typical errors in designing, developing and scaling-up TSG. Consequently, TSG leads to faster process development and reliable scale-up from lab to production scale.