Micronization is an important technique in drug formulation, but not all substances are simple to process. This webinar will give an insight into how micronisation can be developed and scaled up for difficult materials. What technical issues need to be addressed if an API is to be micronized successfully?
After giving an overview of micronisation and common scale-up challenges, the webinar will present a robust process development strategy that ensures all attributes critical for quality are maintained for even the most difficult APIs.
Two case studies will illustrate some of the issues. One is the micronisation of a highly potent API with a tendency to build up on equipment surfaces, and key findings will be presented, including stress testing and solid-state characterization. The second, the micronisation of a fibrous material that was not free-flowing, was successfully scaled up on customized GMP industrial-scale equipment.