Micronization is an important technique in drug formulation, but not all substances are simple to process. This presentation will provide insight into how micronization processes can be developed for challenging inhalation materials.
What technical issues need to be addressed if an API is to be successfully micronized?
A robust process development strategy is presented that ensures all attributes critical for quality are maintained, even for the most challenging. A case study on the micronization of a highly potent inhalation API with a tendency to undergo surface amorphization is also presented.
Key findings, including solid-state characterization and post-micronization conditioning, are shared.