De-Risking Early Phase Micronization With Integrated Solid Form Selection

This webinar explores the crucial role of solid form selection in achieving successful jet milling of APIs for respiratory delivery. We present a case study focused on optimizing the solid form of an API intended for pulmonary administration.

The process began with a solid form screen, exploring potential salts and cocrystals to improve solubility. These forms were then ranked based on class, manufacturability, solubility enhancement, and stability. Two leading candidates were micronized, revealing key differences in their processing behavior. The resulting micronized materials were characterized physically and chemically to assess micronization feasibility. Finally, a lead form was selected for preclinical supply production.

Key Takeaways:

• Discover how to identify suitable salt/cocrystal forms for micronization and solubility enhancement.
• Learn how to evaluate material performance during micronization.
• Understand the critical selection criteria for choosing the lead micronized form for preclinical studies.