With over 70% of emerging small molecules stalling due to poor solubility, unoptimized milling can trigger thermal degradation, yield loss, and uncontrollable particle size distribution (PSD). Download the technical white paper from AGC Pharma Chemicals, a leading CDMO for Small Molecule APIs and HPAPIs, to master precision jet and mechanical impact milling from clinical batches through commercial manufacturing.
Download the Technical White Paper
Developed for Formulation Scientists, CMC Directors, and Process Development Leads.
Beyond Size Reduction: Engineering the Exact Particle Size Distribution
Achieving target dissolution rates for BCS Class II molecules requires far more than basic grinding. Inside this technical guide:
- Targeted PSD (1–10 µm) Without Degradation:How to achieve rapid dissolution and high bioavailability while preventing heat-induced chemical degradation or unwanted polymorphic shifts.
- Jet Milling vs. Mechanical Impact Milling:A direct engineering comparison of opposed bed jet milling (AFG) versus mechanical impact milling (ZPS) using the Hosokawa Alpine platform—and how to select the right technology for abrasive or heat-sensitive compounds.
- Preventing Post-Milling Agglomeration:Operational parameters and containment tactics to eliminate electrostatic charging and maintain free-flowing, stable powders.
- Eliminating Vendor Handoffs:The financial and quality advantages of integrating high-containment micronization directly into the primary API manufacturing train rather than outsourcing to a third-party mill.
