Every gram of your insoluble API matters.
Traditional formulation method like spray drying, solvent evaporation, hot melt extrusion, and micronization can lose significant amounts of valuable material to heat stress, solvent inefficiency, or mechanical hold-up.
Bulk lyophilization stands apart, consistently achieving near-quantitative recovery and delivering the best cost-per-gram outcome for insoluble APIs.
Product Loss in Bulk Formulation
Reported API Yield Ranges by Technique
Spray Drying
• Cyclone fines
• Wall deposition
• Heat stress
API Yield Range: 20-98%
Solvent Evaporation
• Emulsion separation loss
• Solvent inefficiency
• Residual solvent issues
API Yield Range: 42-96%
Hot Melt Extrusion
• Startup purge loss
• Dead volume
• Hold-up equipment
API Yield Range: No widely reported %
Micronization
• Dusting
• Classifier reject
• Thermal/mechanical stress
API Yield Range: 85-100%
Bulk Lyophilization
• Near-quantitative recovery
• Minimal loss with containment trays
API Yield Range: 90-99%
Learn more in our blog “Bulk Lyophilization Transforms Insoluble APIs into Druggable Candidates.”