Preclinical formulations selection
Compendial excipient screening
API-sparing formulation screening
Scale-up path from mg to metric tons
Accelerated molecule to commercial product path
Stage | Purpose | API Requirement |
Characterization/Triage: |
Chemical, physical and biological characteristics determine best solubilization/formulation approaches | ug to mg |
Screening: |
Screens rapidly identify best matrices for formulation development | 10s of mgs |
Feasibility: |
Small-scale manufacturing of formulation intermediates | 100s to 1000s of mgs |
Scale-Up Prep: | Scale-up of successful feasibility prototypes | g to kg |
MicroEvap Prep: | Samples for preclinical in-vivo testing: low-carbon vehicles (lows olvent/surfactant) and amorphous processing enhance solubility without toxicity |
10s to 100s mgs per animal |