Preformulation

Preformulation Capabilities Include:

  • API Form Selection
    • Salts/cocrystals
    • Solvates/hydrates
    • Polymorph screening and stable form selection
    • Crystallization process development
    • Amorphous dispersions
  • API physiochemical evaluation
    • Physical Characterization
      • Microscopy, particle size analysis, SEM
      • Hygroscopicity, thermal properties, XRPD analysis
      • Bulk & tapped density, flowability
    • Solubility
      • Organic solvents, aqueous, pH-dependent, biorelevant, intrinsic dissolution
      • pKa, partition coefficient
    • Stability
      • Pilot/Research, GLP and GMP stability packages
      • Physical and chemical stability
      • Solid state, solutions or suspensions
      • Excipient compatibility