Formulation Development

  • Discovery and GLP formulation optimization
  • Multiple formulation platforms for small molecules:
    • Powder in Capsule and Powder in Bottle (micronized as needed)
    • Experience developing immediate release tablets & capsules
    • Modified/Controlled/Extended-release tablets
    • Enabled formulations for low solubility compounds:
      • pH modification
      • Form Selection
        • Salt/hydrate/solvate/polymorph
        • Amorphous: spray dried dispersion, rotovapping, lyophilization
      • Excipient-based approaches:
        • Cyclodextrins, cosolvents, surfactants, lipidic excipients, emulsions/microemulsions, hot melts
    • Particle size reduction – conical milling, ball milling and jet milling
  • Lyophilized and solution parenteral development
  • Pediatric formulation development and manufacturing