Amorphous solid dispersion (ASD) as solubilizing technologies

Pre-formulation:

  • Theoretical, ab initio simulation
  • Selection of excipients (polymer, surfactant)
  • Phase analysis: Definition of API loading
  • Prediction of miscibility, physical stabilit
  • Mini-formulation screening
  • Biorelevant-supersaturation screening

Prototype formulation, material science:

  • Formulation screening on table top equipment
  • Solid-state characterization and method development
  • In vitro dynamic biorelevant dissolution and in situ phase transformation studies
  • Assessment of  melt rheology
  • Accelerated stability testing

Process design, optimization up to scale up/ tech transfer for GMP supply

A2_Amorphous solid dispersions