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Preformulation Analysis

Preformulation studies on a new drug substance are the foundation of developing a robust, safe and effective drug product formulation. The investigation will generate information on the physicochemical properties of the substance that will allow the formulator to:

  • Increase Stability-physical and chemical
  • Enhance Bioavailability-solubility/permeability
  • Improve compatibility- with excipients and in the processing environment

Scientists at CPES can perform a range of investigations including:

PDRA at PSD instrument

Solid Form Screening

  • Salts
  • Solvates and hydrates
  • Polymorphs
  • Amorphous Forms
  • Co-crystals

Solubility Studies

  • Solubility
  • Dissolution rates
  • Partition Coefficient (Log P)
  • pKa Solubility profiles
  • Common Ion effects

Bulk Powder Properties

  • Particle Size/Morphology
  • Surface Area and Surface Energy
  • Hygroscopicity
  • Powder Flow Properties
  • True Density

Stability Studies

  • Solid State Stability
  • Solution Stability
  • Excipient compatibility