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:
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