Pre-formulation (drug substance and excipient physical/chemical characterization)
- Drug Property Prediction
- Solubility
- pH-rate
- pKa
- Salt form selection
- DSC
- TGA
- XRD
- Dynamic Vapor Sorption
- Microscopy - Optical, Raman
- Particle Size Analysis
- Laser Diffraction (Mastersizer)
- PCS/DLS/QELS (Zetasizer)
- Solid State Stability
- Forced Degradation
Formulation
- Small-scale milling - Retsch
- Suspensions/emulsions - Polytron
- Tablets - Carver press, hardness & friability/abrasion testing
- Capsules - manual filling
Analytical
- HPLC (Agilent, Dionex, Shimadzu)
- Dissolution (Apparatus 1 & 2)
- Gel Electrophoresis
- Chiral Analysis
- Osmolality
- Water by KF Titration
Stability
- 40C/75%RH
- 30C/65%RH
- 25C/60%RH
- 2C-8C (5C)
- -20C
- Photostability
- 50C-80C (Stress Testing)