Pre-formulation
(drug substance and excipient physical/chemical characterization)
Drug Property Prediction
- Solubility
- pH-rate
- pKa
- DSC
- TGA
- XRD
- Dynamic Vapor Sorption
- Particle Size Analysis
- Laser Diffraction (Mastersizer)
- PCS/DLS/QELS (Zetasizer)
- Microscopy – Optical, Raman, SEM
- Solid State Stability
- Forced Degradation
- Surface Tension
- Critical Micelle Concentration (CMC)
Solid Form Selection
- Salt Form Screening
- Polymorph Screening
Advanced Physiochemical Analysis
- Chemometric analysis of spectroscopic and other physiochemical data
- Principal components analysis (PCA)
- Partial least squares (PLS)
- Single crystal structure determination
- via collaboration with the Molecular Structure Laboratory in Chemistry – see UW Centers of Expertise
- Quantitation of amorphous content of multiphase mixtures
Formulation
- Small-scale milling – Retsch
- Suspensions/emulsions
- Polytron
- Microfluidizer
- Small-scale mixing/granulating
- Tablets
- Carver press
- TDP-5N single station press
- hardness testing
- friability/abrasion testing
- Capsules
- Enhanced performance formulations
- Lipid-based formulations
- Complexation
- Nano-suspensions
Analytical
- High Performance Liquid Chromatography (HPLC)
- Dissolution (Apparatus 1 & 2)
- Disintegration
- Gas Chromatography (GC) – headspace, FID
- Gel Electrophoresis
- Chiral Analysis
- Osmolality
- Viscosity via Cone/Plate Viscometer/Rheometer
- Water by KF Titration
- Lipid formulation performance
- Dispersion/precipitation
- Digestion/lipolysis
Stability
- 25C/60%RH
- 30C/65%RH
- 40C/75%RH
- 50C-80C (Stress Testing)
- 2C-8C (5C)
- -20C
- ICH Photostability