Formulation Development
Develop a stable product formulation which includes pre-formulation studies.
- Solubility and Dissolution Rate Studies
- Stability Studies (solid-state, solution-state)
- pH, Oxygen, Thermal, and Light Sensitivity Studies
- Compounding Process Development
- Product Characterization Studies
- Container-Closure Selection
- RLD Characterization Studies
- API and Formulation Screening
- Establishing API, IPC, and Product Specifications