CrownBio can provide a full range of services from pre-formulation development, pre-clinical formulation development and supporting analytical development services. Pre-formulation studies in combination with analytical methods are critical to identifying the best formulation strategy for a particular compound. Certain candidates present specific challenges such as low bioavailability, poor solubility and/or permeability and poor physical stability. Formulation development can be helpful in overcoming many of these issues.
- Solubility and pH-rate Profile
- Log D/Log P
- Stability Evaluation (solution and solid)
- Polymorph Screening
- Salt form selection
- Purity Determination
- Hygroscopicity Studies
- Physicochemical characterization
- Particle Size Distribution
- Excipient Compatibility
- Early formulations for PK, PD and toxicological evaluation
- Novel formulations: nano-suspension, SEDDS and solid dispersions
- Microscale drug characterization and evaluation
- Drug developability assessment.