CoreRx’s pre-formulation activities support and inform every further step in the drug development, formulation and manufacturing process, allowing us to provide our partners with fit-to-need solutions and desired outcomes.
Preformulation is centered around robust and complete Active Pharmaceutical Ingredient (API) characterization. Further, CoreRx applies various technologies to control and reduce particle size, which among other things, can greatly enhance the bioavailability of your compound.
API Characterization
Characterization of the Active Pharmaceutical Ingredient (API) is critical to designing a successful formulation approach. CoreRx will evaluate the characteristics of your API, conduct small scale studies to understand key parameters around solubility and stability, and perform excipient compatibility studies to identify the right ingredients that enhance your APIs performance across a variety of dosage forms.
API Characterization Activities include:
- Particle Size Analysis
- Polymorphism Screening
- pH/Stability/Solubility Profiles
- Partition Coefficient Evaluation
- Thermal Analysis
- Hygroscopicity Evaluation
- Excipient Compatibility Testing
- Chemical & Physical Stability Evaluations
