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.
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
Other Preformulation Services
CoreRx continuously invests in the people, technologies, knowledge and expertise we apply to Preformulation, leading to speedier progression to formulation development, and timely success for our partners. Our goal is to enable you to meet your milestones. Some of our other Preformulation activities and capabilities include
- Purity analysis
- Physicochemical properties
- pH/solubility studies
- Particle size and morphology
- Polymorph identification (XRPD)
- Flux measurements (Pion MicroFlux & MacroFlux)
- Biological membrane dissolution and diffusion analysis (Franz cell
- Bulk/tap density and angle of repose
- Excipient compatibility
- Focus beam reflectance measurement (FBRM)