We are specialists in understanding the physico-chemical properties of APIs and their relative stability.
The understanding and optimisation of the physico-chemical properties of an API are vital for establishing the parameters for producing stable and reproducible drug products.
We can provide you with the following preformulation development services:
- Initial assessment of solid state properties:
- Crystallinity/amorphous content
- Particle size, shape & surface area
- Moisture/ solvent content
- Mechanical screening (Youngʼs modulus, hardness, surface energy)
- Development of analytical methods (chemical and physical) for assessing stability
- Chemical and physical stability
- Heat, pH, light, humidity
- In vitro profiling
- Solubility (physiological buffers)
- Enhanced solubility (solubility in co-solvents, surfactants, complexation agents, salts etc.)
- Intrinsic dissolution
- API-excipient compatibility
During preformulation, our team can rapidly evaluate and detail drug candidatesʼ physical and chemical profiles. These properties will ultimately define the parameters for producing a developable, stable and reproducible product.