Preformulation Development

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
    • Hygroscopicity
    • 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
    • LogP/LogD/pKa
    • 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.