Capabilities

Our solid form development team can help identify the ideal version of your API, from the very beginning of API development or optimise existing processes via four connected areas of solid form investigation:

Salt/Cocrystal Screening

  • Considered when an API may demonstrate poor solubility
  • Finding a suitable salt/cocrystal version will ideally afford enhanced solubility and, theoretically, bioavailability

Polymorph Screening

  • Identify potential of an API to demonstrate polymorphism
  • Determine thermodynamically stable form and form/ version hierarchy
  • Identify most appropriate version of the API that demonstrates the greatest form and chemical stability

Pre-Formulation Evaluation

  • Assessment of API version solubility and stability in biorelevant/aqueous media
  • Stability towards humidity and temperature
  • Stability to mechanical forces akin to drug product manufacture
  • Flow characteristic determination

Crystallisation Development

  • Delivers a robust, optimised process that reproducibly affords the target API version
  • Builds upon form selection and observations from salt/cocrystal/ polymorph screen investigations
  • or standalone body of investigations

To support solid state chemistry development, our team can utilise the following analytical techniques at Sterling;

  • X-Ray Diffraction (XRD)
  • Differential Scanning Calorimetry (DSC)
  • ThermoGravimetric Analysis (TGA)
  • Dynamic Vapour Sorption (DVS)
  • Infra-red Spectroscopy (FTIR)
  • Ultraviolet Spectroscopy (UV)
  • 1H NMR Spectroscopy
  • Ion Chromatography (IC)
  • Optical Microscopy
  • Hot Stage Microscopy (HSM)
  • Particle Size Distribution (PSD)
  • High Pressure Liquid Chromatography (HPLC)
  • Gas Chromatography (GC)
  • Dissolution Assessment