With our world-leading expertise in pre-formulation development of methods for inhaled drug product characterisation, we can provide the solid foundation required for successful transition of early phase development programs

We understand poor pre-formulation studies may lead to delays in pre-clinical and clinical development programs. With our world-leading expertise in development of methods for inhaled drug product characterisation, we can provide the solid foundation required for successful transition of early phase development programs through to clinical. As part of our pre-formulation development package we are able to provide you with the following:

  • Development of assay and stability indicating methods by HPLC/UPLC/LC-MS-MS
  • Conduct force degradation studies.
  • Excipient compatibility studies.
  • Develop methods for determining blend content uniformity of dry powder formulation blends.
  • Develop methods for delivered dose uniformity and aerodynamic particle size distribution by inertial impaction.
  • Conduct ICH based stability testing of APIs and finished products.