Pre-formulation Solutions, Pre-formulation Solutions

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

Pre-formulation Solutions, Pre-formulation SolutionsWe understand poor pre-formulation studies may lead to delays in pre-clinical and clinical development programs. We can provide you with the solid foundation required for successful transition of early phase development programs through to clinical, using our world-leading expertise in development of methods for inhaled drug product characterisation, 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.