Identifying an active ingredient or active pharmaceutical ingredient is important – developing a formulation that allows these compounds to be delivered intact over a commercially feasible shelf life is crucial to the success of a program.  Oculos understands the importance of developing a formulation that supports the Target Product Profile (TPP), and has routinely helped clients develop clinical and non-clinical formulations.

Specific formulation services include:

  • Pre-formulation of APIs (salt form selection, solubility, crystal morphological evaluation, differential scanning calorimetry, thermogravimetric analysis, etc.)
  • Excipient and preservative selection and characterization
  • Preservative evaluation (preservative-efficacy testing, antimicrobial-effectiveness testing)
  • Forced degradation studies
  • Impurity identification/structure elucidation and quantification
  • Accelerated stability program development/testing
  • Rapid toxicology/safety screening during formulation development
  • Preservative-free formulation development