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
