SeraNovo’s feasibility study tests which of our various eutectic inspired formulation platforms is the most suitable for a drug molecule.
To understand the API, we perform rigorous pre-formulation screenings for eutectic partners, precipitation inhibitor efficacy, degradation profile and pH effects on crystalline and amorphous solubility.
The pre-formulation phase shows which excipients have a positive interaction with the API, phase 2 uses this information to build prototypes from one or more of our formulation platforms (Eutectic, Eutectic enteric and LiDES) and complete substantial in vitro testing.
The in vitro testing includes pH shift dissolutions, absorption evaluation and colloid evaluation with dynamic light scattering, concentration measurements & polarized light microscopy.
The lead prototypes from each platform are stored for physical and chemical stability evaluation and analyzed with UPLC. The samples are also produced for in vivo evaluation.
- We keep close communication lines at every phase of the feasibility study
- We decide lead prototypes in accordance with our partners
- We use safe ingredient to develop our prototypes
- Time to complete: 4-6 weeks
- Deliverable: Prototype formulations