Preformulation & Solid-State Chemistry
Pharma companies large and small have found that a small amount of solid-state work can both accelerate and strengthen your development program, as well as your IP. We can make your preclinical formulation development, as well as your API manufacturing, the best it can be.
In addition, baseline screening and understanding will lead to a robust API isolation process that reproducibly gives you the right form, and with the right particle size, at the highest possible yield. The benefits of working with VxP are the following:
- We are a One-stop shop utilizing solid-state and biopharmaceutical properties in design from candidate selection through early development
- We utilize an Integrated approach to find the right form and formulation
- We offer the shortest timeline for appropriate development milestones
- We provide you with an optimized route to achieve exposure, eliminate unnecessary experiments and enable pre-clinical studies
Some of our areas of expertise include the following:
- Solid State Stability
- Solution State Stability
- Solubility Profile
- Salt synthesis and salt form selection
- Polymorph screening
- Cocrystal analysis
- Amorphous Solid Dispersions
- pH/temperature degradation rate profile
- pKa determination
- Container compatibility studies
Early Tox Formulation Development
Variability in crystal form and amorphous content, in addition to varying particle size/surface area, can render your PK studies meaningless and lead to their needing to be repeated all while you give it your “best guess”. This can be expensive… Understanding the physicochemical characteristics of your API is and what happens to it in PK studies, can help eliminate unnecessary variability in your animal studies.
At VxP, our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field. Call us today to learn how we can be of service.