Scantox
GLP-accredited preclinical CRO headquartered in Denmark with sites in Sweden, Austria and the UK. Known for Gottingen minipig work and regulatory toxicology, with discovery pharmacology including CNS and…
About Formulation Development
A compound that works in a test tube can fail in an animal simply because it never dissolves or stays in solution long enough to be absorbed. Preclinical formulation work finds a vehicle that delivers the required dose by the intended route, in a volume the species can tolerate, without the vehicle itself causing findings.
Typical work includes solubility screening across aqueous and co-solvent vehicles, suspensions and cyclodextrin or lipid-based systems for poorly soluble compounds, pH and osmolality adjustment for injectables, and stability testing of the dose formulation under the conditions it will actually be used. For GLP toxicology, dose formulation analysis confirms concentration, homogeneity and stability, and is part of the study record.
Plan formulation early: a vehicle chosen for a rodent PK study often has to change for high-dose toxicology or for a non-rodent species, and late changes can make exposure differ between studies.
Preclinical Formulation Development CROs
Showing 2 CROs. Order rotates daily so no lab is permanently listed first.
Ardena
European CDMO and CRO offering bioanalysis alongside drug substance, drug product and formulation development.
Questions to ask when choosing a Formulation Development CRO
- What vehicles would you screen first for our compound, and what are their tolerability limits in our species and route?
- Do you develop injectable formulations, including pH and osmolality control for IV or subcutaneous dosing?
- Can you run GLP dose formulation analysis for concentration, homogeneity and stability?
- How do you make sure the formulation used in early PK carries forward into toxicology?