LATITUDE’s preformulation services provide key information for formulating APIs in solutions or solids.
Our solution phase program evaluates:
- pH solubility profile and buffer compatibility
- Solubility in pharmaceutically useful solvents
- Drug solubilizer screening
- Ionization constants
- Partition coefficients
- Drug-excipient compatibility, screening
Our solid state program evaluates:
- Salt form selection
- Morphology study
- Hygroscopicity evaluation
- Thermal characterization
- Particle size and size distribution
- Powder density, flowability and compressibility
- Drug-excipient compatibility
LATITUDE’s efficient and unique approaches use a minimum quantity of drug substance to complete a preformulation evaluation. A comprehensive preformulation evaluation, including analytical HPLC method development, typically requires as little as 1-2 grams of API.