PREFORMULATION

LATITUDE’s preformulation services provide key information for formulation development of our client’s APIs as solutions or solids.

Our 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 and API pH solubility and pH stability studies, typically requires as little as 1-2 grams of API.

SOLUTION PHASE →

Our solution phase program can evaluate:

  • pH solubility profile and buffer compatibility

  • pH stability/degradation rate profile

  • Solubility in pharmaceutically acceptable solvents/vehicles

  • Drug solubilizer screening

  • Ionization constants

  • Partition coefficients

  • Drug-excipient compatibility, screening

  • Filter compatibility

SOLID STATE →

Our solid state program can evaluate:

  • Salt form selection

  • Morphology study

  • Hygroscopicity evaluation

  • Thermal characterization

  • Particle size and size distribution

  • Powder density, flowability and compressibility

  • Drug-excipient compatibility