Pre-Formulation Studies

By utilizing small quantities of Active Pharmaceutical Ingredients (API) or druggable candidates, our preformulation services can provide valuable information and expertise to guide the compounds towards the next steps.

Pre-clinical candidate characterization

  • Solubility:
    • pH Solubility profile
    • Solubility in organic solvents
    • Solubility in Fasted State Simulated Intestinal Fluid (FaSSIF), Fed State Simulated Intestinal Fluid (FeSSIF), and Simulated Gastric Fluid (SGF)
  • Stability: Solution, Solid-state, and ICH photo stability
  • Inherent properties: pKa, Log p/Log D, Intrinsic dissolution
  • DOE based solvent, buffer, ionic strength, and stabilizer excipient screening for formulation development

Formulation development for testing

  • Vehicle selection
  • pH adjustment and co-solvent
  • Surfactant solubilization
  • Nano-suspension
  • Micro-emulsion
  • Amorphous solid dispersion

Clinical phase analytical support – Drug product

  • Solid-state characterization
  • Analytical methods development and transfer
  • Analytical method validation
  • Dissolution assay development and testing
  • Stability studies: accelerated and full ICH

CMC Support service

  • Solid state characterization
    • Includes PXRD, TGA, DSC, Polarized Light Microscope (PLM), Dynamic Vapor Sorption (DVS/hygroscopicity), and Particle Size Analysis (PSA)
  • Polymorph screening
    • Identify multiple polymorphs to avoid surprises later in drug development to recommend thermodynamically most stable form
  • Crystallization process development
    • Includes but not limited to polymorphism investigation, crystal size distribution measurement, and drying investigation to deliver API with desired properties
  • Formulation support
    • Excipient compatibility studies
    • Micrometrics (Powder properties evaluation)