Preformulation

Xcelience offers a suite of services from preformulation and development through manufacturing, small-scale commercial manufacturing and clinical packaging and logistics. We have an established reputation in helping companies identify the most suitable formulation options for their compound’s needs.

As the drug substance and drug product continue through the development process, Xcelience provides the following analyses:

  • X-Ray Diffraction (XRD)
    • Polymorph identification
    • Salt screen/selection
    • Crystalline/amorphous evaluations
  • Thermal Evaluation
    • Modulated differential scanning calorimetry (DSC)
    • Thermogravimetric Analysis (TGA)
    • Hot stage
  • Vapor Sorption Analysis
    • Moisture sorption isotherms
    • Isohume
  • Rheometry
    • Stress vs. strain
    • Linear and nonlinear viscoclastic response
  • Laser diffraction particle size analysis
  • Morphology analysis (polarized microscope)
  • pKa determination (calculated or experimental)
  • Log P/log D determination
  • Moisture content (Karl Fischer)
  • pH solubility profiles
  • Water activity
  • Photostability
  • Solution characterization
  • Excipient compatibility
  • Accelerated stability
  • Chiral stability
  • Formulation development and early phase GMP manufacturing