Finished Dosage Form

Preformulation studies

  • Solubility, pH, solution stability
  • Moisture content, sorption analysis
  • Thermal analysis (thermal behavior, melting point).
  • Structural characterization - FTIR, UV/Vis, fluorescence, NMR, MS Particle morphology, size and size distribution
  • X-ray powder diffraction (XRPD)
  • Polymorph screening
  • Solid state stability
  • Drug-excipient compatibility and packaging component compatibility

Formulation development

  • Tablets (Immediate, modified release mono layered and bilayer) 
  • Capsules
  • Particulate, film, enteric coating
  • Oral Solutions and suspensions
  • Powders-blends and Sachets
  • Bottle, blister, sachet and tube packaging
  • Clinical supply and placebo manufacture
  • Review of batch documentation by developmental Quality Assurance team

Stability studies:

  • Informal and formal studies (ICH)
  • Including elevated, ambient, and subambient
  • Temperatures, photo stability
  • Degradation studies-temperature, pH, light, oxidation