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Preformulation

Before pharmaceutical drug product formulation activities are started-up, preformulation studies are initiated. During the preformulation phase, the physical and chemical properties of the active pharmaceutical ingredient (API) are determined. The gained knowledge on the API will help you to select the right salt or polymorphic form and will support the design and development of your dosage form, both for pre-clinical and clinical use.

Preformulation includes:

  • API characterization
    • Dissociation constant (pKa)
    • Partition coefficient (Log P)
    • Particle size and morphology (laser diffraction, microscopic imaging)
    • Crystallinity (X-ray diffraction)
    • Thermal analysis (melting point and glass transition)
  • Solubility studies in organic and pharmaceutical solvents
  • Excipient compatibility studies
  • Forced degradation studies (heat, acid, alkali, light, peroxides, metal ions)