Preformulation Characterization

Preformulation characterization studies generally include accelerated stability (stress) studies, stability-indicating analytical method development, and other physiochemical characterizations designed to pinpoint potential product candidate stability problems and enable formulation optimization. 

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Objectives of pre-formulation research

  • Understanding the pharmaceutically significant physicochemical properties
  • Estimating product’s stability when exposed to various common stresses
  • Developing stability-indicating assays for major degradation products
  • Deciding upon a lyophilized or liquid formulation for initial clinical studies
  • Finalizing a formulation development research protocol (matrix of buffer, pH, stabilizer, tonicity modifier; analytical methods; etc.)