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Preformulation

For a successful product development ExtractumPharma Zrt. considers the implementation of preformulation inspections indispensable during drug design, which includes, but is not limited to the following.

Finding qualified raw material and additive resources

Analysis of the chemical properties of the active substance

  • Contaminants
  • Decomposition products

Analysis of the physical properties of the active substance

  • Solubility analyses
  • Particle size
  • Particle surface
  • Density
  • Hygroscopicity
  • Photostability
  • Polymorphy

Incompatibility analyses

  • Compatibility between additives (strengthening, weakening)
  • Interaction between active substances and additives

Final documentation and evaluation

The results of the preformulation analyses are summarised in the Final documentation and evaluation, which constitutes the basis of the formulation. The detailed, comprehensive evaluation prepared during the preformulation is essential considering the outcome of the formulation development processes. Inadequate migration or absorption properties, e.g. poor solubility, restricted permeability, poor physical stability numbers mean special challenges. The emerging difficulties are resolved by the formulation development.