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Preformulation Studies
  • Organoleptic and Bulk Characters
  • Solubility analysis
  • Stability analysis

It is a phase of research and development to characterize the physical and chemical properties of a drug molecule in order to develop a safe, effective, and stable dosage form.

Usually, Preformulation studies are laboratory studies which are used to determine the characteristics of active substance and excipients that may influence the formulation and process design and performance. It has been described as “Learning before doing”.

A major area of Preformulation studies includes:

Organoleptic and Bulk Characters: These include

  • Crystallinty and Polymorphism
  • Hygroscopicity
  • Fine particle characterization
  • Powder flow properties

Solubility analysis: This includes:

  • Ionization constant-PKa
  • pH solubility profile
  • Common ion effect-Ksp
  • Thermal effects
  • Solubilization
  • Partition co-efficient
  • Dissolution

Stability analysis: This includes:

  • Stability in toxicology formulations
  • Solution stability
  • pH rate profile
  • Solid-state stability
  • Bulk stability
  • Compatibility

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