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
Solubility analysis: This includes:
Stability analysis: This includes: