Preformulation Development

Prerequisite for the Development of New Drugs

Preformulation development studies are conducted to determine the physical and chemical characteristics of the compound of interest, be it a small organic molecule, peptide, or protein. These studies generate the data that are a prerequisite to dosage form development and the data required for the Chemistry, Manufacturing and Controls (CMC) section of an Investigational New Drug application (IND).

IriSys provides the following preformulation development studies:

• Pka and pI
• Partition coefficient and distribution coefficient as a function of pH
• pH-solubility profile
• Intrinsic solubility
• pH-stability profile at accelerated temperatures
• Accelerated stability studies
• Dissociation constants
• Hygroscopicity analysis
• Lipophilicity analysis
• Moisture analysis
• Excipient compatibility studies
• Salt formation characteristics determination
• Accelerated stability studies
• Viscosity analysis
• Disintegration studies
• Dissolution studies