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Part of the New Drug Development Process
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 submission of the Chemistry,
Manufacturing and Controls (CMC) section of the Investigational
New Drug application (IND). IriSys provides the following
general preformulation development studies.
- Pka and or 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 with controlled storage at 40º C/75%
RH, 60º C
- Viscosity analysis
- Disintegration studies
- Dissolution studies
- Preparation and writing of the CMC for the IND
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