To perform Drug-Excipient Compatbility (DEC) study 4 types of samples are required to be preprared:
- API as such
- Excipient as such
- API + Excipient Physical Mixture
- API + Excipient Kneaded Mixture with approx 5% moisture
All these samples are packed in flint glass vial or amber color vial (if API is light sensitive) with and without sealing & exposed for a particular time period i.e. 1 Day, 3 Days, 7 Days, 14 Days and Maximum upto 28 Days at stressed conditions to accelerate the reaction e.g.
- 60°C (to check the effect of heat)
- 90%RH (to check the effect of moisture)
- Option 1 Light Source of ICHQ1B (to check the effect of light)
- 3%H2O2 (to check the effect of oxidation)
After incubation of all the samples at predefined storage conditions for predefined time periods samples are:
- physically observed for any probable color or shade change
- thermally analysed by DSC or TGA for any thermal based change
- solid state characterised by pXRD or FTIR for any polymorphic form change
- chemically analysed by HPLC for known Impurity or LC-MS or GC-MS for Unknown impurity evaluation.
Read also:
- Design of Experiments (DOE) in Drug Formulation Development
- Excipients in Pharmaceutical Applications
Resource person: Dr. Shivang Chaudhary