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Is it the method or the process-separating the causes of low recovery
Wendy Cory1, Kelly Field, Dan Wu-Linhares
1Analytical Research and Development, Pfizer Global Research and Development, Groton, Connecticut, USA. wendy_cory@groton.pfizer.com
Drug Development and Industrial Pharmacy
|November 4, 2004
Summary
Low drug recovery from CP-122,721 tablets was investigated. The selected extraction solvent ensured complete drug recovery, indicating segregation during manufacturing caused the low assay values.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
- Drug Manufacturing
Background:
- Accurate analytical assay methods are crucial for tablet formulation development.
- Low drug recovery during assay can indicate manufacturing issues or incomplete extraction.
Purpose of the Study:
- To identify a suitable solvent for 100% drug extraction from CP-122,721 tablets.
- To determine the cause of consistently low tablet assay values (approx. 95%).
Main Methods:
- Conducted a solvent screen study for CP-122,721 prototype formulations.
- Evaluated drug-excipient interactions in various solvents.
- Investigated process-related sources of low drug recovery.
Main Results:
- The selected extraction solvent demonstrated 100% drug recovery, confirming no drug-excipient interactions.
- Low tablet assay values persisted despite solvent validation.
Conclusions:
- Segregation during the manufacturing process was identified as the primary cause of low drug recovery for CP-122,721 tablets.
- The chosen solvent effectively eliminated drug-excipient interactions, validating its suitability for the assay method.