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Stability and stabilization of insulinotropin in a dextran formulation
1Pharmaceutical Research and Development, Pfizer Central Research, Groton, Connecticut, USA.
PDA Journal of Pharmaceutical Science and Technology
|November 1, 1995
Summary
Insulinotropin stability in dextran formulations was investigated. Cysteine and EDTA combination proved most effective for stabilizing the peptide, identifying tryptophan as the main degradation site.
Area of Science:
- Pharmaceutical Sciences
- Biochemistry
- Drug Formulation
Background:
- Insulinotropin stability is crucial for effective therapeutic delivery.
- Dextran formulations are used but can impact peptide stability.
- Understanding degradation pathways is key to improving drug longevity.
Purpose of the Study:
- To assess insulinotropin stability in a 23% dextran-75 formulation.
- To identify the primary degradation site and factors affecting stability.
- To evaluate antioxidant strategies for stabilizing insulinotropin.
Main Methods:
- Investigated effects of temperature, excipients, and concentrations on stability.
- Utilized Liquid Chromatography-Mass Spectrometry (LC-MS) to pinpoint degradation sites.
- Tested various antioxidants for their stabilizing efficacy.
Main Results:
- The tryptophan residue was identified as the primary site of insulinotropin degradation.
- Temperature, excipients, and concentration influenced peptide stability.
- A combination of cysteine and EDTA demonstrated significant stabilizing effects.
Conclusions:
- Insulinotropin degradation primarily occurs at the tryptophan residue.
- Formulation components and environmental factors impact peptide stability.
- Cysteine and EDTA offer a promising strategy for stabilizing insulinotropin in dextran formulations.