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Formulation and stability of iopentol
K Skinnemoen1, R Fagervoll, L Aanstad
1Analytical Chemistry Department, Nycomed AS, Oslo, Norway.
Acta Radiologica. Supplementum
|January 1, 1987
Summary
Autoclaving studies show that a trometamol buffer is essential for iopentol formulation stability, preventing deiodination. The iopentol formulation demonstrates good stability in ongoing studies.
Area of Science:
- Pharmaceutical Chemistry
- Radiocontrast Agents
Background:
- Development of iodinated contrast media is crucial for medical imaging.
- Iopentol is a non-ionic contrast agent requiring specific formulation for stability.
Purpose of the Study:
- To establish an autoclaving method for iopentol formulation.
- To assess the stability of iopentol under autoclaving conditions.
- To identify critical factors for minimizing deiodination during sterilization.
Main Methods:
- Autoclaving studies were conducted on iopentol formulations.
- Comparison of iopentol formulation with iohexol formulation.
- Evaluation of pH control using trometamol buffer during autoclaving.
Main Results:
- The formulation used for iohexol was found suitable for iopentol.
- Trometamol buffer is essential to lower pH during autoclaving.
- Lowering pH effectively minimizes deiodination post-autoclaving.
- Ongoing stability studies indicate good stability of the final iopentol product.
Conclusions:
- A stable iopentol formulation can be achieved through optimized autoclaving.
- Trometamol plays a critical role in preventing degradation during sterilization.
- The developed formulation exhibits promising long-term stability.