Strategy for determining extractables from rubber packaging materials in drug products

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry
• Materials Science

Background:

• Leachable substances from rubber packaging can migrate into drug products, especially with organic solvents.
• Current recommendations for leachable testing are evolving, and testing packaging materials with simulated solvents is often insufficient for the pharmaceutical industry.

Purpose of the Study:

• To describe a rational strategy for evaluating drug products for packaging extractables.
• To develop a method for identifying and quantifying leachables directly within the drug product matrix.

Main Methods:

• Profiling rubber packaging extractables using various organic solvents and stress conditions.
• Evaluating the drug product matrix for potential interferences with extractable detection.
• Selecting and validating analytical methods according to FDA guidelines.
• Implementing a stability program to establish acceptance criteria.

Main Results:

• A comprehensive extractable profile was generated, guiding targeted analysis in the drug product.
• Potential matrix interferences were identified and addressed in method development.
• Validated analytical procedures were established for reliable leachable detection.
• Acceptance criteria were defined based on stability data.

Conclusions:

• The described strategy provides a robust approach for assessing drug product safety concerning packaging leachables.
• This methodology can be adapted for various pharmaceutical products and packaging materials.
• Direct evaluation of the drug product is crucial for accurate leachable assessment.