The Degradation Map Process - A Tool for Obtaining a Lean Stability Strategy in Drug Development

Area of Science:

• Pharmaceutical Sciences
• Drug Development
• Chemical Stability

Background:

• Drug candidate stability is crucial for pharmaceutical development.
• Stability and degradation data are often siloed across departments.
• A science and risk-based approach can optimize stability strategies.

Purpose of the Study:

• To present a concept for a lean stability strategy using degradation maps.
• To describe a process for utilizing degradation maps during drug development.
• To guide drug product design and stability studies through understanding degradation pathways.

Main Methods:

• Developing theoretical degradation maps.
• Updating maps with data from forced degradation experiments and compatibility studies.
• Utilizing maps to capture intrinsic chemical properties of the active pharmaceutical ingredient (API).

Main Results:

• Degradation maps visualize degradation pathways and reaction mechanisms.
• Maps serve as a cross-functional tool for collecting and visualizing stability information.
• The process facilitates mitigation of stability issues.

Conclusions:

• Degradation maps enable a lean and efficient stability strategy.
• This approach supports informed drug product design and development.
• Maps are valuable for managing stability throughout the drug development lifecycle.