Impact of space environment on stability of medicines: Challenges and prospects

This write-up provides a review of the problem and countermeasure approaches for pharmaceuticals exposed to the space environment. The first part of the article discusses thought processes behind outlining of International Conference on Harmonization drug stability guidelines, Q1A (R2) and Q1B, and its acceptance limits for accelerated stability study. The second part of the article describes the difference in the radiation environment of deep space compared to radiation environment inside the space shuttle based on penetration power of different types of radiation. In the third part of the article, various promising approaches are listed which can be used for assurance of space medicine stability. One of the approaches is the use of ground-based space simulation analogues and statistical treatment to data to calculate failure rate of drugs and probabilistic risk assessment. Another approach is to innovate storage and packaging technology using radiation harden polymer or using cryogenic temperatures.