Key points:
- A review of 17 studies and unpublished data from manufacturers reveals that insulin is not as temperature-sensitive as previously thought.
- Unopened vials and cartridges of human insulin can be stored at up to 25°C for up to 6 months and up to 37°C for a maximum of 2 months without any loss of insulin activity.
- The discovery offers new hope to people with diabetes living in regions with limited access to healthcare or stable powered refrigeration.
A new review reveals that insulin is less temperature-sensitive than previously thought. Insulin can be kept at room temperature for months without losing potency. This discovery offers new hope to people living in regions with limited access to healthcare or stable refrigeration.
Guidance stated that insulin, an essential medicine for those with diabetes, must be kept refrigerated to preserve its efficacy. However, in many countries, electricity and refrigeration remain unavailable.
Now, the new review summarizes 17 previous studies and data from manufacturers to examine effects on insulin when it is stored outside of fridges. It is possible to store unopened vials and cartridges of certain types of human insulin at up to 25°C for up to 6 months and up to 37°C for a maximum of 2 months without any clinically relevant loss of insulin activity.
One specific study demonstrates no loss of insulin activity for some insulin types when stored in oscillating ambient temperatures between 25°C and 37°C for up to 3 months. This is an important fluctuation that mirrors the day-night temperature cycles of tropical countries.
“Our new study opens up new possibilities for individuals living in challenging environments, where access to refrigeration is limited,” said Bernd Richter from the Heinrich-Heine-University. “By understanding the thermal stability of insulin and exploring innovative storage solutions, we can make a significant impact on the lives of those who depend on insulin for their well-being.”
In addition to insight into the thermal stability of insulin, the review highlights future research directions. There is a need to examine mixed insulin, the influence of motion in the case of insulin pumps, contamination in opened vials and cartridges, and the effect of cold environmental conditions.