P4.A002: Comparative Stability of Three Epinephrine Products Under Extreme Temperature Conditions

Background: Epinephrine should be administered immediately after symptoms of a Type I allergic reaction occur to avoid the risk of progression to more severe anaphylaxis. Since time is critical, patients at risk are instructed to carry epinephrine devices with them at all times. When carrying epinephrine exposure to extreme temperature conditions can occur, such as accidentally leaving the product in a car on a summer day. In this study we evaluated the influence of extreme temperature conditions on the potency for different epinephrine product formulations.

Methods: Stability data was collected on epinephrine's potency (assay) from the three products: neffy (epinephrine nasal spray; ARS pharma); EpiPen (Viatris); and Symjepi (Adamis Pharma). Extreme temperature stability was assessed at 50°C (122°F) [car temperature] for 3 months and 40°C (104°F) for 6-months. Reference stability was conducted at room temperature testing conditions 25°C (77°F).

Results: The epinephrine potency changes over 3-months at 50°C were -56.6% (Symjepi), -41.6% (EpiPen), and -8.6% (neffy), respectively. Change in assay results over 6-months at 40°C/75% RH was -27.5% (EpiPen), -17.2% (Symjepi), and -13.9% (neffy) respectively.

Conclusion: effy (epinephrine nasal spray) was more stable than injection products and remained within shelf-life specifications for potency even after 3-months under extreme temperature conditions (50°C). EpiPen and Symjepi showed rapid and extensive degradation and were subpotent at these extreme temperature conditions after a short period of time. The expiration period for injection products is 18-months, while neffy, a needle-free epinephrine alternative, is anticipated to be launched with an initial expiration period of 24-months.