Apart from their measurement and needle, one main criticism about epinephrine auto-injectors is that they can not stand up to important “temperature excursions,” similar to when the gadget is left in a automotive on a sizzling day.
The priority is twofold: the gadget used to inject the epinephrine is advanced and will warp underneath excessive temperatures, and the epinephrine resolution itself could lose efficiency.
Aquestive Therapeutics is within the means of advancing a sublingual epinephrine different by means of medical trials. Anaphylm™ is a small rectangular movie positioned underneath the tongue to ship epinephrine in an anaphylactic emergency.
The corporate offered knowledge from exams of its candidate underneath excessive temperatures at this 12 months’s AAAAI annual assembly.
They saved Anaphylm at 122°F (50°C) for 28 days, examined its efficiency, then saved it at room temperature (77°F/25°C) for an additional 12 months and examined its efficiency once more. After the preliminary 28 days at excessive temperature, the drug remained 97.7% potent, then after the next 12 months, examined at 96.9%.
One other check noticed Anaphylm sampled after the temperature was ratcheted as much as 158°F (70°C) for seven days, then examined once more after 12 months at room temperature. The drug’s efficiency remained at 96.6% after the preliminary check and 91.7% after the 12 months.
The examine demonstrated Anaphylm’s stability throughout a variety of utmost temperatures and reveals the drug maintains efficiency all through its shelf-life underneath real-world circumstances.
