Bioequivalence evaluation of epinephrine autoinjectors with attention to rapid delivery
نویسنده
چکیده
Timely and proper injection of epinephrine is critical to prevent serious consequences relating to anaphylaxis. In a recent bioavailability study comparing epinephrine delivery from the Auvi-Q™ and EpiPen(®) epinephrine autoinjectors, the Auvi-Q failed to meet the bioequivalence threshold when using partial area under the curve (AUC) analyses based on zero to Tmax recommended for highly variable drugs such as epinephrine. Peak plasma epinephrine concentrations for the EpiPen occurred 10 minutes (median Tmax) after dosing, while peak concentrations for the Auvi-Q occurred 20 minutes after dosing. Though bioequivalence may be concluded for Cmax, AUCinf, and AUC0-t, for fast-acting therapeutics used to treat life-threatening conditions, such as epinephrine, additional pharmacokinetic parameters such as AUC zero to Tmax may be important to evaluate when assessing bioequivalence.
منابع مشابه
Demonstration of epinephrine autoinjectors (EpiPen and Anapen) by pharmacists in a randomised, simulated patient assessment: acceptable, but room for improvement
BACKGROUND Successful treatment of anaphylaxis in the community relies on early and correct use of epinephrine autoinjectors. Community pharmacists supply these devices and have a crucial role teaching patients how to use them. Supply of epinephrine autoinjectors in Australia increased 70-fold in the past decade. New EpiPen and Anapen autoinjectors were launched in Australia in 2011 and 2012, w...
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Background: Successful treatment of anaphylaxis in the community relies on early and correct use of epinephrine autoinjectors. Community pharmacists supply these devices and have a crucial role teaching patients how to use them. Supply of epinephrine autoinjectors in Australia increased 70-fold in the past decade. New EpiPen and Anapen autoinjectors were launched in Australia in 2011 and 2012, ...
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