Scientific Poster Session IV: Students Research-in-Progress

Abstract

Research Question or Hypothesis: How long after the expiration date is there enough active drug remaining in 0.15 mg-dosed EAIs?

Study Design: This is an In-vitro study of drug degradation using high-performance liquid chromatography (HPLC) and chiral column.

Methods: Use of HPLC separated epinephrine into chiral forms, where only L(-) configuration demonstrates biological activity, and D(+) configuration is considered biologically inactive. Known stability-indicated methods with HPLC are utilized. This project tested previously expired EAIs collected through community partners, including allergy clinics and retail pharmacies, to be tested in a laboratory setting, as use in humans experiencing allergic reactions would be unethical. The primary outcome is concentration of active epinephrine remaining in expired EAIs, expressed as a percentage (at least 90% meets the FDA’s requirement for an active medication). Inverse correlations will be utilized.

Results: A sample of 41 lower-dose (0.15 mg) EAIs were tested after their expiration dates, and approximately half (n=19) retained at least 90% active epinephrine. These EAIs were tested 1-13 months after expiration as compared with truly expired EAIs (without 90% active drug) that were tested 2-25 months after expiration. Given the number of 0.15 mg EAIs and overlap in time since expiration date, this is ongoing research.

Conclusion: While some EAIs retain at least 90% active epinephrine past expiration dating, the 0.15 mg dosed EAIs adhere more closely to the listed expiration date than do 0.3 mg doses. More data points are needed to confirm these findings.

Presenting Author

Authors