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Stability of Two Long‐Acting Insulin Formulations after 28 Days
Author(s) -
Silva Matthew A,
Chuong Monica,
Kerr Stephen,
Cabrera Adriana
Publication year - 2013
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/j.2055-2335.2013.tb00213.x
Subject(s) - insulin , medicine , vial , insulin detemir , regular insulin , insulin pen , area under the curve , drug packaging , chromatography , zoology , hypoglycemia , chemistry , biology , radiology , insulin glargine
Background Insulin when stored according to manufacturers' recommendations offer at least 28 days of use after opening. A realistic understanding of room temperature storage at home includes exposure to heat and light. Pharmacy refill data suggest that patients tend to use opened insulin beyond 28 days. Insulin quality could be effected after 28 days when stored under uncontrolled conditions. Aim To evaluate the stability of two long‐acting insulin formulations, Humulin 70/30 and Levemir, after 28 days. Method A high‐performance liquid chromatography assay was used to quantify insulin area under the curve (AUC) profiles as an indicator of insulin quality. Human recombinant insulin (Humulin) 70/30 and insulin detemir (Levemir) vials were stored in refrigerated (2–8 °C, 36–46 °F) and room temperature (22–24 °C, 72–75 °F) conditions for up to 42 days, emulating patient managed storage and use patterns. Samples were taken on opening (time 0) and vials were randomised and stored in refrigerated or at room temperature conditions. Samples were taken and evaluated at Days 7, 14, 21, 28, 35 and 42. Results Humulin 70/30 and Levemir generated chromatograms with characteristic peaks at 12 and 21 minutes. Refrigerated Humulin 70/30 and Levemir AUCs were compared to time 0 and no differences were found. By Day 35, some Humulin 70/30 samples at room temperature had changes in AUC (p = 0.002) and loss of symmetry when compared to time 0 and all samples at Day 42 had changes in AUC (p < 0.0001). A similar pattern occurred with Levemir; some samples at room temperature had changes in AUC (p = 0.005) and loss of symmetry when compared to time 0 and all samples at Day 42 had changes in AUC (p < 0.0001). Conclusion Room temperature storage may effect Humulin 70/30 and Levemir AUCs and chromatograms by Day 42. Patients should be advised to store insulin in the refrigerator when possible and reminded that insulin quality can be effected by room temperature storage and beyond date use.