Stability and sterility of diluted enoxaparin under three different storage conditions.
OBJECTIVE
This study assessed whether enoxaparin sodium diluted to a concentration of 20 mg/mL for clinical use with 0.9% sodium chloride remained stable and sterile for up to 43 days under three different storage conditions.


METHODS
Enoxaparin dilutions in polypropylene syringes were stored under three different controlled conditions of temperature and light: (i) room temperature (22-26°C) under natural light; (ii) room temperature (22-26°C) in the dark; and (iii) controlled refrigeration (2-8°C) in the dark. A weekly assay of anti-Xa and anti-IIa activity was undertaken to determine if the diluted enoxaparin preparations retained anticoagulant activity, thus remaining suitable for clinical application.


RESULTS
Our findings indicate that diluted enoxaparin, when stored under the tested varied conditions of light and temperature, retained greater than or equal to 90% of baseline anticoagulant activity for anti-Xa and anti-IIa effect for up to 43 days.


CONCLUSIONS
The study results are significant for families, in that they suggest that at least a month's supply of enoxaparin could be dispensed at a time, reducing the frequency of patients/families returning for supply and providing a more convenient service for paediatric patients.
Murdoch Childrens Research Institute, The University of Melbourne, Melbourne, Victoria, Australia.
Robyn
R
Summerhayes
Maria
M
Chan
Vera
V
Ignjatovic
Richard
R
Prankerd
Paul
P
Monagle
D000925:Anticoagulants / Q000737:chemistry*; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods*; D017984:Enoxaparin / Q000737:chemistry*; D015951:Factor Xa / Q000032:analysis; D010372:Pediatrics; D013696:Temperature
D000925:Anticoagulants; D017984:Enoxaparin; D015951:Factor Xa