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ADMIXTURE STABILITY

Anti-Xa Stability of Diluted Enoxaparin for Use in Pediatrics

Pharmacist Specialist, Department of Pharmaceutical Services, University of California Davis Medical Center, Sacramento, CA; Clinical Professor of Pharmacy, School of Pharmacy, University of California at San Francisco, San Francisco, CA; Associate Clinical Professor of Medicine, School of Medicine, University of California Davis

Robert C Gosselin, CLS

Coagulation Specialist, Department of Pathology, University of California Davis Medical Center

Jeffery H King, PharmD

Clinical Coordinator, Pharmaceutical Services, University of California Davis Medical Center; Associate Clinical Professor of Pharmacy, School of Pharmacy, University of California at San Francisco

Cinda L Christensen, PharmD

Pharmacist Specialist, Pharmaceutical Services, University of California Davis Medical Center; Assistant Clinical Professor of Pharmacy, School of Pharmacy, University of California at San Francisco

John T Owings, MD

Associate Clinical Professor of Surgery, University of California Davis Medical Center

Edward C Larkin, MD

Professor and Vice Chair, Department of Pathology, University of California Davis Medical Center

Reprints: William E Dager PharmD FCSHP, Department of Pharmaceutical Services, University of California Davis Medical Center, 2315 Stockton Blvd., Sacramento, CA 95817-2201, fax 916/703-4031, william.dager{at}ucdmc.ucdavis.edu

BACKGROUND: The use of enoxaparin in low-weight pediatric patients is becoming common practice. Anti-Xa stability of unit-dose syringes prepared after dilution beyond one day is presently unknown.

OBJECTIVE: To evaluate the anti-Xa stability of diluted enoxaparin stored in glass vials and tuberculin syringes.

METHODS: Four separate batches of enoxaparin were diluted with sterile water to a final concentration of 20 mg/mL (2000 IU/mL) and aliquoted into plastic 1-mL syringes containing 6 mg (0.3 mL) or maintained in the glass vial. Syringes were stored at room temperature or under refrigeration. The glass vial used for diluting was stored at room temperature. The anti-Xa activity was measured on the date of preparation to 4 weeks. Statistical comparisons determined whether differences in anti-Xa activity in diluted enoxaparin are affected by the storage medium or temperature. A paired t-test was used to determine any significant differences between the anti-Xa activity on date of preparation (baseline) and subsequent time periods, with p < 0.05 considered statistically significant.

RESULTS: The mean baseline anti-Xa activity was 2607 IU/mL (95% CI 2300 to 2914). No measurable decrease occurred in diluted enoxaparin anti-Xa activity in the glass vial maintained over the 4-week period. Compared with the glass vial, room temperature and refrigerated syringe samples had trending decreases of anti-Xa activity at weeks 3 and 4, but did not reach statistical significance.

CONCLUSIONS: A nonsignificant decrease in anti-Xa activity occurred starting at day 22 for the diluted enoxaparin in tuberculin syringes, regardless of storage temperature. Storage up to 4 weeks of diluted enoxaparin in glass or prefilled syringes does not result in a statistically significant loss of anticoagulant potential, as measured by anti-Xa activity.

Key Words: enoxaparin, low-molecular-weight heparin, pediatrics, stability

Published Online, February 24, 2004. www.theannals.com, DOI 10.1345/aph.1D107

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