title: Stability and Sterility of Enoxaparin 8 mg/mL Subcutaneous Injectable Solution.
abstract: BACKGROUND:Enoxaparin is often diluted to accurately deliver doses to neonatal and infant patients. Current recommendations for dilutions may not be adequate for the smallest patients.METHODS:Review of dosing at our institution occurred, and an 8 mg/mL concentration of enoxaparin was chosen. A concentration of 8 mg/mL was compounded by diluting 0.4 mL of enoxaparin (100 mg/mL) into 4.6 mL of sterile water for injection into an empty sterile vial. Four syringes of the 8 mg/mL concentration were prepared by 5 technicians (20 total syringes). Stability and sterility testing occurred a 0, 7, 14, and 30 days. One-way repeated-measures analysis of variance was used to detect significant differences in Anti-Factor Xa concentrations at the testing time points.RESULTS:The dilution of enoxaparin was sterile at 30 days but exhibited significant degradation at the 30-day point (p < 0.05).CONCLUSION:A dilution of enoxaparin 8 mg/mL is stable and sterile for 14 days refrigerated but is not stable at 30 days.
authors.affiliation: Department of Pharmacy, Texas Children's Hospital, Houston, Texas.
authors.forename: Brady S
authors.initials: BS
authors.lastname: Moffett
authors.affiliation: Department of Pharmacy, Texas Children's Hospital, Houston, Texas.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Dinh
authors.affiliation: Department of Pharmacy, Texas Children's Hospital, Houston, Texas.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Placencia
authors.affiliation: Department of Laboratory, Texas Children's Hospital, Houston, Texas.
authors.forename: Gregory
authors.initials: G
authors.lastname: Pelkey
authors.affiliation: Department of Pathology & Immunology, Pediatrics, Baylor College of Medicine, Houston, Texas.
authors.forename: Shiu-Ki Rocky
authors.initials: SR
authors.lastname: Hui
authors.affiliation: Department of Pathology & Immunology, Pediatrics, Baylor College of Medicine, Houston, Texas.
authors.forename: Jun
authors.initials: J
authors.lastname: Teruya
keywords: Anti–Factor Xa concentrations; enoxaparin; low molecular weight heparin; neonates; stability; sterility