Stability and Sterility of Enoxaparin 8 mg/mL Subcutaneous Injectable Solution

Area of Science:

• Pharmacology
• Pediatric Medicine
• Drug Formulation

Background:

• Enoxaparin dosing in neonates and infants often requires dilution for accuracy.
• Existing enoxaparin dilution guidelines may be insufficient for the smallest patient populations.

Purpose of the Study:

• To assess the stability and sterility of an 8 mg/mL enoxaparin dilution.
• To determine appropriate storage and usage timelines for compounded enoxaparin preparations in pediatric care.

Main Methods:

• Compounding of enoxaparin at 8 mg/mL by diluting 100 mg/mL stock solution with sterile water.
• Sterility and stability testing of the 8 mg/mL enoxaparin dilution at 0, 7, 14, and 30 days.
• Statistical analysis using one-way repeated-measures ANOVA to evaluate Anti-Factor Xa concentration changes over time.

Main Results:

• The 8 mg/mL enoxaparin dilution maintained sterility for up to 30 days.
• Significant degradation of enoxaparin was observed at the 30-day testing point (p < 0.05).

Conclusions:

• The 8 mg/mL enoxaparin dilution is stable and sterile for 14 days when refrigerated.
• This specific enoxaparin preparation is not recommended for use beyond 14 days due to stability issues.