Stability of azacitidine in infusion fluids

Area of Science:

• Pharmaceutical Sciences
• Drug Stability
• Intravenous Infusions

Background:

• Azacitidine is a critical chemotherapy agent.
• Understanding its stability in various infusion solutions is vital for safe administration.
• Previous data on azacitidine stability in common intravenous fluids is limited.

Purpose of the Study:

• To evaluate the stability of azacitidine in four common infusion fluids.
• To determine the impact of different concentrations and containers on azacitidine stability.
• To provide data for optimizing azacitidine preparation and administration protocols.

Main Methods:

• Azacitidine was prepared at 0.2 mg/ml and 2.0 mg/ml in 0.9% sodium chloride, 5% dextrose, lactated Ringer's, and Normosol-R.
• Stability was assessed in glass bottles and plastic IV bags over 25 hours.
• High-performance liquid chromatography (HPLC) was used to quantify azacitidine concentrations.
• The t90 (time to 90% remaining) was calculated for each condition.

Main Results:

• Azacitidine t90 values rarely exceeded three hours across all tested conditions.
• At 0.2 mg/ml, 5% dextrose injection exhibited significantly lower stability (t90 = 0.8 hours) compared to other fluids (t90 ≈ 2 hours).
• In plastic bags, 5% dextrose also showed reduced azacitidine concentration after six hours compared to other solutions.

Conclusions:

• Azacitidine exhibits limited stability in common infusion fluids, necessitating timely administration.
• 5% dextrose injection is not ideal for azacitidine infusions due to rapid degradation.
• Further research may be needed to identify optimal conditions or alternative formulations for extended azacitidine stability.