Stability of Fentanyl Citrate in Polyolefin Bags

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry
• Drug Stability Studies

Background:

• Fentanyl, a potent opioid analgesic, is widely used for pain management.
• Limited data exists on the stability of fentanyl diluted in polyolefin bags.
• Previous studies focused on polyvinyl chloride bags, leaving a gap in polyolefin bag stability knowledge.

Purpose of the Study:

• To evaluate the chemical stability of fentanyl solutions in polyolefin bags.
• To determine the stability of fentanyl at concentrations of 10 µg/mL and 50 µg/mL.
• To assess fentanyl stability under different storage conditions (temperature and light).

Main Methods:

• Aseptic filling of polyolefin bags with fentanyl solutions (10 µg/mL and 50 µg/mL).
• Storage of samples at 5°C (protected from light) and 22°C (exposed to light) for 93 days.
• Monitoring fentanyl degradation using a stability-indicating high-performance liquid chromatographic method, alongside visual inspection and pH measurement.

Main Results:

• No chemical degradation of fentanyl was observed in polyolefin bags after 93 days of storage at either temperature.
• Fentanyl solutions remained colorless and clear throughout the study period.
• A slight decrease in pH was noted during storage, but fentanyl integrity was maintained.

Conclusions:

• Fentanyl solutions (10 µg/mL and 50 µg/mL) are chemically stable in polyolefin bags for 93 days.
• Storage at 5°C or 22°C, with or without light exposure, does not compromise fentanyl stability in these bags.
• Polyolefin bags are suitable for the storage of fentanyl solutions under the tested conditions.