Stability of Naloxone in Normal Saline for Continuous Infusion

Area of Science:

• Pharmaceutical Science
• Clinical Pharmacy
• Drug Stability

Background:

• Continuous naloxone infusions are crucial for managing respiratory depression from long-acting opioids.
• Extemporaneous preparation of naloxone hydrochloride (N-HCl) is often required at concentrations exceeding manufacturer recommendations.
• Evaluating the stability of these preparations is essential for safe and effective patient care.

Purpose of the Study:

• To assess the stability of naloxone hydrochloride (N-HCl) in 0.9% sodium chloride IV bags.
• To determine the stability of N-HCl at concentrations of 40, 80, and 200 mcg/mL.
• To evaluate the impact of light exposure on N-HCl stability.

Main Methods:

• N-HCl was prepared in 0.9% sodium chloride IV bags at concentrations of 40, 80, and 200 mcg/mL.
• Samples were stored at room temperature under ambient light for up to four days.
• Additional 80 mcg/mL samples were protected from light and evaluated over eight weeks.
• High-performance liquid chromatography (HPLC) was used to analyze drug concentrations over time.

Main Results:

• Initial N-HCl concentrations were within 97.9% to 101.5% of theoretical values.
• Concentrations remained above 97.5% for four days at room temperature.
• 80 mcg/mL N-HCl samples showed minimal decrease (approx. 3%) over eight weeks.
• No significant difference in stability was observed between samples exposed to light and those protected from light.

Conclusions:

• Extemporaneously prepared N-HCl in 0.9% normal saline IV bags up to 200 mcg/mL is stable for at least four days at room temperature.
• N-HCl IV bags at 80 mcg/mL demonstrate stability over an eight-week period.
• Ambient laboratory lighting did not negatively impact N-HCl stability within the study's timeframe.