Stability of extemporaneously compounded 5-fluorouracil utilizing high performance liquid chromatography

Area of Science:

• Pharmaceutical Sciences
• Drug Stability
• Compounding Pharmacy

Background:

• 5-fluorouracil (5-FU) is a critical chemotherapeutic agent requiring stable formulations for administration.
• Understanding the stability of compounded 5-FU in various infusion devices and storage conditions is essential for safe and effective patient care.

Purpose of the Study:

• To evaluate the stability of compounded 5-fluorouracil (5-FU) in Intravia™ bags and CADD™ cassettes.
• To assess stability across different concentrations (20-50 mg/mL) and diluents (0.9% NaCl, 5% dextrose).
• To determine stability under refrigeration (2-8°C) and room temperature (25°C, 60% RH) for up to 15 days.

Main Methods:

• Development and utilization of a stability-indicating high-performance liquid chromatography (HPLC) method for 5-FU quantification.
• Assessment of 5-FU concentrations in Intravia™ bags and CADD™ cassettes at predetermined intervals (0, 4, 7, 10, 15 days).
• Adherence to United States Pharmacopeia (USP) guidelines for stability testing, including visual inspection for cloudiness, color change, and precipitation.

Main Results:

• Intravia™ bags maintained 5-FU stability for the full 15-day study period under both storage conditions.
• CADD™ cassettes retained >90% 5-FU for 15 days at room temperature and 10 days under refrigeration.
• Precipitation was noted in CADD™ cassettes at day 15 (both conditions) and day 10 (room temperature, 40 mg/mL in 5% dextrose). No cloudiness or color change observed.

Conclusions:

• Compounded 5-FU demonstrates acceptable stability in Intravia™ bags for 15 days, exceeding standard hospital use recommendations.
• CADD™ cassettes offer extended stability for 5-FU infusions, particularly at room temperature, though refrigeration limits stability.
• The findings support the extended use of compounded 5-FU in these specific infusion devices, provided storage conditions and potential precipitation are considered.