Stability of extemporaneously prepared hydroxyurea solutions.

Area of Science:

• Pharmaceutical Sciences
• Drug Stability
• Extemporaneous Compounding

Background:

• Hydroxyurea is a critical medication for various conditions.
• Extemporaneous preparation of liquid hydroxyurea offers convenience but requires stability assessment.
• Traditional preparation methods can be time-consuming.

Purpose of the Study:

• To evaluate the stability of a novel, rapidly prepared hydroxyurea solution.
• To determine the shelf-life of extemporaneously compounded hydroxyurea (50 mg/mL).

Main Methods:

• A validated high-performance liquid chromatography (HPLC) method with a HILIC column was used for hydroxyurea quantification.
• Hydroxyurea was dissolved and diluted to 50 mg/mL using sterile water and ORA-sweet vehicle.
• Solutions were stored at 4 °C, 26 °C, and 40 °C for 78 days.

Main Results:

• Hydroxyurea solutions maintained potency (<2% loss) for 78 days at 4 °C and 26 °C.
• Solutions stored at 40 °C exhibited >10% loss of potency within 28 days.
• Amber polypropylene plastic bottles were used for storage.

Conclusions:

• Extemporaneously compounded hydroxyurea 50 mg/mL solutions are stable for at least 78 days when stored at room temperature (26 °C) and under refrigeration (4 °C).
• The 1:1 mixture of water and ORA-sweet vehicle is suitable for preparing stable hydroxyurea solutions.
• Elevated temperatures (40 °C) significantly reduce the stability of the compounded hydroxyurea solution.