Temozolomide stability in extemporaneously compounded oral suspensions

Area of Science:

• Pharmaceutical Sciences
• Oncology
• Drug Formulation

Background:

• Temozolomide is an oral alkylating agent crucial for treating brain tumors.
• Compounding oral suspensions offers an alternative administration route for temozolomide capsules.

Purpose of the Study:

• To evaluate the pharmaceutical acceptability and chemical stability of extemporaneously compounded temozolomide oral suspensions.
• To compare the stability of temozolomide in two different suspension vehicles.

Main Methods:

• Temozolomide oral suspensions (10 mg/mL) were prepared from 100-mg capsules using Ora-Plus/Ora-Sweet and Ora-Plus/Ora-Sweet SF mixtures.
• Suspensions were stored at 4°C for 60 days and 23°C for 21 days in amber plastic bottles.
• Stability was assessed using a stability-indicating high-performance liquid chromatographic method.

Main Results:

• Temozolomide showed minimal loss (<10%) in both formulations when stored at 4°C for 60 days.
• At 23°C, temozolomide degradation was more pronounced, with losses up to 11% by 21 days.
• Formulations were deemed pharmaceutically acceptable and chemically stable under recommended storage conditions.

Conclusions:

• Extemporaneous temozolomide oral suspensions are stable for at least 60 days when refrigerated (4°C).
• Refrigerated storage is recommended for optimal stability.
• Room temperature storage should not exceed 1-2 weeks depending on the vehicle used (Ora-Sweet vs. Ora-Sweet SF).