Preparation method and stability of a temozolomide suspension: a pilot study

Abstract

AIM: To investigate a compounding process for temozolomide 10 mg/mL suspension from capsules without using a mortar and pestle; and the stability of the suspension under refrigeration (2 to 8 °C) and at room temperature (22 to 23 °C). METHOD: Temozolomide 10 mg/mL suspension was prepared using a modified formulation and method to contain the product in the final container and limit operator exposure to cytotoxic powder or residue. Decontamination was undertaken of work and finished product surfaces. Samples were stored at room temperature and under refrigeration. Both samples were protected from light and stored in identical polypropylene containers. High-pressure liquid chromatography was used to assay the potency of the suspension. RESULTS: The sample refrigerated and protected from light exhibited little or no chemical degradation for 22 days. At room temperature, the concentration fell below the acceptable concentration after 8 days. An acceptable product was produced which re-suspended evenly when shaken. CONCLUSION: Preliminary results indicate that temozolomide 10 mg/mL suspension prepared via this method, refrigerated, protected from light and stored in polypropylene containers may be stable for up to 22 days.