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Abstract:  Temozolomide, commercially available in capsules, is an oral alkylating agent used to treat brain tumors. The purpose of this study was to determine the pharmaceutical acceptability and chemical stability of temozolomide in two extemporaneously compounded suspension formulations prepared from the capsules. The temozolomide oral suspensions were prepared from 100-mg commercial capsules yielding a nominal temozolomide concentration of 10 mg/mL. The suspension vehicles selected for testing were an equal parts mixture of Ora-Plus and Ora-Sweet and an equal parts mixture of Ora-Plus and Ora-Sweet SF. The suspensions were packaged in amber plastic screw-cap prescription bottles, which were stored at 23°C for 21 days or 4°C for 60 days. Stability-indicating high-performance liquid chromatographic analysis revealed that the temozolomide concentration in both suspension vehicle combinations exhibited little or no loss for 60 days at 4°C. At 23°C, temozolomide losses were somewhat greater. In the Ora-Sweet formulation,

Related Keywords: Lawrence A. Trissel, BS, RPh, FASHP, Yanping Zhang, BS, Susannah E. Koontz, PharmD, BCOP, temozolomide, brain tumors, cancer chemotherapy, oral suspensions, liquid preparations, stability, storage, temperature, vehicles, formulation

Related Categories: CANCER AND AIDS, FORMULATIONS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS, NEUROLOGY

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