Temozolomide Stability in Extemporaneously Compounded Oral Suspensions

Trissel, Lawrence A; Zhang, Yanping; Koontz, Susannah E

Abstract

Temozolomide Stability in Extemporaneously Compounded Oral Suspensions

Author(s): Trissel Lawrence A, Zhang Yanping, Koontz Susannah E

Issue: Sep/Oct 2006 - Dermatology

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Page(s): 396-399

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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,

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