title: Temozolomide stability in extemporaneously compounded oral suspensions.
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 deg C for 21 days or 4 deg 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 deg C. At 23 deg C, temozolomide losses were somewhat greater. In the Ora-Sweet formulation, the loss was 6% at 7 days; in the Ora-Sweet SF formulation, losses were about 8% at 14 days and 10% to 11% at 21 days. Temozolomide extemporaneously prepared as oral suspensions from capsules in equal parts mixtures of Ora-Plus suspension vehicle with Ora-Sweet and with ora-Sweet SF syrups with added povidine k-30 and acidified with citric acid were pharmaceutically acceptable and chemically stable for at least 60 days at 4 deg C. Refrigerated storage is recommended. The suspensions should not be stored at room temperature longer than 1 week if Ora-Sweet is used or longer than 2 weeks if Ora-Sweet SF is used.
authors: TriPharma Research, Cashiers, North Carolina.
authors: Lawrence A
authors: LA
authors: Trissel
authors: Yanping
authors: Y
authors: Zhang
authors: Susannah E
authors: SE
authors: Koontz