Stability of sunitinib in oral suspension.

BACKGROUND: Sunitinib is a novels oral; multitargeted tyrosine kinase inhibitor with antiangiogenic and antitumor activity. No liquid formulation of sunitinib malate is v commercially, available for pediatric administration. OBJECTIVE: To prepare extemporaneously an oral liquid formulation of sunitinib malate from commercially available capsules and study its chemical and physical stability in suspension at room temperature and under refrigeration at 4 degrees C. METHODS: Six independent samples, were, prepared by mixing the contents of 3 of a sunitinib malate capsules (each equivalent to 50 mg of sunitinib) with 15 mL 1:1 mixture of Ora-Plus:Ora-Sweet solution to, yields a final concentration of 10 mg/mL. Suspensions Were stored in amber plastic bottles with child-resistant caps Three samples were refrigerated at 4 degrees C and 3 were stored at room temperature. Aliquots from each bottle were obtained on days 1., 2, 3, 5, 7, 14, 21, 30, and 60 and diluted to a final concentration of 300 ng/mL with 500 ng/mL of clozapine in 50%, acetonitrile. Sunitinib concentrations were. then measured by a liquid chromatography-tandem mass spectrometry assay validated in our laboratory. RESULTS:At room temperature and under refrigeration at 4 degrees C, sunitinib in a 10mg/mL suspension I of sunitinib malate with Ora-Plus:, Ora-Sweet 1:1 1 maintained greater than 96% of its initial concentration for 60 days. Visual appearance (color and consistency) and odor of drug suspension remained unchanged during the study. CONCLUSIONS: Sunitinib is stable in an oral suspension prepared from commercially available capsules for at least 60 days at room temperature and refrigeration at 4 degrees C. This liquid formulation is better suited for administration to children and adults with cancer who cannot swallow sunitinib capsules.