title: Stability of sunitinib in oral suspension.
abstract: BACKGROUND
  Sunitinib is a novel, oral, multitargeted tyrosine kinase inhibitor with antiangiogenic and antitumor activity. No liquid formulation of sunitinib malate is 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 sunitinib malate capsules (each equivalent to 50 mg of sunitinib) with 15 mL of a 1:1 mixture of Ora-Plus:Ora-Sweet solution to yield 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 10-mg/mL suspension of sunitinib malate with Ora-Plus:Ora-Sweet 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.
authors.affiliation: Department of Oncology, St Jude Children's Research Hospital, Memphis, TN 38112, USA. fariba.navid@stjude.org
authors.forename: Fariba
authors.initials: F
authors.lastname: Navid
authors.forename: Robbin
authors.initials: R
authors.lastname: Christensen
authors.forename: Patton
authors.initials: P
authors.lastname: Minkin
authors.forename: Clinton F
authors.initials: CF
authors.lastname: Stewart
authors.forename: Wayne L
authors.initials: WL
authors.lastname: Furman
authors.forename: Sharyn
authors.initials: S
authors.lastname: Baker
mesh_terms: D020533:Angiogenesis Inhibitors / Q000737:chemistry*; D000970:Antineoplastic Agents / Q000737:chemistry*; D004339:Drug Compounding; D004355:Drug Stability; D004356:Drug Storage; D007211:Indoles / Q000737:chemistry*; D011758:Pyrroles / Q000737:chemistry*; D012034:Refrigeration; D000077210:Sunitinib; D013535:Suspensions
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D013535:Suspensions; D000077210:Sunitinib