SUTENT, an oral multi-kinase inhibitor, is the malate salt of
sunitinib. Sunitinib malate is described chemically as Butanedioic
acid, hydroxy-,(2S)-, compound with
N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-
3H-indol-3-ylidine)
methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The
molecular formula is
C22H27FN4O2·C4H6O5 and the molecular weight is
532.6 Daltons.
The chemical structure of sunitinib malate is:
Sunitinib malate is a yellow to orange powder with a pKa of 8.95.
The solubility of sunitinib malate in aqueous media over the range pH
1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution
coefficient (octanol/water) at pH 7 is 5.2.
SUTENT (sunitinib malate) capsules are supplied as printed hard
shell capsules containing sunitinib malate equivalent to 12.5 mg, 25
mg or 50 mg of sunitinib together with mannitol, croscarmellose
sodium, povidone (K-25) and magnesium stearate as inactive
ingredients.
The orange gelatin capsule shells contain titanium dioxide, and red
iron oxide. The caramel gelatin capsule shells also contain yellow
iron oxide and black iron oxide. The printing ink contains shellac,
propylene glycol, sodium hydroxide, povidone and titanium dioxide.