Bosutinib is a kinase inhibitor. The chemical name for
bosutinib monohydrate is 3-Quinolinecarbonitrile,
propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3•H2O
(monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to
530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:
Bosutinib monohydrate is a white to yellowish-tan powder.
Bosutinib monohydrate has a pH dependent solubility across the physiological pH
range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble
compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly.
BOSULIF® (bosutinib) tablets are supplied for oral
administration in two strengths: a 100 mg yellow, oval, biconvex, film-coated
tablet debossed with “Pfizer” on one side and “100” on the other; and a 500 mg
red, oval, biconvex, film-coated tablet debossed with “Pfizer” on one side and
“500” on the other.
Each 100 mg BOSULIF tablet contains 103.40 mg of bosutinib
monohydrate, equivalent to 100 mg of bosutinib; each 500 mg BOSULIF tablet
contains 516.98 mg of bosutinib monohydrate, equivalent to 500 mg of bosutinib.
The following inactive ingredients are included in the tablets:
microcrystalline cellulose, croscarmellose sodium, poloxamer, povidone,
magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol,
talc, and iron oxide yellow (for 100 mg tablet) and iron oxide red (for 500 mg
Last reviewed on RxList: 9/14/2012
This monograph has been modified to include the generic and brand name in many instances.