Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea
Provided herein are low impurity compositions comprising a compound represented by Formula (I): which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFRα kinases, and oncogenic forms thereof.
1. A pharmaceutical composition for orally delivering 50 mg of a compound represented by Formula (I):
the pharmaceutical composition comprising:
a solid dispersion comprising:
(a) 50 mg of the compound wherein the compound is present in amorphous form; and
(b) hydroxypropyl methyl cellulose acetate succinate; and
aniline in an amount equal to or less than about 5% by weight based on the total weight of the pharmaceutical composition.
2. The pharmaceutical composition of claim 1 , comprising aniline in an amount equal to or less than about 3% by weight based on the total weight of the pharmaceutical composition.
3. The pharmaceutical composition of claim 1 , comprising aniline in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutical composition.
4. The pharmaceutical composition of claim 1 , comprising aniline in an amount equal to or less than about 1% by weight based on the total weight of the pharmaceutical composition.
5. The pharmaceutical composition of claim 1 , comprising aniline in an amount equal to or less than about 0.5% by weight based on the total weight of the pharmaceutical composition.
6. A pharmaceutical composition comprising:
a solid dispersion comprising:
(a) a compound represented by Formula (I):
wherein the compound is present in amorphous form; and
(b) hydroxypropyl methyl cellulose acetate succinate; and
aniline in an amount equal to or less than about 5% by weight based on the total weight of the pharmaceutical composition.
7. The pharmaceutical composition of claim 6 , comprising aniline in an amount equal to or less than about 3% by weight based on the total weight of the pharmaceutical composition.
8. The pharmaceutical composition of claim 6 , comprising aniline in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutical composition.
9. The pharmaceutical composition of claim 6 , comprising aniline in an amount equal to or less than about 1% by weight based on the total weight of the pharmaceutical composition.
10. The pharmaceutical composition of claim 6 , comprising aniline in an amount equal to or less than about 0.5% by weight based on the total weight of the pharmaceutical composition.