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):
comprising:
a solid dispersion having 50 mg of the compound wherein the compound is present in amorphous form, and hydroxypropyl methyl cellulose acetate succinate;
about 25-45% by weight of a bulking agent based on the total amount of the pharmaceutical composition;
about 25-45% by weight of a filler based on the total amount of the pharmaceutical composition; and
wherein aniline is present 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 , wherein aniline is present 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 , wherein aniline is present 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 , wherein aniline is present 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 , wherein aniline is present 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) a solid dispersion comprising:
a pharmaceutically acceptable polymer; and
50 mg of an amorphous form of a compound represented by Formula (I):
and
b) one or more pharmaceutically acceptable carriers;
wherein:
aniline is present in an amount equal to or less than about 1.5% by weight based on the total weight of the pharmaceutical composition, wherein the pharmaceutically acceptable polymer is hydroxypropyl methyl cellulose acetate succinate.
7. The pharmaceutical composition of claim 6 , wherein aniline is present in an amount equal to or less than about 1.0% by weight based on the total weight of the pharmaceutical composition.
8. The pharmaceutical composition of claim 6 , wherein aniline is present in an amount equal to or less than about 0.5% by weight based on the total weight of the pharmaceutical composition.
9. A pharmaceutical composition comprising:
a) a solid dispersion comprising:
a pharmaceutically acceptable polymer; and
50 mg of an amorphous form of a compound represented by Formula (I):
and
b) one or more pharmaceutically acceptable carriers;
wherein:
a compound represented by Formula (III):
is present in an amount equal to or less than about 10% by weight based on the total weight of the pharmaceutical composition, wherein the pharmaceutically acceptable polymer is hydroxypropyl methyl cellulose acetate succinate.
10. The pharmaceutical composition of claim 9 , wherein the compound of Formula (III) is present in an amount equal to or less than about 3% by weight based on the total weight of the pharmaceutical composition.
11. The pharmaceutical composition of claim 9 , wherein the compound of Formula (III) is present in an amount equal to or less than about 1% by weight based on the total weight of the pharmaceutical composition.