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; and
about 25-45% by weight of a filler based on the total amount of the pharmaceutical composition.
2. A pharmaceutical composition comprising:
a) a solid dispersion comprising:
hydroxypropyl methyl cellulose acetate succinate; and
50 mg of an amorphous form of a compound represented by Formula (I):
and
b) one or more pharmaceutically acceptable carriers.
3. 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;
a bulking agent; and
a filler.
4. The pharmaceutical composition of claim 3 , comprising about 25-45% by weight of a bulking agent based on the total amount of the pharmaceutical composition.
5. The pharmaceutical composition of claim 3 , comprising about 25-45% by weight of a filler based on the total amount of the pharmaceutical composition.