Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-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 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;
wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutical composition.
2. A pharmaceutical composition for oral delivery, comprising:
a solid dispersion comprising:
(a) an amorphous form of a compound represented by Formula (I):
and
(b) hydroxypropyl methyl cellulose acetate succinate;
wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutical composition.
3. A pharmaceutical composition for oral delivery, comprising:
a solid dispersion and one or more pharmaceutically acceptable carriers, wherein the solid dispersion comprises:
(a) an amorphous form of a compound represented by Formula (I):
and
(b) hydroxypropyl methyl cellulose acetate succinate;
wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutical composition.
4. A pharmaceutical composition for oral delivery, comprising:
a solid dispersion and one or more pharmaceutically acceptable carriers, wherein the solid dispersion comprises:
(a) 50 mg of the compound of Formula (I) in amorphous form):
and
(b) hydroxypropyl methyl cellulose acetate succinate;
wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutical composition.