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 aniline is present in the pharmaceutical composition in an amount equal to or less than about 0.3% by weight based on the total weight of the pharmaceutical composition.
2. The pharmaceutical composition of claim 1 , comprising:
(i) a compound represented by Formula (II):
in an amount equal to or less than about 0.40% by weight based on the total weight of the pharmaceutically acceptable tablet; and
(ii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet.
3. The pharmaceutical composition of claim 1 , comprising:
(i) a compound represented by Formula (II):
in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet; and
(ii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet.
4. 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 aniline is present in the pharmaceutical composition in an amount equal to or less than about 0.3% by weight based on the total weight of the pharmaceutical composition.
5. The pharmaceutical composition of claim 4 , comprising:
(i) a compound represented by Formula (II):
in an amount equal to or less than about 0.40% by weight based on the total weight of the pharmaceutically acceptable tablet; and
(ii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet.
6. The pharmaceutical composition of claim 4 , comprising:
(i) a compound represented by Formula (II):
in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet; and
(ii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet.
7. 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 aniline is present in the pharmaceutical composition in an amount equal to or less than about 0.3% by weight based on the total weight of the pharmaceutical composition.
8. The pharmaceutical composition of claim 7 , comprising:
(i) a compound represented by Formula (II):
in an amount equal to or less than about 0.40% by weight based on the total weight of the pharmaceutically acceptable tablet; and
(ii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet.
9. The pharmaceutical composition of claim 7 , comprising:
(i) a compound represented by Formula (II):
in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet; and
(ii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet.
10. 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) wherein the compound is present in amorphous form:
and
(b) hydroxypropyl methyl cellulose acetate succinate;
wherein aniline is present in the pharmaceutical composition in an amount equal to or less than about 0.3% by weight based on the total weight of the pharmaceutical composition.
11. The pharmaceutical composition of claim 10 , comprising:
(i) a compound represented by Formula (II):
in an amount equal to or less than about 0.40% by weight based on the total weight of the pharmaceutically acceptable tablet; and
(ii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet.
12. The pharmaceutical composition of claim 10 , comprising:
(i) a compound represented by Formula (II):
in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet; and
(ii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet.