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 10% by weight based on the total weight of the pharmaceutical composition.
2. The pharmaceutical composition of claim 1 , wherein diphenyl urea is present in the pharmaceutical composition in 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 diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 1% by weight based on the total weight of the pharmaceutical composition.
4. The pharmaceutical composition of claim 1 , wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 0.5% by weight based on the total weight of the pharmaceutical composition.
5. A pharmaceutical composition for oral delivery, comprising:
a solid dispersion comprising:
(a) an amorphous form of a compound represented by Formula (I):
(b) hydroxypropyl methyl cellulose acetate succinate;
wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 10% by weight based on the total weight of the pharmaceutical composition.
6. The pharmaceutical composition of claim 5 , wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 3% by weight based on the total weight of the pharmaceutical composition.
7. The pharmaceutical composition of claim 5 , wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 1% by weight based on the total weight of the pharmaceutical composition.
8. The pharmaceutical composition of claim 5 , wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 0.5% by weight based on the total weight of the pharmaceutical composition.
9. 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):
(b) hydroxypropyl methyl cellulose acetate succinate;
wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 10% by weight based on the total weight of the pharmaceutical composition.
10. The pharmaceutical composition of claim 9 , wherein diphenyl urea is present in the pharmaceutical composition in 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 diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 1% by weight based on the total weight of the pharmaceutical composition.
12. The pharmaceutical composition of claim 9 , wherein diphenyl urea is present in the pharmaceutical composition in amount equal to or less than about 0.5% by weight based on the total weight of the pharmaceutical composition.