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Last Updated: December 23, 2024

Claims for Patent: 11,395,818

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Summary for Patent: 11,395,818

Title:	Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-- 3-yl)-2-fluorophenyl)-3-phenylurea
Abstract:	Provided herein are low impurity compositions comprising a compound represented by Formula (I): ##STR00001## which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFR.alpha. kinases, and oncogenic forms thereof.
Inventor(s):	Kaufman; Michael D. (Waltham, MA), Bone; Scott (Bend, OR), Bloom; Corey (Bend, OR), Jordan; Fred (Bend, OR)
Assignee:	Deciphera Pharmaceuticals, LLC (Waltham, MA)
Application Number:	17/180,241
Patent Claims:	1. A pharmaceutical solid dispersion 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) ##STR00045## and b) one or more pharmaceutically acceptable carriers; wherein: a compound represented by Formula (II): ##STR00046## is present in the solid dispersion composition in amount of about 0.1% (w/w) to about 0.5% (w/w) by weight based on the total weight of the solid dispersion composition; and aniline and diphenyl urea are each present in amount equal to or less than about 0.5% by weight based on the total weight of solid dispersion composition. 2. A pharmaceutically acceptable composition for orally delivering 50 mg of a compound represented by Formula (I): ##STR00047## comprising: a) a solid dispersion having: 50 mg of the compound wherein the compound is present in amorphous form; hydroxypropyl methyl cellulose acetate succinate; and b) a pharmaceutically acceptable carrier; wherein a compound represented by Formula (II): ##STR00048## is present in composition in amount equal to or less than about 1.5% by weight based on the total weight of the composition; and aniline is present in the composition in amount equal to or less than about 0.5% by weight based on the total weight of the composition. 3. A pharmaceutically acceptable composition for orally delivering 50 mg of a compound represented by Formula (I): ##STR00049## 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 a glidant and/or a lubricant; wherein when exposed to 60% relative humidity at 25.degree. C. for 1 month, the composition has not more than about 0.5% (w/w) of a compound represented by Formula (II): ##STR00050##

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