# US 11,896,585 B2 · Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea

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- Number: US 11,896,585 B2
- Document ID: US11896585B2
- Status: Granted
- Kind: B2
- Application number: 18/148,766
- Filed: 2022-12-30
- Published: 2023-06-29
- Granted: 2024-02-13
- Earliest claimed: 2019-12-30
- Assignees: Deciphera Pharmaceuticals, LLC
- Applicants: Deciphera Pharmaceuticals, LLC
- Inventors: Michael D. Kaufman; Scott Bone; Corey Bloom; Fred Jordan
- Web page: https://patentgrep.com/patent/US11896585B2

## CPC

- A61K 31/4375: the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
- A61P 35/00: Antineoplastic agents
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/10: Dispersions; Emulsions
- A61K 9/146: {with organic macromolecular compounds}
- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/1635: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 9/1682: {Processes}
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2077: {Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets}
- A61K 47/38: Cellulose; Derivatives thereof
- C07D 471/04: Ortho-condensed systems
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)

## Abstract

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.

## Claims

### Claim 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.

### Claim 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.

### Claim 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.

### Claim 4 (depends on 3)

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.

### Claim 5 (depends on 3)

The pharmaceutical composition of claim 3, comprising about 25-45% by weight of a filler based on the total amount of the pharmaceutical composition.