# US 12,213,968 B2 · Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea

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- Number: US 12,213,968 B2
- Document ID: US12213968B2
- Status: Granted
- Kind: B2
- Application number: 18/795,731
- Filed: 2024-08-06
- Published: 2024-11-28
- Granted: 2025-02-04
- 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/US12213968B2

## 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 comprising:
a solid dispersion comprising: a compound represented by Formula (I) or pharmaceutically acceptable salt thereof,
and hydroxypropylmethyl cellulose acetate succinate; and
wherein a compound represented by Formula (II):
is present in an amount equal to or less than about 10% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the compound represented by Formula (II) is present in an amount equal to or less than about 5% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the compound represented by Formula (II) is present in an amount equal to or less than about 3% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, wherein the compound represented by Formula (II) is present in an amount equal to or less than about 1% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 5 (depends on 1)

The pharmaceutical composition of claim 1, wherein the compound represented by Formula (II) is present in an amount equal to or less than about 0.5% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 6

A pharmaceutical composition comprising:
a solid dispersion comprising: a compound represented by Formula (I) or pharmaceutically acceptable salt thereof,
and hydroxypropylmethyl cellulose acetate succinate; and
wherein a compound represented by Formula (III):
is present in an amount equal to or less than about 10% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 7 (depends on 6)

The pharmaceutical composition of claim 6, wherein the compound represented by Formula (III) is present in an amount equal to or less than about 5% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 8 (depends on 6)

The pharmaceutical composition of claim 6, wherein the compound represented by Formula (III) is present in an amount equal to or less than about 3% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 9 (depends on 6)

The pharmaceutical composition of claim 6, wherein the compound represented by Formula (III) is present in an amount equal to or less than about 1% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 10 (depends on 6)

The pharmaceutical composition of claim 6, wherein the compound represented by Formula (III) is present in an amount equal to or less than about 0.5% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 11

A pharmaceutical composition comprising:
a solid dispersion comprising: a compound represented by Formula (I) or pharmaceutically acceptable salt thereof,
and hydroxypropylmethyl cellulose acetate succinate; and
aniline in an amount equal to or less than about 10% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 12 (depends on 11)

The pharmaceutical composition of claim 11, wherein aniline is present in an amount equal to or less than about 5% by weight based on the total weight of the weight of the compound of Formula (I) present in the composition.

### Claim 13 (depends on 11)

The pharmaceutical composition of claim 11, wherein aniline is present in an amount equal to or less than about 3% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 14 (depends on 11)

The pharmaceutical composition of claim 11, wherein aniline is present in an amount equal to or less than about 1% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 15 (depends on 11)

The pharmaceutical composition of claim 11, wherein aniline is present in an amount equal to or less than about 0.5% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 16

A pharmaceutical composition comprising:
a solid dispersion comprising: a compound represented by Formula (I) or pharmaceutically acceptable salt thereof,
and hydroxypropylmethyl cellulose acetate succinate; and
diphenyl urea in an amount equal to or less than about 3% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 17 (depends on 16)

The pharmaceutical composition of claim 16, wherein diphenyl urea is present in an amount equal to or less than about 1% by weight based on the weight of the compound of Formula (I) present in the composition.

### Claim 18 (depends on 16)

The pharmaceutical composition of claim 16, wherein diphenyl urea is present in an amount equal to or less than about 0.5% by weight based on the weight of the compound of Formula (I) present in the composition.