CSF-1R inhibitors and methods of use thereof
Provided herein, in part, is a compound of Formula (I) or a hydrate thereof, essentially free of one or more impurities, compositions thereof, and methods of use thereof.
1 . A pharmaceutically acceptable oral dosage form, comprising:
(i) a dihydrate form of a compound of Formula (I):
(ii) about 10 ppm to about 500 ppm of a compound of Formula (II):
and
(iii) a pharmaceutically acceptable excipient.
2 . The oral dosage form of claim 1 , about 150 ppm to about 400 ppm of the compound of Formula (II) is present in the oral dosage form.
3 . The oral dosage form of claim 1 , wherein no more than about 50 ppm of the compound of Formula (II) is present in the oral dosage form.
4 . The oral dosage form of claim 1 , wherein no more than about 150 ppm of the compound of Formula (II) is present in the oral dosage form.
5 . The oral dosage form of claim 1 , wherein no more than about 300 ppm of the compound of Formula (II) is present in the oral dosage form.
6 . The oral dosage form of claim 1 , wherein no more than about 330 ppm of the compound of Formula (II) is present in the oral dosage form.
7 . The oral dosage form of claim 1 , wherein no more than about 700 ppm of the compound of Formula (II) is present in the oral dosage form.
8 . The oral dosage form of claim 1 , wherein the dihydrate form is present in the pharmaceutical composition in an amount to provide 14 mg of the compound.
9 . The oral dosage form of claim 1 , wherein the dihydrate form is present in the pharmaceutical composition in an amount to provide 20 mg of the compound.
10 . The oral dosage form of claim 1 , wherein the dihydrate form is present in the pharmaceutical composition in an amount to provide 30 mg of the compound.
11 . The oral dosage form of claim 1 , wherein the oral dosage form is a capsule.
12 . A pharmaceutical composition, comprising:
(i) a compound of Formula (I):
or a hydrate thereof; and
(ii) a compound of Formula (II):
wherein the compound of Formula (II) is present in the pharmaceutical composition, in an amount less than about 800 ppm; and
(iii) a pharmaceutically acceptable excipient.
13 . The pharmaceutical composition of claim 12 , wherein less than about 50 ppm of the compound of Formula (II) is present in the pharmaceutical composition.
14 . The pharmaceutical composition of claim 12 , wherein less than about 150 ppm of the compound of Formula (II) is present in the pharmaceutical composition.
15 . The pharmaceutical composition of claim 12 , wherein less than about 300 ppm of the compound of Formula (II) is present in the pharmaceutical composition.
16 . The pharmaceutical composition of claim 12 , wherein less than about 330 ppm of the compound of Formula (II) is present in the pharmaceutical composition.
17 . The pharmaceutical composition of claim 12 , wherein less than about 500 ppm of the compound of Formula (II) is present in the pharmaceutical composition.
18 . The pharmaceutical composition of claim 12 , wherein less than about 700 ppm of the compound of Formula (II) is present in the pharmaceutical composition.
19 . The pharmaceutical composition of claim 12 , comprising a dihydrate form of the compound in an amount to provide 14 mg of the compound.
20 . The pharmaceutical composition of claim 12 , comprising a dihydrate form of the compound in an amount to provide 20 mg of the compound.
21 . The pharmaceutical composition of claim 12 , comprising a dihydrate form of the compound in an amount to provide 30 mg of the compound.