CRYSTALLINE FORMS OF CFTR MODULATORS
Crystalline forms of Compound I: pharmaceutically acceptable salts thereof, and solvates and hydrates thereof are disclosed. Pharmaceutical compositions comprising the same, methods of treating cystic fibrosis using the same, and methods for making the same are also disclosed.
1 . Compound I (free form) Form A
2 .- 8 . (canceled)
9 . A pharmaceutical composition comprising the Compound I (free form) Form A according to claim 1 .
10 . The pharmaceutical composition according to claim 9 , further comprising one or more additional CFTR modulating compounds.
11 .- 12 . (canceled)
13 . The pharmaceutical composition according to claim 10 , wherein the one or more additional CFTR modulating compounds are selected from
14 . A method of treating cystic fibrosis comprising administering the Compound I (free form) Form A according to claim 1 to a subject in need thereof.
15 . The method according to claim 14 , wherein the Compound I (free form) Form A is administered with one or more additional CFTR modulating compounds.
16 . The method according to claim 15 , wherein the one or more additional CFTR modulating compound are selected from
17 . A method of preparing the Compound I (free form) Form A according to claim 1 , comprising:
(a) crystallizing amorphous Compound I in toluene and
(b) drying under vacuum
to provide substantially crystalline Compound I (free form) Form A.
18 . Compound I potassium salt hydrate Form C