Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Compounds of Formula (I): pharmaceutically acceptable salts thereof, deuterated derivatives of any of the foregoing, and metabolites of any of the foregoing are disclosed. Pharmaceutical compositions comprising the same, methods of treating cystic fibrosis using the same, and methods for making the same are also disclosed. Also disclosed are solid state forms of Compound 1 and salts and solvates thereof.
1. Crystalline Form A of Compound 1:
2. Crystalline Form A according to claim 1 in substantially pure form.
3. Crystalline Form A according to claim 1 , characterized by an X-ray powder diffractogram having a signal at at least three two-theta values chosen from 6.6±0.2, 7.6±0.2, 9.6±0.2, 12.4±0.2, 13.1±0.2, 15.2±0.2, 16.4±0.2, 18.2±0.2, and 18.6±0.2.
4. Crystalline Form A according to claim 1 , characterized by an X-ray powder diffractogram having a signal at at least three two-theta values chosen from 6.6±0.2, 9.6±0.2, 13.1±0.2, 15.2±0.2, 18.2±0.2, and 18.6±0.2.
5. Crystalline Form A according to claim 1 , characterized by an X-ray powder diffractogram having a signal at three two-theta values of 6.6±0.2, 13.1±0.2, 18.2±0.2.
6. Crystalline Form A according to claim 1 , characterized by an X-ray powder diffractogram having a signal at six two-theta values of 6.6±0.2, 9.6±0.2, 13.1±0.2, 15.2±0.2, 18.2±0.2, and 18.6±0.2.
7. Crystalline Form A according to claim 1 , characterized by an X-ray powder diffractogram substantially similar to that in FIG. 2 .
8. A pharmaceutical formulation comprising at least one crystalline form according to claim 1 and a pharmaceutically acceptable carrier.