PHARMACEUTICAL COMPOSITIONS AND ADMINISTRATIONS THEREOF
The present invention relates to pharmaceutical compositions comprising a compound of Formula I in combination with one or both of a Compound of Formula II and/or a Compound of Formula III. The invention also relates to solid forms and to pharmaceutical formulations thereof, and to methods of using such compositions in the treatment of CFTR mediated diseases, particularly cystic fibrosis.
1 - 7 . (canceled)
8 . A pharmaceutical composition comprising substantially amorphous N-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1H-quinoline-3-carboxamide (Compound 1) and substantially amorphous (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cycloropanecarboxamide (Compound 3),
wherein the substantially amorphous Compound 1 comprises less than 15% crystalline Compound 1,
wherein the substantially amorphous Compound 3 comprises less than 15% crystalline Compound 3, and
wherein the pharmaceutical composition is a tablet which comprises 50 mg of substantially amorphous Compound 3.
9 . A method of treating a CFTR mediated disease in a human, wherein the method comprises administering to the human an effective amount of the pharmaceutical composition of claim 8 .
10 - 11 . (canceled)
12 . The method of claim 9 , wherein the CFTR mediated disease is cystic fibrosis.
13 - 22 . (canceled)