Claims for Patent: 9,670,163

Summary for Patent: 9,670,163

Title:	Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Abstract:	The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Inventor(s):	Hurter; Patricia (Harvard, MA), Rowe; William (Medford, MA), Young; Christopher R. (Waltham, MA), Costache; Adriana (Cambridge, MA), Connelly; Patrick R. (Harvard, MA), Krawiec; Mariusz (Marlborough, MA), Gong; Yuchuan (Waukegan, IL), Feng; Yushi (Zionsville, IN), Trudeau; Martin (Shannon, CA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	14/852,892
Patent Claims:	1. A solid pharmaceutical composition comprising amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoguinoline- -3-carboxamide and less than about 30% crystalline N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide. 2. The solid pharmaceutical composition of claim 1, further comprising a pharmaceutically acceptable excipient. 3. A method for treating cystic fibrosis in a mammal comprising administering to said mammal an effective amount of the solid pharmaceutical composition according to claim 1. 4. The solid pharmaceutical composition of claim 2, wherein the composition is in the form of a solid dispersion. 5. A process for preparing a solid pharmaceutical composition comprising a) forming a mixture comprising crystalline N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide, a solvent, and optionally a polymer: and b) spray-drying the mixture to form the solid pharmaceutical composition. 6. The solid pharmaceutical composition of claim 1, wherein the composition comprises less than about 5%, based on the composition, of crystalline N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide. 7. A solid pharmaceutical composition comprising 100% amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide as determined by Cu K alpha radiation (2.THETA.) X-ray powder diffraction. 8. The solid pharmaceutical composition of claim 1, further comprising a polymer.