Claims for Patent: 9,931,334

Summary for Patent: 9,931,334

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:	15/584,324
Patent Claims:	1. A method for treating cystic fibrosis in a mammal comprising administering a solid pharmaceutical composition comprising amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide and less than about 30% crystalline N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide in combination with an additional therapeutic agent. 2. The method of claim 1, wherein the additional agent is selected from a mucolytic agent, a bronchodilator, an antibiotic, an anti-infective, an anti-inflammatory, a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, and a nutritional agent. 3. The method of claim 1, wherein the composition further comprises a pharmaceutically acceptable excipient. 4. The method of claim 1, wherein the composition is in the form of a solid dispersion. 5. The method 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. 6. The method of claim 1, wherein the composition further comprises a polymer. 7. A method for treating cystic fibrosis in a mammal comprising administering 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, in combination with an additional therapeutic agent. 8. The method of claim 7, wherein the additional therapeutic agent is selected from a mucolytic agent, a bronchodilator, an antibiotic, an anti-infective, an anti-inflammatory, a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, and a nutritional agent. 9. A solid pharmaceutical composition comprising amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide and less than about 30% crystalline N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide, wherein said composition comprises an additional therapeutic agent. 10. The solid pharmaceutical composition of claim 9, wherein the additional agent is selected from a mucolytic agent, a bronchodilator, an antibiotic, an anti-infective, an anti-inflammatory, a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, and a nutritional agent. 11. The solid pharmaceutical composition of claim 9, further comprising a pharmaceutically acceptable excipient. 12. 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 9. 13. The solid pharmaceutical composition of claim 9, wherein the composition is in the form of a solid dispersion. 14. The solid pharmaceutical composition of claim 9, 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. 15. The solid pharmaceutical composition of claim 9, wherein the composition further comprises a polymer. 16. 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, wherein said composition comprises an additional therapeutic agent. 17. The solid pharmaceutical composition of claim 16, wherein the additional therapeutic agent is selected from a mucolytic agent, a bronchodilator, an antibiotic, an anti-infective, an anti-inflammatory, a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, and a nutritional agent.