Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
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.
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 (2Θ) X-ray powder diffraction.
8. The solid pharmaceutical composition of claim 1 , further comprising a polymer.