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Claims for Patent: 8,410,274

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Claims for Patent: 8,410,274

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 Ryan (Waltham, MA), Costache; Adriana (Roslindale, 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 (Cambridge, MA)
Application Number:13/358,778
Patent Claims: 1. A solid dispersion comprising amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide.

2. The solid dispersion of claim 1, further comprising a surfactant, polymer, or inert pharmaceutically acceptable substance.

3. The solid dispersion of claim 1, further comprising a polymer.

4. The solid dispersion of claim 3, wherein the polymer is hydroxypropylmethylcellulose acetate succinate (HPMCAS).

5. The solid dispersion of claim 3, wherein the polymer is present in an amount of from about 10% by weight to about 80% by weight.

6. The solid dispersion of claim 5, wherein the polymer is present in an amount of less than about 70% by weight.

7. The solid dispersion of claim 1, wherein the N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide is present in an amount of from about 10% by weight to about 80% by weight.

8. The solid dispersion of claim 1, further comprising a surfactant.

9. The solid dispersion of claim 8, wherein the surfactant is sodium lauryl sulfate.

10. The solid dispersion of claim 8, wherein the surfactant is present in an amount from about 0.1 to about 5%.

11. The solid dispersion of claim 10, wherein the surfactant is present in 0.5%.

12. The solid dispersion according to claim 1, wherein the solid dispersion is obtained by spray drying.

13. A pharmaceutical composition comprising amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide as a solid dispersion.

14. The pharmaceutical composition of claim 13, further comprising a polymer.

15. The pharmaceutical composition of claim 14, wherein the polymer is hydroxypropylmethylcellulose (HPMC) or hydroxypropylmethylcellulose acetate succinate (HPMCAS).

16. The solid dispersion of claim 3, wherein the polymer is at least one water-soluble or partially water-soluble polymer.

17. The pharmaceutical composition of claim 14, wherein the polymer is at least one water-soluble or partially water-soluble polymer.

18. A pharmaceutical composition comprising amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide as a solid dispersion and a polymer.

19. The pharmaceutical composition of claim 18, wherein the polymer is at least one water-soluble or partially water-soluble polymer.

20. The pharmaceutical composition of claim 18, wherein the polymer is hydroxypropylmethylcellulose acetate succinate (HPMCAS).

21. A solid dispersion comprising N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide, hydroxypropylmethylcellulose acetate succinate (HPMCAS) and sodium lauryl sulfate.

22. A pharmaceutical composition comprising the solid dispersion of claim 21.
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