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Claims for Patent: 8,883,206

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Claims for Patent: 8,883,206

Title:Pharmaceutical composition and administrations thereof
Abstract: The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.
Inventor(s): Dokou; Eleni (Cambridge, MA), Jamzad; Shahla (Belmont, MA), Caesar, Jr.; John P. (Lancaster, MA), Fawaz; Majed (Foxboro, MA), Das; Laura (Charlestown, MA), Gu; Chong-Hui (Weban, MA), Hurter; Patricia Nell (Harvard, MA), Israni; Meghna Jai (Boston, MA), Johnston; Meghan M. (Wakefield, MA), Knezic; Dragutin (Watertown, MA), Kuzmission; Andrew G. (Shrewsburg, MA), Wang; HongRen (Lexington, MA)
Assignee: Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:14/286,856
Patent Claims: 1. A pharmaceutical composition consisting of: about 35 wt % of a solid dispersion by weight of the composition, wherein the dispersion comprises about 80 wt % of substantially amorphous or amorphous N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide by weight of the dispersion, about 19.5 wt % of HPMCAS by weight of the dispersion, and about 0.5 wt % SLS by weight of the dispersion; about 13.5 wt % of mannitol by weight of the composition; about 41 wt % of lactose by weight of the composition; about 2 wt % of sucralose by weight of the composition; about 6 wt % of croscarmellose sodium by weight of the composition; about 1 wt % of colloidal silicon dioxide by weight of the composition; and about 1.5 wt % of magnesium stearate by weight of the composition.

2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a unit dose form comprising one or a plurality of granules, pellets, particles or mini-tablets, and wherein the unit dose form comprises from about 1 mg to about 100 mg of substantially amorphous or amorphous N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide.

3. The pharmaceutical composition of claim 2, wherein the unit dose form comprises about 50 mg of substantially amorphous or amorphous N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide.

4. The pharmaceutical composition of claim 2, wherein the unit dose form comprises about 75 mg of substantially amorphous or amorphous N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide.

5. The pharmaceutical composition of claim 2, wherein the unit dose form comprises from about 25 to about 40 mini-tablets.

6. The pharmaceutical composition of claim 2, wherein the solid dispersion is present in an amount of about 35 percent by weight of the pharmaceutical composition and the unit dose form comprises from about 26 mini-tablets.

7. The pharmaceutical composition of claim 6, wherein the unit dose form comprises about 50 mg of substantially amorphous or amorphous N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide.

8. The pharmaceutical composition of claim 2, wherein the solid dispersion is present in an amount of about 35 percent by weight of the pharmaceutical composition and the unit dose form comprises about 39 mini-tablets.

9. The pharmaceutical composition of claim 8, wherein the unit dose form comprises about 75 mg of substantially amorphous or amorphous N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide.

10. The pharmaceutical composition of claim 5, wherein the mini-tablet has a shape that is cylinder-like, oval-like, cone-like, sphere-like, ellipsis-like, polygon-like or combinations thereof, wherein the mini-tablet has as its longest dimension or diameter a length of about 2 mm.
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