Claims for Patent: 12,458,635

Summary for Patent: 12,458,635

Title:	Pharmaceutical composition and administrations thereof
Abstract:	The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.
Inventor(s):	William Rowe, Patricia Hurter, Christopher Young, Kirk Dinehart, Marinus Jacobus Verwijs, Kirk Overhoff, Peter D. J. Grootenhuis, Martyn Botfield, Alfredo Grossi
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US18/091,476
Patent Claims:	1. A pharmaceutical composition comprising a single solid dispersion, wherein the solid dispersion comprises: i. about 80 wt % of amorphous or substantially amorphous N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1) by weight of the solid dispersion, wherein the substantially amorphous Compound 1 comprises less than about 15% crystalline Compound 1; ii. about 19.5 wt % of hydroxypropylmethylcellulose acetate succinate (HPMCAS) by weight of the solid dispersion; and iii. about 0.5 wt % of sodium lauryl sulfate (SLS) by weight of the solid dispersion. 2. The pharmaceutical composition of claim 1, wherein the solid dispersion comprises about 150 mg of amorphous or substantially amorphous Compound 1. 3. The pharmaceutical composition of claim 1, wherein the solid dispersion comprises about 75 mg of amorphous or substantially amorphous Compound 1. 4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises: a) 34.1 wt % of the solid dispersion by weight of the pharmaceutical composition; b) 30.5 wt % of microcrystalline cellulose by weight of the pharmaceutical composition; c) 30.4 wt % of lactose by weight of the pharmaceutical composition; d) 3 wt % of sodium croscarmellose by weight of the pharmaceutical composition; e) 0.5 wt % of SLS by weight of the pharmaceutical composition; f) 0.5 wt % of colloidal silicon dioxide by weight of the pharmaceutical composition; and g) 1 wt % of magnesium stearate by weight of the pharmaceutical composition. 5. The pharmaceutical composition of claim 1, wherein the substantially amorphous Compound 1 comprises less than 5% crystalline Compound 1. 6. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a tablet, and the tablet comprises a coating. 7. The pharmaceutical composition of claim 4, wherein the pharmaceutical composition is a tablet. 8. The pharmaceutical composition of claim 7, wherein the tablet further comprises a coating. 9. A method of treating or lessening the severity of cystic fibrosis comprising administering to a patient in need thereof the pharmaceutical composition according to claim 1. 10. The method of claim 9, wherein the patient has cystic fibrosis transmembrane conductance regulator (CFTR) with a ΔF508 mutation. 11. The method of claim 9, wherein the patient has cystic fibrosis transmembrane conductance regulator (CFTR) with a R117H mutation. 12. The method of claim 9, wherein the patient has cystic fibrosis transmembrane conductance regulator (CFTR) with a G551D mutation. 13. The method of claim 9, wherein the pharmaceutical composition is orally administered to the patient once per day. 14. The method of claim 9, wherein the pharmaceutical composition is orally administered to the patient every 12 hours. 15. The method of claim 9, wherein the pharmaceutical composition is orally administered concurrently with food or a beverage. 16. The method of claim 9, wherein the pharmaceutical composition is orally administered 30 minutes after administering food or a beverage. 17. The method of claim 9, wherein the pharmaceutical composition is administered concurrently with, prior to, or subsequent to one or more other desired therapeutics or medical procedures.