US2023263794A1PendingUtilityA1

Solid forms of n-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide

Assignee: VERTEX PHARMAPriority: Dec 28, 2005Filed: Sep 27, 2022Published: Aug 24, 2023

Est. expiryDec 28, 2025(expired)· nominal 20-yr term from priority

Inventors:Patricia Hurter William Rowe Christopher R. Young Adriana Costache Patrick R. Connelly Mariusz Krawiec Yuchuan Gong Yushi Feng Martin Trudeau

A61K 31/47C07D 215/56A61K 2300/00C07B 2200/13Y10T428/2982A61P 1/00A61P 1/12A61P 1/18A61P 11/00A61P 13/02A61P 13/12A61P 17/00A61P 19/08A61P 21/00A61P 21/02A61P 25/00A61P 25/08A61P 25/14A61P 25/16A61P 25/28A61P 27/02A61P 27/04A61P 3/00A61P 35/00A61P 3/06A61P 37/06A61P 43/00A61P 5/00A61P 5/14A61P 5/16A61P 7/00A61P 7/04A61P 7/06A61P 7/10A61P 7/12A61P 3/10

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References

Claims

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.

Claims

exact text as granted — not AI-modified

What is claimed is: 
     
         1 - 132 . (canceled) 
     
     
         133 . A pharmaceutical composition comprising N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound I) and a pharmaceutically acceptable carrier, wherein at least about 75% by weight of Compound I is amorphous. 
     
     
         134 . The pharmaceutical composition of  claim 133 , wherein at least about 80% by weight of Compound I is amorphous. 
     
     
         135 . The pharmaceutical composition of  claim 133 , wherein at least about 85% by weight of Compound I is amorphous. 
     
     
         136 . The pharmaceutical composition of  claim 133 , wherein at least about 90% by weight of Compound I is amorphous. 
     
     
         137 . The pharmaceutical composition of  claim 133 , wherein at least about 98% by weight of Compound I is amorphous. 
     
     
         138 . The pharmaceutical composition of  claim 133 , wherein the composition further comprises a polymer. 
     
     
         139 . The pharmaceutical composition of  claim 138 , wherein the polymer is hydroxypropylmethylcellulose acetate succinate (HPMCAS). 
     
     
         140 . The pharmaceutical composition of  claim 133 , wherein the composition further comprises a surfactant. 
     
     
         141 . The pharmaceutical composition of  claim 140 , wherein the surfactant is sodium lauryl sulfate (SLS). 
     
     
         142 . The pharmaceutical composition of  claim 133 , wherein the amorphous Compound I is in a solid dispersion. 
     
     
         143 . The pharmaceutical composition of  claim 133 , wherein the composition further comprises an additional therapeutic agent. 
     
     
         144 . A method of treating a CFTR mediated disease in a patient in need thereof, comprising administering an effective amount of the pharmaceutical composition of  claim 133 . 
     
     
         145 . The method of  claim 144 , wherein the CFTR mediated disease is cystic fibrosis. 
     
     
         146 . The method of  claim 144 , wherein the method further comprises administering an additional therapeutic agent.

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