Pharmaceutical composition and administrations thereof

摘要

Provided are pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis( 1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (ivacaftor). In one embodiment a pharmaceutical composition comprises a solid dispersion of amorphous or substantially amorphous ivacaftor in an amount of about 15 to about 47 percent by weight of the composition; sucralose in an amount of about 2 percent by weight of the composition; croscarmellose sodium in an amount from about 3 to about 6 percent of by weight of the composition; sodium lauryl sulfate (SLS) in an amount of about 0 to about 0.5 percent by weight of the composition; colloidal silicon dioxide in an amount of about 1 percent by weight of the composition; magnesium stearate in an amount of about 1.5 percent by weight of the composition; and mannitol in an amount of about 42 to about 77.5 percent of by weight of the composition. The pharmaceutical compositions are useful in the treatment of CFTR mediated diseases, such as cystic fibrosis.