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.
Abstract:
Processes of preparing pharmaceutical compositions comprising 3-(6-(1-(2,2- difluorobenzo[d][1,3] dioxol-5 -yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Compound 1) in Form I and a solid dispersion comprising substantially amorphous N-(5- hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-lH-quinoline-3-carboxamide (Compound 2), methods of treating, lessening the severity of, or symptomatically treating CFTR mediated diseases, such as cystic fibrosis, methods of administering, and kits thereof are disclosed.
Abstract:
La presente invención se refiere a composiciones farmacéuticas que contienen una dispersión sólida de N-[2,4-Bis(1,1-dimetilletil)-5-hidroxifenil]-1,4-dihidro-4-oxoquinolin-3-carboxamida incluyendo formulaciones de dispersiones sólidas en polvos, gránulos y minicomprimidos, métodos para fabricar y procesar los polvos, gránulos y minicomprimidos, y métodos para tratar fibrosis quística empleando la composición farmacéutica.
Abstract:
The disclosure 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 (Compound 1) 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 CFTR mediated disease in a pediatric patient employing the pharmaceutical composition, wherein the CFTR mediated disease is cystic fibrosis, COPD, emphysema, dry-eye disease or osteoporosis. Particularly disclosed is a pharmaceutical composition comprising: about 35 wt% of a solid dispersion by weight of the composition, wherein the dispersion comprises about 80 wt% by weight of the dispersion of substantially amorphous or amorphous Compound 1, wherein less than about 15% of Compound 1 is in crystalline form, about 19.5 wt% of hydroxylpropylmethylcellulose acetate succinate (HPMCAS) by weight of the dispersion, and about 0.5 wt% sodium lauryl sulfate (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.
Abstract:
La presente invención se refiere a composiciones farmacéuticas que contienen una dispersión sólida de N-[2,4-Bis(1,1-dimetilletil )-5-hidroxifenil]-1,4-dihidro-4-oxoquinolin-3-carboxamida incluyendo formulaciones de dispersiones sólidas en polvos, gránulos y minicomprimidos, métodos para fabricar y procesar los polvos, gránulos y minicomprimidos, y métodos para tratar fibrosis quística empleando la composición farmacéutica.
Abstract:
The present invention relates to pharmaceutical compositions containing a solid dispersion of N- [2,4-B is( 1, 1 -dimethy lethyl)-5 -hydroxypheny 1] - 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.