Dokou Eleni,Jamzad Shahla,Caesar John P. Jr.,Fawaz Majed,Das Laura,Gu Chong-Hui,Hurter Patricia Nell,Israni Meghna Jai,Johnston Meghan M.,Knezic Dragutin,Kuzmission Andrew G.,Wang Hongren
申请号：
NZ62919913
公开号：
NZ629199A
申请日:
2013.02.27
申请国别(地区):
NZ
年份:
2017
代理人:
摘要：
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.
