CPC A61K 9/205 (2013.01) [A61K 9/143 (2013.01); A61K 9/145 (2013.01); A61K 9/146 (2013.01); A61K 9/1611 (2013.01); A61K 9/1617 (2013.01); A61K 9/1623 (2013.01); A61K 9/1652 (2013.01); A61K 9/2009 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/2054 (2013.01); A61K 9/2072 (2013.01); A61K 9/2077 (2013.01); A61K 9/485 (2013.01); A61K 9/4808 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 31/47 (2013.01); A61K 47/02 (2013.01); A61K 47/12 (2013.01); A61K 47/20 (2013.01); A61K 47/26 (2013.01); A61K 47/38 (2013.01); C07D 215/56 (2013.01)] | 20 Claims |
1. A pharmaceutical composition in a unit dose form comprising one or a plurality of granules, pellets, particles or mini-tablets, wherein the composition comprises:
(a) a solid dispersion in an amount from 30 to 40 percent by weight of the composition, wherein the solid dispersion comprises:
(i) about 80 wt % of substantially amorphous or amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1) by weight of the dispersion,
(ii) about 19.5 wt % of hydroxypropylmethylcellulose acetate succinate (HPMCAS) by weight of the dispersion, and
(iii) about 0.5 wt % sodium lauryl sulfate (SLS) by weight of the dispersion;
(b) a binary filler, wherein the binary filler comprises mannitol and lactose in a ratio of about 1:3 mannitol to lactose;
(c) a sweetener, wherein the sweetener is sucralose;
(d) a disintegrant;
(e) a glidant; and
(f) a lubricant;
wherein the unit dose form comprises at least about 5 mg of substantially amorphous or amorphous Compound 1,
and wherein substantially amorphous Compound 1 has less than 15% crystallinity.
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