Pharmaceutical composition and administrations thereof
AssigneeVertex Pharmaceuticals Incorporated
InventorsWilliam Rowe, Patricia Hurter, Christopher Young, Kirk Dinehart, Marinus Jacobus Verwijs, Kirk Overhoff, Peter D. J. Grootenhuis, Martyn Botfield, Alfredo Grossi
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Abstract
The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.
Claims26
A pharmaceutical composition comprising a solid dispersion, wherein the solid dispersion comprises:
- a) 80% of amorphous or substantially amorphous N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1) by weight of the dispersion, wherein substantially amorphous Compound 1 comprises less than 15% crystalline Compound 1,
- b) 19.5% of hydroxypropylmethylcellulose acetate succinate (HPMCAS) by weight of the dispersion, and
- c) 0.5% of sodium lauryl sulfate (SLS) by weight of the dispersion.
A pharmaceutical table comprising:
- a. a solid dispersion in an amount ranging from 30% to 50% by weight of the tablet, wherein the dispersion comprises:
- i) 80% of amorphous or substantially amorphous N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1) by weight of the dispersion, wherein substantially amorphous Compound 1 comprises less than 15% crystalline Compound 1,
- ii) 19.5% of hydroxypropylmethyl cellulose acetate succinate (HPMCAS) by weight of the dispersion, and
- iii) 0.5% of sodium lauryl sulfate (SLS) by weight of the dispersion;
- b. a filler, in an amount ranging from 25% to 50% by weight of the tablet;
- c. a disintegrant, in an amount ranging from 1% to 10% by weight of the tablet;
- d. a surfactant, in an amount ranging from 0.3% to 2% by weight of the tablet;
- e. a binder, in an amount ranging from 20% to 45% by weight of the tablet;
- f. a glidant, in an amount ranging from 0.09% to 1.0% by weight of the tablet;
- and
- g. a lubricant, in an amount ranging from 0.1% to 2% by weight of the tablet.
Dependencies are inferred from the claim text.