Formulations of pyrimidinedione derivative compounds

摘要

The present disclosure relates to pharmaceutical compositions of pyrimidinedione derivative compounds and methods of preparing and uses thereof. The disclosure also relates to methods of enhancing bioavailability of pyrimidinedione derivative compounds in pharmaceutical compositions administered to a subject and methods of reducing the amount of a pyrimidinedione derivative compound in a pharmaceutical composition while achieving the same bioavailability in a subject.

主权项

1. A pharmaceutical composition comprising:
N-(6-(3-tert-butyl-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-2-methoxyphenyl)naphthalen-2-yl)methanesulfonamide (Compound A), or a pharmaceutically acceptable salt thereof, in an amount of from about 200 mg to about 300 mg on a free acid equivalent weight basis; and a bioavailability enhancing agent which is copovidone in an amount of from about 10% to about 25% by weight of the pharmaceutical composition, wherein the solubility of Compound A as measured by a biphasic dissolution test is at least 20 mcg per mL at 100 minutes.