Patent ID: 11878081
Assignee: TAP PHARMACEUTICALS AG
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 8:
9. A pharmaceutical, unit-dose formulation, suitable for oral administration, comprising:
from 7.5% w/w to 12.5% w/w of a tafamidis-fumaric acid co-crystal;
from 77.5% w/w to 82.5% w/w of a PEG 400;
from 0.25% w/w to 2.5% w/w of a fumaric acid;
from 0.25% w/w to 2.75% w/w of a PVP K 90;
from 1% w/w to 10% w/w of a polysorbate 20; and
from 0.05% w/w to 0.25% w/w of a dibutylhydroxytoluene,, wherein the formulation releases, within 15 minutes in ¾ strength FeSSIF pH 5.8 or in FaSSIF+0.1% polysorbate 80 pH 6.5, at least 85% of the total tafamidis of the formulation, and, wherein the formulation releases, within 45 minutes in modified FeSSIF pH6.5, at least 90% of the total tafamidis of the formulation.