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US 10,765,672 B2Granted
Pharmaceutical formulations of a HIF hydroxylase inhibitor
AssigneeFibroGen, Inc.
InventorsDavid Conca, Lee Allen Flippin, Scott David Leigh, Claudia Witschi, Lee Robert Wright
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Abstract
The present disclosure relates to pharmaceutical formulations of [(4-hydroxy-1-methyl-7-phenoxy-isoquinoline-3-carbonyl)-amino]-acetic acid and methods of use thereof.
Claims6
A tablet comprising a tablet core and a coating, wherein the tablet core comprises [(4-hydroxy-1-methyl-7-phenoxy-isoquinoline-3-carbonyl)-amino]-acetic acid, and the coating comprises a photostabilizing agent, wherein the photostabilizing agent:
- i) consists essentially of from about 0.1 to about 2 mg/cm2 titanium dioxide and from about 0.1 to about 0.4 mg/cm2 Allura Red AC or from about 0.1 to about 0.4 mg/cm2 Allura Red AC in aluminum lake;
- and
- optionally at least one additional dye selected from the group consisting of:
- from about 0.004 to about 0.4 mg/cm2 iron oxide red;
- from about 0.009 to about 0.2 mg/cm2 iron oxide yellow;
- from about 0.01 to about 0.03 mg/cm2 Sunset Yellow FCF;
- and
- from about 0.01 to about 0.03 mg/cm2 Sunset Yellow FCF in aluminum lake;
- wherein the amount of photostabilizing agent is based on surface area of the tablet core;
- and
- ii) prevents the transmission of light at a wavelength range of between about 200 nm and 550 nm
- and further wherein the tablet contains less than about 0.2% w/w photodegradation product of [(4-hydroxy-1-methyl-7-phenoxy-isoquinoline-3-carbonyl)-amino]-acetic acid relative to the amount of [(4-hydroxy-1-methyl-7-phenoxy-isoquinoline-3-carbonyl)-amino]-acetic acid.
9 more elements
Dependencies are inferred from the claim text.