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US 12,576,034 B2Granted
Formulations of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione
AssigneeAmgen Inc.
InventorsSreenivas S. Bhat, Michael T. Kelly
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Abstract
Pharmaceutical compositions and single unit dosage forms of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate thereof, are provided herein. Also provided are methods of treating, managing, or preventing various diseases or disorders.
Claims21
A pharmaceutical composition in the form of an oral tablet comprising:
- a) a core composition, wherein the core composition comprises compound A:
- or a pharmaceutically acceptable salt thereof, a filler, a disintegrant, and a lubricant, wherein the filler comprises i) lactose monohydrate in an amount of 50% to 65% by weight of the pharmaceutical composition and ii) cellulose in an amount of 15% to 40% by weight of the pharmaceutical composition, and
- b) a coating formulation comprising polyvinyl alcohol,
- wherein the coating formulation does not contain medium chain triglycerides (MCTs) and no color fading of the tablet is observed at 48 hours when placed in an open dish stability chamber maintained at 40° C. and 75% relative humidity.
1 more element
Dependencies are inferred from the claim text.