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US 2020/0268671 A1Published application
Film-coated tablet having high chemical stability of active ingredient
AssigneeIntercept Pharmaceuticals, Inc.
InventorsMitsuhiro MATONO, Tetsuya Hayama
Life of this patent
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Abstract
The present invention relates to a film-coated tablet having a high chemical stability of an active ingredient, said film-coated tablet comprising: (a) a tablet core containing obeticholic acid or a pharmaceutically acceptable salt thereof; and (b) a coating layer, which is provided on the surface of the tablet core, containing a film base and being substantially free from any plasticizer or containing at least one kind of specific plasticizer.
Claims25
A film-coated tablet containing obeticholic acid or a pharmaceutically acceptable salt thereof, which contains:
- (a) an uncoated tablet containing obeticholic acid or a pharmaceutically acceptable salt thereof, and
- (b) a film base on the surface of said uncoated tablet, and which has a coating layer which either does not substantially contain a plasticizer or which contains at least one type of specific plasticizer selected from a group consisting of:
- triethyl citrate, lecithin, glycerin fatty acid ester, propylene glycol, triacetin, polyoxyethylene sorbitan fatty acid ester, concentrated glycerin, sorbitan fatty acid ester, sorbitol, glycerin, diethyl phthalate, dibutyl sebacate, tributyl citrate, diethyl sebacate, acetylated monoglyceride, acetyl triethyl citrate, acetyl tributyl citrate, monostearin, dioctyl phthalate, butyl phthalyl butyl glycolate and medium chain fatty acid triglycerides.
Dependencies are inferred from the claim text.