Compositions of obeticholic acid and methods of use
AssigneesIntercept Pharmaceuticals, Inc., Sumitomo Dainippon Pharma Co., Ltd.
InventorsRichard Gail Lancaster, Kay K. Olmstead, Masashi Kagihiro, Mitsuhiro Matono, Ikuko Taoka, Mark Pruzanski, David Shapiro, Roya Hooshmand-Rad, Richard Pencek, Cathi Sciacca, Lise Eliot, Jeffrey Edwards, Leigh A. MacConell, Tonya K. Marmon
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Abstract
The disclosure relates to obeticholic acid formulations with improved stability, dissolution, and/or solubility, methods of preparing the same for use and methods of treating various diseases and conditions.
Claims19
A pharmaceutical composition comprising an active pharmaceutical ingredient, which is obeticholic acid or a pharmaceutically acceptable salt or amino acid conjugate thereof, and one or more pharmaceutically acceptable excipients,
- which provides a peak plasma concentration (Cmax) of obeticholic acid in a subject at a median time (Tmax) of approximately 2 hours after administration of the pharmaceutical composition to the subject.
A method of treating nonalcoholic steatohepatitis (NASH) comprising administering to a subject a pharmaceutical composition,
- the pharmaceutical composition comprises an active pharmaceutical ingredient, which is obeticholic acid or a pharmaceutically acceptable salt or amino acid conjugate thereof, and one or more pharmaceutically acceptable excipients,
- which provides a peak plasma concentration (Cmax) of obeticholic acid in a subject at a median Tmax of approximately 1.5 hours after administration of the pharmaceutical composition to the subject.
Dependencies are inferred from the claim text.