Compositions of obeticholic acid and methods of use
AssigneeIntercept Pharmaceuticals, Inc.
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.
Claims20
A method of treating nonalcoholic steatohepatitis (NASH) in a subject in need thereof, said method comprising administering to the subject a tablet comprising an intra-granular portion and an extra-granular portion, the intra-granular portion comprising obeticholic acid or a pharmaceutically acceptable salt or amino acid conjugate thereof in an amount of about 1 to about 50 mg, and one or more pharmaceutically acceptable excipients, and the extra-granular portion comprising one or more pharmaceutically acceptable excipients,
- wherein at least one pharmaceutically acceptable excipient in the tablet has an alcohol content of less than about 6% (w/w),
- wherein the amount is a starting dose, an adjusted dose or a re-adjusted dose;
- and
- wherein the tablet is administered daily (QD), every other day (Q2D), once a week (QW), twice a week (BID), three times a week (TIW), once a month (QM), or twice a month (Q2M).
A method of treatingnonalcoholic steatohepatitis (NASH) in a subject in need thereof, said method comprising administering to the subject a tablet comprising obeticholic acid or a pharmaceutically acceptable salt or amino acid conjugate thereof in an amount of about 1 to about 50 mg, and one or more pharmaceutically acceptable excipients,
- wherein the obeticholic acid or the pharmaceutically acceptable salt or amino acid conjugate thereof is in the form of jet-milled particles, and wherein at least 50% of the particles have a diameter of 200 μm or less;
- wherein at least one pharmaceutically acceptable excipient in the tablet has an alcohol content of less than about 6% (w/w);
- wherein the amount is a starting dose, an adjusted dose or a re-adjusted dose;
- and
- wherein the tablet is administered daily (QD), every other day (Q2D), once a week (QW), twice a week (BID), three times a week (TIW), once a month (QM), or twice a month (Q2M).
A method of treating nonalcoholic steatohepatitis (NASH) in a subject need thereof, said method comprising administering to the subject a tablet comprising an intra-granular portion and an extra-granular portion, the intra-granular portion comprising obeticholic acid or a pharmaceutically acceptable salt or amino acid conjugate thereof in an amount of about 1 to about 50 mg, and one or more pharmaceutically acceptable excipients, and the extra-granular portion comprising one or more pharmaceutically acceptable excipients,
- wherein the obeticholic acid or the pharmaceutically acceptable salt or amino acid conjugate thereof is in the form of jet-milled particles, and wherein at least 50% of the particles have a diameter of 200 μm or less;
- wherein at least one pharmaceutically acceptable excipient in the tablet has an alcohol content of less than about 6% (w/w);
- wherein the amount is a starting dose, an adjusted dose or a re-adjusted dose;
- and
- wherein the tablet is administered daily (QD), every other day (Q2D), once a week (QW), twice a week (BID), three times a week (TIW), once a month (QM), or twice a month (Q2M).
Dependencies are inferred from the claim text.