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AssigneeAlbireo AB
InventorsRobert Lundqvist, Ingvar Ymen, Martin Bohlin, Eva Byröd, Per-Göran Gillberg, Anna-Maria Tivert, Rikard Bryland, Ann-Charlotte Dahlquist, Jessica Elversson, Nils Ove Gustafsson
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The present invention relates to crystal modifications of 1,1-dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N—{(R)-α-[N—((S)-1-carboxypropyl)carbamoyl]-4-hydroxybenzyl}carbamoylmethoxy)-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepine (odevixibat), more specifically crystal modifications 1 and 2 of odevixibat. The invention also relates to a process for the preparation of crystal modification 1 of odevixibat, to a pharmaceutical composition comprising crystal modification 1, and to the use of this crystal modification in the treatment of various conditions as described herein.
A crystalline hydrate of odevixibat.
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A mixed solvate of odevixibat, containing about two moles of water per mole of odevixibat.
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A process for the preparation of crystal modification 1 of odevixibat, comprising isolating crystal modification 2 of odevixibat from a solution of odevixibat in a solvent mixture comprising water and an organic solvent selected from the group consisting of methanol, ethanol, 2-propanol, acetone, acetonitrile, 1,4-dioxane, DMF and DMSO.
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A method for treating or preventing a liver disease or disorder comprising orally administering to a subject in need of such treatment a therapeutically effective amount of a crystalline hydrate of odevixibat, or a pharmaceutically acceptable salt thereof.
Dependencies are inferred from the claim text.