Albireo Ab

Anna-Maria Tivert

Per-Göran Gillberg

Martin Hans Bohlin

Nils Ove Gustafsson

Jessica Elversson

Ingvar Ymen

Robert Lundqvist

Rikard Bryland

Eva Byröd

Ann-Charlotte Dahlquist

Ingvar Ymén

Jamie Joseph Farrar

Mike Frodsham

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.

Crystal modifications of odevixibat

The invention relates to a pharmaceutical formulation, e.g. a paediatric formulation, of odevixibat, which comprises a plurality of small particles. The formulation may be used in the treatment of liver diseases such as bile acid-dependent liver diseases, and particularly cholestatic liver diseases such as biliary atresia, progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS) and paediatric cholestatic pruritus. The invention also relates to a process for the preparation of the pharmaceutical formulation.

Pharmaceutical formulation of odevixibat

The invention relates to an in vitro method for determining the adsorbing capacity of an adsorbent having limited solubility, such as a bile acid sequestrant, under conditions simulating the mammalian gastrointestinal tract. The method is particularly useful for studying the release profiles of controlled release formulations comprising adsorbents having limited solubility.

In vitro method for determining the adsorbing capacity of an insoluble adsorbant

The present invention relates to crystal modifications of 1,1-dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N&#x2014;{(R)-&#x3b1;-[N&#x2014;((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.

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Gothenburg, Sweden

Anna-Maria Tivert