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US 10,864,228 B2Granted
Oral cholestyramine formulation and use thereof
AssigneeAlbireo AB
InventorsPer-Göran Gillberg, Nils Ove Gustafsson, Nils-Olof Lindberg, Jessica Elversson
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Abstract
The invention relates to an oral formulation for targeted delivery of cholestyramine to the colon, comprising a plurality of cholestyramine pellets that are coated with a diffusion-controlled inner coating and an enteric outer coating. The invention also relates to the use of this formulation in the treatment of bile acid malabsorption.
Claims30
An oral dosage form comprising:
- a) a plurality of extruded and spheronized pellets, each extruded and spheronized pellet comprising a homogenous mixture of 70% to 93% w/w cholestyramine, at least 5% w/w of a vinylpyrrolidone-based polymer, at least 1% of an acrylate copolymer, and from 0 to 20% w/w of microcrystalline cellulose;
- b) a diffusion-controlled inner coating surrounding each extruded and spheronized pellet;
- and
- c) an enteric outer coating;
- wherein the extruded and spheronized pellets exhibit a friability of less than 2.1% as measured using the European Pharmacopoeia 8.0, test 2.9.7.
2 more elements
An oral dosage form comprising:
- a) a plurality of extruded and spheronized pellets, each extruded and spheronized pellet comprising
- 70% to 93% w/w cholestyramine;
- at least 5% w/w of a vinylpyrrolidone-based polymer;
- at least 1% of an acrylate copolymer;
- and
- from 0 to 20% w/w of microcrystalline cellulose,
- wherein the cholestyramine, the vinylpyrrolidone-based polymer, the acrylate copolymer, a liquid, and, if present, the microcrystalline cellulose are combined to form a wet mass that is extruded and spheronized to form the plurality of extruded and spheronized pellets;
- b) a diffusion-controlled inner coating surrounding each extruded and spheronized pellet, and
- c) an enteric outer coating;
- wherein the extruded and spheronized pellets exhibit a friability of less than 2.1% as measured using the European Pharmacopoeia 8.0, test 2.9.7.
7 more elements
Dependencies are inferred from the claim text.