Cholestyramine granules, oral cholestyramine formulations and use thereof
AssigneeAlbireo AB
InventorsPer-Göran Gillberg, Nils Ove Gustafsson, Kurt Lövgren
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Abstract
The invention relates to small granules comprising cholestyramine. The granules have a high cholestyramine content and are stable enough to be coated with one or more coating layers. The invention also relates to a multiparticulate drug delivery system comprising such granules. The invention further relates to an oral formulation for targeted delivery of cholestyramine to the colon, comprising a plurality of cholestyramine granules that are coated with a colon release coating. The invention also relates to the use of this formulation in the treatment of bile acid malabsorption and bile acid diarrhoea.
Claims27
A population of granules, each granule comprising a homogenous mixture of at least 70% w/w cholestyramine and
- i. a combination of at least 6% w/w of a binding agent and at least 2% w/w of an acrylate copolymer;
- or
- ii. a combination of at least 5% w/w of a binding agent and at least 3% w/w of an acrylate copolymer;
- or
- iii. a combination of at least 6% w/w of a binding agent, at least 1% w/w of an acrylate copolymer and from 5% to 15% w/w microcrystalline cellulose;
- wherein the binding agent comprises a cellulose ether, a vinylpyrrolidone-based polymer, or a combination thereof.
A population of granules, each granule comprising at least 70% w/w cholestyramine and
- i. a combination of at least 6% w/w of a binding agent and at least 2% w/w of an acrylate copolymer;
- or
- ii. a combination of at least 5% w/w of a binding agent and at least 3% w/w of an acrylate copolymer;
- or
- iii. a combination of at least 6% w/w of a binding agent, at least 1% w/w of an acrylate copolymer and from 5% to 15% w/w microcrystalline cellulose;
- wherein the binding agent comprises a cellulose ether, a vinylpyrrolidone-based polymer, or a combination thereof;
- and
- wherein the cholestyramine, the binding agent, the acrylate copolymer, and the microcrystalline cellulose, and a liquid are combined to form a wet mass that is dried and milled to form the population of granules.
Dependencies are inferred from the claim text.