FIELD: medicine; pharmaceuticals.
SUBSTANCE: invention refers to the field of medicine and presents the gastro-resistant pharmaceutical or nutraceutical composition, which contains the core that contains the pharmaceutical or the nutraceutical active ingredient, and the gastro-resistant coating layer, where the mentioned coating layer contains at least 30 wt% of (meth)acrylate copolymer, which consists of the following polymerized units: from 10 up to 40 wt% of methacrylic acid, from 10 up to 50 wt% of ethyl acrylate, from 10 up to 80 wt% C4-C18 of alkyl ester of acrylic or methacrylic acid and optionally from 0 up to 20 wt% of methyl methacrylate, where the (meth)acrylate copolymer has the average molecular weight Mw, which is equal to 90,000 or more, where the release of the pharmaceutical or nutraceutical ingredient is not more than 10% under the in-vitro conditions at pH 1.2 after 2 hours in the 0.1 mole HCl medium with or without addition of 20% volume per volume of ethanol.
EFFECT: invention provides the possibility of creating the gastro-resistant composition with the reduced sensitivity to the impact of ethanol on release of the active ingredient.
13 cl, 14 ex, 3 tbl
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Authors
Dates
2018-04-04—Published
2012-06-12—Filed