FIELD: pharmaceutics.
SUBSTANCE: invention relates to pharmaceutics. Pharmaceutical composition for oral administration is described containing: gelatine capsule core, coated with first and second layers of coating. Gelatine capsule core contains omega-3 fatty acid or its alkyl ester. First coating layer contains hydroxypropyl methylcellulose and copolymer of butyl methacrylate, (2-dimethylaminoethyl)methacrylate and methyl methacrylate with weight ratio of 1:2:1; where weight ratio of hydroxypropyl methylcellulose to said copolymer ranges from 1:0.8 to 1:10. Second coating layer contains medicinal agent based on statin as inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase.
EFFECT: invention prevents sticking of gelatine capsules' cores to each other and deformation of gelatin capsules' cores, which can occur in process of aqueous coating application, invention also provides pharmaceutical composition disintegration and stability requirements compliance.
13 cl, 9 tbl, 7 ex
Authors
Dates
2016-10-27—Published
2013-05-21—Filed