FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to pharmacy, in particular to an oral sustained-release pharmaceutical composition and to methods for preparation thereof. Sustained-release pharmaceutical composition comprises (A) hydromorphone hydrochloride or hydroxycodone hydrochloride hydrate, (B) hydroxypropylmethylcellulose acetate succinate having a median size (D50) of 40 mcm or less, (C) hydroxypropylcellulose and (D) saccharide, wherein the relative content of component (C) and component (B) by weight in the composition, (C)/(B) is 10/4 to 8/6. Methods for preparing the composition comprise mixing components (A), (B), (C) and (D) and an additive, followed by molding to produce the sustained-release pharmaceutical composition in the form of a tablet.
EFFECT: group of inventions provides avoiding premature and increased release of the active substance in the presence of alcohol and in the presence of the composition in an acidic medium, such as the upper gastrointestinal tract medium.
23 cl, 6 dwg, 11 tbl, 4 ex
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