OXIDATION STABLE AND BREAKING RESISTANCE DOSAGE FORM Russian patent published in 2015 - IPC A61K31/485 A61K9/20 A61K47/34 A61K47/12 A61K47/46 B65D81/24 

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to thermally moulded pharmaceutical dosage form, which has a breaking resistance of at least 300 N, and to a method for producing it. The above dosage form contains a pharmacologically active ingredient (A) specified in morphine, hydromorphine, oxycodone, oxymorphone, (1R,2R-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol and their pharmaceutically acceptable salts, a free physiologically acceptable acid (B) in an amount of 0.3±0.18 wt % at total weight of the pharmaceutical dosage form, an antioxidant in an amount of 0.001 wt % to 5.0 wt % at total weight of the pharmaceutical dosage form and polyalkylene oxide (C), which has an average molecular weight M_w of at least 200.000 g/mol. A method for producing the above dosage form involves mixing all the ingredients, heating to a melting point of polyethylene oxide (C), extruding through an extruder outlet, separating plastic extrudate and moulding the pharmaceutical dosage form or cooling.

EFFECT: increasing the storage-stability of the pharmaceutical dosage form.

13 cl, 1 dwg, 9 ex