FIELD: medicine; pharmaceutics.
SUBSTANCE: group of inventions relates to a pharmaceutical composition containing: 75–90 wt./wt.% of active pharmaceutical ingredient (API) with coating, wherein the API coating contains a first coating material containing wax and 0.5–5 wt./wt.% of second coating material containing silicon dioxide, attached, partially included and/or completely included in the first coating material; 3–7 wt./wt.% of matrix-forming substance; 2–6 wt./wt.% of structure-forming substance; 0.1–2 wt./wt.% of anti-aeration agent; and 0.01–0.2 wt./wt.% of a viscosity modifier, as well as to a method for preparing a pharmaceutical composition, comprising: coating of ibuprofen with a first coating material to form coated ibuprofen, where the first coating material contains one or more deformable components containing wax; application of mechanical stress to coated ibuprofen for deforming one or more deformable components; coating of ibuprofen with a second coating material containing silicon dioxide; applying mechanical stress to embed a second coating material on the first coated ibuprofen coating material; after introducing the second coating material onto the first coated ibuprofen coating material, sieving the coated ibuprofen to remove excess material of the first coating, wherein the excess first coating material comprises a first coating material not bonded to the coated ibuprofen; forming a pharmaceutical suspension containing double-coated ibuprofen and a matrix solution or suspension; dosing the pharmaceutical suspension into a form; and freeze-drying the dosed pharmaceutical suspension in the form to form a pharmaceutical composition.
EFFECT: group of inventions provides minimizing the agglomeration of the coating material for the coated active pharmaceutical ingredient in order to improve the stability of the pharmaceutical product during storage and increase its storage life.
21 cl, 27 dwg, 9 tbl, 10 ex
