FIELD: medicine; pharmaceuticals.
SUBSTANCE: described is a method for manufacturing a pharmaceutical composition containing from 2.5 to 5 mg of apixaban and a pharmaceutically acceptable diluent or carrier. Method includes the following steps: (1) mixing a raw material containing crystalline particles of apixaban before granulating, (2) granulation of the raw materials from stage (1) using the dry granulation process and (3) mixing the granules from step (2) with a pharmaceutically acceptable diluent or carrier. Crystalline apixaban particles have an average particle size of D90 that is equal to or less than 89 microns. Additionally, the composition of apixaban may contain a surfactant – sodium lauryl sulfate.
EFFECT: use of the dry granulation process in the method according to the invention ensures the preparation of a composition in the form of an apixaban pill characterized by a high dissolution rate.
11 cl, 4 dwg, 6 tbl
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