FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to a granular composition containing oseltamivir or a pharmaceutically acceptable salt thereof, to a method of producing the said composition, to a method of the prevention or treatment of infection caused by the influenza A or influenza B virus, including the administration of the said composition, and to the use of the said composition in the manufacture of a medicament against an infection caused by an influenza A virus or an influenza B virus, and for the treatment of an infection caused by the said viruses. A granular composition containing oseltamivir or a pharmaceutically acceptable salt thereof, wherein the granular composition comprises a granule including a core, a drug layer surrounding the core and containing oseltamivir or a pharmaceutically acceptable salt thereof, and a coating layer surrounding the medicinal product layer and containing a water-soluble polymer and poorly a water-soluble polymer in which the core has an average particle size (D50) of 150 to 250 microns. A method of obtaining the said composition, the method includes the following steps: (a) preparing a solution containing a medicinal product by dissolving or dispersing oseltamivir or a pharmaceutically acceptable salt thereof, a sweetener and a water-soluble polymer binder in a solvent; (b) obtaining a first granule by coating the core with the drug-containing solution obtained in step (a); (c) preparing a coating solution by dissolving or dispersing a water-soluble polymer and a poorly water-soluble polymer in a solvent; and (d) producing a second granule by coating the first granule with a coating solution. A method of preventing or treating an infection caused by an influenza A or influenza B virus, the method comprises the step of administering a therapeutically effective amount of the said composition to a mammal, including humans. The use of the specified composition in the manufacture of a medicinal product against an infection caused by the influenza A or influenza B virus. The use of the specified composition for the treatment of an infection caused by the influenza A or influenza B virus.
EFFECT: group of inventions makes it possible to mask the bitter taste of oseltamivir, minimize the foreign body sensation and residual sensation in the cavity mouth, ensures rapid dissolution of the medicinal product in the oral cavity thus increasing the convenience of taking the medicinal product.
21 cl, 2 dwg, 27 tbl, 13 ex, 9 comp ex, 4 test ex
