PHARMACEUTICAL COMPOSITION CONTAINING RACECADOTRIL AND METHOD FOR ITS PREPARATION Russian patent published in 2021 - IPC A61K9/14 A61K9/16 A61K31/265 A61K31/223 A61K31/70 A61P1/12 

FIELD: pharmaceutical industry.

SUBSTANCE: invention relates to the pharmaceutical industry, namely to an uncoated pharmaceutical composition and a method for its preparation. The uncoated pharmaceutical composition contains racecadotrile, co-crystallized sugar, and pharmacologically acceptable inert excipients selected from diluents, binders, sweetener, baking powder, solvents, lubricants, slip-promoting substances, and flavorings, in which the ratio of racecadotrile to co-crystallized sugar is 1:98.75. The method for preparing an uncoated pharmaceutical composition includes the steps of: (a) sieving racecadotrile, part of the co-crystallized sugar, and pharmacologically acceptable inert excipients to produce a mixture; (b) adding a solvent to polyvinylpyrrolidone to produce a solution or suspension; (c) granulating the mixture obtained in step (a) with the solution or suspension obtained in step (b), to obtain granules; (d) drying of granules obtained in step (c); (e) mixing the other part of the co-crystallized sugar with silicon dioxide to produce an intermediate mixture; (f) mixing the dried granules obtained in step (d) and the intermediate mixture obtained in step (e) to produce the final mixture; (g) filling the final mixture obtained in step (f) in a sachet of suitable size.

EFFECT: above-described pharmaceutical composition obtained by the above-described method does not include an optional and complex coating process, and at the same time has an appropriate taste.

9 cl, 1 dwg, 2 tbl, 1 ex