PHARMACEUTICAL COMPOSITION, INCLUDING ESOMEPRAZOLE (EMBODIMENTS), ORAL DOSAGE FORM BASED ON PHARMACEUTICAL COMPOSITION, INCLUDING ESOMEPRAZOLE, METHOD FOR PRODUCTION AND APPLICATION OF ORAL DOSAGE FORM BASED ON PHARMACEUTICAL COMPOSITION CONTAINING EZOMEPRAZOLE Russian patent published in 2024 - IPC A61K31/4439 A61K47/02 A61K47/10 A61K47/12 A61K47/14 A61K47/20 A61K47/26 A61K47/34 A61K47/38 A61K9/52 A61K9/54 A61P1/04 

FIELD: pharmaceuticals.

SUBSTANCE: group of inventions concerns pharmaceutical compositions, as well as dosage forms, including esomeprazole, methods for their preparation and use of such compositions and dosage forms. The proposed pharmaceutical compositions (embodiments) and oral dosage forms (embodiments) for prevention and treatment of gastroenterological diseases include esomeprazole magnesium dihydrate in form of pellets as the active ingredient, with one pellet fraction providing immediate release of 5.1-50.1% of the active substance, and the other fraction of pellets providing delayed release of the rest of the active substance, which is achieved through the use of a certain qualitative and quantitative composition of excipients when producing pellets of one and the other fraction, respectively. The oral dosage form is made in form of a capsule with a hard shell based on gelatin or hydroxypropyl methylcellulose, which contains the above two fractions of pellets with esomeprazole magnesium dihydrate. Methods for preparing the above dosage forms include preparing immediate release pellets and producing delayed release pellets using a fluidized bed unit and then combining said pellets into one capsule. The use of the above compositions and oral dosage forms for prevention and treatment of gastroenterological diseases is also proposed.

EFFECT: use of a group of inventions ensures an expansion of the range of drugs for prevention and treatment of diseases in the field of gastroenterology, as well as an increase in the therapeutic activity of the pharmaceutical composition and dosage form and simplification of their dosage regimen due to the immediate onset of action and then the effective long-term action of esomeprazole.

12 cl, 16 tbl