FIELD: chemistry.
SUBSTANCE: method is described for producing enteric coated granules containing a proton pump inhibitor with a benzimidazole structure selected from omeprazole, esomeprazole, lansoprazole, pantoprazole and rabeprazole, and used for the preparation of pharmaceutical compositions of a plurality of particles for oral administration. This method involves coating a purely cellulose core with a water-alcohol suspension containing the specified proton pump inhibitor, a dibasic amino acid selected from lysine, histidine and L-arginine, talc and polyvinylpyrrolidone, separation of coated cellulose cores, application of an enteric coating on the particles, drying of the particles and their separation by size. Pharmaceutical composition of a plurality of particles in the form of disintegrating tablets for oral administration, in powder form for the preparation of a suspension or capsules for oral administration, contains enteric coated granules with an average size of 350 to 500 microns and with the content of a proton pump inhibitor with a benzimidazole structure of more than 10.5 %, obtained by the method described above.
EFFECT: enteric coated granules obtained by the method according to the invention have a small size and satisfactory stability in the absence of intermediate coating layers.
26 cl, 10 ex
