FIELD: medicine and pharmacy.
SUBSTANCE: inventions group relates to medicine and pharmacy, in particular to a single-dose pharmaceutical product for peroral mesalazine administration with a plurality of delayed immediate release minitablets (s) containing a compressed mesalazine-containing matrix, with a pH-dependent enteric coating layer, releasing mesalazine at pH of 5.5 or higher in the distal ileum, and with a plurality of (b) sustained-release minitablets with a compressed mesalazine-containing matrix with an internal pH-independent sustained release coating and an external pH-dependent enteric coating layer that release mesalazine at pH of 7 or higher in the large bowel, where from 10 to 90 mass.% of mesalazine is in minitablets (b), and the total amount of mesalazine is from 0.4 to 6 g. Inventions group also relates to a mesalazine administering method to a subject by peroral administration of the specified product, to a inflammatory bowel disease treating method, including peroral administration of the specified product, and to the specified pharmaceutical product obtaining method.
EFFECT: provides pharmaceutical products that implement delayed immediate release of mesalazine in the distal ileum and prolonged release of mesalazine in the large bowel.
22 cl, 13 dwg, 11 ex
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Authors
Dates
2021-03-11—Published
2017-04-18—Filed