KWON, Taek Kwan (KR),КВОН, Тхэк Кван (KR),LEE, Kwang Young (KR),ЛИ, Кван Юн (KR),IM, Ho Taek (KR),ИМ, Хо Тхэк (KR),KIM, Yong Il (KR),КИМ, Юн Ил (KR),PARK, Jae Hyun (KR),ПАК, Ча Хён (KR),WOO, Jong Soo
申请号：
RU2019105024
公开号：
RU0002716025C1
申请日:
2017.07.24
申请国别(地区):
RU
年份:
2020
代理人:
摘要：
FIELD: medicine； pharmaceuticals.SUBSTANCE: presented is a dosage form containing esomeprazole or its pharmaceutically acceptable salt for treating gastric and reflux oesophageal diseases. Dosage form comprises a nucleus containing esomeprazole, a layer of endothelial coating formed on the nucleus, and a coating release coating layer formed on the endothelial coating layer. Layer of endothelial coating contains at least one substance selected from hydroxypropyl methyl cellulose, polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, starch and gelatin. Layer of release-controlling coating contains a polymer in which copolymer S of methacrylic acid and copolymer L of methacrylic acid are mixed in weight ratio of 1.5:1 to 3.5:1 as base material of release-controlling coating, where methacrylic acid copolymer S is an anionic copolymer containing methacrylic acid and methyl methacrylate in ratio of 1:2, and methacrylic acid copolymer L is an anionic copolymer containing methacrylic acid and methyl methacrylate in ratio of 1:1. Weight of copolymer S of methacrylic acid and copolymer L of methacrylic acid as base materials of release-controlling coating ranges from 15 to 40 % relative to weight of the tablet with endothelial coating. Dosage form when eliciting release after 2 hours elutes 5 % or less of esomeprazole or its pharmaceutically acceptable salt, and after 6 hours eluates at least 90 % of esomeprazole or its pharmaceutically acceptable salt. Described also is a method for preparing a dosage form of esomeprazole.EFFECT: dosage form according to the invention is characterized by improved characteristics of pH-dependent release of the preparation, starts releasing esomeprazole or its pharmaceutically acceptable salt after a given delay time for oral administration, continues release for a given time and ends the release through a predetermined time, thereby providing excellent patient comfort and excellent therapeutic effects compared to other standard form
