NERR PHARMA SPOŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
发明人:
GAWROŃSKA, Agnieszka,GAWROŃSKI, Krzysztof,GAWROŃSKA, Mateusz,SIJKA Andrzej
申请号：
PLPL2019/000079
公开号：
WO2020/060426A1
申请日:
2019.09.13
申请国别(地区):
PL
年份:
2020
代理人:
摘要：
An oral preparation in the form of a tablet comprising sodium butyrate consists of i) core composed of: sodium butyrate in an amount of 55-75% by weight, high-viscosity hydroxypropylmethylcellulose in an amount of 15-30% by weight, magnesium stearate in an amount of 0.5-4% by weight, colloidal silica in an amount of 0.1-1% by weight, inorganic calcium salts in an amount of 10-30% by weight； ii) optionally, an inner retarding coating in an amount of 3-10% by weight relative to the core weight, consisting of hydroxypropylmethylcellulose or ethylcellulose and hydroxypropylmethylcellulose in an amount of 60-90% by weight, a plasticizer in an amount of 8-20% by weight, and an anti-caking agent in an amount of 20-45% by weight； iii) enteric coating in an amount of 3-10% by weight relative to the weight of the core made of poly(methyl acrylate-co-methylmethacrylate-co-methacrylic acid) 7:3:1 in an amount of 65-90% by weight, plasticizer in an amount of 1-8% by weight, and an anti-caking agent in an amount of 5-35% by weight, and optionally an emulsifier when using glycerol monostearate. The oral preparation in the form of a capsule comprising sodium butyrate consists of i) granulate composed of: sodium butyrate in an amount of 55-80% by weight, high-viscosity hydroxypropylmethylcellulose in an amount of 15-40% by weight, magnesium stearate in an amount of 0.5-4% by weight, colloidal silica in an amount of 0.1-1% by weight, optionally inorganic calcium salts in an amount of 10-30% by weight； ii) hard capsule, coated with the coating in an amount of 3-10% by weight relative to the weight of the granulate, made of poly(methyl acrylate-co-methylmethacrylate-co-methacrylic acid) 7:3:1 in an amount of 65-90% by weight, plasticizer in an amount 1-8% by weight, anti-caking agent in an amount of 5-35% by weight, and optionally an emulsifier, iii) optionally, an inner retarding coating on the capsule under the enteric coating, in an amount of 3-10% by weight relative to the weight o
