BECKERT THOMAS,PETEREIT HANS-ULRICH,DRESSMAN JENNIFER,RUDOLPH MARKUS
申请号：
SK13742002
公开号：
SK287902B6
申请日:
2001.03.09
申请国别(地区):
SK
年份:
2012
代理人:
摘要：
Multiparticulate drug form suitable for uniform release of an active pharmaceutical ingredient in the small intestine and in the large intestine and comprising at least two forms of pellets A and B, which comprise an active pharmaceutical ingredient in the core and have different polymer coatings, which determine the release of the active ingredient at different pH values, whereby pellet form A is provided with an inner polymer coating which enables continuous release of active ingredient, and has an outer enteric coating which rapidly dissolves above about pH 5.5, and which consists of a (meth)acrylate copolymer of 40 to 60 % by weight methacrylic acid and 60 to 40 % by weight methacrylate or 60 to 40 by weight ethyl acrylate or hydroxypropylmethylcellulose phthalate HPMC, and pellet form B is provided with a polymer coating , which in the USP release test, releases less than20 % of the active ingredient at pH 6.8 in 6 hours and release more than 50 % of the active ingredient at pH 7.2 in 6 hours, wherein the polymer coating of pellet form B is a (meth)acrylate copolymer, which is composed of 60 to 95 % by weight free-radical polymerized C1- to C4- alkyl esters of acrylic or methacrylic acid and 5 to 40 % by weight (meth)acrylate monomers with an acidic group in the alkyl radical. Described is also a method for the preparation of said drug form.Multiparticulate drug form suitable for uniform release of an active pharmaceutical ingredient in the small intestine and in the large intestine and comprising at least two forms of pellets A and B, which comprise an active pharmaceutical ingredient in the core and have different polymer coatings, which determine the release of the active ingredient at different pH values, whereby pellet form A is provided with an inner polymer coating which enables continuous release of active ingredient, and has an outer enteric coating which rapidly dissolves above about pH 5.5, and which consists of a (meth)acrylate copolymer of 40 to 60
