PH-DEPENDENT CONTROLLED RELEASE PHARMACEUTICAL COMPOSITION FOR NON-OPIOIDS WITH RESISTANCE AGAINST THE INFLUENCE OF ETHANOL

摘要

The invention relates to a pH-dependent controlled release pharmaceuticalcomposition, comprising at least onepharmaceutical active ingredient, with the exception of opioids, wherein thecore is coated at least by one coating layer, controllingthe release of the pharmaceutical composition, wherein the coating layercomprises a polymer mixture of i) 40 -95% byweight, based on dry weight of the polymer mixture, of at least one waterinsoluble essentially neutral vinyl polymer or copolymer,and ii) 5 -60% by weight, based on dry weight of the polymer mixture, of atleast one anionic polymer or copolymer, whichis insoluble in a buffered medium below pH 4.0 and soluble at least in therange from pH 7.0 to pH 8.0, characterized in that thecoating layer further comprises 110 to 250 % by weight of a non-porous inertlubricant, 1 to 35 % by weight of at least one neutralcellulosic compound and 1 to 25 % by weight of at least one emulsifier, eachcalculated on dry weight of the polymer mixture.