Pharmaceutical controlled release composition with resistance against the influence of ethanol using a coating comprising neutral vinyl polymers and excipients
BÄR, Hans,FÜRST, Thomas,RENNER, Gerhard,GOTTSCHALK, Michael
申请号：
ES09779169
公开号：
ES2624719T3
申请日:
2009.03.18
申请国别(地区):
ES
年份:
2017
代理人:
摘要：
A controlled release pharmaceutical composition, comprising a core, comprising a pharmaceutical active ingredient, whereby the core is coated by a coating layer that confers resistance to ethanol which has the effect of conferring the release profile of the pharmaceutical active ingredient. to be resistant to the influence of ethanol under in vitro conditions at pH 1.2 and / or pH 6.8 in a buffer medium according to the USP with the addition of 40% (v / v) ethanol, whereby resistant to the influence of ethanol means that the release profile is not accelerated more than 20% and is not delayed more than 20% under the influence of the medium containing 40% ethanol compared to a release profile determined in the same medium without ethanol , whereby the coating layer that confers ethanol resistance comprises at least 70% by weight of a mixture of a polymeric portion a) and an excipient portion b), wherein the polymeric portion ca a) consists of an essentially neutral water-insoluble vinyl polymer or copolymer and the portion of excipient b) consists of excipients b1) 100 to 250% by weight of a non-porous inert lubricant, b2) 1 to 35% by weight of a cellulosic compound, b3) 0.1 to 25% by weight of an emulsifier and additionally or alternatively to b3), b4) 0.1 to 30% by weight of a plasticizer by which the excipients of the portion of excipient b) each is calculated on the dry weight of the polymer portion a).Una composición farmacéutica de liberación controlada, que comprende un núcleo, que comprende un principio activo farmacéutico, por la cual el núcleo se recubre por una capa de recubrimiento que confiere resistencia al etanol que tiene el efecto de conferir el perfil de liberación del principio activo farmacéutico para ser resistente a la influencia del etanol bajo condiciones in vitro a pH 1,2 y/o a pH 6,8 en un medio tamponado según la USP con la adición de 40 % (v/v) de etanol, por la cual resistente a la influencia del etanol significa que el perfil de liberació
