MULLEN, Alexander,STEVENS, Howard,ECCLESTON, Sarah
申请号：
ES11709765
公开号：
ES2659815T3
申请日:
2011.03.04
申请国别(地区):
ES
年份:
2018
代理人:
摘要：
A pressure coated tablet formulation for immediate release, followed by a delayed release of an active ingredient, the tablet comprising (a) a core comprising an active ingredient together with an excipient or excipients； and (b) a delayed-release layer surrounding the core and comprising a wax and a low-substituted micronized hydroxypropylcellulose (L-HPC) with an average diameter of 20 μm that is insoluble in water and comprises a glucose-substituted main chain with hydroxypropyl groups and has a molecular weight of approximately 115,000 and a hydroxypropylcellulose content of approximately 8% in a ratio of 40:60 to 60:40 w / w； wherein the delayed release layer essentially retards the release of the active substance in the core for 3-8 hours after administration of the tablet to a subject and subsequently a pulsed release of the active ingredient from the core occurs, so that at least 70% of the active substance in the nucleus is released in 5-45 minutes； and (c) a topcoat layer comprising a portion of an active ingredient together with a sugar and an L-HPC, wherein at least 70-90% of the active ingredient is released within 5-45 minutes after administration of the tablet to the subject.Una formulación de comprimido recubierto a presión para una liberación inmediata, seguida por una liberación retardada de un principio activo, comprendiendo el comprimido (a) un núcleo que comprende un principio activo junto con un excipiente o excipientes； y (b) una capa de liberación retardada que rodea el núcleo y que comprende una cera y una hidroxipropilcelulosa micronizada poco sustituida (L-HPC) con un diámetro medio de 20 μm que es insoluble en agua y comprende una cadena principal de glucosa sustituida con grupos hidroxipropilo y tiene un peso molecular de aproximadamente 115.000 y un contenido de hidroxipropilcelulosa de aproximadamente el 8 % en una relación de 40:60 a 60:40 p/p； en donde la capa de liberación retardada retarda esencialmente la liberación del principio
