FORMULACIÓN DE FÁRMACO DE LIBERACIÓN RETARDADA QUE COMPRENDE UN NÚCLEO Y UN RECUBRIMIENTO PARA EL NÚCLEO QUE COMPRENDE AL MENOS DOS O TRES CAPAS POLIMÉRICAS.
Roberto Carlos BRAVO GONZÁLEZ,Thomas BUSER,Frédéric Jean-Claude GOUTTE,Abdul Waseh BASIT,Ana Cristina FREIRE,Felipe José OLIVEIRA VARUM
申请号：
MX2018010475
公开号：
MX367127B
申请日:
2013.04.29
申请国别(地区):
MX
年份:
2019
代理人:
摘要：
Delayed release of a drug to the colon is achieved from a delayed release formulation comprising a core and a coating for the core. The core comprises a drug and the coating comprises an outer layer and at least one layer between the core and the outer layer selected from the group consisting of an isolation layer and an inner layer. The outer layer comprises a mixture of a first polymeric material which is susceptible to attack by colonic bacteria, and a second polymeric material which has a pH threshold at about pH 5 or above. The inner layer comprises a third polymeric material which is soluble in intestinal fluid or gastrointestinal fluid, said third polymeric material being selected from an at least partially neutralised polycarboxylic acid and a non-ionic polymer. In embodiments in which the third polymeric material is a non-ionic polymer, the inner layer comprises at least one of a buffer agent and a base. The isolation layer comprises a non-ionic polymer which is soluble in intestinal fluid or gastrointestinal fluid. The outer is applied directly to the inner layer or the isolation layer using a coating preparation formed by combining the first polymeric material in an aqueous medium with a second polymeric material in an organic medium. Advantages of formulations according to the present invention include accelerated release of the drug when exposed to colonic conditions and reduction or elimination of a food and/or alcohol effect on drug release after administration.La liberación retardada de un fármaco al colon se logra de una formulación de liberación retardada que comprende un núcleo y un recubrimiento para el núcleo. El núcleo comprende un fármaco y un recubrimiento que comprende una capa interior y al menos una capa entre el núcleo y la capa exterior seleccionada del grupo que consiste de una capa de aislamiento y una capa interior. La capa exterior comprende una mezcla de un primer material polimérico que es susceptible a ataques por parte de la bact
