LINDELL, Katarina,THYRESSON, Kristina,NICKLASSON, Fredrik,BUNICK, Frank,LUBER, Joe,HUGERTH, Andreas
申请号:
ES09820843
公开号:
ES2592882T3
申请日:
2009.10.13
申请国别(地区):
ES
年份:
2016
代理人:
摘要:
A multi-portion intra-oral dosage form comprising a component for treating tobacco dependence, which is nicotine and / or the metabolites thereof, selected from cotinine, nicotine N'-oxide, nornicotine and (S) - Nicotine-N-β-glucuronide and mixtures, isomers, salts and complexes thereof, in any form, in which at least a portion of the multi-portion intra-oral dosage form disintegrates rapidly and at least one portion is disintegrate slowly, so that the disintegration time for the portion that disintegrates slower is at least twice as much as for the portion that disintegrates more rapidly, and in which each portion comprises at least one article selected from the following articles : a pharmaceutically active component, a component that mimics nicotine, a pH buffering component, a pH regulating component, a flavoring, a barrier component, a color component, an adhesive component, a taste masking agent, a tooth whitening agent, a breath freshening agent, an oral health promoting agent, an anti-caries agent and an anti-inflammatory agent; and wherein the at least a rapidly disintegrating portion further comprises an excipient that swells in water selected from sodium starch glycolate, crospovidone, croscarmellose, microcrystalline cellulose, starches, hydroxypropylcellulose and alginic acid.Una forma de dosificación intra-oral de múltiples porciones que comprende un componente para tratar la dependencia del tabaco, que es nicotina y/o los metabolitos de la misma, seleccionados de cotinina, N'-óxido de nicotina, nornicotina y (S)-nicotina-N-ß-glucurónido y mezclas, isómeros, sales y complejos de los mismos, en cualquier forma, en la que al menos una porción de la forma de dosificación intra-oral de múltiples porciones se disgrega rápidamente y al menos una porción se disgrega lentamente, por lo que el tiempo de disgregación para la porción que se disgrega más lenta es al menos dos veces más que para la porción que se disgrega más rápidamente, y en la que cada porción c