Matthews, Frank,Boehm, Garth,Tang, Lijuan,Liang, Alfred
申请号：
ES13154883
公开号：
ES2600141T3
申请日:
2007.06.19
申请国别(地区):
ES
年份:
2017
代理人:
摘要：
A pharmaceutical composition for oral administration comprising: a) a sequestering subunit comprising: a water-soluble core； a first layer comprising naltrexone, or a pharmaceutically acceptable salt thereof or a combination thereof； a second layer comprising a sequestering polymer, a sodium and talc lauryl sulfate, in which the talc is present in an amount greater than about 66% and less than about 150% of the amount of sequestering polymer based on weight / weight； and an optional third layer comprising an osmotic pressure regulating agent selected from hydroxypropyl methylcellulose and sodium chloride, bromide or iodide, or a combination thereof； and b) an opioid agonist selected from morphine, oxycodone, hydrocodone, hydromorphone, dihydrocodeine, codeine, dihydromorphine or buprenorphine, or a pharmaceutically acceptable salt thereof or a combination thereof； wherein the sequestering subunit sequesters at least 80% of naltrexone or the pharmaceutically acceptable salt thereof, as determined at 72 hours by dissolution test procedures of USP26 <；711>；, for example, by first placing the pharmaceutical composition in 500 ml of a 0.1 N HCl solution for 1 hour at 37 ° C, using the USP paddle procedure, 100 rotations per minute, and then placing the multilayer composition in 500 ml of a phosphate buffer 0 , 05 M, pH 7.5, for 72 hours at 37 ° C, using the USP blade method, 100 rotations per minute, and then determining the amount of naltrexone or the pharmaceutically acceptable salt sequestered.Una composición farmacéutica para administración oral que comprende: a) una subunidad secuestrante que comprende: un núcleo hidrosoluble； una primera capa que comprende naltrexona, o una sal farmacéuticamente aceptable de la misma o una combinación de la misma； una segunda capa que comprende un polímero secuestrante, un laurilsulfato de sodio y talco, en la que el talco está presente en una cantidad superior al aproximadamente 66 % e inferior al aproximadamente 150 % de la c
