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    • 9. 发明申请
    • TAMPER RESISTANT DOSAGE FORM COMPRISING AN ANIONIC POLYSACCHARIDE
    • 包含阴离子多糖的抗篡改剂型
    • WO2018024709A1
    • 2018-02-08
    • PCT/EP2017/069393
    • 2017-08-01
    • GRÜNENTHAL GMBH
    • WENING, KlausSTOMBERG, Carmen
    • A61K9/20A61K31/137
    • A61K47/38A61K9/2031A61K9/205A61K9/2054A61K9/2059A61K31/137A61K31/485A61K45/06A61K47/10
    • The invention relates to a pharmaceutical dosage form having a breaking strength of at least 300 N, said dosage form comprising -an opioid (A) selected from the group consisting of Oxymorphone, Oxycodone, Tapentadol, Hydromorphone, Hydrocodone, Morphine, and the physiologically acceptable salts thereof; wherein the weight content of the opioid (A) is within the range of from 5.0 to 35 wt.-%, based on the total weight of the pharmaceutical dosage form; -an anionic polysaccharide (B) selected from the group consisting of croscarmellose, carmellose, crosslinked carboxymethyl starch, carboxymethyl starch, and the physiologically acceptable salts thereof; wherein the weight content of the anionic polysaccharide (B) is within the range of from 5.0 to 35 wt.-%, based on the total weight of the pharmaceutical dosage form; and -a polyalkylene oxide (C) having a weight average molecular weight of at least 200,000 g/mol; wherein the weight content of the polyalkylene oxide (C) is within the range of from 20 to 80 wt.-%, based on the total weight of the pharmaceutical dosage form; wherein the opioid (A) is present in a controlled-release matrix comprising the anionic polysaccharide (B) and the polyalkylene oxide (C).
    • 本发明涉及断裂强度至少为300N的药物剂型,所述剂型包含选自羟吗啡酮,羟考酮,他喷他多,氢吗啡酮, 氢可酮,吗啡及其生理上可接受的盐; 其中所述阿片样物质(A)的重量含量基于所述药物剂型的总重量在5.0至35重量%的范围内; - 选自交联羧甲基纤维素,羧甲基纤维素,交联羧甲基淀粉,羧甲基淀粉及其生理上可接受的盐的阴离子多糖(B) 其中基于所述药物剂型的总重量,所述阴离子多糖(B)的重量含量在5.0至35重量%的范围内; 和 - 重均分子量为至少200,000g / mol的聚环氧烷(C) 其中所述聚环氧烷(C)的重量含量基于所述药物剂型的总重量在20至80重量%的范围内; 其中阿片样物质(A)存在于包含阴离子多糖(B)和聚环氧烷(C)的控释基质中。