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Taste masked liquid pharmaceutical composition of mebeverine or pharmaceutically acceptable salts thereof

机译:美贝维林或其药物可接受盐的味道掩盖的液体药物组合物

摘要

A taste masked liquid pharmaceutical composition comprises: (a) (RS)-4-(ethyl[1-(4-methoxyphenyl)propan-2-yl]amino)butyl 3,4-dimethoxybenzoate (mebeverine) or pharmaceutically acceptable salts thereof; (b) at least one sweetener; (c) an auxiliary agent; (d) at least one preservative; and (e) one or more pharmaceutically acceptable excipients. Preferably the at least one sweetener is selected from the group consisting of saccharin, saccharin sodium, aspartame, cyclamate, invert syrup, sucralose, acesulfame, acesulfame potassium, neotame, thaumatin, neohesperidine, neohesperidine dihydrochalcone, sucrose, trehalose, lactose, fructose, xylitol, mannitol, sorbitol or combinations thereof; preferably the auxiliary agent is selected from the group consisting of levomenthol, monoammonium glycyrrhizinate, L-arginine, L-lysine, citric acid, lactic acid, cineol and myrtol; preferably the at least one preservative is selected from the group consisting of benzoic acid, methyl paraben, ethyl paraben, propyl paraben, butyl paraben, sodium benzoate and benzalkonium chloride or combinations thereof; and preferably the one or more pharmaceutically acceptable excipients are selected from preservatives, flavouring agents, pH modifiers and solvents, in particular flavouring agents. Preferably the liquid composition is for use in the treatment of irritable bowel syndrome and other conditions including chronic irritable colon, spastic constipation, mucous colitis, spastic colitis, colicky abdominal pain and cramps, persistent non-specific diarrhoea with or without alternating constipation and flatulence. A method of preparing the liquid composition as herein defined is also provided.
机译:一种掩味液体药物组合物,其包含:(a)3,4-二甲氧基苯甲酸酯(美贝维林)的(RS)-4-(乙基[1-(4-甲氧基苯基)丙-2-基]氨基)丁基丁基或其可药用盐; (b)至少一种甜味剂; (c)助剂; (d)至少一种防腐剂; (e)一种或多种药学上可接受的赋形剂。优选地,所述至少一种甜味剂选自糖精,糖精钠,阿斯巴甜,甜蜜素,转化糖浆,三氯蔗糖,乙酰磺胺,乙酰磺胺钾,纽甜,索马汀,新橙皮苷,新橙皮苷二氢查尔酮,蔗糖,海藻糖,乳糖, ,甘露醇,山梨糖醇或其组合;优选的助剂选自左薄荷脑,甘草次酸单铵,L-精氨酸,L-赖氨酸,柠檬酸,乳酸,木糖醇和肉豆蔻醇。优选地,所述至少一种防腐剂选自苯甲酸,对羟基苯甲酸甲酯,对羟基苯甲酸乙酯,对羟基苯甲酸丙酯,对羟基苯甲酸丁酯,苯甲酸钠和苯扎氯铵或其组合;优选一种或多种药学上可接受的赋形剂选自防腐剂,调味剂,pH调节剂和溶剂,特别是调味剂。优选地,液体组合物用于治疗肠易激综合症和其他病症,包括慢性肠易激,痉挛性便秘,粘液性结肠炎,痉挛性结肠炎,腹部绞痛和绞痛,持续性非特异性腹泻,有或没有交替的便秘和肠胃气胀。还提供了制备本文定义的液体组合物的方法。

著录项

  • 公开/公告号GB2551971B

    专利类型

  • 公开/公告日2020-09-16

    原文格式PDF

  • 申请/专利权人 SYRI LIMITED;

    申请/专利号GB20160011276

  • 发明设计人 KAMLESH PATEL;

    申请日2016-06-29

  • 分类号A61K31/235;A61K9;A61K9/08;A61K31/24;A61K47/10;A61K47/12;A61K47/26;A61P1/06;

  • 国家 GB

  • 入库时间 2022-08-21 10:59:52

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