GB2551971A — Taste masked liquid pharmaceutical composition of (RS)-4-(ethyl[1-(4-methoxyphenyl)propan-2-yl]am ino)butyl 3, 4-dimethoxybenzoate

USPTO Abstract

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.