专利名称 | Liquid pharmaceutical composition of flecainide | ||
申请号 | GB1711091 | 申请日 | |
公开(公告)号 | GB2564444A | 公开(公告)日 | 2017-07-10 |
申请(专利权)人 | 发明人 | KAMLESH PATEL; SANJAYKUMAR MAGANBHAI PATEL | |
专利来源 | 国家知识产权局 | 转化方式 | |
摘要 |
A liquid pharmaceutical composition comprising flecainide or pharmaceutically acceptable salts thereof in the range from about 1mg/ml to 20mg/ml, at least a sweetener in the range from 0.05 to 0.5% w/v, a buffer system and at least one preservative, wherein the pH of the composition is from about 5.0 to 6.5 is provided. Flecainide is preferably in the form of an acetate salt. The sweetener is preferably selected from acesulfame potassium, sucralose, cyclamate, saccharin, saccharin sodium and aspartame, in particular sucralose. The buffer system may be selected from glacial acetic acid, sodium acetate trihydrate, citric acid, sodium citrate, sodium dihydrogen phosphate, disodium phosphate, trometamol (Tris), hydrochloric acid, ascorbic acid, and sodium ascorbate as single or any combination thereof. The preferred buffer system is glacial acetic acid and sodium acetate trihydrate. The preservative is preferably selected from methyl paraben, ethyl paraben, propyl paraben, butyl paraben, isobutyl paraben, benzyl paraben, sodium benzoate, benzoic acid, potassium sorbate and combination thereof. The preferred buffer is methyl paraben. A process for the preparation of said liquid pharmaceutical composition as herein defined is also provided. A liquid composition comprising flecainide acetate, sucralose, methyl paraben (methyl parahydroxylbenzoate) and a buffer system which comprises mixture of glacial acetic acid and sodium acetate trihydrate as herein defined is provided. |
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