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2. 发明申请

WO2014006576A1 PHARMACEUTICAL COMPOSITIONS COMPRISING RIFAXIMIN AND AMINO ACIDS, PREPARATION METHOD AND USE THEREOF 审中-公开
标题翻译：包含RIFAXIMIN和氨基酸的药物组合物，制备方法及其用途
公开(公告)号：WO2014006576A1
公开(公告)日：2014-01-09
申请号：PCT/IB2013/055448
申请日：2013-07-03
申请人： ALFA WASSERMANN S.P.A.
发明人： VISCOMI, Giuseppe Claudio , CHELAZZI, Laura , GREPIONI, Fabrizia , BRAGA, Dario , KINDT, Maddalena
IPC分类号： C07D498/22 , A61K31/437 , A61K47/18 , A61K9/00 , A61P31/00
CPC分类号： A61K31/437 , A61K9/0095 , A61K9/08 , A61K9/16 , A61K9/1617 , A61K9/20 , A61K9/2866 , A61K31/198 , A61K31/405 , A61K31/4172 , A61K47/183 , C07B2200/13 , C07D498/22 , G01N33/15 , Y02A50/475
摘要： The object of the present invention concerns rifaximin compositions comprising amino acids, characterized in that they increase rifaximin solubility in aqueous solutions. Rifaximin compositions comprising amino acids are useful in the treatment of disease wherein amino acids and rifaximin are efficacious. The present invention relates to pharmaceutical compositions comprising rifaximin or one of the pharmaceutically acceptable salts thereof and one or more amino acid(s), wherein the molar ratio between the amino acid(s) and rifaximin is comprised between 1:1 and 10:1, preferably between 1:1 and 5:1, together with pharmaceutically acceptable excipients. Moreover, the present invention relates to rifaximin crystals characterized in that they are obtained by means of a process comprising: a) dissolution of the compositions of rifaximin and amino acids, wherein amino acids and rifaximin are in a molar ratio comprised between 1:1 and 10:1 according to Claim 1, in solutions formed by ethanol/water, in a volumetric ratio comprised between 1:1 and 1:10 (v/v); b) evaporation of the solution obtained in step a) at temperatures comprised between room temperature and 40°C, in a time period comprised between 1 and 10 days; wherein the resulting crystals have monoclinic space group P 2 1 and cell parameters comprised in the ranges: a: 13.7(1)-13.8(1) Å; b: 19.7(1)-19.9 (1) Å ; c: 16.4(6)-16.6(6) Å; β: 92.1 (1)-91.9(1) deg.
摘要翻译：本发明的目的是涉及包含氨基酸的利福昔明组合物，其特征在于它们增加了在水溶液中的利福昔明溶解度。包含氨基酸的利福昔明组合物可用于治疗其中氨基酸和利福昔明有效的疾病。本发明涉及包含利福昔明或其药学上可接受的盐之一和一种或多种氨基酸的药物组合物，其中氨基酸和利福昔明之间的摩尔比为1:1至10:1 ，优选1：1至5：1，以及药学上可接受的赋形剂。此外，本发明涉及利福昔明晶体，其特征在于它们通过以下方法获得，该方法包括：a）溶解利福昔明组合物和氨基酸，其中氨基酸和利福昔明的摩尔比为1:1至根据权利要求1的10：1，在由乙醇/水形成的溶液中，体积比为1:1至1:10（v / v）; b）在包含1至10天的时间段内，在室温至40℃之间的温度下蒸发步骤a）中获得的溶液; 其中所得晶体具有单斜晶系空间群P21，并且晶胞参数包括在以下范围内：a：13.7（1）-13.8（1）; b：19.7（1）-19.9（1）Å; c：16.4（6）-16.6（6） beta：92.1（1）-91.9（1）deg。

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