Crystalline dihydrate of a cephalosporin dihydrochloride salt and injectable compositions thereof
申请人:Bristol-Myers Squibb Company
公开号:EP0587121A1
公开(公告)日:1994-03-16
The present invention relates to a new crystalline dihydrochloride dihydrate salt of the cephalosporin antibiotic, cefepime. In particular, this invention provides a temperature and moisture stable crystalline dihydrochloride dihydrate form of cefepime having enhanced stability and a specific x-ray powder diffraction pattern as described herein. The present invention also provides physical admixtures of the new crystalline dihydrochloride dihydrate salt of cefepime with a pharmaceutically acceptable non-toxic organic or inorganic base. In particular, this invention provides physical admixtures of a temperature and moisture stable crystalline dihydrochloride dihydrate form of cefepime having a specific X-ray powder diffraction pattern as described herein with L(+) arginine.
本发明涉及头孢菌素类抗生素头孢吡肟的一种新的结晶二盐酸盐二水合物。特别是,本发明提供了一种温度和湿度稳定的头孢吡肟二盐酸盐二水合物结晶形式,具有更高的稳定性和本文所述的特定 X 射线粉末衍射图样。本发明还提供了头孢吡肟的新型结晶二盐酸盐二水合物与药学上可接受的无毒有机或无机碱的物理混合物。特别是,本发明提供了具有本文所述特定 X 射线粉末衍射图样的头孢吡肟二盐酸盐二水合物晶体的温度和湿度稳定型与 L(+)精氨酸的物理混合物。