Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it

Abstract

A β-Crystalline form of ivabradine of formula (I): characterised by its powder X-ray diffraction data. Medicinal products containing the same which are useful as bradycardics.

1 . A β-Crystalline form of ivabradine hydrochloride of formula (I): 
       
         
           
           
               
               
           
         
       
     
     
         2 . The β-Crystalline form of ivabradine hydrochloride of  claim 1  having a powder X-ray diffraction diagram exhibiting peaks at 9.2, 18.4, 19.7, 21.6 and 25.3 deg 2 theta. 
     
     
         3 . The β-Crystalline form of ivabradine hydrochloride of  claim 1  having a powder X-ray diffraction diagram exhibiting peaks at 9.2, 9.7, 10.0 and 14.8 deg 2 theta. 
     
     
         4 . A pharmaceutical composition comprising as active ingredient the β-crystalline form of ivabradine hydrochloride of  claim 1 , in combination with one or more pharmaceutically acceptable, inert, non-toxic carriers. 
     
     
         5 . A method for treating or preventing a condition requiring a bradycardic, such method comprising administering to a living animal body, including a human, a therapeutically effective amount of the β-crystalline form of ivabradine hydrochloride of  claim 1 . 
     
     
         6 . A method for treating or preventing clinical situations of myocardial ischaemia and/or a condition involving rhythm disturbances, such method comprising administering to a living animal body, including a human, a therapeutically effective amount of the β-crystalline form of ivabradine hydrochloride of  claim 1 . 
     
     
         7 . The method of  claim 6 , wherein the clinical situation of myocardial ischaemia is selected from angina pectoris and myocardial infarct and associated rhythm disturbances. 
     
     
         8 . The method of  claim 6 , wherein the condition involving rhythm disturbances is selected from supra ventricular rhythm disturbances and heart failure.