improved levosimendan formulations for intravenous infusion or injection and infusion concentrates

摘要

The present invention relates to improved formulations of levosimendan for pharmaceutical use and in particular for intravenous administration in the form of infusion or injection and concentrates for infusion. The present invention therefore relates to pharmaceutical compositions comprising levosimendan, wherein levosimendan is present in a solubilized form. The formulations have commercially useful therapeutic concentrations of levosimendan. The solutions of the present invention have improved physiological suitability (pH 7.4) and are particularly useful as infusion or injection solutions or infusion concentrates. The composition according to the present invention may also be spray dried or lyophilized to give a dry powder which is very stable and which forms the original solution upon reconstitution in water or aqueous solvent. levosimendan or (-) - [[4- (1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl) phenyl] hydrazono] propanedinitrile is useful in the treatment of insufficiency. congestive heart