Patent ID: 7803762
Filing Date: 2010-09-28
Classification: A61K,A61P

Abstract:
1. An aqueous, injectable composition that has not been reconstituted from a lyophilizate, comprising: (i) bivalirudin (SEQ ID NO: 1), or salts thereof, at a concentration of about 1 mg/mL to about 10 mg/mL; (ii) one or more pharmaceutically acceptable stabilizing agents, wherein at least one of the stabilizing agents is a buffering agent having a pKa of about 2.5 to about 6.5; (iii) a pH of about 4 to less than 5; and (iv) total impurities in an amount less than about 1.5% area-under-the-curve (“AUC”) as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 215 nm after storage at 25° C. for 1 month.