Patent ID: 7985757
Filing Date: 2011-07-26
Classification: A61K,A61P

Abstract:
1. A method for preparing an aqueous, stable, sterile pharmaceutical solution of a thrombin inhibitor suitable for parenteral administration, the method comprising forming an aqueous solution comprising: a) 0.1 to 10 mg/ml 1-[5-[(aminoiminomethy)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl) sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid hydrate (argatroban), b) an acid to solubilize the argatroban, c) a buffering agent to maintain the solution at a pH of about 3.5 to 8.5, and d) an osmotic-adjusting agent, wherein the aqueous solution is stable for at least 24 months and is free from dehydrated alcohol; and autoclaving the aqueous solution for a period of time sufficient to render the aqueous solution sterile.