Patent ID: 7138419
Filing Date: 2006-11-21
Classification: A61K,A61P,Y02A

Abstract:
1. A process for manufacturing a bulk solution of a pure α-aztreonam lysinate soluble in water or aqueous solvents having an impurity level 1% or lower, said pure α-aztreonam lysinate being suitable for aerosolization and delivery by inhalation, said process comprising steps: (a) preparing separately a solution of: wherein both α-aztreonam and lysine are present in equimolar amounts in a ratio of 1.4:1.0 of α-aztreonam to lysine monohydrate; (b) reacting said α-aztreonam with said lysine to produce α-aztreonam lysinate without need for conversion of α-aztreonam to β-aztreonam, wherein during said reaction said lysine solution is added to said α-aztreonam slurry or said α-aztreonam slurry is added to the lysine solution, and wherein said pure α-aztreonam lysinate has stability for about two years, wherein the level of impurities is 1% or lower.