Patent ID: 7138419

Claim:
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: (i) α-aztreonam dissolved in water or an aqueous solvent at acidic pH lower than pH 6.0 to form a slurry; and (ii) lysine monohydrate dissolved in water or an aqueous solvent; 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.