N-acetylcysteine compositions and methods
Storage stable sterile ready-to-administer formulations comprising N-acetylcysteine are presented with desirable stability characteristics. In preferred aspects, formulations comprise low quantities of one or more chelating agents, contain N-acetylcysteine at a concentration of 25 mg/mL or 50 mg/mL, and are packaged in a suitable format, such as a polymeric bag with a metalized overwrap and a non-contact oxygen scavenger.
1. A sterile and ready-to-administer N-acetylcysteine composition, comprising:
an aqueous solution containing N-acetylcysteine at a concentration suitable for direct administration via intravenous injection to a patient without dilution prior to administration;
wherein the composition has a pH of between 6.0 and 7.5 and comprises a chelating agent at a concentration of between 10 and 60 mcg/mL; and
wherein the ready-to-administer composition contains, after storage over at least three weeks at 80° C., equal or less than 7% total impurities generated from degradation of the N-acetylcysteine.
2. The composition of claim 1 wherein the N-acetylcysteine concentration is 25 mg/mL or 50 mg/mL.
3. The composition of claim 1 wherein the composition has a pH of 7.0±0.2.
4. The composition of claim 1 wherein composition contains, after storage over at least three weeks at 80° C., equal or less than 6% total impurities generated from degradation of the N-acetylcysteine.
5. A kit comprising:
a primary container that contains a sterile and ready-to-administer N-acetylcysteine composition according to claim 1 ;
a secondary container enclosing the primary container, and a non-contact oxygen absorbing agent in a space between the primary and secondary container;
wherein the primary container contains between 100 and 500 mL of the ready-to-administer N-acetylcysteine composition; and
wherein the secondary container is impermeable to light or comprises a metal or metal layer.
6. The kit of claim 5 wherein the primary container contains 200 mL or 250 mL or 300 mL of the ready-to-administer N-acetylcysteine composition.
7. The kit of claim 5 wherein the primary and secondary containers are polymeric bags.
8. The kit of claim 5 wherein the ready-to-administer N-acetylcysteine composition is preservative-free.