Back to results
US 8,148,356 B2Granted
Acetylcysteine composition and uses therefor
AssigneeCumberland Pharmaceuticals Inc.
InventorLeo Pavliv
Life of this patent
Estimating the term…
Loading patent…
Loading patent…
AssigneeCumberland Pharmaceuticals Inc.
InventorLeo Pavliv
Estimating the term…
This invention relates to novel acetylcysteine compositions in solution, comprising acetylcysteine and which are substantially free of metal chelating agents, such as EDTA. Further, this invention relates to methods of making and using the acetylcysteine compositions. The present compositions and methods are designed to improve patient tolerance and compliance, while at the same time maintaining the stability of the pharmaceutical formulation. The compositions and methods of this invention are useful in the treatment of acetaminophen overdose, acute liver failure, various cancers, methacrylonitrile poisoning, reperfusion injury during cardio bypass surgery, and radiocontrast-induced nephropathy, and can also be used as a mucolytic agent.
A stable aqueous pharmaceutical composition comprising between 200 and 250 mg/mL acetylcysteine, wherein the composition is free from a chelating agent, or pharmaceutically acceptable salts thereof, wherein said composition is in a suitable form for intravenous injection, wherein the pH of the composition is from 6 to 7, and wherein said composition is sealed in an airtight container comprising a fill volume of said composition and a headspace volume occupied by a pharmaceutically inert gas.
An aqueous pharmaceutical composition consisting of between 200 and 250 mg/mL acetylcysteine, or pharmaceutically acceptable salts thereof dissolved in deaerated water, and wherein the pH of the composition is adjusted with a pH-adjusting agent to a pH of from 6 to less than 7, wherein said composition is in a suitable form for intravenous injection and is free of a chelating agent, and wherein said composition is sealed in an airtight container comprising a fill volume of said composition and a headspace volume occupied by a pharmaceutically inert gas.
An aqueous pharmaceutical composition consisting of between 200 and 500 mg/mL acetylcysteine, or pharmaceutically acceptable salts thereof, dissolved in deaerated water, and wherein the pH of the composition is adjusted with a pH-adjusting agent to a pH of from 6 to less than 7, wherein said composition is in a suitable form for intravenous injection and is free of a chelating agent, and wherein said composition is sealed in an airtight container comprising a fill volume of said composition and a headspace volume occupied by a pharmaceutically inert gas.
A container comprising:
Dependencies are inferred from the claim text.