Claims for Patent: 8,148,356

Summary for Patent: 8,148,356

Title:	Acetylcysteine composition and uses therefor
Abstract:	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.
Inventor(s):	Pavliv; Leo (Cary, NC)
Assignee:	Cumberland Pharmaceuticals, Inc. (Nashville, TN)
Application Number:	11/209,804
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,148,356
Patent Claims:	1. 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. 2. The aqueous pharmaceutical composition of claim 1, wherein the composition contains no EDTA, or pharmaceutically acceptable salts thereof. 3. The aqueous pharmaceutical composition of claim 1, wherein the pH of the composition is from 6.5 to less than 7.0. 4. The aqueous pharmaceutical composition of claim 3, wherein the pH of the composition is 6.8. 5. The aqueous pharmaceutical composition of claim 1, wherein the composition is stable for at least 12 months at 25.degree. C. 6. The aqueous pharmaceutical composition of claim 1, wherein the composition is stable for at least 6 months at 40.degree. C. 7. 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. 8. 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. 9. A container comprising: an aqueous pharmaceutical composition comprising between 200 and 500 mg/mL acetylcysteine, wherein the composition is free of a chelating agent and has a pH of about 6 to less than 7, or pharmaceutically acceptable salts thereof, and wherein said composition is in a suitable form for intravenous injection; and a headspace consisting essentially of a pharmaceutically inert gas. 10. The container of claim 9, wherein the pharmaceutically inert gas is nitrogen. 11. The composition of claim 1, wherein the composition has a substantially constant acetylcysteine amount through at least 3 months of storage. 12. The composition of claim 1, wherein the composition has a substantially constant acetylcysteine amount through at least 12 months of storage. 13. The composition of claim 1, wherein the acetylcysteine amount through at least 12 months of storage is at least 99% of the original amount. 14. The composition of claim 9, wherein the chelating agent is EDTA.