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Claims for Patent: 8,952,065

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Claims for Patent: 8,952,065

Title:Acetylcysteine composition and uses thereof
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:14/153,978
Patent Claims: 1. A method of treating acute liver failure, comprising: using a stable aqueous pharmaceutical composition comprising from 100 to 250 mg/mL acetylcysteine or pharmaceutically acceptable salts thereof, wherein chelating agents are not added to the composition but may be present as an impurity or undesired contaminant, wherein said composition is in a suitable form for intravenous administration, wherein the pH of the composition in an undiluted state is from 6.0 to 7.5, 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; diluting the composition in an aqueous solution; and administering the diluted composition to a patient in need thereof.

2. The method of claim 1, wherein the composition in an undiluted state comprises about 200 mg/mL acetylcysteine or pharmaceutically acceptable salts thereof.

3. The method of claim 1, wherein the diluted composition is administered as a loading dose of about 150 mg/kg, followed by a second dose of about 50 mg/kg.

4. The method of claim 1, wherein the diluted composition is administered as a loading dose over a period of 15 minutes to 2 hours, followed by a second dose over about 4 hours.

5. The method of claim 1, wherein the aqueous solution comprises at least one of 5% dextrose, 0.45% sodium chloride, and water for injection.

6. A method of treating acute liver failure, comprising: using a stable aqueous pharmaceutical composition comprising from 100 to 250 mg/mL acetylcysteine or pharmaceutically acceptable salts thereof, wherein the composition is free of chelating agents, wherein said composition is in a suitable form for intravenous administration, wherein the pH of the composition in an undiluted state is from 6.0 to 7.5, 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; diluting the composition in an aqueous solution; and administering the diluted composition to a patient in need thereof.

7. The method of claim 6, wherein the composition in an undiluted state comprises about 200 mg/mL acetylcysteine or pharmaceutically acceptable salts thereof.

8. The method of claim 6, wherein the diluted composition is administered as a loading dose of about 150 mg/kg, followed by a second dose of about 50 mg/kg.

9. The method of claim 6, wherein the diluted composition is administered as a loading dose over a period of 15 minutes to 2 hours.
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