.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 8,148,356

« Back to Dashboard

Claims 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 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.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc