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Claims for Patent: 7,645,801

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Claims for Patent: 7,645,801

Title:Reduced irritant enema for treatment of inflammatory bowel disease (IBD)
Abstract:The present invention comprises packaged enemas for the treatment of Inflammatory Bowel Disease (IBD), having substantially pure 5-ASA as the active ingredient, with a liquid carrier medium having a material avoidance of bowel irritant substances, such as anti-oxidants for the 5-ASA active ingredient, including such sulfites as potassium metabisulfite, for example, and contained within a sealed and substantially oxygen-free barrier package, which may preferably be formed of a foil/polymer laminate, and which package contains or otherwise includes an oxygen scavenger, such as a an oxygen scavenging sachet.
Inventor(s): Venkataraman; Bala (Alpharetta, GA), Brown; Lindsey (Atlanta, GA), Patel; Daxa (Marietta, GA)
Assignee: Alaven Pharmaceutical LLC (Marietta, GA)
Application Number:11/749,732
Patent Claims: 1. A packaged enema for the treatment of inflammatory bowel disease and related conditions, comprising: an effective and stable dosage suspension of substantially pure 5-ASA contained within a substantially oxygen-free liquid carrier medium, said liquid carrier medium having a material avoidance of antioxidants for said 5-ASA; at least one application bottle containing said effective dosage suspension; a sealed, substantially oxygen-free barrier package containing therein said at least one application bottle containing said effective dosage suspension, and an oxygen scavenger; and said barrier package sufficient to prevent migration of oxygen thereinto and to said dosage suspension upon prolonged storage.

2. The packaged enema of claim 1, wherein said sealed, substantially oxygen-free barrier package comprises a pouch.

3. The packaged enema of claim 1, wherein said at least one application bottle contained within a sealed oxygen barrier pouch is of sufficient flexibility to facilitate squeeze dispensing of the contents thereof.

4. The packaged enema of claim 1, wherein said oxygen scavenger is contained within said oxygen barrier package.

5. The packaged enema of claim 1, wherein said oxygen scavenger is contained within a sachet.

6. The packaged enema of claim 1, wherein said application bottle is formed from a malleable polymer.

7. The packaged enema of claim 1, wherein said oxygen barrier package comprises a laminate comprising polyester/aluminum foil/linear low density polyethylene.

8. The packaged enema of claim 7, wherein said laminate further comprises at least one compatible adhesive.

9. The packaged enema of claim 1, wherein said oxygen scavenger is disposed within said sealed substantially oxygen-free barrier package in substantially isolated disposition with regard to said stable dosage suspension.

10. The packaged enema of claim 1, wherein said oxygen scavenger is disposed within said sealed substantially oxygen-free barrier package in substantially communicating disposition with regard to said stable dosage suspension.

11. The packaged enema of claim 1, wherein said effective dosage amount is approximately 1 g. to approximately 4 g. of 5-ASA disposed within approximately 20 to approximately 60 ml of said liquid carrier medium.

12. The packaged enema of claim 1, wherein said liquid carrier medium comprises potassium acetate, xanthan gum, carbomer, sodium benzoate, edentate disodium and purified water.

13. The packaged enema of claim 1, wherein said package contains a substantially inert gas.

14. The packaged enema of claim 13, wherein said substantially inert gas comprises nitrogen.

15. The packaged enema of claim 1, wherein said application bottle contains a substantially inert gas.

16. The packaged enema of claim 15, wherein said substantially inert gas comprises nitrogen.

17. The packaged enema of claim 1, wherein said effective dosage has a pH of approximately 3 to approximately 5.

18. The packaged enema of claim 1, wherein said barrier package is further sufficient to prevent discoloration of said dosage suspension upon prolonged storage.
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