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Claims for Patent: 5,716,988

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Claims for Patent: 5,716,988

Title: Pharmaceutically stable preparation of oxaliplatinum
Abstract:A pharmaceutically stable oxaliplatinum preparation for parenteral administration comprises an aqueous solution of oxaliplatinum, in a concentration of 1 to 5 mg/ml, and with a pH in the range of 4.5 to 6. The aqueous oxaliplatinum solution is advantageously provided as a ready-to-use preparation in a sealed container.
Inventor(s): Ibrahim; Houssam (Veyrier, CH), Mauvernay; Rolland-Yves (Lausanne, CH)
Assignee: Debiopharm S.A. (Lausanne, CH)
Application Number:08/776,240
Patent Claims: 1. A pharmaceutically stable preparation of oxaliplatinum for the administration by the parenteral route, consisting of a solution of oxaliplatinum in water at a concentration of 1 to 5 mg/ml and having a pH of 4.5 to 6, the oxaliplatinum content in the preparation being at least 95% of the initial content and the solution remaining clear, colorless and free of precipitate after storage for a pharmaceutically acceptable duration of time.

2. A preparation according to claim 1, in which the concentration of oxaliplatinum is of about 2 mg/ml of water and the pH of the solution has an average value of about 5.3.

3. A preparation according to claim 1, in which the solution of oxaliplatinum has a specific rotatory power in the range from +74.5.degree. to +78.0.degree..

4. A preparation according to claim 1, in the form of an aqueous solution of oxaliplatinum ready to be used and contained in a hermetically sealed container.

5. A preparation according to claim 4, characterized in that said container contains an active unit dose of 50 to 100 mg of oxaliplatinum, which can be administered by infusion.

6. A preparation according to claim 4, characterized in that said container is a glass vial for pharmaceutical use and is closed with a stopper of which, at least, the surface extending inside the vial is inert with respect to said solution.

7. A preparation according to claim 4, characterized in that said container is a flexible pouch for infusion or an ampoule.

8. A packaged pharmaceutical product comprising a glass vial closed with a stopper, said vial containing a pharmaceutically stable preparation of oxaliplatinum consisting of a solution of oxaliplatinum in water at a concentration of 1 to 5 mg/ml and having a pH of 4.5 to 6, the oxaliplatinum content in the preparation being at least 95% of the initial content and the solution remaining clear, colorless and free of precipitate after storage for a pharmaceutically acceptable duration; wherein said stopper has an inner surface which is inert with respect to said solution, said vial further comprising inert gas filling a space between said solution and said stopper.

9. A pharmaceutical product comprising an infusion device having an injection micropump, and a container containing a pharmaceutically stable preparation of oxaliplatinum consisting of a solution of oxaliplatinum in water at a concentration of 1 to 5 mg/ml and having a pH of 4.5 to 6, the oxaliplatinum content in the preparation being at least 95% of the initial content and the solution remaining clear, colorless and free of precipitate after storage for a pharmaceutically acceptable duration.
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