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Claims for Patent: 6,548,079

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Claims for Patent: 6,548,079

Title: Moxifloxacin formulation containing common salt
Abstract:The present invention relates to an aqueous formulation comprising moxifloxacin hydrochloride and sodium chloride, to the formulation for use as a medicament and to the use of the formulation for preparing a medicament for preventing or treating bacterial infections in humans or animals.
Inventor(s): Kuhn; Bernd (Koln, DE), Mahler; Hans-Friedrich (Koln, DE), Eisele; Michael (Bergisch Gladbach, DE)
Assignee: Bayer Aktiengesellschaft (Leverkusen, DE)
Application Number:10/049,095
Patent Claims: 1. Aqueous formulation, comprising from 0.04% to 0.4% (w/v) (based on the amount of moxifloxacin) of moxifloxacin hydrochloride and from 0.4% to 0.9% (w/v) of sodium chloride.

2. Aqueous formulation according to claim 1, comprising from 0.08% to 0.32% (w/v) (based on the amount of moxifloxacin) of moxifloxacin hydrochloride.

3. Aqueous formulation according to claim 1, comprising from 0.1% (w/v) to 0.2% (w/v) (based on the amount of moxifloxacin) of moxifloxacin hydrochloride.

4. Aqueous formulation according to claim 1, comprising from 0.5% to 0.9% (w/v) of sodium chloride.

5. Aqueous formulation according to claim 1, comprising from 0.7% to 0.9% (w/v) of sodium chloride.

6. Process for preparing the aqueous formulation of moxifloxacin hydrochloride, in which a solution of the moxifloxacin hydrochloride in water is prepared initially, and sodium chloride is then added and dissolved.

7. Process for preparing the aqueous formulation of moxifloxacin hydrochloride according to claim 1, characterized in that a solution of moxifloxacin hydrochloride in water having a moxifloxacin hydrochloride concentration (based on the amount of moxifloxacin) of from more than 0.4% (w/v) to 2.4% (w/v) is mixed with an aqueous solution comprising sodium chloride.

8. A method of treating or preventing a disease comprising administering to a host in need thereof an effective amount of an aqueous solution of moxifloxacin hydrochloride in water having a moxifloxacin hydrochloride concentration (based on the amount of moxifloxacin) of from more than 0.4% (w/v) to 2.4% (w/v).

9. A combination preparation comprising an aqueous solution of moxifloxacin hydrochloride in water having a moxifloxacin hydrochloride concentration (based on the amount of moxifloxacin) of from more than 0.4% (w/v) to 2.4% (w/v) and an aqueous solution comprising sodium chloride, wherein said solutions are separated from one another.

10. A pharmaceutical composition comprising an aqueous formulation according to any of claims 1 to 5.

11. A method of preventing or treating bacterial infections in humans or animals comprising administering to a host in need thereof an effective amount of a formulation according to any of claims 1 to 5.
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