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Claims for Patent: 5,662,918

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Claims for Patent: 5,662,918

Title: Pharmaceutical agents containing diphosphonic acids and salts thereof
Abstract:The invention concerns pharmaceutical preparations that are stable on storage, which contain at least one diphosphonic acid and/or at least one physiologically acceptable salt of such an acid as the active substance.
Inventor(s): Winter; Gerhard (Dossenheim, DE), Pichler; Bernhard (Ketsch, DE), Woog; Heinrich (Laudenbach, DE), Heller; Werner (Grunstadt, DE)
Assignee: Boehringer Mannheim GmbH (Mannheim, DE)
Application Number:08/387,818
Patent Claims: 1. Injection solution which is stable on storage in a glass container, said solution being an aqueous solution containing at least one bone-reabsorption-inhibiting diphosphonic acid or physiologically acceptable salt or ester thereof as the active substance, said solution being stabilized by having a pH value of the solution of about 3.0 to 4.5 or by having a pH value of the solution of about 3.0 to 4.2 and the presence of polyethylene glycols.

2. Solution of claim 1, wherein the pH value of the solution is of about 3.0 to 4.5 and the solution contains polyethylene glycols.

3. Solution of claim 1, wherein the pH value of the solution is about 4.

4. Solution of claim 1, wherein the solution contains up to 20% of polyethylene glycols having a molecular weight of about 200-1500.

5. Solution of claim 4, wherein the solution contains about 0.05 to about 0.2 ml of polyethylene glycols per 1 ml of injection solution.

6. Solution of claim 1, wherein the solution contains at least one 1-hydroxy-aminoalkyl-1,1-diphosphonic acid or physiologically acceptable salt or ester thereof as the active substance.

7. Solution of claim 6, wherein the active substance is 1-hydroxy-3-(N-methyl-N-pentyl) aminopropyl-1,1-diphosphonic acid or physiologically acceptable salt thereof.

8. Solution of claim 1, wherein the active substance is in the form of a pharmaceutically acceptable alkali salt.

9. Solution of claim 1, wherein the solution contains the active substance in an amount of about 0.1 to about 1000 mg and NaCl in an amount of less than 10 mg/ml of aqueous solution.

10. A kit comprising a glass container containing an aqueous injection solution of at least one physiologically acceptable bone-reabsorption-inhibiting diphosphonic acid or salt or ester thereof as the active ingredient, said solution being stable on storage in the container for up to 5 years, said solution having a pH value of about 3.0-4.5.

11. A kit comprising a glass container containing one physiologically acceptable bone-reabsorption-inhibiting diphosphonic acid or salt or ester thereof as the active ingredient, said solution being stable on storage in the container for up to 5 years, said solution containing polyethylene glycols and having a pH value of about 3.0-4.5.

12. A method for stabilizing an aqueous injection solution for the treatment of bone diseases, said solution being storage stable for up to 5 years and containing as the active substance at lease one bone-reabsorption-inhibiting diphosphonic acid or physiologically acceptable salt or ester thereof, said solution being stored in a glass container, said method comprising adjusting the pH Value of the solution to about 3.0-4.5 prior to filling the glass container with the solution.

13. A method for stabilizing an aqueous injection solution for the treatment of bone diseases, said solution being storage stable for up to 5 years and containing as the active substance at lease one bone-reabsorption-inhibiting diphosphonic acid or physiologically acceptable salt or ester thereof, said solution being stored in a glass container, said method comprising adjusting the pH to about 3.0 to 4.5 and adding polyethylene glycols to the solution.

14. Method of claim 12, wherein the glass container has been surface-treated before being filled by the solution.

15. Method of claim 12, wherein the pH value is adjusted to about 4.0.

16. Method of claim 13, wherein the glass container has been surface-treated before being filled by the solution.

17. Method of claim 13, wherein the pH value is adjusted to about 4.0.

18. Solution of claim 1, wherein the solution is stabilized by having a pH value of 3 to 4.5, and the solution is free of polyethylene glycols.

19. The kit of claim 10 wherein the glass container has been surface treated.

20. The kit of claim 19 wherein the glass container has been surface treated with ammonium sulfate, sulfur dioxide, sulfur trioxide or ammonium chloride.

21. The kit of claim 11 wherein the glass container has been surface treated.

22. The kit of claim 21 wherein the glass container has been surface treated with ammonium sulfate, sulfur dioxide, sulfur trioxide or ammonium chloride.
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