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Claims for Patent: 5,834,448

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Claims for Patent: 5,834,448

Title: Dosage form of hydroxocobalamin and its use in cyanide poisoning
Abstract:The invention relates to a new dosage form of hydroxocobalamin which serves in the treatment of cyanide poisoning and contains hydroxocobalamin in freeze-dried form. The hydroxocobalamin is freeze-dried in an acidic medium so as to be practically instantly redissolved in a neutral saline solution. The present invention also relates to a process for producing hydroxocobalamin-based pharmaceutical compositions as well as to first aid kits containing these compositions and methods of using such kits for the treatment of cyanide poisoning.
Inventor(s): Pouchol; Gerard (Paris, FR), Bonhomme; Yves (Charbonnieres, FR), Poulain; Marie-Laure (St-Cyr-En-Val, FR), Duran; Michel (St-Cyr-Au-Mont-d'or, FR)
Assignee: Merck Patent Gesellschaft mit beschrankter Haftung (DE)
Application Number:08/748,790
Patent Claims: 1. A pharmaceutical composition comprising hydroxocobalamin in freeze-dried form, wherein the hydroxocobalamin is freeze-dried in an acidic medium so as to be rapidly redissolved in a neutral saline solution.

2. A pharmaceutical composition according to claim 1, wherein the freeze-dried hydroxocobalamin is redissolved in a saline solution.

3. A pharmaceutical composition comprising hydroxocobalamin in freeze-dried form according to claim 1, characterized in that the acidic medium within which the hydroxocobalamin is freeze-dried is selected so as to make it possible to obtain a stable solution.

4. A process for producing a freeze-dried hydroxocobalamin product according to claim 1, which comprises preparing the hydroxocobalamin solution in an acidic medium, optionally supplemented with a filler, and freeze-drying the hydroxocobalamin in the container intended to be used.

5. A process for producing a hydroxocobalamin product according to claim 1 which comprises preparing a hydroxocobalamin solution in an acidic medium, optionally supplemented with a filler, and freeze-drying the hydroxocobalamin, wherein said hydroxocobalamin solution has a pH ranging from 3.5 to 5.5.

6. A process for producing a freeze-dried hydroxocobalamin product according to claim 1 which comprises preparing a hydroxocobalamin solution in an acidic medium, optionally supplemented with a filler, and freeze-drying the hydroxocobalamin, wherein said hydroxocobalamin solution has a pH ranging from 4.0 to 5.0.

7. A process for producing a freeze-dried hydroxocobalamin product according to claim 1 which comprises preparing a hydroxocobalamin solution in an acidic medium, optionally supplemented with a filler, and freeze-drying the hydroxocobalamin, wherein the acidic pH is obtained by adding to a solution of hydroxocobalamin a strong inorganic acid or an organic acid in a calculated amount.

8. A process according to claim 5, wherein a filler chosen from arginine hydrochloride, lactose, glycine or sodium acetate is added to the hydroxocobalamin solution.

9. A process according to claim 5, wherein a buffering agent consisting of a sodium salt of an organic acid is added to the hydroxocobalamin solution.

10. A process according to claim 5, wherein the concentration of hydroxocobalamin in the solution to be freeze-dried ranges from 1 to 5 g per 100 ml.

11. A process according to claim 10, wherein the concentration of hydroxocobalamin in the solution to be freeze-dried is between 2 and 3 g per 100 ml.

12. A process for producing hydroxocobalamin-based pharmaceutical compositions which comprises preparing a solution of hydroxocobalamin in water, adjusting the pH to a value ranging from 3 to 5 by the controlled addition of an inorganic or organic acid and, where appropriate, a filler and/or a buffering agent, freeze-drying the hydroxocobalamin and preparing ampoules of saline solution having a volume of between 20 and 150 ml.

13. A process for producing hydroxocobalamin-based pharmaceutical compositions according to claim 12, in which the saline solution is a solution of sodium chloride.

14. A first aid kit for the treatment of cyanide poisoning consisting of a vial of freeze-dried hydroxocobalamin product, obtained according to the process of claim 5 containing between 1 and 5 g of hydroxocobalamin and an ampoule containing from 20 to 150 ml of a saline solution allowing redissolution of said freeze-dried hydroxocobalamin.

15. A method of using the hydroxocobalamin-based first aid kits according to claim 14, for the treatment of acute or chronic cyanide poisoning, which comprises intravenously administering the aqueous solution of redissolved hydroxocobalamin.

16. A pharmaceutical composition comprising hydroxocobalamin in freeze-dried form according to claim 1, characterized in that the acidic medium within which the hydroxocobalamin is freeze-dried is selected so as to make it possible to obtain a stable solution, with a hydroxocobalamin concentration in the range of 1 to 5 g per 100 ml.

17. A pharmaceutical composition consisting essentially of freeze-dried hydroxocobalamin redissolved in a saline solution.
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