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Claims for Patent: 5,733,874

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Claims for Patent: 5,733,874

Title: Stable dry powders
Abstract:The present invention provides a freeze dried pharmaceutical composition comprising hirudin and a water-soluble salt of calcium and/or magnesium.
Inventor(s): Arvinte; Tudor (Munchenstein, CH)
Assignee: Novartis Corp. (Summit, NJ)
Application Number:08/378,225
Patent Claims: 1. A freeze dried pharmaceutical composition comprising hirudin and a water-soluble salt selected from the group consisting of calcium chloride, magnesium chloride or magnesium sulphate.

2. A composition as claimed in claim 1 in which the molar ratio of water-soluble salt ions to hirudin is up to 40:1.

3. A composition as claimed in claim 1 which also contains a sugar.

4. A composition as claimed in claim 3 in which the sugar is mannitol, trehalose, sucrose, sorbitol, fructose, glucose, maltose, lactose or dextran.

5. A composition as claimed in claim 1 which the hirudin is a desulphatohirudin variant or a mutant thereof.

6. A composition as claimed in claim 5 in which the himdin is desulphatohirudin HV1.

7. A composition as claimed in claim 1 which is obtained by dissolving the ingredients in water and then freeze drying the solution.

8. A composition as claimed in claim 7 in which the pH of the solution before freeze drying is from 4 to 9.

9. A composition as claimed in claim 1 in which the concentration of hirudin in the solution before freeze drying is from 0.1 to 500 mg/ml.

10. A composition as claimed in claim 9 in which the solution before freeze drying is isotonic.
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