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|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)|
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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