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US 2015/0240288 A1Published application
Lyophilised dabigatran
AssigneeBoehringer Ingelheim International GmbH
InventorJoachim STANGIER
Life of this patent
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Abstract
The invention relates to a lyophilised form of dabigatran of formula I its use as a calibrator in the assays for the determination of pharmacodinamic effects of dabigatran etexilate as well as such assays per se.
Claims9
1-4. (canceled)
The lyophilized dabigatran made by the process comprising the steps of:
- (1) dissolving dabigatran in 1M HCl and diluting with purified water to make a dabigatran stock solution,
- (2) diluting aliquots of dabigatran stock solution with human anticoagulated plasma to provide final solutions having different nanomolar concentrations of dabigatran, wherein the human anticoagulated plasma is human citrated plasma or EDTA-anticoagulated plasma, and
- (3) freeze-drying aliquots of the thus obtained final solutions to be used as lyophilized calibrator agents or lyophilized calibrator agents in an anticoagulant assay, optionally storing lyophilized calibrators at −20 ° C.
7-10. (canceled)
14-15. (canceled)
Dependencies are inferred from the claim text.