Back to results
US 9,063,163 B2Granted
Lyophilised dabigatran
AssigneeBoehringer Ingelheim International GmbH
InventorJoachim Stangier
Life of this patent
Estimating the term…
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. In the preparation of the lyophilised standards, dabigatran is dissolved in an aqueous acidic solution before freeze-drying.
Claims1
A method of producing a lyophilized composition comprising dabigatran of formula I
- and human anticoagulated plasma for use as a calibrator agent or calibrator agent in an anticoagulant assay 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.
1 more element
Dependencies are inferred from the claim text.