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US 2012/0040384 A1Published application
Lyophilised dabigatran
AssigneeBoehringer Ingelheim International GmbH
InventorJoachim Stangier
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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. In the preparation of the lyophilised standards, dabigatran is dissolved in an aqueous acidic solution before freeze-drying.
Claims18
Process for the manufacture of lyophilised dabigatran of formula I
- comprising the steps of dissolving dabigatran in aqueous acidic solution, adding the solution to human anticoagulated plasma and freeze-drying the thus obtained solution.
The lyophilized dabigatran made by the process according to 4.
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Dependencies are inferred from the claim text.