Stable warfarin sodium liquid formulation and method of...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C549S286000

Reexamination Certificate

active

11453757

ABSTRACT:
A stable liquid composition comprising warfarin sodium, glycerin, an alcohol such as ethanol, and a pH buffer such as a phosphate buffer providing a pH above 7 is provided. The stability of the composition is characterized by the amount of warfarin sodium in the composition degraded after 1 month at room temperature, which is 5% or less. A method for preparing the composition and a method for providing an anti-coagulant therapy are also disclosed.

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“Coumadin® Tablets; Coumadin® for Injection,” XP-002409141 (Dec. 14, 2004).

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