Treprostinil formulation
AssigneeUnited Therapeutics Corporation
InventorDavid A. Walsh
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Abstract
There is provided a stable monohydrate form of treprostinil and pharmaceutical formulation comprising the same, method of making and using the same.
Claims11
A dry solid product comprising a monohydrate form of treprostinil.
A dry solid product comprising a treprostinil monohydrate, wherein the monohydrate constitutes at least 90% by weight of the product.
A dry solid product comprising a treprostinil monohydrate, wherein the treprostinil monohydrate is in crystalline form.
A process for preparing treprostinil monohydrate, said process comprising
- a. recrystallizing anhydrous or wet treprostinil from an organic solvent/water combination to provide a solid;
- and
- b. air-drying the solid at a temperature from about 15° C. to about 35° C. until no additional solvent evaporates.
A method of storing or shipping treprostinil comprising storing or shipping treprostinil as a dry solid product comprising a monohydrate form of treprostinil.
Dependencies are inferred from the claim text.