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Claims for Patent: 9,358,240

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Claims for Patent: 9,358,240

Title:Treprostinil administration by inhalation
Abstract: Treprostinil can be administered using a metered dose inhaler. Such administration provides a greater degree of autonomy to patients. Also disclosed are kits that include a metered dose inhaler containing a pharmaceutical formulation containing treprostinil.
Inventor(s): Olschewski; Horst (Graz, AT), Roscigno; Robert (Chapel Hill, NC), Rubin; Lewis J. (LaJolla, CA), Schmehl; Thomas (Giessen, DE), Seeger; Werner (Giessen, DE), Sterritt; Carl (Weybridge, GB), Voswinckel; Robert (Giessen, DE)
Assignee: United Therapeutics Corporation (Silver Spring, MD)
Application Number:12/591,200
Patent Claims: 1. A method of treating pulmonary hypertension comprising: administering by inhalation to a human suffering from pulmonary hypertension a therapeutically effective single event dose of a formulation comprising from 200 to 1000 .mu.g/ml of treprostinil or a pharmaceutically acceptable salt thereof with a pulsed ultrasonic nebulizer that aerosolizes a fixed amount of treprostinil or a pharmaceutically acceptable salt thereof per pulse, said pulsed ultrasonic nebulizer comprising an opto-acoustical trigger which allows said human to synchronize each breath to each pulse, said therapeutically effective single event dose comprising from 15 .mu.g to 90 .mu.g of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 18 breaths.

2. The method of claim 1, wherein the formulation comprises 600 .mu.g/ml of the treprostinil or its pharmaceutically acceptable salt thereof.

3. The method of claim 1, wherein the single event dose is not repeated for a period of at least 3 hours.

4. The method of claim 1, wherein the single event dose produces a peak plasma concentration of treprostinil about 10-15 minutes after the single event dose.

5. The method of claim 1, wherein the fixed amount of treprostinil or its pharmaceutically salt for each breath inhaled by the human comprises at least 5 .mu.g of treprostinil or its pharmaceutically acceptable salt.

6. The method of claim 2, wherein the fixed amount of treprostinil or its pharmaceutically salt for each breath inhaled by the human comprises at least 5 .mu.g of treprostinil or its pharmaceutically acceptable salt.

7. The method of claim 1, wherein the single event dose is inhaled in 3-18 breaths by the human.

8. The method of claim 6, wherein the single event dose is inhaled in 3-18 breaths by the human.

9. The method of claim 6, wherein the single event dose is not repeated for a period of at least 3 hours.
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