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Claims for Patent: 9,339,507

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Claims for Patent: 9,339,507

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:13/469,854
Patent Claims: 1. A kit for treating pulmonary hypertension comprising: (i) a formulation comprising 200 to 1000 .mu.g/ml treprostinil or a pharmaceutically acceptable salt thereof; (ii) a pulsed ultrasonic nebulizer comprising an opto-acoustical trigger, configured to (a) aerosolize a fixed amount of treprostinil per pulse, and (b) deliver by inhalation a therapeutically effective single event dose of said formulation, said single event dose comprising 15 .mu.g to 90 .mu.g treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 18 breaths; and (iii) instructions for using the pulsed ultrasonic nebulizer with the formulation to treat a patient with pulmonary hypertension by delivering 15 .mu.g to 90 .mu.g treprostinil or a pharmaceutically acceptable salt thereof in 1 to 18 breaths to the patient in the single event dose.

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

3. The kit of claim 1, further comprising instructions for the human not to repeat the single event dose for a period of at least 3 hours.

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

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

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

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

9. The kit of claim 6, further comprising instructions for the human not to repeat the single event dose for a period of at least 3 hours.
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