IP Library Granted Patent US 9,358,240
Granted Patent B2
US 9,358,240 · App. 12/591,200 · Granted Jun 7, 2016

Treprostinil administration by inhalation

Inventors: Horst Olschewski (Graz, AT); Robert Roscigno (Chapel Hill, NC); Lewis J. Rubin (LaJolla, CA); Thomas Schmehl (Giessen, DE); Werner Seeger (Giessen, DE); Carl Sterritt (Weybridge, GB); Robert Voswinckel (Giessen, DE)
Assignee: United Therapeutics Corporation
A61K31/557A61K9/008A61K9/0078
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Quick Facts
Patent No.
US 9,358,240
App. No.
12/591,200
Granted
Jun 7, 2016
Kind
B2
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.

Claims (13)

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 μg/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 μg to 90 μg 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 μg/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 μg 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 μg 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.

Continuity (3)
Continuation 11748205 · May 14, 2007
Provisional Application 60800016 · May 15, 2006
Related Publication 20100076083A1 · Mar 25, 2010