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.

What is claimed is: 
     
         1 . A pharmaceutical product comprising a formulation comprising treprostinil or a pharmaceutically acceptable salt thereof and an inhalation device configured to administer a single event dose of the formulation to a human comprising at least 15 micrograms of treprostinil or a pharmaceutically acceptable salt thereof that is delivered with 1 to 3 breaths, wherein the inhalation device is further configured to administer the entire single event dose in less than 5 minutes with at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof being inhaled per breath through an actuation of the inhalation device coordinated with each breath. 
     
     
         2 . The product of  claim 1 , wherein the inhalation device is further configured to administer each single event dose at least 3 hours apart from a prior single event dose. 
     
     
         3 . The product of  claim 1 , wherein inhalation device is further configured to administer the formulation as particles less than 5 micrometers in diameter. 
     
     
         4 . The product of  claim 1 , wherein the formulation contains no metacresol. 
     
     
         5 . The product of  claim 1 , wherein the inhalation device is configured to administer the entire single event dose in less than about 1 minute. 
     
     
         6 . The product of  claim 1 , wherein the inhalation device is configured to administer at least about 15 micrograms of treprostinil or its pharmaceutically effective salt per breath. 
     
     
         7 . The product of  claim 6 , wherein the inhalation device is configured to administer up to about 30 micrograms of treprostinil or its pharmaceutically effective salt per breath. 
     
     
         8 . The product of  claim 1 , wherein inhalation device is configured to administer the single event dose to provide a maximal treprostinil plasma concentration in the human of at least 0.65±0.28 ng/ml after inhalation of the single event dose. 
     
     
         9 . The product of  claim 1 , wherein inhalation device is configured to administer the single event dose to provide a peak plasma concentration of treprostinil in the human at about 10-15 minutes after inhalation after inhalation of the single event dose. 
     
     
         10 . The product of  claim 1 , wherein the single event dose comprises from 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof. 
     
     
         11 . The product of  claim 1 , wherein the single event dose comprises from 15 micrograms to 120 micrograms of treprostinil or a pharmaceutically acceptable salt thereof. 
     
     
         12 . The product of  claim 1 , wherein the inhalation device is configured to provide a time between breaths of about 6 seconds. 
     
     
         13 . The product of  claim 1 , wherein the inhalation device is a dry powder inhaler. 
     
     
         14 . The product of  claim 1 , wherein the inhalation device is a soft mist inhaler. 
     
     
         15 . The product of  claim 1 , wherein the inhalation device is a pulsed ultrasonic nebulizer.