Inhalable Epinephrine

Abstract

The present invention is directed toward particles for delivery of epinephrine to the respiratory system and methods for treating a patient in need of epinephrine. The particles and respirable compositions comprising the particles of the present invention described herein comprise the bioactive agent epinephrine, or a salt thereof, as a therapeutic agent. The particles are preferably formed by spray drying. Preferably, the particles and the respirable compositions are substantially dry and are substantially free of propellents. In a preferred embodiment, the particles have aerodynamic characteristics that permit targeted delivery of epinephrine to the site(s) of action.

1 . Spray-dried particles for the delivery of epinephrine to the respiratory system of a patient, the particles comprising:
 (a) epinephrine or a salt thereof; and   (b) at least one pharmaceutically acceptable excipient wherein at least one excipient is crystalline or amorphous.   
     
     
         2 . The particles of  claim 1 , wherein the epinephrine or salt thereof, is present in the particles in an amount ranging from about 1 to about 95 weight percent. 
     
     
         3 . The particles of  claim 2 , wherein the epinephrine or salt thereof, is present in the particles in an amount ranging from about 1 to about 45 weight percent. 
     
     
         4 . The particles of  claim 3 , wherein the epinephrine or salt thereof, is present in the particles in an amount ranging from about 1 to about 30 weight percent. 
     
     
         5 . The particles of  claim 1 , wherein the particles are aerodynamically light. 
     
     
         6 . The particles of  claim 1 , wherein the particles comprise at least 50 micrograms of epinephrine. 
     
     
         7 . The particles of  claim 1 , wherein the particles are amorphous. 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . The particles of  claim 1 , wherein the particles are delivered to the respiratory system via inhalation. 
     
     
         11 . The particles of  claim 10 , wherein the particles comprise at least about 50 micrograms of epinephrine and are administered in a single inhalation. 
     
     
         12 . The particles of  claim 11 , wherein the particles comprise about 250 micrograms to about 5 milligrams of epinephrine and are administered in a single inhalation. 
     
     
         13 . The particles of  claim 1 , wherein the particles are administered to the respiratory system via a breath activated inhaler. 
     
     
         14 . The particles of  claim 13 , wherein the particles are administered to the respiratory system in a single breath activated step. 
     
     
         15 . The particles of  claim 1 , wherein the epinephrine is released from the particles and acts systemically. 
     
     
         16 . The particles of  claim 1  comprising:
 (a) epinephrine or a salt thereof; 
 (b) at least one pharmaceutically acceptable excipient wherein at least one excipient is crystalline or amorphous; and 
 (c) leucine in an amount of from about 62 to about 82 weight percent.