INHALABLE EPINEPHRINE
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 wherein the epinephrine, or salt thereof, contained in the particles is amorphous; and
(b) at least one pharmaceutically acceptable excipient.
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 . The particles of claim 1 , wherein the pharmaceutically acceptable excipient contained in the particles is amorphous.
9 . The particles of claim 1 , wherein the pharmaceutically acceptable excipient contained in the particles is crystalline.
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; and
(c) leucine in an amount of from about 62 to about 82 weight percent.