Inhalable epinephrine
View Patent ↗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. A method for treating a patient in need of epinephrine, the method comprising:
administering an effective amount of substantially dry particles to the respiratory system of the 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 method 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 method 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 method 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 method of claim 1 , wherein the particles are aerodynamically light.
6. The method of claim 1 , wherein the particles are spray dried.
7. The method of claim 1 , wherein the particles are amorphous.
8. The method of claim 1 , wherein the pharmaceutically acceptable excipient contained in the particles is amorphous.
9. The method of claim 1 , wherein the pharmaceutically acceptable excipient contained in the particles is crystalline.
10. The method of claim 1 , wherein the particles are administered via inhalation.
11. The method of claim 10 , wherein the particles comprise at least about 50 micrograms of epinephrine and are administered in a single inhalation.
12. The method 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 method of claim 1 , wherein the particles are administered to the respiratory system via a breath activated inhaler.
14. The method of claim 13 , wherein the particles are administered to the respiratory system in a single breath activated step.
15. The method of claim 1 , wherein a first portion of the particles is deposited in the airways of the respiratory system and a second portion of the particles is deposited to the alveoli region of the lungs.
16. The method of claim 1 , wherein administering an effective amount of particles includes delivering a portion of the particles to the alveoli region of the lungs.
17. The method of claim 1 , wherein administering an effective amount of particles includes delivering a portion of the particles to the upper airways.
18. The method of claim 1 , wherein the epinephrine is released from the particles and acts systemically.
19. A method for treating a patient in need of epinephrine, the method comprising:
administering an effective amount of substantially dry particles to the respiratory system of the patient, the particles comprising:
(a) epinephrine, or a salt thereof wherein the epinephrine, or salt thereof is crystalline; and
(b) at least one pharmaceutically acceptable excipient.
20. A method for treating a patient in need of epinephrine, the method comprising:
administering an effective amount of substantially dry particles to the respiratory system of the patient, the particles comprising:
(a) epinephrine, or a salt thereof; and
(b) at least one pharmaceutically acceptable excipient wherein the excipient is amorphous.
21. A method for treating a patient in need of epinephrine, the method comprising:
administering an effective amount of substantially dry particles to the respiratory system of the patient, the particles comprising:
(a) epinephrine, or a salt thereof; and
(b) at least one pharmaceutically acceptable excipient wherein the excipient is crystalline.
22. A method for treating a patient in need of epinephrine, the method comprising:
administering an effective amount of substantially dry particles to the respiratory system of the patient, the particles comprising:
(a) epinephrine, or a salt thereof; and
(b) at least one pharmaceutically acceptable excipient
wherein the epinephrine is released from the particles in a sustained manner.
23. A method for treating a patient in need of epinephrine, the method comprising:
administering an effective amount of substantially dry particles to the respiratory system of the patient, the particles comprising:
(a) epinephrine, or a salt thereof; and
(b) at least one pharmaceutically acceptable excipient wherein the particles are amorphous.
24. A method for treating a patient in need of epinephrine, the method comprising:
administering an effective amount of substantially dry particles to the respiratory system of the patient, the particles 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.