Treatment with powdered intranasal epinephrine
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- NASUS PHARMA LTD
- Filing Date
- 2026-02-25
- Publication Date
- 2026-06-09
Smart Images
Figure 2026094260000010 
Figure 2026094260000011 
Figure 2026094260000012
Abstract
Claims
1. A pharmaceutical composition in dry powder form for intranasal administration, comprising an anti-anaphylactic adrenergic receptor agonist as an activator, wherein the composition comprises a first type of essentially spherical solid particle and a second type of solid particle comprising a pharmaceutically acceptable carrier, each particle of the first type of essentially spherical solid particle consisting of a homogeneous combination of at least one anti-anaphylactic adrenergic receptor agonist activator and at least one pH adjuster / buffer, wherein at least 90% of the first type of solid particle have an average particle diameter of 10 to 30 microns, less than 10% of the first type of solid particle have an average particle diameter of 10 microns or less, and the second type of solid particle have an average particle diameter of 50 to 200 microns.
2. The pharmaceutical composition according to claim 1, wherein the activator is any of epinephrine, norepinephrine, dopamine, or antihistamine, or a pharmaceutically acceptable salt or derivative thereof.
3. The pharmaceutical composition according to claim 1, wherein the activator is epinephrine or a pharmaceutically acceptable salt thereof.
4. The pharmaceutical composition according to claim 1, wherein the activator is epinephrine or a pharmaceutically acceptable bicarbonate, hydrochloride, or borate thereof.
5. The pharmaceutical composition according to claim 1, wherein the pH adjuster / buffer is sodium dihydrogen phosphate.
6. The pharmaceutical composition according to claim 1, wherein the ratio of the at least one pharmaceutical active agent to the at least one pH adjuster / buffer in the first type of solid particles is predetermined.
7. The pharmaceutical composition according to claim 1, wherein the pharmaceutically acceptable carrier is any one of lactose monohydrate, lactose, a lactose functional analog, or any mixture of at least two thereof.
8. The pharmaceutical composition according to claim 1, wherein the pharmaceutically acceptable carrier is any one of dextrose, sorbitol, mannitol, maltitol, xylitol, cellulose, or starch.
9. The pharmaceutical composition according to claim 1, wherein the weight ratio of the first type of solid particles to the second type of solid particles is 1:9 to 9:
1.
10. An epinephrine pharmaceutical composition for intranasal administration, comprising epinephrine or a pharmaceutically acceptable salt thereof as an activator in the form of a dry powder, wherein the epinephrine pharmaceutical composition comprises essentially spherical particles of a first solid and second solid particles comprising lactose monohydrate as a carrier, each essentially spherical particle of the first solid consisting of a homogeneous combination of epinephrine or a pharmaceutically acceptable salt thereof and physiologically acceptable disodium hydrogen phosphate, wherein at least 90% of the first solid particles have an average particle diameter of 10 to 30 microns, less than 10% of the first solid particles have an average particle diameter of 10 microns or less, and the second solid particles have an average particle diameter of 50 to 200 microns, and provides a measured nominal therapeutically effective amount of epinephrine or a pharmaceutically acceptable salt thereof.
11. The epinephrine pharmaceutical composition according to claim 10, comprising epinephrine bitartrate in a molar ratio of 0.9:1 between epinephrine bitartrate and sodium dihydrogen phosphate.
12. The epinephrine pharmaceutical composition according to claim 11, wherein the therapeutically effective amount of epinephrine corresponds to about 0.3 mg or 0.5 mg of intramuscularly administered epinephrine.
13. A disposable dose unit form for intranasal administration of the pharmaceutical composition according to claim 1 to a subject, wherein the dose unit is loaded with a predetermined single dose amount of the composition and provides the subject with a measured dose of a pharmaceutically active adrenaline receptor agonist.
14. A disposable dose unit form for intranasal administration of the pharmaceutical composition according to claim 10 to a subject, wherein the dose unit is filled with a predetermined single dose amount of the composition and provides the subject with a measured dose of epinephrine.
15. A disposable dose unit form for intranasal administration of the pharmaceutical composition according to claim 12 to a subject, wherein the dose unit is loaded with a predetermined single dose of the composition and provides the subject with a measured dose of epinephrine equivalent to about 0.3 mg or 0.5 mg of intramuscularly administered epinephrine.
16. A kit for intranasal administration of epinephrine, a. At least one dose unit comprising the pharmaceutical composition according to claim 10 for intranasal administration; and b. Instructions for use A kit that includes this.
17. A pharmaceutical composition comprising at least one dose unit according to claim 13 in a therapeutically effective amount for treating anaphylactic shock in patients in need.
18. A pharmaceutical composition comprising a therapeutically effective amount of the epinephrine pharmaceutical composition according to claim 10 for treating anaphylactic shock in patients in need.
19. A pharmaceutical composition comprising at least one dose unit according to claim 14 for treating anaphylactic shock in patients in need.
20. A pharmaceutical composition comprising at least one dose unit according to claim 15 for treating anaphylactic shock in patients in need.