COMPOSITIONS, DEVICES, AND METHODS FOR INTRANASAL DELIVERY OF DRY POWDER EPINEPHRINE
Intranasal dry powder epinephrine compositions are described herein. The compositions include epinephrine or a pharmaceutically acceptable salt thereof, as well as a stabilizing agent and a carrier. The stabilizing agent is operable to include citric acid, or a pharmaceutically acceptable salt derived therefrom. Such intranasal compositions as described herein are useful in the treatment of health conditions which threaten the central nervous system (CNS) and impede the actions of alpha and beta-adrenergic receptors. Such health conditions include anaphylaxis, bronchospasms, respiratory impairment, organophosphate poisoning, and major adverse cardiac events (MACE).
1 . A dry powder pharmaceutical composition comprising:
epinephrine or a pharmaceutically acceptable salt thereof; and
a carrier;
wherein a single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or the pharmaceutically acceptable salt thereof; and
wherein the dry powder pharmaceutical composition remains stable at about 25° C. and at about 60% relative humidity.
2 . The dry powder pharmaceutical composition of claim 1 , wherein the dry powder pharmaceutical composition does not include an alpha-adrenergic blocker.
3 . The dry powder pharmaceutical composition of claim 1 , wherein the carrier includes any of mannitol, a cyclodextrin, citric acid, lactose, or sodium carboxymethylcellulose.
4 . The dry powder pharmaceutical composition of claim 1 , wherein the carrier includes lactose monohydrate.
5 . The dry powder pharmaceutical composition of claim 1 , wherein the dry powder pharmaceutical composition includes about 15% of epinephrine or a pharmaceutically acceptable salt thereof.
6 . The dry powder pharmaceutical composition of claim 1 , wherein the dry powder pharmaceutical composition includes a stabilizing agent, wherein the stabilizing agent is trisodium citrate.
7 . The dry powder pharmaceutical composition of claim 1 , wherein the dry powder pharmaceutical composition is formulated to have a moisture content of between about 3% and about 6%.
8 . The dry powder pharmaceutical composition of claim 1 , wherein the dry powder pharmaceutical composition includes a dispersing agent.
9 . A dry powder pharmaceutical composition comprising:
epinephrine or a pharmaceutically acceptable salt thereof, and
a carrier;
wherein a single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or the pharmaceutically acceptable salt thereof; and
wherein the dry powder pharmaceutical composition remains stable at about 40° C. and at about 75% relative humidity.
10 . The dry powder pharmaceutical composition of claim 9 , wherein the dry powder pharmaceutical composition does not include an alpha-adrenergic blocker.
11 . The dry powder pharmaceutical composition of claim 9 , wherein the carrier includes any of mannitol, a cyclodextrin, citric acid, lactose, or sodium carboxymethylcellulose.
12 . The dry powder pharmaceutical composition of claim 9 , wherein the carrier includes lactose monohydrate.
13 . The dry powder pharmaceutical composition of claim 9 , wherein the dry powder pharmaceutical composition includes about 15% of epinephrine or a pharmaceutically acceptable salt thereof.
14 . The dry powder pharmaceutical composition of claim 9 , wherein the dry powder pharmaceutical composition includes a stabilizing agent, wherein the stabilizing agent is trisodium citrate.
15 . The dry powder pharmaceutical composition of claim 9 , wherein the dry powder pharmaceutical composition is formulated to have a moisture content of between about 3% and about 6%.
16 . A dry powder pharmaceutical composition comprising:
epinephrine or a pharmaceutically acceptable salt thereof; and
a carrier;
wherein a single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or the pharmaceutically acceptable salt thereof; and
wherein the dry powder pharmaceutical composition remains stable at about 50° C.
17 . The dry powder pharmaceutical composition of claim 16 , wherein the dry powder pharmaceutical composition does not include an alpha-adrenergic blocker.
18 . The dry powder pharmaceutical composition of claim 16 , wherein the carrier includes any of mannitol, a cyclodextrin, citric acid, lactose, or sodium carboxymethylcellulose.
19 . The dry powder pharmaceutical composition of claim 16 , wherein the carrier includes lactose monohydrate.
20 . The dry powder pharmaceutical composition of claim 16 , wherein the dry powder pharmaceutical composition includes a stabilizing agent, wherein the stabilizing agent is trisodium citrate.