Epinephrine spray formulations
The present invention is directed to epinephrine spray formulations. The present invention is further directed to methods of treating anaphylaxis by administering epinephrine spray formulations to subjects in need of such treatments.
1. A method of treating anaphylaxis comprising administering via an assembled device an epinephrine solution consisting of:
from about 1% to about 15% w/w epinephrine or a salt thereof;
from 0.9% to 80% w/w water; and
optionally, one or more excipients selected from the group consisting of acids selected from the group consisting of hydrochloric acid, malic acid, tartaric acid, citric acid, succinic acid and combinations thereof, stabilizers selected from the group consisting of butylated hydroxyanisole, butylated hydroxytoluene, ascorbic acid, methionine, sodium ascorbate, sodium thiosulfate, sodium bisulfite, sodium metabisulfite, ascorbyl palmitate, thioglycerol, alpha tocopherol, cysteine hydrochloride, benzalkonium chloride, citric acid, ethylenediaminetetraacetic acid, sodium citrate, propyl gallate, 8-hydroxyquinoline, boric acid, histidine and combinations thereof, solvents, antioxidants, preservatives, permeation enhancers, viscosity modifiers, sweeteners, sweetness enhancers, pH modifiers, isotonicity agents and flavoring agents,
wherein w/w denotes weight by weight of the solution.
2. The method of claim 1 wherein the assembled device comprises a reservoir, a plunger, a cannula, a spray pin, a reservoir holder and an actuator.
3. The method of claim 1 , wherein the assembled device comprises a reservoir, a piston and a swirl chamber.
4. The method of claim 1 , wherein the assembled device delivers one or more doses of the epinephrine solution.
5. The method of claim 4 , wherein assembled device is a unit-dose device that delivers one dose of the epinephrine solution upon a single actuation and comprises a single reservoir containing not more than 250 μL of the epinephrine solution.
6. The method of claim 5 , wherein the single reservoir contains about 237 μL of the epinephrine solution.
7. The method of claim 6 , wherein the assembled device delivers about 200 μL of the pharmaceutical solution upon the single actuation.
8. The method of claim 4 , wherein the assembled device is a unit-dose device that delivers one dose of the epinephrine solution upon a single actuation and comprises a single reservoir containing not more than 140 μL of the epinephrine solution.
9. The method of claim 8 , wherein the single reservoir contains about 127 μL of the epinephrine solution.
10. The method of claim 9 , wherein the assembled device delivers about 100 μL of the pharmaceutical solution upon the single actuation.
11. The method of claim 4 , wherein the assembled device is a bi-dose device that delivers two doses of the epinephrine solution upon two actuations and delivers about 100 μL of the epinephrine solution per actuation.
12. The method of claim 4 , wherein the device is a multi-dose device that delivers multiple doses of the epinephrine solution upon multiple actuations and delivers about 100 μL of the pharmaceutical solution per actuation.
13. The method of claim 1 , wherein the solution has a pH from about 2 to about 5.5.
14. The method of claim 1 , wherein the epinephrine or salt thereof is at a concentration from about 1% to about 10% w/w.
15. The solution of claim 1 , wherein the epinephrine or salt thereof is at a concentration from about 1% to about 13% w/w.
16. The solution of claim 1 , wherein the epinephrine or salt thereof is at a concentration from about 1% to about 7% w/w.