Epinephrine spray formulations
Provided herein are epinephrine spray formulations. Also provided herein are methods of treating anaphylaxis by administering epinephrine spray formulations to subjects in need of such treatment.
1. A pharmaceutical nasal spray formulation, comprising:
(a) about 2% (w/w) of epinephrine, or a pharmaceutically acceptable salt thereof, in water;
(b) about 1% (w/w) of diethylene glycol monoethyl ether;
(c) about 0.1% (w/w) of hypromellose;
(d) about 0.05% (w/w) of sodium metabisulfite;
(e) about 0.21% (w/w) of chlorobutanol;
(f) about 0.42% (w/w) of citric acid monohydrate; and
(g) about 0.4% (w/w) sodium chloride,
wherein the pharmaceutical nasal spray formulation is an aqueous solution suitable for administration as a spray into a nostril of a human subject;
wherein the formulation comprises no more than 2% total impurities after storage for a period of one month at a temperature of about 40° C.
2. The pharmaceutical nasal spray formulation of claim 1 , wherein the pH of the formulation is from about 4.0 to about 6.5.
3. The pharmaceutical nasal spray formulation of claim 1 , wherein a dose of the formulation is about 100 μl.
4. A pharmaceutical nasal spray formulation, comprising:
(a) about 6.5% (w/w) of epinephrine, or a pharmaceutically acceptable salt thereof, in water;
(b) about 1% (w/w) of diethylene glycol monoethyl ether;
(c) about 0.1% (w/w) of hypromellose;
(d) about 0.05% (w/w) of sodium metabisulfite;
(e) about 0.21% (w/w) of chlorobutanol;
(f) about 0.42% (w/w) of citric acid monohydrate; and
(g) about 0.4% (w/w) sodium chloride,
wherein the pharmaceutical nasal spray formulation is an aqueous solution suitable for administration as a spray into a nostril of a human subject;
wherein the formulation comprises no more than 2% total impurities after storage for a period of one month at a temperature of about 40° C.
5. The pharmaceutical nasal spray formulation of claim 4 , wherein the pH of the formulation is from about 4.0 to about 6.5.
6. The pharmaceutical nasal spray formulation of claim 4 , wherein a dose of the formulation is about 100 μl.
7. A pharmaceutical nasal spray formulation, comprising:
(a) about 6% (w/w) of epinephrine, or a pharmaceutically acceptable salt thereof, in water;
(b) about 1% (w/w) of diethylene glycol monoethyl ether;
(c) about 0.1% (w/w) of hypromellose;
(d) about 0.05% (w/w) of sodium metabisulfite;
(e) about 0.21% (w/w) of chlorobutanol;
(f) about 0.42% (w/w) of citric acid monohydrate; and
(g) about 0.4% (w/w) sodium chloride,
wherein the pharmaceutical nasal spray formulation is an aqueous solution suitable for administration as a spray into a nostril of a human subject;
wherein the formulation comprises no more than 2% total impurities after storage for a period of one month at a temperature of about 40° C.
8. The pharmaceutical nasal spray formulation of claim 7 , wherein the pH of the formulation is from about 4.0 to about 6.5.
9. The pharmaceutical nasal spray formulation of claim 7 , wherein a dose of the formulation is about 100 μl.