Methods of stabilizing epinephrine
The present invention is directed to methods of stabilizing a pharmaceutical composition comprising epinephrine containing the steps filling a container, capping the container, assembling the container and placing the assembled capped container (assembled device) in a secondary packaging system.
1. A device comprising a container, wherein the container comprises a pharmaceutical composition comprising from about 1% to about 12% w/w epinephrine, from about 10% to about 60% w/w ethanol, from about 2% to about 20% w/w propylene glycol, from about 0.001% to about 0.02% w/w benzalkonium chloride and from about 0.01% to about 0.1% w/w edetate disodium dihydrate, wherein w/w denotes weight by total weight of the composition and wherein the composition comprises epinephrine as the only active ingredient.
2. The device of claim 1 , wherein the device is an intranasal device.
3. The device of claim 1 , wherein the container is selected from the group consisting of a glass vial, a plastic vial, a glass bottle and a plastic bottle.
4. The device of claim 1 , wherein the container is a glass vial.
5. The device of claim 1 , wherein the container is a unit dose vail.
6. The device of claim 1 , wherein the container is stoppered with a rubber stopper.
7. The device of claim 1 , further comprising a vial holder and an actuator.
8. The device of claim 1 , further comprising a rubber stopper, a vial holder and an actuator, wherein the container is a glass vial.
9. The device of claim 1 , wherein the container further comprises a gas layer.
10. The device of claim 9 , wherein the gas layer consists of a gas selected from the group consisting of helium, neon, argon, krypton, xenon, radon and nitrogen.
11. The device of claim 9 , wherein the gas layer consists of nitrogen.
12. A secondary packaging system comprising the device of claim 1 and an oxygen absorbing means.
13. The secondary packaging system of claim 12 , wherein the secondary packaging system is a pouch or a blister package.
14. The secondary packaging system of claim 12 , wherein the oxygen absorbing means is provided by one or more walls of the secondary packaging system.
15. The secondary packaging system of claim 12 , wherein the oxygen absorbing means is an auxiliary oxygen absorber placed between two or more walls of the secondary packaging system.
16. The secondary packaging system of claim 12 , wherein the oxygen absorbing means is an iron based oxygen absorber.
17. The secondary packaging system of claim 16 , wherein the iron based oxygen absorber is in a form of a pellet, a strip, a sheet or a packet.
18. The secondary packaging system of claim 12 , further comprising an oxygen indicator.
19. The secondary packaging system of claim 18 , wherein the oxygen indicator is in a form of a pellet, a strip, a sheet or a packet.