Pharmaceutical compositions and methods for administering the same
The present invention provides pharmaceutical compositions and methods for dispensing the same using an aerosol whereby the composition takes the form of foam. Additionally, the present invention provides a barrier system including a concentrate separated from a non-chlorine aerosol propellant wherein the concentrate includes a non-aqueous solvent, an emulsifying agent, a thickening agent, at least one medicament and optionally an aqueous solvent.
1. A composition comprising a first part comprising a non-aqueous solvent, a first non-chlorine aerosol propellant, an emulsifying agent, a thickening agent, at least one medicament and optionally an aqueous solvent; and a second part comprising a second non-chlorine aerosol propellant that has a higher pressure than the first non-chlorine aerosol propellant, wherein the second non-chlorine aerosol propellant comprises 1,1,1,2-tetrafluoroethane and has a pressure of about 80 to 100 psig; wherein the first part is separated from the second part and the second part exerts pressure on the first part such that the first non-chlorine aerosol propellant is maintained as a liquid and the first part is a homogenous liquid; and wherein the first part is in the form of a liquid, foam, film or gel when exposed to atmospheric pressure.
2. The composition of claim 1 , wherein the aqueous solvent is water.
3. The composition of claim 1 , wherein the non-aqueous solvent is an alcohol, a glycerol, a glycol or a combination of two or more thereof.
4. The composition of claim 1 , wherein the emulsifying agent is an emulsifying wax, a stearic acid, cetyl alcohol or a combination of two or more thereof.
5. The composition of claim 1 , wherein the emulsifying agent is a combination of an emulsifying wax and a stearic acid.
6. The composition of claim 1 , wherein the thickening agent is a fatty acid, a starch, a vegetable gum, a protein, a sugar, or a combination of two or more thereof.
7. The composition of claim 6 , wherein the sugar is a cyclic oligosaccharide.
8. The composition of claim 1 , wherein at least one medicament is a narcotic blocker, an antibacterial agent, virucidal agent, a fungicidal agent, a beta-blocker, a cardiotropic, a vaso-active agent, a hormone, a decongestant, a vaccine, an analgesic or a sedative.
9. The composition of claim 1 , wherein at least one medicament is midazolam or diazepam.
10. The composition of claim 1 , wherein at least one medicament is naloxone or flumazenil.
11. The composition of claim 1 , wherein at least one medicament is oxymetazoline.
12. The composition of claim 1 , further comprising one or more additives.
13. The composition of claim 1 , wherein the first non-chlorine aerosol propellant is selected from the group consisting of (1,1,1,2,3,3,3-heptaflouropropane), (1,1,1,3,3,3-hexafluoropropane), (1,1,1,3,3-pentaflouropropane), (1,1-diflouroethane) and a combination thereof.
14. The composition of claim 1 , wherein the second non-chlorine aerosol propellant further comprises at least one additional aerosol propellant selected from the group consisting of (1,1-diflouroethane), an atmospheric gas and a combination thereof.
15. The composition of claim 14 , wherein the atmospheric gas is selected from the group consisting of air, nitrogen, nitrous oxide, carbon dioxide and a combination thereof.
16. The composition of claim 1 , wherein at least one medicament is a narcotic blocker.
17. The composition of claim 16 , wherein the narcotic blocker is naloxone.
18. The composition of claim 1 , wherein at least one medicament is a sedative.
19. The composition of claim 18 , wherein the sedative is a benzodiazepine.
20. The composition of claim 1 , wherein at least one medicament is diazepam.
21. The composition of claim 1 , wherein the non-aqueous solvent comprises a combination of propylene glycol and dehydrating alcohol; and the emulsifying agent comprises a combination of an emulsifying wax, cetyl alcohol and Stearth-10.
22. The composition of claim 1 , wherein the composition is stable following storage for 6 months at 25° C. and 60% relative humidity.
23. The composition of claim 1 , wherein the composition is stable following storage for 3 months at 40° C. and 75% relative humidity.
24. The composition of claim 1 , wherein the first non-chlorine aerosol propellant is present in an amount between 15 and 50% by weight of the first part.
25. The composition of claim 1 , wherein multiple doses of medicament are present.
26. The composition of claim 14 , wherein the first non-chlorine aerosol propellant is selected from the group consisting of (1,1,1,2,3,3,3-heptaflouropropane), (1,1,1,3,3,3-hexafluoropropane), (1,1,1,3,3-pentaflouropropane), (1,1-diflouroethane) and a combination thereof.