Administration of benzodiazepine compositions
The invention relates to pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, methods for producing and for using such compositions.
1. A pharmaceutical solution for nasal administration consisting of:
diazepam or a pharmaceutically acceptable salt thereof;
one or more natural or synthetic tocopherols or tocotrienols, or any combinations thereof, in an amount from 30% to 95% (w/w);
ethanol and benzyl alcohol in a combined amount from 10% to 70% (w/w); and
n-dodecyl beta-D-maltoside.
2. The pharmaceutical solution of claim 1 , wherein the diazepam or pharmaceutically acceptable salt thereof is present in the pharmaceutical solution in a concentration from 1 to 20% (w/v).
3. The pharmaceutical solution of claim 1 , wherein the diazepam or pharmaceutically acceptable salt thereof is present in the pharmaceutical solution in a concentration from 10 mg/mL to 250 mg/mL.
4. The pharmaceutical solution of claim 3 , wherein the diazepam or pharmaceutically acceptable salt thereof is present in the pharmaceutical solution in a concentration from 20 mg/mL to 50 mg/mL.
5. The pharmaceutical solution of claim 1 , wherein the one or more natural or synthetic tocopherols or tocotrienols are selected from the group consisting of: α-tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol, α-tocotrienol, β-tocotrienol, γ-tocotrienol, δ-tocotrienol, tocophersolan, and any combinations thereof.
6. The pharmaceutical solution of claim 1 , wherein the one or more natural or synthetic tocopherols or tocotrienols, or any combinations thereof, is in an amount from 45% to 85% (w/w).
7. The pharmaceutical solution of claim 6 , wherein the one or more natural or synthetic tocopherols or tocotrienols, or any combinations thereof, is in an amount from 60% to 75% (w/w).
8. The pharmaceutical solution of claim 1 , wherein the ethanol and benzyl alcohol is in a combined amount from 15% to 55% (w/w).
9. The pharmaceutical solution of claim 8 , wherein the ethanol and benzyl alcohol is in a combined amount from 25% to 40% (w/w).
10. The pharmaceutical solution of claim 1 , wherein the solution consists of diazepam, vitamin E, ethanol, benzyl alcohol, and n-dodecyl beta-D-maltoside.
11. A pharmaceutical solution for nasal administration consisting of:
diazepam or a pharmaceutically acceptable salt thereof;
one or more natural or synthetic α-tocopherols, or any combinations thereof, in an amount from 30% to 95% (w/w);
ethanol and benzyl alcohol in a combined amount from 10% to 70% (w/w); and
n-dodecyl beta-D-maltoside.
12. The pharmaceutical solution of claim 11 , wherein the diazepam or pharmaceutically acceptable salt thereof is present in the pharmaceutical solution in a concentration from 1 to 20% (w/v).
13. The pharmaceutical solution of claim 11 , wherein the diazepam or pharmaceutically acceptable salt thereof is present in the pharmaceutical solution in a concentration from 10 mg/mL to 250 mg/mL.
14. The pharmaceutical solution of claim 13 , wherein the diazepam or pharmaceutically acceptable salt thereof is present in the pharmaceutical solution in a concentration from 20 mg/mL to 50 mg/mL.
15. The pharmaceutical solution of claim 11 , wherein the one or more natural or synthetic α-tocopherols, or any combinations thereof is in an amount from 45% to 85% (w/w).
16. The pharmaceutical solution of claim 15 , wherein the one or more natural or synthetic α-tocopherols, or any combinations thereof is in an amount from 60% to 75% (w/w).
17. The pharmaceutical solution of claim 11 , wherein the ethanol and benzyl alcohol is in a combined amount from 15% to 55% (w/w).
18. The pharmaceutical solution of claim 17 , wherein the ethanol and benzyl alcohol is in a combined amount from 25% to 40% (w/w).