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:
a therapeutically effective amount of diazepam or a pharmaceutically acceptable salt thereof;
one or more natural or synthetic tocopherols or tocotrienols selected from the group consisting of α-tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol, α-tocotrienol, β-tocotrienol, γ-tocotrienol, δ-tocotrienol, tocophersolan, any isomers thereof, any esters thereof, and any combinations thereof, in an amount from 30% to 95% (w/w);
one or more alcohols in an amount from 10% to 70% (w/w), wherein the one or more alcohols comprises benzyl alcohol; and
n-dodecyl beta-D-maltoside.
2. The pharmaceutical solution of claim 1 , wherein the therapeutically effective amount of 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 therapeutically effective amount of 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 therapeutically effective amount of 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 is in an amount from 45% to 85% (w/w).
6. The pharmaceutical solution of claim 5 , wherein the one or more natural or synthetic tocopherols or tocotrienols is in an amount from 60% to 75% (w/w).
7. The pharmaceutical solution of claim 1 , wherein the one or more alcohols is benzyl alcohol and a second alcohol selected from ethanol, propyl alcohol, butyl alcohol, pentanol, any isomers thereof, and any combinations thereof.
8. The pharmaceutical solution of claim 1 , wherein the one or more alcohols are in an amount from 15% to 55% (w/w).
9. The pharmaceutical solution of claim 8 , wherein the one or more alcohols are in an amount from 25% to 40% (w/w).
10. The pharmaceutical solution of claim 1 , wherein the solution consists of diazepam, vitamin E, benzyl alcohol, and n-dodecyl beta-D-maltoside.
11. A pharmaceutical solution for nasal administration consisting of:
a therapeutically effective amount of diazepam or a pharmaceutically acceptable salt thereof;
one or more natural or synthetic α-tocopherols selected from the group consisting of tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol, tocophersolan, any isomers thereof, any esters thereof, and any combinations thereof, in an amount from 30% to 95% (w/w);
one of more alcohols in an amount from 10% to 70% (w/w)), wherein the one or more alcohols comprises benzyl alcohol; and
n-dodecyl beta-D-maltoside.
12. The pharmaceutical solution of claim 11 , wherein the therapeutically effective amount of 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 therapeutically effective amount of 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 therapeutically effective amount of 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 tocopherols 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 tocopherols is in an amount from 60% to 75% (w/w).
17. The pharmaceutical solution of claim 11 , wherein the one or more alcohols is benzyl alcohol and a second alcohol selected from ethanol, propyl alcohol, butyl alcohol, pentanol, any isomers thereof, and any combinations thereof.
18. The pharmaceutical solution of claim 11 , wherein the one or more alcohols are in an amount from 15% to 55% (w/w).
19. The pharmaceutical solution of claim 18 , wherein the one or more alcohols are in an amount from 25% to 40% (w/w).
20. The pharmaceutical solution of claim 1 , wherein the therapeutically effective amount of diazepam or pharmaceutically acceptable salt thereof present in the pharmaceutical solution is from about 5 to about 20 mg.
21. The pharmaceutical solution of claim 11 , wherein the therapeutically effective amount of diazepam or pharmaceutically acceptable salt thereof present in the pharmaceutical solution is from about 1 mg to about 20 mg.
22. The pharmaceutical solution of claim 1 , wherein the n-dodecyl beta-D-maltoside is present in the pharmaceutical solution in an amount from about 0.01% (w/v) to about 1% (w/v).
23. The pharmaceutical solution of claim 11 , wherein the n-dodecyl beta-D-maltoside is present in the pharmaceutical solution in an amount from about 0.01% (w/v) to about 1% (w/v).
24. The pharmaceutical solution of claim 1 , wherein the n-dodecyl beta-D-maltoside is present in the pharmaceutical solution in an amount from about 0.125% (w/v) to about 0.5% (w/v).
25. The pharmaceutical solution of claim 11 , wherein the n-dodecyl beta-D-maltoside is present in the pharmaceutical solution in an amount from about 0.125% (w/v) to about 0.5% (w/v).
26. The pharmaceutical solution of claim 1 , wherein the α-tocopherol is Vitamin E USP.
27. The pharmaceutical solution of claim 11 , wherein the α-tocopherol is Vitamin E USP.