Claims for Patent: 11,241,414

Summary for Patent: 11,241,414

Title:	Administration of benzodiazepine compositions
Abstract:	The invention relates to pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, methods for producing and for using such compositions.
Inventor(s):	Cartt; Steve (Hillsborough, CA), Medeiros; David (Sparks, NV), Gwozdz; Garry Thomas (Jim Thorpe, PA), Loxley; Andrew (Brussels, BE), Mitchnick; Mark (East Hampton, NY), Hale; David F. (San Diego, CA), Maggio; Edward T. (San Diego, CA)
Assignee:	Neurelis, Inc. (San Diego, CA)
Application Number:	17/332,800
Patent Claims:	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: .alpha.-tocopherol, .beta.-tocopherol, .gamma.-tocopherol, .delta.-tocopherol, .alpha.-tocotrienol, .beta.-tocotrienol, .gamma.-tocotrienol, .delta.-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 .alpha.-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 .alpha.-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 .alpha.-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).