Claims for Patent: 8,895,546

Summary for Patent: 8,895,546

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 (San Carlos, CA), Medeiros; David (South San Francisco, CA), Gwozdz; Garry Thomas (Jim Thorpe, PA), Loxley; Andrew (Philadelphia, PA), Mitchnick; Mark (East Hampton, NY), Hale; David (San Diego, CA), Maggio; Edward T. (San Diego, CA)
Assignee:	Hale Biopharma Ventures, LLC (Encinitas, CA)
Application Number:	13/495,942
Patent Claims:	1. A pharmaceutical solution for nasal administration consisting of: (a) a benzodiazepine drug; (b) one or more natural or synthetic tocopherols or tocotrienols, or any combinations thereof, in an amount from about 30% to about 95% (w/w); (c) ethanol and benzyl alcohol in a combined amount from about 10% to about 70% (w/w); and (d) an alkyl glycoside. 2. The pharmaceutical solution of claim 1, wherein the benzodiazepine drug is selected from the group consisting of: alprazolam, brotizolam, chlordiazepoxide, clobazam, clonazepam, clorazepam, demoxazepam, diazepam, flumazenil, flurazepam, halazepam, midazolam, nordazepam, medazepam, nitrazepam, oxazepam, lorazepam, prazepam, quazepam, triazolam, temazepam, loprazolam, any pharmaceutically-acceptable salts thereof, and any combinations thereof. 3. The pharmaceutical solution of claim 2, wherein the benzodiazepine drug is diazepam, or a pharmaceutically-acceptable salt thereof. 4. The pharmaceutical solution of claim 1, wherein said benzodiazepine is present in the pharmaceutical solution in a concentration from about 1 to about 20% (w/v). 5. The pharmaceutical solution of claim 4, wherein said benzodiazepine is diazepam. 6. 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, any isomers thereof, any esters thereof, any analogs or derivatives thereof, and any combinations thereof. 7. The pharmaceutical solution of claim 1, wherein the ethanol is present in the pharmaceutical solution in a concentration of from 1 to 25% (w/v) and the benzyl alcohol is present in the pharmaceutical solution in a concentration from 1 to 25% (w/v). 8. The pharmaceutical solution of claim 1, wherein the ethanol is present in the solution in a concentration of from 10 to 22.5% (w/v) and the benzyl alcohol is present in the solution in a concentration of from 7.5 to 12.5% (w/v). 9. The pharmaceutical solution of claim 8, wherein the benzodiazepine is present in the pharmaceutical solution in a concentration from about 20 mg/mL to about 200 mg/mL. 10. 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 about 45% to about 85% (w/w). 11. The pharmaceutical solution of claim 10, wherein the one or more natural or synthetic tocopherols or tocotrienols, or any combinations thereof, is in an amount from about 50% to about 75% (w/w). 12. The pharmaceutical solution of claim 1, wherein the ethanol and benzyl alcohol are present in the pharmaceutical solution in a combined amount from about 15% to about 55% (w/w). 13. The pharmaceutical solution of claim 12, wherein the ethanol and benzyl alcohol are present in the pharmaceutical solution in a combined amount from about 25% to about 40% (w/w). 14. The pharmaceutical solution of claim 1, consisting of 5-15% (w/v) diazepam, 0.01-1% (w/v) alkyl glycoside, 45-65% (w/v) vitamin E, 10-25% (w/v) ethanol and 5-15% (w/v) benzyl alcohol. 15. The pharmaceutical solution of claim 1, wherein the alkyl glycoside is present in pharmaceutical solution in a concentration of at least about 0.01% (w/w). 16. The pharmaceutical solution of claim 15, wherein the alkyl glycoside is present in the pharmaceutical solution in an amount of 0.01% to 1% (w/w). 17. The solution of claim 1, consisting of diazepam, vitamin E, ethanol, benzyl alcohol and dodecyl maltoside. 18. The solution of claim 17, consisting of about 56.47% (w/v) vitamin E, about 10.5% (w/v) benzyl alcohol, about 10% (w/v) diazepam, about 0.25% (w/v) dodecyl maltoside, q.s. dehydrated ethanol. 19. The pharmaceutical solution of claim 14, consisting of 5-15% (w/v) diazepam, 0.01-1% (w/v) dodecyl maltoside, 45-65% (w/v) vitamin E, 10-25% (w/v) ethanol and 5-15% (w/v) benzyl alcohol. 20. The pharmaceutical solution of claim 14, consisting of 9-11% (w/v) diazepam, 0.1-0.5% (w/v) dodecyl maltoside, 50-60% (w/v) vitamin E, 15-22.5% (w/v) ethanol and 7.5-12.5 (w/v) benzyl alcohol. 21. The pharmaceutical solution of claim 14, consisting of 10% (w/v) diazepam, 0.15-0.3% (w/v) dodecyl maltoside, 50-60 (w/v) vitamin E, 17-20% (w/v) ethanol and 10-12% (w/v) benzyl alcohol. 22. The solution of claim 16, wherein the alkyl glycoside is dodecyl maltoside.