Granted Patent
B1
US 12,268,664 · App. 18/782,666 · Granted Apr 8, 2025
Administration of benzodiazepine compositions
Inventors:
Steve Cartt (Hillsborough, CA); David Medeiros (Sparks, NV); Garry Thomas Gwozdz (Jim Thorpe, PA); Andrew Loxley (Brussels, BE); Mark Mitchnick (East Hampton, NY); David F. Hale (San Diego, CA); Edward T. Maggio (San Diego, CA)
Assignee:
Neurelis, Inc.
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Abstract
The invention relates to pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, methods for producing and for using such compositions.
Claims (19)
1. A pharmaceutical composition for intranasal administration comprising:
about 1 to about 20 mg of diazepam dissolved in about 45% to about 85% (w/w) of 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 esters thereof and any combinations thereof, and about 25% to about 40% (w/w) of one or more alcohols selected from the group consisting of ethanol, propyl alcohol, butyl alcohol, pentanol, benzyl alcohol, and any combinations thereof, and about 0.01% to about 1% (w/v) of dodecyl β-D-maltoside, wherein the pharmaceutical composition is a solution and contains less than 1% water, wherein the pharmaceutical composition is in a pharmaceutically-acceptable spray formulation.
2. The pharmaceutical composition of claim 1 , wherein the one or more natural or synthetic tocopherols or tocotrienols is α-tocopherol.
3. The pharmaceutical composition of claim 1 , wherein the therapeutically effective amount of the diazepam is present in the pharmaceutical solution at a concentration of about 10 mg/mL to about 250 mg/mL.
4. The pharmaceutical composition of claim 1 , wherein the diazepam is present in the pharmaceutical solution at a concentration of about 20 mg/mL to about 50 mg/mL.
5. The pharmaceutical composition of claim 1 , wherein the diazepam is about 2 mg to about 10 mg.
6. The pharmaceutical composition of claim 1 , wherein the pharmaceutical solution comprises one or more natural or synthetic tocopherols or tocotrienols, or any combinations thereof in an amount from about 60% to about 75% (w/w).
7. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises at least one additional ingredient selected from the group consisting of stabilizers, coloring agents, pH adjusters, buffering agents, preservatives, wetting agents, flavoring agents and combinations thereof.
8. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is about 25 μL to about 250 μL.
9. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is about 50 μL to about 150 μL.
10. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is about 100 μL.
11. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition contains less than 0.5% water.
12. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition contains less than 0.25% water.
13. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition contains less than 0.1% water.
14. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition contains no water.
15. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition contains no more than 0.01% of a diazepam impurity.
16. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition contains no more than 0.01% of a diazepam impurity at 25° C. and 60% relative humidity, 30° C. and 65% relative humidity and 40° C. and 75% relative humidity.
17. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition maintains a similar average spray content at 25° C. and 60% relative humidity, 30° C. and 65% relative humidity and 40° C. and 75% relative humidity each measured at one month, three months and six months.
18. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition maintains a similar average spray content uniformity at 25° C. and 60% relative humidity and 40° C. and 75% relative humidity.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 24, 2024
From: CARTT, STEVE; MEDEIROS, DAVID; GWOZDZ, GARRY THOMAS; LOXLEY, ANDREW; MITCHNICK, MARK; HALE, DAVID F.; MAGGIO, EDWARD T.
To: HALE BIOPHARMA VENTURES, LLC
Reel/Frame 068072/0587 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 24, 2024
From: HALE BIOPHARMA VENTURES, LLC
To: NEURELIS, INC.
Reel/Frame 068072/0690 →
Continuity (5)
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