# US 12,005,185 B2 · Medical counter measures including dry powder formulations and associated methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,185 B2 - Document ID: US12005185B2 - Status: Granted - Kind: B2 - Application number: 18/082,311 - Filed: 2022-12-15 - Published: 2023-06-22 - Granted: 2024-06-11 - Earliest claimed: 2021-12-17 - Assignees: Belhaven BioPharma Inc. - Applicants: Belhaven BioPharma Inc. - Inventors: Scott Lyman; Barry Bleske - Web page: https://patentgrep.com/patent/US12005185B2 ## CPC - A61M 15/08: Inhaling devices inserted into the nose - A61K 9/0043: {Nose} - A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 9/145: {with organic compounds} - A61K 9/1611: {Inorganic compounds} - A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules} - A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)} - A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)} - A61K 31/13: Amines {(A61K31/04 takes precedence)} - A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} - A61K 31/27: of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine - A61K 31/277: having a ring, e.g. verapamil - A61K 31/417: Imidazole-alkylamines, e.g. histamine, phentolamine - A61K 31/4425: Pyridinium derivatives, e.g. pralidoxime, pyridostigmine - A61K 31/46: 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine - A61K 31/485: Morphinan derivatives, e.g. morphine, codeine - A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole - A61K 31/5513: 1,4-Benzodiazepines, e.g. diazepam {or clozapine} - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin - A61K 47/38: Cellulose; Derivatives thereof - A61M 11/007: {Syringe-type or piston-type sprayers or atomisers} - A61M 2205/3327: Measuring - A61M 2205/3553: remote, e.g. between patient's home and doctor's office - A61M 2205/3561: local, e.g. within room or hospital - A61M 2209/06: Packaging for specific medical equipment - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract Provided herein are dry powder formulations comprising at least one active pharmaceutical ingredient suitable for nasal application. Also provided are unit dose forms and devices comprising such formulations and methods of using such formulations for the treatment of various conditions including respiratory conditions, hemodynamic collapse, seizures, migraines, and other conditions. ## Claims ### Claim 1 A device for intranasal administration of a pharmaceutical composition comprising: a reservoir and a means for discharging one or more doses of the pharmaceutical composition, wherein the reservoir contains a quantity of the pharmaceutical composition; wherein the pharmaceutical composition is a dry powder comprising: galantamine or a pharmaceutical salt thereof, wherein the pharmaceutical composition provides a dose of about 5 mg to about 75 mg of the galantamine or the pharmaceutical salt thereof; sodium chloride, wherein the pharmaceutical composition comprises about 0.01 mg to about 5 mg of the sodium chloride; and a carrier, wherein the carrier comprises lactose and/or sodium carboxymethylcellulose; wherein a median particle diameter of the pharmaceutical composition is about 20 μm to about 75 μm; wherein the pharmaceutical composition does not include chitosan; and wherein the device further includes a ball, an actuator, and a piston. ### Claim 2 (depends on 1) The device of claim 1, wherein the device includes a nasal probe, and wherein the nasal probe is constructed and configured to be replaced between discharges. ### Claim 3 (depends on 1) The device of claim 1, wherein the pharmaceutical composition further comprises a vasoactive agent, wherein the vasoactive agent is epinephrine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 0.01 mg to about 10 mg of the epinephrine or the pharmaceutically acceptable salt thereof. ### Claim 4 (depends on 1) The device of claim 1, wherein the pharmaceutical composition further comprises an anti-convulsant agent, wherein the anti-convulsant agent is diazepam or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 0.1 mg to about 20 mg of the diazepam or the pharmaceutically acceptable salt thereof. ### Claim 5 (depends on 1) The device of claim 1, wherein the pharmaceutical composition further comprises at least one anticholinergic agent, wherein the at least one anticholinergic agent is atropine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 0.1 mg to about 10 mg of the atropine or the pharmaceutically acceptable salt thereof. ### Claim 6 (depends on 1) The device of claim 1, wherein the pharmaceutical composition further comprises a cholinesterase reactivator, wherein the cholinesterase reactivator is 2-pyridine aldoxime methyl chloride or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 1 mg to about 1000 mg of the pyridine aldoxime methyl chloride or the pharmaceutically acceptable salt thereof. ### Claim 7 (depends on 1) The device of claim 1, wherein the pharmaceutical composition further comprises a vasodilator, wherein the vasodilator is phentolamine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 0.01 mg to about 10 mg of the phentolamine or the pharmaceutically acceptable salt thereof. ### Claim 8 (depends on 1) The device of claim 1, wherein the pharmaceutical composition further comprises a catechol-o-methyl transferase (COMT) inhibitor, wherein the COMT inhibitor is entacapone or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides a dose of about 5 mg to about 20 mg of the entacapone or the pharmaceutically acceptable salt thereof. ### Claim 9 (depends on 1) The device of claim 1, wherein the pharmaceutical composition further comprises an N-Methyl-D-aspartate (NMDA) receptor antagonist, wherein the NMDA receptor antagonist is memantine, wherein the pharmaceutical composition provides a dose of about 1 mg to about 40 mg of the memantine. ### Claim 10 (depends on 1) The device of claim 1, wherein the pharmaceutical composition further comprises a chelator. ### Claim 11 (depends on 1) The device of claim 1, wherein the pharmaceutical composition further comprises one or more agents selected from a group consisting of a mucosal permeation or penetration enhancer, a mucoadhesive, a mucosal transit slowing agent, a mucosal transport enhancer, or any combination thereof. ### Claim 12 (depends on 1) The device of claim 1, wherein the device has 360° functionality and is constructed and configured to dispense a dose from any position. ### Claim 13 (depends on 1) The device of claim 1, wherein the pharmaceutical composition is a spray-dried powder. ### Claim 14 (depends on 1) The device of claim 1, wherein the device further includes a sensor that is adapted to detect a displacement or a deformation of a portion of the delivery device when the dose is dispensed. ### Claim 15 (depends on 1) The device of claim 1, wherein the device further includes a display, a power supply, a timer, a clock, and/or a printed circuit board, wherein the display is constructed and configured to display a time of dose dispensation. ### Claim 16 (depends on 1) The device of claim 1, wherein the device further includes a communications interface, wherein the communications interface is constructed and configured to transmit data wirelessly to at least one remote device. ### Claim 17 A kit for intranasal administration of a pharmaceutical composition comprising: at least one device, wherein each of the at least one device includes a reservoir and a means for discharging one or more doses of the pharmaceutical composition, wherein the reservoir contains a quantity of the pharmaceutical composition; and a pouch and/or a hard case, wherein the at least one device is enclosed in the pouch and/or the hard case; wherein the pharmaceutical composition is a dry powder comprising: galantamine or a pharmaceutical salt thereof, wherein the pharmaceutical composition provides a dose of about 5 mg to about 75 mg of the galantamine or the pharmaceutical salt thereof; sodium chloride, wherein the pharmaceutical composition comprises about 0.01 mg to about 5 mg of the sodium chloride; and a carrier; wherein the pharmaceutical composition does not include chitosan; and wherein the at least one device further includes a nasal probe, a ball, an actuator, and a piston. ### Claim 18 (depends on 17) The kit of claim 17, wherein the hard case includes a desiccant plastic, wherein the desiccant plastic includes a base polymer, a channeling agent, and a desiccant. ### Claim 19 (depends on 17) The kit of claim 17, wherein the pouch and/or the hard case incorporates a pouch attachment ladder system (PALS). ### Claim 20 A device for intranasal administration of a pharmaceutical composition comprising: a reservoir and a means for discharging one or more doses of the pharmaceutical composition, wherein the reservoir contains a quantity of the pharmaceutical composition; wherein the pharmaceutical composition is a spray-dried powder comprising: galantamine or a pharmaceutical salt thereof, wherein the pharmaceutical composition provides a dose of about 5 mg to about 75 mg of the galantamine or the pharmaceutical salt thereof; memantine, wherein the pharmaceutical composition provides a dose of about 1 mg to about 30 mg of the memantine; sodium chloride, wherein the pharmaceutical composition comprises about 0.01 mg to about 5 mg of the sodium chloride; and a carrier, wherein the carrier includes lactose and/or sodium carboxymethylcellulose; wherein a median particle diameter of the pharmaceutical composition is about 20 μm to about 40 μm; wherein the pharmaceutical composition does not include chitosan; and wherein the device further includes a nasal probe, a ball, an actuator, and a piston.