Medical counter measures including dry powder formulations and associated methods
Inventors
Assignees
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Publication Number
US-12005185-B2
Publication Date
2024-06-11
Expiration Date
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.
Core Innovation
The invention relates to intranasal dry-powder medical countermeasures and device-based intranasal delivery of a pharmaceutical composition. The invention further defines intranasal delivery hardware for discharging one or more doses from a reservoir containing the dry powder or spray-dried powder, and the device includes a ball, an actuator, and a piston, with some aspects including a nasal probe as part of the device features.
The dry powder pharmaceutical composition includes galantamine or a pharmaceutical salt thereof, sodium chloride, and a carrier comprising lactose and/or sodium carboxymethylcellulose. The composition provides a dose of about 5 mg to about 75 mg of galantamine or its salt, has a median particle diameter of about 20 µm to about 75 µm, and does not include chitosan.
The invention is also described in a spray-dried powder embodiment with a median particle diameter of about 20 µm to about 40 µm, and in kit embodiments at least one such device is enclosed in a pouch and/or a hard case. The additional functional agent categories include memantine and other agents including 2-PAM, obidoxime, pro-2-PAM, epinephrine, vasopressin, phenylephrine, atropine, diazepam, midazolam, lorazepam, phentolamine, caffeine, entacapone, 3-MP prodrugs, and Vitamin B12 analogs together with nitrite/thiosulfate components.
Claims Coverage
The independent claims define three inventive claim themes: an intranasal administration device for a dry-powder galantamine formulation, a kit enclosing such a device in a pouch and/or hard case, and an intranasal administration device for a spray-dried powder formulation that adds memantine. Across these themes, the inventive features focus on the reservoir/discharge device architecture, specified formulation components and dose ranges, defined particle diameter ranges, exclusion of chitosan, and the inclusion of a nasal probe, ball, actuator, and piston.
Intranasal dry powder galantamine device with specified formulation and discharge mechanism
A device for intranasal administration includes a reservoir and a means for discharging one or more doses, wherein the reservoir contains a dry powder pharmaceutical composition comprising galantamine or a pharmaceutical salt thereof, sodium chloride, and a carrier comprising lactose and/or sodium carboxymethylcellulose, with a median particle diameter of about 20 µm to about 75 µm and no chitosan.
Intranasal galantamine kit enclosed in pouch and/or hard case
A kit for intranasal administration includes at least one device with a reservoir and a means for discharging one or more doses, and the at least one device is enclosed in a pouch and/or a hard case.
Intranasal spray-dried powder galantamine and memantine device
A device for intranasal administration includes a reservoir and a means for discharging one or more doses, wherein the reservoir contains a spray-dried powder pharmaceutical composition comprising galantamine or a pharmaceutical salt thereof, memantine, sodium chloride, and a carrier including lactose and/or sodium carboxymethylcellulose, with a median particle diameter of about 20 µm to about 40 µm and no chitosan.
Nasal probe-ball-actuator-piston structure
The device includes a nasal probe, a ball, an actuator, and a piston.
Overall, claim coverage centers on intranasal reservoir/discharge devices for dry-powder formulations, with specific composition constraints for galantamine and, in one variant, memantine, defined sodium chloride and lactose/sodium carboxymethylcellulose carrier composition, median particle diameter limits, and an explicit exclusion of chitosan. One independent claim adds kit packaging via pouch and/or hard case, and the device claims include a nasal probe, ball, actuator, and piston.
Stated Advantages
Improved stability and fast systemic absorption are described in the document summary.
Documented Applications
Organophosphate nerve agent exposure, including organophosphate nerve agents such as sarin and VX.
Seizures and status epilepticus.
Respiratory distress and related symptoms.
Use in non-hospital, combat, or emergency settings.
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