Dry powder formulations of epinephrine and associated methods
Inventors
Lyman, Scott • Bleske, Barry • Lanpher, Ted William
Assignees
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Publication Number
US-11617716-B2
Publication Date
2023-04-04
Expiration Date
Abstract
Provided herein are dry powder formulations comprising epinephrine alone or in combination with at least one enabling agent 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 anaphylaxis, anaphylactoid reaction, respiratory conditions, hemodynamic collapse, and for administration during cardiopulmonary arrest and other life-threatening conditions.
Core Innovation
The invention relates to an intranasal device for administration of a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof, with defined amounts of sodium chloride and polysorbate and a carrier. The dry powder provides a dose of about 0.01 mg to about 10 mg of the epinephrine or the pharmaceutically acceptable salt thereof and excludes an alpha-adrenergic blocker. The intranasal device includes a reservoir and a means for discharging one or more doses, and further includes a nasal probe, a ball, an actuator, and a piston.
In a further embodiment, the invention provides an intranasal device administering a spray-dried powder pharmaceutical composition. The spray-dried powder includes epinephrine or a pharmaceutically acceptable salt thereof at a dose of about 0.5 mg to about 8 mg, with a median particle diameter of about 20 µm to about 75 µm. The composition includes sodium chloride, polysorbate 80, and a carrier that includes mannitol, a cyclodextrin, citric acid, lactose, and/or sodium carboxymethylcellulose, and excludes an alpha-adrenergic blocker and a preservative.
The invention also includes a kit for intranasal administration that encloses one or more intranasal devices in a pouch and/or a hard case. The kit contains a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof with defined dose and formulation ranges, sodium chloride in a defined amount range, and polysorbate in a defined w/v range, together with a carrier, while excluding an alpha-adrenergic blocker. The intranasal device in the kit includes a nasal probe, a ball, an actuator, and a piston.
Claims Coverage
The independent claims cover three embodiments: an intranasal device, a kit, and an intranasal device with spray-dried powder. Across these claims, the inventive subject matter centers on the epinephrine dry or spray-dried powder formulation with specified dose and component ranges, exclusion of an alpha-adrenergic blocker, and device or kit structural features including discharge components and packaging features.
Intranasal epinephrine dry powder device excluding alpha-adrenergic blocker
An intranasal device having a reservoir and a means for discharging one or more doses, where the reservoir contains a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof, sodium chloride, a polysorbate, and a carrier, and wherein the pharmaceutical composition does not include an alpha-adrenergic blocker; the intranasal device further includes a nasal probe, a ball, an actuator, and a piston.
Intranasal kit with dry powder epinephrine device in pouch or hard case excluding alpha-adrenergic blocker
A kit for intranasal administration including at least one intranasal device with a reservoir and means for discharging one or more doses, where the reservoir contains a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof, sodium chloride, a polysorbate, and a carrier, wherein the pharmaceutical composition does not include an alpha-adrenergic blocker, and wherein each intranasal device further includes a nasal probe, a ball, an actuator, and a piston, and is enclosed in a pouch and/or a hard case.
Intranasal spray-dried powder epinephrine device excluding alpha-adrenergic blocker and preservative with defined particle size
An intranasal device having a reservoir and a means for discharging one or more doses, where the reservoir contains a spray-dried powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof, sodium chloride, polysorbate 80, and a carrier including mannitol, a cyclodextrin, citric acid, lactose, and/or sodium carboxymethylcellulose, wherein the pharmaceutical composition does not include an alpha-adrenergic blocker and does not include a preservative, and wherein the intranasal device further includes a nasal probe, a ball, an actuator, and a piston.
Across the independent claims, the coverage centers on an intranasal device and kit that dispense an epinephrine composition formulated with sodium chloride and polysorbate plus a carrier, while excluding an alpha-adrenergic blocker. In the spray-dried powder device, the claims further specify the epinephrine dose and median particle diameter range and additionally exclude a preservative.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Intranasal administration concepts are described in contexts including treatment of anaphylaxis and nerve-agent exposure, and related cardiopulmonary and respiratory conditions, with delivery through nasal passages and nasal mucosa for systemic delivery.
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