Nicotine salt with meta-salicylic acid and applications therein

Inventors

Myers, Daniel J. • Cassella, James

Assignees

Alexza Pharmaceuticals Inc

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Publication Number

US-10166224-B2

Patent

Publication Date

2019-01-01

Expiration Date


Abstract

The present disclosure relates generally to the field of nicotine delivery. The disclosure teaches a nicotine meta-salicylate. More specifically, the disclosure teaches a condensation nicotine aerosol where nicotine meta-salicylate is vaporized. This disclosure relates to aerosol nicotine delivery devices. The delivery devices can be activated by actuation mechanisms to vaporize thin films comprising a nicotine meta-salicylate. More particularly, this disclosure relates to thin films of nicotine salt with meta salicylic acid for the treatment of nicotine craving and for effecting smoking cessation.

Core Innovation

The drug supply article comprises a heat-conductive substrate having an impermeable surface and a nicotine composition comprising nicotine meta-salicylate coated on at least part of that surface as a film. A heat source supplies heat to the substrate to vaporize some or all of the coated composition, delivering an effective amount of nicotine through vaporization followed by condensation into an aerosol. The claim also specifies a thickness for the film.

The described delivery is proposed for nicotine-craving treatment and smoking cessation. While the problem being solved is not explicitly described in patent background sections, the disclosure provides technical context through testing of nicotine emission, component degradation, phenol detection, aerosol characteristics and deposition, storage stability, and alternative handheld heating-device configurations.

Claims Coverage

The provided claims identify six inventive features across one independent claim directed to a drug supply article and dependent claims adding an excipient and a narrower film-thickness range.

Heat-conductive substrate

The drug supply article includes a heat-conductive substrate having an impermeable surface.

Nicotine meta-salicylate film

A nicotine composition comprising nicotine meta-salicylate is coated on at least a portion of the substrate surface in the form of a film with a specified thickness.

Heat source for vaporization

A heat source supplies heat to the substrate at a rate that vaporizes all or a portion of the coated nicotine composition.

Vaporized composition comprising nicotine

The vaporized nicotine composition comprises an effective amount of nicotine.

Pharmaceutically acceptable excipient

A dependent claim specifies that the nicotine composition further comprises a pharmaceutically acceptable excipient.

Narrower film-thickness range

A dependent claim specifies a narrower film-thickness range than the independent claim.

The claims cover a drug supply article combining an impermeable, heat-conductive substrate, a nicotine meta-salicylate film, and a heat source configured to vaporize the composition to yield nicotine, with dependent claims directed to an excipient and narrowed film thickness.

Stated Advantages

Reported testing found high nicotine dose emission and limited degradation of the nicotine and salicylate components.

No phenol was detected in the reported testing.

The reported aerosol had a small mass median aerodynamic diameter.

Compared with nicotine ortho-salicylate, nicotine meta-salicylate showed lower nicotine mass loss under elevated-temperature storage conditions.

Documented Applications

A drug supply article for heat-vaporizing a nicotine meta-salicylate composition to provide a vaporized composition comprising an effective amount of nicotine.

Nicotine delivery for nicotine-craving treatment.

Nicotine delivery for smoking cessation.

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