Compositions, Devices, And Methods For Nicotine Aerosol Delivery

Patent No. US2014345635 (titled "Compositions, Devices, And Methods For Nicotine Aerosol Delivery") was filed by Njoy on May 21, 2014. The application was issued on Nov 27, 2014.

'635 is related to the field of vaporizing devices, specifically electronic cigarettes, and the compositions used within them. Traditional electronic cigarettes often struggle to deliver nicotine effectively to the deep lung, instead depositing it primarily in the oropharynx or upper respiratory tract. This is due to nicotine being in a gaseous phase or exchanging too rapidly between particulate and gaseous phases. Furthermore, existing devices can suffer from inconsistent dosing, insufficient aerosol production, and overheating issues, leading to a less satisfying user experience.

The underlying idea behind '635 is to improve nicotine delivery in vaporizing devices by controlling the phase partitioning of nicotine within the generated aerosol. This is achieved by introducing an ion pairing agent into the nicotine-containing liquid. The ion pairing agent interacts with the nicotine, influencing the equilibrium between its free base and cationic forms, thereby promoting a higher concentration of nicotine in the particulate phase of the aerosol. This, in turn, facilitates deeper lung deposition and more efficient nicotine absorption.

The claims of '635 focus on a composition for vaporizing devices, comprising nicotine, a solvent, and an ion pairing agent, where at least 85% of the nicotine is in the particulate phase of the aerosol produced upon vaporization and condensation. The claims also cover the resulting aerosol itself, as well as compositions where the molar ratio of the ion pairing agent to nicotine is between 1:2 and 1:1, or where the acid group molar ratio of a carboxylic acid ion pairing agent to nicotine is between 1:2 and 1:1.

In practice, the invention involves carefully selecting an ion pairing agent, such as lactic acid, and adjusting the composition's pH to optimize the partitioning of nicotine into the particulate phase. The resulting aerosol, when inhaled, delivers nicotine more effectively to the deep lung, leading to faster absorption and a more satisfying experience for the user. The device itself may also incorporate features like pulse width modulation to control the heating element and prevent overheating or degradation of the vaporized substance.

The key differentiation from prior approaches lies in the deliberate use of an ion pairing agent to manipulate the gas/particle partitioning of nicotine. Unlike traditional e-liquids where nicotine often exists primarily in the gaseous phase, '635 ensures a higher proportion of nicotine is carried within aerosol particles. This targeted approach enhances deep lung delivery and improves the overall efficiency of nicotine absorption, addressing a significant limitation of earlier vaporizing devices and providing a more effective alternative to traditional cigarettes.

How does this patent fit in bigger picture?

Technical Landscape

In the early 2010s when '635 was filed, electronic cigarettes typically relied on consistent current passage through a heating element to vaporize a nicotine-containing liquid. At a time when aerosol production was often inconsistent, systems commonly relied on simple battery technology. Hardware or software constraints made it non-trivial to provide consistent dosing and responsiveness to user demand.

Prosecution Position

The disclosed invention addresses the problem of inconsistent nicotine delivery and inefficient aerosol production in vaporizing devices. By incorporating an ion pairing agent into a nicotine-containing composition, the invention enables a greater percentage of nicotine to be carried in the particulate phase of the aerosol. This architectural shift allows for improved deep lung delivery of nicotine and overcomes limitations related to nicotine volatility and inconsistent dosing.

Claims

This patent includes 25 claims, with independent claims numbered 1, 15, 33, and 35. The independent claims generally focus on compositions and aerosols containing nicotine, at least one solvent, and at least one ion pairing agent, with specific ratios and characteristics of the components. The dependent claims elaborate on the features of the compositions and aerosols described in the independent claims, providing further details and limitations.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)	Support for Specification	Interpretation
Acid group molar ratio (Claim 35)	In some embodiments, e.g., when the ion pairing agent includes a carboxylic acid group (e.g., a monoprotic carboxylic acid, a diprotic carboxylic acid, or a triprotic carboxylic acid), the amount of ion pairing agent with respect to nicotine may be determined from the molar ratio of the carboxylic acids group(s) of the ion pairing agent to nicotine. As used herein the term “acid group molar ratio” means the molar ratio of the carboxylic acid group(s) of a first compound (e.g., an ion pairing agent) to a second compound (e.g., nicotine). In some embodiments, the acid group molar ratio of ion pairing agent to nicotine (carboxylic acid group(s) of ion pairing agent:nicotine) may range from about 1:3 to about 3:1, such as about from about 2:3 to about 7:8, from about 3:4 to about 5:6, or from about 1:2 to about 1:1.	The molar ratio of the carboxylic acid group(s) of a first compound (e.g., an ion pairing agent) to a second compound (e.g., nicotine).
Carboxylic acid group (Claim 35)	Exemplary organic acids include carboxylic acids such as monoprotic carboxylic acids (e.g., acetic acid, pyruvic acid, lactic acid, levulinic acid, lauric acid, palmitic acid, stearic acid, benzoic acid, salicylic acid, gallic acid, etc.), diprotic carboxylic acids (e.g., malic acid, oxaloacetic acid, oxalic acid, malonic acid, tartaric acid, etc.), and triprotic acids (e.g., citric acid). In some embodiments, the ion pairing agent may comprise at least one monoprotic carboxylic acid. Monoprotic carboxylic acids as ion paring agents may, for example, provide one or more benefits or advantages over diprotic or triprotic carboxylic acids. Such benefits may include enhanced vaporization and/or co-vaporization with nicotine.	A functional group with the structure -C(=O)OH.
Ion pairing agent (Claim 1, Claim 15, Claim 33, Claim 35)	The composition may comprise one or more ion pairing agents, e.g., for forming an ion pair with nicotine to achieve a desired partitioning of nicotine within the aerosol. As used herein, the term “ion pairing agent” includes any ionizable agent such as, e.g., acids, bases, and ionizable buffering agents, that are capable of forming an ion pair with another ion. The choice of ion pairing agent(s) may be determined based on the nature, chemical properties, and/or physical properties of a given ion pairing agent; compatibility between the ion pairing agent and one or more other ions present in the composition such as nicotine; taste and smell; ability for the ion pairing agent to affect or adjust the pH of the composition; ability of the ion pairing agent to vaporize and to co-vaporize with nicotine; and/or based on a subsequent or intended form or use of the composition, such as in an electronic cigarette or other vaporization device.	An ionizable agent (e.g., acids, bases, ionizable buffering agents) that forms an ion pair with another ion, such as nicotine.
Molar ratio (Claim 33)	In at least some embodiments of the present disclosure, the mole fraction of the ion pairing agent is within a range of threefold more or threefold less than the mole fraction of nicotine. For example, the molar ratio of ion pairing agent to nicotine (ion pairing agent:nicotine) may range from about 1:3 to about 3:1, such as about from about 2:3 to about 7:8, from about 3:4 to about 5:6, or from about 1:2 to about 1:1. In some embodiments, the molar ratio of ion pairing agent to nicotine may be less than 1:1, such as a molar ratio of about 1:2, about 1:3, about 1:4, about 2:3,about 2:5, about 3:4, about 3:5, about 3:7, about 3:8, about 4:5, about 4:7, about 4:9, about 5:6, about 5:7, about 5:8, about 5:9, about 6:7, about 7:8, about 7:9, about 8:9, or about 9:10.	The ratio of the number of moles of ion pairing agent to the number of moles of nicotine.
Particulate phase (Claim 1, Claim 15)	Embodiments of the present disclosure may allow for control over the pH of a composition and/or partitioning of compounds between the gaseous phase and particulate phase of an aerosol formed from the composition, e.g., by vaporization and condensation of the composition via use of a vaporizing device, e.g., an electronic cigarette. Without being bound by theory, it is believed that the chemical environment of nicotine, e.g., acidic vs. basic conditions and ability to form an ionic pair with another compound, may affect partitioning of nicotine between the gaseous and particulate phases of an aerosol, ultimately affecting the deposition of nicotine in the body, e.g., within the respiratory system, such as within the deep lung.	The portion of an aerosol that is comprised of particles, as opposed to gas.

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US2014345635

NJOY

Application Number: US201414284194
Filing Date: May 21, 2014
Publication Date: Nov 27, 2014
External Links: Slate, USPTO, Google Patents

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