Flavored nicotine powder

Abstract

To provide a stable powder system that provides nicotine particles to the lungs of a user and flavor particles to preferably the buccal or mouth cavity of the user.SOLUTION: A nicotine powder inhaler (10) comprises a body extending between a mouthpiece portion (12) and a distal end portion (14), an airflow channel (15) extending between the mouthpiece portion, the distal end portion and a nicotine powder receptacle (20) disposed along the airflow channel, and a powder system disposed within the nicotine powder receptacle. The powder system includes a plurality of first particles having a particle size of about (10) micrometers or less and containing nicotine and a plurality of second particles having a particle size of about 20 micrometers or greater and containing flavor. The plurality of first particles comprises an amino acid or nicotine selected from the group consisting of nicotine pyruvate, nicotine mono-pyruvate, nicotine aspartate and nicotine lactate.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to a powder system comprising nicotine-containing particles and flavor-containing particles, wherein the flavor particles are larger than the nicotine particles. [Background technology]

[0002] Dry powder inhalers (DPIs) are well known and are used to treat respiratory disorders by delivering a dry powder containing a pharmaceutical agent in the form of an aerosol to a patient's airways via inhalation. For delivery into the lungs, particles in the 1-5 micrometer range are preferred. In pharmaceutical dry powders, the active pharmaceutical ingredient (API) may be agglomerated on the surface of larger carrier particles (such as lactose). DPIs operate through a complex mechanism to ensure that these agglomerates are dispersed, broken down, or deagglomerated, after which the API can be inhaled into the lungs. Pharmaceutical dry powders containing lactose as a carrier can be in the 20-100 micrometer range. Summary of the Invention [Problem to be solved by the invention]

[0003] DPIs rely on the patient's inhalation force to mix the powder from the device and then grind it into particles small enough to enter the lungs. A sufficiently high inhalation volume is required to ensure the correct dose and complete deagglomeration of the powder. A large amount of the API typically remains attached to the carrier surface and is deposited in the upper respiratory tract due to incomplete deagglomeration of the powder. The inhalation volume of existing DPIs is typically in the range of 20 to 100 liters per minute (L / min). Therefore, existing DPIs are only suitable for delivering dry powder to the user in a manner different from the inhalation volume of a smoking article.

[0004] It would be desirable to provide a stable powder system that delivers nicotine particles to the user's lungs and flavor particles, preferably to the cheeks or oral cavity of the user. The relative particle sizes of the nicotine and flavor should remain stable when combined with each other. It is desirable to provide this stable powder system to the user at an inhalation or airflow rate within the range of inhalation or airflow rates associated with conventional smoking. [Means for solving the problem]

[0005] The powder system includes a first plurality of particles having a particle size of about 10 micrometers or less and comprising nicotine, and a second plurality of particles having a particle size of about 20 micrometers or more and comprising a flavor. The first plurality of particles includes an amino acid or a nicotine selected from the group consisting of nicotine pyruvate, nicotine mono-pyruvate, nicotine aspartate, and nicotine lactate. The particles of the powder system are preferably free-flowing.

[0006] The powder system may have at least about 40% by weight of the nicotine in the powder system comprised of particles with a particle size of about 10 micrometers or less. The powder system may have at least about 60% by weight of the nicotine in the powder system comprised of particles with a particle size of about 10 micrometers or less. The powder system may have at least about 80% by weight of the nicotine in the powder system comprised of particles with a particle size of about 10 micrometers or less. The powder system may have at least about 90% by weight of the nicotine in the powder system comprised of particles with a particle size of about 10 micrometers or less.

[0007] The powder system may have at least about 40% by weight of the nicotine in the powder system comprised of particles with a particle size of about 5 micrometers or less. The powder system may have at least about 60% by weight of the nicotine in the powder system comprised of particles with a particle size of about 5 micrometers or less. The powder system may have at least about 80% by weight of the nicotine in the powder system comprised of particles with a particle size of about 5 micrometers or less. The powder system may have at least about 90% by weight of the nicotine in the powder system comprised of particles with a particle size of about 5 micrometers or less.

[0008] The powder system may have at least about 40% by weight of the nicotine in the powder system consisting of particles with a particle size of about 1 micrometer to about 3 micrometers or less. The powder system may have at least about 60% by weight of the nicotine in the powder system consisting of particles with a particle size of about 1 micrometer to about 3 micrometers or less. The powder system may have at least about 80% by weight of the nicotine in the powder system consisting of particles with a particle size of about 1 micrometer to about 3 micrometers or less. The powder system may have at least about 90% by weight of the nicotine in the powder system consisting of particles with a particle size of about 1 micrometer to about 3 micrometers or less.

[0009] The powder system may have at least about 60% by weight, or at least 80% by weight, of the flavor of the powder system comprised of particles with a particle size of about 20 micrometers or greater. The powder system may have at least about 60% by weight, or at least 80% by weight, of the flavor of the powder system comprised of particles with a particle size of about 50 micrometers or greater. The powder system may have at least about 60% by weight, or at least 80% by weight, of the flavor of the powder system comprised of particles with a particle size of about 150 micrometers or less.

[0010] The powder system may comprise about 50% to about 99% by weight of the first plurality of particles.The powder system may comprise about 1% to about 50% by weight of the second plurality of particles.

[0011] The size of particles referred to herein preferably refers to the aerodynamic diameter of the particles. The aerodynamic diameter of powder systems is preferably measured with a cascade impactor.

[0012] Advantageously, the powder systems described herein provide a stable, free-flowing powder system that selectively delivers nicotine to the user's lungs and selectively delivers flavor to the user's mouth. Advantageously, the powder systems described herein preferably have stable relative particle sizes of each powder component, even when nicotine and flavor particles are combined. Advantageously, inhalers utilizing this powder system may not require powder particle size reduction and may provide the powder system with an inhalation volume or airflow rate within the range of that of conventional smoking.

[0013] The term "nicotine" refers to nicotine and nicotine derivatives, such as free base nicotine, nicotine salts, and the like.

[0014] The term "flavorant" or "flavor" means an organoleptic compound, composition, or material that alters, or is intended to alter, the taste or aroma characteristics of nicotine during its ingestion or inhalation. Preferably, the term "flavorant" or "flavor" refers to compounds disclosed in the Flavor Extract Manufacturers Association (FEMA) Flavor Ingredient Library, and in particular, compounds disclosed in Publications 3-27 on GRAS Flavoring Substances. These FEMA Flavor Ingredient Library publications include: GRAS Flavoring Substances 3,Hall,RL& Oser,BL,Food Technology,February 1965 pg 151-197, GRAS Flavoring Substances 4,Hall,RL& Oser,BL,Food Technology,Vol.24,No.5 pg 25-34,GRAS Substances 5,Hall,RL & Oser,BL,Food Technology,1972 pg 25-37, GRAS Substances 6,Oser,BL& RAFord,Food Technology,Vol.27,No.1,1973 pg 64-67,GRAS Substances 7,Oser,BL& RAFord,Food Technology,Vol.27,No.11,1973 pg 56-57,GRAS Substances 8,Oser,BL& RAFord,Food Technology,September 1974 pg 76-80, GRAS Substances 9,Oser,BL& RAFord,Food Technology,August 1975 pg 70-72,GRAS Substances 10,Oser,BL& RAFord,Food Technology,January 1977 pg 65-74,GRAS Substances 11,Oser,BL & RAFord,Food Technology,February 1978 pg 60-70,GRAS Substances 12,Oser,BL& RAFord,Food Technology,July 1979 pg 65-73、GRAS Substances 13,Oser,B.L.,et al.,Food Technology,October 1984 pg 66-89、GRAS Substances 14,Oser,B.L.,et al.,Food Technology,November 1985 pg 108-117、GRAS Substances 15,Oser,B.L.,et al.,Food Technology,February 1990 pg 78-86、GRAS Substances 16,Smith,R.L.& Ford,R.A.,Food Technology,June 1993 pg 104-117、GRAS Flavoring Substances 17,Smith,et al.,Food Technology,October 1996 pg 72-81、GRAS Flavoring Substances 18,Newberne,P.,et al.,Food Technology,Vol.52,No.9,September 1998 pg 68-92、GRAS Flavoring Substances 19,Newberne,P.,et al.,Food Technology,Vol.54,No.6,June 2000 pg 66-84、GRAS Flavoring Substances 20,Smith,R.L.,et al.,Food Technology,Vol.55,No.12,December 2001 pg 34-55、GRAS Flavoring Substances 21,Smith,R.L.,et al.,Food Technology,Vol.57,No.5,May 2003 pg 46-59、GRAS Flavoring Substances 22,Smith,R.L.,et al.,Food Technology,August 2005 pg 24-62、GRAS Flavoring Substances 23,Waddell,W.J.,et al., Food Technology, August 2007 pp. 22-48; GRAS Flavoring Substances 24, Smith, RL, et al., Food Technology, June 2009 pp. 46-105; GRAS Flavoring Substances 25, Smith, RL, et al., Food Technology, July 2011 pp. 44-75; GRAS Flavoring Substances 26, Marnett, SM, et al., Food Technology, August 2013 pp. 38-56; and GRAS flavoring substances 27 SM Cohen et al., Food Technology Aug. 2015 pp. 40-59. For purposes of this disclosure, nicotine is not considered a flavoring agent or flavor.

[0015] The present disclosure relates to a powder system comprising nicotine-containing particles and flavor-containing particles. The powder system preferentially delivers the nicotine particles to the user's lungs and the flavor particles to the user's buccal or oral cavity. The nicotine-containing particles further comprise an amino acid, or a nicotine selected from the group consisting of nicotine pyruvate, nicotine mono-pyruvate, nicotine aspartate, and nicotine lactate. The relative particle sizes of the nicotine-containing particles and the flavor-containing particles remain stable when combined with each other.

[0016] The nicotine-containing particles may have any size distribution useful for inhalation delivery preferentially to the user's lungs. The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the nicotine in the powder system comprised of particles with a particle size of about 10 micrometers or less. The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the nicotine in the powder system comprised of particles with a particle size of about 5 micrometers or less. The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the nicotine in the powder system comprised of particles with a particle size in the range of about 1 micrometer to about 3 micrometers.

[0017] Preferably, nicotine may be pharmaceutically acceptable free base nicotine, or nicotine salt or nicotine salt hydrate.Useful nicotine salt or nicotine salt hydrate includes, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine mono-pyruvate, nicotine glutamate, or nicotine hydrochloride.Preferred nicotine salt or nicotine salt hydrate includes nicotine pyruvate, nicotine mono-pyruvate, nicotine aspartate, or nicotine lactate.

[0018] The compound that combines with nicotine to form a salt or salt hydrate may be selected based on its expected pharmacological effect. For example, nicotine salicylate may be administered as an anti-inflammatory or analgesic for fever reduction, nicotine fumarate may be administered to treat multiple sclerosis, and nicotine mono-pyruvate may be administered to treat chronic obstructive pulmonary disease (COPD) or for weight loss.

[0019] The nicotine-containing particles may include an amino acid. The amino acid may be disposed on the nicotine or on at least a portion of the coating of the nicotine-containing particles. Preferably, the amino acid may be leucine, such as L-leucine. Providing an amino acid, such as L-leucine, on the nicotine-containing particles, particularly coating the nicotine with an amino acid, may reduce the adhesive force of the nicotine-containing particles and may also reduce the attractive force between the nicotine particles, thereby reducing the aggregation of the nicotine particles. Similarly, the adhesive force to the flavor-containing particles may also be reduced, thereby reducing the aggregation of the nicotine particles with the flavor particles. The powder system described herein may be a free-flowing material, and may have a stable relative particle size of each powder component even when the nicotine particles and flavor particles are combined.

[0020] Preferably, nicotine may be a surface-modified nicotine salt, and in this case, the nicotine salt particles are coated particles.Preferably, the coating material is L-leucine.Particularly useful nicotine-containing particles are one or more of nicotine bitartrate coated with L-leucine, or nicotine pyruvate coated with L-leucine, or nicotine monopyruvate coated with L-leucine, or nicotine aspartate coated with L-leucine, or nicotine lactate coated with L-leucine.

[0021] Particles with a particle size of about 10 micrometers or less may have at least about 20% nicotine by weight, or at least about 30% nicotine by weight, or at least 40% nicotine by weight, or at least 50% nicotine by weight. Particles with a particle size of about 10 micrometers or less may contain in the range of about 20 to about 100% nicotine by weight, or in the range of about 30 to about 90% nicotine by weight.

[0022] Particles having a particle size of about 5 micrometers or less may contain at least about 20% nicotine by weight, or at least about 30% nicotine by weight, or at least 40% nicotine by weight, or at least 50% nicotine by weight. Particles having a particle size of about 5 micrometers or less may contain in the range of about 20 to about 100% nicotine by weight, or in the range of about 30 to about 90% nicotine by weight.

[0023] The flavour-containing particles may have any size distribution useful for inhalation delivery preferentially to the mouth or oral cavity of a user.

[0024] The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the flavor of the powder system comprised of particles with a particle size of about 20 micrometers or greater. The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the flavor of the powder system comprised of particles with a particle size of about 50 micrometers or greater. The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the flavor of the powder system comprised of particles with a particle size in the range of about 50 micrometers to about 150 micrometers.

[0025] Flavoring agents or flavors may be provided as solid flavors (at room temperature of about 22° C. and 1 atmosphere pressure) and may include flavor formulations, flavor-containing materials, and flavor precursors. Flavoring agents may include one or more natural flavoring agents, one or more synthetic flavoring agents, or a combination of natural and synthetic flavoring agents. Flavoring agents, as described herein, are organoleptic compounds, compositions, or materials selected and utilized to alter, or intended to alter, the taste or aroma characteristics of nicotine during its ingestion or inhalation.

[0026] Flavoring agents or flavors refer to various flavoring materials of natural or synthetic origin. These include single compounds and mixtures. The flavors or flavoring agents preferably have flavor characteristics that enhance the nicotine experience during ingestion. The flavors may be selected to provide an experience similar to that obtained from smoking a combustible smoking article. For example, the flavors or flavoring agents may enhance flavor characteristics such as mouthfulness and complexity. Complexity is commonly known as an overall balance of richer flavors, without any single sensory attribute dominating. Mouthfulness is described as the consumer's perception of richness and volume in the mouth and throat.

[0027] Suitable flavors include, but are not limited to, any natural or synthetic flavor, such as tobacco, smoke, menthol, mint (such as peppermint and spearmint), chocolate, licorice, citrus and other fruit flavors, gamma octamer, vanillin, ethyl vanillin, breath freshening flavors, spice flavors (such as cinnamon), methyl salicylate, linalool, bergamot oil, geranium oil, lemon oil, and ginger oil, and the like.

[0028] Other suitable flavors may include flavor compounds selected from the group consisting of acids, alcohols, esters, aldehydes, ketones, pyrazines, combinations or blends thereof, and the like. Suitable flavor compounds may, for example, be selected from the group consisting of phenylacetic acid, solanone, megastigmatrienone, 2-heptanone, benzyl alcohol, cis-3-hexenyl acetate, valeric acid, valeric aldehyde, esters, terpenes, sesquiterpenes, nootkatone, maltol, damascenone, pyrazines, lactones, anethole, iso-s valeric acid, combinations thereof, and the like.

[0029] Further specific examples of flavors may be found in the current literature and are well known to those skilled in the art of flavoring, ie imparting odors or tastes to products.

[0030] Flavorants may be high-potency flavorants and may be used and detected at levels that result in less than 200 parts per million in the inhaled airstream. Examples of such flavorants are major tobacco aroma compounds such as β-damascenone, 2-ethyl-3,5-dimethylpyrazine, phenylacetaldehyde, guaiacol, and furaneol. Other flavorants may only be detected by humans at higher concentration levels. These flavorants, referred to herein as lower-potency flavorants, are generally used at levels that result in orders of magnitude greater amounts of flavor released into the inhaled air. Suitable lower-potency flavorants include, but are not limited to, natural or synthetic menthol, peppermint, spearmint, coffee, tea, spices (such as cinnamon, clove, and ginger), cocoa, vanilla, fruit flavors, chocolate, eucalyptus, geranium, eugenol, and linalool.

[0031] The flavor-containing particles may include a compound that reduces adhesion or surface energy and the resulting aggregation. The flavor particles may be surface-modified with an adhesion-reducing compound to form coated flavor particles. One preferred adhesion-reducing compound may be magnesium stearate. Providing flavor particles, particularly coating them, with an adhesion-reducing compound such as magnesium stearate may reduce the adhesion of the flavor-containing particles and may also reduce the attractive forces between the flavor particles, thus reducing the aggregation of the flavor particles. This in turn may reduce the aggregation of flavor particles with nicotine particles. Therefore, the powder system described herein may have a stable relative particle size of the nicotine-containing particles and the flavor-containing particles, even when the nicotine particles and flavor particles are combined. Preferably, the powder system is free-flowing.

[0032] The flavor particles may have at least about 10% by weight flavor, or at least about 20% by weight flavor, or at least 30% by weight flavor, or at least 40% by weight flavor. The flavor particles may comprise in the range of about 10 to about 100% by weight flavor, or in the range of about 30 to about 90% by weight flavor.

[0033] Conventional formulations for dry powder inhalation generally contain carrier particles that function to increase the fluidization of active particles, because active particles may be too small to be affected by simple airflow through the inhaler.These carrier particles are usually saccharides such as lactose or mannitol with a particle size of more than about 50 micrometers.Carrier particles are used in the formulation to improve dose uniformity by acting as diluent or bulking agent.In the present disclosure, carrier particles such as lactose or mannitol are not considered to be flavoring agents or flavoring materials.

[0034] The powder systems described herein may be carrier-free or substantially free of saccharides such as lactose or mannitol. Being carrier-free or substantially free of saccharides such as lactose or mannitol may allow the nicotine to be inhaled and delivered to the user's lungs at an inhalation dose or airflow rate similar to that of typical smoking. Furthermore, because the nicotine is carrier-free or substantially free of saccharides such as lactose or mannitol, the airflow path of the inhaler may have a simple geometry or configuration.

[0035] The powder system comprises nicotine-containing particles and flavor-containing particles. The nicotine particles and flavor particles may be combined in a single capsule. As described above, the nicotine particles and flavor particles may each have reduced adhesive strength, which results in a stable powder formulation, in which the particle size of the nicotine particles and flavor particles does not substantially change when the nicotine particles and flavor particles are combined. Preferably, the powder system is free-flowing.

[0036] Alternatively, the powder system may include nicotine-containing particles contained within a nicotine capsule or first capsule and flavor-containing particles contained within a flavor capsule or second capsule. The nicotine capsule and the separate flavor capsule may be in a parallel airflow arrangement or fluid connection, or in a series airflow arrangement or fluid connection.

[0037] The nicotine-containing particles and the flavor-containing particles may be combined in any useful relative amounts so that the flavor is detectable by the user when ingested with nicotine. The first plurality of nicotine-containing particles may comprise about 50% to about 99% by weight of the total weight of the powder system, and the second plurality of flavor-containing particles may comprise about 50% to about 1% by weight of the total weight of the powder system. Preferably, the nicotine particles and flavor particles form at least about 90% by weight, or at least about 95% by weight, or at least about 99% by weight, or 100% by weight of the total weight of the powder system.

[0038] The airflow path or channel through the body of the inhaler may be a simple path or channel. Preferably, the airflow path or channel through the body of the inhaler may be parallel to the longitudinal axis of the inhaler and may extend linearly along the entire length of the inhaler body. The inhaler may have only a single main airflow channel with a single capsule receptacle disposed within the single main airflow channel. Alternatively, the inhaler may include two or three coextensive or parallel airflow channels. One, two, or all three airflow channels may have a capsule receptacle disposed therein. The inhaler may be configured to simultaneously deliver nicotine particles and flavor particles.

[0039] Preferably, the nicotine-containing particles and the flavor-containing particles may be mixed dry powder and contained in a single capsule. Alternatively, the flavor-containing particles may be separated from the nicotine-containing particles before inhalation or delivery through the airflow channel of the inhaler. The nicotine-containing particles and the flavor-containing particles may be arranged in a serial airflow arrangement and in a single airflow channel, and the flavor-containing particles may be located either upstream or downstream of the nicotine-containing particles. Alternatively, the nicotine-containing particles and the flavor-containing particles may be arranged in a parallel airflow arrangement and in a pair of airflow channels, where the nicotine-containing particles and the flavor-containing particles may combine to form a mixture downstream of both the nicotine container and the flavor container.

[0040] The nicotine container may receive a capsule containing nicotine and, optionally, a capsule containing a flavor (when combined in a single capsule). The capsule may contain a predetermined amount or dose of nicotine and, optionally, a flavor. The capsule may contain sufficient nicotine to provide at least two inhalations or "puffs," or at least about five inhalations or "puffs," or at least about 10 inhalations or "puffs." Preferably, the capsule may contain sufficient nicotine to provide about 5-50 inhalations or "puffs," or about 10-30 inhalations or "puffs." Each nicotine inhalation or "puff" may deliver particles containing about 0.1 mg to about 3 mg of nicotine to the user's lungs, or about 0.2 mg to about 2 mg of nicotine to the user's lungs, or about 1 mg of nicotine to the user's lungs. Preferably, each "puff" delivers about 50 to about 150 micrograms of nicotine to the user's lungs.

[0041] The capsule may hold or contain at least about 5 mg of nicotine, or at least about 10 mg of nicotine. The capsule may hold or contain less than about 30 mg of nicotine, or less than about 25 mg of nicotine, or less than 20 mg of nicotine. Preferably, the capsule holds or contains between about 5 mg and about 30 mg of nicotine, or between about 10 mg and about 20 mg of nicotine.

[0042] When the flavor-containing particles are blended or combined with the nicotine-containing particles in a capsule, the flavor is present in an amount that provides the desired flavor delivered to the user with each inhalation or "puff."

[0043] The capsule may be made of an airtight material that can be penetrated or punctured by the inhaler. The capsule may be made of a metallic or polymeric material that prevents contaminants from entering the capsule, but that can be penetrated or punctured by the inhaler during use.

[0044] The nicotine powder inhaler includes a body extending between a mouthpiece portion and a distal end portion, and an airflow channel extending between the mouthpiece portion and the distal end portion, a nicotine powder container disposed along the airflow channel, and a powder system described herein disposed within the nicotine powder container.

[0045] The powder system may be delivered using a simple inhaler design at an inhalation volume or airflow rate within the range of that of conventional smoking.

[0046] A method of inhaling nicotine into a user's lungs includes inhaling air at a flow rate of less than about 2 liters / minute through a nicotine powder inhaler described herein to deliver nicotine to the user's lungs. No flavor may be delivered to the user's lungs.

[0047] The inhaler may include a piercing element or a pair of opposing piercing elements configured to pierce the capsule, which may engage with the nicotine powder capsule upon loading the flavor powder capsule into the nicotine powder container or upon demand by an actuator on the inhaler body.

[0048] The flavor-containing particles may be separated from the nicotine-containing particles, and the flavor-containing particles may be contained in a separate capsule. The capsule may be formed of an airtight material that can be penetrated or punctured by the inhaler. The capsule may be formed of a metallic or polymeric material that prevents contaminants from entering the capsule, but that can be penetrated or punctured by the inhaler during use.

[0049] Nicotine inhalers according to the present invention may operate using flow rates of less than about 5 L / min, or less than about 3 L / min, or less than about 2 L / min, or about 1.6 L / min. Preferably, the flow rate is within the range of about 1 L / min to about 3 L / min, or about 1.5 L / min to about 2.5 L / min. The inhalation volume or flow rate is similar to that of Health Canada smoking methods, and more preferably is about 1.6 L / min. In contrast, conventional DPIs operate at flow rates of about 20 to 100 L / min or more and often require an energy source or propellant to drive the airflow to achieve this airflow.

[0050] The nicotine inhalers described herein may be used by consumers, such as smoking a traditional cigarette or vaping an e-cigarette. Such smoking or vaping is characterized by two steps: in the first step, a small volume containing the total amount of nicotine desired by the consumer is drawn into the oral cavity, followed by a second step in which this small volume containing nicotine is further diluted with fresh air and drawn deeper into the lungs. Both steps are controlled by the consumer. During the first inhalation step, the consumer may determine the amount of nicotine to be inhaled. During the second step, the consumer may determine the amount by which to dilute the first volume drawn deeper into the lungs, maximizing the concentration of active agent delivered to the epithelial surface of the airways. This smoking mechanism is sometimes referred to as "puff-inhale-exhale."

[0051] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are provided to facilitate understanding of certain terms used frequently herein.

[0052] The terms "upstream" and "downstream" refer to the relative location of the elements of the described inhaler with respect to the direction of inhalation airflow as it is drawn through the inhaler body from the distal end portion to the mouthpiece portion.

[0053] As used herein, the singular forms "a," "an," and "the" include embodiments having plural referents unless the content clearly dictates otherwise.

[0054] "Or," as used herein, is generally used in its inclusive sense unless the context clearly dictates otherwise. The term "and / or" refers to one or all of the listed elements or a combination of any two or more of the listed elements.

[0055] When used herein, the words "have," "having," "include," "including," "comprise," "comprising," and the like are used in an open-ended sense and generally mean "including, but not limited to." Terms such as "consisting essentially of," "consisting of," and the like will be understood to be encompassed by "including" and the like.

[0056] The words "preferred" and "preferably" refer to embodiments of the invention that may offer certain benefits, under certain circumstances, although other embodiments may also be preferred, under the same or other circumstances. Moreover, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and does not exclude other embodiments from the scope of the present disclosure, including the claims. [Brief explanation of the drawings]

[0057] [Figure 1] FIG. 1 is a schematic diagram of an exemplary nicotine powder inhaler. [Figure 2] FIG. 2 is a schematic diagram of an exemplary nicotine powder inhaler. [Figure 3] FIG. 3 is a schematic diagram of an exemplary nicotine powder inhaler. [Figure 4] FIG. 4 is a schematic diagram of an exemplary nicotine powder inhaler. [Figure 5] FIG. 5 is a schematic diagram of an exemplary nicotine powder inhaler. DETAILED DESCRIPTION OF THE INVENTION

[0058] 1-5 are schematic diagrams of an exemplary nicotine powder inhaler 10. The schematic diagrams are not necessarily to scale and are provided for purposes of illustration, not limitation. The drawings illustrate one or more embodiments described in the present disclosure, although it is understood that other embodiments not depicted in the drawings are within the scope and spirit of the present disclosure.

[0059] 1 and 2, nicotine powder inhaler 10 includes a mouthpiece portion 12 and a distal end portion 14 with a nicotine capsule 20 disposed therebetween. Piercing elements 11A and 11B are configured to pierce capsule 20 and fluidly connect airflow channel 13 in mouthpiece portion 12 to airflow channel 15 in distal end portion 14. The airflow channel extends linearly along the length of nicotine powder inhaler 10. FIG. 2 further illustrates capsule 20 within container 25, which may be reusable.

[0060] Figures 3-5 illustrate schematic diagrams of an inhaler 10. Figure 3 shows a nicotine inhaler 10 with a single flow path and a single capsule 120 containing both nicotine particles and flavor particles. The airflow path includes an upstream portion 15 and a downstream portion 13.

[0061] 4 shows a nicotine inhaler 10 having a single flow path and a nicotine capsule 20 containing nicotine particles in a serial flow arrangement with a flavorant capsule 100 containing flavor particles. The flavorant capsule 100 may be pierced for the nicotine capsule 20 as described above. The airflow path includes an upstream portion 15 and a downstream portion 13.

[0062] 5 shows a nicotine inhaler 10 having parallel flow paths and a nicotine capsule 20 containing nicotine particles in a parallel flow arrangement with a flavorant capsule 100 containing flavor particles. The flavorant capsule 100 may be pierced for the nicotine capsule 20 as described above. The airflow path includes an upstream portion 15 and a downstream portion 13.

Claims

1. 1. A powder system comprising: a first plurality of particles having a particle size of about 10 micrometers or less and comprising nicotine and an amino acid; a second plurality of particles having a particle size of about 20 micrometers or greater and comprising a flavor.

2. 1. A powder system comprising: a first plurality of particles having a particle size of about 10 micrometers or less and comprising nicotine, said nicotine being selected from the group consisting of nicotine pyruvate, nicotine mono-pyruvate, nicotine aspartate, and nicotine lactate; a second plurality of particles having a particle size of about 20 micrometers or greater and comprising a flavor.

3. 3. The powder system according to claim 1, wherein at least about 60% by weight of the nicotine in the powder system consists of particles with a particle size of about 10 micrometers or less.

4. 4. The powder system according to claim 1, wherein at least about 60% by weight of the flavor of the powder system consists of particles with a particle size of about 20 micrometers or greater.

5. 5. The powder system of claim 1, wherein the mass median aerodynamic diameter of the first plurality of particles is about 5 micrometers or less, or about 3 micrometers or less, or in the range of about 1 micrometer to about 3 micrometers, and the mass median aerodynamic diameter of the second plurality of particles is about 50 micrometers or more, or in the range of about 50 micrometers to about 150 micrometers.

6. 6. The powder system according to any one of claims 1 to 5, wherein the nicotine comprises a nicotine salt or a nicotine salt hydrate.

7. 7. The powder system according to any one of claims 1, 3 to 6, wherein the amino acid is located on the nicotine.

8. The powder system according to any one of claims 1, 3 to 7, wherein the amino acid comprises leucine.

9. 9. The powder system according to any one of claims 1 to 8, wherein the first plurality of particles and the second plurality of particles are contained within a single capsule.

10. 9. The powder system according to any one of claims 1 to 8, wherein the first plurality of particles is contained within a first capsule and the second plurality of particles is contained within a second capsule.

11. 11. The powder system according to claim 1, wherein the first plurality of particles is about 50% to about 99% by weight of a total weight of the powder system, and the second plurality of particles is about 50% to about 1% by weight of a total weight of the powder system.

12. 12. The powder system of any one of claims 1 to 11, wherein the second plurality of particles comprises magnesium stearate.

13. 1. A nicotine powder inhaler comprising: a body extending between a mouthpiece portion and a distal end portion; an airflow channel extending between the mouthpiece portion and the distal end portion; A nicotine powder inhaler comprising: a nicotine powder container arranged along the airflow channel, wherein the powder system according to any one of claims 1 to 12 is arranged in the nicotine powder container.

14. 14. The nicotine powder inhaler of claim 13, wherein the first plurality of particles and the second plurality of particles are contained within a single capsule, and the capsule is placed within the nicotine powder container, and the first plurality of particles and the second plurality of particles are released from the single capsule into the airflow channel.

15. 14. The nicotine powder inhaler of claim 13, wherein the first plurality of particles is contained within a first capsule and the second plurality of particles is contained within a second capsule, and the second capsule is upstream or downstream of the first capsule and within the airflow channel.

16. 14. The nicotine powder inhaler of claim 13, further comprising a second airflow channel in parallel airflow relationship with the nicotine powder container, and wherein the first plurality of particles is contained within a first capsule in the nicotine powder container and the second plurality of particles is contained within a second capsule in the second airflow channel.

17. 17. The nicotine powder inhaler of any one of claims 13 to 16, wherein the first plurality of particles is inhaled into the user's lungs at an inhalation rate of less than about 5 liters per minute.

18. 1. A method for inhaling nicotine into a user's lungs, comprising:

18. A method comprising inhaling air through the nicotine powder inhaler of any one of claims 12 to 17 at a flow rate of less than about 2 liters / minute so as to deliver the first plurality of particles to the lungs of the user and to prevent the second plurality of particles from being delivered to the lungs of the user.

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