Inhaler mouthpiece with flavour element

Abstract

An inhaler article comprises a body extending along a longitudinal axis from a mouthpiece end to a distal end, a mouthpiece air outlet and a distal air inlet, and a capsule cavity within the body and downstream of the mouthpiece. A partition is between the capsule cavity and the mouthpiece, comprising at least one aperture to form an airflow path from the distal air inlet, through the capsule cavity, through the mouthpiece to the mouthpiece air outlet. A flavour coating is provided on an inner surface of the mouthpiece, and a protective layer is provided on the flavour coating.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to an inhaler article comprising a mouthpiece having a flavour element. The inhaler article can be a dry powder inhaler, wherein the flavour element is downstream of a dry powder capsule which can be contained within the inhaler. BACKGROUND

[0002] Dry powder inhalers are not necessarily always perfectly suited to deliver dry powder particles to the lungs at an inhalation rate or airflow rate within the inhalation rate or airflow rate of a conventional smoking regime. The operation of a dry powder inhaler can be complex or can involve moving parts. Dry powder inhalers typically aim to deliver the entire dry powder dose or capsule load in a single breath.

[0003] Flavour can be required to consume the inhalable dry powder. To achieve this, flavour particles can be combined with the dry powder material. The flavour particles can be incompatible with the dry powder material. Flavour particles combined with the dry powder can degrade or aggregate the dry powder. SUMMARY

[0004] It is desirable to provide an inhaler having a flavour element separate from a dry powder capsule or container. It is desirable to provide an inhaler in which the flavour element is provided in a mouthpiece but releases flavour according to the needs of the consumer. It is desirable to provide a sealed inhaler which can be assembled at high speed. It is desirable to provide an inhaler having a flavour element which is interchangeable with different flavour elements. It is also desirable to provide an inhaler article having a form which is easy to grip and familiar to a user, similar to a conventional cigarette. It is desirable to provide an inhaler in which the user easily activates the flavour element.

[0005] According to an aspect of the present invention, there is provided an inhaler article comprising a body extending along a longitudinal axis from a mouthpiece end to a distal end, and a mouthpiece air outlet and a distal air inlet. A capsule cavity can be defined within the body and downstream by the mouthpiece. A partition can be between the capsule cavity and the mouthpiece, comprising at least one aperture to form an airflow path. The airflow path extends from the distal air inlet, through the capsule cavity, through the mouthpiece to the mouthpiece air outlet. A flavour coating layer can be provided on an inner surface of the mouthpiece, and a protective layer can be provided on the flavour coating layer.

[0006] The inhaler article separates the flavour element from the dry powder capsule or container, which can improve or enhance the stability of the dry powder contained within the dry powder capsule or container. The protective layer can be in contact with the flavour element and releasably adhered to the flavour coating layer. Advantageously, the user can easily activate or expose the flavour coating layer by removing the protective layer from the inhaler.

[0007] The inhaler article can comprise the flavour coating layer defining at least a portion of a mouthpiece air channel in airflow communication with the capsule cavity. Providing the flavour coating layer in a single airflow path through the inhaler enables simplified construction and high speed assembly.

[0008] The inhaler article can include a flavor coating layer disposed between the protective layer and an inner surface of the mouthpiece. The flavor coating layer can contact and adhere to the inner surface of the mouthpiece. Providing the flavor coating layer in this manner enables simplified construction and high speed assembly.

[0009] The inhaler article can include a flavor coating layer forming a gel layer. Providing the flavor coating layer in gel form can stabilize the flavor and can be a convenient deposition technique during assembly. Providing the flavor coating layer in gel form can allow for tailored control of the release of flavor during consumption.

[0010] The inhaler article can include a flavor coating layer defining an open cylinder. The open cylinder can be coaxial with an inner surface of the mouthpiece. Providing the flavor coating layer in this manner enables simplified construction and high speed assembly.

[0011] The inhaler article can include a protective layer adhered to the flavor coating layer and a protective layer defining a coaxial cylinder having the longitudinal axis of the body. Providing the flavor coating layer and the protective layer in this manner enables simplified construction and high speed assembly.

[0012] The protective layer can have a thickness in a range of about 20 microns to about 60 microns. The inhaler article can include a protective layer comprising a foil, a paper, a polymer, or a combination thereof.

[0013] The inhaler article can further include a mouthpiece end cap sealing the mouthpiece air outlet. The mouthpiece end cap can be configured to be removable from the mouthpiece element to expose the mouthpiece air outlet. The mouthpiece end cap can advantageously seal the mouthpiece end of the inhaler to provide enhanced shelf life of the inhaler and associated powder.

[0014] The inhaler article can include a protective layer affixed to the mouthpiece end cap and configured to be removed from the mouthpiece element with the mouthpiece end cap. Attaching the protective layer to the mouthpiece end cap provides the effect of being convenient for a user to remove.

[0015] The inhaler article can include a protective layer defining a spiral configuration when removed from the mouthpiece element. Advantageously, such a spiral configuration allows for easy removal of the protective layer without damaging the flavor coating layer.

[0016] The inhaler article can further include a circumferential line of weakness forming an interface between the mouthpiece end cap and the mouthpiece end. Advantageously, such a circumferential line of weakness provides a reliable and clean separation interface of the mouthpiece end cap from the inhaler body or the mouthpiece body.

[0017] The inhaler article can include a mouthpiece end cap having an outer diameter equal to an outer diameter of the inhaler article body, and the mouthpiece end cap is coaxial with the inhaler article body.

[0018] The inhaler article can further include a capsule disposed within the capsule cavity. The capsule can contain pharmaceutically active particles including nicotine. The mass median aerodynamic diameter of the pharmaceutically active particles can be about 5 microns or lower, or in a range of about 0.5 microns to about 4 microns, or in a range of about 1 micron to about 3 microns.

[0019] The inhaler article can include a removable and interchangeable mouthpiece to allow a user to select or change the type of flavor coating.

[0020] Advantageously, the inhaler article minimizes moving parts. Advantageously, the inhaler article provides nicotine particles to the lungs at an inhalation rate or airflow rate within a conventional smoking method inhalation rate or airflow rate. The inhaler delivers nicotine powder through an inhaler article having a form similar to a conventional cigarette. The inhaler article described herein can provide dry powder to the lungs at an inhalation rate or airflow rate within a conventional smoking method inhalation rate or airflow rate. The consumer can take multiple inhalations or "puffs," with each "puff" delivering a small amount of the dry powder contained in a capsule contained within a capsule cavity. The inhaler article can have a form similar to a conventional cigarette and can simulate conventional smoking. The inhaler article can be easy to manufacture and convenient for the consumer to use.

[0021] Airflow management through the capsule cavity of the inhaler article can cause a capsule containable therein to rotate during inhalation and consumption. The capsule can contain particles containing nicotine (also referred to as "nicotine powder" or "nicotine particles"). Rotation of the pierced capsule can pause and cause nicotine particles released from the pierced capsule into inhalation air moving through the inhaler article to aerosolize. The particles containing nicotine can pass through or through the flavor element as flavor particles are released from the flavor coating. The flavor particles can be larger than the nicotine particles and can aid in delivering the nicotine particles into the lungs of a user while the flavor particles preferentially remain in the oral or buccal space of the user. The nicotine particles and the flavor particles can be delivered with the inhaler article at an inhalation rate or airflow rate within a conventional smoking method inhalation rate or airflow rate.

[0022] The term "gel" refers to a substantially dilute cross-linked system that exhibits no flow when in the steady state. Gels are predominantly liquid in a sense that they consist of a solid medium containing a liquid. It is the cross-linking within the fluid that gives the gel its structure (hardness) and aids in the adhesive bonding (tackiness). In this way, gels are a dispersion of liquid molecules within a solid medium.

[0023] The term "nicotine" refers to nicotine and nicotine derivatives, such as freebase nicotine, nicotine salts, and the like.

[0024] The term "flavour" or "flavourant" refers to an organoleptic compound, composition, or material that alters and is intended to alter the taste or aroma characteristics of nicotine during its consumption or inhalation.

[0025] The terms "upstream" and "downstream" refer to the relative position of elements of an inhaler article described with respect to the direction of an inhalation airflow as it passes through the inhaler article upon article suction.

[0026] The terms "proximal" and "distal" are used to describe the relative positions of components or portions of components of an inhaler article. An inhaler article according to the present application has a proximal end. In use, nicotine particles exit the proximal end of the inhaler article for delivery to a user. The inhaler article has a distal end opposite the proximal end. The proximal end of the inhaler article can also be referred to as the mouth end or the mouthpiece end.

[0027] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise indicated. Definitions provided herein are to facilitate understanding of certain terms used frequently herein.

[0028] As used herein, the singular forms "a," "an," and "the" encompass embodiments having plural referents unless the content clearly dictates otherwise.

[0029] As used herein, "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise. The term "and / or" means one or all of the listed elements or a combination of any two or more of the listed elements.

[0030] As used herein, "have," "having," "include," "including," "include," "includes," and the like are used in their open, conventional sense, and will be generally construed to mean "comprising." It will be understood that "consisting essentially of," "consisting of," and the like are subsumed in "comprising," and the like.

[0031] The words "preferred" and "preferably" refer to embodiments of the application that can provide certain benefits under certain circumstances. However, other embodiments can also be preferred under the same or other circumstances. Additionally, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude those other embodiments from the scope of the disclosure, including the claims.

[0032] The present disclosure relates to inhaler articles comprising a mouthpiece having a flavour element. The inhaler article can be a dry powder inhaler, wherein the flavour element is downstream of a dry powder capsule that can be contained within the inhaler. The inhaler article can be configured to induce a swirling or rotating inhalation airflow during consumption.

[0033] The inhaler article includes a body extending along a longitudinal axis from a mouthpiece end to a distal end, a mouthpiece air outlet and a distal air inlet. A capsule cavity can be defined within the body and downstream of the mouthpiece by the mouthpiece. A partition can be between the capsule cavity and the mouthpiece, including at least one aperture to form an airflow path. The airflow path extends from the distal air inlet through the capsule cavity, through the mouthpiece to the mouthpiece air outlet. A flavour coating can be provided on an inner surface of the mouthpiece, and a protective layer can be provided on the flavour coating.

[0034] The inhaler article separates the flavour element from the dry powder capsule or container, which can improve or enhance the stability of the dry powder contained within the dry powder capsule or container. The protective layer can be in contact with the flavour element and releasably adhered to the flavour coating. Advantageously, a user can easily activate or expose the flavour coating by removing the protective layer from the inhaler.

[0035] The inhaler article can include a flavour coating defining at least a portion of a mouthpiece air channel in airflow communication with the capsule cavity. Providing the flavour coating in a single airflow path through the inhaler enables simplified construction and high speed assembly.

[0036] The flavour coating can have a uniform thickness around the circumference of the mouthpiece inner diameter. The flavour coating can have a thickness in the range of about 5 microns to about 60 microns, preferably about 10 microns to about 50 microns, most preferably about 15 microns to about 35 microns. The flavour coating can have a longitudinal length that can be coextensive with the mouthpiece element. The flavour coating can have a longitudinal length in the range of about 5 millimetres to about 25 millimetres, preferably about 7 millimetres to about 20 millimetres, most preferably about 9 millimetres to about 18 millimetres.

[0037] The inhaler article can include a flavour coating provided between the protective layer and the mouthpiece inner surface. The flavour coating can contact and adhere to the mouthpiece inner surface.

[0038] The inhaler article can include a flavour coating that is a gel, or an oil or powder that forms the flavour coating upon stabilisation.

[0039] The inhaler article can preferably include a flavour coating that forms a gel layer. Providing the flavour coating in the form of a gel can stabilise the flavour, and can be a convenient deposition technique during assembly. Providing the flavour coating in the form of a gel can allow customised control of the release of the flavour during consumption.

[0040] The inhaler article can include a flavor coating layer defining an open cylinder. The open cylinder can be coaxial with an inner surface of the mouthpiece. The flavor coating layer defining the open cylinder can have a uniform thickness around the circumference of the mouthpiece inner diameter. The flavor coating layer can have a thickness in a range of about 5 microns to about 60 microns, preferably about 10 microns to about 50 microns, most preferably about 15 microns to about 35 microns. The flavor coating layer defining the open cylinder can have a longitudinal length that can be coextensive with the mouthpiece element. The flavor coating layer can have a longitudinal length in a range of about 5 millimeters to about 25 millimeters, preferably about 7 millimeters to about 20 millimeters, most preferably about 9 millimeters to about 18 millimeters.

[0041] The flavor coating layer includes one or more flavorants. The term "flavorant" or "flavor" refers to an organoleptic compound, composition, or material that alters and is intended to alter the taste or aroma properties of a pharmaceutically active or nicotine component during its consumption or inhalation. Preferably, the term "flavorant" or "flavor" refers to a compound disclosed in the Flavor & Extract Manufacturers Association (FEMA) Flavor Ingredient Library, and in particular, for example, GRAS Flavoring Substances (GSF) Publications 3 to 27, see Hall, R.L. and Oser, B.L., Food Technology, February 1965, pp. 151-197, and GSF 27, S.M. Cohen et al., Food Technology, August 2015, pp. 40-59, and Interim GSF Publications 4 to 26.

[0042] Flavorants or flavors refer to a variety of flavor materials of natural or synthetic origin. They include single compounds and mixtures. The flavor or flavorant has a flavor quality that can enhance the experience of a pharmaceutically active or nicotine component during consumption. The flavor can be selected to provide an experience similar to that produced by smoking a combustible smoking article. For example, the flavor or flavorant can enhance flavor attributes such as mouthfulness and complexity. Complexity is generally considered to be a balanced blend of flavors that is richer but not dominant in a single sensory attribute. Mouthfulness is described as the perception of richness and amount in the mouth and throat of the consumer.

[0043] Suitable flavors include, but are not limited to, any natural or synthetic flavor such as tobacco, smoke, menthol, mint (e.g., peppermint and spearmint), chocolate, licorice, citrus and other fruit flavors, beta ionone, vanillin, ethyl vanillin, air freshener flavors, flavoring flavors such as cinnamon, methyl salicylate, linalool, bergamot oil, geranium oil, lemon oil, and ginger oil, and the like.

[0044] Other suitable flavors can include flavor compounds selected from the group consisting of acids, alcohols, esters, aldehydes, ketones, pyrazines, combinations or mixtures thereof. Suitable flavor compounds can be, for example, 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, cyclohexenol, maltol, damascenone, pyrazines, lactones, anethole, isovaleric acid, combinations thereof, and the like.

[0045] Other specific examples of flavors can be found in the current literature and are well known to those skilled in the art of flavoring, i.e., the art of imparting odor or taste to a product.

[0046] The flavorant can be a high potency flavorant and can be used and perceived at levels that will produce an inhalation airstream below 200 parts per million. Examples of such flavorants are key tobacco aroma compounds such as, for example, damascone, 2-ethyl-3,5-dimethylpyrazine, phenylacetaldehyde, guaiacol, and furaneol. Other flavorants can only be perceived by a human at higher concentration levels. These flavorants are referred to herein as low potency flavorants and are typically used in amounts that produce several orders of magnitude more flavorant than is released into the inhaled air. Suitable low potency flavorants include, but are not limited to, natural or synthetic menthol, peppermint, spearmint, coffee, tea, spices (e.g., cinnamon, clove, and ginger), cocoa, vanilla, fruit flavors, chocolate, eucalyptus, geranium, eugenol, and linalool.

[0047] The inhaler article can include a protective layer adhered to the flavorant coating layer and a protective layer defining a coaxial cylinder having the body longitudinal axis. The protective layer preferably covers the entire flavorant coating layer surface. The protective layer can provide a moisture barrier for the flavorant coating layer. The protective layer can prevent migration of flavorant from the flavorant coating layer.

[0048] The inhaler article can include a protective layer comprising a foil, a paper, a polymer, or a combination thereof. The inhaler article can include a protective layer comprising a metal foil. Preferably, the metal foil can be an aluminum foil. The metal foil can be combined with a paper layer or a polymer layer to form a laminate protective layer.

[0049] The inhaler article protective layer can comprise polystyrene, polythiophene, polyethylene terephthalate, polyvinyl chloride, or oriented polyamide.

[0050] The inhaler article protective layer can have a thickness in the range of about 20 micrometers to about 60 micrometers, or in the range of about 25 micrometers to about 40 micrometers, or in the range of about 25 micrometers to about 35 micrometers.

[0051] The inhaler article can further include a mouthpiece end cap that seals the mouthpiece air outlet. The mouthpiece end cap can be configured to be removable from the mouthpiece element to expose the mouthpiece air outlet. The mouthpiece end cap can advantageously seal the mouthpiece end of the inhaler to provide enhanced shelf life of the inhaler and associated powder.

[0052] The inhaler article can include a protective layer secured to the mouthpiece end cap and configured to be removed from the mouthpiece element with the mouthpiece end cap. Attaching the protective layer to the mouthpiece end cap provides the benefit of ease of removal for the user.

[0053] The inhaler article can include a protective layer having a helical or spiral score line or helical or spiral line of weakness along a length of the protective layer. The helical or spiral score line or helical or spiral line of weakness can provide for removal of the protective layer in a helical configuration. This can facilitate removal of the protective layer from the mouthpiece.

[0054] The inhaler article can include a protective layer that defines a helical configuration when removed from the mouthpiece element. Advantageously, such a helical configuration allows for easy removal of the protective layer without damaging the flavour coating.

[0055] The inhaler article can further include a circumferential line of weakness that forms an interface between the mouthpiece end cap and the mouthpiece end. Advantageously, such a circumferential line of weakness provides a reliable and clean interface for separation of the mouthpiece end cap from the inhaler body or mouthpiece body.

[0056] Once the protective layer is removed from the flavour coating, the flavour compounds evaporate from the flavour coating and combine with the fluidised particles including nicotine in the inhalation airflow.

[0057] The inhaler article can include a mouthpiece end cap having an outer diameter equal to an outer diameter of the inhaler article body, and the mouthpiece end cap is coaxial with the inhaler article body.

[0058] The inhaler body can be sized and shaped similar to a smoking article or cigarette. The inhaler body can have an elongate body extending along a longitudinal axis of the inhaler article. The inhaler body can have a substantially uniform outer diameter along a length of the elongate body. The inhaler body can have a circular cross-section that can be uniform along the length of the elongate body. The inhaler body can have an outer diameter in a range of about 6 mm to about 10 mm, or about 7 mm to about 10 mm, or about 7 mm to about 9 mm, or about 7 mm to about 8 mm, or about 7.2 mm. The inhaler body can have a length (along the longitudinal axis) in a range of about 40 mm to about 80 mm, or about 40 mm to about 70 mm, or about 40 mm to about 50 mm, or about 45 mm.

[0059] The mouthpiece element, located downstream of the capsule cavity, can extend from the capsule cavity to the mouthpiece end of the inhaler article. The length of the mouthpiece element can be in the range of about 10 mm to about 30 mm, preferably about 15 mm to about 25 mm, and more preferably about 20 mm to about 22 mm.

[0060] The partition can be between the capsule cavity and the mouthpiece. The partition can comprise at least one aperture to form an airflow path from the distal air inlet through the capsule cavity, through the mouthpiece to the mouthpiece air outlet. The partition can comprise a plurality of apertures to form an airflow path from the distal air inlet through the capsule cavity, through the mouthpiece to the mouthpiece air outlet. The partition can define a downstream end of the capsule cavity. The partition can define an upstream end of the mouthpiece.

[0061] The capsule cavity can define a cylindrical space configured to contain a capsule (e.g., the capsule can have an oblong or circular cross-section). The capsule cavity can have a substantially uniform or uniform diameter along the length of the capsule cavity. The capsule cavity can have a fixed cavity length. The capsule cavity has a cavity inner diameter normal to the longitudinal axis, and the capsule has a capsule outer diameter. The capsule cavity can be sized and shaped to contain an oblong capsule. The capsule cavity can have a substantially cylindrical or cylindrical cross-section along the length of the capsule cavity. The capsule cavity can have a uniform inner diameter. The outer diameter of the capsule can be about 80% to about 95% of the inner diameter of the capsule cavity. The configuration of the capsule cavity relative to the capsule can facilitate limited movement of the capsule during activation or piercing of the capsule.

[0062] The configuration of the capsule cavity relative to the capsule can facilitate stable rotation of the capsule within the capsule cavity. During inhalation, the longitudinal axis of the capsule can stably rotate coaxially with the longitudinal axis of the inhaler body. The configuration of the capsule cavity relative to the capsule can facilitate wobbling rotation of the capsule within the capsule cavity.

[0063] Stable rotation refers to the longitudinal axis of the inhaler body being substantially parallel to or coaxial with the rotational axis of the capsule. Stable rotation can refer to the absence of travel of the rotating capsule. Preferably, the longitudinal axis of the inhaler body can be substantially coextensive with the rotational axis of the capsule. Stable rotation of the capsule can uniformly entrain a portion of the nicotine particles from the capsule upon two or more, or five or more, or ten or more “puffs” or inhalations by the consumer.

[0064] The distal end of the inhaler can be removable to allow placement or replacement of a capsule into the capsule cavity. The distal end of the inhaler can be configured to induce a swirling or rotational airflow through the capsule cavity. The swirling or rotational airflow through the capsule cavity causes the capsule to rotate or spin, as described herein, and releases the powder from the capsule.

[0065] The distal end of the inhaler can comprise an aperture to deliver a needle or perforating element into the capsule cavity and form an aperture in a capsule contained therein.

[0066] The capsule distal end can be sealed with a removable sealing membrane to seal the distal end of the inhaler article. The mouthpiece end cap element seals the proximal end of the inhaler article. Prior to consuming the inhaler article, the user removes both the distal end sealing membrane and the mouthpiece end cap element.

[0067] The capsule can rotate about its longitudinal or central axis when air flows through the inhaler article. The capsule can be formed of a gas-tight material that can be pierced or punctured by a piercing element, which can be separate or combined with the inhaler. The capsule can be formed of a metal or polymeric material that serves to keep the capsule uncontaminated yet can be pierced or punctured by the piercing element prior to consuming the nicotine particles within the capsule. The capsule can be formed of a polymeric material. The polymeric material can be hydroxypropyl methylcellulose (HPMC). The capsule can be a size 1 capsule to a size 4 capsule, or a size 3 capsule.

[0068] The capsule can contain pharmaceutically active particles. For example, the pharmaceutically active particles can include nicotine. The mass median aerodynamic diameter of the pharmaceutically active particles can be about 5 microns or less, or in a range of about 0.5 microns to about 4 microns, or in a range of about 1 micron to about 3 microns.

[0069] The capsule can contain a predetermined amount of nicotine particles. The capsule can contain enough nicotine particles to provide at least 2 inhalations or "puffs," or at least about 5 inhalations or "puffs," or at least about 10 inhalations or "puffs." The capsule can contain enough nicotine particles to provide about 5 to about 50 inhalations or "puffs," or about 10 to about 30 inhalations or "puffs." Each inhalation or "puff" can deliver about 0.1 mg to about 3 mg of nicotine particles to the user's lungs, or about 0.2 mg to about 2 mg of nicotine particles to the user's lungs, or about 1 mg of nicotine particles to the user's lungs.

[0070] The nicotine particles can have any applicable nicotine concentration based on the particular formulation used. The nicotine particles can have at least about 1% wt nicotine up to about 30% wt nicotine, or about 2% wt to about 25% wt nicotine, or about 3% wt to about 20% wt nicotine, or about 4% wt to about 15% wt nicotine, or about 5% wt to about 13% wt nicotine. Preferably, each inhalation or "puff" can deliver about 50 to about 150 micrograms of nicotine to the user's lungs.

[0071] The capsule can hold or contain at least about 5 mg of nicotine particles or at least about 10 mg of nicotine particles. The capsule can hold or contain less than about 900 mg of nicotine particles, or less than about 300 mg of nicotine particles, or less than 150 mg of nicotine particles. The capsule can hold or contain about 5 mg to about 300 mg of nicotine particles or about 10 mg to about 200 mg of nicotine particles.

[0072] The nicotine particles can have any useful particle size distribution to preferably deliver inhalation into the lungs of a user. The capsule can include particles other than nicotine particles. The nicotine particles and other particles can form a powder system.

[0073] The capsule can hold or contain at least about 5 mg of dry powder (also referred to as a powder system) or at least about 10 mg of dry powder. The capsule can hold or contain less than about 900 mg of dry powder, or less than about 300 mg of dry powder, or less than about 150 mg of dry powder. The capsule can hold or contain about 5 mg to about 300 mg of dry powder, or about 10 mg to about 200 mg of dry powder, or about 25 mg to about 100 mg of dry powder.

[0074] The dry powder or powder system can have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the powder system comprised in nicotine particles having a particle size of about 5 microns or lower, or in a range of about 1 micron to about 5 microns.

[0075] The mass median aerodynamic diameter of the particles comprising nicotine can be about 5 microns or lower, or in a range of about 0.5 microns to about 4 microns, or in a range of about 1 micron to about 3 microns, or in a range of about 1.5 microns to about 2.5 microns. Preferably, the mass median aerodynamic diameter is measured with a cascade impactor.

[0076] The nicotine in the powder system or nicotine particles can be a pharmaceutically acceptable free base nicotine or a nicotine salt or a nicotine hydrate salt. Suitable nicotine salts or nicotine hydrate salts include, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine monopyruvate, nicotine glutamate, or nicotine hydrochloride. The compound that forms the salt or hydrate salt in combination with nicotine can be selected based on its expected pharmacological effect.

[0077] It is preferred that the nicotine particles comprise an amino acid. It is preferred that the amino acid can be leucine, such as L-leucine. Providing an amino acid such as L-leucine to the particles comprising nicotine can reduce the adhesion of the particles comprising nicotine and can reduce the attractive forces between nicotine particles and thus reduce agglomeration of the nicotine particles. Thus, the powder system described herein can be a free-flowing material and each powder component has a stable relative particle size even when the nicotine particles are combined with optional particles.

[0078] Preferably, the nicotine can be a surface-modified nicotine salt, wherein the nicotine salt particles comprise coated or composite particles. A preferred coating or composite material can be L-leucine. One particularly useful nicotine particle can be nicotine bitartrate combined with L-leucine. Preferably, the powder system can be free-flowing.

[0079] The inhaler and inhaler system can be less complex than conventional dry powder inhalers and have a simplified air flow path. Advantageously, rotation of the capsule within the inhaler body atomizes the nicotine particles or powder system and can help to maintain a free-flowing powder. Thus, the inhaler article can not require the higher inhalation rates typically utilized by conventional inhalers to deeply deliver the nicotine particles described above into the lungs.

[0080] The inhaler article can use a flow rate of less than about 5 L per minute, or less than about 3 L per minute, or less than about 2 L per minute, or about 1.6 L per minute. Preferably, the flow rate can be in the range of about 1 L per minute to about 3 L per minute, or in the range of about 1.5 L per minute to about 2.5 L per minute. Preferably, the inhalation rate or flow rate can be similar to the rate of Health Canada Smoking Regime, i.e., about 1.6 L per minute.

[0081] A consumer can use the inhaler system like a conventional cigarette or a vaped e-cigarette. Such smoking or vaping can be characterized by two steps: a first step in which a small amount containing the total amount of nicotine desired by the consumer is drawn into the mouth; followed by a second step in which the small amount containing the aerosol comprising the desired amount of nicotine is further diluted by fresh air and drawn deeper into the lungs. Both steps are controlled by the consumer. During the first inhalation step, the consumer can determine the amount of nicotine to be inhaled. During the second step, the consumer can determine the amount to dilute the first amount for deeper inhalation into the lungs, thereby maximizing the concentration of active agent delivered to the respiratory epithelial surface. This smoking mechanism is sometimes referred to as "puff-inhale-exhale".

[0082] The application is defined in the claims. However, a non-exhaustive list of non-limiting examples is provided below. Any one or more features of these examples can be combined with any one or more features of another example, embodiment, or aspect described herein.

[0083] Example Ex1 : An inhaler article comprising: a body extending along a longitudinal axis from a mouthpiece end to a distal end; a mouthpiece air outlet and a distal air inlet; a capsule cavity within the body and downstream defined by a mouthpiece; and a partition between the capsule cavity and the mouthpiece comprising at least one aperture to form an airflow path from the distal air inlet through the capsule cavity through the mouthpiece to the mouthpiece air outlet. A flavour coating layer can be provided on an inner surface of the mouthpiece, and a protective layer can be provided on the flavour coating layer.

[0084] Example Ex2. The inhaler article of Example Ex1, wherein the flavour coating layer defines at least a portion of a mouthpiece air channel in airflow communication with the capsule cavity.

[0085] Example Ex3. The inhaler article of any preceding example, wherein the flavour coating layer is provided between the protective layer and a mouthpiece inner surface.

[0086] Example Ex4. The inhaler article of any preceding example, wherein the flavour coating layer forms a gel layer.

[0087] Example Ex5. The inhaler article of any preceding example, wherein the protective layer has a thickness in a range of about 20 microns to about 60 microns.

[0088] Example Ex6. The inhaler article of any preceding example, wherein the flavour coating layer defines an open cylinder.

[0089] Example Ex7. The inhaler article of any preceding example, wherein the protective layer is adhered to the flavour coating layer, and the protective layer defines a cylinder coaxial with the body longitudinal axis.

[0090] Example Ex8. The inhaler article of any preceding example, wherein the protective layer comprises a foil, a paper, a polymer, or a combination thereof.

[0091] Example Ex9. The inhaler article of any preceding example, further comprising a mouthpiece end cap sealing the mouthpiece air outlet, the mouthpiece end cap configured to be removable from the mouthpiece element to expose the mouthpiece air outlet.

[0092] Example Ex10. The inhaler article of Example Ex9, wherein the protective layer is fixed to the mouthpiece end cap and configured to be removed from the mouthpiece element with the mouthpiece end cap.

[0093] Example Ex11. The inhaler article of Example Ex10, wherein the protective layer defines a helical configuration when removed from the mouthpiece element.

[0094] Example Ex12. The inhaler article of any one of Examples Ex9 to Ex11, further comprising a circumferential line of weakness forming an interface between the mouthpiece end cap and the mouthpiece end.

[0095] Example Ex13. The inhaler article of any one of Examples Ex9 to Ex12, wherein the mouthpiece end cap has an outer diameter equal to an outer diameter of the inhaler article body, and the mouthpiece end cap is coaxial with the inhaler article body.

[0096] Example Ex14. The inhaler article of any preceding Example, further comprising a capsule disposed within the capsule cavity.

[0097] Example Ex15. The inhaler article of Example Ex14, wherein the capsule comprises pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter of about 5 microns or less, or in a range of about 0.5 microns to about 4 microns, or in a range of about 1 micron to about 3 microns.

[0098] Example Ex16. The inhaler article of any preceding Example, wherein the mouthpiece can be removable and interchangeable to allow a user to select or change a type of flavor coating layer.

[0099] Example Ex17. The inhaler article of any preceding Example, wherein the protective layer comprises a helical or spiral score line or helical or spiral line of weakness along a length of the protective layer. BRIEF DESCRIPTION OF DRAWINGS

[0100] Several examples will now be described, with reference to the accompanying drawings, in which:

[0101] Figure 1 is a cross-sectional schematic view of an exemplary inhaler article;

[0102] Figure 2 is a side elevation schematic view of an exemplary inhaler article;

[0103] Figure 3 is a side elevation schematic view of an exemplary inhaler article in which the protective layer and mouthpiece end cap are being removed;

[0104] Figure 4 is a side elevation schematic view of the exemplary inhaler article of Figure 3 in which the protective layer and mouthpiece end cap are removed;

[0105] Figure 5 is a cutaway perspective view of an exemplary mouthpiece; and

[0106] Figure 6 is an exploded side elevational schematic view of an example mouthpiece having a protective layer. DETAILED DESCRIPTION

[0107] The drawings are not necessarily to scale and are presented for purposes of illustration and explanation and not limitation. The drawings depict one or more aspects of the disclosure. However, it will be understood that other aspects not depicted in the drawings fall within the scope and spirit of the disclosure.

[0108] Figure 1 is a cross-sectional schematic view of an example inhaler article 100. Figure 2 is a side elevational schematic view of an example inhaler article 100. Figure 3 is a side elevational schematic view of an example inhaler article 100 with the protective layer 140 and mouthpiece end cap 145 removed. Figure 4 is a side elevational schematic view of an example inhaler article 100 with the protective layer 140 and mouthpiece end cap 145 removed. Figure 3 is a side elevational schematic view of an example inhaler article 100 with the protective layer 140 and mouthpiece end cap 145 removed. Figure 5 is a cutaway perspective view of an example mouthpiece 120, Figure 6 is an exploded side elevational schematic view of an example mouthpiece 120 having a protective layer 140.

[0109] The inhaler article 100 includes a body 110 extending along a longitudinal axis L A from a mouthpiece end 112 to a distal end 114, a mouthpiece air outlet 116, and a distal air inlet 118. A capsule cavity 122 is defined within the body 110 and downstream by a mouthpiece 120. A partition 126 is between the capsule cavity 122 and the mouthpiece 120, including at least one aperture 126 to form an airflow path from the distal air inlet 118 through the capsule cavity 122, through the mouthpiece 120, to the mouthpiece air outlet 116. A flavour coating 130 is disposed on an inner surface 121 of the mouthpiece 120, and a protective layer 140 is disposed on the flavour coating 130.

[0110] The flavour coating 130 defines an open cylinder extending along a portion of the length of the mouthpiece 120. The protective layer 140 is adhered to the flavour coating 130, and the protective layer 140 defines a coaxial cylinder with the longitudinal axis L A of the body 110.

[0111] A mouthpiece end cap 145 seals the mouthpiece air outlet 116, the mouthpiece end cap 145 being configured to be removable from the mouthpiece 120 to expose the mouthpiece air outlet 116. The protective layer 140 can be fixed to the mouthpiece end cap 145 and configured to be removed from the mouthpiece 120 with the mouthpiece end cap 145.

[0112] A circumferential weak line 146 forms an interface between the mouthpiece end cap 145 and the mouthpiece end 112. The capsule 150 can be disposed within the capsule cavity 122.

[0113] like Figure 6 As shown, the mouthpiece 120, the flavor coating layer 130, and the protective layer 140 define a longitudinal axis L of the body 110. A The coaxial cylinder. The protective layer 140 may include spiral or coiled scoring lines 141 or spiral or coiled weak lines 141. The spiral or coiled scoring lines 141 or spiral or coiled weak lines 141 can provide [something] such as... Figure 3 The protective layer 140 is removed from the spiral configuration shown.

[0114] For the purposes of this specification and the appended claims, unless otherwise stated, all figures representing quantities, quantities, percentages, etc., shall be understood to be modified by the term “about” in all cases. Furthermore, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges that may be specifically listed or not listed herein. Thus, in this context, the numeral A is understood as A ± 2% A. Within this context, the numeral A can be considered as a value within the general standard error for the measurement of the attribute modified by the numeral A. In certain instances used in the appended claims, the numeral A may deviate from the percentages listed above, provided that the amount of deviation from A does not materially affect the essential and novel features of the claimed invention. Furthermore, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges that may be specifically listed or not listed herein.

Claims

1. An inhaler article comprising: a body extending along a longitudinal axis from a mouthpiece end to a distal end; a mouthpiece air outlet and a distal air inlet; a capsule cavity within the body and downstream defined by a mouthpiece; a partition between the capsule cavity and the mouthpiece comprising at least one aperture to form an airflow path from the distal air inlet through the capsule cavity, through the mouthpiece to the mouthpiece air outlet; and a flavour coating disposed on an inner surface of the mouthpiece and a protective layer disposed on the flavour coating.

2. The inhaler article of claim 1, wherein the flavour coating defines at least a portion of a mouthpiece air channel in airflow communication with the capsule cavity.

3. The inhaler article of claim 1 or 2, wherein the flavour coating is disposed between the protective layer and a mouthpiece inner surface.

4. The inhaler article of claim 1 or 2, wherein the flavour coating forms a gel layer.

5. The inhaler article of claim 1 or 2, wherein the protective layer has a thickness in the range of 20 microns to 60 microns.

6. The inhaler article of claim 1 or 2, wherein the flavour coating defines an open cylinder.

7. The inhaler article of claim 1 or 2, wherein the protective layer is adhered to the flavour coating and the protective layer defines a cylinder coaxial with the longitudinal axis of the body.

8. The inhaler article of claim 1 or 2, wherein the protective layer comprises a foil, a paper, a polymer, or a combination thereof.

9. The inhaler article of claim 1, further comprising a mouthpiece end cap sealing the mouthpiece air outlet, the mouthpiece end cap configured to be removable from the mouthpiece to expose the mouthpiece air outlet.

10. The inhaler article of claim 9, wherein the protective layer is secured to the mouthpiece end cap and configured to be removed from the mouthpiece with the mouthpiece end cap.

11. The inhaler article of claim 10, wherein the protective layer defines a helical configuration when removed from the mouthpiece.

12. The inhaler article of any one of claims 9 to 11, further comprising a circumferential line of weakness forming an interface between the mouthpiece end cap and the mouthpiece end.

13. The inhaler article of any one of claims 9 to 11, wherein the mouthpiece end cap has an outer diameter equal to an outer diameter of the body of the inhaler article and the mouthpiece end cap is coaxial with the body of the inhaler article.

14. The inhaler article of claim 1 or 2, further comprising a capsule disposed within the capsule cavity.

15. The inhaler article of claim 14, wherein the capsule contains pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter of 5 microns or less.

16. The inhaler article of claim 15, wherein the pharmaceutically active particles have a mass median aerodynamic diameter in the range of 0.5 microns to 4 microns. ​ 17. The inhaler article of claim 16, wherein the pharmaceutically active particles have a mass median aerodynamic diameter in the range of 1 to 3 microns.

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