Inhaler mouthpiece with separate flavour air channel

Abstract

An inhaler article includes a body extending along a longitudinal axis from a mouthpiece end to a distal end. A capsule cavity is within the body, downstream of the mouthpiece. An air inlet is at the distal end and an air outlet is at the mouthpiece end. A first mouthpiece air passage can extend from the distal air inlet through the capsule cavity to the mouthpiece air outlet. A second mouthpiece air passage can extend from a point downstream of the partition to the mouthpiece air outlet. The second mouthpiece air passage can be separate from the first mouthpiece air passage. A flavour coating layer can be provided on a surface of the second mouthpiece air passage, and a protective layer can be provided on the flavour coating layer.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to an inhaler article including a mouthpiece with a separate flavour air channel. The inhaler article can be a dry powder inhaler in which a flavour element is exposed to an air flow channel isolated from a dry powder air flow channel 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 air flow rate within a conventional smoking regime inhalation rate or air flow rate. The operation of dry powder inhalers 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 inhalable dry powder. To achieve this, flavour particles can be combined with the dry powder material. Flavour particles can be incompatible with the dry powder material. Flavour particles combined with dry powder can cause the dry powder to deteriorate or cake.

[0004] It would be desirable to provide an inhaler with a flavour element separate from a dry powder capsule or container. It would be desirable to provide an inhaler in which a flavour element is provided in a mouthpiece. It would be desirable to provide an inhaler with a flavour element exposed to an air flow path. It would be desirable to provide an inhaler with a dry powder air flow path. And, it would be desirable to provide an inhaler with a flavour element in an air flow path isolated from a dry powder air flow. It would be desirable to provide an inhaler that allows a consumer to release flavour on demand. It would be desirable to provide a sealed inhaler that can be assembled at high speed. It would be desirable to provide an inhaler with a flavour element interchangeable with different flavour elements. It would be desirable to provide an inhaler article in a form similar to a conventional cigarette that is easy to grip and familiar to users. It would be desirable to provide an inhaler in which a user easily activates a flavour element. SUMMARY

[0005] According to an aspect of the present invention, there is provided an inhaler article including a body extending along a longitudinal axis from a mouthpiece end to a distal end. A capsule cavity can be within the body, downstream bounded by the mouthpiece. The inhaler can have an air inlet at the distal end and an air outlet at the mouthpiece end. A partition can be between the capsule cavity and the mouthpiece to contain a capsule within the capsule cavity, including at least one aperture to form an air flow path through the capsule cavity to the mouthpiece. A first mouthpiece air channel can extend from the distal air inlet through the capsule cavity to the mouthpiece air outlet. A second mouthpiece air channel can extend from a point downstream of the partition to the mouthpiece air outlet. The second mouthpiece air channel can be separate from the first mouthpiece air channel. A flavour coating layer can be provided on a surface of the second mouthpiece air channel, and a protective layer can be provided on the flavour coating layer.

[0006] The inhaler article separates or isolates 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.

[0007] The inhaler article can comprise a flavour coating defining at least a portion of the second mouthpiece air channel.

[0008] The inhaler article can comprise a second mouthpiece air channel having an air inlet extending through the body of the inhaler. The second mouthpiece air channel having an air inlet through the body or sidewall of the inhaler article provides a separate air inlet that does not contain dry powder particles from the capsule cavity.

[0009] The inhaler article can comprise a second mouthpiece air channel having an air inlet extending through the mouthpiece. The second mouthpiece air channel having an air inlet through the mouthpiece or sidewall of the mouthpiece ensures a separate air inlet that does not contain dry powder particles from the capsule cavity.

[0010] The inhaler article can comprise a flavour coating forming a gel layer. Providing the flavour coating in a gel form can stabilise the flavour and is a convenient deposition technique during assembly. Providing the flavour coating in a gel form can allow customised controlled release of the flavour during consumption.

[0011] The inhaler article can comprise a flavour coating contacting an inner diameter of the mouthpiece.

[0012] The inhaler article can comprise a protective layer adhered to the flavour coating, and the protective layer defines a cylinder coaxial with the body longitudinal axis. Providing the flavour coating and the protective layer in this manner enables simplified construction and high speed assembly.

[0013] The inhaler article can comprise a protective layer comprising foil, paper, polymer or a combination thereof.

[0014] The mouthpiece can fit over the body of the inhaler. The body of the inhaler can be shaped to accommodate the mouthpiece. For example, the body of the inhaler can have a mouthpiece region having a reduced diameter, structured and arranged to fit inside the mouthpiece. The mouthpiece region of the inhaler body and the mouthpiece can form a coaxial cylinder.

[0015] In embodiments, the second air channel is formed between an inner surface of the mouthpiece and an outer surface of a narrowed portion of the mouthpiece end of the inhaler body. The flavour coating can be disposed on the inner surface of the mouthpiece.

[0016] The mouthpiece can be removed from the narrowed mouthpiece end of the inhaler body by using a sliding motion and sliding a new mouthpiece onto the inhaler body. This can be used to replace a spent flavour element or to change the type of flavour element as described by the user.

[0017] The inhaler article can further comprise 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 an extended shelf life of the inhaler and associated powder.

[0018] The inhaler article can comprise a protective layer that is 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 a convenient removal action for the user.

[0019] Additionally, the protective layer secured to the mouthpiece end cap can cover the air inlet of the second air passage before the protective layer is removed by the user. This prevents air from interacting with the flavour coating before the device is activated by the user.

[0020] The inhaler article can comprise a protective layer that defines a spiral configuration when removed from the mouthpiece element. Advantageously, such a spiral configuration allows the protective layer to be easily removed without damaging the flavour coating.

[0021] The inhaler article can further comprise a circumferential line of weakness that forms a demarcation between the mouthpiece end cap and the mouthpiece end. Advantageously, such a circumferential line of weakness provides a reliable and clean demarcation of separation of the mouthpiece end cap from the inhaler body or mouthpiece body.

[0022] The inhaler article can comprise a mouthpiece end cap having an outer diameter equal to the outer diameter of the inhaler article body, and the mouthpiece end cap is coaxial with the inhaler article body.

[0023] The inhaler article can further comprise a capsule disposed within the capsule cavity. The capsule can contain pharmaceutically active particles comprising nicotine. The pharmaceutically active particles can have a mass median aerodynamic diameter of about 5 microns or lower, or in a range from about 0.5 microns to about 4 microns, or in a range from about 1 micron to about 3 microns.

[0024] The inhaler article can comprise a first mouthpiece air passage that is coaxial with the second mouthpiece air passage. The first mouthpiece air passage and the second mouthpiece air passage can be coaxial with a longitudinal axis of the inhaler article body.

[0025] The inhaler article can comprise a removable and interchangeable mouthpiece to allow the user to select or change the type of flavour coating.

[0026] Advantageously, the inhaler article minimizes moving parts. Advantageously, the inhaler article effectively provides nicotine particles to the lungs at an inhalation rate or air flow rate within a conventional smoking manner inhalation rate or air flow 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 air flow rate within a conventional smoking manner inhalation rate or air flow rate. The consumer can take multiple inhalations or "puffs," with each "puff" delivering a small amount of the dry powder contained in the capsules housed within the 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.

[0027] Air flow management through the capsule cavity of the inhaler article can cause the capsules that can be housed therein to rotate during inhalation and consumption. The capsules can contain particles containing nicotine (also referred to as "nicotine powder" or "nicotine particles"). Rotation of the pierced capsule can pause and cause the nicotine particles released from the pierced capsule into the inhalation air moving through the inhaler article to be aerosolized. The particles containing nicotine can pass through a first mouthpiece air channel that is separate or isolated from the flavor element as the flavor particles are released from the flavor coating layer into a second mouthpiece air channel. The flavor particles can be larger than the nicotine particles and can aid in the delivery of the nicotine particles into the user's lungs while the flavor particles are preferentially retained in the user's mouth or buccal cavity. The nicotine particles and the flavor particles can be delivered with the inhaler article at an inhalation rate or air flow rate within a conventional smoking manner inhalation rate or air flow rate.

[0028] The term "gel" refers to a substantially dilute cross-linked system that exhibits no flow when in the steady state. Gels are predominantly liquid by weight, but they exhibit properties that are similar to those of solids due to the three-dimensional cross-linked network within the liquid. It is the cross-linking within the fluid that gives the gel its structure (firmness) and contributes to the gel's tackiness (stickiness). In this way, gels are a dispersion of liquid molecules within a solid medium.

[0029] The term "nicotine" refers to nicotine and nicotine derivatives, such as freebase nicotine, nicotine salts, and the like.

[0030] The term "flavor" or "flavorant" refers to an organoleptic compound, composition, or material that alters and is intended to alter the taste or aroma properties of nicotine during its consumption or inhalation.

[0031] The terms "upstream" and "downstream" refer to the relative position of the described elements of the inhaler article with respect to the direction of the inhalation air flow as it is inhaled through the inhaler article.

[0032] 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.

[0033] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are to facilitate understanding of certain terms used frequently herein.

[0034] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0035] As used herein, "or" is generally employed in its sense of "and / or" unless the context 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.

[0036] As used herein, "have," "having," "include," "including," "include," "includes," and the like are used in their open-ended sense, and generally mean "including, but not limited to." It will be understood that "consisting essentially of," "consisting of," and the like are subsumed in "comprising," and the like.

[0037] 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 or 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.

[0038] The present disclosure relates to an inhaler article that includes a mouthpiece with separate flavor air channels. The inhaler article can be a dry powder inhaler in which a flavor element is isolated from the dry powder air flow within the inhaler. The inhaler article can be configured to induce a vortex or swirling inhalation air flow during consumption.

[0039] An inhaler article includes a body extending along a longitudinal axis from a mouthpiece end to a distal end. A capsule cavity is within the body, downstream of the mouthpiece. An air inlet is at the distal end and an air outlet is at the mouthpiece end. A partition can be between the capsule cavity and the mouthpiece, including at least one aperture to form an air flow path from the capsule cavity to the mouthpiece. A first mouthpiece air channel can extend from the distal air inlet through the capsule cavity to the mouthpiece air outlet. A second mouthpiece air channel can extend from a point downstream of the partition to the mouthpiece air outlet. The second mouthpiece air channel can be separate from the first mouthpiece air channel. A flavour coating layer can be provided on a surface of the second mouthpiece air channel, and a protective layer can be provided on the flavour coating layer.

[0040] Isolating or separating the first mouthpiece air channel from the second mouthpiece air channel prevents air flow from the capsule cavity from flowing through the second mouthpiece air channel. This can be useful in the event that dry powder particles adhere to or degrade the flavour coating layer.

[0041] Preferably, the first mouthpiece air channel is coaxial with the second mouthpiece air channel. Preferably, the first mouthpiece air channel is coaxial and parallel with the second mouthpiece air channel. The first and second mouthpiece air channels can be coaxial with the longitudinal axis of the inhaler article body.

[0042] The second mouthpiece air channel can be formed by providing the mouthpiece around a reduced diameter portion of the inhaler body. The shaped, reduced diameter or narrowed portion of the body can extend along the mouthpiece region to the mouthpiece end of the inhaler article. The mouthpiece can fit over the reduced diameter portion of the inhaler body to form the second mouthpiece air channel.

[0043] The second mouthpiece air channel can define an annular void space between an inner surface of the mouthpiece and an outer surface of the reduced diameter portion of the inhaler body. The flavour coating layer can be provided on the inner surface of the mouthpiece. The flavour coating layer can cover about 50% or more of the inner surface of the mouthpiece. The flavour coating layer can cover about 75% or more of the inner surface of the mouthpiece. The flavour coating layer can cover about 90% or more of the inner surface of the mouthpiece.

[0044] The mouthpiece can be a replaceable element on the inhaler body. Thus, a user can remove a mouthpiece having a depleted flavour coating layer and place a different or newer mouthpiece on the inhaler body.

[0045] The inhaler article can include a flavour coating layer defining at least a portion of the second mouthpiece air channel. The flavour coating layer can have a uniform thickness around the circumference of the second mouthpiece air channel. The flavour coating layer can have a thickness in the range from about 5 microns to about 60 microns, preferably from about 10 microns to about 50 microns, most preferably from about 15 microns to about 35 microns. The flavour coating layer can have a longitudinal length that can co-extend with the second mouthpiece air channel. The flavour coating layer can have a longitudinal length in the range from about 5 mm to about 25 mm, preferably from about 7 mm to about 20 mm, most preferably from about 9 mm to about 18 mm.

[0046] The inhaler article can include a second mouthpiece air channel having an air inlet extending through the body of the inhaler article. The second mouthpiece air channel having an air inlet through the body or sidewall of the inhaler article ensures that the separate air inlet does not contain dry powder particles from the capsule cavity. The air inlet for the second mouthpiece air channel can be defined by a series of apertures or holes through the body or sidewall of the inhaler article. The series of apertures or holes through the body or sidewall of the inhaler article can extend circumferentially around the body or sidewall of the inhaler article.

[0047] The inhaler article can include a second mouthpiece air channel having an air inlet extending through the mouthpiece and along the length of the mouthpiece. The second mouthpiece air channel having an air inlet through the mouthpiece or sidewall of the mouthpiece ensures that the separate air inlet does not contain dry powder particles from the capsule cavity.

[0048] The mouthpiece is removable and interchangeable to allow a user to select or change the type of flavour coating layer.

[0049] The inhaler article can include a flavour coating layer forming a gel layer. Providing the flavour coating layer in the form of a gel can stabilise the flavour and be a convenient deposition technique during assembly. Providing the flavour coating layer in the form of a gel can allow customised controlled release of the flavour during consumption.

[0050] The inhaler article can include a flavour coating layer disposed between the protective layer and the inner surface of the mouthpiece. The flavour coating layer can contact and adhere to the inner surface of the mouthpiece.

[0051] The inhaler article can include a flavour coating layer as a gel, or an oil or powder stabilised to form the flavour coating layer.

[0052] The inhaler article preferably can include a flavour coating layer forming a gel layer. Providing the flavour coating layer in the form of a gel can stabilise the flavour and be a convenient deposition technique during assembly. Providing the flavour coating layer in the form of a gel can allow customised controlled release of the flavour during consumption.

[0053] 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 or an inner surface of the second mouthpiece air passage. 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 from about 5 microns to about 60 microns, preferably from about 10 microns to about 50 microns, most preferably from about 15 microns to about 35 microns. The flavor coating layer defining the open cylinder can have a longitudinal length that is coextensive with the second mouthpiece air passage. The flavor coating layer can have a longitudinal length in a range from about 5 millimeters to about 25 millimeters, preferably from about 7 millimeters to about 20 millimeters, most preferably from about 9 millimeters to about 18 millimeters.

[0054] 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 especially, 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.

[0055] 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 flavor properties 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 properties 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.

[0056] 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, gamma octalactone, vanillin, ethyl vanillin, air freshener flavors, flavoring flavors such as cinnamon, methyl salicylate, linalool, bergamot oil, geranium oil, lemon oil, and ginger oil, among others.

[0057] 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, nootkatone, maltol, damascenone, pyrazines, lactones, anethole, isovaleric acid, combinations thereof, and the like.

[0058] 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., imparting taste or odor to, a product.

[0059] Flavors can be high potency flavors and can be used and perceived at levels that will produce an inspired air stream below 200 parts per million. Examples of such flavors are key tobacco aroma compounds such as beta-damascenone, 2-ethyl-3,5-dimethylpyrazine, phenylacetaldehyde, guaiacol, and furaneol. Other flavors can only be perceived by humans at higher concentration levels. These flavors are referred to herein as low potency flavors and are typically used in amounts that produce several orders of magnitude more flavor than the amount released to the inspired air. Suitable low potency flavors 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.

[0060] The inhaler article can include a protective layer adhered to the flavor coating layer, and the protective layer defines a cylinder coaxial with the body longitudinal axis. The protective layer preferably covers the entire flavor coating layer surface. The protective layer can provide a moisture barrier for the flavor coating layer. The protective layer can prevent migration of the flavor away from the flavor coating layer.

[0061] 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.

[0062] The inhaler article protective layer can comprise polystyrene alcohol, polythiophene, polyethylene terephthalate, polyvinyl chloride, or oriented polyamide.

[0063] The inhaler article protective layer can have a thickness in a range from about 20 micrometers to about 60 micrometers, or in a range from about 25 micrometers to about 40 micrometers, or in a range from about 25 micrometers to about 35 micrometers.

[0064] 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 an extended shelf life of the inhaler and associated powder.

[0065] The inhaler article can include a protective layer that is 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 a convenient removal action for the user.

[0066] The inhaler article can include a protective layer having a spiral or helical score line along a length of the protective layer, or a spiral or helical line of weakness. The spiral or helical score line or spiral or helical line of weakness can provide removal of the protective layer in a spiral configuration. This can facilitate removal of the protective layer from the mouthpiece.

[0067] The inhaler article can include a protective layer that defines 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 flavour coating layer.

[0068] The inhaler article can further include a circumferential line of weakness that forms a demarcation between the mouthpiece end cap and the mouthpiece end. Advantageously, such a circumferential line of weakness provides a secure and clean demarcation of separation of the mouthpiece end cap from the inhaler body or mouthpiece body.

[0069] Once the protective layer is removed from the flavour coating layer, the flavour compounds evaporate from the flavour coating layer and combine with the particles of nicotine that are fluidised in the inhalation air stream.

[0070] 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.

[0071] 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 the 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 outer diameter of the inhaler body can be in a range from about 6 mm to about 10 mm, or from about 7 mm to about 10 mm, or from about 7 mm to about 9 mm, or from about 7 mm to about 8 mm, or about 7.2 mm. The length of the inhaler body (along the longitudinal axis) can be in a range from about 40 mm to about 80 mm, or from about 40 mm to about 70 mm, or from about 40 mm to about 50 mm, or about 45 mm.

[0072] 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 from about 10 mm to about 30 mm, preferably from about 15 mm to about 25 mm, and more preferably from about 20 mm to about 22 mm.

[0073] The partition can be between the capsule cavity and the mouthpiece. The partition can comprise at least one aperture to form an air flow 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 air flow 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.

[0074] The capsule cavity can define a cylindrical space configured to house 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 an inner cavity diameter orthogonal to the longitudinal axis, and the capsule has an outer capsule diameter. The capsule cavity can be sized and shaped to accommodate 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.

[0075] 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.

[0076] 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.

[0077] 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 initiate a swirling or rotational air flow through the capsule cavity. The swirling or rotational air flow through the capsule cavity spins or rotates the capsule and releases the powder from the capsule, as described herein.

[0078] The distal end of the inhaler can comprise an aperture to allow entry of a needle or perforating element into the capsule cavity and form an aperture in a capsule housed therein.

[0079] The capsule distal end can be sealed with a removable sealing film to seal the distal end of the inhaler article. The mouthpiece end cap element seals the proximal end of the inhaler article. The user removes both the distal end sealing film and the mouthpiece end cap element prior to consuming the inhaler article.

[0080] The inhaler article can include a deformable element defining a distal end of the inhaler article. The deformable element deforms to expose an open distal end. The deformable element can define a fan-fold at the distal end of the body. At least a portion of the deformable element can be formed from a cellulosic material. At least a portion of the deformable element can be formed from paper. The deformable element can define at least a portion of a longitudinal side wall of the capsule cavity. The deformable element can define a majority of the capsule cavity. The deformable element can define an upstream boundary and a side wall of the capsule cavity. The deformable element can extend beyond the body in a range from about 0.5 mm to about 5 mm, or from about 1 mm to about 4 mm, or from about 2 mm to about 3 mm. The deformable element can be formed from paper. The deformable element can be formed from one or more paper layers. The deformable element can be formed from paper having a weight in a range from about 50 g / m2to about 150 g / m2, or from about 75 g / m2to about 125 g, or from about 90 g / m2to about 110 g / m2. The deformable element can have a thickness in a range from about 50 microns to about 200 microns, or from about 100 microns to about 150 microns, or from about 110 microns to about 130 microns. Once broken or opened, the deformable element can define an opening having an opening diameter that is at least about 80% or at least about 90% of a diameter of the capsule cavity. Once broken or opened, the deformable element can fold back onto the side wall of the capsule cavity.

[0081] The capsule can rotate about its longitudinal or central axis when air flows through the inhaler article. The capsule can be formed from an air-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 from a metal or polymeric material for keeping the capsule uncontaminated yet pierceable or puncturable by the piercing element before consuming the nicotine particles within the capsule. The capsule can be formed from 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.

[0082] The capsule can contain pharmaceutically active particles. For example, the pharmaceutically active particles can include nicotine. The pharmaceutically active particles can have a mass median aerodynamic diameter of about 5 microns or lower, or in a range from about 0.5 microns to about 4 microns, or in a range from about 1 micron to about 3 microns.

[0083] 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 from about 5 to about 50 inhalations or "puffs", or from about 10 to about 30 inhalations or "puffs". Each inhalation or "puff" can deliver from about 0.1 mg to about 3 mg of nicotine particles to the lungs of a user, or from about 0.2 mg to about 2 mg of nicotine particles to the lungs of a user, or about 1 mg of nicotine particles to the lungs of a user.

[0084] The nicotine particles can have any useful concentration of nicotine depending on the particular formulation used. The nicotine particles can have at least about 1% wt nicotine up to about 30% wt nicotine, or from about 2% wt to about 25% wt nicotine, or from about 3% wt to about 20% wt nicotine, or from about 4% wt to about 15% wt nicotine, or from 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 lungs of a user.

[0085] 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 from about 5 mg to about 300 mg of nicotine particles or from about 10 mg to about 200 mg of nicotine particles.

[0086] The nicotine particles can have any useful particle size distribution to preferably deliver inhalations 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.

[0087] 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 from about 5 mg to about 300 mg of dry powder, or from about 10 mg to about 200 mg of dry powder, or from about 25 mg to about 100 mg of dry powder.

[0088] 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 less, or in the range of from about 1 micron to about 5 microns.

[0089] The particles comprising nicotine can have a mass median aerodynamic diameter of about 5 microns or less, or in the range from about 0.5 microns to about 4 microns, or in the range from about 1 micron to about 3 microns, or in the range from about 1.5 microns to about 2.5 microns. Preferably, the mass median aerodynamic diameter is measured using a cascade impactor.

[0090] 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 mono pyruvate, nicotine glutamate, or nicotine hydrochloride. The compound with which the nicotine is combined to form the salt or hydrate salt can be selected based on its expected pharmacological effect.

[0091] Preferably, the nicotine particles comprise an amino acid. Preferably, 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 the 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.

[0092] Preferably, the nicotine can be a surface modified nicotine salt, wherein the nicotine salt particles comprise a coated or composite particle. A preferred coating or composite material can be L-leucine. One particularly suitable nicotine particle can be nicotine bitartrate bound to L-leucine. Preferably, the powder system can be free flowing.

[0093] 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.

[0094] 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 from about 1 L per minute to about 3 L per minute, or in the range from 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's Smoking Regime, i.e., about 1.6 L per minute.

[0095] A consumer can use an inhaler system like a conventional cigarette is drawn upon or an electronic cigarette is vaped. Such smoking or vaping can be characterized by two steps: a first step in which a small amount containing the full amount of nicotine desired by the consumer is drawn into the mouth; followed by a second step in which the small amount containing an aerosol including 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 "draw-inhale-exhale."

[0096] The present invention 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.

[0097] Example Ex1 : An inhaler article includes a body extending along a longitudinal axis from a mouthpiece end to a distal end. A capsule cavity is within the body, downstream bounded by a mouthpiece. An air inlet is at the distal end and an air outlet is at the mouthpiece end. A partition can be between the capsule cavity and the mouthpiece, including at least one aperture to form an air flow path from the capsule cavity to the mouthpiece. A first mouthpiece air channel can extend from the distal air inlet through the capsule cavity to the mouthpiece air outlet. A second mouthpiece air channel can extend from a point downstream of the partition to the mouthpiece air outlet. The second mouthpiece air channel can be separate from the first mouthpiece air channel. A flavor coating layer can be disposed on a surface of the second mouthpiece air channel, and a protective layer can be disposed on the flavor coating layer.

[0098] Example Ex2. The inhaler article according to Example Ex1, wherein the flavor coating layer defines at least a portion of the second mouthpiece air channel.

[0099] Example Ex3. The inhaler article according to any preceding example, wherein the second mouthpiece air channel has an air inlet extending through the inhaler body.

[0100] Example Ex4. The inhaler article according to any preceding example, wherein the second mouthpiece air channel has an air inlet extending through the mouthpiece.

[0101] Example Ex5. The inhaler article according to any preceding example, wherein the flavor coating layer forms a gel layer.

[0102] Example Ex6. The inhaler article according to any preceding example, wherein the flavor coating layer contacts an inner diameter of the mouthpiece.

[0103] Example Ex7. The inhaler article according to any preceding example, wherein the protective layer is adhered to the flavor coating layer, and the protective layer defines a cylinder coaxial with the body longitudinal axis.

[0104] Example Ex8. The inhaler article according to any preceding example, wherein the protective layer comprises a foil, a paper, a polymer, or a combination thereof.

[0105] Example Ex9. The inhaler article according to 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.

[0106] Example Ex10. The inhaler article according to Example Ex9, wherein the protective layer is secured to the mouthpiece end cap and configured to be removed from the mouthpiece element with the mouthpiece end cap.

[0107] Example Ex11. The inhaler article according to Example Ex10, wherein the protective layer defines a spiral configuration when removed from the mouthpiece element.

[0108] Example Ex12. The inhaler article according to any of Examples Ex9 to Ex11, further comprising a circumferential line of weakness forming an interface between the mouthpiece end cap and the mouthpiece end.

[0109] Example Ex13. The inhaler article according to any 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.

[0110] Example Ex14. The inhaler article according to any preceding example, further comprising a capsule disposed within the capsule cavity.

[0111] Example Ex15. The inhaler article according to Example Ex14, wherein the capsule contains pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter of about 5 microns or lower, or in a range from about 0.5 microns to about 4 microns, or in a range from about 1 micron to about 3 microns.

[0112] Example Ex16. The inhaler article according to any preceding example, wherein the first mouthpiece air passage is coaxial with the second mouthpiece air passage.

[0113] Example Ex17. The inhaler article according to any preceding example, wherein the first mouthpiece air passage and the second mouthpiece air passage are coaxial with a longitudinal axis of the inhaler article body.

[0114] Example Ex17. An inhaler article according to any preceding example, wherein the mouthpiece is removable and interchangeable to allow a user to select or change the type of flavour coating.

[0115] Example Ex18. An inhaler article according to any preceding example, wherein the body defines a narrowed portion extending to the mouthpiece end, and the mouthpiece is disposed about the narrowed portion, and the mouthpiece and the narrowed portion form the second mouthpiece air passage.

[0116] Example Ex19. An inhaler article according to example 18, wherein the mouthpiece and the narrowed portion of the body form coaxial cylinders.

[0117] Example Ex20. An inhaler article according to example 18, wherein the mouthpiece is removable from the inhaler article body, and the flavour coating is disposed on a surface of the mouthpiece.

[0118] Example Ex21. An inhaler article according to example 18, wherein the mouthpiece is removable from the inhaler article body, and the flavour coating is disposed on an inner surface of the mouthpiece.

[0119] Example Ex22. An inhaler article according to any of examples 18 to 21, wherein the inner surface of the mouthpiece and the narrowed portion of the body forming an outer surface define an annular interstitial space forming the second mouthpiece air passage.

[0120] Example Ex23. An inhaler article according to any preceding example, further comprising a deformable element defining a distal end of the inhaler article, the deformable element deformed to expose an open distal end.

[0121] Example Ex24. An inhaler article according to example 23, wherein the deformable element is folded in a fan shape at the distal end of the body. BRIEF DESCRIPTION OF DRAWINGS

[0122] Examples will now be further described with reference to the drawings in which:

[0123] Figure 1 is a cross-sectional schematic view of an exemplary inhaler article;

[0124] Figure 2 is a side elevation schematic view of an exemplary inhaler article;

[0125] Figure 3 is a side elevation schematic view of an exemplary inhaler article with the protective layer and mouthpiece end cap removed;

[0126] Figure 4 is a side elevation schematic view of an exemplary inhaler article of Figure 3 with the protective layer and mouthpiece end cap removed; and

[0127] Figure 5 is a cross-sectional schematic of an exemplary mouthpiece showing separate air flow paths for a first mouthpiece air channel and a second mouthpiece air channel.

[0128] Figure 6 is a cross-sectional schematic of another exemplary inhaler article;

[0129] Figure 7 is a front perspective view of the exemplary inhaler article of Figure 6

[0130] is a front perspective view of the exemplary inhaler article of Figure 8 Figure 6 is a front perspective view of the exemplary inhaler article of

[0131] Figure 9 Figure 6 is a front perspective view of the exemplary inhaler article of

[0132] Figure 10 is a front perspective view of the exemplary inhaler article of Figure 6

[0133] The schematic drawings are not necessarily to scale and are presented for purposes of illustration and not limitation. The drawings depict one or more aspects described in this disclosure. It will be understood that other aspects not depicted in the drawings fall within the scope and spirit of this disclosure. DETAILED DESCRIPTION

[0134] Figure 1 is a cross-sectional schematic of an exemplary inhaler article 100. Figure 2 is a side elevation schematic of the exemplary inhaler article 100. Figure 3 is a side elevation schematic of the exemplary inhaler article 100 with the protective layer and mouthpiece end cap removed. Figure 4 is a side elevation schematic of the exemplary inhaler article 100 of Figure 3 with the protective layer and mouthpiece end cap removed. Figure 5 is a cross-sectional schematic of an exemplary mouthpiece showing separate air flow paths for a first mouthpiece air channel and a second mouthpiece air channel.

[0135] Figure 6 is a cross-sectional schematic of another exemplary inhaler article. Figure 7 is a side elevation schematic of the exemplary inhaler article of Figure 6 Figure 8 is a side elevation schematic of the exemplary inhaler article of Figure 6 with the protective layer and mouthpiece end cap removed.​​​​Figure 9 is an exemplary inhaler article having a fully deformed element 158 Figure 6 is a front perspective view of an exemplary inhaler article. Figure 10 is an exemplary inhaler article having an open deformable element 158 Figure 6 is a front perspective view of an exemplary inhaler article. Figures 6 to 10 The inhaler article of

[0136] 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 capsule cavity 122 can be defined within the body 110 downstream by a mouthpiece 120. An air inlet 118 is at the distal end 114 and an air outlet 116 is at the mouthpiece end 112. A partition 124 can be between the capsule cavity 122 and the mouthpiece 120, including at least one aperture 126 to form an air flow path from the capsule cavity 122 to the mouthpiece 120. A first mouthpiece air passage 125 can extend from the distal air inlet 118 through the capsule cavity 122 to the mouthpiece air outlet 116. A second mouthpiece air passage 135 can extend from a point downstream of the partition 124 to the mouthpiece air outlet 116. The second mouthpiece air passage 135 can be separate from the first mouthpiece air passage 125. A flavour coating 130 can be disposed on a surface of the second mouthpiece air passage 135 and a protective layer 140 can be disposed on the flavour coating 130.

[0137] The second mouthpiece air passage 135 has an air inlet 132 extending through the body 110 of the inhaler 100. The second mouthpiece air passage 135 has an air inlet 132 extendable through the mouthpiece 120. The second mouthpiece air passage 135 has an air inlet 132 extendable through a sidewall of the mouthpiece 120. The second mouthpiece air passage 135 air inlet 132 can be formed by a plurality of holes or apertures positioned circumferentially around the mouthpiece 120.

[0138] The first mouthpiece air passage 125 can be coaxial with the second mouthpiece air passage 135. The first mouthpiece air passage 125 and the second mouthpiece air passage 135 can be coaxial with the longitudinal axis L A of the inhaler article body 110. The first mouthpiece air passage 125 can be coaxial with and parallel to the second mouthpiece air passage 135.

[0139] The second mouthpiece air passage 135 can be formed by disposing the mouthpiece 120 over a reduced diameter portion 111 of the inhaler body 110. The shaped, reduced diameter or narrowed portion 111 of the body can extend along the mouthpiece region to the mouthpiece end 112 of the inhaler article 100. The mouthpiece 120 can fit over the reduced diameter portion 111 of the inhaler body 110 to form the second mouthpiece air passage 135.

[0140] The second mouthpiece air passage 135 can define an annular interstitial space between the inner surface 121 of the mouthpiece and the outer surface of the reduced diameter portion 111 of the inhaler body 110. The flavor coating 130 can contact the inner diameter surface 121 of the mouthpiece 120.

[0141] The mouthpiece 120 can be a replaceable element on the inhaler body 100. Thus, a user can remove the mouthpiece 120 having an exhausted flavor coating 130 and place a different or newer mouthpiece 120 over the reduced diameter portion 111 and on the inhaler body 110.

[0142] The protective layer 140 can be adhered to the flavor coating 130, and the protective layer 140 can define a longitudinal axis L A The protective layer 140 can be a coaxial cylinder. The mouthpiece end cap 145 can seal the mouthpiece air outlet 116, the mouthpiece end cap 145 can be configured to be removable from the mouthpiece 120 to expose the mouthpiece air outlet 116. The protective layer 140 can be secured to the mouthpiece end cap 145 and configured to be removed from the mouthpiece 120 with the mouthpiece end cap 145. As Figure 3 The protective layer 140 can define a helical configuration upon removal from the mouthpiece 120 as shown in FIG. 6.

[0143] The protective layer 140 can seal the air inlet 132 of the second mouthpiece air passage 135. The protective layer 140 can extend from the mouthpiece end cap 145 along the flavor coating 130 and over the air inlet 132 of the second mouthpiece air passage 135 to provide a barrier and reduce or prevent migration of the flavor material of the flavor coating 130.

[0144] The circumferential line of weakness 146 forms an interface between the mouthpiece end cap 145 and the mouthpiece end 112. A user can separate the mouthpiece end cap 145 from the mouthpiece 120 at the circumferential line of weakness 146.

[0145] The capsule 150 can be disposed within the cavity 122. The capsule 150 can be replaced by removing the distal end 114 or the mouthpiece 120 of the inhaler article 100 and removing or inserting the capsule 150. The distal end 114 air inlet 118 can induce a rotational or swirling air flow into the capsule cavity to spin or spin the capsule 150 and release dry powder particles into the air flow.

[0146] As Figure 5As shown in the middle, the air stream from the capsule cavity containing entrained dry powder particles passes through the partition and exits the mouthpiece air outlet 116 along the first air channel 125. A separate air stream passes through the body 110 of the inhaler into the second air channel 135, where the flavouring evaporates into the air stream along the second air channel 135 and exits the mouthpiece air outlet 116. The second air channel 135 can provide a separate and isolated stream of flavouring ventilation air from the air stream from the capsule cavity containing entrained dry powder particles passing through the first air stream channel 125. Thus, the dry powder particles and the flavouring do not contact each other within the inhaler article 100. The dry powder particles and the flavouring only contact each other once they have exited the inhaler article 100. The air stream along the first air stream channel 125 can be parallel and coaxial with the separate air stream along the second air channel 135. Once the air streams from the first air stream channel 125 and the second air channel 135 exit the inhaler article 100, they can combine.

[0147] For purposes of this specification and accompanying claims, unless otherwise indicated, all numbers expressing amounts, quantities, percentages, and so forth, are to be understood as being modified in all instances by the term "about." Also, all ranges include the maximum and minimum points disclosed and include any intermediate ranges that can not be expressly disclosed. Thus, in this context, A is understood to mean A ± 2% A. Within this context, the number A can be considered to include values within the general standard error of a measurement of the property modified by the number A. In certain instances in the appended claims, the number A can deviate from the percentage recited above, provided that the amount by which A deviates does not materially affect the basic characteristics and novel features of the claimed invention. Also, all ranges include the maximum and minimum points disclosed and include any intermediate ranges that can not be expressly disclosed.

Claims

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

2. An inhaler article according to claim 1, wherein the flavour coating defines at least a portion of the second mouthpiece air channel.

3. An inhaler article according to claim 1 or 2, wherein the second mouthpiece air channel has an air inlet extending through the body of the inhaler article.

4. An inhaler article according to claim 1 or 2, wherein the second mouthpiece air channel has an air inlet extending through the mouthpiece.

5. An inhaler article according to claim 1 or 2, wherein the flavour coating forms a gel layer.

6. An inhaler article according to claim 1 or 2, wherein the body defines a narrowing portion extending to the mouthpiece end, and the mouthpiece is disposed around the narrowing portion, and the mouthpiece and the narrowing portion form the second mouthpiece air channel.

7. An inhaler article according to claim 6, wherein the mouthpiece is removable from the body of the inhaler article, and the flavour coating is disposed on an inner surface of the mouthpiece.

8. An inhaler article according to 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.

9. An inhaler article according to claim 1 or 2, wherein the protective layer comprises a foil, a paper, a polymer, or a combination thereof.

10. An inhaler article according to claim 1 or 2, 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, and the protective layer is secured to the mouthpiece end cap and configured to be removed from the mouthpiece with the mouthpiece end cap.

11. An inhaler article according to claim 10, wherein the protective layer defines a helical configuration when removed from the mouthpiece.

12. An inhaler article according to claim 10, further comprising a circumferential line of weakness forming an interface between the mouthpiece end cap and the mouthpiece end.

13. The inhaler article of claim 10, 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 a range from 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 a range from 1 micron to 3 microns.

18. The inhaler article of claim 1 or 2, further comprising a deformable element defining a distal end of the inhaler article, the deformable element deformed to expose an open distal end.

19. The inhaler article of claim 18, wherein the deformable element is folded in a fan shape at the distal end of the body.

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