Inhaler article with twisted distal end element

Abstract

The inhaler article (110) comprises a body (112) extending along a longitudinal axis (A) from a mouthpiece end (113) to a distal end (114), a capsule cavity (116) defined within the body, and a distal end element (118) disposed at the distal end and extending into the capsule cavity. The distal end element includes an element distal end (120), an element inner end (122), a solid core portion (124), and at least two grooves (126). The solid core portion extends from the element distal end to the element inner end. The at least two grooves are helical grooves that rotate around the solid core portion along the longitudinal axis from the element distal end to the element inner end. The at least two helical grooves extend along the outer surface (128) of the distal end element.

Description

[Technical field]

[0001] The present disclosure relates to inhaler articles having twisted distal tip elements and methods of making the twisted distal tip elements. [Background technology]

[0002] Dry powder inhalers are not always fully adequate to deliver dry powder particles to the lungs at inhalation volumes or airflow rates within the range of conventional smoking methods. Dry powder inhalers can be complicated to operate or involve moving parts. Dry powder inhalers often attempt to deliver the entire dry powder dose in a single breath.

[0003] Dry powder inhalers are typically made of materials that are not biodegradable. Additionally, they are often made of materials that may require injection molding or casting, and the assembly of these parts can be disruptive to the manufacturing process and difficult to produce at high speeds.

[0004] It would be desirable to provide an inhaler article that can be assembled quickly. It would also be desirable to provide an inhaler article that has a form similar to a conventional cigarette that is easy to hold and familiar to the user. It would also be desirable to provide an inhaler article that is convenient to use by the consumer. It would be desirable to provide a dry powder inhaler that is substantially biodegradable. Summary of the Invention

[0005] According to one aspect of the invention, an inhaler article is provided, comprising a body extending along a longitudinal axis from a mouthpiece end to a distal end of the inhaler article, a capsule cavity defined within the body, and a distal end element disposed at the distal end and extending into the capsule cavity. The distal end element includes an element distal end, an element inner end, a solid core portion, and at least two helical grooves. The solid core portion extends from the element distal end to the element inner end. The at least two grooves are helical grooves that rotate about the solid core portion along the longitudinal axis from the element distal end to the element inner end. The at least two helical grooves extend along an outer surface of the distal end element.

[0006] According to one aspect of the invention, an inhaler article is provided, comprising a body extending along a central longitudinal axis from a mouthpiece end to a distal end of the inhaler article, a capsule cavity defined within the body, and a distal end element disposed at the distal end and extending into the capsule cavity. The distal end element includes an element distal end, an element inner end, a solid core portion, and at least two helical grooves. The solid core portion extends from the element distal end to the element inner end. The at least two grooves are helical grooves that rotate about the solid core portion along the central longitudinal axis from the element distal end to the element inner end. The at least two helical grooves extend along an outer surface of the distal end element.

[0007] The term "solid core portion" refers to a core portion of a distal end element that is solid, i.e., the core portion has no internal cavity, or the core portion is not hollow, or the core portion has no substantial gaps, channels, or passages. The solid core portion may be formed of a homogenous material along the entire length of the distal end element. The solid core portion may be formed of a homogenous porous material along the entire length of the distal end element. Such a core portion may be a central portion of the distal end element.

[0008] "Substantial gap, channel or passage" is understood to mean an opening that is larger than the pores (if any) of the material forming the end element. Substantial gap, channel or passage is understood to mean an opening that has a lateral dimension of 1 mm or more.

[0009] Also provided is an inhaler article comprising a body extending along a longitudinal axis from a mouthpiece end to a distal end, a capsule cavity defined within the body, and a distal end element disposed at the distal end of the inhaler article and extending into the capsule cavity. The distal end element includes an element distal end, an element inner end, and at least two helical grooves on an outer surface of the distal end element extending from the element distal end to the element inner end. The distal end element having at least two grooves may be twisted to form a twisted distal end element. Preferably, such at least two grooves in the distal end element material are substantially straight before twisting and helical after twisting.

[0010] The distal end element is preferably a distal end plug.

[0011] The solid core portion extends from the element distal end to the element inner end forming a continuous solid core. The at least two grooves may be parallel grooves rotating about a continuous core along a longitudinal central axis from the element distal end to the element inner end. The at least two helical grooves extend along an outer surface of the distal end element. The solid core portion may be formed of a porous material. The solid core portion is preferably formed of a cellulosic material such as cellulose acetate. The solid core portion is preferably formed of a polylactic acid material.

[0012] The distal tip element is preferably formed of a biodegradable material. The distal tip element preferably comprises a fibrous material. The distal tip element is preferably formed of a porous material. The distal tip element is preferably formed of a cellulosic material, such as cellulose acetate. The distal tip element is preferably formed of a polylactic acid material.

[0013] Advantageously, the distal end element may be formed from materials used to construct conventional cigarettes. Advantageously, the inhaler article may be formed from biodegradable materials.

[0014] The term "biodegradable" refers to materials that can be broken down by bacterial decomposition to produce natural by-products such as gases (CO2 and N2), water, biomass, and inorganic salts. Biodegradable materials include plant-derived materials such as polysaccharides, cellulose, cellulose acetate, starch rubber, microbial-derived materials such as polyhydroxyalkanoates (PHAs), and synthetic materials such as polylactides and polylactic acids (PLA). These biodegradable materials can be fibrous or porous. The distal end element can be formed of biodegradable, fibrous, or porous materials. The biodegradable materials can be, for example, cellulose, cellulose acetate, or polylactic acid.

[0015] The parallel grooves may preferably rotate at least 90 degrees from the element distal end to the element inner end. The parallel grooves may rotate at least 180 degrees from the element distal end to the element inner end. The element distal end is preferably substantially aligned with the distal end of the inhaler article or body.

[0016] Advantageously, the distal end element may provide or create a "swirling" effect on the inhalation airflow into the capsule cavity that may be useful for effective depletion of the capsule during use. Advantageously, this "swirling" inhalation airflow may induce a rotation of the capsule that provides uniform entrainment of a portion or fraction of the nicotine particles from the capsule over two or more, or five or more, or ten or more inhalations or "puffs" by the user.

[0017] The capsule is preferably disposed within a capsule cavity of the inhaler article. The capsule preferably contains medicamentously active particles including nicotine. The medicamentously active particles may have a mass median aerodynamic diameter of about 5 micrometers or less, or within the range of about 0.5 micrometers to about 4 micrometers, or within the range of about 1 micrometer to about 3 micrometers.

[0018] The capsule may further contain a second population of flavor particles having a mass median aerodynamic diameter of about 20 micrometers or more, or about 50 micrometers or more, or within the range of about 50 to about 200 micrometers, or about 50 to 150 micrometers.

[0019] According to one aspect of the invention, there is provided an inhaler system comprising an inhaler article as described herein and a holder configured to receive the inhaler article.

[0020] The holder may further include a piercing element releasably engageable with the inhaler article to activate the capsule, the twisted distal end element being configured to be pierced by the piercing element when activating the capsule.

[0021] According to one aspect of the invention, there is provided a method of manufacturing a distal end element for an inhaler article, the method comprising: providing a distal end element material having a longitudinal axis, an outer surface, an element material distal end and an element material inner end, the distal end element material including at least two grooves on the outer surface extending from the element material distal end to the element material inner end; and twisting at least one of the element material distal end and the element material inner end about the longitudinal axis such that the grooves are formed in a helical shape about the longitudinal axis to form a twisted distal end element.

[0022] The twisting step preferably deforms the distal element material such that the twisted configuration is maintained. The twisting step preferably rotates the element distal end at least 90 degrees or at least 180 degrees relative to the element inner end. The twisting step preferably permanently deforms the distal element.

[0023] Advantageously, the distal end element may be simply and reliably formed. Advantageously, the distal end element may be simply and reliably assembled into a dry powder inhaler article. Advantageously, the inhaler article is of a similar form to a conventional cigarette. This may allow for rapid assembly or manufacturing of the inhaler article.

[0024] The inhaler article described herein may provide dry powder to the lungs at an inhalation volume or airflow rate within the range of that of traditional smoking methods. A user may take multiple inhalations or "puffs", with each "puff" delivering a portion of the dry powder contained in the capsule contained within the capsule cavity. The inhaler article may have a form similar to a traditional cigarette and may mimic the routine of traditional smoking. The inhaler may be simple to manufacture and convenient for the user to use.

[0025] The inhaler articles described herein may be combined with a piercing element or device (which may form part of the holder) to deliver nicotine particles from the capsule to the user. The piercing element or device may be separate from a portion of the inhaler article or may not form part of the inhaler article. Multiple inhaler articles may be combined with a piercing element or device to form a kit.

[0026] Airflow management through the capsule cavity may rotate the capsule during inhalation and consumption. The capsule contains nicotine particles containing nicotine (also referred to as "nicotine powder" or "nicotine particles"), and optionally, flavor-containing particles (also referred to as "flavor particles"). Rotation of the pierced capsule may suspend and aerosolize the nicotine particles released from the pierced capsule into the inhaled air moving through the inhaler article. The flavor particles may be larger than the nicotine particles and help deliver the nicotine particles to the user's lungs, while the flavor particles preferentially remain in the user's mouth or oral cavity. The nicotine particles and optional flavor particles may be delivered by the inhaler article at an inhalation volume or airflow within the range of inhalation volumes or airflows of conventional smoking methods.

[0027] The term "porous" refers to a material that contains pores. In particular, porous refers to a nonwoven fibrous material when formed with a fibrous matrix that defines pores. The porous material has a "resistance to draw" or "RTD" that is within the range of about 30 to about 90 millimeters of water (mm).

[0028] The term "resistance to draw" or "RTD" refers to the static pressure difference between the two ends of a sample when crossed by a stream of air under steady conditions with a volumetric flow rate of 17.5 milliliters per second at the output end. The RTD of a sample can be measured using the method described in ISO standard 6565:2002.

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

[0030] The term "flavoring agent" or "flavor" 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. The term "flavoring agent" or "flavor" preferably refers to compounds disclosed in the Flavor Extracts Manufacturers Association (FEMA) Flavor Ingredients Library, and in particular in publications 3-27 on GRAS flavoring substances (e.g., Hall, RL & Oser, BL, Food Technology, February 1965 pg 151-197), GRAS flavoring substances 27 (SM Cohen et al., Food Technology Aug. 2015 pg. 40-59), and publications 4-26 on intermediate GRAS flavoring substances. For the purposes of this disclosure, nicotine is not considered a flavoring agent or flavor.

[0031] The terms "upstream" and "downstream" refer to the relative locations of elements of the inhaler described with respect to the direction of inhalation airflow as it is drawn through the body of the inhaler from the distal end to the mouthpiece portion.

[0032] The terms "proximal" and "distal" are used to describe the relative positions of components or portions of components of a holder, inhaler article, or system. An inhaler article according to the invention has a proximal end, from which particles exit the inhaler article for delivery to a user during use, and an opposing distal end, which receives the inhalation airflow entering the inhaler article. The proximal end of the inhaler article may also be referred to as the mouth end.

[0033] As used herein, the singular forms "a," "an," and "the" include embodiments having plural referents unless the content clearly dictates otherwise.

[0034] As used herein, "or" is generally used in its inclusive sense, unless the context clearly dictates otherwise. The term "and / or" refers to one or all of the listed elements or a combination of any two or more of the listed elements.

[0035] As used herein, the words "have," "having," "include," "including," "comprise," "comprising," and the like are used in an open-ended sense and generally mean "including, but not limited to." It should be understood that "consisting essentially of," "consisting of," and the like are encompassed by "comprising" and the like.

[0036] The words "preferred" and "preferably" refer to embodiments of the invention that may, under particular circumstances, offer certain advantages. However, other embodiments may also be preferred, under the same or other circumstances. Moreover, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the present disclosure, including the claims.

[0037] An inhaler article according to the present disclosure includes a body extending along a longitudinal central axis from a mouthpiece end to a distal end. A capsule cavity is defined in the body. A distal end element is disposed at the distal end and extends into the capsule cavity. The distal end element includes an element distal end and an element inner end adjacent to the capsule cavity. The distal end element includes a continuous solid core portion and at least two helical grooves extending from the element distal end to the element inner end. The at least two helical grooves are parallel grooves that rotate about the continuous solid core portion along the longitudinal central axis from the element distal end to the element inner end. The at least two helical grooves may extend along an outer surface or periphery of the distal end element.

[0038] The body of the inhaler article, or "inhaler body", may have any suitable shape. The body of the inhaler article, or "inhaler body", may be similar in size and shape to a smoking article or a conventional cigarette. The inhaler body may have an elongated cylindrical body extending along a longitudinal central axis of the inhaler article. In other words, the inhaler body may have a length that is substantially greater than other dimensions of the inhaler body. The inhaler body may have a substantially uniform outer diameter along the length of the inhaler body. The inhaler body may have a substantially uniform inner diameter along the length of the inhaler body. The inhaler body may have any suitable cross-sectional shape. For example, the cross-section may be circular, elliptical, square, or rectangular. The inhaler body may have a circular cross-section that is uniform along the length of the inhaler body, forming an elongated cylindrical body. The inhaler body may be or define the outer wrapper of the inhaler article.

[0039] The inhaler body may have an outer diameter within the range of about 6 mm to about 10 mm, or about 6 mm to about 9 mm, or about 6 mm to about 8 mm. The inhaler body may have a length (along the longitudinal axis) within the range of about 40 mm to about 100 mm, or about 40 mm to about 80 mm, or about 40 mm to about 60 mm.

[0040] The inhaler body may be formed of a polymeric or cellulosic material, or any other suitable material. The inhaler body may be formed of a biodegradable material. The inhaler body may be formed of paperboard or cardboard. The inhaler body may have a uniform thickness along its length. The inhaler body may have a thickness in the range of about 1 mm to about 2 mm.

[0041] The inhaler body may form a unitary structure in which the body extends continuously from the distal end element to the mouthpiece end. The distal end element, the capsule cavity (and capsule, if present), and the porous support element (or filter) may be arranged in series within the inhaler body. In other words, the distal end element, the capsule cavity (and capsule, if present), and the porous support element (or filter) may be arranged end-to-end along the longitudinal axis of the inhaler body. The porous support element (or filter) may be arranged within the mouthpiece of the body. The mouthpiece air channel may extend from the porous support element (or filter) to the mouthpiece end. The porous support element (or filter) may extend from the capsule cavity to the mouthpiece end of the inhaler device.

[0042] The inhaler body may be formed of two or more sections. The two or more sections may be axially aligned in serial adjacent relationship and grouped together to form the inhaler body. A wrapper may be utilized to group the two or more sections together. The wrapper may be a biodegradable material. The wrapper may be a paper wrapper.

[0043] The distal end element may be disposed within a distal end of the body. The element distal end may be substantially aligned with the distal end of the body. The distal end element may define an upstream boundary of the capsule cavity.

[0044] The distal end element may be configured to induce a swirling airflow within the capsule cavity of the inhaler body. The distal end element may include a helical groove forming an air channel or passageway through which air enters the capsule cavity of the inhaler body at the element distal end and extends through the distal end element and exits at the element inner end. The distal end element may induce a rotating or swirling airflow as air flows through the helical groove and through the capsule cavity. Airflow through the inhaler device preferably enters the inhaler device at the element distal end, flows along the longitudinal axis of the inhaler device, and exits the mouthpiece end at the proximal end of the inhaler device.

[0045] The distal end element may have a length extending along the longitudinal axis (or central longitudinal axis) of the inhaler body between the element distal end and the element inner end. The distal end element may have any suitable length, such as from about 5 mm to about 15 mm. The distal end element may have a length within the range of from about 7 mm to about 12 mm.

[0046] The distal end element (including its outer circumference) may substantially occupy the inner diameter of the inhaler body. The distal end element may have an outer diameter within a range of about 7 mm to about 7.5 mm, or about 7.1 mm to about 7.2 mm. The distal end element may be sized and shaped to fit within and against the inner surface of the body. The distal end element may have an outer diameter sufficient to form a friction or interference fit with the inner surface of the inhaler body.

[0047] The groove in the distal end element may extend along an inner surface of the body. The groove may be longitudinally closed along the outer periphery of the distal end element by the inner surface of the body. The groove may be defined along the outer surface or periphery of the distal end element. The groove may be open (unclosed) along the outer surface of the distal end element.

[0048] The grooves of the distal end element may extend from the outer diameter of the core to the outer circumference of the distal end element. In other words, the outer diameter of the core may define the inner circumference of the grooves. The distal end element may include at least two helical grooves extending non-parallel to the longitudinal axis (or central longitudinal axis) of the inhaler device. The grooves may be continuously non-parallel to the longitudinal axis of the inhaler device along the entire length of the distal end element. The at least two grooves may extend curved linearly or helically along the longitudinal length of the distal end element. The at least two grooves extend parallel to each other. The at least two grooves may preferably include three grooves, may preferably include four grooves, and may preferably include more than four grooves. The at least two grooves preferably extend along the outer circumference of the distal end element. The at least two grooves may be radially offset from each other. The at least two grooves may be equally radially spaced around the outer circumference of the distal end element.

[0049] Each of the grooves may have a generally triangular cross-section with sides defined by a generally rectangular extension of the distal end element extending radially from the core at the periphery. In other words, each of the grooves extends between adjacent extensions of the distal end element's core at the periphery. The at least two grooves may have any suitable or useful shape, such as a semicircular cross-section, a generally rectangular or square cross-section, or other suitable cross-sectional shape, to provide a swirling airflow to the capsule cavity. The grooves may define a total air inlet cross-sectional area in the range of about 1 square mm to about 2 square mm, or about 1.4 square mm to about 1.8 square mm, or about 1.6 square mm. The term "total air inlet cross-sectional area" refers to the sum of the cross-sectional areas of all air inlets that provide inhaled air into the capsule cavity of the inhaler article.

[0050] The core of the distal end element may be centrally located along the longitudinal axis of the distal end element. The core and groove may each extend continuously from the element distal end to the element inner end. The core may be formed as a continuous body of material. The core may be formed as a continuous solid body of material. Preferably, the core forms a continuous solid core that extends the entire longitudinal length of the distal end element.

[0051] The core may extend along a central longitudinal axis of the article. The core may have a circular cross-section. The core may have a diameter within a range of about 50% to about 75% of the diameter of the distal end element. The core may have a diameter within a range of about 4 mm to about 6 mm, or about 4.7 mm to about 5 mm, or about 4.8 mm to about 4.9 mm.

[0052] The distal end element may be formed of a fibrous material. The distal end element may be formed of a porous material. The distal end element may be formed of a biodegradable or bio-based material. Some biodegradable or bio-based materials that may be used to form the distal end element include polyvinyl alcohol (PVOH), polylactic acid (PLA), or polyhydroxybutyrate (PHB).

[0053] The distal end element may be sufficiently porous or fibrous to permit passage of the piercing element to permit mechanical penetration of the capsule within the capsule cavity. The distal end element may restore or fill the penetration opening formed by the piercing element when the piercing element is removed from the distal end element.

[0054] The distal end element may be formed of a cellulose material.The distal end element may be formed of a cellulose acetate material.The distal end element may be formed of a polylactic acid material.

[0055] The distal end element may be formed by twisting a distal end element material having at least two linear grooves about the central longitudinal axis such that the grooves become curved and linear. The distal end element may be formed using an extrusion process such that the distal end element includes linear grooves which are then twisted into a helical configuration. The twisting process may rotate the element distal end at least 90 degrees relative to the element inner end. The twisting process may rotate the element distal end at least 180 degrees relative to the element inner end. The distal end element material may be twisted such that the core extends continuously along the central longitudinal axis and the grooves move into a parallel helical formation.

[0056] The twisting process may deform the distal tip element material such that the groove helically forms about the longitudinal axis to form a twisted distal tip element. The twisting process may deform the distal tip element to maintain the twisted configuration.

[0057] The distal tip element may be sprayed or coated to permanently affix the distal tip element in a twisted configuration. The distal tip element may be formed by an extrusion process, where an extrusion die head rotates to form grooves in a spiral pattern on the periphery as the distal tip element is extruded to form grooves having the desired pitch and depth. The distal tip element may be cut to the appropriate length before being inserted into the body of the inhaler.

[0058] The capsule cavity may be axially aligned with the distal end element and disposed in series downstream with the distal end element. The distal end element may form an upstream or distal end or boundary of the capsule cavity. The capsule cavity may define a cylindrical space configured to contain a capsule. The capsule cavity may define a space configured to receive a capsule having an oval or rounded rectangular shape. The capsule cavity may have a substantially uniform or uniform diameter along the length of the capsule cavity. The capsule cavity may have a circular cross-section along the length of the capsule cavity. The capsule cavity may have a cylindrical shape. The configuration of the capsule cavity relative to the capsule may allow the capsule to rotate with stability within the capsule cavity. The longitudinal axis of the capsule may rotate with stability about the longitudinal axis of the inhaler body during inhalation.

[0059] Stable rotation means that the longitudinal axis of the inhaler body is substantially parallel to the axis of rotation of the capsule. Stable rotation may mean a lack of forward movement of the rotating capsule. The longitudinal axis of the inhaler body is preferably substantially coextensive with the axis of rotation of the capsule. Stable rotation of the capsule may provide a uniform incorporation of a portion of the nicotine particles from the capsule over two or more, or five or more, or ten or more "puffs" by the consumer.

[0060] The capsule cavity may have a fixed cavity length bounded at the upstream or inner end of the distal end element and bounded at the downstream end by a porous support element or filter. The capsule cavity may have a cavity length of at least about 110% to less than about 200% of the length of the capsule contained therein, or a cavity length of about 120% to about 130% of the length of the capsule, or a cavity length of about 125% of the length of the capsule. The cavity length may be in the range of about 15 mm to about 25 mm and the capsule length may be in the range of about 14 mm to about 18 mm, or the cavity length may be about 20 mm and the capsule length may be about 16 mm. The cavity length may be about 20 mm. The capsule cavity and the distal end element may have a combined length of about 25 mm to about 35 mm, or the combined length may be about 27 mm to about 32 mm.

[0061] The capsule cavity has an inner diameter perpendicular to the longitudinal axis, and the capsule has an outer diameter. The outer diameter may be in the range of about 80% to about 99% of the inner diameter of the cavity, or the outer diameter may be in the range of about 85% to about 95% of the inner diameter of the cavity, or the outer diameter may be about 90% of the inner diameter of the cavity. The outer diameter may be in the range of about 5.4 mm to about 6.4 mm, and the inner diameter may be in the range of about 6 mm to about 7 mm.

[0062] The insert body may be contained within the capsule cavity. The insert body may define a cylindrical space configured to contain the capsule. The insert body may provide additional rigidity to the body along the capsule cavity. The insert body may have a substantially uniform or uniform diameter along the length of the capsule cavity. The insert body may have a length of at least about 110% to less than about 200% of the length of the capsule contained therein, or about 120% to about 130% of the length of the capsule, or about 125% of the length of the capsule. The insert body may be formed of the same or different material as the body. The insert body is preferably formed of paperboard or cardboard.

[0063] The capsule cavity may be bounded by a distal end element at the upstream end and by a porous support element or filter at the downstream end or mouthpiece side. The distal end element and the porous support element may cooperate to longitudinally contain the capsule within the capsule cavity. The distal end element and the porous support element may each occupy an inner diameter of the elongated inhaler body. The porous support element may allow the airflow to exhibit a uniform airflow through the porous support element along the cross section of the elongated inhaler body. The porous support element may act as a filter or diffuser to reduce turbulence or edge effects and ensure or maintain a desired airflow pattern through the capsule cavity. The porous support element may support the capsule inside the capsule cavity during capsule activation, such as by providing support to the capsule when a piercing element is received in the inhaler article at the distal end and pierces the capsule to activate the capsule.

[0064] The capsule may be sealed in the inhaler article prior to consumption. For transport and storage, the inhaler article may be contained in a sealed or airtight container or bag. The inhaler article may include one or more peelable seal layers to cover one or more air inlet channels at the distal end of the inhaler article or the air outlet at the mouthpiece end of the inhaler article. This may ensure that the inhaler article maintains proper hygiene and freshness, or prevent the capsule from becoming dry, hard, or easily friable.

[0065] The capsule may rotate about its longitudinal axis or longitudinal central axis as air is drawn through the inhaler article. The capsule may be formed of an airtight material that substantially contains the particles inside the capsule. The capsule may be configured to be pierced or perforated by a piercing element when the capsule is in the capsule cavity. The piercing element may be separate from or combined with the inhaler article. The capsule may be formed of any suitable material. The capsule may be formed of a metallic or polymeric material that functions to keep contaminants out of the capsule but may be pierced or perforated by a piercing element prior to consumption to allow release of nicotine particles from within the capsule. The capsule may be formed of a polymeric material. The polymeric material may be hydroxypropyl methylcellulose (HPMC). The capsule may have any suitable size. The capsule may be a size 1 to size 4 capsule, or a size 3 capsule, or a size 3 capsule.

[0066] The inhaler system includes an inhaler article as described herein and a holder configured to receive the inhaler article. The holder may include a piercing element for actuating or piercing a capsule disposed within a capsule cavity of the inhaler device.

[0067] The inhaler system may include a separate piercing element, such as a metal or rigid needle. The piercing element forms a single opening through the capsule received within the capsule cavity. The piercing element may be configured to pass through the continuous solid core portion of the distal end element and into the capsule cavity. The continuous solid core portion of the distal end element may be formed of a porous material, as described above. The distal end element may be substantially self-sealing after the piercing element is removed from the inhaler article.

[0068] The capsule comprises nicotine particles containing nicotine (also referred to as "nicotine powder" or "nicotine particles"), and optionally, flavor-containing particles (also referred to as "flavor particles"). The capsule may include a predetermined amount of nicotine particles and optional flavor particles. The capsule may contain sufficient 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 may contain sufficient nicotine particles to provide about 5-50 inhalations or "puffs", or about 10-30 inhalations or "puffs". Each inhalation or "puff" may 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.

[0069] The nicotine particles may have any useful concentration of nicotine based on the particular formulation employed. The nicotine particles may have at least about 1% up to about 30% nicotine by weight, or about 2% to about 25% nicotine by weight, or about 3% to about 20% nicotine by weight, or about 4% to about 15% nicotine by weight, or about 5% to about 13% nicotine by weight. Preferably, with each inhalation or "puff", about 50 to about 150 micrograms of nicotine can be delivered to the user's lungs.

[0070] The capsule may hold or contain at least about 5 mg of nicotine particles, or at least about 10 mg of nicotine particles. The capsule may 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 may hold or contain between about 5 mg and about 300 mg of nicotine particles, or between about 10 mg and about 200 mg of nicotine particles.

[0071] When the flavor particles are blended or combined with the nicotine particles in the capsule, the flavor particles may be present in an amount that provides the desired flavor to each inhalation or "puff" delivered to the user.

[0072] The nicotine particles may have any size distribution useful for preferential inhalation delivery into the lungs of the user. The capsule may contain particles other than nicotine particles. The nicotine particles and other particles may form a powder system.

[0073] The capsule may hold or contain at least about 5 mg of dry powder (also called a powder system), or at least about 10 mg of dry powder. The capsule may 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 may 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 may 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 consisting of nicotine particles with a particle size of about 5 micrometers or less, or within the range of about 1 micrometer to about 5 micrometers.

[0075] The mass median aerodynamic diameter of the nicotine-containing particles may be about 5 micrometers or less, or in the range of about 0.5 micrometers to about 4 micrometers, or in the range of about 1 micrometer to about 3 micrometers, or in the range of about 1.5 micrometers to about 2.5 micrometers. The mass median aerodynamic diameter is preferably measured with a cascade impactor.

[0076] The flavor-containing particles may have a mass median aerodynamic diameter of about 20 micrometers or more, or about 50 micrometers or more, or in the range of about 50 to about 200 micrometers, or in the range of about 50 to about 150 micrometers. The mass median aerodynamic diameter is preferably measured with a cascade impactor.

[0077] The dry powders may have a median particle size of about 60 micrometers or less, or in the range of about 1 micrometer to about 40 micrometers, or in the range of about 1.5 micrometers to about 25 micrometers, where median particle size refers to the median particle size per mass and is preferably measured by laser diffraction, laser diffusion, or electron microscopy.

[0078] The nicotine in powder system or nicotine particles can be nicotine free base, or nicotine salt or nicotine salt hydrate that is pharma- ceutical acceptable.Useful nicotine salt or nicotine salt hydrate includes, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine mono-pyruvate, nicotine glutamate, or nicotine hydrochloride.The compound that combines with nicotine to form salt or salt hydrate can be selected based on its expected pharmacological effect.

[0079] Preferably, the nicotine particles include an amino acid. Preferably, the amino acid may be leucine, such as L-leucine. Providing nicotine-containing particles with an amino acid, such as L-leucine, may reduce the adhesive force of the nicotine-containing particles and may also reduce the attractive force between the nicotine particles, and therefore reduce the aggregation of the nicotine particles. Similarly, it may also reduce the adhesive force to the flavor-containing particles, and therefore reduce the aggregation of the nicotine particles with the flavor particles. Therefore, the powder system described herein may be a free-flowing material, and has a stable relative particle size of each powder component, even when the nicotine particles and flavor particles are combined.

[0080] The nicotine may preferably be a surface-modified nicotine salt, in which case the nicotine salt particles include coated or composite particles. A preferred coating or composite material may be L-leucine. One particularly useful nicotine particle may be nicotine bitartrate with L-leucine.

[0081] The powder system may include a population of flavour particles, which may have any size distribution useful for selective inhalation delivery to the mouth or oral cavity of a user.

[0082] The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the population of flavor particles of the powder system consisting of particles with a particle size of about 20 micrometers or more. The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the population of flavor particles of the powder system consisting of particles with a particle size of about 50 micrometers or more. The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the population of flavor particles of the powder system consisting of particles with a particle size in the range of about 50 micrometers to about 150 micrometers.

[0083] The flavour-containing particles may include a compound that reduces adhesion or surface energy and the resulting agglomeration. The flavour particles may be surface-modified with an adhesion-reducing compound to form coated flavour particles. One preferred adhesion-reducing compound may be magnesium stearate. Providing flavour particles, particularly coating the flavour particles, with an adhesion-reducing compound such as magnesium stearate may reduce the adhesion of the flavour-containing particles and may also reduce the attractive forces between the flavour particles and therefore reduce the agglomeration of the flavour particles. Therefore, the agglomeration of flavour particles with nicotine particles may also be reduced. Therefore, the powder system described herein may have a stable relative particle size of the nicotine-containing particles and the flavour-containing particles even when the nicotine particles and the flavour particles are combined. Preferably, the powder system may be free-flowing.

[0084] Conventional formulations for dry powder inhalation contain carrier particles that function to increase the fluidization of active particles, because active particles may be too small to be affected by simple airflow through the inhaler.Powder systems may contain carrier particles.These carrier particles may be saccharides such as lactose or mannitol, which may have a particle size of more than about 50 micrometers.Carrier particles may be utilized in formulations to improve dose uniformity by acting as diluents or bulking agents.

[0085] Powder systems utilized with the nicotine powder delivery systems described herein may be carrier-free or substantially free of saccharides such as lactose or mannitol. The absence of a carrier or the substantial absence of saccharides such as lactose or mannitol may allow the nicotine to be inhaled and delivered to the user's lungs at an inhalation volume or airflow similar to that of a typical smoking method.

[0086] The nicotine particles and the flavor can be combined in a single capsule. As mentioned above, the nicotine particles and the flavor can each have a reduced adhesive force, which results in a stable particle formulation, in which the particle size of each component does not change substantially when the nicotine-containing particles and the flavor-containing particles are combined. Alternatively, the powder system includes nicotine particles contained in a single capsule and flavor particles contained in a second capsule.

[0087] The nicotine particles and flavor particles may be combined in any useful relative amounts such that the user detects the flavor particles when consumed together with the nicotine particles. Preferably, the nicotine particles and flavor particles form at least about 90% by weight, or at least about 95% by weight, or at least about 99% by weight, or 100% by weight of the total weight of the powder system.

[0088] The inhaler and inhaler system are less complicated and have a simplified airflow path compared to conventional dry powder inhalers. Advantageously, the rotation of the capsule in the inhaler body may aerosolize the nicotine particles or powder system and help maintain a free-flowing powder. Therefore, the inhaler article may not require the high inhalation volume typically utilized by conventional inhalers to deliver the above-mentioned nicotine particles deep to the lungs.

[0089] The inhaler article may use a flow rate of less than about 5 L / min, or less than about 3 L / min, or less than about 2 L / min, or less than about 1.6 L / min. Preferably, the flow rate may be in the range of about 1 L / min to about 3 L / min or about 1.5 L / min to about 2.5 L / min. Preferably, the inhalation volume or flow rate may be similar to the Health Canada smoking method flow rate, i.e., about 1.6 L / min.

[0090] The inhaler system can be used by the consumer as in smoking a traditional cigarette or vaping an electronic cigarette. Such smoking or vaping can be characterized by two steps, in the first step, a small amount containing the total amount of nicotine desired by the consumer is drawn into the oral cavity, followed by a second step in which this small amount, containing the aerosol containing 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 decide the amount of nicotine to be inhaled. During the second step, the consumer can decide the amount to dilute the first amount drawn deeper into the lungs, maximizing the concentration of active agent delivered to the epithelial surface of the airway. This smoking mechanism is sometimes called "puff-inhale-exhale".

[0091] The dry powder utilized in the dry powder inhaler of the present invention may eliminate or substantially reduce any exhalation of medicamentously active particles during the "exhalation" stage. Preferably, substantially all, or at least about 99%, or at least about 95%, or at least 90% of the medicamentously active particles have a particle size that is delivered to the lungs but is not small enough to be exhaled normally by breathing. The medicamentously active particle size may be within the range of about 0.75 micrometers to about 5 micrometers, or 0.8 micrometers to about 3 micrometers, or 0.8 micrometers to about 2 micrometers.

[0092] The inhaler articles described herein may be combined with a holder that activates the inhaler article by piercing the capsule, provides positive activation of the capsule in the inhaler article (by piercing the capsule with a piercing element of the holder), and releases the particles contained within the capsule, allowing the article to deliver the particles to the consumer. Although the holder is separate from the inhaler article, the consumer may utilize both the inhaler article and the holder while consuming the particles released in the inhaler article. A plurality of these inhaler articles may be combined with a holder to form a system or kit. A single holder may be utilized with 10 or more, or 25 or more, or 50 or more, or 100 or more inhaler articles to activate (puncture or pierce) the capsule contained within each inhaler article, provide positive activation, or, optionally, a visual indication (marking) of the inhaler article activation for each inhaler article.

[0093] The inhaler system may include an inhaler and a holder. The holder for the inhaler may include a housing. The holder for the inhaler may include a piercing element. The holder for the inhaler may include a sleeve configured to receive the inhaler article and may be movable within the holder.

[0094] The holder may hold an activated inhaler article, and a user may grasp the holder to consume particles within the inhaler article. The housing has an outer housing surface and an inner housing surface. The inner housing surface defines an inhaler article cavity. The housing extends the length of the housing along a housing longitudinal axis from a distal end to an open proximal end. The open proximal end of the housing is configured to receive a distal end of an inhaler within the inhaler article cavity. The piercing element is secured to the inner housing surface and extends the length of the piercing element from the inner housing surface into the inhaler article cavity along the piercing element longitudinal axis. The piercing element is recessed a recessed distance from the open proximal end. The sleeve is disposed within the inhaler article cavity and configured to hold the inhaler. The sleeve is movable along the housing longitudinal axis.

[0095] The holder may include a spring element configured to bias the sleeve toward the open proximal end of the housing between a relaxed position and a compressed position. The spring element may be housed within the inhaler article cavity of the holder and may be compressed as the movable sleeve and the inhaler article move toward the piercing element. The spring element may be between the sleeve and the distal end of the housing and contact the sleeve and the distal end of the housing. The spring element may be between the distal end of the sleeve and the distal end of the housing. The spring element may contact the distal end of the sleeve and the distal end of the housing. The spring element may be disposed around the piercing element. The spring element may be coaxial with the piercing element. The spring element may be a conical spring.

[0096] The spring element biases the inhaler article away from the piercing element. In use, a user may insert an inhaler article into the inhaler article cavity of the holder. This may compress the spring, allowing the inhaler article to move toward the distal end of the inhaler article cavity. Eventually, the piercing element may penetrate a capsule disposed within the inhaler article. Once penetration occurs, the user may release the inhaler article, allowing the spring to bias the inhaler article toward the proximal end of the inhaler article cavity and away from the piercing element. The user may then inhale on the proximal end of the inhaler article.

[0097] The sleeve may define a first air inlet zone including at least one air opening through the sleeve. The first air inlet zone is proximate a proximal end of the sleeve. The first air inlet zone is configured to allow air to flow from an interior of the sleeve to an airflow channel formed between the sleeve and the housing inner surface. The sleeve may include a second air inlet zone including at least one air opening through the sleeve. The second air inlet zone is proximate a distal end of the sleeve. The second air inlet zone is configured to allow air to flow from the airflow channel to an interior of the sleeve.

[0098] The sleeve may define an internal cavity, a portion of which may have a reduced inner diameter relative to the remainder of the internal cavity. Preferably, the portion of the internal cavity may have an inner diameter that is the same as or smaller than the outer diameter of the inhaler article.

[0099] Reference is now made to the drawings, in which certain aspects of the present invention are illustrated.

[0100] The schematic drawings are not necessarily to scale and are presented for purposes of illustration, not limitation. The drawings depict one or more aspects described in the present disclosure. However, it will be understood that other aspects not depicted in the drawings fall within the scope and spirit of the present disclosure. [Brief description of the drawings]

[0101] [Figure 1] FIG. 1 is a cross-sectional view of an inhaler system including an exemplary inhaler article taken along its longitudinal axis. [Diagram 2] FIG. 2 is a cross-sectional view of an inhaler system including another exemplary inhaler article taken along its longitudinal axis. [Diagram 3] FIG. 3 is a side schematic view of an exemplary distal end element useful in the inhaler article shown in FIGS. [Figure 4A] 4A is a transverse cross-sectional view of the proximal and distal ends of the distal end element shown in FIG. [Figure 4B] 4B is a transverse cross-sectional view of the proximal and distal ends of the distal end element shown in FIG. [Figure 4C] 4C is a transverse cross-sectional view of the proximal and distal ends of the distal end element shown in FIG. [Figure 5A] FIG. 5A is a side elevation schematic diagram of an exemplary planar holder useful for an inhaler article. [Figure 5B] FIG. 5B is a top elevation schematic view of the exemplary planar holder of FIG. 5A. [Figure 5C] FIG. 5C is a cross-sectional schematic view of the exemplary planar holder of FIG. 5B taken along line AA. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0102] 1 and 2 show an exemplary inhaler system 100 that includes an inhaler article 110. The inhaler article 110 may include a capsule 130 that is disposed within the inhaler article 110 to comprise the inhaler system 100.

[0103] The inhaler article 110 includes a body 112 extending along a longitudinal central axis "A" from a mouthpiece end 113 to a distal end 114. The mouthpiece end 113 forms the downstream end of the inhaler article 110, and the distal end 114 forms the upstream end. In other words, the mouthpiece end 113 is downstream from the distal end, as indicated by the arrow. A capsule cavity 116 is defined within the body 112. A distal end element 118 is disposed at the distal end 114 and extends into the capsule cavity 116.

[0104] The distal end element 118 includes an element distal end 120 and an element inner end 122 adjacent the capsule cavity 116. The distal end element 118 includes a solid core portion 124 and at least two helical grooves 126 extending from the element distal end 120 to the element inner end 122. The at least two helical grooves 126 are parallel grooves extending about the longitudinal central axis "A" from the element distal end 120 to the element inner end 122. The at least two helical grooves 126 extend along a circumference 128 of the distal end element 118.

[0105] The distal end element 118, the capsule cavity 116 (and capsule 130, if present), and the porous support element 132 may be axially aligned and disposed in series within the body 112. The distal end element 118 may form an upstream or distal end or boundary of the capsule cavity 116. The capsule cavity 116 may define a space configured to contain the capsule 130. The capsule cavity 116 may have a fixed cavity length bounded at the element inner end 122 of the distal end element 118 and bounded at a downstream end by the porous support element 132. As shown in FIG. 1, the porous support element 132 may be disposed within a mouthpiece air channel portion 134 of the body 110. The mouthpiece air channel portion 134 may extend beyond the porous support element 132 to the mouthpiece end 112.

[0106] The distal end element 118 may be disposed within the distal end 114 of the body 112. The element distal end 120 may be substantially aligned with the distal end 114 of the body 112. The distal end element 118 may include at least two helical grooves 126 to form an air channel or passageway extending through the distal end element 118 from the element distal end 120 to the element inner end 122. With further reference to FIG. 3, each of the at least two helical grooves 126 includes an air inlet 136 at the element distal end 120 and an air outlet 138 at the element inner end 122. The at least two helical grooves 126 may extend non-parallel to the central longitudinal axis "A" of the inhaler article. The helical grooves 126 may be continuously non-parallel to the central longitudinal axis "A" of the inhaler article 110 along the entire length of the distal end element 118.

[0107] 2, the inhaler article 110 may include an insert body 140 that defines a capsule cavity 116 to contain the capsule 130 and provides support and rigidity to the body 112 along the capsule cavity 116. A porous support element 132 extends from the capsule cavity 116 to the mouthpiece end 113 of the inhaler article 110.

[0108] 3 and 4A-4C illustrate the distal end element 118 of the inhaler article 110 of FIGS. 1 and 2. FIG. 3 is a side view of the distal end element 118. FIGS. 4A-4C are cross-sectional views of the proximal and distal ends of the distal end element 118. FIG. 4B is taken along line BB. The distal end element 118 includes a solid core portion 124 extending along a longitudinal central axis "A". The core portion 124 and the helical grooves 126a-126d may each extend continuously from the element distal end 120 to the element inner end 122. FIGS. 4A-4C show the distal end element 118 including four helical grooves 126a-126d extending along the outer surface 142 or circumference of the distal end element 118. The helical grooves 126a-126d may be open (not closed) along the circumference 142 of the distal end element 118. The helical grooves 126a-126d of the distal end element 118 may extend from the outer diameter 144 of the core portion 124 to the circumference 142 of the distal end element 118. The helical grooves 126a-126d may extend in a curved straight line along the longitudinal length of the distal end element 118 between the element distal end 120 and the element inner end 122. The helical grooves 126a-126d extend parallel to one another. The helical grooves 126a-126d are radially offset from one another from the element distal end 120 to the element inner end 122. The parallel helical grooves 126a-126d may rotate at least 90 degrees from the element distal end 120 to the element inner end 122. The helical grooves 126 a - 126 d may be equally radially spaced around the circumference 142 of the element 118 .

[0109] 5A-5C, the inhaler system includes an inhaler article 110 and a holder 150. The inhaler article 110 comprises a body 112 that defines an inhaler outer surface. The inhaler article 110 may be similar to either of the exemplary inhaler articles 110 of FIG. 1 or FIG. 2. The body 112 extends the length of the body along the inhaler longitudinal axis from a mouthpiece or proximal end 113 to a distal end 114.

[0110] The holder 150 for the inhaler article 110 includes a housing 151 and a piercing element 160. The holder 150 may also include a marking element 190. The housing 151 has an outer housing surface and an inner housing surface. The inner housing surface defines an inhaler article cavity 154 configured to receive the inhaler article 110. The housing 151 extends along a housing longitudinal axis from a distal end 155 to an open proximal end 156 to define a housing length. The open proximal end 156 is configured to receive the distal end 114 of the inhaler article 110 within the inhaler article cavity 154. The piercing element 160 is secured to the inner housing surface and extends from the inner housing surface to the inhaler article cavity 154 along the piercing element longitudinal axis the length of the piercing element. The piercing element 160 is set back a setback distance from the open proximal end 156. The piercing element 160 is configured to be movable to penetrate the distal end element 118 and the capsule 130 contained within the capsule cavity 116. The spring element 200 may bias the inhaler article 110 away from the piercing element 160.

[0111] The above exemplary embodiments are not limiting, and other embodiments consistent with the above exemplary embodiments will be apparent to those skilled in the art.

Claims

1. 1. An inhaler article comprising: a body extending along a central longitudinal axis from a mouthpiece end to a distal end; a capsule cavity defined within the body; a distal end element disposed at the distal end of the inhaler article and extending into the capsule cavity, the distal end element comprising an element distal end, an element inner end, a solid core portion, and at least two grooves, the solid core portion comprising a central portion of the distal end element, the central portion being solid and extending along the longitudinal central axis from the element distal end to the element inner end, the at least two grooves being helical grooves rotating about the solid core portion along the longitudinal central axis from the element distal end to the element inner end, the at least two helical grooves extending along an outer surface of the distal end element; An inhaler article, wherein the distal end element is formed from a biodegradable material.

2. The inhaler article of claim 1 , wherein the distal end element comprises a fibrous material.

3. The inhaler article of claim 1 or 2, wherein the distal end element is formed of a porous material.

4. The inhaler article of any of claims 1 to 3, wherein the distal end element is formed from a cellulosic material.

5. The inhaler article of any of claims 1 to 4, wherein the distal end element is formed from a cellulose acetate material.

6. The inhaler article of any one of claims 1 to 3, wherein the distal end element is formed from a polylactic acid material.

7. The inhaler article of any of claims 1-6, wherein the groove rotates at least 90 degrees from the element distal end to the element inner end.

8. The inhaler article of any of claims 1-7, wherein the element distal end is substantially aligned with the distal end.

9. The inhaler article of any one of claims 1 to 8, wherein a capsule is disposed within the capsule cavity of the inhaler article.

10. 10. The inhaler article of claim 9, wherein the capsule contains nicotine-containing pharma- ceutical active particles, the pharma- ceutical active particles having a mass median aerodynamic diameter of about 5 micrometers or less, or in the range of about 0.5 micrometers to about 4 micrometers, or in the range of about 1 micrometer to about 3 micrometers.

11. 1. An inhaler system comprising: An inhaler article according to any one of claims 1 to 10; a holder configured to receive the inhaler article.

12. 1. A method of manufacturing a distal end element for an inhaler article, the method comprising: providing a distal end element material having a longitudinal axis, an outer surface, an element material distal end, and an element material inner end, the distal end element material including at least two grooves on the outer surface extending from the element material distal end to the element material inner end, a solid core portion including a central portion of the distal end element, extending along the longitudinal axis from the element material distal end to the element material inner end, the central portion being solid; and twisting at least one of the element material distal end and the element material inner end about the longitudinal axis such that the groove helically forms about the longitudinal axis to form a twisted distal end element; The method wherein the distal end element is formed from a biodegradable material.

13. The method of claim 12 , wherein the twisting step deforms the distal tip element material such that the twisted distal tip element configuration is maintained.

14. 14. The method of claim 12 or 13, wherein the twisting step comprises rotating the element material distal end at least 90 degrees relative to the element material inner end.

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