Piercing attachment for an inhaler article and system

Abstract

An inhaler system includes an inhaler article and a piercing article. The piercing article includes a recessed piercing element and is configured to receive a distal end of the inhaler article. When the inhaler article is seated in the piercing article, the piercing element pierces or punctures a single aperture in a capsule contained within the inhaler article.

Description

[0001] This application is a divisional application of the patent application entitled "Piercing accessory for inhaler articles and systems", international application number PCT / IB2018 / 058209, international filing date 22 October 2018, national application number 201880064252.7. TECHNICAL FIELD

[0002] The present disclosure relates to a piercing accessory for an inhaler article and an inhaler system comprising the piercing accessory and an inhaler article. BACKGROUND

[0003] Dry powder inhalers are not necessarily always perfectly adapted to deliver dry powder particles to the lungs at inhalation rates or airflow rates within the inhalation rates or airflow rates of conventional smoking patterns. The operation of dry powder inhalers can be complex or can involve moving parts. Dry powder inhalers often strive to deliver the entire dry powder dose or capsule load in a single breath.

[0004] It would be desirable to provide an inhaler system that minimizes moving parts. It would be desirable for the piercing accessory to have a protected piercing end. It would be desirable to provide an inhaler system having a reusable piercing accessory. It would be desirable to provide an inhaler system comprising a piercing accessory having a compact profile and being reusable.

[0005] It would be desirable to provide a nicotine powder inhaler that delivers nicotine particles to the lungs at inhalation rates or airflow rates within the inhalation rates or airflow rates of conventional smoking patterns. It would also be desirable to deliver nicotine powder by an inhaler article having a form similar to a conventional cigarette. It would also be desirable to provide an inhaler article that is simple to manufacture and easy for a consumer to use. SUMMARY

[0006] The present disclosure relates to an inhaler system comprising an inhaler article and a piercing article. The piercing article comprises a recessed piercing element and is configured to receive a distal end of the inhaler article. When the inhaler article is seated in the piercing article, the piercing element pierces or punctures a single aperture in a capsule contained within the inhaler article. The inhaler article is separated from the piercing article and then utilized by a consumer. The piercing article can be reused on subsequent inhaler articles. The piercing article preferably defines a cylindrical body.

[0007] The inhaler article includes a body defining an inhaler outer surface. The body extends along an inhaler longitudinal axis from a mouthpiece end to a distal end. The body has an inhaler length along the longitudinal axis. The piercing article includes a cylindrical housing defining a cylindrical housing outer surface and a cylindrical housing inner surface. The cylindrical housing extends along a cylindrical housing longitudinal axis from a distal end to an open proximal end a cylindrical housing length. A piercing element is contained within or secured to the cylindrical housing or the distal end. The piercing element extends along a piercing element longitudinal axis from the secured distal end to a piercing end a piercing element length. The piercing element is recessed from the open proximal end a recessed distance. The cylindrical housing open proximal end is configured to receive the distal end of the inhaler article.

[0008] Advantageously, the inhaler system provides an inhaler system that minimizes moving parts. Advantageously, the inhaler system utilizes a separate piercing accessory. This can enable the piercing accessory to be reusable and the inhaler article to be disposable after a single use. Advantageously, recessing the protected piercing element can facilitate protection of the piercing element and protection of the user from the piercing element. The piercing element can be recessed from the piercing accessory open end at least 25% of the total length of the piercing accessory.

[0009] Advantageously, the inhaler system provides nicotine particles to the lungs at an inhalation rate or airflow rate within the inhalation rate or airflow rate of a conventional smoking regime. The inhaler delivers nicotine powder through an inhaler article having a form similar to a conventional cigarette. The inhaler article and the boundary element can be formed through simple manufacturing methods.

[0010] The piercing article cylindrical housing can have a tapered inner diameter that decreases from the open end to the recessed end. The cylindrical housing inner diameter can taper in a range of about 3% to about 13% or in a range of about 5% to about 10%. The piercing article distal end can mate with the inhaler article distal end when the inhaler article is received within the piercing article.

[0011] Advantageously, the tapered inner diameter can provide a guided alignment of the piercing element to accurately pierce the capsule within the inhaler article. The tapered inner diameter can provide a reliable hard stop or interference fit with the outer surface of the inhaler article when the inhaler article is fully seated or received within the piercing article. Tapering the inner diameter of the cylindrical housing can facilitate positioning of the piercing accessory on the distal end of the inhaler article.

[0012] The piercing element is preferably formed of a polymeric material. The polymeric material forming the cylindrical housing can be a different type of polymeric material than the polymeric material forming the piercing element. The cylindrical housing can be formed of a first polymeric material and the piercing element can be formed of a second polymeric material different from the first polymeric material.

[0013] The piercing article and the piercing element can be formed of a polymeric material. The piercing element can be formed of a fiber-reinforced polymeric material. The polymeric piercing element or the fiber-reinforced polymeric piercing element can have a first diameter adjacent the piercing end and a second diameter near the fixed distal end, the second diameter being greater than the first diameter. In one example, the piercing element can be formed of a fiber-reinforced polymeric material and the piercing article cylindrical housing is formed of a polymeric material that does not contain fibers.

[0014] Advantageously, the polymeric piercing element or the fiber-reinforced polymeric piercing element can be readily formed with the polymeric piercing article cylindrical housing and can be simply joined or fixed to one another. Advantageously, the piercing article is a separate component from the inhaler article.

[0015] The inhaler systems described herein can provide dry powder to the lungs at inhalation rates or airflow rates within conventional smoking rates. The consumer can take multiple inhalations or "puffs," where each "puff" delivers a small amount of the dry powder contained in the capsules contained within the capsule cavity. The inhaler can have a form similar to a conventional cigarette and can mimic the habit of conventional smoking. The inhaler can be simple to manufacture and convenient for the consumer to use.

[0016] Airflow management through the capsule cavity can cause the capsule to rotate during inhalation and consumption. The capsule can contain particles containing nicotine (also referred to as "nicotine powder" or "nicotine particles") and, optionally, particles containing a flavorant (also referred to as "flavorant particles"). Rotation of the pierced capsule can be paused and cause the nicotine particles released from the pierced capsule into the inhalation air moving through the inhaler article to be aerosolized. The flavorant 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 flavorant particles are preferentially retained in the user's oral cavity or buccal space. The nicotine particles and optional flavorant particles can be delivered with the inhaler article at inhalation rates or airflow rates within conventional smoking rates.

[0017] The term "nicotine" refers to nicotine and nicotine derivatives, such as freebase nicotine, nicotine salts, and the like.

[0018] The term "flavor" or "flavorant" 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.

[0019] The piercing article described herein can be combined with an inhaler article comprising a capsule to activate the inhaler article by piercing the capsule, releasing the particles contained within the capsule and enabling the article to deliver the particles to a consumer. The piercing article is separate from the inhaler article. The piercing article is not coupled to the inhaler article or does not form any part of the inhaler article. Advantageously, the piercing article does not form part of the inhaler article and defines a compact profile. A plurality of such inhaler articles can be combined with the piercing article to form a kit. A single piercing element can be used on 10 or more, or 25 or more, or 50 or more, or 100 or more inhaler articles to activate (pierce or puncture) the capsule contained within each inhaler article.

[0020] The inhaler article comprises a body extending along a longitudinal axis from a mouthpiece end to a distal end. The body has an inhaler length extending between the mouthpiece end and the distal end. The body defines an inhaler outer surface. A capsule cavity is defined within the body and extends along the longitudinal axis. A mouthpiece air passage extends from the capsule cavity to the mouthpiece end. A boundary element is located between the capsule cavity and the mouthpiece air passage. The boundary element comprises an aperture fluidly connecting the capsule cavity and the mouthpiece air passage. The distal end can comprise an end cap or end piece element.

[0021] The piercing article comprises a cylindrical housing. The cylindrical housing defines a cylindrical housing outer surface and a cylindrical housing inner surface. The piercing article is defined by the cylindrical housing. The cylindrical housing extends along a cylindrical housing longitudinal axis from a distal end to an open proximal end by a cylindrical housing length. The cylindrical housing open proximal end is configured to receive the distal end of an inhaler article. The distal end can be restricted. For example, the diameter of the restricted distal end can be less than the diameter of the open proximal end. For example, the restricted distal end can be substantially closed and define a closed distal end.

[0022] The piercing element is contained within or fixed to the cylindrical housing or the distal end. The piercing element extends along a piercing element longitudinal axis from a fixed distal end to a piercing end by a piercing element length. The piercing element is recessed from the open proximal end by a recessed distance.

[0023] Recessing the piercing element into the cylindrical housing can prevent the piercing element from coming into contact with surfaces that are not intended to be received within the piercing element. Recessing the piercing element into the cylindrical housing can also protect the piercing element from damage or modification by surfaces that are not intended to be received within the piercing element.

[0024] The piercing element can be recessed from the open proximal end by any suitable recessed distance. For example, the piercing element can be recessed from the open proximal end by a recessed distance of at least about 10%, at least about 20%, at least about 25%, or at least about 30%, or at least about 35%, or at least about 40% of the length of the cylindrical housing. The piercing element can be recessed from the open proximal end by a recessed distance in a range of about 5% to about 50%, or about 10% to about 40%, or about 15% to about 40%, or about 20% to about 40% of the length of the cylindrical housing.

[0025] The piercing element length can be any suitable length relative to the length of the cylindrical housing. For example, the piercing element length can be about 30% to about 70%, or about 40% to about 60% of the length of the cylindrical housing. The distal end of the piercing element can be fixed to a distal end at or near the distal end of the cylindrical housing. Where the distal end is closed and includes a distal end wall, the piercing element can be fixed to the distal end wall. The entire length of the piercing element can be coextensive within the length of the cylindrical housing.

[0026] The fixed distal end of the piercing element can be fixed to the cylindrical housing or the distal end by direct bonding. The closed distal end of the piercing article can define an end cap that seals the distal end of the cylindrical housing. The closed distal end can include a recessed portion recessed from the outer surface into the closed distal end. The recessed portion can be coaxial with the longitudinal axis of the piercing element. The outer periphery of the closed distal end can form a smooth rounded edge that joins the cylindrical housing outer surface with the closed distal end. The closed distal end can include two or more reinforcing ribs or struts that connect the cylindrical housing inner surface with the piercing element fixed distal end. The cylindrical housing inner surface adjacent to the closed distal end can be configured to mate with the distal end of the inhaler article to provide a mating or base fit.

[0027] The fixed distal end of the piercing element can be fixed to the cylindrical housing or the distal end by direct bonding with the distal end of the piercing article. The distal end can have one or more openings defined through the distal end. The distal end can include a recessed portion recessed from the outer surface into the distal end. The recessed portion can be coaxial with the longitudinal axis of the piercing element. The outer periphery of the distal end can form a smooth rounded edge that joins the cylindrical housing outer surface with the distal end. The distal end can include two or more reinforcing ribs or struts that connect the cylindrical housing inner surface with the piercing element fixed distal end. The cylindrical housing inner surface adjacent to the distal end can be configured to mate with the distal end of the inhaler article to provide a mating or base fit.

[0028] The cylindrical housing inner surface has an open proximal diameter and a distal diameter. The distal diameter can be less than the open proximal diameter. The cylindrical housing inner surface diameter can taper from the open proximal diameter to the distal diameter. The cylindrical housing inner surface diameter can taper any suitable amount. For example, the cylindrical housing inner surface diameter can taper in the range of about 3% to about 13%, or about 5% to about 10% of the cylindrical housing inner diameter at the proximal end.

[0029] The piercing article has a cylindrical housing outer surface diameter. The cylindrical housing outer surface diameter can be a uniform diameter along the length of the cylindrical housing. The cylindrical housing outer surface diameter can vary by less than about 2%. The cylindrical housing outer surface can be configured to closely mimic the outer surface of the inhaler article to provide a piercing article having a compact profile. The cylindrical housing outer surface can have a smooth cylindrical shape similar to the outer surface of the inhaler article. The inhaler surface outer diameter can be any suitable diameter. For example, the cylindrical housing outer surface diameter can be less than about 150%, or less than about 140% of the inhaler outer surface diameter.

[0030] The piercing element is formed from a rigid material. The rigid material has sufficient rigidity to pierce, puncture, or activate a capsule contained within the inhaler article. The piercing element can be formed from a metal. The piercing element can be formed from stainless steel, such as 316 stainless steel. The piercing element can be formed from a polymeric material. The piercing element can be formed from a fiber-reinforced polymeric material.

[0031] For example, polymeric materials that can be used to form the piercing element include polycarbonate, polypropylene, polyethylene, nylon, acrylonitrile-butadiene-styrene, styrene-acrylonitrile, polyacrylate, polystyrene, PBT polyester, PET polyester, polyoxymethylene, polysulfone, polyethersulfone, polyether ether ketone, or liquid crystal polymer. Polycarbonate or liquid crystal polymer is a preferred material for forming the piercing element.

[0032] The polymeric material can be fiber-reinforced and include a plurality of fibers forming a fiber dispersion throughout the piercing element. The fibers forming the fiber dispersion can have an average length of less than about 1 mm, or in the range of about 0.1 mm to about 1 mm, and an average diameter of less than 50 microns. For example, the fibers forming the fiber dispersion can be formed from glass, carbon, basalt, graphite, DuPont Kevlar® aramid fiber, ceramic, natural fiber, polymeric fiber, and metal. Preferably, the fibers forming the fiber dispersion are composed of glass fibers. When present in the polymeric material forming the piercing element, the fiber dispersion can be in the range of about 5% to about 60% by weight, or about 10% to about 50% by weight, or about 20% to about 45% by weight, or about 30% to about 40% by weight. Fiber-reinforced polycarbonate or fiber-reinforced liquid crystal polymer is a preferred material for forming the piercing element.

[0033] The cylindrical housing can be formed from any rigid material. The cylindrical housing can be formed from a polymeric material. For example, polymeric materials that can be used to form the cylindrical housing include polycarbonate, polypropylene, polyethylene, nylon, acrylonitrile butadiene styrene, styrene acrylonitrile, polyacrylate, polystyrene, PBT polyester, PET polyester, polyoxymethylene, polysulfone, polyethersulfone, polyether ether ketone, or liquid crystal polymer. Polypropylene, polyethylene, or copolymers thereof are preferred materials for forming the cylindrical housing.

[0034] The polymeric material forming the cylindrical housing can be a different type of polymeric material than the polymeric material forming the piercing element. The polymeric material forming the cylindrical housing can be fiber-free, and the polymeric material forming the piercing element can be a fiber-reinforced polymeric material. In one example, the polymeric material forming the cylindrical housing can be polypropylene, polyethylene, or a copolymer thereof, and the polymeric material forming the piercing element can be a fiber-reinforced polycarbonate, a liquid crystal polymer, or a fiber-reinforced liquid crystal polymer.

[0035] The piercing element can define two or more diameters. The piercing element can have a first diameter adjacent the piercing end and a second diameter adjacent the fixed distal end that is greater than the first diameter. The piercing element can have a first length segment adjacent the piercing end and a second length segment adjacent the fixed distal end. The first length segment can have a substantially constant or uniform diameter. The second length segment can have a substantially constant or uniform diameter, or the second length segment can have a reduced diameter that decreases from the fixed distal end to the first length segment.

[0036] The inhaler article can be contained within the piercing article such that the inhaler article outer surface and the piercing article cylindrical housing outer surface are concentric. The piercing element longitudinal axis can be coaxial with the cylindrical housing longitudinal axis and the inhaler longitudinal axis when the inhaler article is contained within the piercing article. At least about 80% or at least about 90% of the cylindrical housing length can be coextensive with the inhaler length when the inhaler article is contained within the piercing article.

[0037] The piercing article can be formed by insert molding techniques. For example, the piercing element can be first formed by molding, and then the cylindrical housing can be molded around the piercing element to bond to the piercing element. The piercing element can be a metal piercing element, and the cylindrical housing can be molded around the metal piercing element to secure the metal piercing element to the cylindrical housing. The metal piercing element can include a protrusion or a recess at the distal end of the piercing element to increase the surface area of the distal end of the piercing element and improve the securing within the cylindrical housing molding material.

[0038] The air passage of the inhaler article can extend through the end cap or end piece element to provide airflow through the inhaler article. The air passage supplying airflow to the capsule cavity can be configured to induce a swirling airflow pattern within the capsule cavity of the inhaler body. The air passage configuration can induce a rotational airflow or swirling airflow as air flows through the air passage and the capsule cavity. The airflow through the inhaler device can enter the inhaler device at the distal end of the inhaler device and move along the longitudinal axis of the inhaler device to the mouthpiece end. The airflow through the inhaler device can enter the inhaler device upstream of the inhaler body or along the capsule cavity and move along the longitudinal axis of the inhaler device to the mouthpiece end.

[0039] The inhaler article end cap or end piece element can include a linear piercing passage extending through the length of the end cap or end piece element. The linear piercing passage can extend along a central axis of the end cap or end piece element. The linear piercing passage can be coaxial with the longitudinal axis of the inhaler body. The linear piercing passage can be sized to allow a piercing element to pass through the linear piercing passage. The end cap or end piece element can define a resealable element disposed along or within the linear piercing passage. The resealable element can seal the linear piercing passage. The resealable element can form an air-tight seal or barrier along the linear piercing passage when the piercing element is not within the resealable element. The linear piercing passage can be formed of a pierceable material. The piercing element can pass through the resealable element and pierce a capsule within the capsule cavity. The resealable element can reseal once the piercing element is retracted or removed from the resealable element. The resealable element or membrane can comprise a septum or septum-like element. The resealable element or membrane can be formed of an elastomeric material such as rubber, silicone, metal foil co-laminated with a polymer, or latex, among others, or a cellulose acetate tow such as a high density cellulose acetate tow.

[0040] The inhaler body can be sized and shaped similar to a smoking article or cigarette. The inhaler body can have an elongate cylindrical 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 cylindrical body. The inhaler body can have a circular cross-section that can be uniform along the length of the elongate cylindrical body. The inhaler body can have an outer diameter in a range of about 6 mm to about 10 mm, or about 7 mm to about 10 mm, or about 7 mm to about 9 mm, or about 7 mm to about 8 mm, or about 8 mm. The inhaler body can have a length (along the longitudinal axis) in a range of about 40 mm to about 90 mm, or about 50 mm to about 80 mm, or about 50 mm to about 70 mm, or 55 mm.

[0041] The capsule cavity can define a cylindrical space configured to house a capsule (e.g., 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 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 85% 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.

[0042] 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.

[0043] Stable rotation refers to the longitudinal axis of the inhaler body being substantially parallel 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.

[0044] Prior to consumption, the capsule can be sealed within the inhaler article. The inhaler article can be contained within a sealed or air-tight container or pouch. The inhaler article can include one or more peelable or removable seal layers to cover one or more air inlet channels or air outlets or mouthpieces of the inhaler article.

[0045] The capsule can rotate about its longitudinal or central axis when air flows through the inhaler article. The capsule can be formed of 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 of a metal or polymeric material for maintaining the capsule free from contamination yet can be pierced or punctured by the piercing element prior to consumption of the nicotine particles within the capsule. The capsule can be formed of a polymeric material. The polymeric material can be hydroxypropyl methylcellulose (HPMC). The capsule can be a size 1 to size 4 capsule, or a size 3 capsule.

[0046] The described separate piercing article forms a single orifice through a capsule housed in the capsule cavity. The piercing article piercing element can pass through a resealable element to seal the piercing channel on the end cap.

[0047] The capsule contains nicotine particles (also referred to as "nicotine powder" or "nicotine granules") comprising nicotine, and optionally flavor particles (also referred to as "flavor granules"). The capsule can contain a predetermined amount of nicotine particles and optional flavor particles. The capsule can contain nicotine particles sufficient 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 nicotine particles sufficient to provide about 5 to about 50 inhalations or "puffs," or about 10 to about 30 inhalations or "puffs." Each inhalation or "puff" can deliver about 0.1 mg to about 3 mg of nicotine particles to the lungs of a user, or 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.

[0048] The nicotine particles can have any applicable nicotine concentration depending on the particular formulation used. The nicotine particles can have at least about 1% wt nicotine up to about 30% wt nicotine, or about 2% wt to about 25% wt nicotine, or about 3% wt to about 20% wt nicotine, or about 4% wt to about 15% wt nicotine, or about 5% wt to about 13% wt nicotine. Preferably, each inhalation or "puff" can deliver about 50 to about 150 micrograms of nicotine to the lungs of a user.

[0049] The capsule can hold or contain at least about 5 mg of nicotine particles or at least about 10 mg of nicotine particles. The capsule can hold or contain less than about 900 mg of nicotine particles, or less than about 300 mg of nicotine particles, or less than 150 mg of nicotine particles. The capsule can hold or contain about 5 mg to about 300 mg of nicotine particles or about 10 mg to about 200 mg of nicotine particles.

[0050] When the flavor particles are blended or mixed with the nicotine particles in the capsule, the flavor particles can be present in an amount to provide the desired flavor for each inhalation or "puff" delivered to the user.

[0051] The nicotine particles can have any particle size distribution suitable for preferential inhalation delivery to the lungs of a user. The capsule can contain particles other than nicotine particles. The nicotine particles and other particles can form a powder system.

[0052] The capsule can hold or contain at least about 5 mg of dry powder (also referred to as a powder system) or at least about 10 mg of dry powder. The capsule can hold or contain less than about 900 mg of dry powder, or less than about 300 mg of dry powder, or less than about 150 mg of dry powder. The capsule can hold or contain about 5 mg to about 300 mg of dry powder, or about 10 mg to about 200 mg of dry powder.

[0053] 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 comprising nicotine particles having a particle size of about 5 microns or less, or in the range of about 1 micron to about 5 microns.

[0054] The mass median aerodynamic diameter of the particles comprising nicotine can be about 5 microns or less, or in the range of about 0.5 microns to about 4 microns, or in the range of about 1 micron to about 3 microns, or in the range of about 1.5 microns to about 2.5 microns. Preferably, the mass median aerodynamic diameter is measured using a cascade impactor.

[0055] The mass median aerodynamic diameter of the particles comprising flavorant can be about 20 microns or greater, or about 50 microns or greater, or in the range of about 50 to about 200 microns, or in the range of about 50 to about 150 microns. Preferably, the mass median aerodynamic diameter is measured using a cascade impactor.

[0056] The average diameter of the dry powder can be about 60 microns or less, or in the range of about 1 micron to about 40 microns, or in the range of about 1.5 microns to about 25 microns. Average diameter refers to the average diameter per unit mass, and is preferably measured by laser diffraction, laser light diffusion, or electron microscopy.

[0057] The nicotine in the powder system or nicotine particles can be a pharmaceutically acceptable free base nicotine or a nicotine salt or 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.

[0058] Preferably, the nicotine particles comprise an amino acid. Preferably, the amino acid can be leucine, such as L-leucine. Providing the particles comprising nicotine with L-leucine and the like amino acids can reduce the stickiness of the particles comprising nicotine, and can reduce the attractive forces between nicotine particles and thus reduce agglomeration of the nicotine particles. Similarly, the stickiness to the particles comprising flavorant can also be reduced, thereby also reducing agglomeration of the nicotine particles with the flavorant 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 the flavorant particles.

[0059] Preferably, the nicotine can be a surface-modified nicotine salt, wherein the nicotine salt particles comprise coated or complexed particles. A preferred coating or complexing material can be L-leucine. One particularly useful nicotine particle can be nicotine bitartrate bound to L-leucine.

[0060] The powder system can comprise a population of flavour particles. The flavour particles can have any particle size distribution suitable for selective delivery to the mouth or buccal cavity of a user upon inhalation.

[0061] The powder system can have at least about 40 wt%, or at least about 60 wt%, or at least about 80 wt% of the population of flavour particles comprising particles having a particle size of about 20 microns or greater. The powder system can have at least about 40 wt%, or at least about 60 wt%, or at least about 80 wt% of the population of flavour particles comprising particles having a particle size of about 50 microns or greater. The powder system can have at least about 40 wt%, or at least about 60 wt%, or at least about 80 wt% of the population of flavour particles comprising particles having a particle size in the range of about 50 microns to about 150 microns.

[0062] The flavour or flavourant can be provided as a solid flavourant (at room temperature of about 22 degrees Celsius and one atmosphere of pressure) and can comprise a flavour formulation, a flavour-containing material, and a flavour precursor. The flavourant can include one or more natural flavours, one or more synthetic flavours, or a combination of natural and synthetic flavours. A flavour as described herein is an organoleptic compound, composition, or material that is selected and used to alter or intended to alter the taste or aroma properties of the nicotine component during its consumption or inhalation.

[0063] Flavour or flavourant refers to a plurality of flavouring materials of natural or synthetic origin. They include single compounds and mixtures. The flavour or flavourant has flavour properties that can enhance the experience of the nicotine component during consumption. The flavour can be selected to provide an experience similar to that produced by smoking a combustible smoking article. For example, the flavour or flavourant can enhance flavour attributes such as mouthful and complexity. Complexity is generally considered to be a balanced blend of flavours that is richer but not dominant of a single sensory attribute. Mouthfullness is described as the perception of richness and amount in the mouth and throat of the consumer.

[0064] Suitable flavourants include, but are not limited to, any natural or synthetic flavourant, such as tobacco, smoke, menthol, mint (e.g., peppermint and spearmint), chocolate, liquorice, citrus and other fruit flavours, beta ionone, vanillin, ethyl vanillin, air freshener flavours, flavouring flavours such as cinnamon, methyl salicylate, linalool, bergamot oil, geranium oil, lemon oil, and ginger oil, and the like.

[0065] Other suitable flavors can include flavor compounds selected from the group consisting of acids, alcohols, esters, aldehydes, ketones, pyrazines, combinations or mixtures thereof, or the like. Suitable flavor compounds can be, for example, selected from the group consisting of benzeneacetic acid, solanone, megastigmatrienone, 2-heptanone, benzyl alcohol, cis-3-hexenyl acetate, valeric acid, valeraldehyde, esters, terpenes, sesquiterpenes, cyclohexenol, maltol, damascenone, pyrazines, lactones, anethole, isovaleric acid, combinations thereof, and the like.

[0066] Other specific examples of flavors can be found in the current literature and are well known to those skilled in the art of flavoring, i.e., the art of imparting odor or taste to a product.

[0067] Flavors can be high potency flavors and can be used and perceived in amounts that will result in less than 200 parts per million of the inhaled air stream. Examples of such flavors are key tobacco aroma compounds such as, for example, 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 result in several orders of magnitude higher amounts of flavor released into the inhaled 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.

[0068] Flavors can be high potency flavors and can be used and perceived in amounts that will result in less than 200 parts per million of the inhaled air stream. Examples of such flavors are key tobacco aroma compounds such as, for example, 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 result in several orders of magnitude higher amounts of flavor released into the inhaled 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.

[0069] Because active particles can be too small to be affected by simple air flow through an inhaler, conventional formulations for dry powder inhalation contain carrier particles to increase fluidization of the active particles. The powder system can include carrier particles. These carrier particles can be sugars, such as lactose or mannitol, which can have a particle size greater than about 50 microns. Carrier particles can be used to improve the uniformity of the dose by acting as a diluent or bulking agent in the formulation.

[0070] The powder system used in conjunction with the nicotine powder delivery system described herein can be free of carriers or substantially free of sugars such as lactose or mannitol. Being free of carriers or substantially free of sugars such as lactose or mannitol can allow for inhalation and delivery of nicotine into the lungs of a user at an inhalation rate or airflow rate similar to that of a typical smoking regime.

[0071] The nicotine particles and flavourant can be mixed in a single capsule. As described above, the nicotine particles and flavourant can each have a reduced adhesion force which results in the formation of a stable particulate formulation in which the particle size of each component does not substantially change on mixing. Alternatively, the powder system comprises nicotine particles contained within a single capsule and flavourant particles contained within a second capsule.

[0072] The nicotine particles and flavourant particles can be combined in any suitable relative amounts such that the flavourant particles are perceptible to a user when consumed with the nicotine particles. Preferably, the nicotine particles and flavourant particles form at least about 90%wt, or at least about 95%wt, or at least about 99%wt or 100%wt of the total weight of the powder system.

[0073] In comparison to conventional dry powder inhalers, the inhaler and inhaler system can be less complex and the airflow path is simplified. Advantageously, rotation of the capsule within the inhaler body atomises the nicotine particles or powder system and can assist in maintaining free-flowing powder. As a result, the inhaler article can not require the higher inhalation rates typically utilised by conventional inhalers to deliver the nicotine particles described above deeply into the lungs.

[0074] The inhaler article can 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 about 1.6 L / min. Preferably, the flow rate can 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 rate or flow rate can be similar to the inhalation rate or flow rate of the Health Canada Smoking Regime, i.e. about 1.6 L / min.

[0075] A consumer can use the inhaler like a conventional cigarette is smoked or a e-vaping device is vaped. Such smoking or vaping can be characterised by two steps: a first step during which a small amount containing a sufficient amount of nicotine desired by the consumer is drawn into the mouth; followed by a second step during which the small amount containing an aerosol including the desired amount of nicotine is further diluted by fresh air and drawn more deeply 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 maximising the concentration of active agent delivered to the respiratory epithelial surface. This smoking mechanism is sometimes referred to as "puff-inhale-exhale".

[0076] 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.

[0077] The terms "upstream" and "downstream" refer to the relative positions of the elements of the inhaler described with respect to the direction of the flow of air as it is drawn through the inhaler body from the distal portion to the mouthpiece portion.

[0078] As used herein, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise.

[0079] As used herein, "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise. The term "and / or" means one or all of the listed elements or a combination of any two or more of the listed elements.

[0080] As used herein, "have," "having," "include," "including," "contain," "containing," and the like are used in their open, conventional sense, and generally mean "including, but not limited to." It will be understood that "consisting essentially of," "consisting of," and the like are open terms, and are not to be construed as excluding additional components.

[0081] 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 other embodiments from the scope of the disclosure, including the claims. BRIEF DESCRIPTION OF DRAWINGS

[0082] Figure 1 is a transparent perspective view of an exemplary inhaler system.

[0083] Figure 2 is a cross-sectional schematic view of an exemplary piercing accessory.

[0084] Figure 3 is Figure 2 is a top schematic view of the open end of the piercing accessory shown.

[0085] Figure 4 is a cross-sectional schematic view of another exemplary piercing accessory.

[0086] Figure 5 is a top schematic view of the open end of the piercing accessory shown in Figure 4. DETAILED DESCRIPTION

[0087] The drawings are not necessarily to scale and are presented for purposes of illustration and explanation and not limitation. The drawings show one or more aspects of the disclosure. However, it will be understood that other aspects not depicted can fall within the scope and spirit of the disclosure.

[0088] Figure 1 A transparent perspective view of an exemplary inhaler system 100 is shown. The inhaler system 100 includes an inhaler article 110 and a separate piercing article 150. The inhaler article 110 can be housed within the piercing article 150 to activate or pierce a capsule 130 disposed within the inhaler article 110. The inhaler article 110 is withdrawn from the piercing article 150 prior to use by a consumer.

[0089] The inhaler article 110 includes a longitudinal axis L A A body 112 extending from a mouth end 116 to a distal end 118, and a capsule cavity 125 defined within the body 112. The body 112 can have a uniform diameter of about 7.5 mm and a length of about 55 mm. The body 112 can have a uniform inner diameter of about 6.5 mm. The body 112 can have a uniform thickness of about 1 mm. A mouthpiece air passage 115 extends from the capsule cavity 125 to the mouth end 116. An end cap or end element 122 is disposed within the distal end 118 and extends into the capsule cavity 125. The end cap or end element 122 includes an air passage 123 extending along the end cap or end element 122. The air passage 123 creates a vortex air flow through the capsule cavity 125. The end cap or end element 122 and the boundary element 120 bound the capsule cavity 125. A capsule 130 is disposed within the capsule cavity 125. The capsule 130 contains granules containing nicotine. The end cap or end element 122 and the boundary element 120 cooperate to longitudinally house the capsule 130 in the capsule cavity 125. The rotational axis of the capsule 130 can be coaxial with the longitudinal axis L A The rotational axis of the capsule 130 can be coaxial with the longitudinal axis L

[0090] The inhaler article end cap or end element 122 can include a linear piercing passage 124 extending through the length of the end cap or end element 122. The linear piercing passage 124 can be coaxial with the longitudinal axis L A The linear piercing passage 124 can be sized to allow a piercing element 160 to pass through the linear piercing passage 124. The end cap or end element 122 can define a resealable element disposed along or within the linear piercing passage 124. The resealable element or membrane can comprise a septum or septum-like element. The resealable element or membrane can be formed of an elastomeric material such as rubber, silicone, metal foil co-laminated with a polymer, or latex, among others, or a cellulose acetate tow such as a high density cellulose acetate tow.

[0091] Figure 2is a cross-sectional schematic view of an example piercing article 150 or accessory. Figure 3 is a top schematic view looking toward the open proximal end 153 of the piercing article 150 or accessory shown in Figure 4. Figure 2 is a top schematic view looking toward the open proximal end 153 of the piercing article 150 or accessory shown in Figure 4. Figure 5 is a cross-sectional schematic view of an example piercing article 150 or accessory. Figure 3 is a top schematic view looking toward the open proximal end 153 of the piercing article 150 or accessory shown in Figure 4.

[0092] The piercing article 150 includes a cylindrical housing 152 defining a cylindrical housing outer surface 154 and a cylindrical housing inner surface 156. The cylindrical housing extends along a cylindrical housing longitudinal axis L A The cylindrical housing length 159 extending from the closed distal end 151 toward the open proximal end 153 can be about 33 mm. The closed distal end 151 is shown as a closed end cap. The cylindrical housing open proximal end 153 is configured to receive the distal end 118 of the inhaler article 110. A piercing element 160 is contained within the cylindrical housing 152 or the closed distal end 151 and is fixed to the cylindrical housing or distal end. The piercing element 160 extends along a piercing element longitudinal axis L A The piercing element length 169 extending from the fixed distal end 162 toward the piercing end 164 can be about 17 mm or about 18 mm. The piercing element 160 is recessed from the open proximal end 153 by a recessed distance 170 that can be about 12 mm or about 13 mm. The piercing element 160 has a cutting surface 161 at the piercing end 164 that can be at an angle of about 30 degrees to the piercing element longitudinal axis L A The flat surface forms an angle of about 30 degrees.

[0093] Figure 2 and Figure 3 show a piercing element 160 having two different diameters. The piercing element 160 has a first length segment 166 adjacent the piercing end and a second length segment 168 adjacent the fixed distal end 162. The first length segment 166 can have a substantially constant or uniform diameter. The first length segment can have a diameter of about 0.8 mm and a length of about 11 mm or about 12 mm. The second length segment 168 can have a substantially constant or uniform diameter that is greater than the diameter of the first length segment 166, or the second length segment 168 can have a reduced diameter that decreases from the fixed distal end 162 toward the first length segment 166 (as shown). Figures 4 and Figure 5 show a piercing element 160 having a constant or uniform diameter. The second length segment 168 can have an initial diameter of about 1.8 mm, a final diameter of about 1.5 mm, and a length of about 6 mm or about 7 mm.

[0094] The cylindrical housing inner surface 156 of the cylindrical housing 152 of the piercing article 150 has an open proximal end 153 diameter and a closed distal end 151 diameter that is less than the open proximal end 153 diameter. The cylindrical housing inner surface 156 diameter tapers from the open proximal end diameter 153 to the closed distal end 151 diameter. The cylindrical housing outer surface 154 diameter can be constant at about 9.8 mm, and the cylindrical housing inner surface 156 diameter can be about 8.4 mm at the open proximal end 153 and about 7.7 mm at the closed distal end 151.

[0095] The fixed distal end 162 of the piercing element 160 is fixed to the distal end by direct adhesion to the closed distal end 151 of the piercing article 150. The closed distal end 151 of the piercing article 150 can define an end cap that seals the distal end of the cylindrical housing 152. The closed distal end 151 can include a recessed portion 157 that recesses the closed distal end 151 from the outer surface. The recessed portion 157 can be coaxial with the longitudinal axis L A The outer periphery 155 of the closed distal end 151 can form a smooth rounded edge that joins the cylindrical housing outer surface 154 with the closed distal end 151.

[0096] FIG. 4 and Figure 5 A piercing element 160 having a uniform diameter is shown. The piercing element 160 has a length segment that extends from a piercing end 164 to a fixed distal end 162. The length segment can have a length of about 17 mm or about 18 mm. The uniform diameter of the piercing element 160 can be about 1.2 mm. The piercing element 160 can be a metal piercing element 160. The fixed distal end 162 includes a surface that includes a recess to allow the material forming the closed distal end 151 of the cylindrical housing 152 to form a tight bond with the fixed distal end 162 of the piercing element 160. During assembly of the piercing article 150, the piercing element 160 can be pushed into place by the material forming the closed distal end 151 of the cylindrical housing 152. Alternatively, the piercing element 160 can be placed in a mold and the material forming the closed distal end 151 of the cylindrical housing 152 molded around the fixed distal end 162 of the piercing element 160 during assembly of the piercing article 150.

[0097] The fixed distal end 162 of the piercing element 160 is fixed to the distal end by direct or mechanical fixation to the closed distal end 151 of the piercing article 150. The closed distal end 151 of the piercing article 150 can define an end cap that seals the distal end of the cylindrical housing 152. The closed distal end 151 can include a recessed portion 157 that recesses the closed distal end 151 from the outer surface. The recessed portion 157 can be coaxial with the longitudinal axis L ACoaxial. The recessed portion 157 can be defined by a distal portion of the fixed distal end 162 of the piercing element 160. The bottom planar portion of the recessed portion 157 can be defined by a distal portion of the fixed distal end 162 of the piercing element 160. The outer periphery 155 of the closed distal end 151 can form a smooth rounded edge that joins the cylindrical housing outer surface 154 with the closed distal end 151.

[0098] The cylindrical housing inner surface 156 of the cylindrical housing 152 of the piercing article 150 has an open proximal end 153 diameter and a closed distal end 151 diameter that is smaller than the open proximal end 153 diameter. The cylindrical housing inner surface 156 diameter tapers from the open proximal end 153 diameter to the closed distal end 151 diameter. The cylindrical housing outer surface 154 diameter can be constant at about 9.8 mm and the cylindrical housing inner surface 156 diameter can be about 8.4 mm at the open proximal end 153 and about 7.7 mm at the closed distal end 151.

[0099] FIG. 3 and Figure 5 is a top view schematic of the open end of the piercing attachment 150. The piercing element 160 extends out of the page and is surrounded by the cylindrical housing 152. The closed distal end 151 houses four reinforcing ribs or struts 158. The reinforcing ribs or struts 158 connect the cylindrical housing inner surface 156 with the fixed distal end 162 of the piercing element 160. The cylindrical housing inner surface 156 is adjacent to the closed distal end 151 and can be configured to mate with the distal end 118 of the inhaler article 110 to provide a mating or base fit. The reinforcing ribs or struts 158 can mate with the distal end 118 of the inhaler article 110 to provide a mating or base fit.

Claims

1. A dry powder inhaler system, comprising: An inhaler article comprising a body defining an inhaler outer surface, the body extending along an inhaler longitudinal axis (L A ) from a mouthpiece end to a distal end by an inhaler length; as well as Passive puncture article, the puncture article comprising: A cylindrical shell, the cylindrical shell defining an outer surface and an inner surface of the cylindrical shell, the cylindrical shell along a longitudinal axis (L) A The cylindrical housing extends from its distal end to its open proximal end, the open proximal end of the cylindrical housing being configured to receive the distal end of the inhaler article; and A piercing element, which is contained within and fixed to the distal end of the cylindrical housing, the piercing element being along its longitudinal axis (L... A The length of the piercing element extends from its fixed distal end to its piercing end, the piercing element being recessed a certain distance from the open proximal end; The cylindrical shell has an outer surface diameter along its length; The distal end of the cylindrical shell is a closed distal end.

2. The dry powder inhaler system according to claim 1, wherein, The diameter of the outer surface along the length of the cylindrical shell is a uniform diameter along the length of the cylindrical shell.

3. The dry powder inhaler system according to claim 2, wherein, The piercing element is fixed to the closed distal end.

4. The dry powder inhaler system according to claim 1, wherein, The piercing element is recessed from the proximal end of the opening by a distance of at least 25% of the length of the cylindrical shell.

5. The dry powder inhaler system according to any one of claims 1-4, wherein, The piercing element is formed of a polymeric material or a fiber-reinforced polymeric material.

6. The dry powder inhaler system according to any one of claims 1-4, wherein, The piercing element is formed of polycarbonate or liquid crystal polymer.

7. The dry powder inhaler system according to any one of claims 1-4, wherein, The piercing element is made of metal.

8. The dry powder inhaler system according to any one of claims 1-4, wherein, The cylindrical shell is formed of a polymer material.

9. The dry powder inhaler system according to any one of claims 1-4, wherein, The diameter of the outer surface of the cylindrical shell is less than 150% of the diameter of the outer surface of the inhaler.

10. The dry powder inhaler system according to any one of claims 1-4, wherein when the inhaler article is accommodated within the piercing article, the longitudinal axis (L) of the piercing element is... A '') and the longitudinal axis (L) of the cylindrical shell A ') and the longitudinal axis of the inhaler (L) A The two are basically coaxial.

11. The dry powder inhaler system according to any one of claims 1-4, wherein when the inhaler article is accommodated within the puncture article, the distal end of the inhaler article engages with the distal end of the puncture article.

12. The dry powder inhaler system according to any one of claims 1-4, wherein the length of the piercing element is 40% to 60% of the length of the cylindrical housing.

13. The dry powder inhaler system according to any one of claims 1-4, wherein the piercing element has a first diameter adjacent to the piercing end and a second diameter adjacent to the fixed distal end, the second diameter being larger than the first diameter.

14. The dry powder inhaler system according to any one of claims 1-4, wherein when the inhaler article is housed within the punctured article, at least 80% of the length of the cylindrical housing is co-linear with the length of the inhaler.

15. The dry powder inhaler system according to any one of claims 1-4, wherein when the inhaler article is housed within the punctured article, at least 90% of the length of the cylindrical housing is co-linear with the length of the inhaler.

16. The dry powder inhaler system according to any one of claims 1-4, wherein, The diameter of the outer surface of the cylindrical shell is less than 140% of the diameter of the outer surface of the inhaler.

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