Inhaler article

Abstract

An inhaler article (10) having an upstream end (1) and a downstream end (2) is provided. The inhaler article includes an upstream section (3) including an end plug (5). The inhaler article includes a downstream section (4) downstream of and spaced apart from the upstream section. The downstream section includes a filter section (6). The filter section has a resistance to draw per unit length greater than 0 mm of water column per mm and less than about 3 mm of water column per mm. The inhaler article includes a cavity (7) defined between the upstream section and the downstream section and configured to be in fluid communication with the exterior of the article. The inhaler article includes a capsule (9) containing inhalable material and located in the cavity. An inhaler system (100) including such an inhaler article and a holder (120) is also provided.

Description

Technical Field

[0001] This disclosure relates to an inhaler article having a specific filter segment. This disclosure also relates to an inhaler system comprising a retainer for receiving the inhaler article and the inhaler article itself. Background Technology

[0002] Inhaler products such as dry powder inhalers are not always perfectly suited to deliver dry powder particles to the lungs at inhalation or airflow rates within the range of conventional smoking inhalation rates or airflow rates. Dry powder inhalers may be complex to operate or may involve moving parts. Dry powder inhalers typically aim to deliver an appropriate dry powder dose or capsule load in a single inhalation.

[0003] Some dry powder inhalers have a component for storing dry powder, such as a capsule. The capsule may be located inside the inhaler and can be activated by being punctured by a separate puncture element. Once the capsule is activated, the consumer inhales at the mouth end (downstream or proximal) of the inhaler to generate an airflow through the inhaler, causing the capsule to rotate around itself. The agitation of the capsule within the inhaler article and the airflow pressure cause the dry powder to be released from the punctured capsule. The released dry powder is carried by the airflow to the user's mouth.

[0004] Some inhaler articles include a retaining segment located downstream of the capsule. The retaining or supporting segment is primarily provided to hold the capsule within the inhaler. The retaining segment can be hollow or porous to allow dry powder to pass through. However, some hollow or relatively very porous retaining or supporting segments can allow a relatively large amount of dry powder to pass through. This can mean that when a consumer inhales from the article, the dose is too large, and therefore the capsule may be exhausted prematurely, which can be detrimental to the consumer experience. Alternatively, the retaining element or segment can have relatively low porosity, and given the relatively high inhalation resistance of the inhaler article and the relatively small dose inhaled by the consumer, the consumer may not be able to fully exhaust the capsule.

[0005] Furthermore, the upstream (distal) end of the retainer segment of a capsule-containing inhaler article is subjected to considerable axial force during capsule activation. During this activation process, a piercing element extends into the upstream end of the inhaler article to contact and pierce the capsule located within the article. Upon initial contact, the piercing element pushes the capsule against the upstream end of the retainer (or support) segment to successfully pierce the capsule. Therefore, the downstream components of the inhaler article (particularly the retainer segment) should be relatively resistant to deformation, especially under compression, and particularly in the longitudinal direction, while also being sufficiently porous or having appropriately sized longitudinal airflow channels so that the inhalation resistance (RTD) of the inhaler article ensures a pleasant experience for the consumer. Summary of the Invention

[0006] It is desirable to provide an inhaler article that is cost-effective and quick to manufacture, and performs effectively by ensuring reliable depletion of the capsule during use, so as to provide a satisfactory experience for consumers of inhalers or aerosol-generating articles.

[0007] According to one aspect of this disclosure, an inhaler article having an upstream end and a downstream or mouth end is provided. The inhaler article includes an upstream section. The upstream section includes an end plug. The inhaler article includes a downstream section located downstream of and spaced apart from the upstream section. The downstream section includes a filter segment (also referred to as a support segment or mouthpiece segment). The draw resistance per unit length of the filter segment is greater than 0 mmH2O (also expressed as mmH2O, mmH2O, mmH2O, mmH2O gauge, mmWG, or mmH2O) per millimeter (mm) and less than about 3 mmH2O per millimeter. This may be similar to or equivalent to the draw resistance of a conventional cigarette or a conventional dry powder inhaler. The inhaler article includes a cavity defined between the upstream and downstream sections. The cavity is configured to be in fluid communication with the outside of the inhaler article. The inhaler article includes a capsule containing inhalable material. The capsule is located within the cavity.

[0008] According to one aspect of this disclosure, an inhaler article having an upstream end and a downstream end is provided. The inhaler article may include an upstream segment. The upstream segment may include an end plug. The inhaler article may include a downstream segment located downstream of and spaced apart from the upstream segment. The downstream segment may include a mouthpiece segment or a filter segment. The inhalation resistance per unit length of the mouthpiece segment or filter segment may be greater than 0 mm H2O per mm and less than about 3 mm H2O per mm. The inhaler article may include a cavity defined between the upstream segment and the downstream segment. The cavity may be configured to receive a capsule containing inhalable material. The cavity may be configured to be in fluid communication with the outside of the inhaler article.

[0009] Inhaler articles may include capsules containing inhalable material. The capsule may be located inside the cavity.

[0010] According to one aspect of this disclosure, a mouthpiece segment or filter segment is also provided for use in inhaler articles or any other aerosol-generating articles. The suction resistance per unit length of the mouthpiece segment or filter segment can be greater than 0 mm water column per mm and less than about 3 mm water column per mm.

[0011] It has been found that providing a filter segment downstream of the capsule, with a suction resistance (RTD) between approximately 0 mm water column per mm and approximately 3 mm water column per mm, is advantageous in ensuring that the user can generate a suitable airflow due to the RTD characteristics of the filter segment. This provides a suitable airflow rate to achieve effective depletion of the inhalable material contained within the capsule.

[0012] The term "filter segment" in this disclosure may alternatively be referred to as a "support segment," "mouthpiece segment," "retainer segment," "downstream segment," or "downstream section" of the inhaler article. The cavity is preferably defined between the upstream section and the filter segment, and more preferably between the end plug and the filter segment.

[0013] The terms "upstream" and "downstream" refer to the relative positions of the components of the described retainer, inhaler article, and inhaler system with respect to the direction of the inhaled airflow as the inhaled airflow is drawn through the inhaler article, retainer, and inhaler system. "Downstream" is the mouth end. "Upstream" is the distal end of the mouth end.

[0014] The term "longitudinal" refers to the direction extending between the upstream and downstream ends, corresponding to the main longitudinal axis of the inhaler article or inhaler system. During use, air is drawn longitudinally from the upstream end to the downstream end through the aerosol-generating article or inhaler article. The term "lateral" refers to the direction perpendicular to the longitudinal axis. Unless otherwise specified, any reference to the "section" of the inhaler article or its components refers to a cross-section. The term "length" indicates the dimension of a component of the aerosol-generating article or inhaler article in the longitudinal direction. For example, it can be used to indicate the dimension of a capsule or filter segment in the longitudinal direction. The term "tangential" refers to a direction at an angle to a reference direction. For example, the tangential angle is not parallel to the reference direction.

[0015] The terms "proximal" and "distal" are used to describe the relative positions of components or portions of components in an inhaler article, retainer, or inhaler system. A retainer or element forming a retainer (e.g., a sleeve) according to this disclosure has: a proximal end that receives the inhaler article in use; and an opposing distal end, which may be a closed end or have an end closer to the proximal end of the retainer. An inhaler article according to this disclosure has a proximal end. In use, nicotine particles exit the proximal end of the inhaler article for delivery to the user. The inhaler has a distal end opposite the proximal end. The proximal end of the inhaler article may also be referred to as the oral end or downstream end. The distal end of a component may correspond to the upstream end of this component. The proximal end of a component may also correspond to the downstream end of this component.

[0016] Unless otherwise specified, the draw resistance (RTD) of a component or inhaler article is measured according to ISO 6565-2015. RTD refers to the pressure required to force air through the entire length of the component. The terms "pressure drop" or "draw resistance" for a component or article can also refer to "resistance to draw." These terms generally refer to measurements according to ISO 6565-2015 typically performed at a temperature of about 22 degrees Celsius, a pressure of about 101 kPa (about 760 Torr), and a relative humidity of about 60%, at a volumetric flow rate of about 17.5 ml / s at the output or downstream end of the measured component.

[0017] The suction resistance per unit length of a particular component, such as a filter segment, can be calculated by dividing the measured suction resistance of the component by the total axial length of the component. The RTD per unit length refers to the pressure required to force air through a unit length of the component. Throughout this disclosure, unit length refers to a length of 1 mm. Therefore, to determine the RTD per unit length of a particular filter segment, a sample of a filter segment of a specific length (e.g., 15 mm) can be used for measurement. The RTD of such samples is measured according to ISO 6565-2015. For example, if the measured RTD is approximately 15 mm of water column, then the RTD per unit length of the filter segment is approximately 1 mm of water column per mm. The RTD per unit length of the filter segment depends on the structural properties of the material used for the filter segment, the cross-sectional geometry or profile of the filter segment, and other factors.

[0018] The relative RTD or RTD per unit length of a filter segment can be between approximately 0 mm water column per mm and approximately 3 mm water column per mm. Alternatively, the RTD per unit length of a filter segment can be between approximately 0 mm water column per mm and approximately 2.5 mm water column per mm. Alternatively, the RTD per unit length of a filter segment can be between approximately 0 mm water column per mm and approximately 2 mm water column per mm. The RTD per unit length of a filter segment can be between approximately 0 mm water column per mm and approximately 1 mm water column per mm. The RTD per unit length of a filter segment can be between approximately 0 mm water column per mm and approximately 0.75 mm water column per mm.

[0019] As described above, the relative RTD or RTD per unit length of a filter segment can be greater than about 0 mm water column per mm and less than about 3 mm water column per mm. Alternatively, the RTD per unit length of a filter segment can be greater than about 0 mm water column per mm and less than about 2.5 mm water column per mm. Alternatively, the RTD per unit length of a filter segment can be greater than about 0 mm water column per mm and less than about 2 mm water column per mm. The RTD per unit length of a filter segment can be greater than about 0 mm water column per mm and less than about 1 mm water column per mm. The RTD per unit length of a filter segment can be greater than about 0 mm water column per mm and less than about 0.75 mm water column per mm.

[0020] The RTD per unit length of a filter segment can be greater than or equal to 0.01 mm water column per mm. Therefore, the RTD per unit length of a filter segment can be between approximately 0.01 mm water column per mm and approximately 3 mm water column per mm. Alternatively, the RTD per unit length of a filter segment can be between approximately 0.01 mm water column per mm and approximately 2.5 mm water column per mm. Alternatively, the RTD per unit length of a filter segment can be between approximately 0.01 mm water column per mm and approximately 2 mm water column per mm. The RTD per unit length of a filter segment can be between approximately 0.01 mm water column per mm and approximately 1 mm water column per mm. The RTD per unit length of a filter segment can be between approximately 0.01 mm water column per mm and approximately 0.75 mm water column per mm.

[0021] The suction resistance of a filter segment can be greater than 0 mm water column and less than approximately 20 mm water column. The suction resistance of a filter segment can be greater than 0 mm water column and less than approximately 15 mm water column. The suction resistance of a filter segment can be greater than 0 mm water column and less than approximately 10 mm water column. The suction resistance of a filter segment can be greater than 0 mm water column and less than approximately 10 mm water column.

[0022] The filter segment can be configured to withstand forces of up to about 15 Newtons applied to its upstream end without deforming substantially in the longitudinal direction. As described above, the filter segment located downstream of the capsule should be configured to withstand the compressive forces applied by the capsule to its upstream end during capsule activation. Therefore, the filter segment can be sufficiently rigid to withstand such activation of the capsule. The filter segment may comprise a rigid material.

[0023] The filter segment can be configured to withstand forces of up to about 12 Newtons applied to its upstream end without substantially deforming in the longitudinal direction. The filter segment can be configured to withstand forces of up to about 7 Newtons applied to its upstream end without substantially deforming. The filter segment can be configured to withstand forces of at least about 3 Newtons applied to its upstream end without substantially deforming. The filter segment can be configured to withstand forces between at least about 3 Newtons and about 15 Newtons applied to its upstream end without substantially deforming. The filter segment can be configured to withstand forces between at least about 3 Newtons and about 12 Newtons applied to its upstream end without substantially deforming. It has been found that ensuring the filter segment can withstand any of the forces within this range applied to its upstream end ensures that the filter segment is not damaged during capsule activation, thereby not negatively impacting the performance of the inhaler article and the consumer experience.

[0024] The phrase "substantially non-deformable" is used in this document to mean that the filter segment does not plastically, irreversibly, or permanently deform. Advantageously, the filter segment is rigid and strong enough to withstand forces of up to approximately 15 Newtons applied to its upstream end without plastically, irreversibly, or permanently deforming in the longitudinal direction. Any permanent deformation retained in the filter segment after capsule puncture could be detrimental to the overall performance and structural integrity of the inhaler article.

[0025] Filter segments can be formed from fibrous materials. Filter segments can be formed from porous materials. Filter segments can be formed from biodegradable materials. Filter segments can be formed from cellulose materials such as cellulose acetate. Filter segments can be formed from polylactic acid-based materials. Filter segments can be formed from bioplastic materials (preferably starch-based bioplastic materials). Filter segments can be made by injection molding or extrusion. Bioplastic-based materials are advantageous because they can provide filter segment structures that are simple and inexpensive to manufacture, with specific and complex cross-sectional profiles, which can include multiple relatively large airflow channels extending through the filter segment material, providing suitable RTD properties to ensure adequate capsule depletion, while also being strong enough to withstand the forces borne by the filter segment during capsule activation.

[0026] Filter segments can be formed from sheets of suitable material that have been rolled, pleated, aggregated, woven, or folded into elements defining multiple longitudinally extending channels. Such sheets of suitable material can be formed from paper, cardboard, polymers (e.g., polylactic acid), or any other cellulose-based, paper-based, or bioplastic-based material. The cross-sectional profile of such filter segments can show the channels as randomly oriented.

[0027] Filter segments can be formed in any other suitable manner. For example, filter segments can be formed from bundles of longitudinally extending tubes. The longitudinally extending tubes can be formed from polylactic acid. Filter segments can be formed by extrusion, molding, lamination, injection molding, or shredding of suitable materials. Therefore, it is preferable that there is a low pressure drop (or RTD) from the upstream end of the filter segment to the downstream end of the filter segment, but not zero.

[0028] A filter segment may include at least one filter (airflow) channel extending along the filter segment. Preferably, at least one filter airflow channel extends along the entire length of the filter segment. At least one filter channel may have a substantially circular cross-section. At least one filter channel may have a substantially Y-shaped or T-shaped cross-section. A filter segment may include multiple such filter airflow channels extending along the filter segment. A filter segment may include at least three filter airflow channels. Providing at least one filter airflow channel in a filter segment allows the filter segment to meet a specific RTD value without sacrificing the strength of the filter segment to withstand the capsule activation process.

[0029] The ratio of the total cross-sectional area of ​​at least one filter channel to the total cross-sectional area of ​​the filter segment can be at least 25%. In other words, the open area of ​​the filter segment can be at least 25%. The ratio of the total cross-sectional area of ​​at least one filter channel to the total cross-sectional area of ​​the filter segment can be at least 50%. The ratio of the total cross-sectional area of ​​at least one filter channel to the total cross-sectional area of ​​the filter segment can be at least 75%. The ratio of the total cross-sectional area of ​​at least one filter channel to the total cross-sectional area of ​​the filter segment can be at least 80%. Additionally, the filter segment itself can be porous. Providing a large proportion of filter channels or open areas ensures that the RTD of the filter segment and the RTD per unit length are sufficiently low to ensure proper capsule depletion. Furthermore, this allows for the use of appropriate rigidity and stronger materials for the filter segment, which can withstand the puncture forces applied to the capsule and the filter segment, while also providing low RTD characteristics.

[0030] The filter channel of the filter segment is preferably smaller than the diameter of the capsule. Therefore, the width of the filter channel can be smaller than the diameter of the capsule. This diameter of the capsule refers to the maximum diameter of the capsule. The width of the filter channel can be less than 6 mm, more preferably less than 5.5 mm, and even more preferably less than 5 mm.

[0031] The filter segment may not consist of a hollow tubular segment that defines a single unobstructed airflow passage between its upstream and downstream ends and has a wall thickness of less than 1 mm. This hollow tubular segment would effectively provide an RTD of 0 mm water column and an RTD per unit length. This would be too low to provide a pleasant user experience, and the hollow tubular segment might not be able to retain the capsule within the cavity during activation and use.

[0032] The Young's modulus (or elastic modulus) of the filter segment material may be greater than or at least about 10 MPa. Unless otherwise specified, the Young's modulus of the filter segment material shall be measured according to ASTM E111-17. The Young's modulus (or elastic modulus) of the filter segment material may be greater than or at least about 20 MPa. The Young's modulus (or elastic modulus) of the filter segment material may be greater than or at least about 30 MPa. The Young's modulus (or elastic modulus) preferably refers to the Young's modulus of the material of the component along the longitudinal axis or direction of the component.

[0033] Capsules can be defined by having a specific puncture strength (in Newtons). The puncture strength of a capsule refers to the specific puncture or bursting force (in Newtons) required to puncture or activate the capsule by a puncturing element or needle. Methods for measuring the puncture strength of capsules are known to a person skilled in the art. For example, the puncture strength of capsules can be measured according to ASTM F1306-16. Puncture elements or needles can range from 27 gauge (outer diameter = 0.42 mm) to 4 gauge (outer diameter = 5 mm). For example, the puncture strength of a sample capsule can be measured using a 3.2 mm (8 gauge) diameter puncture element or a hemispherical probe.

[0034] The filter segment can be configured to withstand a force of at least about 50% of the puncture strength of the capsule applied to the upstream end of the filter segment without deforming substantially. The filter segment can be configured to withstand a force of up to about 100% of the puncture strength of the capsule applied to the upstream end of the filter segment without deforming substantially. The filter segment can be configured to withstand a force of up to about 200% of the puncture strength of the capsule applied to the upstream end of the filter segment without deforming substantially. The filter segment can be configured to withstand a force of at least 50% to about 100% of the puncture strength of the capsule applied to the upstream end of the filter segment without deforming substantially. The filter segment can be configured to withstand a force of at least 50% to about 200% of the puncture strength of the capsule applied to the upstream end of the filter segment without deforming substantially.

[0035] The filter segment (or element) may extend from the cavity to the downstream end of the inhaler article. In other words, the length of the downstream section of the inhaler article is the same as the length of the filter segment.

[0036] The length of a filter segment may be greater than or at least about 10 mm. The length of a filter segment may be greater than or at least about 15 mm. The length of a filter segment may be greater than or at least about 20 mm. The length of a filter segment may be less than about 30 mm. The length of a filter segment may be between about 10 mm and 30 mm. The length of a filter segment may be between about 10 mm and about 20 mm.

[0037] Preferably, the length of the filter segment can be between approximately 15 mm and 20 mm. The length of the filter segment can be approximately 17 mm.

[0038] The outer diameter of the inhaler article can range from about 6 mm to about 10 mm, or from about 7 mm to about 10 mm, or from about 7 mm to about 9 mm, or from about 7 mm to about 8 mm, or about 7.2 mm. The length of the inhaler article (along the longitudinal axis) can range from about 40 mm to about 100 mm, or from about 40 mm to about 80 mm, or from about 40 mm to about 60 mm. Preferably, the length of the inhaler article is about 45 mm. Preferably, the length of the inhaler article is selected such that the mouthpiece end of the inhaler article protrudes from the retainer of the inhaler system, as described in more detail below.

[0039] The (distal, forward, or upstream) end plug can extend from the upstream end of the inhaler article into the cavity.

[0040] The end plug may define at least one airflow inlet passage (or air inlet) extending from the upstream end of the inhaler article or the end plug into the cavity, thereby establishing fluid communication between the cavity and the outside of the inhaler article.

[0041] An end plug may define a central puncture channel extending from the distal end of an inhaler article toward the capsule cavity. The end plug may include a central channel extending through a body of the end plug. As described in this disclosure, the central channel may be configured to provide passage to the cavity for a puncture element. The puncture central channel of the end plug may be coaxial with the longitudinal axis of the inhaler article. The size of the linear puncture channel may be set to allow the puncture element to pass through the linear puncture channel.

[0042] The end plug may include a resealable element disposed on or within the central channel. A resealable element, such as a diaphragm or a resealable membrane, may be disposed at either end of the central puncture channel.

[0043] Advantageously, the puncture channel along the end plug allows for reliable puncture of the capsule contained within the capsule cavity. Furthermore, the resealable element maintains the integrity of the desired airflow pattern within the capsule cavity.

[0044] A resealable element can seal a central channel. The resealable element can form a tight or airtight seal or barrier along the central channel. The central channel can be formed of a puncture-resistant material. A puncture element can penetrate the resealable element and puncture the capsule within the capsule cavity. Once the puncture element retracts or is removed from the resealable element, the resealable element can be resealed. The resealable element or membrane can comprise a diaphragm or diaphragm-type element. The resealable element or membrane can be formed of an elastic material, such as rubber, silicone, metal foil co-laminated with a polymer, or latex, etc.

[0045] The end plug may include at least one airflow inlet passage that allows air to enter the cavity of the inhaler article.

[0046] At least one airflow inlet passage may extend in a direction tangential to the central passage. In such embodiments, air may enter the central passage via one side of the inhaler article. However, in this disclosure, it is preferred that the airflow inlet passage extends along the body of the end plug in a direction not parallel to the longitudinal axis of the inhaler article.

[0047] At least one airflow inlet passage may extend from the distal end or distal face of the end plug to the inner end or inner face of the end plug. The airflow inlet passage may extend the length of the end plug body. The airflow inlet passage may extend from the distal end or distal face of the end plug to the inner end or inner face of the end plug and define a curved, helical, spiral, or arcuate path. The airflow inlet passage may extend from the distal end or distal face of the end plug to the inner end or inner face of the end plug and define a curved, helical, spiral, or arcuate path along the outer surface of the end plug body. At least one airflow inlet passage may extend along the end plug in the longitudinal direction and around the end plug in the circumferential direction. In other words, at least one airflow inlet passage may extend in a direction not parallel to the longitudinal axis of the inhaler article and the end plug. Therefore, at least one airflow inlet passage may follow a spiral, helical, arcuate, or curved profile along the outer surface of the end plug body.

[0048] A curved, spiral, helical, or arc-shaped air inlet passage can be configured to induce a vortex airflow pattern within the capsule cavity of the inhaler article. The air inlet passage draws inlet air from the distal end of the end cap into the capsule cavity of the inhaler article. As airflow passes through the air inlet passage and through the capsule cavity, the air inlet passage can induce a rotating or vortex airflow. The airflow through the inhaler article preferably enters the inhaler article at the distal end face or distal end of the end cap and moves along the longitudinal axis of the inhaler article in a vortex airflow pattern to the mouth or downstream end. The inlet of the airflow passage can be defined within the distal end face of the end cap. The distal end face of the end cap can be orthogonal to the longitudinal axis of the inhaler article.

[0049] The air inlet passage may be continuously non-parallel to the longitudinal axis of the inhaler article along its entire length. The air inlet passage may be parallel for a portion of its length and non-parallel for the remainder. The air inlet passage may be parallel in a first or upstream portion and non-parallel in a second or downstream portion exiting into the capsule cavity. The second portion may define approximately 50% or less of the total air passage length, or approximately 5% to approximately 50%, or approximately 10% to approximately 30%.

[0050] The end plug can be inserted into the distal end of the inhaler article and can be secured to or within the inhaler article by friction fit or interference fit. The distal portion of the inhaler article, such as a hollow tubular element (described below), can cooperate with the end plug air inlet passage to close the air inlet passage or form the remainder of the air inlet passage.

[0051] The air inlet passage may extend along an arc coaxial with the longitudinal axis for a distance. The air inlet passage may be curved relative to the longitudinal axis of the inhaler article. The air inlet passage may rotate about the circumference of the end cap, depending on its position along the end cap. The air inlet passage may rotate about 5% to about 100%, or about 25% to about 50%, of the circumference of the end cap. The air inlet passage may rotate about the circumference of the end cap by a certain arc length (the distance when viewing the end cap from the distal end face), the central angle of which (may coincide with the longitudinal axis of the inhaler article) being in the range of about or from about 5 degrees to about 360 degrees, or from about 45 degrees to about 180 degrees, or from about 45 degrees to about 135 degrees.

[0052] The air inlet channel may enter the capsule cavity at an angle relative to the longitudinal axis. The air inlet channel may enter the capsule cavity at an angle ranging from about 5 degrees to about 89 degrees, or about 45 degrees to about 89 degrees, or about 60 degrees to about 89 degrees, or about 70 degrees to about 88 degrees. The air inlet channel may have a first portion parallel to the longitudinal axis and a second portion that exits at an angle relative to the longitudinal axis into the capsule cavity as described above.

[0053] An end plug may include at least two, or two or more, air inlet channels formed in the end plug body. An end plug may include at least three, or three or more, air inlet channels formed in the end plug body. The air inlet channels may be symmetrically positioned about the end plug. The air inlet channels may be opposite each other along the length of the end plug. One or more air inlet channels may have a helical shape (forming part of a helix). Helical air inlet channels may be symmetrically arranged along the length of the end plug, and preferably opposite each other along the length of the end plug. Each air inlet channel may extend a distance along its own arc coaxial with the longitudinal axis.

[0054] At least one airflow inlet channel (or air inlet) may include two airflow inlet channels configured to generate a vortex airflow within the cavity. This rotating or vortex airflow is delivered to the capsule cavity of the inhaler article. The rotating or vortex airflow causes the capsule contained within the capsule cavity to rotate and releases inhalable material particles into the rotating or vortex airflow, which is guided downstream through a filter section and to the consumer.

[0055] The end cap and the air inlet passage defined thereon can be precisely designed and manufactured to impart the desired airflow pattern to the capsule cavity of the inhaler article.

[0056] The body of the inhaler article, or "inhaler article," may have any suitable shape. The body of the inhaler article, or "inhaler article," may resemble a smoking product or a conventional cigarette in size and shape. The inhaler article may have a substantially uniform outer diameter along its length. The inhaler article may have a substantially uniform inner diameter along its length. The inhaler article may have any suitable cross-sectional shape. For example, the cross-section may be circular, elliptical, square, or rectangular. The inhaler article preferably has a circular cross-section, which may be uniform along its length, thus forming an elongated cylinder.

[0057] The inhaler article may include a hollow tubular element extending from the upstream end of the inhaler article to a filter segment, such that an end plug and a capsule can be located within the hollow tubular element. The hollow tubular element may be formed of a polymeric material, a cellulose material, or any other suitable material. The inhaler article may be formed of a biodegradable material. Preferably, the inhaler article may be formed of cardboard or cardboard. The hollow tubular element may have a uniform thickness along its length. The hollow tubular element may have a thickness ranging from about 1 mm to about 2 mm.

[0058] The end plug may include a collar portion having a larger diameter than the rest of the end plug body. The collar portion serves as a physical stop to ensure proper placement of the end plug within the distal portion of the hollow tubular element. The collar portion may abut an elongated inhaler article. The diameter of the collar portion may be approximately 0.5 mm to approximately 1 mm larger than the diameter of the rest of the end plug body. The collar portion may have a diameter substantially similar to or the same as the outer diameter of the hollow tubular element or inhaler article.

[0059] Inhaler articles may include filter packaging defining a filter segment of a downstream section. Inhaler articles may include packaging material or inhaler article packaging defining a hollow tubular element and a downstream section. The packaging material may axially align and secure the downstream section with the end plug. The packaging material may be formed of a biodegradable material. The packaging material may be formed of packaging paper.

[0060] The length of the end plug can range from about 3 mm to about 12 mm, or from about 4 mm to about 10 mm, or from about 5 mm to about 9 mm, or about 8 mm. The end plug can have an outer diameter sufficient to form a tight or frictional fit with the inner diameter of the hollow tubular element. The outer diameter of the end plug can range from about 5 mm to about 10 mm, or from about 6 mm to about 9 mm, or from about 6.5 mm to about 8.5 mm, or about 7.5 mm. The length of the central channel can be equal to the length of the end plug.

[0061] An end plug may be disposed at the distal end of the body. The end plug may define the distal end of the inhaler article. Preferably, at least one air inlet of the end plug is located near the distal or upstream end of the inhaler article. The central channel may include a first end defining the upstream boundary of the capsule cavity and a second opposing end defining the distal end of the inhaler article body. Preferably, the second opposing end defines an open distal end of the inhaler article body. The central channel may extend along the longitudinal axis of the inhaler article and define an opening coaxial with the longitudinal axis of the inhaler article at the distal end of the inhaler article.

[0062] Advantageously, the end plug may include an open orifice along the longitudinal axis and may not have elements that block or close the open distal end of the inhaler article in order to reduce the complexity of the inhaler article. Once the capsule is punctured, the consumer can simply close or block the open distal end with the retainer or the consumer's finger to guide the inhaled airflow substantially through the air inlet on the inhaler article.

[0063] Preferably, the end plug is formed of a biodegradable material. Preferably, the end plug comprises a fibrous material. Preferably, the end plug is formed of a porous material. Preferably, the end plug is formed of a cellulose material such as cellulose acetate. Preferably, the end plug is formed of a polylactic acid material. Advantageously, the end plug may be formed of a material used for assembling conventional cigarettes. Advantageously, the inhaler article may be formed of a biodegradable material.

[0064] The airflow through the inhaler article preferably enters the inhaler article through the airflow inlet channel at the upstream end of the inhaler article, and then exits at the mouthpiece or downstream end of the inhaler article along the longitudinal axis of the inhaler article, via the capsule cavity and filter segment.

[0065] The central channel may have a consistent inner diameter or open diameter extending from the capsule cavity to the open distal or most upstream end of the inhaler article. The diameter of the central channel may be at least about 50%, at least about 70%, or at least about 75% of the diameter of the inhaler article. The diameter of the central channel may range from about 3 mm to about 6.5 mm, or from about 4 mm to about 6 mm, or from about 5 mm to about 6 mm, or about 5.5 mm. Alternatively, the diameter of the central channel may range from about 0.5 mm to about 2 mm.

[0066] Preferably, the capsule is retained within the capsule cavity. The central channel may have a uniform diameter extending from the capsule cavity to the open distal or upstream end of the inhaler article or end plug. The diameter of the central channel may be at least about 50%, at least about 70%, or at least about 75% of the diameter of the distal end of the body. The diameter of the central channel of the end plug may range from about 50% to about 90% of the diameter of the capsule retained within the capsule cavity. Such dimensions of the central channel ensure that the capsule may not fall out of the inhaler article via the central channel of the end plug.

[0067] As described above, when air is drawn through the airflow inlet channel of the end cap and through the capsule cavity, the end cap can induce a rotating or vortex airflow. Advantageously, after the capsule has been punctured, this vortex airflow generated by the airflow inlet channel of the end cap can be used to efficiently deplete the capsule during consumption. Advantageously, the "vortex" effect can agitate or rotate the capsule to provide a uniform entrainment of a portion or a small fraction of nicotine particles from the capsule in two or more, or five or more, or ten or more inhalations or "puffs" by the user.

[0068] The inhalable material may include nicotine. Preferably, the capsule contains pharmaceutically active particles. The pharmaceutically active particles may include nicotine. The median aerodynamic diameter of the pharmaceutically active particles may be about 5 micrometers or less, or in the range from about 0.5 micrometers to about 4 micrometers, or in the range from about 1 micrometer to about 3 micrometers.

[0069] Advantageously, the inhaler article delivers nicotine particles effectively to the lungs at an inhalation rate or airflow rate within the range of conventional smoking inhalation rates or airflow rates. The inhaler delivers the nicotine product using an inhaler article that resembles a conventional cigarette. The inhaler article or system described herein can deliver dry powder to the lungs at an inhalation rate or airflow rate within the range of conventional smoking inhalation rates or airflow rates. The consumer can take multiple inhalations or "puffs," each "puff" delivering a small amount of the dry powder contained in the capsule cavity. The inhaler article can have a form similar to a conventional cigarette and can simulate the habit of conventional smoking. The inhaler article is easy to manufacture and convenient for consumers to use.

[0070] Airflow management through the capsule cavity of an inhaler article can cause the capsule contained therein to rotate during inhalation and consumption. The capsule may contain nicotine particles (also referred to as "nicotine powder" or "nicotine particles") and optionally, particles including flavorings (also referred to as "flavoring particles"). Rotation of the punctured capsule can be paused, and the nicotine particles released from the punctured capsule into the inhaled air, which moves through the inhaler article. Flavoring particles may be larger than nicotine particles and may aid in the delivery of the nicotine particles to the user's lungs, while the flavoring particles are preferentially retained in the user's oral cavity or buccal space. The nicotine particles and optional flavoring particles can be delivered using the inhaler article at an inhalation rate or airflow rate within the range of conventional smoking inhalation rates or airflow rates.

[0071] The term "nicotine" refers to nicotine and nicotine derivatives, such as free nicotine base and nicotine salts.

[0072] The term "fragrance" or "flavoring" refers to a sensory compound, composition, or material that alters or is intended to alter the taste or aroma properties of nicotine during its consumption or inhalation.

[0073] According to another aspect of this disclosure, an inhaler system is provided, comprising an inhaler article as described herein and a retainer for receiving the inhaler article. The retainer includes a housing defining a housing cavity configured to receive the inhaler article. The retainer includes a piercing element configured to extend into the housing cavity and pierce a capsule of the inhaler article.

[0074] The retainer may include a puncture element extending into the housing cavity, the puncture element being configured to puncture the capsule of the inhaler article.

[0075] A retainer for an inhaler article can be combined with an inhaler article containing a capsule (described herein) to activate the inhaler article by piercing the capsule, thereby providing reliable activation of the capsule within the inhaler article (by piercing the capsule with the retainer's piercing element) and releasing the particles contained within the capsule, and enabling the article to deliver the particles to the consumer. The retainer is separate from the inhaler article, but the consumer can use both the inhaler article and the retainer to simultaneously consume the particles released within the inhaler article. Multiple such inhaler articles can be combined with retainers to form a system or kit. A single retainer 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 and provide reliable activation and optional visual indication (marking) for each inhaler article to activate the inhaler article.

[0076] A retainer for an inhaler article includes a housing for receiving a housing cavity of the inhaler article and a sleeve configured to retain the inhaler article within the housing cavity. The sleeve includes a sleeve cavity and is movable within the housing cavity along a longitudinal axis of the housing. The sleeve includes a first open end and a second opposing end. The first open end is configured to receive the distal end of the inhaler article. The second opposing end of the sleeve is configured to contact the distal end of the inhaler article. The second opposing end of the sleeve is configured to guide substantially all inhaled air through the inhaler article via at least one air inlet extending in a direction not parallel to a central channel.

[0077] The inhaler system includes the inhaler article described herein, having a capsule disposed within a capsule cavity and a retainer for receiving the inhaler article. The retainer includes a housing having a housing cavity for receiving the inhaler article and a sleeve configured to retain the inhaler article within the housing cavity. The sleeve includes a sleeve cavity and is movable within the housing cavity along a longitudinal axis of the housing. The sleeve includes a first open end and a second opposing end. The first open end is configured to receive the inhaler article, and the second opposing end of the sleeve is configured to contact the distal end of the inhaler article.

[0078] The method includes inserting an inhaler article into a sleeve of a retainer for the inhaler article, as described herein, until the distal end of the inhaler article contacts a second opposing end of the sleeve. The inhaler article includes a body extending distally along the longitudinal axis of the inhaler from the mouthpiece end, and a capsule disposed within the body of the inhaler article. The inhaler article and sleeve are then moved toward a piercing element until the piercing element pierces the capsule. Air is then drawn into the second opposing end of the sleeve of the retainer to direct the inhaled airflow to an air inlet on the inhaler article, thereby creating a rotating or vortex airflow through a cavity of the inhaler article. This vortex inhaled airflow is transmitted to the capsule cavity when the inhaler article is disposed within the retainer for the inhaler article. The consumed inhaler article can then be removed from the retainer and discarded. A fresh inhaler article can then be inserted into the retainer, and the method repeated.

[0079] The inhaler articles described herein may be combined with a piercing element or a retainer including a piercing element to deliver nicotine particles from a capsule to a user. The piercing element or piercing device (or retainer) may be separate from or not form part of the inhaler article. Multiple inhaler articles may be combined with a piercing element or piercing device (or retainer) to form a kit.

[0080] The retainer includes a housing having a housing cavity for receiving an inhaler article and a sleeve configured to retain the inhaler article within the housing cavity. The sleeve includes a sleeve cavity and is movable within the housing cavity along a longitudinal axis of the housing. The sleeve includes a first open end and a second opposing end. The first open end is configured to receive the inhaler article, and the second opposing end of the sleeve is configured to contact the distal end of the inhaler article.

[0081] Preferably, the second opposite end of the sleeve is configured to guide substantially all of the inhaled airflow through at least one air inlet of the inhaler article, which extends in a direction not parallel to the central channel.

[0082] Advantageously, the retainer can cooperate with the inhaler article to guide virtually all inhaled airflow through the air inlet of the end plug of the inhaler article.

[0083] Preferably, the retainer further includes a piercing element fixed to and extending from the inner surface of the housing. The piercing element is configured to extend through a second opposing end of the sleeve and into the capsule cavity to pierce the capsule along the longitudinal axis of the housing.

[0084] The capsules may be sealed within the inhaler article before 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 seals to cover one or more air inlet passages at the distal end of the inhaler article or air outlet at the mouthpiece end of the inhaler article. This ensures that the inhaler article maintains proper hygiene and freshness, or prevents the capsules from drying out and hardening or becoming brittle.

[0085] The capsule can rotate about its longitudinal or central axis as air is inhaled through the inhaler article. The capsule can be formed of an airtight material that substantially contains the particles within the capsule. The capsule can be configured to be punctured or ruptured by a puncturing element when it is within the capsule cavity. The puncturing element can be separate from or integrated with the inhaler article. The capsule can be formed of any suitable material. The capsule can be formed of a metallic or polymeric material to keep the capsule from contamination, but can be punctured or ruptured by the puncturing element before consumption to allow the release of nicotine particles from within the capsule. The capsule can be formed of a polymeric material. The polymeric material can be hydroxypropyl methylcellulose (HPMC). The capsule can have any suitable size. The capsule can be a size 1 to size 4 capsule, or a size 3 capsule, or a size 3 capsule.

[0086] The system may include a separate piercing element, such as a metal or rigid needle. The piercing element may form a single opening through the capsule received in the capsule cavity. The piercing element may be configured to penetrate the end plug, specifically the center of the end plug, and enter the capsule cavity.

[0087] A retainer for an inhaler article can be combined with an inhaler article containing a capsule (as described herein) to activate the inhaler article by piercing the capsule, thereby providing reliable activation of the capsule within the inhaler article (by piercing the capsule with the retainer's piercing element) and releasing the particles contained within the capsule, and enabling the article to deliver the particles to the consumer. The retainer is separate from the inhaler article, but the consumer can use both the inhaler article and the retainer to simultaneously consume the particles released within the inhaler article. Multiple such inhaler articles can be combined with retainers to form a system or kit. A single retainer 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 and provide reliable activation and optional visual indication (marking) for each inhaler article to activate the inhaler article.

[0088] A retainer for an inhaler article includes a housing for receiving a housing cavity of the inhaler article and a sleeve configured to retain the inhaler article within the housing cavity. The sleeve includes a sleeve cavity and is movable within the housing cavity along a longitudinal axis of the housing. The sleeve includes a first open end and a second opposing end. The first open end is configured to receive a distal or upstream end of the inhaler article. The second opposing end of the sleeve is configured to contact the distal end of the inhaler article. The second opposing end of the sleeve is configured to guide substantially all inhaled airflow through at least one air inlet of the inhaler article, the at least one air inlet extending in a direction not parallel to a central channel of the end plug.

[0089] An inhaler system may include the inhaler article described herein, having a capsule disposed within a capsule cavity and a retainer for receiving the inhaler article. The retainer includes a housing having a housing cavity for receiving the inhaler article and a sleeve configured to retain the inhaler article within the housing cavity. The sleeve includes a sleeve cavity and is movable within the housing cavity along a longitudinal axis of the housing. The sleeve includes a first open end and a second opposing end. The first open end is configured to receive the inhaler article, and the second opposing end of the sleeve is configured to contact the distal end of the inhaler article.

[0090] The retainer may also include a piercing element fixed to and extending from the inner surface of the housing. The piercing element may be configured to extend through a second opposing end of the sleeve and into the capsule cavity to pierce the capsule along the longitudinal axis of the housing.

[0091] The retainer may also include a spring element configured to face an open proximal end of the housing and bias the sleeve between a relaxed and a compressed position. The spring element may be received within a housing cavity (also referred to as an inhaler article cavity) of the retainer and is compressed as the movable sleeve and inhaler article move toward the puncturing element. The spring element may be located between the distal ends of the sleeve and the housing and contacts the distal ends of both the sleeve and the housing. The spring element may be located between the distal ends of the sleeve and the distal ends of the housing. The spring element may contact the distal ends of the sleeve and the distal ends of the housing. The spring element may be disposed around the puncturing element. The spring element may be coaxial with the puncturing element. The spring element may be a conical spring.

[0092] A spring element biases the inhaler article away from the piercing element. In use, the user inserts the inhaler article into the inhaler article cavity of the retainer. By doing so, the spring is compressed, allowing the inhaler article to move distally toward the inhaler article cavity. Ultimately, the piercing element pierces the capsule disposed within the inhaler article. Once this occurs, the user releases the inhaler article, allowing the spring to bias the inhaler article proximal to the inhaler article cavity and away from the piercing element. The user can then inhale proximally onto the inhaler article.

[0093] The sleeve may define a first air inlet region, the first air inlet region including at least one air orifice through the sleeve. The first air inlet region is located near the proximal end of the sleeve. The first air inlet region is configured to allow air to flow from the interior of the sleeve to an airflow channel formed between the inner surfaces of the sleeve and the housing. The sleeve may include a second air inlet region, the second air inlet region including at least one air orifice through the sleeve. The second air inlet region is located near the distal end of the sleeve. The second air inlet region is configured to allow air to flow from the airflow channel into the interior of the sleeve.

[0094] The retainer may include a marking element extending into the cavity of the housing (or inhaler article). The marking element may be configured to mark the surface of the inhaler article. The marking element may extend orthogonally to the longitudinal axis of the retainer or inhaler article. The marking element may be configured to mechanically mark the outer surface of the inhaler article. For example, the marking element may be configured to scratch, cut, abrade, scuff, fold, or bend the outer surface of the inhaler article. The marking element may have a sharp end configured to scratch the outer surface of the inhaler when received within the housing cavity. When received within the housing cavity, the marking element may apply color to the outer surface of the inhaler article. When a piercing element penetrates the capsule disposed within the inhaler article, the marking element may mark the outer surface of the inhaler article. Thus, it indicates that the inhaler article has been activated and is ready for consumption by the user. This also advantageously prevents the user from attempting to reuse a previously activated inhaler article.

[0095] The marking element may extend orthogonally to the longitudinal axis of the retainer or inhaler article. The marking element may be formed of a rigid material configured to provide a visual indication that the marking element has contacted the outer surface of the inhaler. The marking element may be secured to the retainer housing. As described above, the marking element may form an alignment pin.

[0096] The marking element may extend through at least a portion of the thickness of the retainer. The marking element may extend through the sleeve. The marking element may extend into the housing cavity and into the sleeve. The marking element may extend beyond at least the marking distance of the sleeve such that when the inhaler article is received within the housing cavity, the marking element contacts the outer surface of the inhaler. The marking element may be aligned and engaged with an elongated groove in the sleeve.

[0097] The capsule may contain pharmaceutically active nicotine-containing particles (also known as "nicotine powder" or "nicotine granules"), and optionally contain flavoring particles (also known as "flavoring granules"). The capsule may contain a predetermined amount of nicotine granules and optionally flavoring granules. The capsule may contain sufficient nicotine granules 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 granules to provide about 5 to about 50 inhalations or "puffs," or about 10 to about 30 inhalations or "puffs." Each inhalation or "puff" delivers about 0.1 mg to about 3 mg of nicotine granules to the user's lungs, or about 0.2 mg to about 2 mg of nicotine granules to the user's lungs, or about 1 mg of nicotine granules to the user's lungs.

[0098] Depending on the specific formulation used, nicotine particles can have any useful concentration of nicotine. Nicotine particles can have at least about 1% wt of nicotine up to about 30% wt of nicotine, or about 2% wt to about 25% wt of nicotine, or about 3% wt to about 20% wt of nicotine, or about 4% wt to about 15% wt of nicotine, or about 5% wt to about 13% wt of nicotine. Preferably, each inhalation or "puff" delivers about 50 to about 150 micrograms of nicotine to the user's lungs.

[0099] The capsule may contain or hold at least about 5 mg of nicotine granules or at least about 10 mg of nicotine granules. The capsule may contain or hold less than about 900 mg of nicotine granules, or less than about 300 mg of nicotine granules, or less than 150 mg of nicotine granules. The capsule may contain or hold about 5 mg to about 300 mg of nicotine granules or about 10 mg to about 200 mg of nicotine granules.

[0100] When flavoring particles are mixed or combined with nicotine particles inside the capsule, the flavoring particles can provide the desired amount of flavor to the user with each inhalation or "puff".

[0101] Nicotine particles may have any useful particle size distribution for preferential delivery to the user's lungs upon inhalation. Capsules may include particles other than nicotine particles. Nicotine particles and other particles may form a powder system.

[0102] The capsule may contain at least about 5 mg of dry powder (also known as a powder system) or at least about 10 mg of dry powder. The capsule may 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 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.

[0103] The dry powder or powder system may include at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of nicotine particles having a particle size of about 5 micrometers or less, or in the range of about 1 micrometer to about 5 micrometers.

[0104] The mass median aerodynamic diameter of particles including nicotine can 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. Preferably, the mass median aerodynamic diameter is measured using a cascade impactor.

[0105] The mass median aerodynamic diameter of the particles, including the fragrance, can be about 20 micrometers or greater, or about 50 micrometers or greater, or in the range of about 50 to about 200 micrometers, or in the range of about 50 to about 150 micrometers. Preferably, the mass median aerodynamic diameter is measured using a cascaded impactor.

[0106] The average diameter of the dry powder can be 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. The average diameter refers to the average diameter per unit mass, and is preferably measured by laser diffraction, laser diffusion, or electron microscopy.

[0107] The nicotine or nicotine particles in the powder system may be pharmaceutically acceptable free nicotine, nicotine salts, or nicotine hydrates. Suitable nicotine salts or nicotine hydrates include, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine monopyruvate, nicotine glutamate, or nicotine hydrochloride. The compounds that combine with nicotine to form salts or hydrates may be selected based on their expected pharmacological effects.

[0108] Preferably, the nicotine particles contain amino acids. Preferably, the amino acid can be leucine, such as L-leucine. Providing the nicotine-containing particles with an amino acid such as L-leucine reduces the adhesive force of the nicotine-containing particles and reduces the attraction between nicotine particles, thus reducing particle agglomeration. Similarly, the adhesive force with fragrance-containing particles can be reduced, thereby also reducing the agglomeration of nicotine and fragrance particles. Therefore, even when nicotine and fragrance particles are combined, the powder system described herein can be a free-flowing material with each powder component having a stable relative particle size.

[0109] Preferably, the nicotine can be a surface-modified nicotine salt, wherein the nicotine salt particles include coated or composite particles. A preferred coating or composite material is L-leucine. A particularly useful nicotine particle is a nicotine tartrate bound to L-leucine.

[0110] The powder system may contain a group of flavor particles. The flavor particles may have any useful particle size distribution for selective delivery into the user's mouth or buccal cavity for inhalation.

[0111] The powder system may include at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the fragrance particle group of the powder system in particles having a particle size of about 20 micrometers or larger. The powder system may include at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the fragrance particle group of the powder system in particles having a particle size of about 50 micrometers or larger. The powder system may include at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the fragrance particle group of the powder system in particles having a particle size in the range of about 50 micrometers to about 150 micrometers.

[0112] The particles containing fragrance may include compounds for reducing adhesion or surface energy and the resulting agglomeration. The fragrance particles may be surface-modified using these adhesion-reducing compounds to form coated fragrance particles. A preferred adhesion-reducing compound is magnesium stearate. Providing the fragrance particles with adhesion-reducing compounds such as magnesium stearate, especially coating the fragrance particles, reduces the adhesive force of the fragrance-containing particles and the attraction between the particles, thus reducing agglomeration of the fragrance particles. Therefore, agglomeration of the fragrance particles with nicotine particles is also reduced. Thus, even when nicotine particles and fragrance particles are combined, the powder system described herein can have a stable relative particle size between the nicotine-containing particles and the fragrance-containing particles. Preferably, the powder system is free-flowing.

[0113] Because the active particles may be too small to be affected by the simple airflow through the inhaler, conventional formulations for dry powder inhalation contain carrier particles to increase the fluidity of the active particles. Powder systems may include carrier particles. These carrier particles may be sugars, such as lactose or mannitol, with a particle size greater than about 50 micrometers. Carrier particles can be used to improve dosage uniformity by acting as a diluent or loosening agent in the formulation.

[0114] The powder system used in conjunction with the nicotine powder delivery system described herein may be carrier-free or substantially sugar-free, such as lactose or mannitol. Carrier-free or substantially sugar-free, such as lactose or mannitol, allows nicotine to be inhaled and delivered to the user's lungs at an inhalation rate or airflow rate similar to that of typical smoking.

[0115] Nicotine particles and flavorings can be combined in a single capsule. As described above, the nicotine particles and flavorings can each have reduced adhesive forces, resulting in a stable granular formulation in which the particle size of each component remains substantially unchanged upon combination. Alternatively, the powder system comprises nicotine particles contained in a single capsule and flavoring particles contained in a second capsule.

[0116] The nicotine particles and flavor particles can be combined in any useful relative amount such that the flavor particles are noticeable to the user when consumed together with the nicotine particles. Preferably, the nicotine particles and flavor 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.

[0117] Compared to conventional dry powder inhalers, inhalers and inhaler systems may be less complex and have a simplified airflow path. Advantageously, the rotation of the capsule within the inhaler article atomizes the nicotine particles or powder system and helps maintain free-flowing powder. Therefore, the inhaler article may not require the higher inhalation rates typically used by conventional inhalers to deliver the nicotine particles described above deep into the lungs.

[0118] Inhaler articles may use flow rates below about 5 L / min, or below about 3 L / min, or below about 2 L / min, or 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 rate or flow rate may be similar to the inhalation rate or flow rate of Health Canada smoking, i.e., about 1.6 L / min.

[0119] Consumers can use the inhaler system just like smoking a regular cigarette or an e-cigarette. This type of smoking or vaping is characterized by two steps: a first step in which a small amount containing the consumer's desired amount of nicotine is inhaled into the mouth; followed by a second step in which the small amount containing the desired amount of nicotine is further diluted with fresh air and inhaled 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 used to dilute the first amount for deeper inhalation into the lungs, thereby maximizing the concentration of the active agent delivered to the surface of the respiratory epithelium. This smoking mechanism is sometimes referred to as "inhale-exhale."

[0120] The dry powder used with the dry powder inhaler of this disclosure can eliminate or substantially reduce any exhalation of the pharmaceutically active particles during the “exhalation” phase. Preferably, almost all or at least about 99% or at least about 95% or at least 90% of the pharmaceutically active particles have a particle size that is delivered to the lungs but not small enough to be exhaled by tidal breathing. Such pharmaceutically active particle size can range from about 0.75 micrometers to about 5 micrometers, or from 0.8 micrometers to about 3 micrometers, or from 0.8 micrometers to about 2 micrometers.

[0121] The following provides a non-exhaustive list of non-limiting examples. Any one or more features of these examples may be combined with any one or more features of another example, embodiment, or aspect described herein.

[0122] Example 1: An inhaler article having an upstream end and a downstream end, the inhaler article comprising: an upstream section including an end plug; a downstream section located downstream of and spaced apart from the upstream section, the downstream section including a filter segment, a mouthpiece segment, a support segment, a downstream segment, or a retaining segment, wherein the inhalation resistance per unit length of the filter segment, mouthpiece segment, support segment, downstream segment, or retaining segment is greater than 0 mmH2O and less than 3 mmH2O; a cavity defined between the upstream section and the downstream section, wherein the cavity is configured to be in fluid communication with the outside of the inhaler article; and a capsule containing inhalable material, wherein the capsule is located in the cavity.

[0123] Example 2: Inhaler article according to Example 1, wherein the suction resistance per unit length of the filter segment, mouthpiece segment, support segment, downstream segment or retaining segment is greater than 0 mm water column per millimeter and less than 1 mm water column per millimeter.

[0124] Example 3: An inhaler article according to Example 1 or 2, wherein the filter segment, mouthpiece segment, support segment, downstream segment, or retaining segment is configured to withstand a force of up to 15 Newtons applied to its upstream end without deforming substantially.

[0125] Example 4: Inhaler article according to any of the foregoing examples, wherein the material of said filter segment, mouthpiece segment, support segment, downstream segment or retaining segment has a Young's modulus greater than or at least 10 MPa.

[0126] Example 5: Inhaler article according to any of the preceding examples, wherein the suction resistance of the filter segment, mouthpiece segment, support segment, downstream segment or retaining segment is greater than 0 mm water column and less than 10 mm water column.

[0127] Example 6: An inhaler article according to any of the foregoing examples, wherein the length of the filter segment, mouthpiece segment, support segment, downstream segment, or retaining segment is between 10 mm and 20 mm.

[0128] Example 7: An inhaler article according to any of the preceding examples, wherein the filter segment, mouthpiece segment, support segment, downstream segment, or retaining segment extends from the cavity to the downstream end of the inhaler article.

[0129] Example 8: An inhaler article according to any of the foregoing examples further includes a hollow tubular element extending from an upstream end of the inhaler article to the filter segment, mouthpiece segment, support segment, downstream segment, or retaining segment, wherein the end plug and the capsule are located within the hollow tubular element.

[0130] Example 9: An inhaler article according to Example 8, wherein the inhaler article includes packaging material defining the hollow tubular element and the downstream section, wherein the packaging material axially aligns and fixes the downstream section to the hollow tubular element.

[0131] Example 10: An inhaler article according to any of the preceding examples, wherein the end plug defines at least one airflow inlet passage extending from the upstream end of the end plug to the cavity, thereby establishing fluid communication between the cavity and the outside of the inhaler article.

[0132] Example 11: According to the inhaler article of Example 10, wherein the at least one airflow inlet passage includes two airflow inlet passages configured to generate a vortex airflow within the cavity.

[0133] Example 12: An inhaler article according to any of the foregoing examples, wherein the filter segment, mouthpiece segment, support segment, downstream segment or retaining segment includes at least one filter airflow passage extending along the filter segment, mouthpiece segment, support segment, downstream segment or retaining segment.

[0134] Example 13: An inhaler article according to any of the preceding examples, wherein the inhalable material comprises nicotine.

[0135] Example 14: An inhaler article according to any of the preceding examples, wherein the end plug includes a central channel extending through the end plug, the central channel being configured to provide passage to the cavity for a puncture element.

[0136] Example 15: An inhaler system comprising an inhaler article according to any of the preceding examples and a retainer for receiving the inhaler article, the retainer comprising: a housing defining a housing cavity configured to receive the inhaler article; and a piercing element configured to extend into the housing cavity and pierce a capsule of the inhaler article. Attached Figure Description

[0137] The invention will now be further described with reference to the accompanying drawings, in which:

[0138] Figure 1 This is a cross-sectional view of the inhaler article disclosed herein;

[0139] Figure 2 This is a cross-sectional perspective view of the inhaler article disclosed herein;

[0140] Figure 3 This is a cross-sectional view of an inhaler system according to this disclosure;

[0141] Figure 4 This is a plan view of the inhaler system; and

[0142] Figure 5 , Figure 6 , Figure 7 , Figure 8 , Figure 9 and Figure 10 Front elevation views of different embodiments of filter segments used in inhaler articles of this disclosure are shown. Detailed Implementation

[0143] Figure 1 and 2 An inhaler article 10 according to the present disclosure is shown. The inhaler article 10 extends between its upstream end 1 and its downstream (or oral) end 2. The inhaler article 10 includes an upstream segment 3 and a downstream segment 4, the downstream segment being located downstream of and spaced apart from the upstream segment 3. A cavity 7 configured to receive a capsule 9 containing inhalable material is located between the upstream segment 3 and the downstream segment 4 of the inhaler article 10. The inhalable material includes nicotine.

[0144] like Figure 1 and 2 As shown, the upstream section 3 includes an end plug 5, and the downstream section 4 includes a filter segment 6. The end plug 5 extends from the upstream end 1 of the inhaler article 10 to the cavity 7 or its upstream portion. The filter segment 6 extends from the cavity 7 or its downstream portion to the downstream end 2 of the inhaler article 10.

[0145] The inhaler article 10 also includes a hollow tubular element 12, a filter package 14 surrounding a filter segment 6, and an entire package 8 enclosing both the hollow tubular element 12 and the filter segment 6. The hollow tubular element 12 includes both an end plug 5 and a cavity 7. The cavity 7 is defined by the downstream end of the end plug 5 of the upstream segment 3 and the upstream end of the filter segment 6. The end plug 5 is held together with the hollow tubular element 12 by a tight or frictional fit established between them. The downstream end of the hollow tubular element 12 abuts the upstream end of the filter segment 6 of the downstream segment 4. The filter segment 6 and the filter package 14 together form the downstream segment 4. The entire package 8 defines both the hollow tubular element 12 and the downstream segment 4. The package 8 axially aligns and secures the downstream segment 4 with the hollow tubular element 12.

[0146] exist Figure 1 and Figure 2 In the illustrated embodiment, the total length of the inhaler article 10 is approximately 45 mm. The length of the end plug 5 is approximately 8 mm, the length of the cavity 7 is approximately 20 mm, and the length of the filter segment 6 is approximately 17 mm. The length of the hollow tubular element 12 surrounding both the end plug 5 and the cavity 7 is between approximately 25 mm and approximately 28 mm. The inner diameter of the hollow tubular element 12 is approximately 6.6 mm, and the outer diameter of the hollow tubular element 12 is approximately 7.1 mm. The length of the packaging material 8 is approximately 45 mm. The length of the filter packaging 14 is approximately 17 mm. The diameter of the inhaler article 10 is approximately 7 mm. The relative RTD or RTD per unit length of the filter segment 6 is approximately 0.02 mm water column per mm. The RTD of the filter segment 6 is approximately 0.34 mm water column. The diameter of the capsule 9 is approximately 6 mm, and the length of the capsule 9 is approximately 16 mm.

[0147] End plug 5 defines a central channel or passage 55 extending from the upstream end of end plug 5 through the center of the body of end plug 5. The central channel 55 of end plug 5 is open at its upstream end and closed at its downstream end by a resealable member 54. The downstream end of the central channel 55 and the resealable member 54 are adjacent to cavity 7. Figure 3 The diagram shows a central channel 55 of the end plug 5 arranged to provide passage to a cavity 7 for a piercing element. This piercing element is configured to pierce a membrane 54 and extend into the cavity 7, piercing or bursting the capsule 9 to enable it for consumption. The length of the central channel 55 is the same as the length of the end plug 5. The diameter of the central channel 55 is less than about 6 mm. The central channel is configured to accommodate piercing elements or needles ranging from size 27 (outer diameter = 0.42 mm) to size 4 (outer diameter = 5 mm).

[0148] The end plug 5 includes at least one airflow inlet channel 51, 52, which extends from the upstream end of the end plug 5 to the cavity 7, thereby establishing fluid communication between the cavity 7 of the inhaler article 10 and the outside. Figure 2 As shown, at least one airflow passage includes two air inlet channels 51, 52 extending along and partially around the outer surface of the end plug 5 in a helical or spiral path. The inlet channels 51, 52 extend in both the longitudinal and circumferential directions defined by the end plug 5. In other words, each of the inlet channels 51, 52 extends in a direction deviating from the direction parallel to the longitudinal axis of the inhaler article 10 and the end plug 5. Therefore, the inlet channels 51, 52 are not parallel to the longitudinal axis of the inhaler article 10. The inlet channels 51, 52 follow a spiral path around the end plug 7. Thus, the inlet channels 51, 52 are configured to generate a vortex airflow within the cavity 7. The vortex airflow is arranged to agitate and rotate the capsule 9 within the cavity 7 such that once the capsule 9 has been punctured, the inhalable material is released downstream toward the mouth end or downstream end 2 of the inhaler article 10.

[0149] Figure 3 and Figure 4 An inhaler system 100 is shown, comprising an inhaler article 10 and a retainer or device 120 for receiving the inhaler article 10. The retainer 120 includes a housing 122 defining a housing cavity configured to receive the inhaler article 10. The housing cavity 125 is arranged to receive the upstream end 1 of the inhaler article 10.

[0150] The retainer 120 also includes a piercing element 110 configured to extend into the housing cavity 125 and pierce the capsule 9 of the inhaler article 10. During use, the piercing element 110 is arranged to be aligned with the center of the longitudinal axis of the inhaler article 10 and the center channel 55 of the end plug 5. Figure 3 As shown, when the inhaler article 10 is further pushed into the housing cavity 125 by the consumer, the piercing element 110 extends into the cavity 7 of the inhaler article 10 through the resealable member 54 passing through the central channel 55 and the end plug 5. Once the capsule 9 is activated (or pierced), the consumer can inhale at the mouth end or downstream end 2 of the inhaler article 10 when the inhaler article 10 is received in the retainer 100 or when the inhaler article 10 is pulled out of the retainer 100 after the capsule is activated, and the user blocks the pierced central channel 55 to allow air to enter through the air inlet channels 51, 52.

[0151] The retainer 120 also includes a marking element 130. The marking element 130 is arranged to mark or provide an indication that the inhaler article 10 has been consumed on the outer packaging 8 of the inhaler article 10. The marking element 130 can be actuated when the puncture element 110 is actuated.

[0152] The retainer 120 also includes a sleeve 124 configured to retain the inhaler article 110 within a housing cavity 125. The sleeve 124 includes a sleeve cavity and is movable within the housing cavity 125 along the longitudinal axis of the housing 122 of the retainer 100. The sleeve 124 includes a first open end and a second opposite end. The first open end is configured to receive the upstream end 1 of the inhaler article 10. The second opposite end of the sleeve 124 is configured to abut the upstream end 1 of the inhaler article 10. A piercing element 110 is arranged to extend through the second opposite end of the sleeve 124 to extend into the inhaler article 10 and ultimately pierce the capsule 9.

[0153] The piercing element 110 is fixed to the interior of the retainer housing 122 and configured to extend along the longitudinal axis of the retainer 120 into the housing cavity 125 and the sleeve cavity.

[0154] The retainer 120 includes a spring element 115 arranged to bias the sleeve 124 and the inhaler article 10, positioned within the sleeve cavity, away from the piercing element 110 and toward the entrance of the housing cavity 125. To activate the capsule, the consumer can push the inhaler article 10, thereby pushing the sleeve 124 further into the housing cavity, causing the piercing element 110 to penetrate deeper into the inhaler article 10 and ultimately activating the capsule 9 of the inhaler article 10. Upon proper activation or piercing of the capsule 9, the consumer can stop pushing the inhaler article 10, and the spring element 115 will push or bias the sleeve 124 and the inhaler article 10 away from the distal end of the housing cavity 125 and toward the entrance of the housing cavity 125. The consumer will be able to infer from audible or tactile feedback that the capsule 9 has been successfully pierced by the piercing element 110.

[0155] The filter segment 6 of the inhaler article 10 includes at least one filter airflow passage 16 extending along the filter segment 6. Figure 5 An embodiment of a filter segment 61 including a single Y-shaped airflow channel 161 is shown. The Y-shaped channel 161 can be considered as consisting of three channels connected together along the central axis of the filter segment 61 via a central channel to form a single Y-shaped airflow channel 161. The cross-sectional area of ​​the airflow channel 161 is at least 25% of the total cross-sectional area of ​​the filter segment 61. The filter segment 61 is formed from cellulose acetate tow or other suitable materials. The RTD per unit length of the filter segment 61 is approximately 0.02 mm water column per mm.

[0156] Figure 6 An embodiment of a filter segment 62 including three airflow channels 162 is shown. (As...) Figure 6As shown, the airflow channel 162 is circular and arranged in a triangular shape. The total cross-sectional area of ​​the airflow channel 162 is at least 10% of the total cross-sectional area of ​​the filter segment 62. The filter segment 62 is formed of cellulose acetate tow or other suitable material.

[0157] Figure 7 An embodiment of a filter segment 63 comprising five airflow channels 163 is shown. (As...) Figure 7 As shown, the airflow channel 163 is in the shape of an annular segment and is uniformly distributed circumferentially near the outer periphery of the filter segment 63. The total cross-sectional area of ​​the airflow channel 163 is at least 10% of the total cross-sectional area of ​​the filter segment 63. The filter segment 63 is formed of cellulose acetate tow or other suitable material. The RTD per unit length of the filter segment 63 is approximately 0.05 mm water column per mm.

[0158] Figure 8 An embodiment of a filter segment 64 comprising seven airflow channels 164 is shown. The total cross-sectional area of ​​the airflow channels 164 is at least 75% of the total cross-sectional area of ​​the filter segment 64. The filter segment 64 is formed of a bioplastic material. The RTD per unit length of the filter segment 64 is approximately 0.01 mm water column per mm.

[0159] Figure 9 An embodiment of a filter segment 65 is shown, formed of bundles of polylactic acid fibers extending longitudinally along the filter segment 65. The gaps between the fibers (not shown) effectively provide airflow channels. The cross-sectional area of ​​the filter segment 65 occupied by the fibers is at least about 95% of the total cross-sectional area of ​​the filter segment 65. The RTD per unit length of the filter segment 65 is about 0.6 mm water column per mm.

[0160] Figure 10 An embodiment of a filter segment 65 comprising a rolled sheet of paper-based material is shown. A longitudinally extending gap is defined within the rolled sheet material along the entire length of the filter segment 65. The RTD per unit length of the filter segment 65 is approximately 0.25 mm water column per mm.

[0161] For the purposes of this specification and the appended claims, unless otherwise stated, all figures representing quantities, quantities, percentages, etc., shall be understood to be modified by the term "about" in all cases. Furthermore, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges therein, which may or may not be specifically listed herein. Thus, in this document, the number A is understood to be ±10% of A. In this document, the number A may be considered to include a value within the general standard error of the measurement of the property modified by the number A. In some cases as used in the appended claims, the number A may deviate from the percentage listed above, provided that the amount of deviation from A does not significantly affect the fundamental and novel features of the claimed invention. Furthermore, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges therein, which may or may not be specifically listed herein.

Claims

1. An inhaler article having an upstream end and a downstream end, the inhaler article comprising: An upstream section, the upstream section including an end plug; A downstream section located downstream of and spaced apart from the upstream section, the downstream section comprising filter segments, wherein the suction resistance per unit length of the filter segments is greater than 0 mm water column per millimeter and less than 3 mm water column per millimeter, and wherein the filter segments are configured to withstand forces of up to 15 Newtons applied to the upstream end of the filter segments without substantially deforming. A cavity defined between the upstream section and the downstream section, wherein the cavity is configured to be in fluid communication with the outside of the inhaler article; as well as A capsule containing inhalable material, wherein the capsule is located in the cavity.

2. The inhaler article according to claim 1, wherein the suction resistance per unit length of the filter segment is greater than 0 mm water column per millimeter and less than 1 mm water column per millimeter.

3. The inhaler article according to claim 1 or 2, wherein the material of the filter segment has a Young's modulus greater than 10 MPa.

4. The inhaler article according to claim 1 or 2, wherein the suction resistance of the filter segment is greater than 0 mm water column and less than 10 mm water column.

5. The inhaler article according to claim 1 or 2, wherein the length of the filter segment is between 10 mm and 20 mm.

6. The inhaler article according to claim 1 or 2, wherein the filter segment extends from the cavity to the downstream end of the inhaler article.

7. The inhaler article of claim 1 or 2, further comprising a hollow tubular element extending from an upstream end of the inhaler article to the filter segment, wherein the end plug and the capsule are located within the hollow tubular element.

8. The inhaler article of claim 7, wherein the inhaler article includes packaging material defining the hollow tubular element and the downstream section, wherein the packaging material axially aligns and secures the downstream section to the hollow tubular element.

9. The inhaler article of claim 1 or 2, wherein the end plug defines at least one airflow inlet passage extending from the upstream end of the end plug to the cavity, thereby establishing fluid communication between the cavity and the outside of the inhaler article.

10. The inhaler article of claim 9, wherein the at least one airflow inlet channel comprises two airflow inlet channels configured to generate a vortex airflow within the cavity.

11. The inhaler article according to claim 1 or 2, wherein the filter segment includes at least one filter airflow passage extending along the filter segment.

12. The inhaler article according to claim 1 or 2, wherein the inhalable material comprises nicotine.

13. The inhaler article of claim 1 or 2, wherein the end plug includes a central channel extending through the body of the end plug, the central channel being configured to provide passage to the cavity for a piercing element.

14. An inhaler system comprising an inhaler article according to any one of the preceding claims and a retainer for receiving the inhaler article, the retainer comprising: A housing defining a housing cavity configured to receive the inhaler article; as well as A piercing element configured to extend into the housing cavity and pierce the capsule of the inhaler article.

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