Inhaler system with a single planar piercing element

Abstract

The inhaler system includes a housing defining a housing cavity, a sleeve extending along a sleeve longitudinal axis and positioned within the housing cavity, a capsule contained within the sleeve, and a piercing element having only a single shaft extending from a fixed end to a tip along the piercing element longitudinal axis. The piercing element longitudinal axis is parallel to the sleeve longitudinal axis. The piercing element has a piercing element diameter ranging from 0.5 to 0.9 mm. The single piercing element tip has only a single cutting surface, defining a cutting surface angle between the piercing element longitudinal axis and the single cutting surface. The cutting surface angle is within a range of about 25 degrees to about 35 degrees.

Description

[Technical Field]

[0001] The present invention relates to an inhaler system that includes a single planar piercing element that provides comfortable capsule activation and uniform dry particle delivery over at least five inhalations. [Background technology]

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

[0003] The inhaler article holds capsules containing dry powder. These capsules can be activated by piercing an opening in the capsule wall with a piercing element. The user then puffs (inhales or inhales) through the mouthpiece side of the consumable. This action forces air through the dry powder inhaler.

[0004] Activating a dry powder capsule requires piercing the capsule to create an opening. The dry powder particles can then exit the capsule through the opening during inhalation and consumption by entraining the dry powder particles in the inhalation airstream to the consumer. However, reliably creating an opening on the hemispherical end of the capsule has proven difficult. Perforating elements are known to provide non-uniform openings. The openings also tend to close again when the perforating element is withdrawn from the capsule, further resulting in non-uniform openings. Such non-uniform openings can result in non-uniform or even prevented particle release from the capsule, resulting in unpredictable and variable dry powder delivery to consumers.

[0005] It would be desirable to provide an inhaler system that reliably pierces capsules to form a uniform, single, and stable opening. It would be desirable to provide an inhaler system that reliably pierces capsules with a simple design. It would be desirable to provide an inhaler system that reliably pierces capsules to provide a user with a predictable and uniform dry powder delivery over multiple inhalations. It would be desirable to provide an inhaler system that comfortably pierces or activates capsules containing dry powder particles. Summary of the Invention

[0006] According to one aspect of the present invention, an inhaler system is provided, comprising: a housing defining a housing cavity; a sleeve extending along a sleeve longitudinal axis and positioned within the housing cavity; a capsule contained within the sleeve having a capsule longitudinal axis; and a piercing element having only a single shaft extending from a fixed end to a tip along the piercing element longitudinal axis. The piercing element longitudinal axis is parallel to the sleeve longitudinal axis. The piercing element has a piercing element diameter ranging from 0.5 to 0.9 mm. The single piercing element tip has only a single cutting surface, defining a cutting surface angle between the piercing element longitudinal axis and the single cutting surface. The cutting surface angle ranges from about 25 degrees to about 35 degrees. The sleeve is movable within the housing cavity between a first position and a second position. When the sleeve is moved from the first position to the second position, only a single opening is formed in the capsule.

[0007] Applicant has discovered that the use of a piercing element having a single cutting surface with a cutting angle ranging from about 25 degrees to about 35 degrees, in combination with a piercing element having a diameter ranging from 0.5 to 0.9 mm, advantageously results in reliable and repeatable activation of the capsule, resulting in a uniform or consistent dose or particle release over at least five inhalations of the inhaler system. Furthermore, this combination of piercing elements advantageously provides a comfortable piercing or activation force experienced by the user. This combination of piercing element features also advantageously provides a robust and simple mechanical design that is easy to assemble.

[0008] According to one aspect of the present invention, an inhaler system is provided, comprising: a housing defining a housing cavity; a sleeve extending along a sleeve longitudinal axis and positioned within the housing cavity; a capsule contained within the sleeve having a capsule longitudinal axis; and a piercing element having only a single shaft extending from a fixed end to a tip along the piercing element longitudinal axis. The piercing element may be solid. The piercing element may be hollow. The piercing element longitudinal axis is parallel to and offset from the sleeve longitudinal axis. The piercing element has a piercing element diameter ranging from 0.5 to 0.9 mm. The single piercing element tip has only a single cutting surface, defining a cutting surface angle between the piercing element longitudinal axis and the single cutting surface. The cutting surface angle ranges from about 25 degrees to about 35 degrees. The sleeve is movable within the housing cavity between a first position and a second position. When the sleeve is moved from the first position to the second position, only a single opening is formed in the capsule.

[0009] Inhaler systems utilizing a single piercing element to pierce a capsule are typically positioned such that the piercing element is aligned with the central longitudinal axis of the device or capsule cavity so that the piercing element strikes the capsule at its central axis. This configuration is expected to provide a balanced piercing force on the capsule and avoid bending moments on the piercing element or capsule upon activation.

[0010] Applicant has discovered that positioning a single piercing element parallel to, but offset from, the longitudinal axis of the inhaler device or capsule cavity improves the quality and reliability of the opening formed by the offset piercing element in the hemispherical end of the capsule. Specifically, when the single offset piercing element begins cutting from a surface near the central longitudinal axis of the inhaler device (along the hemispherical surface of the capsule end cap) to a surface further away from the initial cut point, a hinge of capsule material forms on the portion of the opening perimeter farthest from the initial cut point. This particular orientation of the cut surface of the piercing element produces a more stable opening than any other orientation of the cut surface of the piercing element.

[0011] Advantageously, providing a single offset piercing element results in a single, repeatably and reliably opening in the capsule. The single offset piercing element is a simple mechanical configuration. The single offset piercing element is relatively easy to assemble into an inhaler article holder. The single offset piercing element provides improved, predictable uniformity of dosing over multiple inhalations.

[0012] The present disclosure is directed to a holder for an inhaler article, referred to as an "inhaler article holder." The inhaler article holder includes a single offset piercing element. The inhaler article holder is configured to receive a consumable inhaler article, activate a capsule within the inhaler article by piercing the capsule, and induce a swirling inhalation airflow into the inhaler article during consumption. The inhaler article holder and the inhaler article may form an inhaler system, which is directed to the present disclosure.

[0013] The inhaler article holder described herein can be combined with an inhaler article containing a capsule. The inhaler article can be used to activate the inhaler article by puncturing the capsule and provide reliable activation of the capsule by puncturing the capsule using a puncturing element in the inhaler article holder. Particles can be released from the capsule as an airflow is drawn or created around the punctured capsule. In this manner, the inhaler system delivers dry powder particles to the consumer. Although the inhaler article holder is separate from the inhaler article, the consumer utilizes both the inhaler article and the inhaler article holder while consuming the dry powder particles released within the inhaler article. Multiple inhaler articles can be combined with the inhaler article holder to form a system or kit. A single inhaler article holder can be utilized with 10 or more, 25 or more, 50 or more, or 100 or more inhaler articles to activate (puncture or puncture) the capsule contained within each inhaler article and provide reliable activation. The inhaler article may optionally provide for each inhaler article a visual indication (marking) of activation of the inhaler article.

[0014] The inhaler article has an airflow path. Airflow is introduced into the inhaler article by inhalation (or puffing) from a user. The inhaler article holder generates a swirling inhalation airflow. This swirling inhalation airflow is introduced into the inhaler article. The distal or most upstream end of the inhaler article includes an open opening defining an open central passage of an open tubular element configured to receive the swirling inhalation airflow.

[0015] The swirling inhalation airflow then continues downstream into the capsule cavity and induces rotation of the capsule within the capsule cavity. The activated capsule then releases a dose of particles into the downstream swirling inhalation airflow through the mouthpiece to the consumer. Thus, a swirling inhalation airflow is generated upstream of the inhaler article, with the swirling inhalation airflow entering the distal or most upstream end of the inhaler article.

[0016] The inhaler article comprises an elongated tubular body extending along the longitudinal axis of the inhaler from the mouthpiece end to the distal end. The mouthpiece end is the proximal, or downstream, end. The distal end is the upstream end. A capsule cavity is defined within the body bounded downstream by a filter element and upstream by an open tubular element defining a central passage. Prior to insertion into the inhaler article holder, the distal end of the inhaler article may be closed. After insertion into the inhaler article holder, the distal end of the inhaler article may be open. The distal end of the inhaler article may interact with a complementary structure within the inhaler article holder such that the distal end of the inhaler article may open upon introduction of the inhaler article into the inhaler article holder. When introduced into the inhaler article holder, the distal end of the inhaler article has a central passageway forming an open air inlet opening extending from the distal end of the body to the capsule cavity. The capsule is disposed within the capsule cavity, and the central passageway may have a smaller diameter than the capsule, so that the capsule may not pass through the central passageway and is retained within the capsule cavity.

[0017] The inhaler article holder includes a housing having a housing cavity for receiving an inhaler article and a sleeve configured to hold the inhaler article within the housing cavity. The housing cavity is defined by a single housing opening extending into the housing along a longitudinal axis of the housing to a closed end. The single housing opening is configured to receive the inhaler article.

[0018] The sleeve is contained within the housing cavity and is movable along the longitudinal axis of the housing between a first position and a second position. The sleeve may be slidable along the longitudinal axis of the housing between the first position and the second position. In the first position, the sleeve is positioned adjacent to the single housing opening. In the second position, the sleeve is spaced a further lateral distance along the longitudinal axis from the single housing opening.

[0019] The sleeve extends from an open end to a closed (or restricted) end and defines a cylindrical lumen along the sleeve longitudinal axis. The open end of the sleeve is aligned with the single housing opening.

[0020] The sleeve closed end includes an airflow element and an opening to allow a piercing element to pass through the closed end and extend into the sleeve lumen. The airflow element includes one or more inhalation air inlets that provide airflow communication from the annular space around the sleeve into the sleeve cylindrical lumen. The airflow element is configured to induce a rotating or swirling inhalation airflow into the sleeve cylindrical lumen and directly into the inhaler article capsule cavity. This swirling or rotating inhalation airflow can be transmitted to the inhaler article, causing the capsule to rotate and expel the dry powder contained within the capsule.

[0021] The sleeve airflow element includes a tubular element having a central passageway in fluid communication with the sleeve cavity, the airflow element having at least one air inlet that allows intake air to enter the central passageway, and the at least one air inlet extending in a direction tangential to the central passageway to create a swirling or rotating intake airflow.

[0022] The sleeve airflow element includes a tubular element having a central passageway in fluid communication with the sleeve cavity, the airflow element having at least two air inlets that allow intake air to enter the central passageway, and the at least two air inlets extend in a direction tangential to the central passageway to create a swirling or rotating intake airflow.

[0023] The sleeve airflow element includes a tubular element having a central passageway in fluid communication with the sleeve cavity, the airflow element having at least three air inlets that allow intake air to enter the central passageway, and the at least three air inlets extend in a direction tangential to the central passageway to create a swirling or rotating intake airflow.

[0024] The airflow element may include an opening that receives the piercing element and allows the piercing element to pass through the airflow element.

[0025] Inhaled air can enter the inhaler article holder through an open opening that receives the inhaler article and travel along the length of the inhaler article into the housing cavity to the air flow element at the closed end of the sleeve, or alternatively, inhaled air can enter the inhaler article holder through an air inlet through the housing surface.

[0026] The inhaler article holder includes a piercing element secured to and extending from the inner surface of the hollow housing. The piercing element includes a single solid shaft extending from the secured end to the distal end along the longitudinal axis of the piercing element. The piercing element is configured to extend along the longitudinal axis of the housing, through the closed end of the sleeve, and into the sleeve cavity. The piercing element contacts and penetrates the capsule of the received inhaler article as the sleeve moves from the first position to the second position. Moving the sleeve from the second position to the first position removes the piercing element from the capsule and exposes an opening in the capsule, allowing the dry particles contained therein to be released from the capsule as inhaled air rotates the capsule.

[0027] The inhaler system or inhaler article holder piercing element described herein is a single piercing element having a single cutting surface with a diameter ranging from 0.5 to 0.9 mm and a cutting surface angle ranging from about 25 degrees to about 35 degrees. Preferably, the piercing element shaft defines a solid cylinder with a single cutting surface defined on the free end tip of the piercing element. The piercing element may also be hollow with a single cutting surface defined on the free end tip of the piercing element. The inhaler system has fewer than two piercing elements. The inhaler system forms fewer than two openings in the capsule containing the dry powder particles.

[0028] The inhaler system or inhaler article holder piercing element described herein is a single piercing element having a single cutting surface with a diameter of 0.5 to 0.9 mm and a cutting surface angle ranging from about 25 degrees to about 35 degrees, and the single piercing element may be offset from the longitudinal axis of the inhaler article holder, from the inhaler article holder movable sleeve that receives the inhaler article, from the capsule cavity containing the capsule, or from the longitudinal axis of the capsule or the axis of rotation of the capsule as the capsule rotates during inhalation or consumption of dry particles released from an activated capsule. The inhaler system has fewer than two piercing elements. The inhaler system forms fewer than two openings in the capsule containing the dry powder particles.

[0029] The inhaler system or inhaler article holder piercing element described herein is a single piercing element that strikes and pierces the hemispherical end cap of the capsule contained within the capsule cavity of the inhaler device. The single piercing element strikes and pierces the hemispherical end cap of the capsule. The single piercing element may strike and pierce the hemispherical end cap of the capsule that is offset from the capsule central longitudinal axis, the sleeve central longitudinal axis, and the capsule cavity central longitudinal axis. The single piercing element may strike and pierce the hemispherical end cap of the capsule rather than the capsule central longitudinal axis.

[0030] The piercing element shaft has a shaft diameter. The shaft diameter is in the range of about 0.5 mm to about 0.9 mm. Preferably, the shaft diameter is in the range of about 0.6 mm to about 0.9 mm. Preferably, the shaft diameter is in the range of about 0.7 mm to about 0.9 mm. Preferably, the shaft diameter is in the range of about 0.75 mm to about 0.85 mm. Preferably, the shaft diameter is about 0.8 mm.

[0031] Applicants have discovered that perforating elements having shaft diameters greater than about 1 mm result in uneven release of dry particles from an activated capsule during multiple inhalations, e.g., high release of dry particles during the first two inhalations, with the capsule being substantially depleted by the fourth or fifth inhalation.

[0032] The piercing element has only a single cutting surface that defines a cutting surface angle between the longitudinal axis of the piercing element and the single cutting surface in the range of about 25 degrees to about 35 degrees. Preferably, the cutting surface angle is in the range of about 28 degrees to about 32 degrees. Preferably, the cutting surface angle is about 30 degrees. These preferred cutting surface angles have been found to require a force of about 5 Newtons or less to activate or pierce a capsule in the inhaler systems described herein.

[0033] Applicant has discovered that piercing elements having cutting surface angles greater than about 40 degrees result in piercing or activation forces of about 7 Newtons or greater, which consumers have reported are uncomfortably high forces to apply to an inhaler article holder or inhaler system.

[0034] Applicant has also discovered that piercing elements having a cutting surface angle of less than about 20 degrees result in piercing elements that are not robust and may not form uniform or repeatable openings in the capsule.

[0035] The cutting surface of the piercing element may define a pointed elliptical shape. One point of the pointed elliptical shape may define a tip of the piercing element. The opposing tip of the pointed elliptical shape may define a terminus of the cutting surface at an intersection with the shaft periphery.

[0036] The piercing element longitudinal axis can be offset from the sleeve longitudinal axis or the capsule cavity longitudinal axis by at least one piercing element diameter or at least one shaft diameter, or by at least 1.5 piercing element diameters or at least 1.5 shaft diameters, or by at least two piercing element diameters or at least two shaft diameters, or by one to two piercing element diameters, or by one to two shaft diameters.

[0037] The hemispherical end cap of the capsule has a 0% radius at the central longitudinal axis of the capsule and a 100% radius at the outer periphery of the hemispherical end cap of the capsule. A single offset piercing element may pierce the hemispherical end cap of the capsule in a range of 25% to 90% of the capsule radius away from the capsule longitudinal axis, or in a range of 33% to 80% of the capsule radius away from the capsule longitudinal axis, or in a range of 50% to 75% of the capsule radius away from the capsule longitudinal axis.

[0038] The hemispherical end cap of the capsule can have an outer radius in the range of 2.6 mm to 3.2 mm, or about 3 mm, or a diameter in the range of about 5.4 mm to about 6.4 mm, or about 6 mm. The piercing element can pierce the capsule at the curved end or hemispherical end cap of the capsule at a radial distance of at least 1 mm from the capsule longitudinal axis, or in the range of about 1 mm to about 2.5 mm from the capsule longitudinal axis, or in the range of about 1.5 mm to about 2.2 mm from the capsule longitudinal axis, or at a radial distance of about 2 mm from the capsule longitudinal axis.

[0039] The piercing element tip has only a single bevel or cutting surface that can be specifically oriented relative to the offset of the piercing element to achieve reliable and repeatable piercing without the need for orientation or alignment of the capsule relative to the piercing element.

[0040] The single bevel or cutting surface of the piercing element may define a plane facing the sleeve longitudinal axis. The single bevel or cutting surface of the piercing element may define a plane facing the capsule longitudinal axis. The single bevel or cutting surface of the piercing element may define a plane facing the sleeve inner diameter surface closest to the plane. The single bevel of the piercing element may face toward the capsule. The single bevel of the piercing element may face away from the capsule.

[0041] The piercing element forms a single opening in the capsule that defines only a single hinge of capsule material that extends into the capsule cavity. The single hinge of capsule material can be located at a point around the single opening that is furthest from the capsule longitudinal axis.

[0042] The piercing element forms a single opening in the capsule, defining only a single hinge of the capsule material that extends into the capsule cavity. The hinge is formed when the chamfered tip of the piercing element pierces the capsule. As the chamfered tip of the piercing element enters the capsule, it cuts the capsule to form an opening. The chamfered tip of the piercing element then continues to enter and cut the capsule. The hinge is formed when the end of the bevel enters the capsule. Then, as the piercing element is removed from the capsule, an opening with a hinge is formed in the capsule. Thus, an opening is formed in the capsule that is substantially related to the size of the piercing element, with the hinge being formed on the opening opposite the tip of the piercing element. When the single bevel of the piercing element faces the capsule, the hinge is formed on the inner edge of the opening, which is closer to the longitudinal axis of the capsule. When the single bevel of the piercing element faces away from the capsule, the hinge is formed at the outer edge of the opening, the outer edge being furthest from the longitudinal axis of the capsule. When the chamfered tip of the piercing element faces away from the longitudinal axis of the capsule, the single hinge of the capsule material is formed to be located at the point of the single opening furthest from the longitudinal axis of the capsule.

[0043] The sleeve closed end may further include a sleeve bottom element substantially forming the sleeve closed end. The sleeve bottom element may be fixed and in contact with the airflow element. The sleeve bottom element may extend away from the airflow element a distance along the sleeve longitudinal axis and toward the closed end of the housing cavity. The sleeve bottom element may have an opening that contains the piercing element and allows the piercing element to pass through the opening in the sleeve bottom element.

[0044] The inhaler article holder may further include a spring member configured to bias the sleeve away from the piercing element. The spring member may bias the sleeve away from the second position to the first position. The spring member may be in a relaxed state when the sleeve is in the first position. The spring member may be in a compressed state when the sleeve is in the second position. The piercing element is preferably disposed within the spring member.

[0045] The sleeve may include an elongated slot extending along a longitudinal length of the sleeve. The housing may further include a pin extending from an inner surface of the housing cavity. The pin may be configured to mate with the elongated slot to maintain alignment of the sleeve as it moves between the first and second positions.

[0046] An inner housing may be contained within the housing cavity. The inner housing may separate at least a portion of the sleeve from an inner surface of the housing cavity. The inner housing may separate the fixed end of the piercing element from the inner surface of the housing cavity. The inner housing may separate the spring member from the inner surface of the housing cavity.

[0047] The inhalable powder may comprise a variety of active agents. The active agent may comprise, for example, nicotine or an alkaloid, such as anatabine or anabasine. Preferably, the active agent comprises a solid salt of an alkaloid, such as a nicotine salt.

[0048] The amount of active agent may be selected based on the desired or intended use of the inhalable dry powder. For example, the amount of active agent may be 0.5% to 10% by weight of the total weight of the dry powder particles. The dry powder particles may contain 0.5% or more, 1% or more, 2% or more, or 3% or more by weight of active agent, and 12% or less, 10% or less, 9% or less, 8% or less, or 7% or less by weight of active agent, or 0.5% to 10%, 1% to 8%, 1.5% to 6%, or 2% to 5% by weight of active agent.

[0049] The dry powder particles may comprise 0.5% by weight or more, 1% by weight or more, 2% by weight or more, or 3% by weight or more nicotine, and 12% by weight or less, 10% by weight or less, 9% by weight or less, 8% by weight or less, or 7% by weight or less nicotine, or 0.5% by weight to 10% by weight, 1% by weight to 8% by weight, 1.5% by weight to 6% by weight, or 2% by weight to 5% by weight nicotine.

[0050] The amount of active agent per dose may be selected. The inhalable powder may be packaged in a single-dosage or multi-dosage form. For example, the inhalable powder may contain 0.5 mg or more, 1 mg or more, 2 mg or more, or 5 mg or more of active agent per dose. The inhalable powder may contain 500 mg or less, 200 mg or less, 100 mg or less, 50 mg or less, 20 mg or less, or 10 mg or less of active agent per dose. In some embodiments, the inhalable powder contains 0.01 to 10 mg of anatabine, nicotine, or anabasine per dose, 0.05 to 5 mg of anatabine, nicotine, or anabasine per dose, or 0.1 to 1 mg of anatabine, nicotine, or anabasine per dose.

[0051] In embodiments, the capsule contains 1 to 20 doses. In embodiments, the capsule contains 1 to 10 doses. In embodiments, the capsule contains 10 to 20 doses. In embodiments, the capsule contains 1 dose. In embodiments, the capsule contains 2 doses. In embodiments, the capsule contains 3 doses. In embodiments, the capsule contains 4 doses. In embodiments, the capsule contains 5 doses. In embodiments, the capsule contains 6 doses. In embodiments, the capsule contains 7 doses. In embodiments, the capsule contains 8 doses. In embodiments, the capsule contains 9 doses. In embodiments, the capsule contains 10 doses. In embodiments, the capsule contains 11 doses. In embodiments, the capsule contains 12 doses. In embodiments, the capsule contains 13 doses. In embodiments, the capsule contains 14 doses. In embodiments, the capsule contains 15 doses. In embodiments, the capsule contains 16 doses. In embodiments, the capsule contains 17 doses. In embodiments, the capsule contains 18 doses. In embodiments, the capsule contains 19 doses. In embodiments, the capsule contains 20 doses.

[0052] The dry powder particles may have a particle size of 20 μm or less, 10 μm or less, or 5 μm or less, or 0.1 μm or more, 0.2 μm or more, or 0.5 μm or more, or in the range of 0.5 μm to 10 μm, or 0.75 μm to 5 μm, or 1 μm to 5 μm, or 1 μm to 3 μm, or 1.5 μm to 2.5 μm. The desired particle size range can be achieved by spray drying, milling, sieving, or a combination thereof.

[0053] The dry powder particles may be further mixed with a second population of particles to form a powder system. The second population of particles preferably has a different or larger particle size than the dry powder particles. For example, the second population of particles may have a particle size of about 20 micrometers or more, or about 50 micrometers or more, 200 micrometers or less, 150 micrometers or less, or in the range of 50 micrometers to 200 micrometers, or 50 micrometers to 150 micrometers. The second population of particles may optionally have any useful size distribution for inhalation delivery into the user's mouth or oral cavity. The larger second population of flavorant particles may aid in delivery of the dry powder particles to the user's inhalation airstream.

[0054] The dry powder particles and the second population of particles may be combined in any useful relative amounts such that the user is aware of the second population of particles when consumed along with the dry powder particles. Preferably, the dry powder particles and the second population of particles form at least about 90% by weight, or at least about 95% by weight, or at least about 99% by weight, or 100% by weight of the total weight of the powder system.

[0055] The dry powder particles may be further mixed with a second population of flavorant particles to form a powder system. The second population of flavorant particles preferably has a different or larger particle size than the dry powder particles. For example, the flavorant particles may have a particle size of about 20 micrometers or more, or about 50 micrometers or more, 200 micrometers or less, 150 micrometers or less, or in the range of 50 micrometers to 200 micrometers, or 50 micrometers to 150 micrometers. The second population of flavorant particles may optionally have any useful size distribution for inhalation delivery into the user's mouth or oral cavity. The larger second population of flavorant particles may aid in delivery of the dry powder particles to the user's inhalation airstream.

[0056] The dry powder particles and the second population of flavor particles may be combined in any useful relative amounts such that the user notices the second population of flavor particles when consumed with the dry powder particles. Preferably, the dry powder particles and the second population of flavor particles form at least about 90% by weight, or at least about 95% by weight, or at least about 99% by weight, or 100% by weight of the total weight of the powder system.

[0057] The dry powder particles or powder system may be provided in a suitable dosage form. For example, the dry powder particles or powder system may be provided in a capsule. The dosage form (e.g., capsule) may be configured for use with a suitable inhaler. For example, the capsule may be utilized in an inhaler device having a capsule cavity. Airflow management through the capsule cavity of the inhaler device may cause the capsule contained therein to rotate during inhalation and consumption. The capsule may contain the dry powder particles or powder system.

[0058] Unless otherwise specified, the term "particle size" is used herein to refer to the mass median aerodynamic diameter (MMAD) of a particle or set of particles. Such a value is the mass median aerodynamic diameter (MMAD) of a particle or set of particles that has the same aerodynamic behavior as the particle being characterized. 3 The particle size distribution is based on the aerodynamic particle size distribution, which is defined as the diameter of a sphere having a density of 1 / 2.

[0059] In particular, powder systems generally refer to the mass median aerodynamic diameter (MMAD), which is one of the most widely adopted metrics as a single numerical descriptor of the aerodynamic particle size distribution. MMAD is a statistically derived numerical value for a particle sample; as an example, an MMAD of 5 micrometers means that 50 percent of the total sample mass is present in particles having an aerodynamic diameter less than 5 micrometers, and the remaining 50 percent of the total sample mass is present in particles having an aerodynamic diameter greater than 5 micrometers. In the context of the present invention, when describing a powder system, the term "particle size" preferably refers to the MMAD of the powder system.

[0060] The MMAD of powder systems is preferably measured using a cascade impactor. Cascade impactors are widely used devices for sampling and separating airborne particles to determine the aerodynamic size classification of aerosol particles. In practice, cascade impactors separate incoming samples into discrete fractions based on particle inertia, which is a function of particle size, density, and velocity. Cascade impactors typically include a series of stages, each of which includes a plate with a specific nozzle arrangement and collection surface. As the number of stages increases, both the nozzle size and total nozzle area decrease, so the sample-laden air moves through the device at higher velocities. At each stage, particles with sufficient inertia are deflected from the main airflow and impact the collection surface. Thus, at any given flow rate, each stage is associated with a cutoff diameter, a feature that defines the size of particles that will be collected. As the number of stages increases, velocity increases and the stage cutoff diameter decreases. Therefore, the cutoff diameter associated with a given stage is a function of the airflow rate used in the test. To reflect in-use performance, nebulizers are routinely tested at 15 L / min and dry powder inhalers may be tested at flow rates up to 100 L / min.

[0061] In the context of the present invention, the MMAD of a powder system is preferably measured using a Next Generation Impactor (NGI) 170 (available from Copley Scientific AG). The NGI is a high-performance, high-precision particle-classifying cascade impactor with seven stages and a micro-orifice collector (MOC). The characteristics and operating principle of the NGI are described, for example, in Marple et al., Journal of Aerosol Medicine—Volume 16, Number 3 (2003). More preferably, measurements are performed at 20±3 degrees Celsius and 35±5 percent relative humidity.

[0062] Dry powder formulations typically contain about 15 weight percent or less moisture, preferably about 10 weight percent or less moisture, and even more preferably about 6 weight percent or less moisture. Most preferably, dry powder formulations contain about 5 weight percent or less moisture, or about 3 weight percent or less moisture, or about 1 weight percent or less moisture.

[0063] All values ​​reported as percentages are assumed to be weight percent based on total weight.

[0064] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are intended to facilitate understanding of certain terms used frequently herein.

[0065] As used herein, the singular forms "a," "an," and "the" include embodiments having plural referents unless the content clearly dictates otherwise.

[0066] As used herein, "or" is generally employed in its inclusive sense, unless the context clearly dictates otherwise. The term "and / or" refers to one or all of the listed elements or a combination of any two or more of the listed elements.

[0067] As used herein, the words "have," "having," "include," "including," "comprise," "comprising," and the like are used in their open-ended sense and generally mean "including, but not limited to." It will be understood that "consisting essentially of," "consisting of," and the like are encompassed by "including," and the like.

[0068] The words "preferred" and "preferably" refer to embodiments of the invention that may offer certain advantages, under particular circumstances. However, other embodiments may also be preferred, under the same or other circumstances. Moreover, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the present disclosure, including the claims.

[0069] The term "substantially," as used herein, has the same meaning as "significantly," and may be understood to modify the associated term by at least about 90%, at least about 95%, or at least about 98%. The term "not substantially," as used herein, has the same meaning as "not significantly," and may be understood to have the opposite meaning of "substantially," i.e., modifying the associated term by no more than 10%, no more than 5%, or no more than 2%.

[0070] The present invention is defined in the claims. However, the following provides a non-exhaustive list of non-limiting examples. Any one or more of the features of these examples may be combined with any one or more features of any other example, embodiment, or aspect described herein.

[0071] Example 1 The inhaler system includes a housing defining a housing cavity, a sleeve extending along a sleeve longitudinal axis and positioned within the housing cavity, a capsule contained within the sleeve and having a capsule longitudinal axis, and a piercing element having only a single shaft extending from a fixed end to a tip along the piercing element longitudinal axis. The piercing element longitudinal axis is parallel to the sleeve longitudinal axis. The piercing element has a piercing element diameter ranging from 0.5 to 0.9 mm. The single piercing element tip has only a single cutting surface, defining a cutting surface angle between the longitudinal axis of the piercing element and the single cutting surface. The cutting surface angle ranges from about 25 degrees to about 35 degrees. The sleeve is movable within the housing cavity between a first position and a second position. When the sleeve is moved from the first position to the second position, only a single opening is formed in the capsule. Example 2 An inhaler system includes a housing defining a housing cavity and a sleeve extending along a sleeve longitudinal axis and positioned within the housing cavity. The sleeve is movable within the housing cavity between a first position and a second position. The sleeve extends from an open end to a closed end and defines a cylindrical lumen for receiving an inhaler article. The open end of the sleeve is aligned with an opening in the housing for receiving the inhaler article. A capsule is contained within the inhaler article and received within the sleeve. The capsule has a capsule longitudinal axis. The piercing element has only a single shaft extending from a fixed end to a tip along the piercing element longitudinal axis. The piercing element longitudinal axis is parallel to the sleeve longitudinal axis. The piercing element has a piercing element diameter in the range of 0.5 mm to 0.9 mm, and the single piercing element tip has only a single cutting surface, defining a cutting surface angle between the piercing element longitudinal axis and the single cutting surface. The cutting angle is within the range of about 25 degrees to about 35 degrees. When the sleeve moves from the first position to the second position, only a single opening is formed in the capsule. Example 3 3. The inhaler system of example 1 or 2, wherein the perforating element diameter is in the range of 0.7 to 0.9 mm. Example 4 An inhaler system according to any one of Examples 1 to 3, wherein the cutting surface angle is within the range of about 28 degrees to about 32 degrees. Example 5 An inhaler system according to any one of Examples 1 to 4, wherein the diameter of the piercing element is about 0.8 mm. Example 6 An inhaler system according to any one of Examples 1 to 5, wherein the cutting surface angle is about 30 degrees. Example 7 7. An inhaler system according to any one of Examples 1 to 6, wherein the piercing element cut surface defines a pointed oval. Example 8 An inhaler system according to any of Examples 1 to 7, wherein the piercing element comprises a single solid cylindrical shaft extending from a fixed end to a tip along the piercing element longitudinal axis. Example 9 An inhaler system according to any one of Examples 1 to 8, wherein the capsule has a diameter in the range of about 5.2 to 6.4 mm. Example 10 10. An inhaler system according to any of Examples 1-9, wherein the piercing element forms a single opening in the capsule that defines only a single hinge of capsule material that extends into the capsule cavity. Example 11 An inhaler system according to any of Examples 1 to 10, wherein the force required for the piercing element to pierce the capsule is about 5 N or less. Example 12 12. An inhaler system according to any of the preceding examples, wherein the piercing element longitudinal axis is offset from the sleeve longitudinal axis. Example 13 An inhaler system according to any one of Examples 1 to 12, wherein the perforating element perforates the capsule at the capsule curved end in a range of 25% to 90% of the capsule radius away from the capsule longitudinal axis, or 33% to 80% of the capsule radius away from the capsule longitudinal axis, or 50% to 75% of the capsule radius away from the capsule longitudinal axis. Example 14 An inhaler system as described in any of Examples 1 to 13, wherein the sleeve extends from an open end to a closed end and defines a cylindrical cavity for receiving the inhaler article, the open end of the sleeve is aligned with the housing opening for receiving the inhaler article, and the closed end of the sleeve comprises an airflow element configured to create a swirling airflow that rotates the capsule about the longitudinal axis of the capsule during use. Example 15 An inhaler system described in any of Examples 1 to 14, wherein the capsule is contained within an inhaler article extending along the longitudinal axis of the inhaler article from the distal end to the mouthpiece end, and the sleeve is configured to receive the distal end of the inhaler article and transmit a swirling or rotational inhalation airflow into the distal end of the inhaler article. Example 16 16. An inhaler system according to any of the preceding examples, wherein the housing cavity comprises a spring member that biases the capsule away from the piercing element. Example 17 17. An inhaler system according to any one of Examples 1 to 16, wherein the capsule contains pharmaceutically active particles comprising nicotine, and the pharmaceutically active particles have a mass median aerodynamic diameter of about 5 micrometers or less, or in the range of about 0.5 micrometers to about 4 micrometers, or in the range of about 1 micrometer to about 3 micrometers. Example 18 18. The inhaler system of any of Examples 1-17, wherein the capsule further contains flavor particles having a mass median aerodynamic diameter of about 20 micrometers or more, or about 50 micrometers or more, or in the range of about 50 to about 200 micrometers, or in the range of about 50 to about 150 micrometers. Example 19 An inhaler system includes a housing defining a housing cavity, a sleeve extending along a sleeve longitudinal axis and positioned within the housing cavity, a capsule contained within the sleeve and having a capsule longitudinal axis, and a piercing element having only a single shaft extending from a fixed end to a tip along the piercing element longitudinal axis. The piercing element longitudinal axis is parallel to and offset from the sleeve longitudinal axis. The piercing element has a piercing element diameter in the range of 0.5 to 0.9 mm. The single piercing element tip has only a single cutting surface, defining a cutting surface angle between the longitudinal axis of the piercing element and the single cutting surface. The cutting surface angle is in the range of about 25 degrees to about 35 degrees. The sleeve is movable between a first position and a second position within the housing cavity. When the sleeve is moved from the first position to the second position, only a single opening is formed in the capsule. Example 20 The inhaler system of Example 19, wherein the piercing element longitudinal axis is offset from the sleeve longitudinal axis by at least one piercing element diameter, or at least 1.5 piercing element diameters, or at least two piercing element diameters, or in the range of 1 to 2 piercing element diameters. Example 21 21. The inhaler system of any of Examples 1-20, wherein the inhaler system has less than two piercing elements. Example 22 An inhaler system according to any of Examples 1 to 21, wherein a single bevel or cut surface of the piercing element defines a plane opposite the longitudinal axis of the sleeve. Example 23 An inhaler system according to any of Examples 1 to 22, wherein the single bevel or cut surface of the piercing element defines a plane opposite the capsule longitudinal axis. Example 24 An inhaler system according to any of Examples 1 to 23, wherein a single bevel or cut surface of the piercing element defines a plane facing the inner diameter surface of the sleeve that is closest to the plane. Example 25 An inhaler system according to any of Examples 19 to 24, wherein the perforating element perforates the capsule at the capsule curved end in a range of 25% to 80% of the capsule radius away from the capsule longitudinal axis, or in a range of 33% to 75% of the capsule radius away from the capsule longitudinal axis, or in a range of 50% to 75% of the capsule radius away from the capsule longitudinal axis. Example 26 26. An inhaler system according to any of Examples 19 to 25, wherein the piercing element forms a single opening in the capsule that defines only a single hinge of capsule material that extends into the capsule cavity. Example 27 27. An inhaler system according to any of Examples 19 to 26, wherein the single hinge of the capsule material is located at a point around the single opening that is furthest from the capsule longitudinal axis. Example 28 An inhaler system according to any of Examples 19 to 27, wherein the piercing element comprises a single solid shaft extending from a fixed end to a tip along the longitudinal axis of the piercing element. Example 29 An inhaler system according to any of Examples 19 to 28, wherein the capsule has a radius in the range of 2.6 mm to 3.2 mm, and the piercing element pierces the capsule at the capsule curved end at a radial distance of at least 1 mm from the capsule longitudinal axis, or in the range of about 1 mm to about 2 mm from the capsule longitudinal axis. Example 30 An inhaler system described in any of Examples 19 to 29, wherein the sleeve extends from an open end to a closed end and defines a cylindrical cavity for receiving the inhaler article, the open end of the sleeve is aligned with the housing opening for receiving the inhaler article, and the closed end of the sleeve is provided with an airflow element configured to create a swirling airflow that rotates the capsule about the longitudinal axis of the capsule during use. Example 31 An inhaler system described in any of Examples 19 to 30, wherein the capsule is contained within the inhaler article, the inhaler article extends along the inhaler article longitudinal axis from the distal end to the mouthpiece end, and the sleeve is configured to receive the distal end of the inhaler article. Example 32 32. The inhaler system of example 31, wherein the inhaler article longitudinal axis is offset from the piercing element longitudinal axis. Example 33 33. An inhaler system according to any of Examples 19 to 32, wherein the capsule contains pharmaceutically active particles comprising nicotine, and the pharmaceutically active particles have a mass median aerodynamic diameter of about 5 micrometers or less, or in the range of about 0.5 micrometers to about 4 micrometers, or in the range of about 1 micrometer to about 3 micrometers. Example 34 34. The inhaler system of Example 33, wherein the capsule further contains flavor particles having a mass median aerodynamic diameter of about 20 micrometers or more, or about 50 micrometers or more, or in the range of about 50 to about 200 micrometers, or in the range of about 50 to about 150 micrometers. [Brief explanation of the drawings]

[0072] The embodiments will now be further described with reference to the following figures:

[0073] [Figure 1] FIG. 1 is a schematic cross-sectional view of an exemplary inhaler system. [Figure 2] FIG. 2 is a perspective exploded view of an exemplary inhaler article holder. [Figure 3A] FIG. 3A is a schematic cross-sectional view of an exemplary inhaler system in which an inhaler article is received within an inhaler article holder and pierces a capsule in a second position. [Figure 3B] FIG. 3B is a schematic cross-sectional view of the exemplary inhaler system of FIG. 3A with the piercing element retracted from the capsule in a first position. [Figure 4] FIG. 4 is another schematic cross-sectional view of FIG. 3B illustrating the inhalation airflow path through the inhaler system. [Figure 5] FIG. 5 is a front elevation view of an exemplary inhaler article holder into a sleeve. [Figure 6A] FIG. 6A is a perspective view of an exemplary airflow element having perforation elements. [Figure 6B]FIG. 6B is a perspective view of the airflow element showing six alternative offset locations of the perforation elements around the centerline of the airflow element. [Figure 7] FIG. 7 is a schematic cross-sectional view of an exemplary piercing element containing a capsule end cap. [Figure 8] FIG. 8 is a schematic cross-sectional view of an exemplary capsule cavity with a capsule and a piercing element. [Figure 9A] FIG. 9A is a front elevation view of an exemplary capsule end cap after being pierced by a piercing element described herein. [Figure 9B] FIG. 9B is a front elevation view of another exemplary capsule end cap after being pierced by a piercing element described herein. [Figure 10] FIG. 10 is a perspective view of an exemplary piercing element tip.

[0074] The schematic drawings are not necessarily to scale and are presented for purposes of illustration, not limitation. The drawings illustrate one or more aspects described in the present disclosure. However, it will be understood that other aspects not depicted in the drawings fall within the scope and spirit of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0075] Figure 1 is a schematic cross-sectional view of an exemplary inhaler system 10. Figure 2 is a perspective exploded view of an exemplary inhaler article holder 30. Figure 3A is a schematic cross-sectional view of an exemplary inhaler system 10 in which an inhaler article 20 is received within the inhaler article holder 30 and pierces a capsule 25 (contained within the inhaler article 20) in a second or compressed position. Figure 3B is a schematic cross-sectional view of the exemplary inhaler system 10 of Figure 3A in which a piercing element 50 is retracted from the capsule 25 in a first or relaxed position. Figure 4 is another schematic cross-sectional view of Figure 3B illustrating the inhalation airflow 150 path (arrows) through the inhaler system 10.

[0076] The inhaler article holder 30 is configured to receive a separate consumable inhaler article 20 and induce a swirling inhalation airflow into and through the inhaler article 20 during consumption. The inhaler article holder 30 and the inhaler article 20 form the inhaler system 10. The inhaler article 20 remains within the inhaler article holder 30 during use by the consumer. The inhaler article holder 30 is configured to induce a swirling inhalation airflow into the received inhaler article 20.

[0077] The exemplary inhaler article 20 includes a body 22 extending from a mouthpiece end 21 to a distal end 23. A capsule cavity 24 is defined within the body 22. A capsule 25 is contained within the capsule cavity 24. The dry powder particles described above may be contained within the capsule 25. The capsule 25 may be pierced to form an opening through the body of the capsule 25, and inhaled air may flow through the inhaler article 20 to release the crystalline dry powder particles from the pierced capsule 25 into the inhaled airstream and out the mouthpiece end 21.

[0078] The inhaler article holder 30 includes a housing 32 defining a housing cavity defined by a housing inner surface 34 and an outer surface 35. A sleeve 40 is positioned within the housing cavity. The sleeve 40 is disposed to receive the inhaler article 20, and the sleeve 40 is movable within the housing cavity along the longitudinal axis of the housing cavity between a first position and a second position.

[0079] The piercing element 50 is positioned to pierce the capsule 25 within the inhaler article 20 received within the sleeve 40 when the sleeve 40 is in the second position as illustrated in Figure 3A.

[0080] The piercing element 50 may be configured to extend into the sleeve 40 along the longitudinal axis of the housing 32. The inhaler article holder 30 may include a spring member 60 configured to bias the sleeve 40 and any received inhaler article 20 away from the piercing element 50.

[0081] Sleeve 40 extends from an open end 42 to a closed end 44 (or restricted end) and defines a sleeve cavity 45 or cylindrical bore 45 along the longitudinal axis of sleeve 40. Sleeve open end 42 is aligned with single housing opening 36.

[0082] The sleeve closed end 44 includes an airflow element 46 and an opening to allow a piercing element to pass through the closed end 44 and extend into the sleeve lumen 45. The airflow element 46 includes one or more inhalation air inlets 47 that provide airflow communication from the annular space around the sleeve 40 into the sleeve cylindrical lumen 45. The airflow element 46 is configured to induce a rotating or swirling inhalation airflow into the sleeve cylindrical lumen 45 and directly into the inhaler article capsule cavity 24. This swirling or rotating inhalation airflow may be transmitted into the inhaler article 20 to rotate the capsule 25 and expel the dry powder contained within the capsule 25.

[0083] The airflow element 46 of the sleeve 40 includes a tubular element having a central passageway in fluid communication with the sleeve cavity 45. The airflow element 46 has at least one air inlet 47 that allows intake air 150 to enter into the central passageway. The at least one air inlet 47 extends in a direction tangential to the central passageway to create a swirling or rotating intake airflow.

[0084] The sleeve 40 includes a tubular element that may extend approximately 5 mm into the sleeve cavity 45 and may have an outer diameter of approximately 5.5 mm and an inner diameter of approximately 4 mm. The open distal end 23 of the received inhaler article 20 may have an inner diameter of approximately 5.5 mm to provide an interference fit with the tubular element of the airflow element 46.

[0085] The sleeve closed end 44 may further include a sleeve bottom element 48 that substantially forms the closed end of the sleeve 40. The sleeve bottom element 48 may be fixed to and in contact with the air flow element 46. The sleeve bottom element 48 may extend away from the air flow element 46 a distance along the sleeve longitudinal axis and toward the closed end of the housing cavity. The sleeve bottom element 48 may have an opening that contains a piercing element 50 and allows the piercing element 50 to pass through the opening in the sleeve bottom element 48.

[0086] An inner housing 70 may be contained within the housing cavity. The inner housing 70 may separate at least a portion of the sleeve 40 from the inner surface of the housing cavity. The inner housing 70 may separate the fixed end of the piercing element 50 from the inner surface of the housing cavity. The inner housing 70 may separate the spring member 60 from the inner surface of the housing cavity.

[0087] The annular cover 38 may secure the inner housing 70 and the sleeve 40 within the housing cavity. The annular cover 38 defines a single housing opening 36 for receiving the inhaler article 20. The annular cover 38 may be secured to the housing 32 using pin elements 39.

[0088] FIG. 4 illustrates the path of the inhalation airflow 150 through the inhaler system 10. The inhalation airflow 150 enters the inhaler article holder 30 along the outer surface of the received inhaler article 20 and the annular cover 38. Once inside the housing cavity, the inhalation air 150 travels along the length of the sleeve 40 to the closed end 44 of the sleeve 40. The inhalation air 150 then enters the air inlet 47 of the airflow element 46 and forms swirling or rotating inhalation air 150 within the sleeve lumen 45. This swirling or rotating inhalation air is then transmitted to the distal end 23 of the inhaler article 20 and directly into the capsule cavity 24. The swirling inhalation airflow rotates or agitates the capsule 25, and dry powder particles are entrained in the inhalation airflow. The entrained inhalation airflow then exits the inhaler article via the mouthpiece end 21 and flows to the user 100. In FIG. 4, the path of the inhalation airflow 150 is illustrated using arrows.

[0089] Figure 5 is a front elevation view of an exemplary inhaler article holder into sleeve 40. Figure 6A is a perspective view of an exemplary airflow element 46 having piercing elements 50. Figure 6B is a perspective view of airflow element 46 showing six alternative offset positions of piercing elements 50 around the centerline of airflow element 46.

[0090] The single cutting surface or bevel 54 is offset or spaced from the centerline of the airflow element 46 and faces opposite or opposite the centerline of the airflow element 46. Figure 6B shows the solid embodiment and five phantom alternative piercing element 50 offset positions relative to the centerline of the airflow element 46. Each alternative position shows the single cutting surface or bevel 54 being offset or spaced from the centerline of the airflow element 46 and facing opposite or opposite the centerline of the airflow element 46.

[0091] The central longitudinal axis L of the sleeve 40 CL is located at the intersection of the X and Y axes. Air flow element 46 defines the closed end of sleeve 40. Inner housing 70 is secured to sleeve 40. Perforating element 50 extends through air flow element 46 and is aligned with central longitudinal axis L. CL The central longitudinal axis L of the airflow element 46 is offset by a distance R0.CL is the central longitudinal axis L of the sleeve 40 CL The cutting end of the piercing element is defined by a single cutting surface or bevel 54 that terminates in a tip 52.

[0092] 7 is a schematic cross-sectional view of an exemplary piercing element 50 containing a capsule end cap 26. FIG. 8 is a schematic cross-sectional view of an exemplary capsule cavity 24 of an inhaler article 20 having a capsule 25 and a piercing element 50.

[0093] The orientation of the cut surface or bevel 54 is shown in Figure 7. The cut location is aligned with the central longitudinal axis L of the sleeve 40. CL The central longitudinal axis L of the capsule cavity 24 CL is the central longitudinal axis L of the sleeve 40 CL The tip 52 first penetrates the capsule's hemispherical end cap 26 to form an open opening, and continues to cut through the capsule's hemispherical end cap 26 until the entire circumference of the piercing element shaft is in the capsule 25. The periphery that forms the opening is aligned with and coincides with the central longitudinal axis L. CL The hinge of the encapsulant forming a portion of the opening is located closest to the central longitudinal axis L CL It faces the part of the periphery closest to it.

[0094] The piercing element 50 has a central longitudinal axis L CL is parallel to and at a distance R from it O The capsule hemispherical end cap 26 is offset by a radius R C The piercing element 50 has a central longitudinal axis L, as described above. CL than the circumference radius R C The capsule may contact the hemispherical end cap 26 at a point close to the

[0095] Figure 9A is a front elevation view of an exemplary capsule 25 end cap having an opening 29 after being pierced by a piercing element described herein. Figure 9B is a front elevation view of another exemplary capsule 25 end cap having an opening 29 after being pierced by a piercing element described herein.

[0096] 10 is a perspective view of tip 52 of an exemplary piercing element 50. Piercing element 50 has only a single shaft extending from a fixed end along the piercing element longitudinal axis to tip 52. The piercing element has a piercing element diameter D in the range of 0.5 mm to 0.9 mm, and single piercing element tip 52 has only a single cutting surface 54 and defines a cutting surface angle θ between the piercing element longitudinal axis and single cutting surface 54. Cutting surface angle θ is in the range of about 25 degrees to about 35 degrees.

[0097] For purposes of this specification and the appended claims, unless otherwise indicated, all numbers expressing amounts, quantities, percentages, and the like should be understood in all instances to be modified by the term "about." Also, all ranges include the disclosed maximum and minimum points, and any intermediate ranges thereof, which may or may not be specifically recited herein. Thus, in this context, the number A is understood as A ± 2%. Within this context, the number A may be considered to include a numerical value that is within the typical standard error for the measurement of the property that the number A modifies. In some cases, as used in the appended claims, the number A may deviate by the percentages recited above, provided that the amount by which A deviates does not materially affect the basic and novel property(ies) of the claimed invention. Also, all ranges include the disclosed maximum and minimum points, and any intermediate ranges thereof, which may or may not be specifically recited herein.

Claims

1. 1. An inhaler system comprising: a housing defining a housing cavity; a sleeve extending along a sleeve longitudinal axis and positioned within the housing cavity, the sleeve being movable within the housing cavity between a first position and a second position, the sleeve extending from an open end to a closed end and defining a cylindrical lumen for receiving an inhaler article, the open end of the sleeve being aligned with an opening in the housing for receiving the inhaler article; a capsule contained within the inhaler article and received within the sleeve, the capsule having a capsule longitudinal axis; and a piercing element including only a single shaft extending from a fixed end along a piercing element longitudinal axis to a tip, said piercing element longitudinal axis being parallel to said sleeve longitudinal axis, said piercing element having a piercing element diameter in the range of 0.5 to 0.9 mm, said single piercing element tip having only a single cutting surface defining a cutting surface angle between said piercing element longitudinal axis and said single cutting surface, said cutting surface angle being in the range of about 25 degrees to about 35 degrees, said piercing element longitudinal axis being offset from said sleeve longitudinal axis; An inhaler system, wherein only a single opening is formed in the capsule when the sleeve moves from the first position to the second position.

2. 10. The inhaler system of claim 1, wherein the piercing element diameter ranges from 0.7 to 0.9 mm and the cutting surface angle ranges from about 28 degrees to about 32 degrees.

3. 3. The inhaler system of claim 1 or 2, wherein the piercing element cutting surface defines a pointed ellipse.

4. 4. An inhaler system according to any one of claims 1 to 3, wherein the piercing element comprises a single solid cylindrical shaft extending from the fixed end to a tip along the piercing element longitudinal axis.

5. An inhaler system according to any one of claims 1 to 4, wherein the capsule has a diameter in the range of about 5.2 to 6.4 mm.

6. 6. An inhaler system according to any one of claims 1 to 5, wherein the end of the piercing element cutting surface forms a single opening in the capsule defining only a single hinge of capsule material extending into the capsule cavity.

7. 7. An inhaler system according to any one of claims 1 to 6, wherein the force required for the piercing element to pierce the capsule is about 5N or less.

8. 8. The inhaler system according to claim 1, wherein the piercing element pierces the capsule at the capsule curved end in the range of 25% to 90% of the capsule radius away from the capsule longitudinal axis, or 33% to 80% of the capsule radius away from the capsule longitudinal axis, or 50% to 75% of the capsule radius away from the capsule longitudinal axis.

9. 9. An inhaler system according to any preceding claim, wherein the closed end of the sleeve comprises an airflow element configured to create a swirling airflow to rotate the capsule about the capsule longitudinal axis during use.

10. 10. The inhaler system of claim 9, wherein the capsule is contained within an inhaler article extending along the longitudinal axis of the inhaler article from the distal end to the mouthpiece end, and the sleeve is configured to receive the distal end of the inhaler article and transmit a swirling or rotating inhalation airflow into the distal end of the inhaler article.

11. An inhaler system according to any preceding claim, wherein the housing cavity includes a spring member that biases the capsule away from the piercing element.

12. 12. The inhaler system of any of claims 1 to 11, wherein the capsule contains pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a mass median aerodynamic diameter of about 5 micrometers or less, or in the range of about 0.5 micrometers to about 4 micrometers, or in the range of about 1 micrometer to about 3 micrometers.

13. 13. The inhaler system of claim 12, wherein the capsule further contains flavor particles having a mass median aerodynamic diameter of about 20 micrometers or more, or about 50 micrometers or more, or in the range of about 50 to about 200 micrometers, or in the range of about 50 to about 150 micrometers.

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