Inhaler system with a single planar perforation 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 comprising a single planar perforating element. The perforating element provides comfortable capsule activation and uniform delivery of dry particles over at least five inhalations. [Background technology]

[0002] Dry powder inhalers are not always perfectly suitable for delivering dry powder particles to the lungs at inhalation volumes or airflows that fall within the range of inhalation volumes or airflows of conventional smoking methods. Dry powder inhalers can be complex to operate or may have 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 perforating an opening in the capsule wall with a perforating element. The user then inhales (inhales or breathes) the powder from the mouthpiece side of the consumable. This action forces air through the dry powder inhaler.

[0004] To activate a dry powder capsule, it is necessary to perforate the capsule to form an opening. The dry powder particles can then escape from the capsule through the opening during inhalation and consumption by mixing the dry powder particles into the inhaled airflow to the consumer. However, it has been found that reliably forming an opening on the hemispherical end of the capsule is difficult. Perforating elements are known to provide non-uniform openings. The opening also tends to close again when the perforating element is withdrawn from the capsule, which results in even more non-uniform openings. Such non-uniform openings lead to uneven or even obstruction of particle release from the capsule. As a result, the dry powder delivered to the consumer becomes unpredictable and variable.

[0005] It is desirable to provide an inhaler system that reliably punctures capsules to form a uniform, single, stable opening. It is desirable to provide an inhaler system with a simple design that reliably punctures capsules. It is desirable to provide an inhaler system that reliably punctures capsules and provides the user with predictable and uniform dry powder over multiple inhalations. It is desirable to provide an inhaler system that comfortably punctures or activates capsules containing dry powder particles. [Overview of the project]

[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 the longitudinal axis of the sleeve and positioned within the housing cavity, a capsule contained within the sleeve having a longitudinal axis of the capsule, and a perforating element having only a single shaft extending from a fixed end to a tip along the longitudinal axis of the perforating element. The longitudinal axis of the perforating element is parallel to the longitudinal axis of the sleeve. The perforating element has a perforating element diameter in the range of 0.5 to 0.9 mm. The tip of the single perforating element has only a single cross-section, defining a cross-sectional angle between the longitudinal axis of the perforating element and the single cross-section. The cross-sectional 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 moves from the first position to the second position, only a single opening is formed in the capsule.

[0007] The applicant has found that by using a perforating element having a single cross-section with a cutting angle in the range of approximately 25 to 35 degrees in combination with a perforating element having a diameter in the range of 0.5 to 0.9 mm, it is advantageous that reliable and repeatable activation of the capsule is obtained, resulting in the release of a uniform or constant dose or particles over at least five inhalations of the inhaler system. Furthermore, this combination of perforating elements advantageously provides a comfortable perforation or activation force experienced by the user. This combination of perforating 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 the longitudinal axis of the sleeve and positioned within the housing cavity, a capsule contained within the sleeve having a longitudinal axis of the capsule, and a perforating element having only a single shaft extending from a fixed end to a tip along the longitudinal axis of the perforating element. The perforating element is Nakajitsu It is possible that the perforation element is hollow. The longitudinal axis of the perforation element is parallel to and offset from the longitudinal axis of the sleeve. The perforation element has a diameter in the range of 0.5 to 0.9 mm. The tip of a single perforation element has only a single cross-section, defining the cross-sectional angle between the longitudinal axis of the perforation element and the single cross-section. The cross-sectional angle is in the range of approximately 25 to 35 degrees. The sleeve is movable between a first position and a second position within the housing cavity. When the sleeve moves from the first position to the second position, only a single opening is formed in the capsule.

[0009] In an inhaler system that uses a single perforating element to perforate a capsule, this single perforating element is aligned with the central longitudinal axis of the device or capsule cavity, so that the perforating element strikes the capsule at its central axis. This configuration is expected to provide a balanced perforating force on the capsule and avoid bending moments on the perforating element or the capsule when the capsule is activated.

[0010] The applicant discovered that positioning a single perforating 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 at the hemispherical end of the capsule by the offset perforating element. Specifically, when this single offset perforating 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 cutting point, the hinge of the capsule material is formed on the portion that forms the periphery of the opening furthest from the initial cutting point. This particular orientation of the cutting surface of the perforating element produces a stable opening compared to any other orientation of the cutting surface of this perforating element.

[0011] Advantageously, by providing a single offset perforation element, a reliably consistent single opening is formed within the capsule. The single offset perforation element has a simple mechanical configuration. The single offset perforation element is relatively easy to assemble into the inhaler article holder. The single offset perforation element provides predictable, improved, and uniform dosing over multiple inhalations.

[0012] This disclosure relates to a holder for an inhaler article, referred to as an “inhaler article holder.” The inhaler article holder comprises a single offset perforating element. The inhaler article holder is configured to receive a consumable inhaler article, activate a capsule within the inhaler article by perforating the capsule, and induce a swirling inhalation airflow into the inhaler article during consumption. The inhaler article holder and the inhaler article may form the inhaler system covered by this disclosure.

[0013] The inhaler article holders described herein may be combined with inhaler articles containing capsules. The inhaler article may be used to activate the inhaler article by puncturing the capsule and to provide reliable activation of the capsule by puncturing the capsule using the puncturing element of the inhaler article holder. Particles may be released from the capsule as airflow is drawn in or created around the punctured capsule. In this way, 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 such inhaler articles may be combined with inhaler article holders to form a system or kit. A single inhaler article holder may be used with 10 or more, or 25 or more, or 50 or more, or 100 or more inhaler articles to activate (puncture or perforate) the capsule contained within each inhaler article and provide reliable activation. Each inhaler can optionally be provided with a visual indication (marking) of its activation.

[0014] The inhaler article has an airflow path. Airflow is introduced into the inhaler article by inhalation (or smoke inhalation) from the user. The inhaler article holder generates a swirling inhalation airflow. This swirling inhalation airflow is introduced into the inhaler article. The distal end or the most upstream end of the inhaler article includes an open opening that defines 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, inducing rotation of the capsule within the cavity. The activated capsule then releases a single dose of particles into the downstream swirling inhalation airflow through the mouthpiece to the consumer. Thus, the swirling inhalation airflow is generated upstream of the inhaler article and enters 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 end, or downstream end. The distal end is the upstream end. The capsule cavity is defined within the body, bounded downstream by a filter element and bound upstream by an open tubular element defining a central passage. Before 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 complementary structures within the inhaler article holder so that the distal end of the inhaler article may open as the inhaler article is introduced into the inhaler article holder. When introduced into the inhaler article holder, the distal end of the inhaler article has a central passage that forms an open air intake opening extending from the distal end of the body to the capsule cavity. The capsule is placed within the capsule cavity, and the central passage may have a smaller diameter than the capsule. Therefore, the capsule may not pass through the central passage and may be held within the capsule cavity.

[0017] The inhaler article holder includes a housing comprising 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 that extends into the housing along the 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 between a first position and a second position along the longitudinal axis of the housing. The sleeve may also be slidable between the first position and the second position along the longitudinal axis of the housing. In the first position, the sleeve is located adjacent to a single housing opening. In the second position, the sleeve is located further laterally from the single housing opening along the longitudinal axis.

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

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

[0021] The airflow element of the sleeve includes a tubular element having a central passage that is in fluid communication with the sleeve cavity. The airflow element has at least one air inlet that allows intake air to enter into the central passage. The at least one air inlet extends in a direction that is tangential to the central passage to generate a swirling or rotational intake airflow.

[0022] The airflow element of the sleeve includes a tubular element having a central passage that is in fluid communication with the sleeve cavity. The airflow element has at least two air inlets that allow intake air to enter into the central passage. The at least two air inlets extend in a direction that is tangential to the central passage to generate a swirling or rotational intake airflow.

[0023] The airflow element of the sleeve includes a tubular element having a central passage that is in fluid communication with the sleeve cavity. The airflow element has at least three air inlets that allow intake air to enter into the central passage. The at least three air inlets extend in a direction that is tangential to the central passage to generate a swirling or rotational intake airflow.

[0024] The airflow element may include an aperture 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 aperture that receives the inhaler article, move within the housing cavity along the length of the inhaler article, and reach the airflow element at the closed end of the sleeve. 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 fixed to the inner surface of the cavity housing and extending from the inner surface of the cavity housing. The piercing element extends along the longitudinal axis of the piercing element from the fixed end to the tip as a single Nakajitsu shaft. The piercing element is configured to extend through the closed end of the sleeve and into the sleeve cavity along the longitudinal axis of the housing. As the sleeve moves from the first position to the second position, the piercing element contacts and penetrates the capsule of the received inhaler article. Moving the sleeve from the second position to the first position removes the piercing element from the capsule and exposes the aperture in the capsule, which allows inhaled air to release dry particles contained in the capsule from the capsule as the capsule rotates.

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

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

[0029] The inhaler system or inhaler article holder perforating element described herein is a single perforating element that strikes and perforates the hemispherical end cap of a capsule contained within the capsule cavity of an inhaler device. The single perforating element perforates by striking the hemispherical end cap of the capsule. The single perforating element may perforate by striking the hemispherical end cap of the capsule, which is offset from the longitudinal axis of the capsule center, the longitudinal axis of the sleeve center, and the longitudinal axis of the capsule cavity center. The single perforating element may perforate by striking the hemispherical end cap of the capsule, rather than the longitudinal axis of the capsule center.

[0030] The drilling 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] The applicant discovered that perforating elements with a shaft diameter exceeding approximately 1 mm resulted in uneven release of dry particles from the activated capsule during multiple inhalations. For example, a large amount of dry particles were released during the first two inhalations, while the capsule was substantially depleted after four to five inhalations.

[0032] The perforating element has only one cross-section that defines a cross-sectional angle between the longitudinal axis of the perforating element and the single cross-section in the range of about 25 degrees to about 35 degrees. Preferably, the cross-sectional angle is in the range of about 28 degrees to about 32 degrees. Preferably, the cross-sectional angle is about 30 degrees. These preferred cross-sectional angles have been found to require a force of about 5 Newtons or less to activate or perforate the capsule in the inhaler system described herein.

[0033] The applicant discovered that perforating elements with a cross-sectional angle exceeding approximately 40 degrees produce a perforating or activating force of approximately 7 Newtons or more. According to consumer reports, a perforating or activating force of approximately 7 Newtons or more is an uncomfortably high force when applied to inhaler article holders or inhaler systems.

[0034] The applicant also found that perforating elements with a cross-sectional angle of less than approximately 20 degrees result in non-robust perforating elements. Perforating elements with a cross-sectional angle of less than approximately 20 degrees may not form a uniform or repeatable opening within the capsule.

[0035] The cross-section of the drilling element may define a pointed ellipse. One point of the pointed ellipse may define the tip of the drilling element. Opposite tips of the pointed ellipse may define the end of the cross-section at their intersection with the shaft periphery.

[0036] The longitudinal axis of the drilling element may be offset from the longitudinal axis of the sleeve or the longitudinal axis of the capsule cavity by a range of at least one drilling element diameter or at least one shaft diameter, or at least 1.5 drilling element diameters or at least 1.5 shaft diameters, or at least two drilling element diameters or at least two shaft diameters, or one to two drilling element diameters, or one to two shaft diameters.

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

[0038] The hemispherical end cap of the capsule may 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 perforating element may perforate the capsule at the curved end or hemispherical end cap of the capsule at a radial distance of at least 1 mm from the longitudinal axis of the capsule, or in the range of about 1 mm to about 2.5 mm from the longitudinal axis of the capsule, or in the range of about 1.5 mm to about 2.2 mm from the longitudinal axis of the capsule, or at a radial distance of about 2 mm from the longitudinal axis of the capsule.

[0039] The tip of the drilling element has only a single bevel or cut surface. This single bevel or cut surface can be specifically oriented with respect to the offset of the drilling element to achieve reliable and repeatable drilling without oriented or aligning the capsule relative to the drilling element.

[0040] A single bevel or cut surface of the perforating element may define a plane opposite the longitudinal axis of the sleeve. A single bevel or cut surface of the perforating element may define a plane opposite the longitudinal axis of the capsule. A single bevel or cut surface of the perforating element defines a plane that may face the inner diameter surface of the sleeve closest to the plane. A single bevel of the perforating element may face toward the capsule. A single bevel of the perforating element may face away from the capsule.

[0041] The perforating element forms a single opening within the capsule, defining only a single hinge of the capsule material extending within the capsule cavity. The single hinge of the capsule material may be located at a point around the single opening furthest from the longitudinal axis of the capsule.

[0042] The perforating element forms a single opening within the capsule, defining only a single hinge of the capsule material extending within the capsule cavity. The hinge is formed when the chamfered tip of the perforating element perforates the capsule. As the chamfered tip of the perforating element enters the capsule, it cuts through the capsule to form an opening. The chamfered tip then continues to enter the capsule, continuing to cut through it. The hinge is formed when the end of the bevel enters the capsule. Then, when the perforating element is removed from the capsule, an opening with the hinge is formed within the capsule. Thus, the capsule has an opening that is substantially related to the size of the perforating element, and the hinge is formed in the opening opposite the tip of the perforating element. If the single bevel of the perforating 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. If a single bevel of the perforating element faces away from the capsule, the hinge is formed on the outer edge of the opening, which is far from the longitudinal axis of the capsule. If the chamfered tip of the perforating 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 closure end may further include a sleeve bottom element that substantially forms the sleeve closure end. The sleeve bottom element may be fixed and in contact with an airflow element. The sleeve bottom element may extend away from the airflow element by a certain distance along the longitudinal axis of the sleeve and toward the closure end of the housing cavity. The sleeve bottom element may have an opening that includes a perforating element, and that allows the perforating element to pass through the opening of the sleeve bottom element.

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

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

[0046] The inner housing may be contained within the housing cavity. The inner housing may separate at least a portion of the sleeve from the inner surface of the housing cavity. The inner housing may separate the fixed end of the perforating 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 contain various active agents. The active agents may include, for example, alkaloids such as nicotine, anatabine, or anabasine. Preferably, the active agent contains a solid salt of an alkaloid, such as a nicotine salt.

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

[0049] The dried powder particles may contain 0.5% by weight or more, 1% by weight or more, 2% by weight or more, or 3% by weight or more of 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 of nicotine, or 0.5% to 10% by weight, 1% to 8% by weight, 1.5% to 6% by weight, or 2% to 5% by weight of nicotine.

[0050] The amount of activator may be selected for each dose. The inhalable powder may be packaged in a single dosage form or multiple dosage forms. 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 activator 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 activator per dose. In some embodiments, the inhalable powder contains 0.01 to 10 mg of anatabine or nicotine or anabasine / dose, 0.05 to 5 mg of anatabine or nicotine or anabasine / dose, or 0.1 to 1 mg of anatabine or nicotine or anabasine / dose.

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

[0052] The dried powder particles may have particle sizes in the range 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 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, grinding, sieving, or a combination thereof.

[0053] The dry powder particles may be further mixed with a second group of particles to form a powder system. Preferably, the second group of particles has a different or larger particle size than the dry powder particles. For example, the second group of particles may have particle sizes ranging from about 20 micrometers or more, or from about 50 micrometers or more, 200 micrometers or less, 150 micrometers or less, or from 50 micrometers to 200 micrometers, or from 50 micrometers to 150 micrometers. The second group of particles may have any useful size distribution for selective inhalation delivery into the user's mouth or oral cavity. A larger second group of flavoring particles may assist in the delivery of the dry powder particles to the inhaled airflow to the user.

[0054] The dry powder particles and the second group of particles may be combined in any useful relative amounts so that the user will notice the second group of particles when consumed together with the dry powder particles. Preferably, the dry powder particles and the second group 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 group of flavoring particles to form a powder system. Preferably, the second group of flavoring particles has a different or larger particle size than the dry powder particles. For example, the flavor particles may have particle sizes ranging from about 20 micrometers or more, or from about 50 micrometers or more, 200 micrometers or less, 150 micrometers or less, or from 50 micrometers to 200 micrometers, or from 50 micrometers to 150 micrometers. The second group of flavoring particles may have any useful size distribution for selective inhalation delivery into the user's mouth or oral cavity. A larger second group of flavoring particles may assist in the delivery of the dry powder particles to the inhaled airflow to the user.

[0056] The second group of dry powder particles and flavoring particles may be combined in any useful relative amounts so that the user will notice the second group of flavoring particles when consumed together with the dry powder particles. Preferably, the second group of dry powder particles and flavoring particles constitute 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] Dry powder particles or powder systems may be provided in a suitable dosage form. For example, dry powder particles or powder systems may be provided in capsules. The dosage form (e.g., capsules) may be configured for use with a suitable inhaler. For example, capsules may be used with an inhaler device having a capsule cavity. Airflow control through the capsule cavity of the inhaler device may rotate the capsule contained therein during inhalation and consumption. Capsules may contain dry powder particles or powder systems.

[0058] Unless otherwise specified, the term “particle size” here refers to the aerodynamic median mass diameter (MMAD) of a particle or set of particles. Such a value is 1 gm / cm², representing the same aerodynamic behavior as the particle being characterized. 3 Based on the distribution of aerodynamic particle diameters, defined as the diameter of a sphere having a certain density.

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

[0060] The MMAD of a powder system is preferably measured using a cascade impactor. A cascade impactor is a widely used apparatus for sampling and separating airborne particles to determine the aerodynamic size classification of aerosol particles. In practice, a cascade impactor separates an incoming sample into distinct fractions based on particle inertia, which is a function of particle size, density, and velocity. A cascade impactor typically includes a series of stages, each containing a plate with a specific nozzle configuration and collection surface. As the number of stages increases, both the nozzle size and total nozzle area decrease, so the air containing the sample increases in velocity as it moves through the apparatus. At each stage, particles with sufficient inertia force are separated from the main flow of air and collide with the collection surface. Thus, at any given flow rate, each stage is associated with a cutoff diameter, a form that defines the size of the particles being collected. As the number of stages increases, the velocity increases and the stage cutoff diameter decreases. Thus, the cutoff diameter associated with a given stage is a function of the airflow rate used in the test. To reflect performance during use, nebulizers are regularly 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 classification cascade impactor having seven stages and a micro-orifice collector (MOC). The features and operating principle of the NGI are described, for example, in Marple et al., Journal of Aerosol Medicine - Volume 16, Number 3 (2003). The measurement is more preferably performed at 20 ± 3 degrees Celsius and 35 ± 5 percent relative humidity.

[0062] The dried powder formulation typically contains about 15% by weight or less of moisture, preferably about 10% by weight or less, and more preferably about 6% by weight or less. Most preferably, the dried powder formulation contains about 5% by weight or less of moisture, or about 3% by weight or less of moisture, or about 1% by weight or less of moisture.

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

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

[0065] As used herein, the singular forms ("a," "an," and "the") include embodiments that have plural subjects, unless otherwise clearly defined by their content.

[0066] As used herein, "or" generally includes "and / or," unless otherwise clearly defined by the context. The term "and / or" means one or all of the enumerated elements, or any combination of two or more of the enumerated elements.

[0067] As used herein, “have,” “having,” “include,” “including,” “comprise,” “comprising,” and similar terms are used in their unrestricted sense, generally meaning “include, but not limited to.” Naturally, “essentially consist of,” “consist of,” and similar terms are subsumed within “include,” “comprising,” and similar terms.

[0068] The terms “preferred” and “preferred” refer to embodiments of the present invention that may provide certain advantages under specific circumstances. However, other embodiments may also be preferred under the same or other circumstances. Furthermore, the enumeration of one or more preferred embodiments does not imply that other embodiments are unhelpful, nor is it intended to exclude other embodiments from the scope of this disclosure, including the claims.

[0069] The term "substantially" as used herein has the same meaning as "significantly" and can be understood as modifying the related term by at least approximately 90%, at least approximately 95%, or at least approximately 98%. The term "substantially not" as used herein has the same meaning as "significantly not" and is the opposite of "substantially," meaning that it modifies the related term by only 10% or less, 5% or less, or 2% or less.

[0070] The present invention is defined in the claims. However, a non-exclusive list of non-limiting embodiments is provided below. Any one or more features of these embodiments may be combined with any one or more features of other embodiments, forms, or aspects described herein.

[0071] Example 1 An inhaler system comprising a housing defining a housing cavity, a sleeve extending along the longitudinal axis of the sleeve and positioned within the housing cavity, a capsule contained within the sleeve and having a longitudinal axis of the capsule, and a perforating element having only a single shaft extending from a fixed end to a tip along the longitudinal axis of the perforating element. The longitudinal axis of the perforating element is parallel to the longitudinal axis of the sleeve. The perforating element has a perforating element diameter in the range of 0.5 to 0.9 mm. The tip of the single perforating element has only a single cross-section, defining a cross-sectional angle between the longitudinal axis of the perforating element and the single cross-section. The cross-sectional angle is in the range of approximately 25 to 35 degrees. The sleeve is movable between a first position and a second position within the housing cavity. When the sleeve moves from the first position to the second position, only a single opening is formed in the capsule. Example 2 An inhaler system comprising a housing defining a housing cavity and a sleeve extending along the longitudinal axis of the sleeve and positioned within the housing cavity. The sleeve is movable between a first position and a second position within the housing cavity. 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 aligns with the opening of the housing for receiving the inhaler article. The capsule is contained within the inhaler article and received within the sleeve. The capsule has a capsule longitudinal axis. The perforating element comprises only a single shaft extending from a fixed end to a tip along the longitudinal axis of the perforating element. The longitudinal axis of the perforating element is parallel to the longitudinal axis of the sleeve. The perforating element has a perforating element diameter in the range of 0.5 mm to 0.9 mm, and the single perforating element tip has only a single cross-section, defining a cross-sectional angle between the longitudinal axis of the perforating element and the single cross-section. The cutting angle is in the range of approximately 25 to 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 An inhaler system according to Example 1 or 2, wherein the diameter of the perforating element 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 cross-sectional angle is in the range of approximately 28 degrees to approximately 32 degrees. Example 5 An inhaler system according to any of Examples 1 to 4, wherein the diameter of the perforating element is approximately 0.8 mm. Example 6 An inhaler system according to any of Examples 1 to 5, wherein the cross-sectional angle is approximately 30 degrees. Example 7 An inhaler system according to any one of Examples 1 to 6, wherein the cross-section of the perforating element defines a pointed ellipse. Example 8 The drilling element is a single element that extends from a fixed end along the longitudinal axis of the drilling element to the tip. Nakajitsu An inhaler system according to any one of Examples 1 to 7, including a cylindrical shaft. Example 9 An inhaler system according to any of Examples 1 to 8, wherein the capsule has a diameter in the range of approximately 5.2 to 6.4 mm. Example 10 An inhaler system according to any one of Examples 1 to 9, wherein the perforating element forms a single opening within the capsule, defining only a single hinge of the capsule material extending within the capsule cavity. Example 11 An inhaler system according to any one of Examples 1 to 10, wherein the force required for the perforating element to perforate the capsule is approximately 5N or less. Example 12 An inhaler system according to any one of Examples 1 to 11, wherein the longitudinal axis of the perforation element is offset from the longitudinal axis of the sleeve. Example 13 An inhaler system according to any one of Examples 1 to 12, wherein the perforating element perforates the capsule at the curved end of the capsule at a distance of 25% to 90% of the capsule radius away from the longitudinal axis of the capsule, or 33% to 80% of the capsule radius away from the longitudinal axis of the capsule, or 50% to 75% of the capsule radius away from the longitudinal axis of the capsule. Example 14 An inhaler system according to any one of Examples 1 to 13, wherein the sleeve extends from an open end to a closed end, defining a cylindrical lumen for receiving an inhaler article, the open end of the sleeve aligns with a housing opening for receiving the inhaler article, and the closed end of the sleeve comprises an airflow element configured to form a swirling airflow that rotates the capsule around its longitudinal axis during use. Example 15 An inhaler system according to any one 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 An inhaler system according to any one of Examples 1 to 15, wherein the housing cavity includes a spring member that biases the capsule away from the perforating element. Example 17 An inhaler system according to any one of Examples 1 to 16, wherein the capsule contains pharmaceutically active particles containing nicotine, and the pharmaceutically active particles have an aerodynamic mass median diameter in the range 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 An inhaler system according to any one of Examples 1 to 17, wherein the capsule further contains flavor particles having an aerodynamic median mass 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 comprising a housing defining a housing cavity, a sleeve extending along the longitudinal axis of the sleeve and positioned within the housing cavity, a capsule contained within the sleeve and having a longitudinal axis of the capsule, and a perforating element having only a single shaft extending from a fixed end to a tip along the longitudinal axis of the perforating element. The longitudinal axis of the perforating element is parallel to and offset from the longitudinal axis of the sleeve. The perforating element has a perforating element diameter in the range of 0.5 to 0.9 mm. The tip of the single perforating element has only a single cross-section, defining a cross-sectional angle between the longitudinal axis of the perforating element and the single cross-section. The cross-sectional angle is in the range of approximately 25 to 35 degrees. The sleeve is movable between a first position and a second position within the housing cavity. When the sleeve moves from the first position to the second position, only a single opening is formed in the capsule. Example 20 The inhaler system according to Example 19, wherein the longitudinal axis of the perforating element is offset from the longitudinal axis of the sleeve by at least one perforating element diameter, or at least 1.5 perforating element diameter, or at least two perforating element diameters, or in the range of 1 to 2 perforating element diameters. Example 21 An inhaler system according to any one of Examples 1 to 20, wherein the inhaler system has fewer than two perforating elements. Example 22 An inhaler system according to any one of Examples 1 to 21, wherein a single bevel or cut surface of the perforating element defines a plane opposite the longitudinal axis of the sleeve. Example 23 An inhaler system according to any one of Examples 1 to 22, wherein a single bevel or cross-section of the perforating element defines a plane opposite to the longitudinal axis of the capsule. Example 24 An inhaler system according to any of Examples 1 to 23, wherein a single bevel or cut surface of the perforating 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 one of Examples 19 to 24, wherein the perforating element perforates the capsule at the curved end of the capsule in the range of 25% to 80% of the capsule radius away from the longitudinal axis of the capsule, or 33% to 75% of the capsule radius away from the longitudinal axis of the capsule, or 50% to 75% of the capsule radius away from the longitudinal axis of the capsule. Example 26 An inhaler system according to any of Examples 19 to 25, wherein the perforating element forms a single opening within the capsule, defining only a single hinge of the capsule material extending within the capsule cavity. Example 27 An inhaler system according to any of Examples 19 to 26, wherein a single hinge of the capsule material is located at a point around the single opening furthest from the longitudinal axis of the capsule. Example 28 The drilling element is a single element that extends from a fixed end along the longitudinal axis of the drilling element to the tip. Nakajitsu An inhaler system according to any one of Examples 19 to 27, comprising a shaft. Example 29 An inhaler system according to any one of Examples 19 to 28, wherein the capsule has a radius in the range of 2.6 mm to 3.2 mm, and the perforating element perforates the capsule at the curved end of the capsule at a radial distance in the range of at least 1 mm from the longitudinal axis of the capsule, or in the range of about 1 mm to about 2 mm from the longitudinal axis of the capsule. Example 30 An inhaler system according to any one of Examples 19 to 29, wherein the sleeve extends from an open end to a closed end, defining a cylindrical lumen for receiving an inhaler article, the open end of the sleeve aligns with a housing opening for receiving the inhaler article, and the closed end of the sleeve comprises an airflow element configured to form a swirling airflow that rotates the capsule around its longitudinal axis during use. Example 31 An inhaler system according to any one of Examples 19 to 30, wherein a capsule is contained within an inhaler article, the inhaler article extends along the longitudinal axis of the inhaler article from the distal end to the mouthpiece end, and a sleeve is configured to receive the distal end of the inhaler article. Example 32 The inhaler system according to Example 31, wherein the longitudinal axis of the inhaler article is offset from the longitudinal axis of the perforation element. Example 33 An inhaler system according to any of Examples 19 to 32, wherein the capsule contains pharmaceutically active particles containing nicotine, and the pharmaceutically active particles have an aerodynamic mass median diameter in the range 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 The inhaler system according to Example 33, wherein the capsule further contains flavor particles having an aerodynamic mass median 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 drawing]

[0072] Here, we will further describe the examples with reference to the following figures.

[0073] [Figure 1] Figure 1 is a schematic cross-sectional view of an exemplary inhaler system. [Figure 2] Figure 2 is an exploded perspective view of an exemplary inhaler article holder. [Figure 3A] Figure 3A is a schematic cross-sectional view of an exemplary inhaler system in which an inhaler article is received in an inhaler article holder and the capsule is punctured in a second position. [Figure 3B] Figure 3B is a schematic cross-sectional view of the exemplary inhaler system of Figure 3A, with the perforating element withdrawn from the capsule in the first position. [Figure 4] Figure 4 is another schematic cross-sectional view of Figure 3B illustrating the inhalation airflow path through the inhaler system. [Figure 5] Figure 5 is a front elevation view of an exemplary inhaler article holder inside a sleeve. [Figure 6A] Figure 6A is a perspective view of an exemplary airflow element having a perforated element. [Figure 6B] Figure 6B is a perspective view of the airflow element, showing the offset positions of six alternative perforation elements around the centerline of the airflow element. [Figure 7] Figure 7 is a schematic cross-sectional view of an exemplary perforating element containing a capsule end cap. [Figure 8] Figure 8 is a schematic cross-sectional view of an exemplary capsule cavity having a capsule and a perforating element. [Figure 9A] Figure 9A is a front elevation view of an exemplary capsule end cap after it has been perforated by the perforating element described herein. [Figure 9B] Figure 9B is a front elevation view of another exemplary capsule end cap after being perforated by the perforating element described herein. [Figure 10] Figure 10 is a perspective view of the tip of an exemplary drilling element.

[0074] The schematic diagrams are not necessarily proportional to actual size and are presented for illustrative purposes only, not limiting purposes. The drawings illustrate one or more aspects described in this disclosure. However, naturally, other aspects not depicted in the drawings are also within the scope and intent of this disclosure. [Modes for carrying out the invention]

[0075] Figure 1 is a schematic cross-sectional view of an exemplary inhaler system 10. Figure 2 is an exploded perspective 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 in the inhaler article holder 30 and perforates the 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 the perforating 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 path (arrow) of the inhaled airflow 150 through the inhaler system 10.

[0076] The inhaler article holder 30 is configured to receive a separate consumable inhaler article 20 and to induce a swirling inhalation airflow 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 inside the inhaler article holder 30 during consumer use. The inhaler article holder 30 is configured to induce a swirling inhalation airflow entering the received inhaler article 20.

[0077] An 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 aforementioned dry powder particles may be contained within the capsule 25. The capsule 25 may be perforated to form an opening through the body of the capsule 25, and inhaled air may flow through the inhaler article 20, releasing crystalline dry powder particles from the perforated capsule 25 into the inhaled airflow, outside the mouthpiece end 21.

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

[0079] The perforating element 50 is positioned to penetrate the capsule 25 in 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 perforating 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 perforating element 50.

[0081] The sleeve 40 extends from an open end 42 to a closed end 44 (or restricting end) and defines a sleeve cavity 45 or cylindrical lumen 45 along the longitudinal axis of the sleeve 40. The sleeve open end 42 aligns with a single housing opening 36.

[0082] The sleeve closure end 44 includes an airflow element 46 and an opening to allow a perforating element to pass through the closure end 44 and extend into the sleeve lumen 45. The airflow element 46 includes one or more intake 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 directly induce a rotational or swirling intake airflow into the sleeve cylindrical lumen 45 and into the inhaler article capsule cavity 24. This swirling or rotational intake airflow may be transmitted into the inhaler article 20 to rotate the capsule 25 and release the dry powder contained within the capsule 25.

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

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

[0085] The sleeve closing end 44 may further include a sleeve bottom element 48 that substantially forms the closing end of the sleeve 40. The sleeve bottom element 48 may be fixed and in contact with the airflow element 46. The sleeve bottom element 48 may extend away from the airflow element 46 by a certain distance along the longitudinal axis of the sleeve and toward the closing end of the housing cavity. The sleeve bottom element 48 may have an opening that includes a perforating element 50, and that allows the perforating element 50 to pass through the opening of the sleeve bottom element 48.

[0086] The 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 perforating 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 sleeve 40 into 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] Figure 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 intake 47 of the airflow element 46 and forms a swirling or rotating inhalation air 150 within the sleeve lumen 45. This swirling or rotating inhalation air is then directly delivered to the distal end 23 of the inhaler article 20 and into the capsule cavity 24. The swirling inhalation airflow rotates or agitates the capsule 25, and dry powder particles are drawn into the inhalation airflow. The drawn inhalation airflow then flows out of the inhaler article via the mouthpiece end 21 and to the user 100. In Figure 4, the path of the inhalation airflow 150 is illustrated with arrows.

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

[0090] The single cross-section or bevel 54 is offset or spaced away from the centerline of the airflow element 46 and faces opposite or in the opposite direction to the centerline of the airflow element 46. Figure 6B shows the offset positions of the alternative perforation elements 50 with respect to the centerline of the airflow element 46, indicated by the solid lines and the five phantom lines. Each alternative position indicates that the single cross-section or bevel 54 is offset or spaced away from the centerline of the airflow element 46 and faces opposite or in the opposite direction to the centerline of the airflow element 46.

[0091] Sleeve 40's central longitudinal axis L CL It is located at the intersection of the X and Y axes. The airflow element 46 defines the closed end of the sleeve 40. The inner housing 70 is fixed to the sleeve 40. The perforation element 50 penetrates the airflow element 46 and along the central longitudinal axis L CL It is offset by a distance RO from the center of the airflow element 46 along its longitudinal axis L.CL is aligned with and coincides with the central longitudinal axis L of the sleeve 40. The cut end of the piercing element is defined by a single cut plane or bevel 54 that terminates at the tip 52. CL The orientation of the cut plane or bevel 54 is shown in FIG. 7. The cutting location is opposite the central longitudinal axis L of the sleeve 40. The central longitudinal axis L of the capsule cavity 24

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

[0093] is aligned with and coincides with the central longitudinal axis L of the sleeve 40. The tip 52 first forms an opening through the hemispherical end cap 26 of the capsule and continues to cut the hemispherical end cap 26 of the capsule until the entire circumference of the piercing element shaft enters the capsule 25. The surrounding portion forming the opening is at the position closest to the central longitudinal axis L. The hinge of the capsule material forming a part of the opening is opposite the surrounding portion closest to the central longitudinal axis L. CL is opposite to it. The central longitudinal axis L of the capsule cavity 24 CL is aligned with and coincides with the central longitudinal axis L of the sleeve 40. CL The tip 52 first forms an opening through the hemispherical end cap 26 of the capsule and continues to cut the hemispherical end cap 26 of the capsule until the entire circumference of the piercing element shaft enters the capsule 25. The surrounding portion forming the opening is at the position closest to the central longitudinal axis L. The hinge of the capsule material forming a part of the opening is opposite the surrounding portion closest to the central longitudinal axis L. CL is closest. The hinge of the capsule material forming a part of the opening faces the surrounding portion closest to the central longitudinal axis L. CL opposite to the surrounding portion closest to the central longitudinal axis L.

[0094] The piercing element 50 is parallel to the central longitudinal axis L CL and offset from it by a distance R. The capsule hemispherical end cap 26 has a radius R around the capsule 25. The piercing element 50 can contact the capsule hemispherical end cap 26 at a point closer to the circumferential radius R O than the central longitudinal axis L as described above. C as described above, the piercing element 50 can contact the capsule hemispherical end cap 26 at a point closer to the circumferential radius R CL than the central longitudinal axis L. C to the capsule hemispherical end cap 26.

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

[0096] Figure 10 is a perspective view of the tip 52 of an exemplary drilling element 50. The drilling element 50 has only a single shaft extending from a fixed end along the longitudinal axis of the drilling element to the tip 52. The drilling element has a drilling element diameter D in the range of 0.5 mm to 0.9 mm, and the single drilling element tip 52 has only a single cross-section 54, defining the cross-sectional angle θ between the longitudinal axis of the drilling element and the single cross-section 54. The cross-sectional angle θ is in the range of approximately 25 degrees to approximately 35 degrees.

[0097] For the purposes of this specification and the appended claims, unless otherwise indicated, all numbers representing amounts, quantities, percentages, etc., should be understood in all cases as being modified by the term “approximately.” Furthermore, all ranges include the disclosed maximum and minimum points and any intermediate ranges therebetween, which may or may not be specifically listed herein. Thus, in this context, the number A is understood as A ± 2%. In this context, the number A may be considered to include a number that falls within the general standard error to the measurement of the characteristic that the number A modifies. In some cases as used in the appended claims, the number A may deviate by the percentage listed above, provided that the amount of deviation does not substantially affect the basic and novel characteristics(s) of the claimed invention. Furthermore, all ranges include the disclosed maximum and minimum points and any intermediate ranges therebetween, which may or may not be specifically listed herein.

Claims

1. Inhaler system, Housing that defines the housing cavity, A sleeve extending along its longitudinal axis and positioned within the housing cavity, wherein 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, defines a cylindrical lumen for receiving an inhaler article, and the open end of the sleeve aligns 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 longitudinal axis, and A drilling element comprising only a single shaft extending from a fixed end along the longitudinal axis of the drilling element to the tip, wherein the longitudinal axis of the drilling element is parallel to the longitudinal axis of the sleeve, the drilling element has a drilling element diameter in the range of 0.5 to 0.9 mm, the tip of the single drilling element has only a single cross-section, a cross-section angle is defined between the longitudinal axis of the drilling element and the single cross-section, the cross-section angle is in the range of about 25 degrees to about 35 degrees, and the longitudinal axis of the drilling element is offset from the longitudinal axis of the sleeve. An inhaler system in which, when the sleeve moves from the first position to the second position, only a single opening is formed in the capsule.

2. The inhaler system according to claim 1, wherein the diameter of the perforating element is in the range of 0.7 to 0.9 mm, and the angle of the cutting surface is in the range of about 28 degrees to about 32 degrees.

3. The inhaler system according to claim 1 or 2, wherein the cross-section of the perforating element defines a pointed ellipse.

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

5. The 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. The inhaler system according to any one of claims 1 to 5, wherein the end of the cut surface of the perforating element forms a single opening within the capsule that defines only a single hinge of the capsule material extending into the capsule cavity.

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

8. The inhaler system according to any one of claims 1 to 7, wherein the perforating element perforates the capsule at the curved end of the capsule in the range of 25% to 90% of the capsule radius away from the longitudinal axis of the capsule, or 33% to 80% of the capsule radius away from the longitudinal axis of the capsule, or 50% to 75% of the capsule radius away from the longitudinal axis of the capsule.

9. The inhaler system according to any one of claims 1 to 8, wherein the closed end of the sleeve comprises an airflow element configured to form a swirling airflow and rotate the capsule around the longitudinal axis of the capsule during use.

10. The inhaler system according to claim 9, wherein the capsule is contained within an inhaler article that extends along the longitudinal axis of the inhaler article from its 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. The inhaler system according to any one of claims 1 to 10, wherein the housing cavity includes a spring member that biases the capsule away from the perforation element.

12. The inhaler system according to any one of claims 1 to 11, wherein the capsule contains pharmaceutically active particles containing nicotine, and the pharmaceutically active particles have an aerodynamic mass median diameter in the range 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. The inhaler system according to claim 12, wherein the capsule further contains flavor particles having an aerodynamic median mass 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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