Inhaler article holder for high dose delivery

Abstract

An inhaler article holder is configured to introduce a vortex inhalation airflow into an inhaler article. The holder is configured to cooperate with the inhaler article to deliver a high dose of dry powder to a user in a limited number of inhalations. The holder and inhaler article can form an inhaler system to which the present disclosure also relates.

Description

Technical Field

[0001] This disclosure relates to an inhaler article retainer configured to generate a vortex inhalation airflow into an inhaler article received in the inhaler article retainer. Background Technology

[0002] Dry powder inhalers may not always be perfectly suited for delivering dry powder particles to the lungs at inhalation or airflow rates within the range of those used in conventional smoking. Operating a dry powder inhaler can be complex or may involve moving parts.

[0003] Inhaler products hold a capsule containing dry powder. These capsules are activated by puncturing an opening in the capsule wall. The user inhales (inhales) from the mouthpiece side of the consumer product. This action forces airflow through the dry powder inhaler. Consumers with impaired lung function may have difficulty operating these dry powder inhalers or delivering the dry powder to their lungs.

[0004] It is desirable to provide a retainer for an inhaler article that activates the inhaler article, holds the inhaler article during consumption, and delivers a high dose of dry powder to the user in a limited number of inhalations. It is desirable to provide an inhaler system comprising a thin and reusable retainer for an inhaler article that can activate the inhaler article. It is desirable to provide an inhaler article made of recyclable materials. It is desirable to provide a powder inhaler that delivers the full dose of particles to the lungs at an inhalation or airflow rate within a conventional smoking state or within a limited number of inhalations. It is desirable to provide an inhaler system for delivering dry powder over several inhalations. It is desirable to provide an inhaler system for delivering dry powder in a single inhalation. It is also desirable to deliver powder using an inhaler article having a form similar to a conventional cigarette. Summary of the Invention

[0005] This disclosure relates to a retainer for an inhaler article. The retainer is configured to direct a vortex inhalation airflow to the inhaler article during consumption. The retainer is configured to cooperate with the inhaler article to deliver a high dose of dry powder to the user in a limited number of inhalations. For example, the retainer and inhaler article can deliver the full dose of dry powder to the user in five or fewer inhalations. The retainer and inhaler article can form the inhaler system also involved in this disclosure.

[0006] According to one aspect of the invention, an inhaler article retainer is provided, the retainer comprising a housing defining a housing cavity, a sleeve positioned within the housing cavity, and a piercing element positioned within the housing cavity. The sleeve is arranged to receive an inhaler article and is movable within the housing cavity along a longitudinal axis of the housing cavity between a first position and a second position. The sleeve includes a sleeve cavity defined by the sleeve, a first open end configured to receive an inhaler article, and a second end opposite to the first open end. The first open end may be angled. The second end includes an end wall that at least partially closes the second end. A tubular member is fixed to the end wall and extends a first length from the end wall into the sleeve cavity through the open end of the tubular member. The tubular member defines a tubular member cavity having a longitudinal axis of the tubular member. At least two air inlets extend into the tubular member cavity. The at least two air inlets extend orthogonally to the longitudinal axis of the tubular member. The at least two air inlets enter the tubular member cavity tangentially to induce a vortex airflow pattern on the inhaled air entering the sleeve cavity. At least two air inlets each enter the tubular member cavity through a sleeve sidewall, and each of the at least two air inlets has a lateral opening size in the range of about 0.2 mm to about 0.5 mm. The at least two air inlets each enter the tubular member cavity through the sleeve sidewall and adjacent to the end wall, and each of the at least two air inlets has a lateral opening size in the range of about 0.2 mm to about 0.5 mm. The piercing element is arranged to penetrate the end wall and pierce the inhaler article received within the sleeve when the sleeve is in the second position.

[0007] According to another aspect of the invention, an inhaler system includes an inhaler article and a retainer for the inhaler article as described herein. The inhaler article includes a body extending distally along a longitudinal axis of the inhaler from a mouthpiece end and a sleeve disposed within the body of the inhaler article. The sleeve retains the inhaler article received within the sleeve cavity.

[0008] Advantageously, incorporating the vortex-generating structure into a reusable retainer simplifies the construction of inhaler articles and reduces the complexity of inhaler systems. The described configuration of the retainer allows operation at inhalation rates of approximately five liters per minute or less, expelling at least 75% by weight or substantially all of the dry powder contained in the capsule with five or fewer inhalations, or three or fewer inhalations. Inhaler articles that receive a vortex inhalation flow can be easier to manufacture and have a simpler construction than inhaler articles that include structures that initiate or generate a vortex inhalation flow. Simpler inhaler articles may also result in a less environmentally burdensome design.

[0009] Inhaler product retainers and inhaler products can be used to inhale any desired dry powder. According to one embodiment, a capsule contained in an inhaler product contains dry powder comprising particles containing one or more pharmaceutically active agents. Examples of pharmaceutically active agents include nicotine, neonicotinoids, hydroxychloroquine, adrenaline, melatonin, caffeine, antiviral compounds such as acyclovir; anti-inflammatory compounds such as salicylic acid, aceclofenac, or ketoprofen; antidiabetic compounds such as metformin or glipizide; antihypertensive compounds such as oxenolol; antiemetic compounds such as promethazine; antidepressant compounds such as seroxetine; anticoagulant compounds such as pyrcotahistine; bronchodilators such as clenbuterol; or anticancer compounds such as β-lapaquinone. The capsule may contain any dry powder pharmaceutically active agent.

[0010] Pharmaceutical active agents may include pharmaceutically acceptable salts of pharmaceutical active agents. Suitable salts include, for example, salts of lactic acid (“lactate”), salts of tartaric acid (“tartrate” or “bitate”), salts of aspartic acid (“aspartate”), salts of pyruvate (“pyruvate”), salts of citric acid (“citricate”), salts of salicylic acid (“salicylate”), salts of glutamic acid (“glutamate”), salts of gentianic acid (“gentianate”), salts of benzoic acid (“benzoate”), salts of fumaric acid (“fumarate”), salts of hydrochloric acid (“hydrochloride”), salts of α-dihydroxybenzoic acid (“α-dihydroxybenzoate”), salts of β-dihydroxybenzoic acid (“β-dihydroxybenzoate”), salts of oxalic acid (“oxalate”), salts of p-anisinic acid (“anisate”), salts of glutaric acid (“glutarate”), etc.

[0011] The capsule may contain 5 mg or more, or 10 mg or more of dry powder particles. The capsule may contain 900 mg or less, 600 mg or less, 300 mg or less, or 150 mg or less of dry powder particles. The capsule may contain 5 mg to 300 mg, or 10 mg to 200 mg, or 25 mg to 100 mg, or 30 mg to 75 mg of dry powder particles.

[0012] The capsule may contain flavoring particles. When the flavoring particles are mixed or combined with the active pharmaceutical particles in the capsule, the flavoring particles may be present in an amount that provides the desired flavor to each inhalation or "vape" delivered to the user. The active pharmaceutical particles may comprise 40% or more, 60% or more, or 80% or more of the dry powder. The active pharmaceutical particles may comprise 50% to 90% of the dry powder, or 60% to 85% of the dry powder, or 70% to 80% of the dry powder.

[0013] The capsule can be made of any suitable material. For example, the capsule can be made of a polymeric material, gelatin, or any other suitable material used to manufacture fillable capsules. In one embodiment, the capsule is made of a polymeric material, preferably hydroxypropyl methylcellulose (“HPMC”). For example, the capsule can be a size 1 HPMC capsule. The capsule can be a size 2 HPMC capsule. The capsule can be a size 3 HPMC capsule. The capsule can be a size 4 HPMC capsule. The capsule can be a size 1 capsule. The capsule can be a size 2 capsule. The capsule can be a size 3 capsule. The capsule can be a size 4 capsule.

[0014] The activated capsule includes only a single orifice for releasing dry powder from within the capsule. The single orifice may have a lateral opening size ranging from about 1.5 mm to about 0.7 mm or from 1.2 mm to about 0.8 mm.

[0015] For example, an activated capsule of size 3 or size 4 with a single orifice having a maximum lateral opening in the range of 1.2 mm to about 0.8 mm and containing 40 to 60 grams of dry powder can be used with the inhaler system described herein to release at least 75% or at least 80% by weight of the dry powder from the single orifice of the capsule in two or fewer inhalations at a flow rate of about 5 liters per minute for a duration of about 2 seconds per inhalation.

[0016] The retainer of an inhaler product is configured to cooperate with the inhaler product to deliver a high dose of dry powder to the user in a limited number of inhalations. For example, the retainer and inhaler product may deliver substantially the entire dose of the dry powder contained in the capsule to the user in five or fewer inhalations. Alternatively, the retainer and inhaler product may deliver substantially the entire dose of the dry powder contained in the capsule to the user in four or fewer inhalations. Or, the retainer and inhaler product may deliver substantially the entire dose of the dry powder contained in the capsule to the user in three or fewer inhalations. Or, the retainer and inhaler product may deliver substantially the entire dose of the dry powder contained in the capsule to the user in two or fewer inhalations. Or, the retainer and inhaler product may deliver substantially the entire dose of the dry powder contained in the capsule to the user in a single inhalation. "Substantially the entire dose of dry powder" means at least 75% by weight of the total dry powder contained in the capsule.

[0017] Inhalation can occur at an inhalation flow rate within the range of a normal smoking state, where the inhaled airflow passes through the inhaler. Inhalation can occur at an inhalation flow rate less than five liters per minute, or within the range of two to five liters per minute, three to five liters per minute, or four to five liters per minute.

[0018] Each inhalation lasts for a duration equal to the user's normal inhalation. Each inhalation lasts for a duration in the range of approximately 1 to 4 seconds. Each inhalation lasts for a duration in the range of approximately 1 to 3 seconds. Each inhalation lasts for a duration in the range of approximately 1.5 to 2.5 seconds. Each inhalation lasts for a duration in the range of approximately 2 seconds.

[0019] The capsule may contain a pharmaceutically active powder comprising particles with a median mass aerodynamic diameter (MMAD) size ranging from 0.5 to 10 micrometers or from 0.5 to 5 micrometers. In one embodiment, the capsule contains nicotine powder including nicotine particles having an MMAD size ranging from 0.5 to 10 micrometers or from 0.5 to 5 micrometers. The capsule may also contain flavor particles with an MMAD size of 10 micrometers or larger, 20 micrometers or larger, or 40 micrometers or larger. The flavor particles may have an MMAD size of 200 micrometers or smaller, 150 micrometers or smaller, or 120 micrometers or smaller. The flavor particles may have an MMAD size ranging from 20 micrometers to 200 micrometers or from 40 micrometers to 120 micrometers. In some embodiments, the capsule contains nicotine particles with an MMAD particle size ranging from 0.5 micrometers to 10 micrometers or from 0.5 micrometers to 5 micrometers and flavor particles with an MMAD particle size ranging from 20 micrometers to 200 micrometers or from 50 micrometers to 150 micrometers.

[0020] In some cases, the capsule contains pharmaceutically active particles including nicotine. For example, the capsule may contain a dry powder comprising nicotine salts. The dry powder may also contain other components, such as sugars or sugar alcohols, amino acids, flavorings, cough suppressants, or other pharmaceutically acceptable ingredients suitable for use in inhalable powders. In one embodiment, the capsule contains nicotine powder comprising nicotine particles, wherein the nicotine particles comprise nicotine salts, sugars or sugar alcohols, and amino acids. The nicotine powder particles may be synthetic particles, wherein at least selected particles or each particle comprises nicotine salts, sugars or sugar alcohols, and amino acids. The capsule may also comprise flavoring particles, cough suppressant particles, or both flavoring particles and cough suppressant particles. Flavorings and cough suppressant particles are collectively referred to herein as flavoring particles.

[0021] The nicotine or nicotine particles in the powder system can be pharmaceutically acceptable free nicotine, or nicotine salts or nicotine salt hydrates. Useful nicotine salts or nicotine salt hydrates include, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine monopyruvate, nicotine glutamate, or nicotine hydrochloride. The nicotine particles preferably include amino acids. Preferably, the amino acid can be leucine, such as L-leucine. Providing nicotine-containing particles with an amino acid such as L-leucine reduces the adhesive force of the particles and the attraction between nicotine particles, thereby reducing the clumping of nicotine particles and adhesion of nicotine particles to surfaces. Similarly, the adhesive force to particles including flavorings can also be reduced. The powder system can be a free-flowing material and has a stable relative particle size for each powder component, even when nicotine particles are combined with flavoring particles.

[0022] This disclosure relates to a retainer for an inhaler article, referred to as an "inhaler article retainer". The inhaler article retainer includes one or more puncture elements. The inhaler article retainer is configured to receive a consumable inhaler article, activate a sac within the inhaler article by puncturing the sac, and introduce a vortex inhalation airflow into the inhaler article during consumption. The inhaler article retainer and the inhaler article may form the inhaler system to which this disclosure relates. The inhaler article retainer may include a single puncture element.

[0023] The inhaler product retainer described herein can be combined with an inhaler product containing a capsule. The inhaler product can be used to activate the inhaler product by puncturing the capsule, thereby achieving reliable activation of the capsule by puncturing the capsule with the puncturing element of the inhaler product retainer. Particles can be released from the capsule upon drawing or forming an airflow around the punctured capsule. The inhaler system thus delivers dry powder particles to the consumer. The inhaler product retainer is separate from the inhaler product, but the consumer can use both the inhaler product and the inhaler product retainer to simultaneously consume the dry powder particles released within the inhaler product. Multiple such inhaler products can be combined with the inhaler product retainer to form a system or kit. A single inhaler product retainer can be used on 10 or more, or 25 or more, or 50 or more, or 100 or more inhaler products to activate (puncture or perforate) the capsule contained within each inhaler product and provide reliable activation. Optionally, each inhaler product may be provided with a visual indication (marker) for activation of the inhaler product.

[0024] The inhaler article includes an elongated tubular body extending along the longitudinal axis of the inhaler from a mouthpiece end to a distal end. The mouthpiece end is the proximal or downstream end. The distal end is the upstream end. A bladder cavity is defined within the body, downstream by a filter element and upstream by an open tubular element defining a central passage. The distal end of the inhaler article can be closed before insertion into an inhaler article retainer. After insertion into the inhaler article retainer, the distal end of the inhaler article can be open. The distal end of the inhaler article can interact with complementary structures in the inhaler article retainer such that the distal end of the inhaler article can be opened after the inhaler article is introduced into the inhaler article retainer. When introduced into the inhaler article retainer, the distal end of the inhaler article has a central passage forming an open air inlet orifice extending from the distal end of the body to the bladder cavity. The bladder is disposed within the bladder cavity, and the central passage may have a smaller diameter than the bladder. Therefore, the bladder cannot pass through the central passage and is held within the bladder cavity.

[0025] The inhaler article has an airflow path. Airflow is introduced into the inhaler article by inhalation (or inhalation) from the user. The inhaler article retainer generates a vortex inhalation airflow. This vortex inhalation airflow is introduced into the inhaler article. The distal or upstream end of the inhaler article includes an open orifice defining an open central passage of an open tubular element configured to receive the vortex inhalation airflow.

[0026] The vortex inhalation airflow then continues downstream into the capsule cavity, causing the capsule within to rotate. The activated capsule then releases a dose of particles into the vortex inhalation airflow, which travels downstream through the mouthpiece to the consumer. Thus, a vortex inhalation airflow is generated upstream of the inhaler article, and this vortex inhalation airflow reaches the distal or most upstream end of the inhaler article.

[0027] The applicant has discovered that the number, size, and placement of air inlets in the vortex air-generating structure within the described inhaler article retainer cause different capsules of dry powder to be depleted during use. Specifically, the number, size, and placement of air inlets in the vortex air-generating structure within the inhaler article retainer alter the capsule rotation rate and capsule agitation frequency. When three or four air inlets are used in the vortex air-generating structure, with each air inlet having a lateral size or diameter in the range of 0.2 mm to 0.5 mm, or 0.2 mm to 0.4 mm, or 0.2 mm to 0.3 mm, at least 75% by weight of the total dry powder is withdrawn from the capsule within two inhalations (each at a rate of about 4 to about 5 liters per minute, lasting about 2 seconds). The suction resistance can be in the range of about 30 mmWG to about 110 mmWG.

[0028] The inhaler article retainer includes a housing comprising a housing cavity for receiving an inhaler article and a sleeve configured to retain 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 towards a closed end. The single housing opening is configured to receive the inhaler article.

[0029] 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 is also slidable along the longitudinal axis of the housing between the first and second positions. In the first position, the sleeve is positioned close to a single housing opening. In the second position, the sleeve is positioned a lateral distance away from the single housing opening along the longitudinal axis. The sleeve is arranged and configured to receive an inhaler article.

[0030] The sleeve extends from a first open end to a second end opposite the first open end, and defines a cylindrical inner cavity or sleeve cavity along the longitudinal axis of the sleeve. The open end of the sleeve is aligned with a single housing opening and configured to receive an inhaler article. The second end includes an end wall that at least partially closes the second end. The open end of the sleeve may be angled. This angle facilitates insertion of the open end of the sleeve into the inhaler article when it is introduced into the device. Additionally, an angled open end facilitates the manufacture of the sleeve component by allowing for easy removal of the component from a plastic mold.

[0031] A tubular member is fixed to an end wall and extends a first length from the end wall into a sleeve cavity through the open end of the tubular member. The tubular member defines a tubular member cavity having a longitudinal axis. Preferably, the longitudinal axis of the tubular member is coaxial with the longitudinal axis of the sleeve.

[0032] At least two air inlets extend into the tubular member cavity. The at least two air inlets extend orthogonally to the longitudinal axis of the tubular member. The at least two air inlets enter the tubular member cavity tangentially to induce a vortex airflow pattern on the intake air entering the sleeve cavity.

[0033] The two, three, or four air inlets are arranged and configured to dispense at least 75% by weight or at least 80% by weight of dry powder from the bladder via a single orifice in two or fewer inhalations. Each of the at least two air inlets enters the tubular member cavity adjacent to the end wall. Each of the at least two air inlets has a lateral opening size in the range of about 0.2 mm to about 0.5 mm.

[0034] Placing the air inlets closer to the end wall improves the dispensing characteristics of the inhaler article. Placing the air inlets furthest from the opening end of the tubular member improves the dispensing characteristics of the inhaler article. Each of the at least two air inlets enters the tubular member cavity near the end wall. The tubular member has a first length value from the end wall to the opening end. The at least two air inlets enter the tubular member cavity within the first 25% of the first length value from the end wall. The at least two air inlets enter the tubular member cavity within the first 10% of the first length value from the end wall. The at least two air inlets enter the tubular member cavity within the first 5% of the first length value from the end wall. The at least two air inlets enter the tubular member cavity at a distance value from the end wall, said distance value being less than the lateral opening size of each air inlet. The at least two air inlets enter the tubular member cavity at the intersection of the end wall and the tubular member.

[0035] When the three air inlets extend into the tubular component cavity, at least 75% by weight of the total dry powder is extracted from the capsule in two suctions (each at a rate of about 4 to about 5 liters per minute, lasting about 2 seconds). The three air inlets extend orthogonally to the longitudinal axis of the tubular component. The three air inlets enter the tubular component cavity tangentially to induce a vortex airflow pattern on the suction air entering the sleeve cavity. Each of the three air inlets enters the tubular component cavity adjacent to the end wall. Each of the three air inlets has a lateral opening size or diameter in the range of 0.25 mm to 0.4 mm, or 0.27 mm to 0.33 mm, or about 0.3 mm. The suction resistance may be in the range of 30 mmWG to about 70 mmWG, or 50 mmWG to about 70 mmWG.

[0036] When the four air inlets extend into the tubular component cavity, at least 75% by weight of the total dry powder is extracted from the capsule in two suctions (each at a rate of about 4 to about 5 liters per minute, lasting about 2 seconds). The four air inlets extend orthogonally to the longitudinal axis of the tubular component. The four air inlets enter the tubular component cavity tangentially to induce a vortex airflow pattern on the suction air entering the sleeve cavity. Each of the four air inlets enters the tubular component cavity adjacent to the end wall. Each of the four air inlets has a lateral opening size or diameter in the range of 0.2 mm to 0.3 mm, or 0.24 mm to 0.3 mm, or about 0.29 mm. Suction resistance can range from 45 mmWG to about 110 mmWG.

[0037] The sleeve end wall includes an orifice to allow a piercing element to pass through the end wall and extend into the sleeve cavity. An air inlet provides airflow communication from the annular space surrounding the sleeve to the cylindrical cavity within the sleeve. The air inlet and tubular member are configured to introduce a rotating or vortex-like inhalation airflow into the cylindrical cavity of the sleeve and directly into the inhaler article's capsule cavity. This vortex or rotating inhalation airflow can be delivered into the inhaler article to rotate the capsule and release the dry powder contained within.

[0038] The inhaler article retainer may include a piercing element fixed to and extending from an inner surface of the housing. The piercing element is configured to extend through an end wall of the sleeve and into the sleeve cavity along the longitudinal axis of the housing. Once the sleeve is moved from a first position to a second position, the piercing element contacts and pierces 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 an orifice in the capsule that allows dry particles contained within the capsule to be released from the capsule when inhaled air rotates the capsule.

[0039] The inhaler article retainer may further include a spring member configured to bias the sleeve away from the piercing element. The spring member biases the sleeve away from the second position to a first position. The spring member may be in a relaxed state in the first position of the sleeve. The spring member may be in a compressed state in the second position. Preferably, the piercing element is disposed within the spring member.

[0040] The sleeve may include an elongated slot extending along the longitudinal length of the sleeve. The housing may also 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 the sleeve moves between first and second positions.

[0041] 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 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.

[0042] A tubular element may extend into a sleeve cavity and form an annular recess with the sleeve cavity, the annular recess being configured to receive the distal end of the inhaler article. The tubular element may extend into a sleeve cavity and form an annular recess with the sleeve cavity, the annular recess being configured to hold the distal end of the inhaler article. The tubular element may be configured to extend into the distal end of the inhaler article received within the sleeve cavity. Essentially all inhaled air enters the tubular element in a direction tangential to the longitudinal axis of the tubular member.

[0043] Advantageously, providing a feature on the second opposite end of the sleeve that mates with the received inhaler article can improve a reliable airflow connection from the sleeve that induces turbulence to the inhaler article received in the sleeve. The annular recess can be configured to hold the distal end of the inhaler article in an interference fit. The interference fit between the annular recess and the distal end of the inhaler article also provides a secure engagement of the inhaler article received in the sleeve, preventing it from falling out of the sleeve or associated retainer.

[0044] Unless otherwise stated, the term "particle size" is used herein to refer to the mass median aerodynamic diameter (MMAD) of a particle or aggregate of particles. Such values ​​are based on a mass median aerodynamic diameter (MMAD) of 1 gm / cm², defined as having the same aerodynamic behavior as the particle being characterized. 3 The distribution of the density of the sphere's diameter and the diameter of the aerodynamic particles.

[0045] Specifically, for powder systems, the mass median aerodynamic diameter (MMAD) is typically referenced, as it is one of the most widely used measures as a single numerical descriptor of aerodynamic particle size distribution. MMAD is a statistically derived graph of a particle sample: for example, an MMAD of 5 micrometers means that 50% of the total sample mass will be present in particles with an aerodynamic diameter of less than 5 micrometers, and the remaining 50% of the total sample mass will be present in particles with an aerodynamic diameter greater than 5 micrometers. In the context of this invention, when describing powder systems, the term "particle size" preferably refers to the MMAD of the powder system.

[0046] MMAD for powder systems is preferably measured using a cascade impactor. Cascade impactors are instruments widely used to sample and separate airborne particles to determine the aerodynamic size classification of aerosol particles. Essentially, a cascade impactor separates an incoming sample into discrete parts based on particle inertia, which varies with particle size, density, and velocity. A cascade impactor typically comprises a series of stages, each including a plate with a specific nozzle arrangement and collection surface. The velocity of the sample-carrying air increases as the number of stages increases, while the nozzle size and total nozzle area decrease with increasing stage number. At each stage, particles with sufficient inertia detach from the main airflow to impact the collection surface. Therefore, at any given flow rate, each stage is associated with a cutoff diameter, which numerically defines the size of the collected particles. As the number of stages increases, the velocity increases, and thus the stage cutoff diameter decreases. Therefore, the cutoff diameter associated with a given stage is a function of the airflow rate used for testing. To reflect in-service performance, aerosol inhalers are routinely tested at 15 L / min, and dry powder inhalers can be tested at flow rates up to 100 L / min.

[0047] Preferably, in the context of this invention, the MMAD of the powder system is measured using a Next-Generation Impactor (NGI) 170 (purchased from Copley Scientific AG). The NGI is a high-performance, precise cascade impactor for particle sorting with seven stages plus a micropore collector (MOC). The features and operating principles of the NGI are described, for example, in Marple et al., Journal of Aerosol Medicine, Vol. 16, No. 3 (2003). More preferably, the measurements are performed at 20 ± 3 degrees Celsius and 35 ± 5% relative humidity.

[0048] Dry powder formulations typically contain less than or equal to about 15% by weight of water, preferably less than or equal to about 10% by weight, and even more preferably less than or equal to about 6% by weight. Most preferably, dry powder formulations contain less than or equal to about 5% by weight of water, or even less than or equal to about 3% by weight, or even less than or equal to about 1% by weight.

[0049] The phrase "suction resistance" or "RTD" refers to the static pressure difference between the two ends of a sample when the gas flow passes through it under steady-state conditions at an output flow rate of 17.5 mL / s. The RTD of a sample can be measured using the method specified in ISO standard 6565:2002.

[0050] All values ​​reported as percentages are assumed to be weight percentages based on total weight.

[0051] All scientific and technical terms used in this article have their common meanings in the field, unless otherwise specified. The definitions provided are for ease of understanding of certain terms used frequently in this article.

[0052] As used herein, unless the content explicitly indicates otherwise, the singular forms “a” and “the” cover embodiments having plural referents.

[0053] As used herein, unless otherwise expressly indicated by the content, "or" is generally used in its meaning as including "and / or". The term "and / or" means one or all of the listed elements or any combination of two or more of the listed elements.

[0054] As used in this text, "having," "containing," "including," etc., are used in their open sense and generally mean "including (but not limited to)." It should be understood that phrases such as "basically composed of," "composed of," etc., fall under the category of "including."

[0055] The terms "preferred" and "ideally" refer to embodiments of the invention that provide certain benefits in certain environments. However, other embodiments may also be preferred in the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are useless, and is not intended to exclude other embodiments from the scope of this disclosure, including the claims.

[0056] As used herein, the term “substantially” has the same meaning as “significantly” and can be understood as modifying the relevant term by at least about 90%, at least about 95%, or at least about 98%. As used herein, the term “generally not” has the same meaning as “significantly not” and can be understood as having the opposite meaning to “generally”, i.e., modifying the relevant term by no more than 10%, no more than 5%, or no more than 2%.

[0057] The terms “upstream” and “downstream” refer to the relative positions of the components of the described retainer, inhaler article, and inhaler system with respect to the direction of the inhaled airflow as the inhaled airflow passes over the retainer body, inhaler article, and inhaler system.

[0058] The invention is defined in the claims. However, a non-exhaustive list of non-limiting examples is provided below. Any one or more features of these examples may be combined with any one or more features of another example, embodiment, or aspect described herein.

[0059] Example Ex1. An inhaler article retainer includes a housing defining a housing cavity, a sleeve positioned within the housing cavity, and a piercing element positioned within the housing cavity. The sleeve is arranged to receive an inhaler article and is movable within the housing cavity along a longitudinal axis of the housing cavity between a first position and a second position. The sleeve includes a sleeve cavity defined by the sleeve, a first open end configured to receive an inhaler article, and a second end opposite the first open end. The second end includes an end wall that at least partially closes the second end. A tubular member is fixed to the end wall and extends a first length from the end wall into the sleeve cavity through the open end of the tubular member. The tubular member defines a tubular member cavity having a longitudinal axis of the tubular member. At least two air inlets extend into the tubular member cavity. The at least two air inlets extend orthogonally to the longitudinal axis of the tubular member. The at least two air inlets enter the tubular member cavity tangentially to induce a vortex airflow pattern on the inhaled air entering the sleeve cavity. The at least two air inlets each enter the tubular member cavity adjacent to the end wall, and each of the at least two air inlets has a lateral opening size in the range of about 0.2 mm to about 0.5 mm. The piercing element is arranged to pass through the end wall and pierce the inhaler article received within the sleeve when the sleeve is in the second position.

[0060] An inhaler article retainer of Example Ex2.Ex1, wherein the tubular member includes three air inlets extending into a cavity of the tubular member. The three air inlets extend orthogonally to the longitudinal axis of the tubular member. The three air inlets enter the cavity of the tubular member tangentially to induce a vortex airflow pattern on the inhaled air entering the sleeve cavity. Each of the three air inlets enters the cavity of the tubular member adjacent to an end wall.

[0061] The inhaler article retainer of example Ex3.Ex2, wherein each of the three air inlets has a lateral opening size in the range of about 0.25 mm to about 0.4 mm, or in the range of about 0.27 mm to about 0.33 mm, or about 0.3 mm.

[0062] Example Ex4.Ex1 is an inhaler article retainer, wherein the tubular member includes four air inlets extending into a cavity of the tubular member. The four air inlets extend orthogonally to the longitudinal axis of the tubular member. The four air inlets enter the cavity of the tubular member tangentially to induce a vortex airflow pattern on the inhaled air entering the sleeve cavity. Each of the four air inlets enters the cavity of the tubular member adjacent to an end wall.

[0063] The inhaler article retainer of example Ex5.Ex4, wherein each of the four air inlets has a lateral opening size in the range of about 0.2 mm to about 0.3 mm, or in the range of about 0.24 mm to about 0.3 mm, or about 0.29 mm.

[0064] Examples of inhaler article retainers, such as Ex6, Ex2, or Ex3, have suction resistance in the range of about 30 mmWG to about 70 mmWG and about 50 mmWG to about 70 mmWG.

[0065] Examples of inhaler article retainers, such as Ex7, Ex4, or Ex5, have suction resistance in the range of approximately 45 mmWG to approximately 110 mmWG.

[0066] Example Ex8. An inhaler article retainer of any of the preceding examples, wherein each air inlet enters the tubular member cavity at a distance from the end wall, the distance being less than the lateral opening size of the air inlet.

[0067] Example Ex9. An inhaler article retainer of any of the preceding examples, wherein each air inlet enters the tubular member cavity at the intersection of the end wall and the tubular member.

[0068] Example Ex10. An inhaler article retainer of any of the preceding examples, wherein the tubular member extends into the sleeve cavity and forms an annular recess with the sleeve cavity, the annular recess being configured to receive the distal end of the inhaler article.

[0069] Example Ex11. An inhaler article retainer of any of the preceding examples, wherein the tubular member is coaxial with the longitudinal axis of the sleeve.

[0070] Example Ex12. An inhaler system includes an inhaler article and a retainer for the inhaler article according to any of the foregoing examples. The inhaler article includes a body extending from a mouthpiece end to a distal end along a longitudinal axis of the inhaler and a bladder disposed within the body of the inhaler article. The bladder retains the inhaler article received in the bladder cavity.

[0071] The inhaler article system of Examples Ex13 and Ex12, wherein the capsule is held within a capsule cavity and configured to receive a vortex inhalation airflow formed by a second end of the sleeve, the capsule cavity being defined downstream by a porous element and upstream by an open tubular element.

[0072] Inhaler systems of Examples Ex14, Ex12, or Ex13, wherein the capsule contains pharmaceutically active particles. The median aerodynamic diameter of the pharmaceutically active particles is 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.

[0073] Inhaler systems of Examples Ex15, Ex12 to Ex14, wherein the tubular member and the sleeve form an annular recess, and the distal end of the inhaler article mates with the annular recess.

[0074] Inhaler systems of Examples Ex16, Ex10, or Ex15, wherein the open end of the sleeve is angled. Attached Figure Description

[0075] The embodiments will now be described further with reference to the accompanying drawings, in which:

[0076] Figure 1 This is a schematic cross-sectional view of an illustrative inhaler system;

[0077] Figure 2 It is an exploded perspective view of the retainer of an illustrative inhaler product;

[0078] Figure 3A It is a schematic cross-sectional view of an illustrative inhaler system, wherein the inhaler article is received in an inhaler article holder and punctured in a second position;

[0079] Figure 3B yes Figure 3AA schematic cross-sectional view of an illustrative inhaler system, in which the puncture element is retracted from the sac in a first position;

[0080] Figure 4 yes Figure 3B Another schematic cross-sectional view shows the path of the inhaled airflow through the inhaler system;

[0081] Figure 5 This is a schematic cross-sectional view of the illustrative sleeve; and

[0082] Figure 6-8 This is a schematic cross-sectional view of an illustrative tubular component with one to four tangential air inlets. Detailed Implementation

[0083] The illustrations are not necessarily to scale and are presented for illustrative rather than limiting purposes. The accompanying drawings depict one or more aspects described in this disclosure. However, it should be understood that other aspects not depicted in the drawings fall within the scope and spirit of this disclosure.

[0084] Figure 1 This is a schematic cross-sectional view of the illustrative inhaler system 10. Figure 2 This is an exploded perspective view of the retainer 30 of the illustrative inhaler product. Figure 3A This is a schematic cross-sectional view of an illustrative inhaler system 10, wherein the inhaler article 20 is received in the inhaler article holder 30, and the sac 25 is punctured by the puncturing element 50 when the inhaler article holder 30 is in a second or compressed position. Figure 3B yes Figure 3A A schematic cross-sectional view of an illustrative inhaler system 10, wherein the puncture element 50 is retracted from the sac 25 in a first or relaxed position. Figure 4 This shows the path (arrow) of the inhalation airflow 150 through the inhaler system 10. Figure 3B Another schematic cross-sectional view.

[0085] The inhaler product holder 30 is configured to receive a single consumable inhaler product 20 and to induce a vortex of inhalation airflow into and through the inhaler product 20 during consumption. The inhaler product holder 30 and the inhaler product 20 form the inhaler system 10. During use by the consumer, the inhaler product 20 is held in the inhaler product holder 30. The inhaler product holder 30 is configured to induce a vortex of inhalation airflow into the received inhaler product 20.

[0086] The illustrative inhaler article 20 includes a body 22 extending distally from a mouthpiece end 21 to a distal end 23. A cavity 24 is defined within the body 22. A sac 25 is contained within the cavity 24. The dry powder particles described above may be contained within the sac 25. The sac 25 may be punctured to form an opening through the body of the sac 25, and inhaled air may flow through the inhaler article 20 to release the dry powder particles from the punctured sac 25 into the inhaled airflow and exit from the mouthpiece end 21.

[0087] The inhaler article retainer 30 includes a housing 32 defining a housing cavity defined by an inner surface 34 and an outer surface 35. A sleeve 40 is positioned within the housing cavity. The sleeve 40 is arranged to receive the inhaler article 20, and the sleeve 40 is in a first position within the housing cavity along the longitudinal axis of the housing cavity. Figure 3B ) and second position ( Figure 3A It can move between ().

[0088] The piercing element 50 is arranged such that when the sleeve 40 is in the position of Figure 3A The second position shown punctures the sac 25 within the inhaler article 20 received within the sleeve 40. The puncturing 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 puncturing element 50.

[0089] The sleeve 40 extends from a first open end 42 to an opposing second end 44 and defines a sleeve cavity 45 that defines a cylindrical inner cavity along the longitudinal axis of the sleeve 40. The sleeve cavity 45 may optionally have ridges or other structures within the cavity to assist in holding the inhaler article 20 in place during use. The first open end 42 of the sleeve is aligned with a single housing opening 36. The second end 44 includes an end wall 48 that at least partially closes the second end. The end wall 48 includes an orifice to allow a piercing element 50 to pass through the end wall 48 and extend into the cavity of the sleeve 40.

[0090] The tubular member 46 is fixed to the end wall 48 and extends a first length from the end wall 48 into the cavity of the sleeve 40. The tubular member 46 defines a tubular member cavity having a longitudinal axis. The first length may be about 5 mm. The tubular member 46 may have an outer diameter of about 5.5 mm and an inner diameter of about 4 mm. The distal end 23 of the opening of the received inhaler article 20 may have an inner diameter of about 5.5 mm to provide an interference fit with the tubular member 46.

[0091] At least two air inlets 47 extend into the cavity of the tubular member 46. The at least two air inlets 47 extend orthogonally to the longitudinal axis of the tubular member. The at least two air inlets 47 enter the cavity of the tubular member 46 tangentially to induce a vortex airflow pattern on the intake air entering the cavity of the sleeve 40. Each of the at least two air inlets 47 enters the cavity of the tubular member 46 through a sidewall of the sleeve 40. Each of the at least two air inlets 47 may enter the cavity of the tubular member 46 adjacent to an end wall 48. Each of the at least two air inlets 47 has a lateral opening size in the range of about 0.2 mm to about 0.5 mm.

[0092] The tubular member 46 includes two or more inhalation air inlets 47 that provide airflow communication from the annular space surrounding the sleeve 40 into the sleeve cavity 45. This tubular member 46 is configured to induce a rotating or vortex inhalation airflow into the sleeve cavity 45 and directly into the inhaler article bladder cavity 24. This vortex or rotating inhalation airflow can be directed into the inhaler article 20 to rotate the bladder 25 and release the dry powder contained within it.

[0093] 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 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.

[0094] The annular cover 38 secures the inner housing 70 and the 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 can be secured to the housing 32 with a pin element 39.

[0095] Figure 4 The path of the inhalation airflow 150 through the inhaler system 10 is shown. The inhalation airflow 150 is introduced into the device by the user's inhalation. The inhalation air 150 enters the inhaler article holder 30 between the outer surface of the received inhaler article 20 and the annular cap 38 defining the inhalation inlet 37. The inhalation inlet 37 entering the device may define an annular opening coaxial with the received inhaler article 20.

[0096] Once inside the housing cavity, the intake air 150 travels along the length of the sleeve 40 toward the second end 44 of the sleeve 40. The intake air 150 then enters the air inlet 47 of the tubular member 46 and forms a vortex or rotating intake airflow 150 within the sleeve cavity 45. This vortex or rotating intake air is then directly transmitted to the distal end 23 of the inhaler article 20 and enters the bladder cavity 24. The vortex intake airflow rotates or agitates the bladder 25, and dry powder particles are entrained in the intake airflow. The entrained intake airflow then flows out of the inhaler article via the mouthpiece end 21 and toward the user 100. Figure 4 The arrow in the middle indicates the path of the intake airflow 150.

[0097] Figure 5 This is a schematic cross-sectional view of the illustrative sleeve 40. Figure 6-8 It is a schematic cross-sectional view of an illustrative tubular member 46 having two to four tangential air inlets 47.

[0098] The sleeve 40 extends from the first open end 42 to the opposite second end 44 and defines a sleeve cavity 45. The second end 44 includes an end wall 48 that at least partially closes the second end 44.

[0099] The second end 44 of the sleeve 40 includes a tubular member 46 defining a tubular member cavity 49. The tubular member 46 extends from the end wall 48 to an open end 43. The open end 43 may be angled. This angle facilitates insertion of the tubular member 46 into the inhaler article 20 when it is introduced into the device. The tubular member cavity 49 is in fluid communication with the sleeve cavity 45. The open end 43 of the tubular member 46 extends into the sleeve cavity 45. The tubular member 46 includes at least two air inlets 47 to allow air to enter the tubular member cavity 49. The at least two air inlets 47 extend in a direction tangential to the tubular member cavity 49.

[0100] The tubular member cavity 49 extends longitudinally from the end wall 48 to an open end 43 defining a length of approximately 5 mm. At least two air inlets 47 can enter the tubular member cavity 49 within the first 2 mm (first 40%) of its length from the end wall 48. At least two air inlets 47 can enter the tubular member cavity 49 within the first 1.5 mm (first 30%) of its length from the end wall 48. At least two air inlets 47 can enter the tubular member cavity 49 within the first 1 mm (first 20%) of its length from the end wall 48. At least two air inlets 47 can enter the tubular member cavity 49 within the first 0.5 mm (first 10%) of its length from the end wall 48.

[0101] The distal end 23 of the inhaler article 20 slides onto the tubular member 46. An inhalation air inlet 47 enters the tubular member 46 at a position tangential to the tubular member cavity 49, forming a vortex inhalation airflow to the received inhaler article 20. The tubular member 46 extends into the sleeve cavity 45 and forms an annular recess 41 with the sleeve cavity 45, the annular recess being configured to receive the distal end 23 of the inhaler article 20. A protrusion formed by the tubular member 46 slides into the open distal end 23 of the inhaler article 20. The tubular member 46 is configured to extend into the distal end 23 of the inhaler article 20 received within the sleeve cavity 45.

[0102] Figure 6-9 is a schematic cross-sectional view of an illustrative tubular member 46 having a tubular member cavity 49, which has two to four tangential air inlets 47. The inner diameter of the tubular member 46 is approximately 4 mm. Figure 6 Two tangential air inlets 47 are shown, each having a diameter or lateral opening size of about 0.4 mm to about 0.5 mm, to enter the tubular member 46 at 180 degrees to each other. Figure 7 Three tangential air inlets 47 are shown, each having a diameter or lateral opening size of about 0.3 mm to about 0.4 mm, to enter the tubular member 46 at 120 degrees to each other. Figure 8 Four tangential air inlets 47 are shown, each having a diameter or lateral opening size of about 0.25 mm to about 0.3 mm, to enter the tubular member 46 at 90 degrees to each other.

[0103] Example

[0104] Inhalation tests were performed on the inhaler system described herein. All tests used an inhaler article with a size 3 capsule containing 50 mg of nicotine salt powder and flavoring particles (75% nicotine salt: 25% flavoring particles by weight). The nicotine salt particles had a MMAD of approximately 1-3 micrometers. The flavoring particles had a MMAD of approximately 50-100 micrometers. The capsule was activated using a 1.2 mm diameter puncture element to create a single orifice within the capsule. Each test provided an inhaled airflow of 75 ml / s for approximately 2 seconds per inhalation.

[0105] Tested as Figure 7 The inhaler system shown has three air inlets with diameters or lateral opening sizes of 0.36 mm (Example A) and 0.30 mm (Example B), which enter the tubular member at 120 degrees to each other.

[0106] Example A has an RTD of approximately 35 mmWG and releases approximately 75% by weight of the total dry powder dose from the capsule after two inhalations.

[0107] Example B has an RTD of approximately 60 mmWG and releases approximately 80% by weight of the total dry powder dose from the capsule after two inhalations.

[0108] Tested as Figure 8 The inhaler system shown has four air inlets with diameters or lateral opening sizes of 0.3 mm (Example C) and 0.25 mm (Example D), which enter the tubular member at 120 degrees to each other.

[0109] Example C has an RTD of approximately 50 mmWG and releases approximately 75% by weight of the total dry powder dose from the capsule after two inhalations.

[0110] Example D has an RTD of approximately 100 mmWG and releases approximately 75% by weight of the total dry powder dose from the capsule after two inhalations.

[0111] The applicant found that these results were achieved once the air inlet was located close to the end wall of the tubular member.

[0112] For comparison, the applicant tested as follows Figure 7 The inhaler system shown has three air inlets, each with a diameter or lateral opening size of 0.85 mm (Example C1), which enter the tubular member at 120 degrees to each other. Here, the test provided an inhalation airflow of 40 ml / s for approximately 2 seconds per inhalation.

[0113] Comparative Example C1 has an RTD of approximately 35 mmWG and delivers a lower dose of powder per inhalation, which is generally consistent over 12–20 inhalations to achieve approximately 75% by weight of the total dry powder dose released from the capsule.

[0114] For the purposes of this specification and the appended claims, unless otherwise stated elsewhere, all figures representing quantities, quantities, percentages, etc., shall be understood to be modified by the term "about" in all cases. Furthermore, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges that may be specifically listed or not listed herein. Thus, in this context, the numeral A is understood to be A ± 2% A. Within this context, the numeral A can be considered as including a value within the general standard error for the measurement of the attribute modified by the numeral A. In certain instances used in the appended claims, the numeral A may deviate from the percentages listed above, provided that the amount of deviation from A does not materially affect the essential and novel features of the claimed invention. Furthermore, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges that may be specifically listed or not listed herein.

Claims

1. An inhaler product retainer, comprising: The shell that defines the cavity; A sleeve positioned within the housing cavity, the sleeve being arranged to receive an inhaler article, the inhaler article comprising a body extending along the longitudinal axis of the inhaler from a mouthpiece end to an open distal end of the inhaler article, and a bladder disposed within the body of the inhaler article, the sleeve being movable within the housing cavity along the longitudinal axis of the housing cavity between a first position and a second position, the sleeve comprising: The sleeve cavity defined by the sleeve; The first open end is configured to receive the inhaler article; A second end opposite to the first open end, the second end including an end wall that at least partially closes the second end; A tubular member, fixed to the end wall and extending a first length from the end wall into the sleeve cavity through an open end of the tubular member, the tubular member defining a tubular member cavity having a longitudinal axis of the tubular member, the tubular member configured to slide into the open distal end of the inhaler article; and At least two air inlets extend into the cavity of the tubular member, the at least two air inlets extending orthogonally to the longitudinal axis of the tubular member, the at least two air inlets entering the cavity of the tubular member tangentially to induce a vortex airflow pattern on the intake air entering the sleeve cavity, each of the at least two air inlets entering the cavity of the tubular member adjacent to the end wall, and each of the at least two air inlets having a lateral opening size in the range of 0.2 mm to 0.5 mm; A spring member configured to bias the sleeve away from the second position to the first position; and A piercing element, the piercing element being arranged to pass through the end wall and pierce the inhaler article received within the sleeve when the sleeve is in the second position.

2. The inhaler article retainer of claim 1, wherein the tubular member includes three air inlets extending into the tubular member cavity, the three air inlets extending orthogonally to the longitudinal axis of the tubular member, the three air inlets entering the tubular member cavity tangentially to induce a vortex airflow pattern on the inhaled air entering the sleeve cavity, each of the three air inlets entering the tubular member cavity adjacent to the end wall.

3. The inhaler article retainer according to claim 2, wherein each of the three air inlets has a lateral opening size in the range of 0.25 mm to 0.4 mm.

4. The inhaler article retainer of claim 2, wherein each of the three air inlets has a lateral opening size in the range of 0.27 mm to 0.33 mm.

5. The inhaler article retainer according to claim 2, wherein each of the three air inlets has a lateral opening size of about 0.3 mm.

6. The inhaler article retainer of claim 1, wherein the tubular member includes four air inlets extending into the tubular member cavity, the four air inlets extending orthogonally to the longitudinal axis of the tubular member, the four air inlets entering the tubular member cavity tangentially to induce a vortex airflow pattern on the inhaled air entering the sleeve cavity, each of the four air inlets entering the tubular member cavity adjacent to the end wall.

7. The inhaler article retainer of claim 6, wherein each of the four air inlets has a lateral opening size in the range of 0.2 mm to 0.3 mm.

8. The inhaler article retainer of claim 6, wherein each of the four air inlets has a lateral opening size in the range of 0.24 mm to 0.3 mm.

9. The inhaler article retainer of claim 6, wherein each of the four air inlets has a lateral opening size of about 0.29 mm.

10. The inhaler article retainer according to claim 2, wherein the suction resistance is in the range of 30 mmWG to 70 mmWG.

11. The inhaler article retainer according to claim 2, wherein the suction resistance is in the range of 50 mmWG to 70 mmWG.

12. The inhaler article retainer according to claim 6, wherein the suction resistance is in the range of 45 mmWG to 110 mmWG.

13. The inhaler article retainer according to any one of claims 1-12, wherein each air inlet enters the tubular member cavity within a distance from the end wall, the distance being less than the lateral opening size of the air inlet.

14. The inhaler article retainer according to any one of claims 1-12, wherein each air inlet enters the tubular member cavity at the intersection of the end wall and the tubular member.

15. The inhaler article retainer according to any one of claims 1-12, wherein the tubular member extends into the sleeve cavity and forms an annular recess with the sleeve cavity, the annular recess being configured to receive the distal end of the inhaler article.

16. The inhaler article retainer according to any one of claims 1-12, wherein the tubular member is coaxial with the longitudinal axis of the sleeve.

17. An inhaler system comprising: An inhaler article comprising a body extending along a longitudinal axis of the inhaler from a mouthpiece end to a distal end, and a bladder disposed within the body of the inhaler article; as well as The inhaler article retainer according to any one of claims 1-16, wherein the sleeve holds the inhaler article received in the sleeve cavity.

18. The inhaler system of claim 17, wherein the capsule is held within a capsule cavity and configured to receive a vortex of inhaled airflow formed by a second end of the sleeve, the capsule cavity being defined downstream by a porous element and upstream by an open tubular element.

19. The inhaler system of claim 17, wherein the capsule comprises pharmaceutically active particles having a median aerodynamic diameter of 5 micrometers or less.

20. The inhaler system of claim 17, wherein the capsule comprises pharmaceutically active particles having a median aerodynamic diameter in the range of 0.5 micrometers to 4 micrometers.

21. The inhaler system of claim 17, wherein the capsule comprises pharmaceutically active particles having a median aerodynamic diameter in the range of 1 micrometer to 3 micrometers.

22. The inhaler system according to any one of claims 17 to 21, wherein the tubular member and the sleeve form an annular recess, and the distal end of the inhaler article mates with the annular recess.

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