Patent Description:
Dry powder inhalers are not always fully suitable to provide dry powder particles to the lungs at inhalation or air flow rates that are within conventional smoking regime inhalation or air flow rates. Dry powder inhalers may be complex to operate or may involve moving parts. The disclosure of <CIT> discloses a nicotine powder delivery system. The nicotine poweder delivery system includes an inhaler article that include an inhaler body extending between a mouthpiece portion and a distal end portion or end cap element. A nicotine powder receptacle defining a capsule cavity is disposed within the inhaler body and between the mouthpiece portion and the distal end portion. An air inlet port extends through the inhaler body and into the nicotine powder receptacle. The document further discloses an illustrative article packaging illustrative nicotine poweder derlivery systems. The article includes a container that contains a plurality of nicotine powder delivery systems and a single piercing element. A user can remove the nicotine powder delivery system from the container and can inserts an end cap element of the nicotine powder delivery system onto the piercing element until the piercing element pierces through a capsule forming a single aperture through the capsule. Then the user can remove the pierced nicotine powder delivery system from the piercing element and can consume the nicotine powder. The piercing element is fixed to the article. The one or more air inlet ports may have a diameter from about <NUM> to <NUM>.

Inhaler articles may retain capsules containing dry powder. These capsules may be activated by piercing an aperture though the capsule wall. A user puffs (draws or inhales) from the consumable mouthpiece side. This action forces air flow through the dry powder inhaler. Consumers with compromised lung function may have a difficult time operating these dry powder inhalers or delivering dry powder into their lungs.

It is desirable to provide a holder for an inhaler article that activates the inhaler article, retains the inhaler article during consumption, and delivers a high dose of dry powder to the user over a limited number of inhalations. It would be desirable to provide an inhaler system that includes a low-profile and reusable holder for an inhaler article that can activate the inhaler article. It would be desirable to provide an inhaler article made from recyclable material. It would be desirable to provide a powder inhaler that provides an entire dose of particles to the lungs at inhalation or air flow rates that are within conventional smoking regime inhalation or air flow rates within a limited number of inhalations. It would be desirable to provide an inhaler system for providing dry powder in a few inhalations. It would be desirable to provide an inhaler system for providing dry powder in a single inhalation. It would also be desirable to deliver the powder with an inhaler article that has a form similar to a conventional cigarette.

This disclosure is directed to a holder for an inhaler article. The holder is configured to induce swirling inhalation airflow to an inhaler article during consumption. The holder is configured to cooperate with the inhaler article to deliver a high dose of dry powder to the user over a limited number of inhalation. For example, the holder and inhaler article may deliver the entire dose of dry powder to the user over five or fewer inhalations. The holder and an inhaler article may form an inhaler system to which this disclosure is also directed.

According to an aspect of the present invention, there is provided an inhaler article holder including 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 between a first position and a second position along a longitudinal axis of the housing cavity. The sleeve includes a sleeve cavity defined by the sleeve, a first open end configured to receive an inhaler article, and a second end opposing the first open. The first open end may be angled. The second end includes an end wall at least partially closing the second end. A tubular member is fixed to the end wall and extending, a first length, from the end wall to a tubular member open end, into the sleeve cavity. The tubular member defines a tubular member cavity having a tubular member longitudinal axis. At least two air inlets extend into the tubular member cavity. The at least two air inlets extend orthogonally to the tubular member longitudinal axis. The least two air inlets enter the tubular member cavity tangentially to induce a swirled airflow pattern on inhalation air entering the sleeve cavity. The at least two air inlets each enter the tubular member cavity through a sleeve side wall and each of the at least two air inlets have a lateral opening dimension in a range from about <NUM> to about <NUM>. The at least two air inlets each enter the tubular member cavity through a sleeve side wall and adjacent to the end wall and each of the at least two air inlets have a lateral opening dimension in a range from about <NUM> to about <NUM>. 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.

According to another aspect of the present invention, an inhaler system includes an inhaler article and the holder for an inhaler article described herein. The inhaler article includes a body extending along an inhaler longitudinal axis from a mouthpiece end to a distal end, and a capsule disposed within the inhaler article body. The sleeve retains the inhaler article received in the sleeve cavity.

Advantageously, incorporating a swirl generating structure into a reusable holder may simplify the construction of the inhaler articles and reduce the complexity of the inhaler system. The described configuration of the holder may discharge the at least <NUM>%-wt or substantially the entire mass of dry powder contained within a capsule with five or fewer inhalations, or three or fewer inhalations, operating at about five litres/min or less inhalation rate. Inhaler articles that receive swirling inhalation airflow may be easier to manufacture and have a simpler construction than inhaler articles that incorporate structures to induce or form swirling inhalation airflow. The simpler inhaler articles may also present less environmental burden.

The inhaler article holder and inhaler article may be used for the inhalation of any desired dry powder. According to an embodiment, a capsule contained by the inhaler article contains dry powder comprising particles containing one or more pharmaceutically active agents. Examples of pharmaceutically active agents include nicotine, anatabine, hydroxychloroquine, epinephrine, 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 oxprenolol; antiemetic compounds such as promethazine; antidepressant compounds such as seproxetine; anticoagulant compounds such as picotamide; bronchodilators such as clenbuterol; or anticancer compounds such as beta-lapachone. The capsule may contain any dry powder pharmaceutically active agent.

The pharmaceutically active agent may include a pharmaceutically acceptable salt of the agent. Suitable salts include, for example, a salt of lactic acid ("lactate"), tartaric acid ("tartrate" or "bitartrate"), aspartic acid ("aspartate"), pyruvic acid ("pyruvate"), citric acid ("citrate"), salicylic acid ("salicylate"), glutamic acid ("glutamate"), gentisic acid ("gentisate"), benzoic acid ("benzoate"), fumaric acid ("fumarate"), hydrochloric acid ("hydrochlorate"), alfa-resorcylic acid ("alfa-resorcylate"), beta-resorcylic acid ("beta-resorcylate"), oxalic acid ("oxalate"), p-anisic acid ("anisate"), glutaric acid ("glutarate"), and the like.

The capsule may hold or contain <NUM> or more, or <NUM> or more of dry powder particles. The capsule may hold or contain <NUM> or less, <NUM> or less, <NUM> or less, or <NUM> or less of dry powder particles. The capsule may hold or contain from <NUM> to <NUM>, or from <NUM> to <NUM>, or from <NUM> to <NUM>, or from <NUM> to <NUM> of dry powder particles.

The capsule may contain flavor particles. When flavor particles are blended or combined with the pharmaceutically active particles in the capsule, the flavor particles may be present in an amount that provides the desired flavor to each inhalation or "puff" delivered to the user. The pharmaceutically active particles may make up <NUM> wt-% or more, <NUM> wt-% or more, or <NUM> wt-% or more of the dry powder. The pharmaceutically active particles may make up from <NUM> wt-% to <NUM> wt-%, or from <NUM> wt-% to <NUM> wt-%, or <NUM> wt-% to <NUM> wt-% of the dry powder.

The capsule may be made of any suitable material. For example, the capsule may be made of a polymeric material, gelatin, or any other suitable material for making fillable capsules. In one embodiment, the capsule is made from polymeric material, preferably hydroxypropylmethylcellulose ("HPMC"). For example, the capsule may be a size <NUM> HPMC capsule. The capsule may be a size <NUM> HPMC capsule. The capsule may be a size <NUM> HPMC capsule. The capsule may be a size <NUM> HPMC capsule. The capsule may be a size <NUM> gelatin capsule. The capsule may be a size <NUM> gelatin capsule. The capsule may be a size <NUM> gelatin capsule. The capsule may be a size <NUM> gelatin capsule.

The activated capsule includes only a single aperture for releasing the dry powder from within the capsule. The single aperture may have a lateral dimension opening in a range from about <NUM> to about <NUM>, or from <NUM> to about <NUM>.

For example, a size <NUM> or size <NUM> capsule activated with a single aperture having a largest lateral dimension opening in a range from <NUM> to about <NUM> and containing from <NUM> to <NUM> grams of dry powder, may release at least <NUM>%-wt or at least <NUM>%-wt of the dry powder from the capsule single aperture in two or less inhalations a flow rate of about <NUM> litres/min each having a duration of about <NUM> seconds, utilizing the inhaler system described herein.

The inhaler article holder is configured to cooperate with the inhaler article to deliver a high dose of dry powder to the user over a limited number of inhalation. For example, the holder and inhaler article may deliver substantially the entire dose of dry powder contained within the capsule to the user over five or fewer inhalations. The holder and inhaler article may deliver substantially the entire dose of dry powder contained within the capsule to the user over four or fewer inhalations. The holder and inhaler article may deliver substantially the entire dose of dry powder contained within the capsule to the user over three or fewer inhalations. The holder and inhaler article may deliver substantially the entire dose of dry powder contained within the capsule to the user over two or fewer inhalations. The holder and inhaler article may deliver substantially the entire dose of dry powder contained within the capsule to the user over a single inhalation. "Substantially the entire dose of dry powder" means at least <NUM>%-wt of the total dry powder contained in the capsule.

The inhalations may flow thought the inhaler article at an inhalation flow rate that is within conventional smoking regime inhalation air flow rates. The inhalations may flow thought the inhaler article at an inhalation flow rate less than five litres/min, or in a range from two litres/min to five litres/min, or from three litres/min to five litres/min, or from four litres/min to five litres/min.

Each inhalation may flow thought the inhaler article in a time duration equal to a normal inhalation breath of a user. Each inhalation may flow thought the inhaler article in a time duration in a range from about <NUM> to <NUM> seconds. Each inhalation may flow thought the inhaler article a time duration in a range from about <NUM> to <NUM> seconds. Each inhalation may flow thought the inhaler article in a time duration in a range from about <NUM> to <NUM> seconds. Each inhalation may flow thought the inhaler article in a time duration of about <NUM> seconds.

The capsule may contain a pharmaceutically active powder comprising particles with mass median aerodynamic diameter (hereinafter "MMAD") particle size in the range of <NUM> to <NUM> micrometers, or <NUM> to <NUM> micrometers. In one embodiment, the capsule contains nicotine powder comprising nicotine particles, where the nicotine particles have MMAD particle size in the range of <NUM> to <NUM> micrometers, or <NUM> to <NUM> micrometers. The capsule may further contain flavor particles having MMAD particle size of <NUM> micrometers or greater, <NUM> micrometers or greater, or <NUM> micrometers or greater. The flavor particles may have MMAD particle size of <NUM> micrometers or less, <NUM> micrometers or less, or <NUM> micrometers or less. The flavor particles may have MMAD particle size of <NUM> micrometers to <NUM> micrometers or from <NUM> micrometers to <NUM> micrometers. In some embodiments, the capsule contains nicotine particles having MMAD particle size in the range of <NUM> micrometers to <NUM> micrometers, or <NUM> micrometers to <NUM> micrometers and flavor particles having MMAD particle size of <NUM> micrometers to <NUM> micrometers or from <NUM> micrometers to <NUM> micrometers.

In some cases, the capsule contains pharmaceutically active particles comprising nicotine. For example, the capsule may contain a dry powder comprising nicotine salt. The dry powder may further contain other components, such as sugar or sugar alcohol, amino acid, flavorant, cough suppressant, or other pharmaceutically acceptable ingredients that are suitable for use in inhalable powders. In one embodiment, the capsule contains nicotine powder comprising nicotine particles, where the nicotine particles comprise nicotine salt, sugar or sugar alcohol, and amino acid. The nicotine powder particles may composite particles where at least selected or each particle includes nicotine salt, sugar or sugar alcohol, and amino acid. The capsule may further comprise flavor particles, cough suppressant particles, or both flavor and cough suppressant particles. Flavor and cough suppressant particles are collectively referred to here as flavor particles.

The nicotine in the powder system or nicotine particles may be a pharmaceutically acceptable free-base nicotine, or nicotine salt or nicotine salt hydrate. Useful nicotine salts or nicotine salt hydrates include nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine mono-pyruvate, nicotine glutamate or nicotine hydrochloride, for example. The nicotine particles preferably include an amino acid. Preferably the amino acid may be leucine such as L-leucine. Providing an amino acid, such as L-leucine, with the particles comprising nicotine may reduce adhesion forces of the particles and may reduce attraction between nicotine particles, thus reducing agglomeration of nicotine particles and adherence of the nicotine particles to surfaces. Similarly, adhesion forces to particles comprising flavor may also be reduced. The powder system may be a free-flowing material and possess a stable relative particle size of each powder component even when the nicotine particles and the flavor particles are combined.

This disclosure is directed to a holder for an inhaler article, referred to as an "inhaler article holder". The inhaler article holder includes one or more piercing elements. The inhaler article holder is configured to receive a consumable inhaler article, activate the capsule within the inhaler article by piercing the capsule, and induce swirling inhalation airflow into an inhaler article during consumption. The inhaler article holder and an inhaler article may form an inhaler system to which this disclosure is directed. The inhaler article holder may include a single piercing element.

The inhaler article holder described herein may be combined with an inhaler article containing a capsule. The inhaler article may be used to activate the inhaler article by piercing the capsule, providing reliable activation of the capsule by puncturing the capsule with the piercing element of the inhaler article holder. Particles may be released from the capsule upon drawing or creating an airflow around the pierced capsule. The inhaler system thus delivers the dry powder particles to a consumer. The inhaler article holder is separate from the inhaler article, but the consumer utilizes both the inhaler article and the inhaler article holder while consuming the dry powder particles released within the inhaler article. A plurality of these inhaler articles may be combined with an inhaler article holder to form a system or kit. A single inhaler article holder may be utilized on <NUM> or more, or <NUM> or more, or <NUM> or more, or <NUM> or more, inhaler articles to activate (puncture or pierce) a capsule contained within each inhaler article and provide reliable activation. The inhaler article may optionally provide a visual indication (marking), for each inhaler article of the activation of the inhaler article.

An inhaler article comprises an elongated tubular body extending along an inhaler longitudinal axis from a mouthpiece end to a distal end. The mouthpiece end is the proximal end, or the downstream end. The distal end is the upstream end. A capsule cavity is defined within the body bounded downstream by a filter element and bounded upstream by an open tubular element defining a central passage. Prior to insertion into an inhaler article holder, the distal end of the inhaler article may be closed. After insertion into an inhaler article holder, the distal end of the inhaler article may be open. The distal end of the inhaler article may interact with complimentary structures in the inhaler article holder so that, upon introducing the inhaler article into the inhaler article holder, the distal end of the inhaler article may open. When introduced into the inhaler article holder, the distal end of the inhaler article has a central passage which forms an open air-inlet aperture extending from the distal end of the body to the capsule cavity. A capsule is disposed within the capsule cavity, the central passage may have a smaller diameter then the capsule. Thus, the capsule may not pass through the central passage and is retained within the capsule cavity.

The inhaler article has an airflow path. Airflow is introduced into the inhaler article by an inhalation (or puff) from a user. The inhaler article holder creates swirling inhalation airflow. This swirling inhalation airflow is introduced to the inhaler article. The distal end or upstream-most end of the inhaler article includes an open aperture that defines an open central passage of the open tubular element configured to receive swirling inhalation airflow.

The swirling inhalation airflow then continues downstream into the capsule cavity and induces rotation of a capsule in the capsule cavity. The activated capsule then releases a dose of particles into the swirling inhalation airflow downstream through the mouthpiece to the consumer. Thus, the swirling inhalation airflow is created upstream from the inhaler article and swirling inhalation airflow enters the distal end or upstream-most end of the inhaler article.

Applicant has discovered that the number, size, and placement of air inlets into the swirling air generating structure within described the inhaler article holder results in different capsule depletions of dry powder during use. Specifically, the number, size, and placement of air inlets into the swirling air generating structure within the inhaler article holder changes the rate of capsule spinning and capsule shaking frequency. At least <NUM>%-wt of the total dry powder is withdrawn from the capsule within two inhalations (each at a rate of about <NUM> to about <NUM> liters/min for about <NUM> seconds) when three or four air inlets are utilized into the swirling air generating structure where each air inlet has a lateral size or diameter in a range from <NUM> to <NUM>, or from <NUM> to <NUM>, or from <NUM> to <NUM>. Resistance to draw may be in a range from <NUM> mmWG to about <NUM> mmWG.

The inhaler article holder includes a housing comprising a housing cavity for receiving an inhaler article and a sleeve configured to retain an inhaler article within the housing cavity. The housing cavity is defined by a single housing opening that extends into the housing to a closed end along a housing longitudinal axis. The single housing opening is configured to receive the inhaler article.

The sleeve is contained within the housing cavity and is movable along the housing longitudinal axis between a first position and a second position. The sleeve may be slidable along the housing longitudinal axis between a first position and a second position. In the first position the sleeve is located adjacent to the single housing opening. In the second position the sleeve is further away from the single housing opening a lateral distance along the longitudinal axis. The sleeve is arranged and configured to receive an inhaler article.

The sleeve extends from a first open end to a second end opposing the first open end and defines a cylindrical lumen or sleeve cavity along a longitudinal axis of the sleeve. The open end of the sleeve aligns with the single housing opening and is configured to receive the inhaler article. The second end includes an end wall at least partially closing the second end. The open end of the sleeve may be angled. This angle may facilitate insertion of the open end of the sleeve into the inhaler article when the inhaler article is introduced into the device. In addition, an angled open end may facilitate manufacture of the sleeve part by facilitating the removal of the part from a plastic mold.

A tubular member is fixed to the end wall and extends a first length, from the end wall to a tubular member open end, into the sleeve cavity. The tubular member defines a tubular member cavity having a tubular member longitudinal axis. The tubular member longitudinal axis preferable is co-axial with the sleeve longitudinal axis.

At least two air inlets extend into the tubular member cavity. The at least two air inlets extend orthogonally to the tubular member longitudinal axis. The least two air inlets enter the tubular member cavity tangentially to induce a swirled airflow pattern on inhalation air entering the sleeve cavity.

The two, three or four air inlets are arranged and configured to dispense at least <NUM>%-wt or at least <NUM>%-wt of the dry powder from the capsule via a capsule single aperture with two or fewer inhalations. The at least two air inlets each enter the tubular member cavity adjacent to the end wall. Each of the at least two air inlets have a lateral opening dimension in a range from about <NUM> to about <NUM>.

Placing the air inlets closer to the end wall improves the dispensing properties of the inhaler article. Placing the air inlets furthest from the tubular member open end improves the dispensing properties of the inhaler article. The at least two air inlets each enter the tubular member cavity close to the end wall. The tubular member has a first length value from the end wall to the open end. The at least two air inlets enter the tubular member cavity within the first <NUM>% of the first length value from the end wall. The at least two air inlets enter the tubular member cavity within the first <NUM>% of the first length value from the end wall. The at least two air inlets enter the tubular member cavity within the first <NUM>% of the first length value from the end wall. The at least two air inlets enter the tubular member cavity within a distance value to the end wall being less than the lateral opening dimension of each air inlet. The at least two air inlets enter the tubular member cavity at an intersection of the end wall and the tubular member.

At least <NUM>%-wt of the total dry powder is withdrawn from the capsule within two inhalations (each at a rate of about <NUM> to about <NUM> liters/min for about <NUM> seconds) when three air inlets extend into the tubular member cavity. The three air inlets extend orthogonally to the tubular member longitudinal axis. The three air inlets enter the tubular member cavity tangentially to induce a swirled airflow pattern on inhalation air entering the sleeve cavity. The three air inlets each enter the tubular member cavity adjacent to the end wall. Each of the three air inlets has a lateral opening dimension or diameter in a range from <NUM> to <NUM>, or from <NUM> to <NUM>, or about <NUM>. Resistance to draw may be in a range from <NUM> mmWG to about <NUM> mmWG, or from <NUM> mmWG to about <NUM> mmWG.

At least <NUM>%-wt of the total dry powder is withdrawn from the capsule within two inhalations (each at a rate of about <NUM> to about <NUM> liters/min for about <NUM> seconds) when four air inlets extend into the tubular member cavity. The four air inlets extend orthogonally to the tubular member longitudinal axis. The four air inlets enter the tubular member cavity tangentially to induce a swirled airflow pattern on inhalation air entering the sleeve cavity. The four air inlets each enter the tubular member cavity adjacent to the end wall. Each of the four air inlets has a lateral opening dimension or diameter in a range from <NUM> to <NUM>, or from <NUM> to <NUM>, or about <NUM>. Resistance to draw may be in a range from <NUM> mmWG to about <NUM> mmWG.

The sleeve end wall includes an aperture to allow the piercing element to pass through the end wall and extend into the sleeve lumen. The air inlets provide airflow communication from the annular space around the sleeve into the sleeve cylindrical lumen. The air inlets and tubular member are configured to induce rotating or swirling inhalation airflow into the sleeve cylindrical lumen and directly into the inhaler article capsule cavity. This swirling or rotational inhalation airflow may be transmitted into an inhaler article to rotate a capsule and release dry powder contained within the capsule.

The inhaler article holder includes a piercing element fixed to and extending from a housing inner surface of the cavity. The piercing element is configured to extend through the end wall of the sleeve and into the sleeve cavity along a longitudinal axis of the housing. The piercing element contacts and pierces the capsule of a received inhaler article once the sleeve moves from the first position to the second position. Moving the sleeve from the second position to the first position removes the piercing element from the capsule and exposes an aperture in the capsule that allows dry particles contained within the capsule to be released from the capsule as inhalation air rotates the capsule.

The inhaler article holder further includes 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 the first position. The spring member may be in a relaxed state in the sleeve first position. The spring member may be in a compressed state in the second position. Preferably the piercing element is disposed within the spring member.

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

An 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 a fixed end of the piercing element from the inner surface of the housing cavity. The inner housing may separate at the spring member from the inner surface of the housing cavity.

The tubular element may extend into the sleeve cavity and may form an annular recess with the sleeve cavity configured to receive a distal end of an inhaler article. The tubular element may extend into the sleeve cavity and forms an annular recess with the sleeve cavity configured to retain a distal end of an inhaler article. The tubular element may be configured to extend into a distal end of an inhaler article received within the sleeve cavity. Substantially all of the inhalation air enters the tubular element in a direction that is tangential to the tubular member longitudinal axis.

Advantageously, providing features on the second opposing end of the sleeve that mate with a received inhaler article may improve the reliable airflow connection from the swirl inducing sleeve to the inhaler article received in the sleeve. The annular recess may be configured to retain the distal end of an inhaler article with an interference fit. An interference fit between the annular recess and the distal end of the inhaler may also provide a secure engagement of the inhaler article received in the sleeve so that the inhaler article will not fall out of the sleeve or associated holder.

The term "particle size" is used here to refer to the mass median aerodynamic diameter (MMAD) of the particle or set of particles, unless otherwise stated. Such values are based on the distribution of the aerodynamic particle diameters defined as the diameter of a sphere with a density of <NUM> gm/cm<NUM> that has the same aerodynamic behavior as the particle which is being characterized.

In particular for a powder system reference is commonly made to the mass median aerodynamic diameter (MMAD), one of the metrics most widely adopted as a single number descriptor of aerodynamic particle-size distribution. The MMAD is a statistically derived figure for a particle sample: by way of example, an MMAD of <NUM> micrometres means that <NUM> percent of the total sample mass will be present in particles having aerodynamic diameters of less than <NUM> micrometres, and that the remaining <NUM> percent of the total sample mass will be present in particles having an aerodynamic diameter greater than <NUM> micrometres. In the context of the present invention, when describing a powder system, the term "particle size" preferably refers to the MMAD of the powder system.

The MMAD of a powder system is preferably measured with a cascade impactor. Cascade impactors are instruments which have been extensively used for sampling and separating airborne particles for determining the aerodynamic size classification of aerosol particles. In practice, cascade impactors separate an incoming sample into discrete fractions on the basis of particle inertia, which is a function of particle size, density and velocity. A cascade impactor typically comprises a series of stages, each of which comprises a plate with a specific nozzle arrangement and a collection surface. As nozzle size and total nozzle area both decrease with increasing stage number, the velocity of the sample-laden air increases as it proceeds through the instrument. At each stage, particles with sufficient inertia break free from the prevailing air stream to impact on the collection surface. Therefore, at any given flow rate, each stage is associated with a cut-off diameter, a figure that defines the size of particles collected. With increasing stage number, velocity increases and so stage cut-off diameter decreases. Thus, the cut-off diameter associated with a given stage is a function of the air-flow rate used for testing. To reflect in-use performance, nebulisers are routinely tested at <NUM>/min and dry powder inhalers may be tested at flow rates up to <NUM>/min.

Preferably, in the context of the present invention, the MMAD of a powder system is measured with a Next Generation Impactor (NGI) <NUM> (available from Copley Scientific AG). The NGI is a high performance, precision, particle classifying cascade impactor having seven stages plus a Micro-Orifice Collector (MOC). Characteristics and operation principle of a NGI are described, for example, in <NPL>). More preferably, measurements are carried out at <NUM> ±<NUM> degrees Celsius and relative humidity of <NUM> ± <NUM> percent.

A dry powder formulation typically contains less than or equal to about <NUM> percent by weight moisture, preferably less than or equal to about <NUM> percent moisture, even more preferably less than or equal to about <NUM> percent by weight moisture. Most preferably a dry powder formulation contains less than or equal to about <NUM> percent by weight moisture or even less than or equal to about <NUM> percent by weight moisture or even less than or equal to about <NUM> percent by weight moisture.

The phrase "resistance to draw" or "RTD", refers to the static pressure difference between the two ends of a specimen when it is traversed by an air flow under steady conditions in which the volumetric flow is <NUM> millilitres per second at the output end. The RTD of a specimen can be measured using the method set out in ISO Standard <NUM>:<NUM>.

All values reported as a percentage are presumed to be weight percent based on the total weight.

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

As used herein, "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

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

The words "preferred" and "preferably" refer to embodiments of the invention that may afford certain benefits, under certain circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful and is not intended to exclude other embodiments from the scope of the disclosure, including the claims.

The term "substantially" as used here has the same meaning as "significantly," and can be understood to modify the relevant term by at least about <NUM> %, at least about <NUM> %, or at least about <NUM> %. The term "not substantially" as used here has the same meaning as "not significantly," and can be understood to have the inverse meaning of "substantially," i.e., modifying the relevant term by not more than <NUM>%, not more than <NUM>%, or not more than <NUM>%.

The terms "upstream" and "downstream" refer to relative positions of elements of the holder, inhaler article and inhaler systems described in relation to the direction of inhalation air flow as it is drawn through the body of the holder, inhaler article and inhaler systems.

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

The Examples will now be further described with reference to the figures in which:.

The schematic drawings are not necessarily to scale and are presented for purposes of illustration and not limitation. The drawings depict one or more aspects described in this disclosure.

<FIG> is a schematic cross-sectional diagram of an illustrative inhaler system <NUM>. <FIG> is perspective exploded view of an illustrative inhaler article holder <NUM>. <FIG> is a schematic cross-sectional diagram of an illustrative inhaler system <NUM> where the inhaler article <NUM> is received in the inhaler article holder <NUM> and the capsule <NUM> is pierced by the piercing element <NUM> when the inhaler article holder <NUM> is in a second or compressed position. <FIG> is a schematic cross-sectional diagram of the illustrative inhaler system <NUM> of <FIG> where the piercing element <NUM> is retracted from the capsule <NUM> in a first or relaxed position. <FIG> is another schematic cross-sectional diagram of <FIG> illustrating the inhalation airflow <NUM> path (arrows) through the inhaler system <NUM>.

The inhaler article holder <NUM> is configured to receive a separate consumable inhaler article <NUM> and induce swirling inhalation airflow into and through an inhaler article <NUM> during consumption. The inhaler article holder <NUM> and an inhaler article <NUM> form an inhaler system <NUM>. The inhaler article <NUM> remains in the inhaler article holder <NUM> during use by the consumer. The inhaler article holder <NUM> is configured to induce swirling inhalation airflow entering the received inhaler article <NUM>.

The illustrative inhaler article <NUM> includes a body <NUM> extending from a mouthpiece end <NUM> to a distal end <NUM>. A capsule cavity <NUM> is defined within the body <NUM>. A capsule <NUM> is contained within the capsule cavity <NUM>. Dry powder particles described above may be contained within the capsule <NUM>. The capsule <NUM> may be pierced to form an aperture through the body of the capsule <NUM> and inhalation air may flow through the inhaler article <NUM> to release dry powder particles from the pierced capsule <NUM> and into the inhalation airflow and out of the mouthpiece end <NUM>.

The inhaler article holder <NUM> includes a housing <NUM> defining a housing cavity defined by a housing inner surface <NUM>, and an outer surface <NUM>. A sleeve <NUM> is positioned within the housing cavity. The sleeve <NUM> is arranged to receive an inhaler article <NUM> and the sleeve <NUM> is movable within the housing cavity between a first position (<FIG>) and a second position (<FIG>), along a longitudinal axis of the housing cavity.

A piercing element <NUM> is arranged to pierce the capsule <NUM> within the inhaler article <NUM> received within the sleeve <NUM> when the sleeve <NUM> is in the second position as illustrated in <FIG>. The piercing element <NUM> may be configured to extend into the sleeve <NUM> along a longitudinal axis of the housing <NUM>. The inhaler article holder <NUM> may include a spring member <NUM> configured to bias the sleeve <NUM> and any received inhaler article <NUM> away from the piercing element <NUM>.

The sleeve <NUM> extends from a first open end <NUM> to an opposing second end <NUM> and defines a sleeve cavity <NUM> defines a cylindrical lumen along a longitudinal axis of the sleeve <NUM>. The sleeve cavity <NUM> may optionally have ridges or other structures inside the lumen to assist with holding the inhaler article <NUM> in place during use. The first open end <NUM> of the sleeve aligns with the single housing opening <NUM>. The second end <NUM> includes an end wall <NUM> at least partially closing the second end. The end wall <NUM> includes an aperture to allow the piercing element <NUM> to pass through the end wall <NUM> and extend into the sleeve <NUM> cavity.

A tubular member <NUM> is fixed to the end wall <NUM> and extends from the end wall <NUM> into the sleeve <NUM> cavity a first length. The tubular member <NUM> defining a tubular member cavity having a tubular member longitudinal axis. The first length may be about <NUM>. The tubular member <NUM> may have an outer diameter of about <NUM> and an inner diameter of about <NUM>. The received inhaler article <NUM> open distal end <NUM> may have an inner diameter of about <NUM> to provide an interference fit with the tubular member <NUM>.

At least two air inlets <NUM> extend into the tubular member <NUM> cavity. The at least two air inlets <NUM> extend orthogonally to the tubular member longitudinal axis. The least two air inlets <NUM> enter the tubular member <NUM> cavity tangentially to induce a swirled airflow pattern on inhalation air entering the sleeve <NUM> cavity. The at least two air inlets <NUM> each enter the tubular member <NUM> cavity through the sidewall of the sleeve <NUM>. The at least two air inlets <NUM> may each enter the tubular member <NUM> cavity adjacent to the end wall <NUM>. Each of the at least two air inlets <NUM> have a lateral opening dimension in a range from about <NUM> to about <NUM>.

The tubular member <NUM> includes two or more inhalation air inlets <NUM> that provide airflow communication from the annular space around the sleeve <NUM> into the sleeve cavity <NUM>. This tubular member <NUM> is configured to induce rotating or swirling inhalation airflow into the sleeve cavity <NUM> and directly into the inhaler article capsule cavity <NUM>. This swirling or rotational inhalation airflow may be transmitted into an inhaler article <NUM> to rotate a capsule <NUM> and release dry powder contained within the capsule <NUM>.

An inner housing <NUM> may be contained within the housing cavity. The inner housing <NUM> may separate at least a portion of the sleeve <NUM> from the inner surface of the housing cavity. The inner housing <NUM> may separate a fixed end of the piercing element <NUM> from the inner surface of the housing cavity. The inner housing <NUM> may separate the spring member <NUM> from the inner surface of the housing cavity.

An annular cover <NUM> may secure the inner housing <NUM> and sleeve <NUM> into the housing cavity. The annular cover <NUM> defines the single housing opening <NUM> for receiving the inhaler article <NUM>. The annular cover <NUM> may be fixed to the housing <NUM> with a pin element <NUM>.

<FIG> illustrates the inhalation airflow <NUM> path through the inhaler system <NUM>. Inhalation airflow <NUM> is introduced into the device by the inhalation of a user. Inhalation air <NUM> enters the inhaler article holder <NUM> between the outer surface of the received inhaler article <NUM> and the annular cover <NUM> defining an inhalation inlet <NUM>. This inhalation inlet <NUM> into the device may define an annular opening coaxial with the received inhaler article <NUM>.

Once inside the housing cavity, the inhalation air <NUM> travels along the sleeve <NUM> length to the second end <NUM> of the sleeve <NUM>. The inhalation air <NUM> then enters the air inlets <NUM> of the tubular member <NUM> and forms swirling or rotating inhalation airflow <NUM> within the sleeve cavity <NUM>. This swirling or rotating inhalation air is then directly transmitted into the distal end <NUM> of the inhaler article <NUM> and into the capsule cavity <NUM>. The swirling inhalation airflow rotates or agitates the capsule <NUM> and dry powder particles are entrained in the inhalation airflow. The entrained inhalation airflow then flows out of the inhaler article via the mouthpiece end <NUM> and to the user <NUM>. The inhalation airflow <NUM> path is illustrated in <FIG> with arrows.

<FIG> is a cross-sectional schematic diagram of an illustrative sleeve <NUM>. <FIG> are cross-sectional schematic diagrams of illustrative tubular members <NUM> with two to four tangential air inlets <NUM>.

The sleeve <NUM> extends from a first open end <NUM> to an opposing second end <NUM> and defining a sleeve cavity <NUM>. The second end <NUM> includes an end wall <NUM> at least partially closing the second end <NUM>.

The second end <NUM> of the sleeve <NUM> includes a tubular member <NUM> defining a tubular member cavity <NUM>. The tubular member <NUM> extend from the end wall <NUM> to an open end <NUM>. The open end <NUM> may be angled. This angle may facilitate insertion of the tubular member <NUM> into the inhaler article <NUM> when the inhaler article <NUM> is introduced into the device. The tubular member cavity <NUM> is in fluid communication with the sleeve cavity <NUM>. The tubular member <NUM> open end <NUM> extends into the sleeve cavity <NUM>. The tubular member <NUM> includes at least two air inlets <NUM> allowing air to enter into tubular member cavity <NUM>. The at least two air inlets <NUM> extend in a direction that is tangential to the tubular member cavity <NUM>.

The tubular member cavity <NUM> may extend a longitudinally from the end wall <NUM> to an open end <NUM> defining a length having a distance of about <NUM>. The at least two air inlets <NUM> may enter the tubular member cavity <NUM> within the first <NUM> (first <NUM>%) of the length of the tubular member cavity <NUM> from the end wall <NUM>. The at least two air inlets <NUM> may enter the tubular member cavity <NUM> within the first <NUM> (first <NUM>%) of the length of the tubular member cavity <NUM> from the end wall <NUM>. The at least two air inlets <NUM> may enter the tubular member cavity <NUM> within the first <NUM> (first <NUM>%) of the length of the tubular member cavity <NUM> from the end wall <NUM>. The at least two air inlets <NUM> may enter the tubular member cavity <NUM> within the first <NUM> (first <NUM>%) of the length of the tubular member cavity <NUM> from the end wall <NUM>.

The distal end <NUM> of the inhaler article <NUM> slides onto the tubular member <NUM>. Inhalation air inlets <NUM> enter the tubular member <NUM> at a tangent to the tubular member cavity <NUM> and form swirling inhalation airflow to the received inhaler article <NUM>. The tubular member <NUM> extends into the sleeve cavity <NUM> and forms an annular recess <NUM> with the sleeve cavity <NUM> configured to receive a distal end <NUM> of an inhaler article <NUM>. The projection formed by the tubular member <NUM> slides into the inhaler article <NUM> open distal end <NUM>. The tubular member <NUM> is configured to extend into a distal end <NUM> of an inhaler article <NUM> received within the sleeve cavity <NUM>.

s <NUM>-<NUM> are cross-sectional schematic diagrams of illustrative tubular members <NUM> with tubular member cavity <NUM> with two to four tangential air inlets <NUM>. The inner diameter of the tubular members <NUM> is about <NUM>. <FIG> illustrates two tangential air inlets <NUM> each having a diameter or lateral opening dimension of about <NUM> to about <NUM> entering the tubular member <NUM> at <NUM> degrees from each other. <FIG> illustrates three tangential air inlets <NUM> each having a diameter or lateral opening dimension of about <NUM> to about <NUM> entering the tubular member <NUM> at <NUM> degrees from each other. <FIG> illustrates four tangential air inlets <NUM> each having a diameter or lateral opening dimension of about <NUM> to about <NUM> entering the tubular member <NUM> at <NUM> degrees from each other.

Inhalation tests were performed on the inhaler systems described herein. All the tests utilized an inhaler article having a size <NUM> capsule containing <NUM> of nicotine salt powder and flavor particles (<NUM>% nicotine salt:<NUM>% Flavor particles weight ratio). The nicotine salt particles had a MMAD of about <NUM>-<NUM> micrometers. The flavor particles had a MMAD of about <NUM>-<NUM> micrometers. The capsules were activated with a <NUM> diameter piercing element to form a single aperture in the capsule. Each test provided inhalation airflow through the inhaler system at <NUM>/s for about <NUM> second for each inhalation.

An inhaler system having three air inlets as illustrated in <FIG> was tested having a diameter or lateral opening dimension of <NUM> (Example A) and <NUM> (Example B) entering the tubular member at <NUM> degrees from each other.

Example A had a RTD of about <NUM> mmWG and released about <NUM>%-wt of the total dry powder dose from the capsule after two inhalations.

Example B had a RTD of about <NUM> mmWG and released about <NUM>%-wt of the total dry powder dose from the capsule after two inhalations.

An inhaler system having four air inlets as illustrated in <FIG> was tested having a diameter or lateral opening dimension of <NUM> (Example C) and <NUM> (Example D) entering the tubular member at <NUM> degrees from each other.

Example C had a RTD of about <NUM> mmWG and released about <NUM>%-wt of the total dry powder dose from the capsule after two inhalations.

Example D had a RTD of about <NUM> mmWG and released about <NUM>%-wt of the total dry powder dose from the capsule after two inhalations.

Applicant discovered that these results were realized once the air inlets were located close to the end wall of the tubular member.

For comparison, Applicant tested the inhaler system having three air inlets as illustrated in <FIG> was tested having a diameter or lateral opening dimension of <NUM> (Example C1) entering the tubular member at <NUM> degrees from each other. Here the test provided inhalation airflow through the inhaler system at <NUM>/s for about <NUM> second for each inhalation.

Comparative Example C1 had an RTD of about <NUM> mmWG and delivered a lower dose of powder for each inhalation that was generally uniform for <NUM>-<NUM> inhalations to achieve release of about <NUM>%-wt of the total dry powder dose from the capsule.

Claim 1:
An inhaler article holder (<NUM>) comprising:
a housing (<NUM>) defining a housing cavity;
a sleeve (<NUM>) positioned within the housing cavity, the sleeve (<NUM>) is arranged to receive an inhaler article (<NUM>), the inhaler article (<NUM>) comprising a body (<NUM>) extending along an inhaler longitudinal axis from a mouthpiece end (<NUM>) to an inhaler article open distal end (<NUM>) and a capsule (<NUM>) disposed within the inhaler article body (<NUM>), the sleeve (<NUM>) is movable within the housing cavity between a first position and a second position along a longitudinal axis of the housing cavity, the sleeve (<NUM>) comprises:
a sleeve cavity (<NUM>) defined by the sleeve (<NUM>);
a first open end (<NUM>) configured to receive an inhaler article (<NUM>);
a second end (<NUM>) opposing the first open end (<NUM>), the second end (<NUM>) comprises an end wall (<NUM>) at least partially closing the second end (<NUM>);
a tubular member (<NUM>) fixed to the end wall (<NUM>) and extending, a first length from the end wall (<NUM>) to a tubular member open end, into the sleeve cavity (<NUM>) the tubular member (<NUM>) defining a tubular member cavity (<NUM>) having a tubular member longitudinal axis, the tubular member (<NUM>) configured to slide into the inhaler article open distal end (<NUM>); and
at least two air inlets (<NUM>) extend into the tubular member cavity (<NUM>); the at least two air inlets (<NUM>) extend orthogonally to the tubular member longitudinal axis, the at least two air inlets (<NUM>) enter the tubular member cavity (<NUM>) tangentially to induce a swirled airflow pattern on inhalation air entering the sleeve cavity (<NUM>), the at least two air inlets (<NUM>) each enter the tubular member cavity (<NUM>) adjacent to the end wall and each of the at least two air inlets (<NUM>) have a lateral opening dimension in a range from about <NUM> to about <NUM>;
a spring member (<NUM>) configured to bias the sleeve (<NUM>) away from the second position to the first position; and
a piercing element (<NUM>) arranged to pass through the end wall (<NUM>) and pierce the inhaler article (<NUM>) received within the sleeve when the sleeve (<NUM>) is in the second position.