NZ747467A - Nicotine inhaler system - Google Patents

Abstract

inhaler system suitable for providing nicotine particles includes a mouthpiece portion removably coupled to a distal end portion. The mouthpiece portion includes a capsule cavity and a mouthpiece air channel extending from the mouthpiece end to the capsule cavity. The distal end portion includes a piercing element coupled to the distal end portion and a resealable membrane configured to seal the capsule cavity when the mouthpiece portion is coupled to the distal end portion. The resealable membrane is configured to reseal when the piercing element moves out of the resealable membrane. a piercing element coupled to the distal end portion and a resealable membrane configured to seal the capsule cavity when the mouthpiece portion is coupled to the distal end portion. The resealable membrane is configured to reseal when the piercing element moves out of the resealable membrane.

Description

NICOTlNE INHALER SYSTEM This disclosure relates to a nicotine inhaler system that provides multi—use delivery of nicotine particles.

Nicotine particle inhalers are not always suitable to provide nicotine particles to the lungs at inhalation or air flow rates that are within conventional smoking regime inhalation or air flow rates. Nicotine le inhalers do not always include nicotine particle consumable which is easily replaceable once consumed.

It is desirable to e a nicotine inhaler system that provides multi—use delivery of nicotine les. It is desirable that the nicotine inhaler system may e a modular component capsule receptacle that may be easily replaceable once consumed. It is desirable that the article facilitates delivery of nicotine les to the consumer at conventional smoking regime inhalation or airflow rates. The nicotine inhaler system may alleviate one or more of the above mentioned problems.

This disclosure is ed to an inhaler system suitable for providing nicotine particles that includes a mouthpiece portion removably coupled to a distal end portion. The mouthpiece portion includes a capsule cavity and a mouthpiece air channel extending from the mouthpiece end to the e cavity. The distal end portion includes a piercing element coupled to the distal end portion and a resealable membrane configured to seal the capsule cavity when the mouthpiece portion is coupled to the distal end portion. The resealable membrane is configured to reseal when the ng element moves out of the resealable membrane.

The inhaler system suitable for providing nicotine particles may e an inhaler body extending from a mouthpiece end to a distal end and include a mouthpiece portion removably coupled to a distal end portion. The iece portion extends between the mouthpiece end and a first mating end. The distal end n extends between a second mating end and the distal end. The mouthpiece portion includes a capsule cavity defined within the first mating end and a mouthpiece air l extending from the mouthpiece end to the e cavity. The distal end portion includes a piercing element coupled to the distal end portion and a able membrane sealing the capsule cavity at the first mating end when the iece end is coupled to the distal end. The piercing element is configured to move between a relaxed W0 2018l007886 position and a piercing position. The piercing element extends into the capsule cavity in the piercing position. The resealable membrane is configured to reseal when the piercing element moves from the piercing position to the relaxed position. ably a receptacle may be disposed within the capsule . The receptacle being a replaceable e of the r. The receptacle contains a capsule that may contain particles that include nicotine. The receptacle may be sealed with a membrane at a receptacle first end and define an air outlet at an opposing receptacle second end. The receptacle may include an air inlet. Airflow management h the r system may cause the capsule to rotate and release nicotine les (once pierced) into the airflow. 1O ably the resealable membrane contacts the receptacle first end. The resealable membrane may contact the membrane at a receptacle first end when the mouthpiece portion is couple to the distal end portion. The resealable membrane may prevent air flow into the receptacle first end through the membrane at a acle first end.

The receptacle and capsule article may be a modular component of the multi—use nicotine inhaler system. The article may be easily replaceable within the use inhaler. Once consumed, the article may be removed from the multi—use inhaler and discarded.

Advantageously, the inhaler system described herein provides a reusable modular component approach when combined with a consumable receptacle containing a capsule. The resealable membrane ensures the air flow path though the inhaler system originates from the air inlets and exits thorough the mouthpiece air channel. This air flow management ensures that the capsule may rotate during tion and consumption. This rotation may suspend and aerosolize the nicotine les in the inhalation air moving through the inhaler system. The nicotine particles may be red with the inhaler at inhalation or w rates that are within conventional smoking regime inhalation or air flow rates.

The term “nicotine” refers to nicotine and nicotine derivatives such as free—base nicotine, nicotine salts and the like.

The term “flavourant” or “flavour” refers to organoleptic compounds, compositions, or materials that alter and are intended to alter the taste or aroma characteristics of nicotine during consumption or inhalation thereof. The term “flavourant” or “flavour” preferably refers to W0 2018l007886 compounds disclosed in the Flavor & Extract cturers Association (FEMA) Flavor Ingredient Library and in ular in the GRAS Flavoring Substances publications 3 to 27, for example, see Hall, R.L. & Oser, B.L., Food Technology, February 1965 pg 151—197, and in the GRAS flavoring substances 27 SM. Cohen et al., Food logy Aug. 2015 pg. 40-59, and intervening GRAS Flavoring Substances publications 4 to 26. For the purpose of this disclosure, nicotine is not considered as a flavourant or flavour.

The size of a particle, stated herein, preferably refers to the aerodynamic diameter of the particle. The aerodynamic diameter of the particles is ably measured with a cascade impactor.

The r system described herein may be combined with one or more modular nicotine particle delivery ables to deliver the nicotine particles to a consumer. A plurality of these modular nicotine le delivery consumables (similar of different formulation or flavors) may be ed with an inhaler system to form a kit.

An inhaler system includes a mouthpiece portion removably coupled to a distal end portion. The mouthpiece portion includes a e cavity and a mouthpiece air channel extending from the iece end to the capsule cavity. The distal end portion includes a piercing element coupled to the distal end portion and a resealable membrane configured to seal the capsule cavity when the mouthpiece portion is coupled to the distal end portion. The resealable membrane is configured to reseal when the ng element moves out of the resealable membrane.

The inhaler system es an r body extending between a mouthpiece portion and a distal end portion. An inhaler receptacle cavity or capsule cavity may be defined within the inhaler body between the mouthpiece portion and the distal end portion. A modular nicotine particle delivery consumable or receptacle e (receptacle containing a capsule containing particles including nicotine) may define an outer surface that mates with the inhaler receptacle cavity. A consumer may access the inhaler receptacle cavity to insert the modular receptacle article into the inhaler receptacle cavity or e a depleted modular receptacle article with a full or d modular receptacle article into the inhaler receptacle cavity. An air inlet may extend through the inhaler body and into the inhaler receptacle cavity. A mouthpiece air channel W0 2018l007886 is fluidly connected to the inhaler receptacle cavity and a proximal end of the mouthpiece. The inhaler body may resemble a smoking article or cigarette in size and shape.

In some embodiments, a capsule alone is inserted into the capsule cavity. A consumer may access the inhaler capsule cavity to insert the capsule consumable into the inhaler capsule cavity or replace a capsule consumable with a full or un—used capsule consumable into the inhaler capsule cavity.

The air inlet or air inlets that extend through the inhaler body may mate or align with the air inlet or air inlets that extend through the sidewall of the receptacle article placed into the inhaler receptacle cavity. The modular receptacle article air outlet extending thought the acle second end may mate or align with the mouthpiece air l of the inhaler body.

Once the r acle e is placed into the inhaler receptacle cavity, air may flow through the modular receptacle e from the air inlet through the cavity and through the air outlet onto the mouthpiece air channel.

The resealable membrane may be fixed to the distal end and form a portion of the second mating end of the distal portion. The resealable ne may separate the piercing t from the e cavity. The resealable ne may t the receptacle article when the mouthpiece portion is coupled to the distal portion. The resealable membrane may secure the receptacle article within the inhaler receptacle cavity. The resealable membrane may contact the membrane of the receptacle. The piercing element may pierce both the resealable membrane and the membrane of the receptacle when piercing the capsule contained within the receptacle article. When the piercing element moves back to its relaxed position and out of the resealable membrane, being spaced apart from the resealable membrane, the resealable membrane may reseal and prevent air from passing into the receptacle article through the void created in the membrane of the receptacle by the piercing element. Preferably the resealable ne provides an air tight seal. The resealable membrane may provide an air tight seal after being pierced by the piercing element. The resealable ne may provide an air tight seal while being pierced by the piercing element.

The distal portion is coupled to the ng element. The distal portion may surround a portion of the piercing element. The ng element may move along a longitudinal axis between a piercing (activated) position and a relaxed position. A biasing element may maintain the piercing element in the relaxed position. The biasing t may be a spring member. The W0 2018l007886 biasing element may compress when the piercing element is pressed into the ng position.

Releasing the piercing element allows the biasing element to force the piercing t back to the relaxed position.

The piercing element may be a rigid element capable of piercing the resealable membrane and a capsule contained within the receptacle article or capsule cavity. The piercing element may be a metal element such as a needle.

The able membrane contacts the membrane of the receptacle and may effectively seal the void created in the ne of the receptacle by the piercing element. Thus air flow through the inhaler system may not pass though the pierced membrane of the acle.

The resealable membrane is configured to close a void created in the resealable membrane created by a piercing element such as a needle. The able membrane may be pierced and seal or close the void a ity of times, such as at least about 3 three times, or at least about 5 times, or at least about 10 times or at least about 20 times. The void is created through the thickness of the resealable membrane. The resealable membrane may have a thickness in a range from about 0.1 to about 5 millimetres, or from about 0.5 to about 2 millimetres. The resealable membrane may be formed of any resilient material. Resealable membranes may include a septum—like element. Resealable nes may be formed of elastic material such as rubber, silicone, metal foil co—laminated with a r, or latex and the like.

The inhaler system includes a mouthpiece portion removably coupled to a distal end portion. The mouthpiece portion has a first mating end that fits or mates with a second mating end of the distal portion. The first mating end couples to the second mating end. The first mating portion may snap—fit to the second mating end. The first mating portion may screw onto or be in threaded engagement with the second mating end. The first mating portion may form an air tight fit or tion with the second mating end.

A modular receptacle e may be configured to be replacably ed within the inhaler receptacle cavity or capsule cavity defined in the first mating end of the mouthpiece portion. The modular receptacle e includes a receptacle defining a cavity. A capsule is disposed within the cavity. The receptacle is configured to contain the capsule within the cavity.

The cavity may have a circular cross—section extending along at least a portion of the cavity W0 2018l007886 length. The cavity may have a central axis or centroid longitudinal axis. ably the cavity has a shape r to the shape of the capsule. The cavity may have a circular cross-sectional shape and a first diameter and the capsule may have a second diameter that is less than the first diameter. The second diameter may be in a range from about 80% to about 99% of the first diameter, or the second diameter may be in a range from about 90% to about 98% of the first diameter.

The receptacle includes a receptacle second end that is configured to contain the capsule and t the capsule from passing through the receptacle second end. The receptacle second end may be defined by a lateral wall integral with the body of the receptacle. 1O The receptacle second end may be defined by an end cap that is fixed to the body of the acle. One or more air outlets may extend through the acle second end to allow air to flow from the article cavity to the exterior of the receptacle.

A membrane may seal the receptacle first end. The e may be placed into the cavity of the receptacle through an open first end and then the membrane may seal the open first end to retain the capsule within the cavity of the article. The membrane may form a ic or airtight seal or barrier.

The membrane may be formed of a pierce-able material. The inhaler system piercing element passes through the ne and punctures the capsule within the receptacle. The membrane may re—seal once the piercing element is retracted from the membrane. atively, the membrane may not re—seal once the piercing element is retracted from the membrane and be formed of resealable materials described herein. Membranes that may not re—seal include metal foil, for example.

An air inlet may extend through the receptacle body and into the cavity. Air inlets h the inhaler body may align with or be in air communication with the air inlets that extend through the receptacle body. Air inlets may be disposed on one or both of the inhaler body mouthpiece portion and distal portion. Preferably these air inlets are adjacent to or form part of the first or second mating ends. Air inlets that are on both the inhaler body mouthpiece portion and distal portion may align when the mouthpiece portion is coupled to the distal portion.

The cavity may have a length in a range from about 15 mm to about 25 mm or from about 20 mm to about 24 mm. The cavity may have an inner diameter in a range from about 5 W0 2018l007886 mm to about 10 mm or from about 6 mm to about 8 mm. The cavity may have a length of about mm and an inner er of about 6.6 mm when containing a capsule size 3 flat. The cavity may have a length of about 24 mm and an inner diameter of about 7.7 mm when containing a capsule size 1 flat.

The air inlet may be closer to the receptacle first end than the receptacle second end.

The air inlet may be located within about 5 mm or within about 4 mm or within about 3 mm or within about 2 mm of the acle first end. The air inlet may be located from about 1 mm to about 5 mm of the acle first end or from about 2 mm to about 4 mm of the receptacle first end. '10 The air inlet may be off—set from the centroid longitudinal (central) axis of the receptacle cavity or capsule contained within the cavity. The off—set air inlet s the capsule to rotate or spin within the receptacle article during inhalation by the consumer. The air inlet may be off—set from the longitudinal (central) axis of the capsule or acle cavity by about 1 mm or about 2 mm or about 3 mm or about 4 mm where the cavity may have an inner diameter of about 5 mm to about 10 mm or from about 6 mm to about 8 mm. The one or more air inlets may have a diameter from about 0.5 to about 1.5 mm or about 0.7 mm to about 0.9 mm. Preferably, the air inlet directs air tangentially to the outer diameter of the capsule contained within the receptacle The receptacle article receptacle preferably has a circular cross—sectional shape extending (a length distance) along its central axis and forming a cylindrical acle.

Preferably the receptacle defines a right circular cylinder with a radius and having a length extending along a central axis. The air inlet may enter the receptacle tangentially to the cylindrical receptacle. Two or more air inlets enter the receptacle cavity tangentially to the cylindrical receptacle. Preferably these air inlets oppose each other and a first air inlet directs air tangentially to the cylindrical receptacle in a first direction and the second air inlet directs air tangentially to the cylindrical receptacle in a second direction that opposes or is in the opposite direction as the first direction. These ng air inlets may direct tion air at opposing sides of the e contained within the receptacle promoting the rotation of the capsule contained within the receptacle.

The capsule may be sealed within the receptacle article prior to consumption or placement into the inhaler system. The receptacle article may be contained within a sealed or W0 2018l007886 airtight container or bag. The receptacle article may include one or more peelable seal layers to cover the one or more air inlets or one or more air outlets on the receptacle article. An air outlet seal layer may be disposed on the air . This seal layer may be red to be punctured or be peelable to expose the air outlet. An air inlet seal layer may be disposed on the air inlet.

This seal layer may be red to be punctured or be peelable to expose the air inlet. The r system may include air inlet piercing element or an air outlet piercing element that are configured to puncture one or both of these seal layers upon insertion of the receptacle article into the inhaler receptacle cavity or upon activation of the inhaler.

The capsule may be configured to rotate about its’ longitudinal or central axis when air 1O flows through the r system (from the air inlet through the receptacle to the air outlet). The capsule may be formed of an airtight material that may be pierced or punctured by the piercing element of the inhaler system. The capsule may formed of a metallic or polymeric material that serves to keep contaminates out of the capsule but may be pierced or red by a piercing element prior to consumption of the nicotine particles within the capsule. Preferably, the capsule is formed of a polymer material. The polymer material may be hydroxypropylmethylcellulose (HPMC). Preferably, the capsule is a size 1 to size 4 or a size 3 capsule.

The capsule contains solid nicotine les (also referred to as “nicotine ” or “particles comprising nicotine”) and optional flavour les. The capsule may n a predetermined amount of nicotine particles and optional flavour particles. The capsule may contain enough nicotine particles to provide at least 2 tions or “puffs”, or at least about 5 inhalations or “puffs", or at least about 10 inhalations or “puffs”. Preferably, the capsule may contain enough nicotine particles to provide from about 5 to 50 inhalations or “puffs”, or from about 10 to 30 inhalations or “puffs”. Each inhalation or “pufl” may deliver from about 0.1 mg to about 3 mg of nicotine particles to the lungs of the user or from about 0.2 mg to about 2 mg of nicotine particles to the lungs of the user or about 1 mg of nicotine particles to the lungs of the user.

The nicotine particles may have any useful concentration of ne based on the particular formulation employed. The nicotine particles may have at least about 5%wt nicotine up to about 30%wt, or from about 5%wt to about 25%wt, or from about 5%wt to about 20%wt, or from about 5%wt to about 15%wt, or from about 7%wt to about 13%wt, nicotine. Preferably, W0 2018l007886 about 50 to about 150 micrograms of nicotine is delivered to the lungs of the user with each “puff”.

The capsule may hold or n at least about 5 mg of nicotine particles or at least about 10 mg of nicotine particles. ably, the capsule holds or contains less than about 900 mg of nicotine particles, or less than about 300 mg of nicotine particles, or less than 150 mg of nicotine particles. The capsule may hold or contain from about 5 mg to about 300 mg of nicotine les or from about 10 mg to about 200 mg of nicotine particles.

When flavour particles are blended or combined with the nicotine particles within the capsule, the r particles are present in an amount that es the desired flavour to each 1O inhalation or “puff” delivered to the user.

The nicotine particles may have any useful size distribution for inhalation delivery preferentially into the lungs of a user. The capsule may include other les than the nicotine particles. The ne particles and the other particles form a powder system.

The capsule may hold or contain at least about 5 mg of a powder system or at least about 10 mg of a powder system. Preferably, the e holds or contains less than about 900 mg of a powder system, or less than about 300 mg of a powder system, or less than 150 mg of a powder system. The capsule may hold or contain from about 5 mg to about 300 mg of a powder system or from about 10 mg to about 200 mg of a powder system.

The powder system may have at least about 40% or at least about 60%, or at least about 80%, by weight of the powder system comprised in nicotine particles having a particle size of about 10 micrometres or less, or 5 micrometers or less, or in a range from about 1 micrometer to about 3 micrometres.

Nicotine in the powder system or nicotine particles is ably a pharmaceutically acceptable free-base nicotine, or nicotine salt or nicotine salt hydrate. Useful nicotine salts or ne salt hydrates include nicotine pyruvate, nicotine e, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine mono-pyruvate, nicotine glutamate or nicotine hydrochloride, for example. The compound combining with nicotine to form the salt or salt hydrate may be chosen based on its expected pharmacological effect.

W0 2018l007886 The nicotine particles ably include an amino acid. Preferably the amino acid is 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 comprising nicotine and may reduce attraction between nicotine particles and thus reduce agglomeration of nicotine les.

Similarly, adhesion forces to particles comprising flavour is also reduced thus agglomeration of nicotine particles with flavour particles is also reduced. The powder system described herein thus may be a free flowing material and s a stable relative particle size of each powder component even when the ne particles and the flavour particles are The powder system may include flavour particles. The flavour particles may have any useful size distribution for inhalation delivery selectively into the mouth or buccal cavity of a user.

The powder system may have at least about 40%, or at least about 60%, or at least about 80%, by weight of the r of the powder system comprised in particles having a particle size of about 20 micrometres or greater. The powder system may have at least about 40% or at least about 60%, or at least about 80%, by weight of the flavour of the powder system comprised in particles having a particle size of about 50 micrometres or greater. The powder system may have at least about 40% or at least about 60%, or at least about 80%, by weight of the flavour of the powder system comprised in particles having a particle size in a range from about 50 micrometer to about 150 micrometres.

Flavourants or flavours may be provided as a solid flavour (at room temperature of about 22 degrees centigrade and one atmosphere pressure) and may e flavour formulations, flavour—containing als and flavour precursors. The flavourant may include one or more natural rants. one or more tic flavourants, or a ation of natural and synthetic flavourants. Flavourants as described herein are organoleptic compounds, compositions, or materials that are selected and utilized to alter or are intended to alter the taste or aroma characteristics of the nicotine component during consumption or inhalation f.

Flavourants or flavours refer to a variety of flavour materials of natural or tic origin.

They include single compounds and mixtures. Preferably the flavour or flavourant has flavour W0 2018l007886 properties that enhance the experience of the nicotine component during consumption.

Preferably, the flavour is chosen to provide an experience similar to that resulting from smoking a combustible smoking article. For e, the flavour or flavourant may enhance flavour properties such as mouth fullness and complexity. Complexity is generally known as the overall balance of the flavour being richer without dominating single y attributes. Mouth fullness is described as perception of richness and volume in the mouth and throat of the consumer.

Suitable rs include, but are not limited to, any l or synthetic flavour, such as tobacco, smoke, l, mint (such as peppermint and Spearmint), chocolate, licorice, citrus and other fruit flavours, gamma octalactone, vanillin, ethyl vanillin, breath freshener flavours, 1O spice flavours such as on, methyl salicylate, linalool, bergamot oil, geranium oil, lemon oil, and ginger oil, and the like.

Other le flavours may include flavour compounds selected from the group consisting of an acid, an l, an ester, an aldehyde, 3 ketone, a pyrazine, combinations or blends thereof and the like. le flavour compounds may be selected, for example, from the group consisting of phenylacetic acid, solanone, igmatrienone, 2—heptanone, benzylalcohol, cis—3—hexenyl acetate, valeric acid, valeric aldehyde, ester, terpene, sesquiterpene, nootkatone, maltol, damascenone, pyrazine, lactone, anethole, iso~s valeric acid, combinations thereof, and the like.

Further specific examples of flavours may be found in the current literature, and are well- known to the person skilled in the art of flavouring, i.e. of imparting an odor or taste to a product.

The flavourant may be a high-potency flavourant, and may be used and detected at levels that would result in less than 200 parts per million in inhalation air flow. Examples of such flavourants are key tobacco aroma compounds such as amascenone, 2—ethyI—3,5— dimethylpyrazine, phenylacetaldehyde, guaiacol, and furaneol. Other flavourants may only be sensed by humans at higher concentration levels. These flavourants, which are referred to herein as the lower potency flavourants, are typically used at levels that results in orders of ude higher amounts of flavourant released into the inhalation air. Suitable lower potency rants include, but are not limited to, natural or synthetic menthol, peppermint, int, coffee, tea, spices (such as cinnamon, clove and ginger), cocoa, vanilla, fruit flavours, ate, eucalyptus, geranium, eugenol and linalool.

W0 2018l007886 The particles comprising r may e a compound to reduce adhesion forces or surface energy and resulting agglomeration. The flavour particle may be surface modified with an adhesion ng nd to form a coated flavour particle. One preferred adhesion reducing compound is magnesium stearate. Providing an adhesion reducing compound such as magnesium stearate with the flavour particle, especially coating the flavour particle, reduces adhesion forces of the particles comprising flavour and may reduce attraction between flavour particles and thus reduce agglomeration of flavour particles. Thus agglomeration of flavour particles with ne particles is also reduced. The powder system described herein thus may possess a stable ve le size of the particles comprising nicotine and the particles comprising flavour even when the nicotine particles and the flavour particles are combined. The powder system ably is free flowing.

Conventional formulations for dry powder inhalation typically contain carrier particles that serve to increase the fluidization of the active les since the active particles may be too small to be influenced by simple airflow though the inhaler. The powder system may comprise carrier particles. These carrier particles may be a saccharide such as lactose or mannitol that have a particle size greater than about 50 micrometres. The carrier particles may be ed to improve dose uniformity by acting as a diluent or bulking agent in a ation.

The powder system utilized with the ne powder delivery system described herein may be carrier—free or substantially free of a saccharide such as lactose or mannitol. Being carrier—free or substantially free of a saccharide such as lactose or mannitol may allow the nicotine and to be d and delivered to the user’s lungs at inhalation or airflow rates that are r to typical smoking regime tion or airflow rates. In on, since the nicotine is carrier—free or substantially free of a saccharide such as lactose or mannitol, the airflow path of the inhaler may have simple geometry or a simple configuration.

The nicotine powder and a flavour may be combined in a single capsule. As described above, the nicotine powder and a flavour may each have reduced adhesion forces that result in a stable powder formulation where the particle size of each component does not substantially change when combined.

The nicotine particles and flavour particles may be combined in any useful relative amount so that the flavour particles are detected by the user when consumed with the nicotine W0 2018l007886 2017/053545 particles. Preferably the nicotine particles and a r particles form at least about 90%wt or at least about 95%wt or at least about 99%wt or 100%wt of the total weight of the powder system.

The inhaler systems described herein are less complex and have a simplified storage and airflow path as compared to conventional dry powder inhalers. Advantageously, rotation of the capsule within the inhaler system aerosolizes the nicotine particles or powder system and may assist in ining a free flowing powder. Thus, this inhaler system does not require the typical high inhalation rates of tional inhalers to deliver the ne particles described above deep into the lungs.

The inhaler system may use a flow rate of less than about 5 L/min or less than about 3 L/min or less than about 2 LJmin or about 1.6 L/min. Preferably, the flow rate is in a range from about 1 L/min to about 3 L/min or from about 1.5 L/min to about 25 L/min. Preferably, the tion rate or flow rate is similar to that of Health Canada smoking regime, that is, about 1.6 L/min.

The inhaler system may be used by a consumer like smoking a conventional cigarette or vaping an onic cigarette. Such smoking or vaping is characterized by two steps: a first step during which a small volume containing the full amount of nicotine desired by the consumer is drawn into the mouth cavity, followed by a second step during which this small volume comprising the aerosol comprising the desired amount of nicotine is further diluted by fresh air and drawn deeper into the lungs. Both steps are controlled by the consumer. During the first tion step the er may determine the amount of ne to be inhaled. During the second step, the consumer may determine the volume for diluting the first volume to be drawn deeper into the lungs, maximizing the concentration of active agent delivered to the ainNay epithelial surface. This smoking mechanism is sometimes called inhale—exhale".

All scientific and technical terms used herein haVe meanings commonly used in the art unless othenzvise specified. The definitions provided herein are to facilitate understanding of certain terms used frequently herein.

The terms “upstream” and “downstream” refer to relative positions of elements of the inhaler described in relation to the direction of inhalation airflow as it is drawn through the body of the inhaler from a distal end portion to the mouthpiece portion.

W0 2018l007886 As used herein, the singular forms n i! (i , an”, and “the” ass embodiments having plural referents, unless the content clearly dictates othenivise.

As used herein, “or” is generally employed in its sense including “and/or” unless the content clearly dictates othenNise. The term “and/or” means one or all of the listed elements or a combination of any two or more of the listed elements.

As used herein, "have”, “having”, “include”, “including", “compriseI) (I , 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 rred” and “preferably” refer to embodiments of the invention that may afford certain ts, under certain circumstances. However, other ments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not ed to exclude other embodiments from the scope of the disclosure, including the claims.

The schematic gs 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 sure. However, it will be understood that other aspects not depicted in the drawing fall within the scope and spirit of this disclosure.

Referring to an inhaler system 10 includes a mouthpiece portion 20 removably d to a distal end portion 30. The mouthpiece portion 20 includes a capsule cavity 26 and a mouthpiece air channel 25 ing from the mouthpiece end 22 to the capsule cavity 26. A capsule cavity outlet air channel 23 couples the iece air channel 25 to the capsule cavity 26. The capsule cavity 26 is defined by a cavity wall 26. The distal end portion 30 includes a ng element 36 coupled to the distal end portion 30 and a resealable membrane 40 configured to seal the capsule cavity 26 when the mouthpiece portion 20 is coupled to the distal end portion 30. The resealable ne 40 is configured to reseal when the piercing element 36 or needle 37 moves out of the resealable membrane 40. One or more air inlets 28 pass through the cavity wall 26.

W0 07886 FIG 2 is a schematic diagram of another illustrative inhaler system 10 with the distal end portion 30 un-coupled from the mouthpiece n 20 and a nicotine powder delivery consumable 100 or receptacle article disposed within the capsule cavity 26. is schematic diagram the illustrative inhaler system 10 with the distal end portion 30 coupled from the mouthpiece portion 20 and containing a capsule 120 within a receptacle article 100. is schematic diagram the illustrative inhaler system 10 with the piercing element 36, 37 piercing the capsule 120 within a receptacle article 100 and piercing the resealable membrane 40.

The inhaler system 10 may include an inhaler body 12 extending from a mouthpiece end 22 to a distal end 32 and include a mouthpiece portion 20 removably coupled to a distal end 1O n 30. The mouthpiece portion 20 extends between the mouthpiece end 22 and a first mating end 24. The distal end portion 30 extends between a second mating end 34 and the distal end 32. The mouthpiece portion 20 includes a capsule cavity 26 defined within the first mating end 24 and a mouthpiece air channel 25 extending from the mouthpiece end 22 to the capsule cavity 26. A capsule cavity outlet air channel 23 couples the mouthpiece air channel 25 to the capsule cavity 26.

The distal end n 30 es a piercing element 36 coupled to the distal end portion 30 and a resealable membrane 40 g the capsule cavity 26 at the first mating end 24 when the mouthpiece end 20 is d to the distal end 30. The piercing element 36 is configured to move between a relaxed position ( and a ng position (. The piercing element 37 extends into the capsule cavity 28 or 116 in the piercing position. The resealable membrane 40 is configured to reseal when the ng element 37 moves from the piercing position to the relaxed position. A biasing element 31 or spring may provide the force to return the piercing element 36 to the relaxed position.

One or more air inlets 28, 38 on the inhaler body may align to provide inlet air to the capsule cavity 28. The one or more air inlets 28, 38 may extend h a side wall forming the capsule cavity 26. The air inlets 28, 38 may align with or be in air communication with the air inlets 117 of the receptacle article 100. The receptacle cavity 26 is configured to mate with the receptacle article 100. The detachable distal n 30 may be removed from the mouthpiece portion 20 to expose the receptacle cavity 26 to replace the modular and used or depleted receptacle e 100 with an un—used or full receptacle article 100.

W0 2018l007886 and illustrative a nicotine powder delivery consumable 100 or receptacle article. The nicotine powder delivery consumable or receptacle article 100 includes a receptacle 110 having a body or sidewall 112 extending from a acle first end 111 to an opposing receptacle second end 113 and defining a cavity 116. A capsule 120 is disposed within the cavity 116. The capsule 120 contains particles comprising nicotine. illustrates the capsule 120 ed away from the receptacle 110. The nicotine powder delivery consumable or receptacle article 100 may be formed by inserting the capsule 120 into the receptacle 110 and applying the membrane 115 on the receptacle first end 111 to seal the receptacle first end 111 and retain the e 120 within the receptacle 110.

The receptacle 110 includes a lateral wall fixed to or integral with the receptacle body or sidewall 112 and an air outlet extending through the lateral wall and into the cavity 116. A membrane 115 seals the receptacle first end 111. An air inlet 117 s through the sidewall or body 112 and into the cavity 116. The air inlet 117 is proximate the receptacle first end 111 or closer to the receptacle first end 111 than the receptacle second end 113. The cavity 116 has a length value and a diameter value. The air inlet 117 is proximate the receptacle al end 111 a distance. The air inlet 117 may mate with, ore register with, or align with the one or more air inlets 28, 38 on the r body.

The nicotine powder delivery able or receptacle e 100 may be a modular or a replaceable component of a multi—use inhaler 10.

W0 2018l007886 -17_

Claims (15)

CLAIMS 1.:

1. An inhaler system suitable for providing nicotine particles, comprising: an inhaler body extending from a mouthpiece end to a distal end, the r body comprising a mouthpiece portion removably coupled to a distal end portion, the mouthpiece portion extending between the mouthpiece end and a first mating end, the distal end portion extending between a second mating end and the distal end, the mouthpiece portion comprising: a capsule cavity defined within the first mating end; 10 a mouthpiece air channel extending from the mouthpiece end to the capsule cavity; the distal end portion comprising: a piercing element coupled to the distal end portion, the piercing element being configured to move between a relaxed position and a piercing 15 position, the piercing element ing through the resealable membrane and into the capsule cavity in the ng position; a resealable membrane sealing the capsule cavity at the first mating end; wherein the resealable ne is ured to reseal when the piercing element moves from the piercing position to the relaxed position where the 20 ng element is spaced apart from the able membrane.

2. The inhaler system according to claim 1, further comprising a receptacle disposed within the capsule cavity, the receptacle being a eable article of the inhaler. 25

3. The inhaler system according to claim 2, wherein the receptacle ns a capsule, the receptacle is sealed with a membrane at a receptacle first end and defines an air outlet at an opposing receptacle second end, the receptacle includes an air inlet. W0 2018l007886 _ 18 _

4. The inhaler system according to any one of claims 2 or 3, wherein the able membrane ts the receptacle.

5. The inhaler system according to claim 4, wherein the resealable membrane ts the receptacle membrane.

6. The inhaler system according to any one of claims 3 to 5, wherein the capsule contains solid particles comprising nicotine

7. The inhaler system according to any one of claims 3 to 6, wherein the inhaler body comprises an air inlet that is in fluid connection with the receptacle air inlet.

8. The inhaler system according to any one of claims 3 to 7, wherein the receptacle air 15 outlet is in fluid connection with the mouthpiece air channel.

9. The inhaler system according to any one of the preceding , wherein the resealable membrane is fixed to the second mating end of the distal end portion. 20

10. The inhaler system ing to any one of the preceding , wherein the resealable ne is a septum element.

11. A method, comprising: placing a receptacle containing a capsule, comprising solid particles comprising nicotine, 25 in the capsule cavity of the inhaler system according to any of the preceding claims; W0 2018l007886 coupling the iece portion to the distal end portion; moving the piercing element to pierce the resealable membrane and the capsule; moving the piercing element to the relaxed position and out of the able ne; flowing air through the inhaler body to remove the solid particles comprising nicotine and 5 forming a depleted capsule, wherein air does not flow through the resealable membrane.

12. The method according to claim 11, further comprising: uncoupling the mouthpiece portion from the distal end portion to expose the receptacle 10 containing the depleted capsule; removing the receptacle containing the depleted capsule from the capsule cavity of the inhaler system.

13. The method according to claim 12, further comprising: 15 placing a new acle containing a capsule, comprising solid les comprising nicotine, in the capsule cavity of the inhaler system; and coupling the mouthpiece portion to the distal end portion.

14. The method according to any one of claims 11 to 13, wherein the placing steps comprise 20 ng the acle air outlet with the mouthpiece air l.

15. The method according to any one of claims 11 to 14, wherein the flowing air step rotates the capsule about its longitudinal axis. WO 07886 7W. . ‘— 3-5;)»: A WO 07886 115 hm (.’hm 112 112 h113 h113 FIG. 6