RU2826109C1 - Inhalation product with open distal end and inhalation system - Google Patents

Abstract

FIELD: smoking accessories.

SUBSTANCE: group of inventions relates to dry powder inhalation. Inhalation article for use in an inhalation system for delivering a dry powder to the lungs of a user of the inhalation system comprises a body extending along the longitudinal axis of the inhalation article from the mouth end to the far upstream end, a cavity for a capsule formed inside the housing and limited downstream by a filter element, and an earlier limited in the flow direction by a tubular element forming a central passage in fluid communication with the capsule cavity, a capsule located in the capsule cavity and containing a dry powder. Central passage forms an air inlet extending along the longitudinal axis of the inhalation article and from the far end of the body to the capsule cavity. Tubular element has an inner diameter of the central passage in range of 70% to 90% of the inner diameter of the cavity for the capsule. Inhalation product is configured to receive the vortex inhaled air flow into the central passage.

EFFECT: efficient delivery of nicotine particles into the lungs at inhalation or airflow rates within the range of inhalation or airflow rates in a normal smoking mode.

14 cl, 7 dwg

Description

The present invention relates to an inhalation article and to an inhalation system that comprises a holder and an inhalation article. The inhalation article comprises an open distal end for receiving a flow of air inhaled into the inhalation article during consumption.

Dry powder inhalers are not always fully capable of delivering dry powder particles to the lungs at inhalation or air flow rates that are within the inhalation or air flow rates of normal smoking. Dry powder inhalers may be difficult to operate or may contain moving parts. Dry powder inhalers are often designed to deliver the entire dose of dry powder or capsule contents in a single inhalation.

Document US 2019/282769 A1 describes an article in the form of an inhaler comprising a housing extending along the longitudinal axis from the end of the mouthpiece to the distal end, and a capsule cavity formed inside the housing. The capsule cavity is characterized by a length extending along the longitudinal axis. An air passage of the mouthpiece extends from the capsule cavity to the end of the mouthpiece. The capsule is located in the capsule cavity and is characterized by the capsule length.

Document US 2011/232637 A1 describes an inhaler for inhaling powdered medicinal products from capsules, wherein the inhaler comprises a holder inserted into the lower part, a mouthpiece which is designed with the possibility of being fixed in the lower part. The holder is designed with the possibility of inserting a replaceable tube as an ejection channel, wherein the replaceable tube includes a capsule chamber containing a capsule.

Document WO 2018/185014 A1 describes a smoking article comprising an aerosol-generating substrate and a mouthpiece attached to a downstream end of the aerosol-generating substrate. The aerosol-generating substrate may comprise a tobacco rod.

Document US 4 889 114 A describes an inhaler for inhaling powdered pharmaceutical compositions from capsules. The inhaler comprises a chamber for accommodating capsules, wherein the chamber has a greater internal width and a greater length than the diameter and length of the capsule, respectively.

Document WO 2018/007886 A1 describes an inhalation system useful for delivering nicotine particles, comprising a mouthpiece portion removably connected to a distal end portion. The mouthpiece portion comprises a capsule cavity and a mouthpiece air passage extending from the end of the mouthpiece to the capsule cavity. The distal end portion comprises a piercing element connected to the distal end portion and a resealing membrane configured to seal the capsule cavity when the mouthpiece portion is connected to the distal end portion. The resealing membrane is configured to reseal when the piercing element exits the resealing membrane.

Document WO 2019/186372 A1 describes an inhalation article comprising a housing that extends along a longitudinal axis from a near mouthpiece end to a far end. The article includes an end member located at the far end. The article has a cavity for a capsule formed inside said housing and extending along the longitudinal axis for the length of the cavity.

It would be desirable to provide an inhalation article that minimizes complex parts and provides high-speed assembly of the inhalation article. It would be desirable to provide an inhalation system that efficiently expels particles from a capsule during consumption. It would be desirable to provide an inhalation article that receives a vortex of inhaled air into the inhalation article. It would be desirable to provide an inhalation article that is substantially biodegradable. It would be desirable to provide an inhalation article that is formed from materials used in the manufacture of traditional cigarettes or smoking articles.

It would be desirable to provide a holder that can activate and hold an inhalation article and transmit a vortex or swirling air flow to the inhalation article during consumption. It would be desirable to provide an inhalation system that includes a compact and reusable holder for an inhalation article that can activate the inhalation article. It would be desirable to provide an inhalation system for nicotine powder that delivers nicotine particles to the lungs at inhalation or air flow rates that are within the inhalation or air flow rates of normal smoking. It would also be desirable to deliver nicotine powder using an inhalation article that is shaped similarly to a conventional cigarette.

The present invention relates to an inhalation article. The inhalation article is designed to receive a vortex or swirled inhaled air flow during consumption. The inhalation article can receive a vortex or swirled inhaled air flow from a holder designed to supply a vortex inhaled air flow to the inhalation article during consumption. The holder and the inhalation article can form an inhalation system, to which the present invention also relates.

According to one aspect of the present invention, the inhalation article comprises a body extending along the longitudinal axis of the inhalation article from the mouthpiece end to the distal end, a cavity for a capsule and a capsule retained in the cavity for a capsule. The cavity for a capsule is formed inside the body and is limited along the flow by a filter element and is limited against the flow by a tubular element defining a central passage communicating via a fluid medium with the cavity for a capsule. The central passage forms an air inlet opening extending along the longitudinal axis of the inhalation article and from the distal end of the body in the direction of the cavity for a capsule. The tubular element has an internal diameter of the central passage in the range from about 50% to about 90% of the internal diameter of the cavity for a capsule. The capsule is located in the cavity for a capsule. The inhalation article is designed with the possibility of receiving a vortex inhaled air flow into the central passage.

An inhalation product that has an open distal end that receives a vortex or swirling inhaled air flow during consumption reduces the complexity of the inhalation product and allows the inhalation product to be assembled at high speed, which is an advantage.

The tubular element extends from a first end defining an upstream boundary of the capsule cavity to a second opposite end defining the distal end of the inhalation product body.

The tubular element may have an internal diameter of the central passage that is smaller than the diameter of the capsule. The tubular element may have an internal diameter of the central passage in the range of from about 70% to about 90% of the internal diameter of the cavity for the capsule.

The tubular element can be formed from a cellulose material. The tubular element can be formed from acetyl cellulose. The tubular element can be formed from a biodegradable resin, such as a starch-based thermoplastic plastic (TPS), polyhydroxyalkanoate (PHA), polylactic acid (PLA), polybutylene succinate (PBS), polycaprolactone (PCL) or hemp-based plastic. Preferably, the tubular element is formed from a biodegradable resin of extrusion grade. Preferably, the tubular element is formed from a material based on polylactic acid.

Tubular elements formed from cellulose material or acetyl cellulose, or polylactic acid-based material are essentially biodegradable and can reduce the environmental impact of the inhalation product, which is an advantage.

A membrane may be attached to the second opposite end of the tubular element. The membrane may contain two or more slits or weakened lines. The membrane may be in the form of a disk. The membrane may be formed from a cellulose material. The membrane may be formed from paper, thick paper or cardboard.

Membranes formed from cellulose material are essentially biodegradable and can reduce the environmental impact of the inhalation product, which is an advantage. The membrane can provide a protective coating or hygienic barrier for the retained capsule and the inhalation product prior to use of the inhalation product.

The wrapping layer may connect the filter element, the capsule cavity and the tubular element, successively axially adjacent to each other. The wrapping layer may be formed from a cellulose material.

The wrapping layer formed from cellulose material is essentially biodegradable and can reduce the environmental impact of the inhalation product, which is an advantage. The connection of the inhalation product elements by the wrapping layer enables high-speed assembly of the inhalation product.

The capsule may contain pharmaceutically active particles. For example, the pharmaceutically active particles may contain nicotine. The pharmaceutically active particles may have a mass median aerodynamic diameter of about 5 micrometers or less, or in the range of about 0.5 micrometers to about 4 micrometers, or in the range of about 1 micrometer to about 3 micrometers.

According to another aspect of the present invention, an inhalation system comprises an inhalation article described in this document and a holder for the inhalation article, wherein the holder is designed to supply a vortex or swirling inhaled air flow to the inhalation article. The holder comprises a casing that forms a casing cavity.

Incorporating a swirl element into a reusable holder can simplify the design of the inhalation product and reduce the complexity of the inhalation system, which is an advantage. Inhalation products that receive a swirl of inhaled air flow can be easier to manufacture and have a simpler design than inhalation products that must create a swirl of inhaled air flow. Simpler inhalation products may also pose less of a burden on the environment.

The holder may comprise a sleeve, which is configured to hold the inhalation article inside the cavity of the casing. The sleeve comprises a sleeve cavity and may be configured to move inside the cavity of the casing along the longitudinal axis of the casing. The sleeve comprises a first open end and a second opposite end. The second opposite end of the sleeve may be configured to pass air entering the cavity of the sleeve. The second opposite end of the sleeve may comprise a tubular element of the sleeve extending into the cavity of the sleeve. The tubular element of the sleeve may be configured to extend into the tubular element of the inhalation article and fix the inhalation article inside the sleeve.

The tubular member of the sleeve may form an upstream boundary of the capsule cavity when the inhalation article is positioned in the cavity of the sleeve.

The holder may further comprise a piercing element attached to the inner surface of the holder casing and extending from it. The piercing element may be configured to extend through the second opposite end of the sleeve into the cavity of the sleeve along the longitudinal axis of the casing and activate the capsule.

The second opposite end of the sleeve may be configured to create a vortex or swirling air flow on the inhaled air flow entering the capsule cavity.

The use of a reusable holder to create a swirling or vortex air flow can improve the uniform formation of a swirling or vortex air flow that is supplied to a plurality of inhalation products, which is an advantage. This swirling or vortex air flow can be supplied to the capsule cavity of the inhalation product placed in the holder sleeve. The swirling or vortex air flow causes the capsule enclosed in the capsule cavity to rotate and release particles into the swirling or vortex air flow that goes to the consumer.

Providing elements at the second opposite end of the sleeve that mate with the inhalation article placed therein can improve the reliable connection along the air flow from the sleeve creating the swirl to the inhalation article placed in the sleeve, which is an advantage. The friction fit can also provide a reliable engagement of the inhalation article placed in the sleeve, such that the inhalation article will not fall out of the sleeve or the corresponding holder.

A reusable holder that creates a swirling or vortex air flow reduces the complexity of the corresponding inhalation disposable product, which is an advantage. This can reduce the overall manufacturing cost of these inhalation systems and can improve the reliability or efficiency of dispensing particles in capsules.

Advantageously, the inhalation system is an inhalation system that minimizes the number of moving parts. The inhalation system uses a separate holder that supplies a swirling or vortex air flow to the inhalation article placed in the holder, which is an advantage. This can provide the ability to reuse the holder and dispose of the inhalation article after a single use. The inhalation system effectively delivers nicotine particles to the lungs at inhalation or air flow rates that are within the inhalation or air flow rates of a normal smoking regimen, which is an advantage. The inhaler delivers nicotine powder using an inhalation article that is shaped like a regular cigarette. The inhalation system described herein can deliver dry powder to the lungs at inhalation or air flow rates that are within the inhalation or air flow rates of a normal smoking regimen. The user may take several inhalations or "puffs," with each "puff" delivering a small amount of dry powder contained in a capsule that is located in the capsule cavity. This inhalation product may be shaped similar to a regular cigarette and may be able to simulate regular smoking. This inhalation product may be simple to manufacture and convenient for the user to use.

Directing the air flow through the capsule cavity of the inhalation product may cause the capsule therein to rotate during inhalation and consumption. The capsule may contain particles containing nicotine (also referred to as "nicotine powder" or "nicotine particles") and, optionally, particles containing a flavoring agent (also referred to as "flavoring particles"). Rotation of the punctured capsule may cause the nicotine particles released from the punctured capsule to be suspended and aerosolized into the inhaled air passing through the inhalation product. The flavoring particles may be larger than the nicotine particles and may facilitate the transport of nicotine particles into the user's lungs, while the flavoring particles preferably remain in the user's oral cavity or cheek cavity. Nicotine particles and, if necessary, flavour particles may be delivered by the inhalation product at inhalation or air flow rates that do not exceed the inhalation or air flow rates in normal smoking mode.

The term "nicotine" refers to nicotine and its derivatives such as free nicotine base, nicotine salts, etc.

The term "flavoring agent" or "flavoring substance" refers to organoleptic compounds, compositions or materials that alter the taste or aroma characteristics of nicotine when it is consumed or inhaled and are intended to do so.

The terms "upstream" and "downstream" refer to the relative positions of the elements of the holder, inhalation device and inhalation systems, described with respect to the direction of the inhaled air flow as it is drawn through the body of the holder, inhalation device and inhalation systems.

The terms "proximal" and "distal" are used to describe the relative positions of components or parts of components of a holder, an inhalation article or a system. The holders or elements (such as a sleeve) that form a holder according to the present invention have a proximal end, which receives the inhalation article during use, and an opposite distal end, which may be a closed end or have an end located closer to the proximal end of the holder. Inhalation articles according to the present invention have a proximal end. During use, nicotine particles exit from the proximal end of the inhalation article for delivery to the user. The inhalation article has a distal end opposite the proximal end. The proximal end of the inhalation article may also be referred to as a mouthpiece end.

The inhalation article can be combined with a holder to form an inhalation system. The holder is designed to supply a vortex or swirling inhaled air flow to the inhalation article. The holder can also activate the inhalation article by puncturing the said capsule, which ensures reliable activation of the capsule (as a result of perforating the capsule with the piercing element of the holder) inside the inhalation article, and release of particles enclosed inside the capsule, and ensuring the possibility of delivering these particles by means of the article to the consumer. The holder is separate from the inhalation article, but the consumer can use both the inhalation article and the holder when consuming particles released inside the inhalation article. A plurality of these inhalation articles can be combined with the holder to form a system or a kit. One holder may be used on 10 or more, or 25 or more, or 50 or more, or 100 or more inhalation products to activate (perforate or pierce) the capsule contained within each inhalation product and provide reliable activation and, if necessary, visual indication (marking) of inhalation product activation for each inhalation product.

The present invention relates to an inhalation article. The inhalation article is designed to receive a vortex or swirled inhaled air flow during consumption. The inhalation article can receive a vortex or swirled inhaled air flow from a holder designed to supply a vortex inhaled air flow to the inhalation article during consumption. The holder and the inhalation article can form an inhalation system, to which the present invention also relates.

The inhalation product comprises a housing extending along the longitudinal axis of the inhalation product from the mouthpiece end to the distal end, a cavity for a capsule and a capsule held in the cavity for a capsule. The cavity for a capsule is formed inside the housing and is limited along the flow by a filter element and is limited against the flow by a tubular element defining a central passage communicating via a fluid medium with the cavity for a capsule. The central passage forms an air inlet opening extending from the distal end of the housing in the direction of the cavity for a capsule. The central passage forms an air inlet opening extending from the distal end of the housing to the cavity for a capsule.

The inhalation article receives a vortex or swirling inhaled air flow at the air inlet. The vortex or swirling inhaled air flow passes through the inhalation article from the far end of the central passage to the capsule cavity to the filter and out of the mouthpiece end of the inhalation article. The flow of the inhaled air flow preferably coincides with the longitudinal axis of the tubular element as it passes through the tubular element.

The inhalation product is designed to receive a vortex inhaled air flow directly into the air inlet opening at the far end of the inhalation product. The vortex inhaled air flow continues along the flow into the capsule cavity and stimulates rotation of the capsule placed or located in the capsule cavity. The activated capsule releases a dose of particles into the vortex inhaled air flow along the flow through the mouthpiece to the consumer. Thus, the vortex inhaled air flow is created against the flow from the inhalation product, and the vortex inhaled air flow enters the far end or the end located earliest along the flow of the inhalation product and passes into the capsule cavity, providing rotation or twisting of the capsule located in the capsule cavity.

The inhaler body may be similar in size or shape to a smoking article or a cigarette. The inhaler body may have an elongated body extending along the longitudinal axis of the inhalation article. The inhaler body may be characterized by a substantially constant external diameter along the length of the elongated body. The inhaler body may have a circular cross-section, which may be constant along the length of the elongated body. The inhaler body may have an external diameter in the range of about 6 mm to about 10 mm, from about 7 mm to about 10 mm, from about 7 mm to about 9 mm, from about 7 mm to about 8 mm, or about 7.2 mm. The inhaler body may have a length (along the longitudinal axis) in the range of about 40 mm to about 80 mm, from about 40 mm to about 70 mm, or from about 40 mm to about 50 mm, or about 45 mm.

The filter element located downstream of the capsule cavity may extend from the capsule cavity to the mouthpiece end of the inhalation article. The filter element may have a length in the range of about 10 mm to about 30 mm, or about 15 mm to about 25 mm, and more preferably about 20 mm to about 22 mm.

The tubular element has an outer surface or diameter that contacts the housing or forms the distal end of the housing of the inhalation article. Inhaled air passes through the center of the tubular element along the central passage of the tubular element. The tubular element may have a diameter substantially equal to the outer diameter of the housing of the inhalation article. The tubular element may have a diameter in the range from about 6 mm to about 9 mm or from about 6 mm to about 8 mm.

The tubular element is coaxial with the longitudinal axis of the inhalation article. The tubular element extends from the first end defining the upstream boundary of the capsule cavity to the second opposite end defining the distal end of the inhalation article body. The tubular element may have the same cross-section from the first end to the second opposite end of the tubular element.

The tubular element may have a thickness in the range from about 0.5 mm to about 1.5 mm or from about 0.5 mm to about 1 mm. Preferably, the thickness of the tubular element is the same from the first end to the second opposite end of the tubular element.

The open tubular member may have a length in the range of from about 3 mm to about 12 mm, or from about 3 mm to about 7 mm, or from about 4 mm to about 6 mm, or about 5 mm.

The tubular element can be formed from a biodegradable material. The tubular element can be formed from a fibrous material. The tubular element can be formed from a cellulose material. The tubular element can be formed from acetyl cellulose. The tubular element can be formed from a biodegradable resin, such as a starch-based thermoplastic plastic (TPS), polyhydroxyalkanoate (PHA), polylactic acid (PLA), polybutylene succinate (PBS), polycaprolactone (PCL) or hemp-based plastic. Preferably, the tubular element is formed from a biodegradable resin of extrusion grade. Preferably, the tubular element is formed from a material based on polylactic acid.

The tubular element may be formed from a cellulose material. The tubular element may be formed from acetyl cellulose. The tubular element may be formed from a polylactic acid-based material.

The tubular element forms a central passage. The central passage is an open empty space. The central passage may form an open empty space (or an open channel) from the first end to the second opposite end of the tubular element. The central passage may provide the possibility of fluid communication from the first end to the second opposite end of the tubular element. The central passage may be free of obstructions.

The central passage is coaxial with the longitudinal axis of the inhalation product. The central passage may have the same cross-section from the first end to the second opposite end of the tubular element. The central passage may have a diameter that is smaller than the diameter of the capsule. Due to this, the capsule may not pass through the central passage and is retained in the capsule cavity.

The tubular element may have an internal diameter of the central passage in the range from about 50% to about 90% of the internal diameter of the capsule cavity. The tubular element may have an internal diameter of the central passage in the range from about 70% to about 90% of the internal diameter of the capsule cavity.

The central passage may have a uniform internal or open diameter in the range of from about 3 mm to about 6.5 mm, or from about 4 mm to about 6 mm, or from about 5 mm to about 6 mm, or about 5.5 mm.

The central passage may have a length in the range of from about 3 mm to about 12 mm, or from about 3 mm to about 7 mm, or from about 4 mm to about 6 mm, or about 5 mm.

A membrane may be attached to the second opposite end of the tubular member. The membrane may be adhered to the second opposite end of the tubular member. The membrane may be adhered to the second opposite end of the tubular member with an adhesive. The membrane may provide a barrier to reduce or prevent contaminants or foreign materials from entering the central passage of the tubular member.

The membrane may be easily ruptured to allow inhaled air to pass into the central passage. The membrane may be ruptured or opened to expose substantially the entire central passage. The membrane may provide a protective covering or hygienic barrier for the retained capsule and the inhalation product prior to use of the inhalation product.

The membrane may be configured to deform between a closed configuration and an open configuration. In the closed configuration, the membrane defines a closed boundary that defines a cavity for the capsule. In the open configuration, the deformable element defines an opening through which air can flow into the cavity for the capsule.

The membrane may be arranged to contact the holder such that the membrane is deformed from a closed configuration to an open configuration upon insertion into the holder. The term "deform" should be understood to mean that the shape of the membrane is changeable. The deformation of the membrane may include elastic deformation, in which the membrane returns to a closed configuration when no force is applied to it. In an alternative embodiment, the deformation of the membrane may include plastic deformation, in which the membrane is held in an open configuration after a force is applied.

The membrane may comprise two or more slits or weakened lines. Two or more slits or weakened lines may intersect each other. Two or more slits or weakened lines may intersect the longitudinal axis of the tubular element. The membrane may comprise a hinge element or a plurality of hinge elements that move about a pivot axis so that the membrane can move between open and closed configurations.

The membrane can be made in the form of a disk. The membrane can be formed from a biodegradable material. The membrane can be formed from a cellulose material. The membrane can be formed from paper, thick paper or cardboard.

The wrapping layer may connect the filter element, the capsule cavity and the tubular element, successively axially adjacent to each other. The wrapping layer may be formed from a cellulose material.

The capsule cavity can form a cylindrical space configured to accommodate a capsule (which can have a rectangular shape with rounded corners or, for example, a circular cross-section). The capsule cavity can be characterized by a substantially constant or constant diameter along the length of the capsule cavity. The capsule cavity can have a fixed cavity length. The capsule cavity has an internal cavity diameter perpendicular to the longitudinal axis, and the capsule has an external capsule diameter. The capsule cavity can be sized to accommodate a capsule in the shape of a cylinder with hemispherical ends. The capsule cavity can have a substantially cylindrical or cylindrical cross-section along the length of the capsule cavity. The capsule cavity can have a constant internal diameter. The capsule can have an external diameter that is from about 80% to about 95% of the internal diameter of the capsule cavity. The configuration of the capsule cavity relative to the capsule may facilitate limited capsule movement during capsule activation or puncturing.

The cavity for the capsule may be formed by a tubular element of the inhalation article. This tubular element may be connected between and in adjacent alignment with the tubular element forming the distal end of the inhalation article and the filter element. These elements may be connected by a wrapper. The open tubular element forming the cavity for the capsule may be formed from a biodegradable material such as thick paper or cardboard.

The configuration of the capsule cavity relative to the capsule can promote stable rotation of the capsule in the capsule cavity. The longitudinal axis of the capsule can stably rotate coaxially with the longitudinal axis of the inhaler body during inhalation. The configuration of the capsule cavity relative to the capsule can promote rotation of the capsule with some shaking in the capsule cavity.

Stable rotation refers to the longitudinal axis of the inhaler body being substantially parallel to or coaxial with the axis of rotation of the capsule. Stable rotation may refer to the absence of precession of the rotating capsule. Preferably, the longitudinal axis of the inhaler body may substantially coincide with the axis of rotation of the capsule. Stable rotation of the capsule may ensure uniform entrainment of a portion of the nicotine particles from the capsule over two or more, five or more, or ten or more "puffs" or inhalations of the user.

Before use, the capsule in the inhalation product may be sealed. The inhalation product may be enclosed within a sealed or airtight container or bag. The inhalation product may comprise a membrane (covering the second opposite end of the tubular element) and one or more layers of peelable or removable seal on the air outlet or mouthpiece of the inhalation product.

The capsule is capable of rotating around its longitudinal or central axis when air flows through the inhalation product. The capsule may be made of an airtight material that can be punctured or pierced by a piercing element, which may be made separately or combined with the inhaler. The capsule may be made of a metal or polymer material that serves to prevent contaminants from entering the capsule, but may be punctured or pierced by a piercing element before consuming nicotine particles in the capsule. The capsule may be made of a polymer material. The polymer material may be hydroxypropyl methylcellulose (HPMC). The capsule may be a capsule of size 1 to 4 or a capsule of size 3.

The capsule may contain pharmaceutically active particles. For example, the pharmaceutically active particles may contain nicotine. The pharmaceutically active particles may have a mass median aerodynamic diameter of about 5 micrometers or less, or in the range of about 0.5 micrometers to about 4 micrometers, or in the range of about 1 micrometer to about 3 micrometers.

The capsule may comprise nicotine particles containing nicotine (also referred to as "nicotine powder" or "nicotine particles") and, optionally, particles containing a flavoring substance (also referred to as "flavoring particles"). The said capsule may comprise a predetermined number of nicotine particles and, optionally, flavoring particles. The capsule may comprise a sufficient number of nicotine particles to provide at least 2 inhalations or "puffs", at least about 5 inhalations or "puffs", or at least about 10 inhalations or "puffs". The capsule may comprise a sufficient number of nicotine particles to provide from about 5 to about 50 inhalations or "puffs", or from about 10 to about 30 inhalations or "puffs". Each inhalation, or "puff," can deliver from about 0.1 mg to about 3 mg of nicotine particles to the user's lungs, or from about 0.2 mg to about 2 mg of nicotine particles to the user's lungs, or about 1 mg of nicotine particles to the user's lungs.

The nicotine particles may have any suitable concentration of nicotine, determined by the particular formulation used. The nicotine particles may contain at least about 1% by weight of nicotine to about 30% by weight of nicotine, about 2% by weight to about 25% by weight of nicotine, about 3% by weight to about 20% by weight of nicotine, about 4% by weight to about 15% by weight of nicotine, or about 5% by weight to about 13% by weight of nicotine. Preferably, each inhalation or "puff" may deliver from about 50 to about 150 micrograms of nicotine to the user's lungs.

The capsule may hold or contain at least about 5 mg of nicotine particles or at least about 10 mg of nicotine particles. The capsule may hold or contain less than about 900 mg of nicotine particles, 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 particles or from about 10 mg to about 200 mg of nicotine particles.

If the flavor particles are mixed or combined in a capsule with nicotine particles, the flavor particles may be present in an amount that ensures that the desired flavor is delivered to the user with each inhalation or "puff."

The nicotine particles may have any suitable size distribution for inhalation delivery primarily to the user's lungs. The capsule may contain particles other than nicotine particles. The nicotine particles and other particles may form a powder system.

The capsule may hold or contain at least about 5 mg of dry powder (also referred to as a powder system) or at least about 10 mg of dry powder. The capsule may hold or contain less than about 900 mg of dry powder, less than about 300 mg of dry powder, or less than about 150 mg of dry powder. The capsule may hold or contain from about 5 mg to about 300 mg of dry powder, from about 10 mg to about 200 mg of dry powder, or from about 25 mg to about 100 mg of dry powder.

Said dry powder or powder system may have at least about 40 wt.%, at least about 60 wt.%, or at least about 80 wt.% of the powder system contained in the form of nicotine particles having a particle size of about 5 micrometers or less or in the range from about 1 micrometer to about 5 micrometers.

The nicotine-containing particles may have a mass median aerodynamic diameter of about 5 micrometers or less, in the range of about 0.5 micrometers to about 4 micrometers, in the range of about 1 micrometer to about 3 micrometers, or in the range of about 1.5 micrometers to about 2.5 micrometers. The mass median aerodynamic diameter is preferably measured by a cascade impactor.

The particles containing the flavoring substance may have a mass median aerodynamic diameter of about 20 micrometers or more, about 50 micrometers or more, in the range of about 50 to about 200 micrometers, or from about 50 to about 150 micrometers. The mass median aerodynamic diameter is preferably measured by a cascade impactor.

The dry powder may have an average diameter of about 60 micrometers or less, in the range of about 1 micrometer to about 40 micrometers, or in the range of about 1.5 micrometers to about 25 micrometers. The average diameter refers to the average diameter per unit mass, and is preferably measured using laser diffraction, laser diffusion, or an electron microscope.

Nicotine in the form of a powder system or nicotine particles may be a pharmaceutically acceptable nicotine free base, a nicotine salt or a nicotine salt hydrate. Suitable nicotine salts or nicotine salt hydrates include, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine monopyruvate, nicotine glutamate or nicotine hydrochloride. The compound combined with nicotine to form a salt or salt hydrate may be selected based on its expected pharmacological effect.

The nicotine particles preferably comprise an amino acid. Preferably, the amino acid may be leucine, such as L-leucine. By providing an amino acid, such as L-leucine, together with the nicotine-containing particles, it is possible to reduce the adhesive forces of the nicotine-containing particles and to reduce the attraction between the nicotine particles, and thus reduce the agglomeration of the nicotine particles. Similarly, it is also possible to reduce the adhesive forces to the flavor-containing particles, and thus reduce the agglomeration of the nicotine particles with the flavor particles. In this way, it is possible that the powder system described in this document will be a free-flowing material and have a stable relative particle size of each component of the powder even when mixing nicotine particles and flavor particles.

Preferably, the nicotine may be a surface modified nicotine salt, wherein the nicotine salt particles are coated particles or composite particles. A preferred coating material or composite material may be L-leucine. One particularly useful nicotine particle may be nicotine bitartrate with L-leucine.

The powder system may contain a plurality of flavor particles. The flavor particles may have any suitable size distribution for inhalation delivery selectively to the oral or buccal cavity of the user.

The powder system may contain at least about 40 wt. %, at least about 60 wt. %, or at least about 80 wt. % of a plurality of aromatic particles of the powder system contained in the form of particles having a particle size of about 20 micrometers or more. The powder system may contain at least about 40 wt. %, at least about 60 wt. %, or at least about 80 wt. % of a plurality of aromatic particles of the powder system contained in the form of particles having a particle size of about 50 micrometers or more. The powder system may contain at least about 40 wt. %, or at least about 60 wt. %, or at least about 80 wt. % of a plurality of flavor particles of the powder system contained in the form of particles having a particle size in the range from about 50 micrometers to about 150 micrometers.

The flavour-containing particles may comprise a compound for reducing the adhesive forces or surface energy and the resulting agglomeration. The surface of the flavour particles may be modified by a compound for reducing adhesion to form coated flavour particles. One preferred adhesion-reducing compound is magnesium stearate. By providing a compound for reducing adhesion, such as magnesium stearate, together with the flavour particles, in particular in the form of a coating of the flavour particles, it is possible to reduce the adhesive forces of the flavour-containing particles and to reduce the attraction between the flavour particles, and thus reduce the agglomeration of the flavour particles. In this way, it is also possible to reduce the agglomeration of the flavour particles with the nicotine particles. In this way, it is possible that the powder system described herein will have a stable relative size of the nicotine-containing particles and the flavour-containing particles, even when the nicotine particles and the flavour particles are mixed. The powder system may preferably be free flowing.

Conventional dry powder inhalation formulations contain carrier particles that serve to enhance fluidization of the active particles, since these active particles may be too small to be affected by the air flow through the inhaler alone. The powder system may contain carrier particles. These carrier particles may be a saccharide, such as lactose or mannitol, that has a particle size greater than about 50 micrometers. Carrier particles may be used to improve dose uniformity by acting as a diluent or bulking agent in the formulation.

The powder system used with the nicotine powder delivery system described herein may be carrier-free or substantially free of a saccharide such as lactose or mannitol. The absence of carriers or the substantial absence of a saccharide such as lactose or mannitol may allow nicotine to be inhaled and delivered to the user's lungs at inhalation rates or airflow rates that are close to the inhalation rates or airflow rates of a typical smoking regimen.

The nicotine particles and the flavoring substance may be mixed in one capsule. As described above, both the nicotine particles and the flavoring substance may have reduced adhesive forces, resulting in a stable particle composition in which the particle size of each component does not change significantly upon mixing. In an alternative embodiment, the powder system comprises nicotine particles enclosed within a first capsule and flavoring particles enclosed within a second capsule.

The nicotine particles and the flavor particles may be mixed in any suitable relative amount so that the flavor particles are perceived by the user when consuming the nicotine particles. Preferably, the nicotine particles and the flavor particles constitute at least about 90 wt.%, at least about 95 wt.%, at least about 99 wt.%, or 100 wt.% of the total weight of the powder system.

The said inhaler and inhalation system may be less complex and have a simplified air flow path compared to conventional dry powder inhalers. The rotation of the capsule inside the inhaler body provides the advantage of aerosolizing the nicotine particles or powder system and the ability to help maintain the free-flowing state of the powder. Thus, it is possible that the inhalation product will not require the increased inhalation rates typically used in conventional inhalers to deliver the above-described nicotine particles deep into the lungs.

The inhalation product may use a flow rate of less than about 5 L/min, less than about 3 L/min, less than about 2 L/min, or about 1.6 L/min. Preferably, the flow rate may be in the range of about 1 L/min to about 3 L/min or about 1.5 L/min to about 2.5 L/min. Preferably, the inhalation rate or flow rate may be close to the smoking mode value set by Health Canada, which is about 1.6 L/min.

The inhalation system comprises an inhalation article described in this document and a holder for the inhalation article, wherein the holder is designed with the possibility of supplying a vortex or swirling inhaled air flow to the inhalation article.

The holder may comprise a sleeve, which is configured to hold the inhalation article inside the cavity of the casing. The sleeve comprises a sleeve cavity and may be configured to move inside the cavity of the casing along the longitudinal axis of the casing. The sleeve comprises a first open end and a second opposite end. The second opposite end of the sleeve may be configured to pass air entering the cavity of the sleeve. The second opposite end of the sleeve may comprise a tubular element of the sleeve extending into the cavity of the sleeve. The tubular element of the sleeve may be configured to extend into the tubular element of the inhalation article and fix the inhalation article inside the sleeve.

The holder may further comprise a piercing element attached to the inner surface of the casing and extending from it. The piercing element may be configured to extend through the second opposite end of the sleeve into the cavity of the sleeve along the longitudinal axis of the casing and activate the capsule.

The second opposite end of the sleeve may be configured to create a vortex or swirling air flow on the inhaled air flow entering the capsule cavity.

The method includes inserting an inhalation product into a sleeve of a holder for an inhalation product. The inhalation product comprises a body, wherein the body extends along the longitudinal axis of the inhaler from the mouthpiece end to the distal end, the length of the body and a capsule placed inside the body of the inhalation product. Then moving the inhalation product and the sleeve in the direction of the piercing element until the piercing element pierces the capsule. Then drawing air into the second opposite end of the sleeve of the holder to form a vortex inhaled air flow. This vortex inhaled air flow is then transferred to the inhalation product, when the inhalation product is located inside the holder for the inhalation product. Then the used inhalation product can be removed from the holder and discarded. Then a new inhalation product can be inserted into the holder and the method can be repeated.

The inhalation product is designed to receive a vortex inhaled air flow directly into the distal end of the inhalation product. The vortex inhaled air flow then passes further along the flow path into the cavity for the capsule and stimulates the rotation of the capsule placed in the cavity for the capsule. The activated capsule then releases a dose of particles into the vortex inhaled air flow along the flow path through the mouthpiece to the consumer. The distal end or the end located earliest along the flow path of the inhalation product contains an open opening that forms an open central passage of the open tubular element. Thus, the vortex inhaled air flow is created against the flow from the inhalation product, and the vortex inhaled air flow enters the distal end or the end located earliest along the flow path of the inhalation product.

The holder for the inhalation product comprises a casing comprising a casing cavity for receiving the inhalation product and a sleeve configured to hold the inhalation product inside the casing cavity. The sleeve comprises a sleeve cavity configured to move inside the casing cavity along the longitudinal axis of the casing. The sleeve comprises a first open end and a second opposite end. The second opposite end of the sleeve is configured to pass air entering the sleeve cavity. The second opposite end of the sleeve is configured to create a swirl of air entering the sleeve cavity.

The second opposite end of the sleeve defines a vortex element, which is designed to create a vortex or swirling inhaled air flow. This vortex or swirling inhaled air flow can be transmitted to the inhalation product for rotating the capsule and releasing the dry powder contained in the capsule.

The second opposite end of the bushing comprises a tubular element of the bushing having a central passage communicating through a fluid medium with the cavity of the bushing. The second opposite end of the bushing has at least one air inlet allowing air to enter the central passage. The said at least one air inlet extends in a direction that is tangential with respect to the central passage. The second opposite end of the bushing may have at least two air inlets allowing air to enter the central passage. The said at least two air inlets extend in a direction that is tangential with respect to the central passage. The second opposite end of the bushing may have at least three air inlets allowing air to enter the central passage. The said at least three air inlets extend in a direction that is tangential with respect to the central passage. The second opposite end of the bushing may have four air inlets allowing air to enter the central passage. The four air inlets indicated extend in a direction that is tangential to the central passage.

The tubular element of the bushing may be coaxial with the longitudinal axis of the casing. The tubular element of the bushing may be coaxial with the cavity of the bushing. The tubular element of the bushing may be coaxial with both the longitudinal axis of the casing and the cavity of the bushing.

The tubular element of the bushing having a central passage may have a diameter in the range from about 30% to about 70% of the diameter of the bushing cavity. The tubular element of the bushing having a central passage may have a diameter in the range from about 40% to about 60% of the diameter of the bushing cavity.

The tubular element of the sleeve, having a central passage, can pass into the cavity of the sleeve and form an annular recess with the cavity of the sleeve, made with the possibility of receiving the distal end of the inhalation product. The tubular element of the sleeve, having a central passage, can pass into the cavity of the sleeve and form an annular recess with the cavity of the sleeve, made with the possibility of holding the distal end of the inhalation product.

The tubular element of the sleeve, having a central passage, can pass into the distal end of the inhalation article placed in the cavity of the sleeve. The annular recess can be designed with the possibility of holding the distal end of the inhalation article by means of a friction fit.

The tubular element of the sleeve, having a central passage, can pass into the tubular element of the inhalation product, placed in the cavity of the sleeve. The tubular element of the sleeve, having a central passage, can pass into the far end of the central passage of the inhalation product, placed in the cavity of the sleeve.

The tubular element of the sleeve, having a central passage, can destroy, penetrate into or open the membrane seal or the element closing the central passage of the tubular element of the inhalation article. Parts of the destroyed membrane can be displaced onto the surface forming the central passage of the tubular element of the inhalation article. Preferably, the tubular element of the sleeve, having a central passage, opens the entire diameter of the central passage of the tubular element of the inhalation article after insertion into the central passage of the tubular element of the inhalation article.

At least a part of the tubular element of the sleeve, having a central passage, is located against the flow from the inhalation article placed in the sleeve. The tubular element of the sleeve, having a central passage, is preferably coaxial with the longitudinal axis of the inhalation article placed therein.

The tubular element of the sleeve, having a central passage, can have a size suitable for coupling with the tubular element of the distal end of the inhalation article, forming the central passage. The tubular element of the sleeve, having a central passage, can adjoin the tubular element of the distal end of the inhalation article, forming the central passage. The tubular element of the sleeve, having a central passage, can mutually engage with the tubular element of the distal end of the inhalation article, forming the central passage. The tubular element of the sleeve, having a central passage, can be received in the tubular element of the distal end of the inhalation article, forming the central passage. The central passage of the tubular element of the sleeve can have an internal diameter in the range from about 3 mm to about 5 mm or about 4 mm.

The tubular element of the sleeve, having a central passage, may contain at least one air inlet, which passes in a direction, which is tangential with respect to the central passage. The tubular element of the sleeve may contain at least two air inlets, which pass in a direction, tangential with respect to the central passage. The tubular element of the sleeve may contain at least three air inlets, which pass in a direction, tangential with respect to the central passage.

One or more air inlets may extend through the side wall forming the opposite second end of the bushing. One or more air inlets may extend in a direction perpendicular to the longitudinal axis of the bushing or casing. One or more air inlets may extend in a direction perpendicular to the longitudinal axis of the tubular element of the bushing having a central passage.

The tubular element of the bushing having a central passage may comprise one air inlet which extends in a direction which is tangential to the central passage. The tubular element of the bushing having a central passage may comprise two air inlets which extend in a direction which is tangential to the central passage. The tubular element of the bushing having a central passage may comprise three air inlets which extend in a direction which is tangential to the central passage. The tubular element of the bushing having a central passage may comprise four air inlets which extend in a direction which is tangential to the central passage.

Preferably, at least one air inlet enters the central passage of the tubular element of the sleeve along the inner diameter of the tubular element of the sleeve, forming the inner diameter or periphery of the central passage. Preferably, at least two air inlets enter the central passage along the inner diameter of the tubular element of the sleeve, forming the inner diameter or periphery of the central passage. Preferably, at least three air inlets enter the central passage along the inner diameter of the tubular element of the sleeve, forming the inner diameter or periphery of the central passage. Preferably, four air inlets enter the central passage along the inner diameter of the tubular element of the sleeve, forming the inner diameter or periphery of the central passage.

Two or more air inlets are preferably located at equal distances from each other around the circumference of the central passage of the tubular element of the sleeve.

At least one air inlet, which passes in a direction tangential to the central passage of the tubular element of the bushing, enters the central passage near the end surface defining the distal end of the bushing. The end surface forms a substantially closed end surface, which allows only the piercing element to pass through the end surface. The end surface passes perpendicular to the longitudinal axis of the bushing. The end surface prevents the inhaled air from flowing out through the distal end of the bushing. The end surface directs the inhaled air into the cavity of the bushing.

Preferably, at least one air inlet, which passes in a direction that is tangential to the central passage of the tubular element of the sleeve, enters the tubular element of the sleeve having a central passage on the end surface. Improved consumption of the capsule occurs when the tangential air inlets are located closer to the end surface of the central passage.

The tubular element of the sleeve may be a single structure with the sleeve (i.e. be made in one piece), designed to hold the inhalation article in the cavity of the casing. The tubular element of the sleeve may form part of the second opposite end of the sleeve. The tubular element of the sleeve and the sleeve may be formed using an injection molding process. The tubular element of the sleeve and the sleeve may be formed simultaneously with the injection molding process.

A tubular element of the bushing having a central passage may extend or project into the cavity of the bushing. This tubular element of the bushing having a central passage may have an outer surface having an outer diameter that faces the inner surface of the bushing. The inner surface of the bushing forms the cavity of the bushing.

The tubular element of the sleeve having a central passage can extend into the cavity of the sleeve for a distance in the range from about 2 mm to about 10 mm, or from about 3 mm to about 7 mm, or from about 4 mm to about 6 mm, or about 5 mm. In these and other embodiments, the tubular element of the sleeve having a central passage can have an outer diameter in the range from about 4 mm to about 6.5 mm, or from about 5 mm to about 6 mm, or from about 5 mm to about 5.5 mm, or preferably about 5.25 mm. At least a portion of the tubular element of the sleeve having a central passage can be inserted into the received inhalation article. Preferably, at least 50% of the tubular element of the sleeve having a central passage can be inserted into the received inhalation article.

The tubular element of the sleeve, having a central passage extending into the cavity of the sleeve, can form an annular recess with the cavity of the sleeve, made with the possibility of receiving the distal end of the inhalation article. The tubular element of the sleeve, having a central passage extending into the cavity of the sleeve, can form an annular projection with the cavity of the sleeve, made with the possibility of its reception by the distal end of the inhalation article. The tubular element of the sleeve, having a central passage extending into the cavity of the sleeve, can form both an annular recess and an annular projection in the cavity of the sleeve, made with the possibility of receiving the distal end of the inhalation article.

The distal end of the inhalation article can be made with the possibility of coupling with an annular recess formed by a tubular element of the sleeve having a central passage extending into the cavity of the sleeve. The distal end of the inhalation article can be made with the possibility of coupling with an annular projection formed by a tubular element of the sleeve having a central passage extending into the cavity of the sleeve. The distal end of the inhalation article can be made with the possibility of coupling with an annular recess and an annular projection formed by a tubular element of the sleeve having a central passage extending into the cavity of the sleeve. The tubular element of the sleeve having a central passage can be made with the possibility of extending into the distal end of the inhalation article located in the cavity of the sleeve.

An annular projection formed by a tubular element of the sleeve having a central passage extending into the cavity of the sleeve can be accommodated or pushed into the tubular element of the distal end of the placed inhalation article. An annular projection formed by a tubular element of the sleeve having a central passage extending into the cavity of the sleeve can be accommodated in the tubular element of the distal end of the inhalation article. An annular projection formed by a tubular element of the sleeve having a central passage extending into the cavity of the sleeve can create a friction fit inside the tubular element of the distal end of the inhalation article. Accordingly, the central passage of the tubular element of the sleeve having a central passage can be accommodated in the tubular element of the distal end of the inhalation article having a central passage.

The holder for the inhalation article may comprise a piercing element designed to pierce or activate the capsule in the inhalation article. The piercing element may be attached to the inner surface of the casing and extend from it. The piercing element may be designed to extend through the second end surface of the second opposite surface of the sleeve and into the cavity of the sleeve along the longitudinal axis of the casing.

The piercing element may pass through an opening in the end surface of the bushing. The piercing element may pass through a resealable element in the end surface of the bushing. The resealable element may form an airtight seal or barrier on the end surface of the bushing when the piercing element is not located inside the resealable element. The piercing element may pass through an opening in the end surface of the bushing and substantially block the air flow through the opening.

The piercing element may extend through the end surface and perforate the capsule inside the capsule cavity. The resealable element, if present on the piercing opening, may be resealed after the piercing element is removed or ejected from the resealable element. The resealable elements or membranes may comprise a partition or an element similar to a partition. The resealable elements or membranes may be made of an elastic material such as rubber, silicone, metal foil with a polymer layer or latex, etc., or acetyl cellulose fiber, such as high-density acetyl cellulose fiber.

The piercing element may be attached to the inner surface of the casing and extend from it into the cavity of the casing along the longitudinal axis of the piercing element for the length of the piercing element. The piercing element may be recessed relative to the open near end of the casing for the recess distance.

The distal end or the end located most downstream of the inhalation article may contact the second opposite end of the sleeve and cause the sleeve to move in the direction of the piercing element. The sleeve may be coaxial with the piercing element. The sleeve may align the inhalation article so that the piercing element reliably activates the capsule inside the inhalation article. The sleeve or holder may also mechanically retain the piercing element and support the piercing element to prevent or reduce displacement of the piercing element.

The sleeve may form a first air inlet zone comprising at least one air opening passing through the sleeve. The first air inlet zone may comprise two or more, three or more, four or more, or from approximately 1 to approximately 10 air openings, or from approximately 3 to approximately 9 air openings. The first air inlet zone is located near the first open end of the sleeve. The first air inlet zone is designed in such a way that it allows air flow to flow into the air flow channel formed between the sleeve and the casing.

The sleeve may comprise a second air inlet zone downstream of the first air inlet zone. The second air inlet zone comprises a second opposite end of the sleeve, designed to pass air entering the sleeve cavity. The second air inlet zone may comprise one, two or more, three or more, or four or more air openings directing the inlet or inhaled air into the second opposite end of the sleeve tangentially to the central passage of the sleeve tubular element to form a vortex inhaled air flow.

The holder may comprise a retaining ring element attached to the open proximal end of the casing. The retaining ring element retains the sleeve within the cavity for the inhalation product. The retaining ring has a thickness sufficient to stop or retain the movement of the sleeve within the cavity for the inhalation product of the holder.

The holder may comprise a spring element configured to bias the sleeve between a relaxed (or undeformed) state and a compressed (or deformed) state in the direction of the open proximal end of the casing or away from the piercing element. The spring element may be enclosed within the cavity of the holder casing, and it may be compressed as the movable sleeve and the inhalation article move in the direction of the piercing element. The spring element may be located between the sleeve and the closed end of the casing and be in contact with the sleeve and the closed end of the casing. The spring element may be located around the piercing element. The spring element may be coaxial with the piercing element. The spring element may be a conical spring.

The spring element may be attached to the distal or closed end of the holder. The spring element may be attached to the second opposite end of the sleeve. The spring element may be attached to both the distal end of the holder and the second opposite end of the sleeve. The spring element may be a conical spring. A conical spring may provide such a compact design that it can provide a more flexible design and a smaller overall compression thickness, which is an advantage. Providing a conical spring may also reduce the likelihood that the spring will bend when compressed compared to a coil spring, which is an advantage.

The spring element biases the inhalation article from the piercing element when the piercing element activates the inhalation article. The spring element may be located around the piercing element. The spring element may be coaxial with the piercing element. The piercing element may extend beyond the spring element when the spring element is in a relaxed position. The piercing element may extend beyond the spring element when the spring element is in a compressed position. The piercing element may extend beyond the spring element when the spring element is both in a relaxed position and in a compressed position. The piercing element may extend beyond the spring element when the sleeve compresses the spring element.

The sleeve may comprise an elongated slot extending along the longitudinal length of the sleeve. If the sleeve comprises an elongated slot, the casing may further comprise a mounting pin extending from the inner surface of the casing cavity. The mounting pin may be configured to mate with the elongated slot. The elongated slot and the mounting pin provide a reliable path of movement between the relaxed and compressed positions, which is an advantage.

The holder may contain a marking element that extends into the cavity for the inhalation product. The marking element may be designed to mark the surface of the inhalation product. The marking element may extend perpendicular to the longitudinal axis of the holder or the inhalation product. The marking element may be designed to mechanically mark the outer surface of the inhalation product. For example, the marking element may be designed to scratch, incise, scrape, notch, bend, or fold the outer surface of the inhalation product. The marking element may have a sharp end designed to scratch the outer surface of the inhaler when placed in the cavity for the inhalation product. The marking element may apply color to the outer surface of the inhaler when placed in the cavity for the inhalation product. The marking element may mark the outer surface of the inhaler when the piercing element penetrates the capsule located inside the inhalation product. This shows that the inhalation product has been activated and can be consumed by the user. This can also prevent the user from attempting to reuse an inhalation product that has already been activated previously, which is an advantage.

The marking element may extend perpendicular to the longitudinal axis of the holder or the inhalation article. The marking element may be made of a rigid material designed to provide a visual indication that the marking element has contacted the outer surface of the inhaler. The marking element may be attached to the casing of the holder. The marking element may form a mounting pin, as described above.

The marking element can pass through at least a part of the thickness of the holder. The marking element can pass through the sleeve. The marking element can pass into the cavity for the inhalation article and into the sleeve. The marking element can extend beyond at least the sleeve by a marking distance, so that the marking element is in contact with the outer surface of the inhaler when the inhalation article is placed inside the cavity for the inhalation article. The marking element can be aligned with and coupled with the oblong slot of the sleeve.

The piercing element may be recessed relative to the open proximal end by any suitable recess distance. For example, the piercing element may be recessed relative to the open proximal end by a recess distance of at least about 10%, at least about 20%, at least about 25%, or at least about 30%, or at least about 35%, or at least about 40% of the length of the casing. The piercing element may be recessed relative to the open proximal end by a recess distance in the range from about 5% to about 50%, or from about 10% to about 40%, or from about 15% to about 40%, or from about 20% to about 40% of the length of the casing.

The length of the piercing element may be any suitable length relative to the length of the casing. For example, the length of the piercing element may be from about 25% to about 60% or from about 30% to about 50% of the length of the casing. The distal end of the piercing element may be attached to the distal end adjacent to the distal end of the casing or on it. The piercing element may coincide with the length of the casing along its entire length.

The piercing element is made of a rigid material. The rigid material is sufficiently rigid to pierce, puncture or activate the capsule contained in the inhalation product. The piercing element may be made of metal. The piercing element may be made, for example, of stainless steel, such as 316 stainless steel. The piercing element may be made of a polymer material. The piercing element may be formed of a fiber-reinforced polymer material.

The housing may be made of any rigid material. The housing may be made of a polymeric material. Polymeric materials suitable for the housing include polycarbonate, polypropylene, polyethylene, nylon, acrylonitrile butadiene styrene, styrene acrylonitrile, polyacrylate, polystyrene, PBT polyester, PET polyester, polyoxymethylene, polysulfone, polyethersulfone, polyetheretherketone, or liquid crystal polymer.

The inhalation product can be placed in the holder in such a way that the outer surface of the inhalation product and the outer surface of the holder casing are concentric. The longitudinal axis of the piercing element can be coaxial with the longitudinal axis of the casing and the longitudinal axis of the inhaler when the inhalation product is placed inside the holder. At least approximately 50% or at least approximately 75% of the casing length can coincide with the length of the inhaler when the inhalation product is placed inside the holder.

The holder may be formed by insert molding methods. The piercing element, for example, may first be formed by molding, and then the casing may be molded around the piercing element with a bond with the piercing element. The piercing element may be a metal piercing element, wherein the casing may be molded around the metal piercing element with a fixed attachment of the metal piercing element to the casing. The metal piercing element may contain projections or recesses at the distal end of the piercing element to increase the surface area of the distal end of the piercing element and improve the fixed anchoring in the molded material of the casing.

The inhalation system may be used by the consumer in a manner similar to smoking a conventional cigarette or vaping an electronic cigarette. Such smoking or vaping may be characterized by two stages: a first stage in which a small volume containing the entire amount of nicotine required by the consumer is drawn into the oral cavity, followed by a second stage in which this small volume containing an aerosol containing the required amount of nicotine is further diluted with fresh air and drawn deeper into the lungs. Both stages are controlled by the consumer. During the first stage of inhalation, the consumer can determine the amount of nicotine to be inhaled. During the second stage, the consumer can determine the volume to dilute the first volume to be drawn deeper into the lungs, maximizing the concentration of the active agent delivered to the surface of the respiratory tract epithelium. This smoking mechanism is sometimes called "puff-inhale-exhale".

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

As used herein, the singular forms "a", "an", and "the" include embodiments with plural references unless the content clearly dictates otherwise.

In this document, the conjunction "or" is generally used in its meaning, including "and/or", unless the content clearly indicates otherwise. 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, the expressions "have," "having," "include," "including," "contain," "containing," or the like are used in their broad sense and generally mean "including without limitation." It should be understood that the expressions "consisting essentially of," "consisting of," etc., refer to the category of "containing," etc.

The words "preferred" and "preferably" refer to those embodiments of the present invention that are capable of providing certain advantages under certain conditions. However, other embodiments may also be preferred under the same or other conditions. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are not applicable, and is not intended to exclude other embodiments from the scope of the present invention, including the claims.

The invention will now be further described with reference to the figures, in which:

Fig. 1 is a schematic cross-sectional view of an illustrative inhalation article;

Fig. 2 is a schematic frontal view of an illustrative membrane;

Fig. 3 is a top view of an illustrative inhalation system;

Fig. 4 is a schematic cross-sectional view of the illustrative inhalation system of Fig. 3;

Fig. 5 is a schematic cross-sectional view of an illustrative bushing;

Fig. 6 is a schematic cross-sectional view of another illustrative bushing; and

Fig. 7 is a schematic cross-sectional view of the illustrative inhalation article of Fig. 1 housed in the sleeve shown in Fig. 6.

These schematic drawings are not necessarily to scale and are provided for purposes of illustration and not limitation. The drawings depict one or more aspects described in the present invention. However, it should be understood that other aspects not depicted in the drawings are within the scope and spirit of the present invention.

Fig. 1 is a schematic cross-sectional view of an exemplary inhalation article 150. The inhalation article 150 comprises a body 151 extending along the longitudinal axis of the inhalation article from a mouthpiece end 154 to a distal end 156, a capsule cavity 155, and a capsule 160 retained in the capsule cavity 155. The capsule cavity 155 is formed within the body 151 and is defined downstream by a filter element 157 and is defined upstream by a tubular element 153 defining a central passage 152 in fluid communication with the capsule cavity 155. The central passage 152 defines an air inlet extending from the distal end 156 of the body 151 to the capsule cavity 155.

The tubular element 153 extends from a first end 148 defining a counter-current boundary of the cavity 155 for the capsule to a second opposite end 149 defining a distal end 156 of the body 151 of the inhalation article.

In one embodiment, the tubular element 153 is formed from cellulose acetate and may be referred to as a hollow element made of cellulose acetate. The tubular element 153 has an outer diameter of approximately 7 mm and an inner diameter of approximately 5.3 mm to approximately 5.5 mm, so that the central passage has a diameter of approximately 5.3 mm to approximately 5.5 mm. The tubular element 153 has a thickness of approximately 0.5 mm to approximately 1 mm. The cavity 155 for the capsule has a length of approximately 18 mm to approximately 20 mm and a diameter of the outer diameter of approximately 7 mm and an inner diameter of approximately 6 mm to approximately 6.5 mm. The filter element 157 has a length of approximately 20 mm to approximately 22 mm and a diameter of the outer diameter of approximately 7 mm. The paper wrapper 151 connects the tubular element 153, the cavity 155 for the capsule and the filter element 157 in such a way that they are successively adjacent to each other and are aligned axially. The overall length of the illustrative inhalation article 150 is from about 43 mm to about 47 mm with an external uniform diameter of about 7.2 mm.

Fig. 2 is a frontal schematic illustration of a portion of an exemplary membrane 158. The membrane 158 shown has three intersecting weakened lines 159 or cuts that intersect in the center of the membrane 158. In one embodiment, the membrane 158 has the shape of a disk with a diameter of approximately 7.3 mm. The weakened lines 159 preferably do not extend to the periphery of the membrane 158. The membrane 158 may be attached to a second opposite end 149 of a tubular element 153 defining a distal end 156 of a body 151 of an inhalation article.

The holder described below may be configured to collapse or open the membrane 158 when received in the holder.

Fig. 3 is a perspective view of an exemplary inhalation system 100. Fig. 4 is a schematic cross-sectional view of an exemplary inhalation system 100 of Fig. 3. Fig. 5 is a schematic cross-sectional view of an exemplary sleeve 120. Fig. 6 is a schematic cross-sectional view of another exemplary sleeve 120.

The inhalation system 100 comprises an inhalation article 150 and a separate holder 110. The inhalation article 150 can be placed inside the holder 110 for activating or puncturing the capsule 160 placed inside the inhalation article 150. The inhalation article 150 remains in the holder 110 during use by the consumer. The holder 110 is designed with the possibility of creating a vortex inhaled air flow entering the placed inhalation article 150.

The inhalation system 100 comprises an inhalation article 150 and a holder 110. The inhalation article 150 comprises a housing 151 which extends along the longitudinal axis L _A of the inhaler. The holder 110 comprises a movable sleeve 120 which holds the inhalation article 150 placed in the cavity 122 of the sleeve.

The holder 110 for the inhalation article 150 comprises a casing 111 comprising a casing cavity 112 for receiving the inhalation article 150 and a sleeve 120 configured to hold the inhalation article 150 inside the casing cavity 112. The sleeve 120 forms a sleeve cavity 122 and is configured to move inside the casing cavity 112 along the longitudinal axis L _A of the casing 111. The sleeve 120 comprises a first end 124 and a second opposite end 126. The second opposite end 126 of the sleeve 120 is configured to pass air entering the cavity 122 of the sleeve. The second opposite end 126 of the sleeve 120 is configured to create swirls of air entering the cavity 122 of the sleeve.

The holder 110 may comprise a piercing element 101 attached to the inner surface 109 of the casing and extending from it. The piercing element 101 may be configured to extend through the second opposite end 126 of the sleeve 120 and into the cavity 122 of the sleeve along the longitudinal axis of the casing 111. The holder 110 may comprise a spring element 102 configured to bias the sleeve 120 away from the piercing element 101.

The sleeve 120 may comprise an elongated slot 128 (see Fig. 5) extending along the longitudinal length of the sleeve 120. The casing 111 may further comprise a pin 127 extending from the inner surface 109 of the cavity 112 of the casing. The pin 127 may be configured to mate with the elongated slot 128.

Fig. 5 is a schematic cross-sectional view of an illustrative sleeve 120. The second opposite end 126 of the sleeve 120 comprises a tubular member 130 of the sleeve defining a central passage 132, an end surface 136 and an open end 134. The central passage 132 is in fluid communication with the cavity 122 of the sleeve.

The distal end 156 of the inhalation article 150 (when received in the sleeve 120) adjoins the central passage 132 of the tubular element 130 of the sleeve at the open end 134. The inlets 138 for inhaled air enter the tubular element 130 of the sleeve tangentially to the tubular element 130 of the sleeve and form a vortex inhaled air flow in the central passage 152 of the tubular element 153 of the placed inhalation article 150. The vortex inhaled air flow flows along the central passage 152 of the tubular element 153 of the placed inhalation article 150 in the direction of flow into the cavity 155 for the capsule and causes the capsule to rotate and release particles into the inhaled air flow.

The sleeve 120 forms a first air inlet zone 170 comprising at least one air opening 129 passing through the sleeve 120. The first air inlet zone 170 is located near the first open end 124 of the sleeve 120. The first air inlet zone 170 is configured to allow air to flow into an air flow channel formed between the sleeve 120 and the casing 111. The sleeve comprises a second air inlet zone 180 downstream of the first air inlet zone 170. The second air inlet zone 180 comprises a second opposite end 126 of the sleeve 120 configured to pass air entering the cavity 122 of the sleeve. The second air inlet zone 180 comprises at least one air opening or air inlet 138 through the sleeve 120 and into the tubular element 130 of the sleeve having a central passage 132.

Fig. 6 is a schematic cross-sectional view of another illustrative sleeve 120. The second opposite end 126 of the sleeve 120 comprises a tubular member 130 of the sleeve defining a central passage 132, an end surface 136 and an open end 134. The central passage 132 is in fluid communication with the cavity 122 of the sleeve. The open end 132 of the tubular member 130 of the sleeve can extend into the cavity 122 of the sleeve. The tubular member 130 of the sleeve comprises at least one air inlet 138 allowing air to enter the central passage 132. The at least one air inlet 138 extends in a direction that is tangential to the central passage 132.

The distal end 156 of the inhalation article 150 can be pushed onto the tubular element 130 of the sleeve, as shown in Fig. 7. When the membrane 158 is attached to the distal end 156 of the inhalation article 150, the open end 134 of the tubular element 130 of the sleeve is deformed and passes with force through the membrane 158 such that the tubular element 130 of the sleeve passes into the tubular element 153 of the placed inhalation article 150.

When the inhalation article 150 is inserted into the holder 110, the open end 134 of the tubular element 130 of the sleeve is deformed and passes with force through the membrane 158 in such a way that the tubular element 130 of the sleeve passes into the tubular element 153 of the placed inhalation article 150. The membrane 158 can be displaced in the direction toward the longitudinal axis of the inhalation article in such a way that the inhalation article 150 captures the holder, thereby holding the inhalation article 150 in place in the holder 110.

The inlets 138 for inhaled air enter the tubular element 130 of the sleeve tangentially to the central passage 132 and form a vortex inhaled air flow to the central passage 152 of the tubular element 153 of the placed inhalation article 150. The vortex inhaled air flow flows along the central passage 152 of the tubular element 153 of the placed inhalation article 150 along the flow path into the cavity for the capsule and causes the capsule to rotate and release particles into the inhaled air flow.

The tubular element 130 of the sleeve can extend into the cavity 122 of the sleeve and form an annular recess 131 with the cavity 122 of the sleeve, made with the possibility of receiving the distal end 156 of the inhalation article 150. The projection formed by the tubular element 130 of the sleeve is pushed into the tubular element 153 of the inhalation article 150. The tubular element 130 of the sleeve is made here with the possibility of extending into the distal end 156 of the inhalation article 150, placed in the cavity 122 of the sleeve.

The tubular element 130 of the sleeve can extend into the cavity 122 of the sleeve by approximately 5 mm and have an outer diameter of approximately 5.5 mm and an inner diameter of approximately 4 mm. The central passage 152 of the tubular element 153 of the placed inhalation article 150 can have an inner diameter of approximately 5.5 mm to ensure a friction fit involving the tubular element 130 of the sleeve and the annular recess 131.

Fig. 7 is a schematic cross-sectional view of an illustrative inhalation article 150 positioned in the sleeve 120 shown in Fig. 6. As shown in Fig. 7, the central passage 152 of the tubular member 153 of the inhalation article 150 aligns and mates with and extends into the central passage 132 of the tubular member 130 of the sleeve.

Claims (21)

1. An inhalation product for use in an inhalation system for delivering dry powder to the lungs of a user of the inhalation system, comprising: a body extending along the longitudinal axis of the inhalation device from the mouthpiece end to the far end located upstream of the flow; a capsule cavity formed inside the housing and limited further downstream by a filter element and limited earlier downstream by a tubular element forming a central passage communicating through a fluid medium with the capsule cavity, wherein the central passage forms an air inlet opening extending along the longitudinal axis of the inhalation product and from the distal end of the housing to the capsule cavity, wherein the tubular element has an internal diameter of the central passage in the range from 70% to 90% of the internal diameter of the capsule cavity; a capsule located in the capsule cavity and containing dry powder; wherein the inhalation product is designed with the ability to receive a vortex inhaled air flow into the central passage. 2. An inhalation product according to item 1, characterized in that the tubular element is formed from a cellulose material. 3. An inhalation product according to item 1, characterized in that the tubular element is formed from acetyl cellulose. 4. An inhalation product according to claim 1, characterized in that the tubular element is formed from a material based on a biodegradable resin, preferably a material based on polylactic acid. 5. An inhalation product according to any of the preceding claims, characterized in that the tubular element extends from a first end defining an upstream boundary of the cavity for the capsule, to a second opposite end defining the distal end of the body of the inhalation product. 6. The inhalation article according to claim 5, further comprising a membrane attached to the second opposite end of the tubular element. 7. An inhalation product according to item 6, characterized in that the membrane contains two or more slits or weakened lines. 8. An inhalation product according to item 6 or 7, characterized in that the membrane has the shape of a disk. 9. An inhalation product according to any of the preceding paragraphs, characterized in that the wrapping layer connects the filter element, the capsule cavity and the tubular element, successively axially adjacent to each other. 10. An inhalation product according to any of the preceding paragraphs, characterized in that the capsule contains pharmaceutically active particles. 11. An inhalation system comprising: an inhalation product according to any of the preceding paragraphs; and a holder for an inhalation product, wherein the holder comprises a casing containing a casing cavity, and the holder is designed with the possibility of supplying a vortex or swirling inhaled air flow into the inhalation product. 12. The inhalation system according to claim 11, characterized in that the holder comprises a sleeve configured to hold the inhalation product in the cavity of the casing, wherein the sleeve comprises a cavity of the sleeve and is configured to move within the cavity of the casing along the longitudinal axis of the casing, wherein the sleeve comprises a first open end and a second opposite end, wherein the second opposite end of the sleeve is configured to allow air to pass through, entering the cavity of the sleeve; and the second opposite end of the sleeve contains a tubular element of the sleeve, passing into the cavity of the sleeve, wherein the tubular element of the sleeve is designed with the possibility of passing into the tubular element of the inhalation product and with the possibility of fixing the inhalation product inside the sleeve. 13. An inhalation system according to claim 12, characterized in that the holder additionally contains a piercing element attached to the inner surface of the casing and extending from it, wherein the piercing element is designed with the possibility of passing through the second opposite end of the sleeve and into the cavity of the sleeve along the longitudinal axis of the casing and with the possibility of activating the capsule. 14. An inhalation system according to paragraphs 12, 13, characterized in that the second opposite end of the sleeve is designed with the possibility of creating a vortex or swirling flow on the inhaled air flow entering the cavity for the capsule.

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