Method for manufacturing an article for a dry powder inhaler having an upstream elastic element

Abstract

The present disclosure provides a method of manufacturing an inhaler article having an upstream elastic element (101) to be inserted into a holder to form an inhaler system for delivering dry powder to a user's lungs, the method comprising: moving a ribbon of elastic material (402) from a feeder reel (401) to a cutting stage (405); disposing the ribbon of elastic material at the cutting stage; cutting at least one disk of elastic material from the ribbon of elastic material to form at least one disk of cut elastic material; disposing the at least one disk of cut elastic material at a bonding stage (501); providing at least one ring of adhesive (502); applying the at least one ring of adhesive to the at least one disk of cut elastic material; disposing the at least one disk of cut elastic material with the ring of adhesive applied to an upstream end (120) of an inhaler article; and attaching the at least one disk of cut elastic material with the ring of adhesive applied to the upstream end of the inhaler article to form an inhaler article having an attached upstream elastic element.

Description

[Technical field]

[0001] The present disclosure relates to a method of manufacturing an inhaler article that is inserted into a holder to form an inhaler system for delivering an active ingredient in the form of a dry powder to the lungs of a user. Such an inhaler system may comprise two parts: an inhaler article and a holder. The inhaler article can accommodate a capsule filled with dry powder. When the inhaler article and the holder are combined, the inhaler system is formed. [Background technology]

[0002] Dry powder inhaler articles are not always fully suitable for providing optimized airflow for dry powder drug delivery during use, while also minimizing leakage of dry powder or loss of capsules from the inhaler article before and after use. Summary of the Invention [Problem to be solved by the invention]

[0003] It may be desirable to provide a dry powder inhaler article that is closed before and after use and can also be opened during use. It may be desirable to provide a dry powder inhaler article that is sufficiently closed before and after use to prevent loss of the capsule contained in the dry powder inhaler article. It may be desirable to provide a dry powder inhaler article that is sufficiently closed before and after use to prevent loss of the dry powder contained in the capsule contained in the dry powder inhaler article. It may be desirable to provide a dry powder inhaler article that is sufficiently open during use to allow optimal airflow through the dry powder inhaler article during use. It may be desirable to provide a dry powder inhaler article with an upstream elastic element that is closed before and after use and open during use. It may be desirable to provide a dry powder inhaler article with an elastic element at its upstream end to accommodate a capsule or dry powder.

[0004] It may be desirable to provide a dry powder inhaler article containing a capsule that is protected from being opened to expose or remove the capsule. For example, it may be desirable to provide a dry powder inhaler article containing a capsule where the capsule is not visible. If the capsule is visible inside the inhaler article, it may be tempting to open the inhaler article to remove the capsule.

[0005] It may be desirable to provide an inhaler article that prevents the capsule from being removed from the inhaler article. The capsule may be removed from the inhaler article intentionally or accidentally. It may be desirable to provide a dry powder inhaler article with an element at its upstream end to prevent the capsule from being removed intentionally or unintentionally from the inhaler article.

[0006] A suitable manufacturing method is desirable so that the elastic element is reliably affixed to the inhaler article such that the capsule is safely contained within the inhaler article.

[0007] It may be desirable to provide a dry powder inhaler article with an improved appearance at the upstream end of the inhaler article. For example, the upstream end of the inhaler article may be covered by adding an element to the upstream end of the inhaler article. The added element may hide inconsistencies that may occur at the upstream end of the inhaler article and improve the appearance of the upstream end of the inhaler article. The upstream element may provide a pleasing end surface. Additionally, the upstream element may be provided with indicia. The indicia may indicate origin, flavor, strength, or other information to the user. The indicia may be a color, a symbol, or a combination of a color and a symbol.

[0008] The manufacturing method desirably ensures that the resilient element is affixed to the inhaler article such that the inhaler article has the desired end surface.

[0009] The inhaler article may be a tubular article having an upstream end and a downstream end. The upstream end may be inserted into the holder. The downstream end, or mouth end, is engaged with the user's mouth to allow inhalation of the dry powder into the user's lungs. The inhaler article includes one or more doses of dry powder active ingredient. The dry powder may be contained within a capsule within the inhaler article. The inhaler article may be a disposable article. To use the inhaler system, a user may insert the inhaler article into the holder, activate the system to release the dry powder from the capsule, inhale the dry powder, and then remove the used inhaler article from the holder. Activating the system may include piercing the capsule.

[0010] It may be desirable for the inhaler article to be constructed and arranged to optimize delivery of the dry powder from the inhaler system to the user's lungs during use. Additionally, it may be desirable to ensure that the capsule and the active ingredient of the dry powder are safely contained within the inhaler article before and after use. That is, it may be desirable for the capsule to not fall out of the inhaler article before or after use. It may also be desirable for the dry powder contained within the capsule to not fall out of the inhaler article before or after use. [Brief description of the drawings]

[0011] [Figure 1A] 1A-1C show embodiments of inhaler articles of the present disclosure, illustrating one embodiment of the inhaler article having a resilient element at its upstream end that is slit to form a flap. [Figure 1B] 1 illustrates an embodiment of an inhaler article of the present disclosure, the inhaler article having a resilient element at an upstream end, the resilient element having a central opening. [Diagram 2] 1 shows an inhaler article of the present disclosure inserted into a holder forming an inhaler system. [Figure 3A] 1 illustrates the insertion of an inhaler article of the present disclosure into a holder, illustrating the inhaler article having a resilient element at its upstream end that is notched to form a flap. [Figure 3B]Illustrates the insertion of an inhaler article of the present disclosure into a holder, illustrating an inhaler article having an elastic element at its upstream end that is notched to form a flap and inserted into the holder, where the flap is opened by the holder. [Figure 4A] 1 illustrates the insertion of an inhaler article of the present disclosure into a holder, and illustrates an inhaler article having a resilient element at an upstream end, the resilient element having a central opening. [Figure 4B] Illustrates the insertion of an inhaler article of the present disclosure into a holder, illustrating an inhaler article having an elastic element at its upstream end with a central opening, inserted into the holder, where the central opening is opened by the holder. [Figure 5A] 1 illustrates an embodiment of an inhaler article of the present disclosure having a resilient element at an upstream end that is slit to form a flap, and illustrates the flap that folds back to form an interior opening. [Figure 5B] 1 illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap, and 1 illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap and has six radial cuts and forms six flaps. [Figure 5C] 1 illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap, and 1 illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap and has eight radial cuts and forms eight flaps. [Figure 5D] Illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap; illustrates one embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap and has six radial cuts and forms six flaps; and illustrates the ratio of the length of the cuts to the diameter of the inhaler article in one embodiment. [Figure 5E]1 illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap; FIG. 2 illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap and has six radial cuts and forms six flaps; and illustrates the ratio of the length of the cuts to the diameter of the inhaler article in one embodiment. [Figure 5F] Illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap; illustrates one embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end that is cut to form a flap and has six radial cuts and forms six flaps; and illustrates the ratio of the length of the cuts to the diameter of the inhaler article in one embodiment. [Figure 5G] Illustrating an embodiment of an inhaler article of the present disclosure having an elastic element at its upstream end that is slit to form a flap, is a diagram of an embodiment of an inhaler article having a central opening and a flap. [Figure 6A] 1 illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at an upstream end, the elastic element having a central opening; FIG. 1 illustrates a view of the central opening of the elastic element at the upstream end of the inhaler article. [Figure 6B] FIG. 1 illustrates an embodiment of an inhaler article of the present disclosure having an elastic element at its upstream end; FIG. 2 is another view of an inhaler article of the present disclosure having an elastic element at its upstream end, the elastic element having a central opening. [Figure 6C] 1 illustrates an embodiment of an inhaler article of the present disclosure having a resilient element at its upstream end, a diagram of a resilient element 101 having a central opening 105. FIG. [Figure 7A] FIG. 1 is a diagram of an embodiment of an inhaler article 100 of the present disclosure, showing an elastic element 101 having a ring of adhesive 108 applied thereto prior to affixing the elastic element 101 to the upstream end 120 of the inhaler article 100. [Figure 7B] FIG. 1 is a diagram of an embodiment of an inhaler article 100 of the present disclosure, including a photograph of one embodiment of the upstream end 120 of the inhaler article 100 before an elastic element 101 is applied thereto. [Figure 7C]FIG. 1 is a diagram of an embodiment of an inhaler article 100 of the present disclosure, illustrating the attachment of a resilient element 101 to an upstream end 120 of the inhaler article 100. [Figure 7D] FIG. 1 is a diagram of an embodiment of an inhaler article 100 of the present disclosure, showing a view of the inhaler article 100 after an elastic element has been affixed to the upstream end 120 of the inhaler article 100. [Figure 8A] A manufacturing setup is illustrated for producing an embodiment of an inhaler article having a resilient element affixed to the upstream end of the inhaler article, and a ribbon cutter is illustrated cutting a disk of resilient material to create the resilient element. [Figure 8B] 1 illustrates a manufacturing facility for producing an embodiment of an inhaler article having a resilient element affixed to an upstream end of the inhaler article, showing a stage in the manufacturing process for providing a ring of adhesive. [Figure 8C] 1 illustrates a manufacturing setup for producing embodiments of inhaler articles having an elastic element affixed to the upstream end of the inhaler article, showing a holder for housing three inhaler articles, which are placed on the elastic element having a ring of adhesive applied during the manufacturing process. [Figure 9A] 1 illustrates a manufacturing setup for producing an embodiment of an inhaler article having an elastic element affixed to the upstream end of the inhaler article, showing the ribbon cutter before the elastic element of elastic material is cut from the ribbon of elastic material. [Figure 9B] 1 illustrates a manufacturing setup for producing an embodiment of an inhaler article having an elastic element affixed to the upstream end of the inhaler article, showing the ribbon cutter after the elastic element, which is a disk of elastic material, has been cut from a ribbon of elastic material. [Figure 10A] In an embodiment of an inhaler article having an elastic element affixed to an upstream end of the inhaler article, a manufacturing apparatus and method for affixing the elastic element to the inhaler article is illustrated, illustrating the steps of placing the elastic element at a bonding station. [Figure 10B] In an embodiment of an inhaler article having a resilient element affixed to the upstream end of the inhaler article, a manufacturing apparatus and method for affixing the resilient element to the inhaler article is illustrated, illustrating the step of carrying a ring of adhesive. [Figure 10C] In an embodiment of an inhaler article having an elastic element affixed to the upstream end of the inhaler article, a manufacturing apparatus and method for affixing the elastic element to the inhaler article is illustrated, illustrating the step of applying an adhesive to the elastic element. [Figure 11A] 1 illustrates a manufacturing facility for producing an embodiment of an inhaler article having an elastic element affixed to the upstream end of the inhaler article, and illustrates a perspective view of the elastic element having a ring of adhesive applied thereto after the manufacturing process of FIG. [Figure 11B] Illustrated is a manufacturing setup for producing an embodiment of an inhaler article having an elastic element affixed to the upstream end of the inhaler article, with the inhaler article positioned on the adhesive side of the elastic element having a ring of adhesive applied thereto. [Figure 11C] A manufacturing facility is illustrated for producing an embodiment of an inhaler article having an elastic element affixed to the upstream end of the inhaler article, and an embodiment of an inhaler article is illustrated having an elastic element affixed to the upstream end of the inhaler article. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] There is provided an inhaler article having a resilient element at an upstream end of the inhaler article, the resilient element being in a closed position before being inserted into a holder, and in use when the inhaler article is inserted into the holder, the resilient element opens to an open position in response to an opening force applied to the resilient element, and when the inhaler article is removed from the holder after use, the resilient element closes to a closed position. In one aspect, the upstream end of the capsule space of the inhaler article may be a resilient element that forms an openable closed end of the inhaler article.

[0013] A conventional smoking article has no element at the upstream end of the smoking article. The upstream end of a conventional smoking article is the lit end. The upstream end of the conventional smoking article is lit and an aerosol released by combustion of the aerosol-generating substrate is inhaled. An element at the upstream end of the conventional smoking article is lit and an aerosol released by combustion of such element at the upstream end is inhaled.

[0014] In the dry powder inhaler articles disclosed herein, the upstream end is not lit during use, and therefore the upstream end of the inhaler article can provide a utility not desired in conventional smoking devices.

[0015] The present disclosure provides a method of manufacturing an inhaler article having an elastic element at an upstream end of the inhaler article, the method of manufacturing includes the steps of moving a ribbon of elastic material from a feeder reel to a cutting stage, placing the ribbon of elastic material on the cutting stage, cutting at least one disk of elastic material from the ribbon of elastic material, placing the at least one cut disk on a bonding stage, providing at least one ring of adhesive, applying the at least one ring of adhesive to the at least one disk of elastic material, placing the at least one cut disk with the applied ring of adhesive at an upstream end of the inhaler article, and attaching the at least one disk with the applied ring of adhesive to the upstream end of the inhaler article to form an inhaler article having an upstream elastic element. The upstream elastic element is attached to the upstream end of the inhaler article.

[0016] The present disclosure provides a method of manufacture in which an inhaler article comprises a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end, and a capsule space containing a capsule, the upstream boundary of the capsule space being defined by an elastic element, and the attached elastic element retains the capsule within the capsule space. In an embodiment, the downstream mouthpiece end comprises a blocker element. The blocker element may be a filter. The tubular body may be made of cardboard.

[0017] The elastic element of the present disclosure has the advantage that the capsule in the inhaler article is securely contained within the inhaler article prior to use. The elastic element opens when inserted into the holder, providing an airflow path from the upstream end of the inhaler article to the downstream mouthpiece end of the inhaler article. As air passes through the inhaler article, the dry powder released from the capsule is entrained in the airflow and delivered to the mouthpiece end of the inhaler article for inhalation by the user. That is, the elastic element is configured and arranged to open during use to optimize delivery of the dry powder from the inhaler system to the lungs of the user. After use, when the inhaler article is removed from the holder, the elastic element closes to hold the capsule within the inhaler article. It is advantageous for the inhaler article to open when inserted into the holder during use, providing sufficient airflow to deliver the pharma- ceutically active agent to the lungs of the user. It is advantageous for the inhaler article to be closed prior to use to prevent the capsule from falling out of the inhaler article prior to use. It is advantageous for the inhaler article to be closed after use to prevent the capsule from falling out of the inhaler article after use. After the inhaler article is actuated, it is advantageous for the inhaler article to be sufficiently closed after use to prevent the capsule from falling out of the inhaler article after use. The elastic element allows the upstream end of the inhaler to be both opened and closed both before and after use of the inhaler article. When engaging with the holder, the elastic element can be opened to provide sufficient airflow, optimizing the delivery of dry powder to the lungs of the user, and can be closed to prevent the capsule from falling out of the inhaler before and after inserting the inhaler article into the holder. The elastic element on the upstream end of the inhaler article provides the advantage of both allowing sufficient airflow and also protecting against undesired loss of pharma- ceutically active agent from the inhaler article before and after use.

[0018] According to one embodiment, the elastic element of the inhaler article is an elastic element that is pre-slit to form flaps. The flaps of the elastic element, when inserted into the holder, fold to provide an opening that forms an airflow path from the upstream end of the inhaler article to the downstream mouthpiece end of the inhaler article. As air passes through the inhaler article, dry powder released from the capsule is entrained in the airflow and delivered to the mouthpiece end of the inhaler article to be inhaled by the user. That is, the flaps of the elastic element open to optimize delivery of dry powder from the inhaler system to the lungs of the user during use. After use, when the inhaler article is removed from the holder, the elastic element closes to hold the capsule within the inhaler article. The elastic element may be pre-slit to form at least four flaps. The elastic element may be pre-slit to form at least six flaps. The slits may extend from about 65% to about 95% of the diameter of the elastic element. The resilient material provided at the upstream end of the inhaler article in the form of a flap, when inserted into the holder, may open or close in a manner suitable for opening the inhaler article during use, and may also be closed to prevent the capsule from falling out of the inhaler article before and after use.

[0019] The open inhaler article provides an enlarged airflow path, improving airflow through the inhaler system and providing a higher powder dose to the user. When the upstream end of the inhaler article is closed before use, the piercing pin pierces the upstream end of the inhaler article. The hole made by the piercing pin at the upstream end of the inhaler article is generally related to the size of the piercing pin. Generally, the hole made by the piercing pin is not large enough to allow sufficient airflow through the inhaler system to provide a suitable dose of powder to the user. That is, a small hole at the upstream end of the inhaler article in the inhaler system results in a large resistance to draw (RTD) due to the narrow opening related to the size of the piercing pin. This can result in an inhaler system that does not ensure sufficient airflow to provide a user with a suitable dose of powder released from the capsule. One solution to this RTD problem is to realize an inhaler article with an open upstream end. Providing an inhaler article with an upstream end that has a flap or opening that opens in response to an opening force provided by the holder allows for a larger opening and creates an airflow path that is not restricted to a pinhole-sized area in the airflow path.

[0020] The present disclosure provides an inhaler article for insertion into a holder to form an inhaler system for delivering dry powder to a user's lungs. The inhaler article may be a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end, with a capsule space within the tubular body between the downstream mouthpiece end and the upstream end, the capsule space housing a capsule. The upstream of the inhaler article may have an elastic element. When the inhaler article is inserted into the holder, the elastic element opens to an open position in response to an opening force provided by the holder. When the inhaler article is removed from the holder, the opening force is removed from the inhaler article. When the opening force is removed from the inhaler article, the elastic element closes to a closed position, sufficiently closed to hold a capsule in the capsule space of the inhaler article between the elastic element at the upstream end and the downstream mouthpiece end. The elastic element is made of an elastic material suitable for opening and closing as described.

[0021] According to one aspect of the disclosure, the inhaler article may be a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end, with a capsule space within the tubular body between the downstream mouthpiece end and the upstream end, the capsule space housing a capsule. In one aspect, the downstream mouthpiece end has a blocker element. In one aspect, the blocker is a filter element. The blocker element functions to ensure that the capsule does not leave the downstream end of the tubular body before, during, and after use. When the blocker is a filter, the filter element ensures that the pharma- ceutical active powder delivered to the lungs of the user is a powder small enough to pass through the filter. This ensures that the pharma- ceutical active powder is suitable for delivery to the lungs of the user.

[0022] According to one embodiment, the elastic element is a disk. In one embodiment, the elastic element is circular. In one embodiment, the elastic element is cut from a ribbon of elastic material to form a disk. The elastic element may be cut from the elastic ribbon by a stamp cutter. The elastic elements may be cut from the ribbon of elastic material one at a time, i.e., the cutter that cuts the disk of elastic material from the ribbon of elastic material may have one cutting head. Alternatively, the elastic elements may be cut from the ribbon of elastic material two at a time, i.e., the cutter that cuts the disk of elastic material from the ribbon of elastic material may have two cutting heads. Alternatively, the elastic elements may be cut from the ribbon of elastic material three at a time, i.e., the cutter that cuts the disk of elastic material from the ribbon of elastic material may have three cutting heads. Alternatively, the elastic elements may be cut from the ribbon of elastic material more than three at a time, i.e., the cutter that cuts the disk of elastic material from the ribbon of elastic material may have more than three cutting heads.

[0023] In one aspect, the elastic element is an attached or affixed elastic element. The elastic element may be affixed to the upstream end of the inhaler article. The elastic element may be attached to the upstream end of the inhaler article by any process suitable for affixing an elastic element to an inhaler article, including gluing, heat sealing, pressing, frictional engagement, or other means. The elastic element may be affixed to the upstream end of the inhaler article by gluing. The elastic element may be attached to the upstream end of the inhaler article by heat sealing. The elastic element may be affixed to the upstream end of the inhaler article by pressing the elastic element into the inhaler article. The elastic element may be affixed to the upstream end of the inhaler article by frictional engagement. The elastic element may be affixed to the upstream end of the inhaler article by any suitable means.

[0024] In one aspect, the capsule is inserted into the inhaler article before the elastic element is attached or affixed to the upstream end of the inhaler article, i.e., the elastic element is affixed to the upstream end of the inhaler article that contains the capsule.

[0025] In one aspect, the elastic element is affixed to the upstream end of the inhaler article by gluing. In one aspect, the gluing stage can provide a ring of adhesive. The ring of adhesive can be slightly smaller than the circumference of the disk of elastic material. After the disk of elastic material is cut, the disk of elastic material can be placed in the gluing stage with the ring of adhesive provided. The ring of adhesive can be applied to the disk of cut elastic material by pressing the disk of cut elastic material against the ring of adhesive provided on the gluing stage. The cut disk can be transported to the gluing station by a holder. The adhesive can be introduced to the gluing stage. For example, the adhesive can be applied to the stage. The adhesive can be pressure-fed to a ring of adhesive sized slightly smaller than the diameter of the elastic element disk at the gluing stage. In an embodiment, the adhesive can be placed in the ring of adhesive by forcing adhesive into the ring of adhesive from a reservoir of adhesive below the gluing stage. Alternatively, the adhesive can be placed in dots, discontinuous rings, thick rings, thin rings, or any other shape to provide adhesive to the adhesive station. Suitable adhesives may include starch adhesives, such as dextrin, casein-based adhesives, polyamide blue, hot melt adhesives, cyanoacrylates, organic adhesives, or any other suitable adhesives.

[0026] According to one embodiment, the elastic element of the inhaler article is an elastic element that is cut to form flaps. The cuts in the disk of elastic material may be made by the same cutter that cuts the disk of elastic material. In one embodiment, the cuts are made by a stamp cutter. These cuts do not extend completely to the outer periphery of the disk of elastic material. That is, each cut in the disk of elastic material crosses the center of the disk of elastic material, and the cuts cross in all directions across the disk of elastic material. If more than one cut is made through the center of the disk of elastic material, a disk with sectors is formed. A sector is a shape enclosed between an arc and two radii at either end of the arc. As the sectors are cut into the elastic material, these sectors form flaps. The flaps are movable sectors.

[0027] The flaps of the elastic element, when inserted into the holder, fold to provide an opening that forms an airflow path from the upstream end of the inhaler article to the downstream mouthpiece end of the inhaler article. As air passes through the inhaler article, dry powder released from the capsule is entrained in the airflow and delivered to the mouthpiece end of the inhaler article to be inhaled by the user. That is, the flaps of the elastic element open, optimizing the delivery of dry powder from the inhaler system to the lungs of the user during use. After use, when the inhaler article is removed from the holder, the elastic element closes to hold the capsule within the inhaler article.

[0028] The elastic element may be cut with at least two flaps to form at least four flaps. The elastic element may be cut with at least three flaps to form at least six flaps. The elastic element may be cut with at least four flaps to form at least eight flaps. The slits may extend from about 65% to about 95% of the diameter of the elastic element. The elastic material provided at the upstream end of the inhaler article in the form of flaps, when inserted into the holder, may open or close in a manner suitable for opening the inhaler article during use, and may be closed to prevent the capsule from falling out of the inhaler article before and after use.

[0029] In one embodiment, the flap may open to an open position by folding the notched flap into the capsule space of the inhaler article in response to an opening force. The opening force may be provided by the holder. That is, a portion of the holder may fit inside the upstream end of the inhaler article when the inhaler article is inserted into the holder. When a portion of the holder fits inside the inhaler article, the holder may fold the flap into the capsule space. When the flap is folded into the capsule space of the inhaler article, an opening opens and an airflow path is formed. The inhaler article according to any one of claims 6 to 9, wherein the elastic element having a notch forming the flap opens to an open position by folding the notched flap into the capsule space in response to an opening force. Inserting the inhaler article into the holder may provide an opening force that pushes the flap of the notched elastic element into the capsule space of the inhaler article.

[0030] In one embodiment, the elastic element may be cut to provide a central opening in the disk of elastic material. The cutting of the disk of elastic material may be performed by the same cutter that cuts the disk of elastic material. In one embodiment, the cutting is performed by a stamp cutter. In one embodiment, the central opening has a diameter that is less than 30% of the diameter of the elastic element.

[0031] The cutter may cut both the incisions (which form the flaps) and the central opening.

[0032] In one embodiment, the elastic element of the inhaler article is an elastic element having a central opening that stretches and opens in response to an opening force to an open position. That is, in one embodiment, the elastic element of the inhaler article is an annular elastic element of an elastic material that stretches and opens in response to an opening force to an open position. The diameter of the central opening may be less than 30% of the diameter of the elastic element. The opening force may be provided by the holder. The opening force may be provided by a protrusion of the holder moving into the central opening at the upstream end of the inhaler article when the inhaler article is inserted into the holder. Inserting the inhaler article into the holder provides an opening force that can cause the central opening to stretch and open in response to the opening force.

[0033] After the elastic elements are severed from the ribbon of elastic material, the ribbon of elastic material can travel away from the cutting stage and be collected by a take-up reel.

[0034] The elastic element of the inhaler article may be made of an elastic material. The elastic element of the inhaler article may be made of, for example, silicone, latex, plastic, paper, paper tape, layered PLA laminated on a paper layer, or cardboard. The elastic element may be made of silicone, latex, rubber, or a combination. The elastic element of the inhaler article may be made of, for example, silicone. The elastic element of the inhaler article may be made of, for example, latex. The elastic element of the inhaler article may be made of, for example, plastic. The elastic element of the inhaler article may be made of, for example, paper. The elastic element of the inhaler article may be made of, for example, aluminum foil. The elastic element of the inhaler article may be made of, for example, paper tape. The elastic element of the inhaler article may be made of, for example, layered PLA laminated on a paper layer. The elastic element of the inhaler article may be made of, for example, cardboard. The elastic element of the inhaler article may be made of, for example, rubber. The elastic element of the inhaler article may be made of, for example, a combination of materials. The elastic element of the inhaler article may, for example, be made of any suitable elastic material.

[0035] In one aspect, when the elastic element is in an open position and engaged with the holder, the resulting opening or aperture provides an unrestricted or less restricted airflow into the capsule space. In one aspect, the holder is configured to generate a swirling or rotating inhalation airflow in the inhaler article. In one aspect, the holder comprises a housing defining a housing space and a movable cap configured to hold the inhaler article in the housing space, the movable cap being movable within the housing space along a longitudinal axis of the housing, the movable cap comprising a protrusion and a piercing end. When the inhaler article is engaged with the holder, the protrusion of the movable cap extends into the elastic element at the upstream end of the inhaler article. A piercing element affixed to the inner surface of the bottom of the holder extends through the piercing end of the movable cap. When the movable cap moves relative to the piercing element, the inhaler article moves to be positioned on the piercing element. The piercing element then pierces the capsule in the inhaler article to release the pharma- ceutically active dry powder from the capsule.

[0036] In one embodiment, the capsule comprises a pharma- ceutical active dry powder, which may be nicotine.

[0037] Typically, the capsule may be free of tobacco industry filler material. Typically, the tobacco industry filler material is tobacco, e.g., small pieces of chopped or shredded tobacco plant leaves or stems. It may be undesirable to deliver small pieces of tobacco leaves or stems directly to the lungs of a user. Delivery of small pieces of tobacco leaves or stems to the lungs of a user does not deliver pharma- tically active nicotine to the user. Delivery of small pieces of plant material to the lungs of a user is likely to be harmful to the user.

[0038] In one aspect, the elastic element may include indicia. In an embodiment, the indicia may be a color. In an embodiment, the indicia may be one or more symbols. In an embodiment, the ribbon of elastic material may be colored. In an embodiment, the ribbon of elastic material may comprise one or more symbols. Alternatively, the ribbon of elastic material may comprise both a color and one or more symbols. If the ribbon of elastic material comprises a color, the cut disk of elastic material will be colored when attached or affixed to the upstream end of the inhaler article. If the ribbon of elastic material comprises one or more symbols, the cut disk of elastic material will comprise one or more symbols when attached or affixed to the upstream end of the inhaler article. The color and the symbol are indicia. The indicia may indicate the origin, flavor, strength, or other information of the product.

[0039] As used herein, the singular forms "a," "an," and "the" also include embodiments having plural referents unless the content clearly dictates otherwise.

[0040] As used herein, "or" is generally employed in its meaning including "and / or," unless the context clearly dictates otherwise. The term "and / or" refers to one or all of the listed elements or a combination of any two or more of the listed elements.

[0041] As used herein, the words "have," "having," "include," "including," "comprise," "comprising," and the like are used in their open-ended sense and generally mean "including, but not limited to." It should be understood that "consisting essentially of," "consisting of," and the like are encompassed by "comprising" and the like.

[0042] The words "preferred" and "preferably" refer to embodiments of the invention that may offer certain advantages, under particular circumstances. However, other embodiments 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 intended to exclude other embodiments from the scope of the present disclosure, including the claims.

[0043] As used herein, "providing" in the context of providing a device or system means manufacturing the device or system, purchasing the device or system, or otherwise acquiring the device or system.

[0044] As used herein, "or" is generally employed in its meaning including "and / or," unless the context clearly dictates otherwise. The term "and / or" refers to one or all of the listed elements or a combination of any two or more of the listed elements.

[0045] Any directions referred to herein, such as "top," "bottom," "left," "right," "upper," "lower," and other directions or orientations, are described herein for clarity and brevity, but are not intended to limit the actual device or system. The devices and systems described herein may be used in numerous directions and orientations.

[0046] As used herein, "downstream" and "proximal" refer to the mouthpiece end of the inhaler article. "Downstream" and "proximal" refer to the end of the tubular inhaler article that is intended to be contacted with the mouth of a user. "Upstream" and "distal" refer to opposite ends of the inhaler article. "Upstream" and "distal" refer to the end of the tubular inhaler article that is intended to be inserted into a holder.

[0047] The term "nicotine" refers to nicotine and nicotine derivatives, such as free base nicotine, nicotine salts, and the like.

[0048] As used herein, the term "closed" means sufficiently closed to retain a capsule inside the inhaler article before and after use. "Closed" means sufficiently closed to reduce loss of medicamentously active powder from the inhaler article before and after use. An inhaler article may be less closed after use than it was before use, but may still be considered closed if it has features that reduce loss of the contents of the inhaler article.

[0049] As used herein, the term "use" refers to the steps of inserting an inhaler article into a holder, initiating airflow through the holder and the inhaler article, and inhaling the pharma- ceutically active powder. "Use" may, if desired, include the additional step of removing the inhaler article from the holder.

[0050] Inhaler systems are used to deliver pharma- ceutically active dry powder to the lungs of a user. The present disclosure provides systems, particularly inhaler articles, that are constructed and arranged to contain the active dry powder before and after use, and allow the dry powder to exit or be delivered from the inhaler article during use. The inhaler article has two ends, an upstream end and a downstream end. The downstream end is a mouthpiece end. During use, a user places the downstream end of the inhaler article into the user's mouth and inhales.

[0051] The upstream end of the inhaler article is inserted into the holder during use. When the upstream end of the inhaler article is inserted into the holder, the upstream end of the inhaler article opens. When the upstream end of the inhaler article is inserted into the holder, the inhaler article and the holder form an inhaler system. The inhaler article is inserted into the holder during use. The upstream end of the inhaler article opens during use, allowing air to flow through the inhaler article and release the pharma- ceutical active dry powder to a user. The upstream end of the inhaler article opens when the inhaler article is inserted into the holder. The holder provides an opening force to the inhaler article, opening the inhaler article and releasing the pharma- ceutical active powder from the inhaler article during use.

[0052] The upstream end of the inhaler article is closed before use to prevent the pharma- ceutically active dry powder from falling out of the inhaler article. After use, the upstream end of the inhaler article is closed after the inhaler article is removed from the holder to prevent the pharma-ceutically active dry powder from falling out of the inhaler after use. The upstream end of the inhaler article is open when inserted into the holder and is closed before and after the inhaler article is inserted into the holder.

[0053] To enable the upstream end of the inhaler article to close before use, open during use and then close again after use, the upstream end of the inhaler article is a resilient element. The resilient element closes before use, opens during use and then returns to a closed position after use. The resilient element closes before use, opens when the inhaler article is inserted into the holder and then closes again when the inhaler article is removed from the holder.

[0054] The inhaler article may be of any shape or size. To facilitate insertion into the holder, the inhaler article may be a tubular article. The inhaler article may be a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end. The inhaler article may be cylindrical. The inhaler article contains a pharma- ceutically active powder.

[0055] The inhaler article may resemble a smoking article or a cigarette in size and shape. The inhaler article may be a tubular body extending along the longitudinal axis of the inhaler article. The inhaler article may have a substantially uniform outer diameter along the length of the elongate body. The inhaler body may have a circular cross-section that may be uniform along the length of the elongate body. The inhaler body may have an outer diameter in the range of about 6 mm to about 10 mm, or about 7 mm to about 10 mm, or about 7 mm to about 9 mm, or 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, or about 40 mm to about 70 mm, or about 40 mm to about 50 mm, or a length of 45 mm.

[0056] The inhaler article may be a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end, with a central space between the downstream mouthpiece end and the upstream end.

[0057] The downstream end of the inhaler article is a mouthpiece end. That is, the downstream end of the inhaler article is intended to engage with the mouth of a user to allow the contents of the inhaler article to be inhaled by the user. The downstream end is configured and arranged to engage with the mouth of a user. The downstream end is sized and shaped to engage with the mouth of a user. The downstream end of the inhaler article functions as a conduit for delivering the pharma- cetically active powder to the mouth and lungs of the user. The downstream end of the inhaler article has a rigidity or hardness, a size, and a shape for engaging with the mouth of a user. The downstream end of the inhaler article may have a blocker. The blocker may be an element of the inhaler article that provides rigidity or hardness. The rigidity or hardness of the blocker is suitable for insertion into the mouth of a user during use of the inhaler system. The blocker may have a size and a shape for engaging with the mouth of a user.

[0058] Additionally, the blocker may be a filter element. The filter element may have an internal structure that allows smaller particles to flow through the filter element and blocks larger particles from flowing through the filter element. The filter element may act to filter larger particles of the pharma- ceutical active powder as they flow out of the inhaler article. The filter element may act to control the size of the pharma- ceutical active powder particles as they flow out of the inhaler article. The filter element may allow the pharma- ceutical active powder particles to flow out of the inhaler article to the user. The filter element may allow sufficiently small pharma- ceutical active powder particles to flow out of the inhaler article to the user through the filter element. The filter element may be formed of a cellulose acetate material. The filter element may be cellulose tow. The filter may be formed of a biodegradable material.

[0059] The blocker element may extend from the central space of the inhaler article to the mouthpiece end. The blocker element may extend from the capsule space of the inhaler article to the mouthpiece end. The filter element may have a length in the range of about 10 mm to about 30 mm, preferably about 15 mm to about 25 mm, more preferably about 20 mm to about 22 mm.

[0060] The inhaler article has an upstream end. The upstream end has an elastic element. The elastic element of the inhaler article may have cuts that allow the elastic element to open when a protrusion is inserted into the elastic element. These cuts can be referred to as cuts or cutouts. These cuts can be described as radial cuts or diametric cuts. Two diametric cuts result in the formation of four flaps in the elastic element. Two diametric cuts that extend partially along the diameter of the elastic element are the same as four radial cuts that extend partially along the radius of the elastic element. The cuts may extend in the range of 65% to 95% of the diameter of the elastic element.

[0061] When an inhaler article having an elastic element with a notch (and a flap) is inserted into the holder, the protrusion of the holder pushes the flap into the inside of the inhaler article. When the protrusion of the holder pushes the flap into the inside of the inhaler article, the inhaler article opens. The protrusion of the holder provides an opening force, opening the upstream end of the inhaler article. When the inhaler article is open, an airflow flow path is created that improves airflow through the inhaler system. When the inhaler article is withdrawn from the holder, the protrusion is withdrawn from the inhaler article and the flaps return to their position at the upstream end of the inhaler article. When the opening force is released, the inhaler article closes. When the inhaler article is removed from the holder, the opening force is removed from the upstream end of the inhaler article. When the opening force is removed from the inhaler article, the elastic element returns to the closed position. When the opening force is removed, the elastic element closes to the closed position. The elastic element with the notch and the flap may not be completely closed before and after use, but is partially closed before and after use. It is not open after use.

[0062] The elastic element of the inhaler article may have a central opening that stretches and opens to an open position in response to an opening force. That is, in one embodiment, the elastic element of the inhaler article is an annular elastic element of an elastic material that stretches and opens to an open position in response to an opening force. The diameter of the central opening may be less than 30% of the diameter of the elastic element. The opening force may be provided by the holder. The opening force may be provided by a protrusion of the holder moving into the central opening of the upstream end of the inhaler article when the inhaler article is inserted into the holder. Inserting the inhaler article into the holder provides an opening force that can stretch and open the central opening in response to the opening force. Furthermore, the elastic element returns to the closed position when the opening force is removed. When the inhaler article is removed from the holder, the opening force is removed from the upstream end of the inhaler article. When the opening force is removed from the inhaler article, the elastic element returns to the closed position. When the opening force is removed, the elastic element closes to the closed position. The elastic element with a central opening may not be completely closed before or after use, but is partially closed before or after use. It is not open after use.

[0063] The elastic element of the inhaler article may have a combination of a cut and a central opening that stretches and opens in response to an opening force to an open position. That is, in one embodiment, the elastic element of the inhaler article is an annular elastic element of an elastic material that stretches and opens in response to an opening force to an open position. The diameter of the central opening may be less than 30% of the diameter of the elastic element. The cut may extend in the range of 65% to 95% of the diameter of the elastic element. The opening force may be provided by the holder. The opening force may be provided by a protrusion of the holder moving into the central opening at the upstream end of the inhaler article when the inhaler article is inserted into the holder. Inserting the inhaler article into the holder provides an opening force that may cause the central opening to stretch and open in response to the opening force.

[0064] When the inhaler article is removed from the holder, the protrusion is removed from the inhaler article and the elastic element closes. When the inhaler article is removed from the holder, the opening force is removed. When the protrusion is removed from the inhaler article, the opening force is removed. When the opening force is removed, the elastic element closes. When the inhaler article is removed from the holder, the opening force is removed from the upstream end of the inhaler article. When the opening force is removed from the inhaler article, the elastic element returns to the closed position. When the opening force is removed, the elastic element closes to the closed position.

[0065] Between the downstream and upstream ends of the tubular body is a central space containing the pharma- ceutically active powder, the central space may have a length ranging 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.

[0066] The space may contain a pharma- ceutical active powder contained within a capsule. If the space contains a pharma- ceutical active powder contained within a capsule, then the space is a capsule space.

[0067] The capsule space may be within the inhaler article between the downstream blocker element and the upstream elastomeric element. The downstream blocker element may be connected to the upstream elastomeric element by a wrapper. The wrapper may form the tubular body of the inhaler article. The tubular body defining the capsule space may be formed of a biodegradable material, such as cardboard or paperboard.

[0068] The capsule space may have an inner diameter within the range of about 6 mm to about 7 mm, or about 6.5 mm to about 6.7 mm. The capsule space may have a lateral length within the range of about 15 mm to about 30 mm, or about 20 mm to about 25 mm.

[0069] The capsule space may define a cylindrical space configured to contain the capsule (e.g., the capsule may have an oval or circular cross-section). The capsule space may have a substantially uniform or uniform diameter along the length of the capsule space. The capsule space may have a fixed space length. The capsule space has a space inner diameter perpendicular to the longitudinal axis, and the capsule has a capsule outer diameter. The capsule space may be sized to contain an oval capsule. The capsule space may have a substantially cylindrical or cylindrical cross-section along the capsule space length. The capsule space may have a uniform inner diameter. The capsule may have an outer diameter that is about 80% to about 95% of the capsule space inner diameter. The configuration of the capsule space relative to the capsule may facilitate limited movement of the capsule during activation or penetration of the capsule.

[0070] The configuration of the capsule space relative to the capsule may encourage the capsule to rotate stably within the capsule space. The longitudinal axis of the capsule may rotate stably coaxially with the longitudinal axis of the inhaler body during inhalation. The configuration of the capsule space relative to the capsule may encourage the capsule to rotate with some vibration within the capsule space.

[0071] Stable rotation refers to the longitudinal axis of the inhaler body being substantially parallel or coaxial with the axis of rotation of the capsule. Stable rotation can refer to the lack of forward movement of the rotating capsule. It is preferred that the longitudinal axis of the inhaler body is substantially coextensive with the axis of rotation of the capsule. Stable rotation of the capsule can provide uniform mixing of a portion of the nicotine particles from the capsule over two or more, or five or more, or ten or more "puffs" or inhalations by the consumer.

[0072] The capsule may be contained within the inhaler article prior to consumption. The inhaler article may be contained within the capsule space by an elastic element.

[0073] The capsule may be formed of an airtight material that may be pierced or perforated by a piercing element that may be separate from the inhaler or may be combined with the inhaler. The capsule may be formed of a metallic or polymeric material that serves to keep contaminants out of the capsule but may be pierced or perforated by a piercing element prior to consumption of the nicotine particles therein. The capsule may be formed of a polymeric material. The polymeric material may be hydroxypropyl methylcellulose (HPMC). The capsule may be a size 1 to size 4 capsule, or a size 3 capsule.

[0074] The capsule contains medicamentally active particles. The medicamentally active particles may include nicotine (also referred to as "nicotine powder" or "nicotine particles") and, optionally, flavor-containing particles (also referred to as "flavor particles"). The capsule may include a predetermined amount of nicotine particles and optional flavor particles. The capsule may contain sufficient nicotine particles to provide at least 2 inhalations or "puffs", or at least about 5 inhalations or "puffs", or at least about 10 inhalations or "puffs". The capsule may contain sufficient nicotine particles to provide about 5-50 inhalations or "puffs", or about 10-30 inhalations or "puffs". Each inhalation or "puff" may deliver about 0.1 mg to about 3 mg of nicotine particles to the user's lungs, or 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.

[0075] The nicotine particles may have any useful concentration of nicotine based on the particular formulation employed. The nicotine particles may have at least about 1% up to about 30% nicotine by weight, or about 2% to about 25% nicotine by weight, or about 3% to about 20% nicotine by weight, or about 4% to about 15% nicotine by weight, or about 5% to about 13% nicotine by weight. Preferably, with each inhalation or "puff", about 50 to about 150 micrograms of nicotine may be delivered to the user's lungs.

[0076] 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, or less than about 300 mg of nicotine particles, or less than 150 mg of nicotine particles. The capsule may hold or contain between about 5 mg and about 300 mg of nicotine particles, or between about 10 mg and about 200 mg of nicotine particles.

[0077] When flavor particles are blended or combined with the nicotine particles in the capsule, the flavor particles may be present in an amount that provides the desired flavor with each inhalation or "puff" delivered to the user.

[0078] The nicotine particles may have any size distribution useful for preferential inhalation delivery into the lungs of the user. The capsule may contain particles other than nicotine particles. The nicotine particles and other particles may form a powder system.

[0079] The capsule may hold or contain at least about 5 mg of dry powder (also called 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, or less than about 300 mg of dry powder, or less than about 150 mg of dry powder. The capsule may hold or contain about 5 mg to about 300 mg of dry powder, or about 10 mg to about 200 mg of dry powder, or about 25 mg to about 100 mg of dry powder.

[0080] The dry powder or powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the powder system consisting of nicotine particles with a particle size of about 5 micrometers or less, or within the range of about 1 micrometer to about 5 micrometers.

[0081] The nicotine-containing 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, or in the range of about 1.5 micrometers to about 2.5 micrometers. The mass median aerodynamic diameter is preferably measured using a cascade impactor.

[0082] The flavor-containing particles may have a mass median aerodynamic diameter of about 20 micrometers or more, or about 50 micrometers or more, or in the range of about 50 to about 200 micrometers, or in the range of about 50 to about 150 micrometers. The mass median aerodynamic diameter is preferably measured using a cascade impactor.

[0083] The dry powders may have a median particle size of about 60 micrometers or less, or in the range of about 1 micrometer to about 40 micrometers, or in the range of about 1.5 micrometers to about 25 micrometers, where median particle size refers to the median particle size per mass and is preferably measured by laser diffraction, laser diffusion, or electron microscopy.

[0084] The filter element can provide a structure that allows particles of a desired size to pass through while preventing larger sized particles from passing through the filter. For example, the filter element can allow dry powders having an average diameter of about 60 micrometers or less to pass through the filter element while preventing dry powders having an average diameter of more than about 60 micrometers from passing through the filter element. Alternatively, if flavor particles are desired, the filter element can provide a structure that allows particles up to 200 micrometers to pass through the filter.

[0085] The nicotine in powder system or nicotine particles can be nicotine free base, or nicotine salt or nicotine salt hydrate that is pharma- ceutical acceptable.Useful nicotine salt or nicotine salt hydrate includes, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine mono-pyruvate, nicotine glutamate, or nicotine hydrochloride.The compound that combines with nicotine to form salt or salt hydrate can be selected based on its expected pharmacological effect.

[0086] Preferably, the nicotine particles include an amino acid. Preferably, the amino acid may be leucine, such as L-leucine. Providing nicotine-containing particles with an amino acid, such as L-leucine, may reduce the adhesive force of the nicotine-containing particles and may also reduce the attractive force between the nicotine particles, thus reducing the aggregation of the nicotine particles. Similarly, it may also reduce the adhesive force to the flavor-containing particles, thus reducing the aggregation of the nicotine particles with the flavor particles. Therefore, the powder system described herein may be a free-flowing material, and has a stable relative particle size of each powder component, even when the nicotine particles and the flavor particles are combined.

[0087] The nicotine may be a surface-modified nicotine salt, in which case the nicotine salt particles include 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.

[0088] The powder system may comprise a population of flavour particles, which may have any size distribution useful for selective inhalation delivery to the mouth or oral cavity of a user.

[0089] The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the population of flavor particles of the powder system comprised of particles with a particle size of about 20 micrometers or more. The powder system may have at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the population of flavor particles of the powder system comprised of particles with a particle size of about 50 micrometers or more. The powder system may be comprised of at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the population of flavor particles of the powder system comprised of particles having a particle size in the particle size range of about 50 micrometers to about 150 micrometers.

[0090] The flavour-containing particles may include a compound to reduce adhesion or surface energy and the resulting agglomeration. The flavour particles may be surface-modified with an adhesion-reducing compound to form coated flavour particles. One preferred adhesion-reducing compound may be magnesium stearate. Providing flavour particles, particularly coating the flavour particles, with an adhesion-reducing compound such as magnesium stearate may reduce the adhesion of the flavour-containing particles and may reduce the attractive forces between flavour particles and therefore reduce the agglomeration of the flavour particles. Hence, the agglomeration of flavour particles with nicotine particles may also be reduced. Thus, the powder system described herein may have a stable relative particle size of the nicotine-containing particles and the flavour-containing particles even when the nicotine and flavour particles are combined. The powder system may preferably be free-flowing.

[0091] Conventional formulations for dry powder inhalation contain carrier particles that function to increase the fluidization of active particles, since the active particles may be too small to be affected by simple airflow through the inhaler.Powder systems may include carrier particles.These carrier particles may be saccharides, such as lactose or mannitol, that may have a particle size of more than about 50 micrometers.Carrier particles may be utilized in formulations to improve dose uniformity by acting as diluents or bulking agents.

[0092] Powder systems utilized with the nicotine powder delivery systems described herein may be carrier-free or substantially free of saccharides such as lactose or mannitol. The absence of carriers or the substantial absence of saccharides such as lactose or mannitol may allow the nicotine to be inhaled and delivered to the user's lungs at an inhalation volume or airflow similar to that of a typical smoking method.

[0093] The nicotine particles and the flavor can be combined in a single capsule. As mentioned above, the nicotine particles and the flavor can each have a reduced adhesive force, which results in a stable particle formulation, in which the particle size of each component does not change substantially when the nicotine-containing particles and the flavor-containing particles are combined. Alternatively, the powder system includes nicotine particles contained in a single capsule and flavor particles contained in a second capsule.

[0094] The nicotine particles and flavor particles may be combined in any useful relative amounts such that the user detects the flavor particles when consumed together with the nicotine particles. Preferably, the nicotine particles and flavor particles form at least about 90% by weight, or at least about 95% by weight, or at least about 99% by weight, or 100% by weight of the total weight of the powder system.

[0095] The holder for the inhaler article comprises a housing with a housing space for receiving the inhaler article, a movable cap for allowing the inhaler article to engage with the piercing element, the piercing element, a protrusion for insertion into the upstream end of the inhaler article when the inhaler article is inserted into the holder, and an air inlet and air flow passage for allowing a swirling airflow through the inhaler article when the inhaler article is engaged in the holder. This swirling or rotating inhalation airflow may be delivered to the inhaler article, rotating and agitating the capsule and releasing the dry powder contained within the capsule. The holder has an open end and a perforated end. The housing space is sized to receive the inhaler article. The inhaler article is inserted into the open end.

[0096] The holder has a piercing element. The piercing element is attached to the inside of the bottom surface of the holder. The piercing element length can be any suitable length relative to the housing length. For example, the piercing element length can be about 25% to about 60%, or about 30% to about 50% of the housing length. The distal end of the piercing element can be fixed at or at a distal end adjacent to the distal end of the housing. The piercing element overall length can be coextensive within the housing length. The piercing element is formed of a rigid material. The rigid material is sufficiently rigid to pierce, puncture, or activate a capsule contained within the inhaler article. The piercing element can be formed of a metal. The piercing element can be formed of stainless steel, such as, for example, 316 stainless steel. The piercing element can be formed of a polymeric material. The piercing element can be formed of a fiber-reinforced polymeric material.

[0097] The piercing element extends through the movable cap. The movable cap is movable relative to the piercing element. When the inhaler article is inserted and pushed into the holder, the movable cap moves downwards in the holder and the piercing element is exposed. When the inhaler article is pressed against the movable cap, the piercing element extends into the inhaler article and pierces the capsule. Perforating the capsule activates the capsule. Perforating the capsule activates the inhaler system. Perforating the capsule allows for the release of powder from the capsule.

[0098] When the inhaler article is inserted into the holder, a portion of the holder is inserted into the upstream end of the inhaler article to open the upstream end of the inhaler article. When a portion of the holder is inserted into the upstream end of the inhaler article, the holder exerts an opening force on the inhaler article. In an embodiment, the portion of the holder that is inserted into the upstream end of the inhaler article is a protrusion. When the inhaler article is inserted into the holder, the protrusion of the holder is inserted into the upstream end of the inhaler article. When the protrusion of the holder is inserted into the upstream end of the inhaler article, the protrusion exerts an opening force on the inhaler article. When the protrusion of the holder is inserted into the upstream end of the inhaler article, the upstream end of the inhaler article is opened. When the protrusion of the holder is inserted into the upstream end of the inhaler article, an opening force is applied to the upstream end of the inhaler article. When the protrusion of the holder is inserted into the upstream end of the inhaler article, which is an elastic element, the elastic element opens. When the inhaler article is removed from the holder, the opening force is removed from the upstream end of the inhaler article. When the opening force is removed from the inhaler article, the elastic element returns to a closed position. When the opening force is removed, the elastic element closes to a closed position.

[0099] When the inhaler article is inserted into the holder, a portion of the holder is inserted into the elastic element at the upstream end of the inhaler article to open the elastic element of the inhaler article. When a portion of the holder is inserted into the elastic element of the inhaler article, the holder applies an opening force to the inhaler article. When a portion of the holder is inserted into the elastic element of the inhaler article, the holder applies an opening force to the elastic element. When a portion of the holder is inserted into the upstream end of the inhaler article, the holder applies an opening force to the upstream end of the inhaler article. When the inhaler article is removed from the holder, the opening force is removed from the upstream end of the inhaler article. When the opening force is removed from the inhaler article, the elastic element returns to the closed position. When the opening force is removed, the elastic element closes to the closed position.

[0100] The protrusions can be shaped and sized to optimize insertion into the upstream end of the inhaler article. The protrusions can be shaped and sized to optimize insertion into the elastic element of the inhaler article. For example, if the elastic element has a central opening, the protrusions can be angled to optimize insertion into the central opening and expansion of the elastic element. There can be more than one protrusion. For example, there can be two protrusions. There can be three protrusions. There can be four protrusions. There can be five protrusions. There can be six protrusions. There can be seven or more protrusions. Alternatively, the protrusions can refer to an annular ring that is inserted into the upstream end of the inhaler article. Alternatively, the protrusions can refer to an annular ring that is inserted into the elastic element of the inhaler article.

[0101] The housing may be formed of any rigid material. The housing may be formed of a polymeric material. Polymeric materials useful for forming the housing include, for example, polycarbonate, polypropylene, polyethylene, nylon, acrylonitrile, butadiene styrene, styrene acrylonitrile, polyacrylate, polystyrene, PBT polyester, PET polyester, polyoxymethylene, polysulfone, polyethersulfone, polyetheretherketone, or liquid crystal polymer.

[0102] The present disclosure provides an inhaler article having a pharma- ceutically active dry powder contained within a capsule to a user's lungs. An inhaler article is disclosed herein that contains a capsule, the capsule containing a pharma- ceutically active powder. In an embodiment, the pharma- ceutically active powder contains nicotine, but other pharma- ceutically active powders are contemplated in the present disclosure, as described below. The inhaler article can be used to deliver the pharma- ceutically active powder to a user when the user inhales from the mouthpiece end (downstream end, proximal end) of the inhaler article. To deliver the pharma- ceutically active dry powder contained within the capsule to a user, the pharma- ceutically active powder is released from the capsule, the powder is aerosolized, and inhaled by the user. That is, the powder is released from the capsule and entrained in the airflow generated by the user when the user inhales from the mouthpiece end (downstream end, proximal end) of the inhaler article.

[0103] According to the present disclosure, the inhaler article has a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end. Inside the tubular body is a capsule space. The capsule space contains a capsule containing a pharma- ceutically active powder.

[0104] In order to release the pharma- ceutically active powder from a capsule contained in the capsule space of the inhaler article, the capsule must be opened in a manner that allows the release of the powder contained inside the capsule. In one embodiment, the capsule is pierced. When the capsule is pierced, a hole is introduced into the capsule. This releasing or piercing process can also be considered as "actuation". According to the present disclosure, the capsule is actuated when it is pierced by a piercing element. In an embodiment, the piercing element is disposed in the holder.

[0105] When the inhaler article is inserted into the holder, the upstream end of the inhaler article is inserted into the holder. During the insertion of the inhaler article into the holder, the inhaler article is pressed against a piercing element disposed in the holder, and the capsule can be pierced by the piercing element. When inserted, the downstream end of the inhaler article extends from the holder and can reach the mouth of the user. When the capsule is pierced or actuated, the powder contained in the capsule can be released from the capsule. The powder from the capsule can then be released into the airflow and inhaled by the user. The inhaler article is inserted into the holder to form an inhaler system, the capsule is pierced by the piercing element of the holder, and the airflow is initiated by the user, the airflow passes through the inhaler article, entraining the powder released from the capsule, and the pharma- ceutically active powder is delivered to the mouth of the user.

[0106] Although the holder is separate from the inhaler article, a consumer may utilize both the inhaler article and the holder while consuming the particles released in the inhaler article. A plurality of these inhaler articles may be combined with a holder to form a system or kit. A single holder may be utilized with 10 or more, or 25 or more, or 50 or more, or 100 or more inhaler articles to activate (puncture or pierce) and reliably activate the capsules contained within each inhaler article.

[0107] The holder for an inhaler article comprises a housing with a housing space for receiving an inhaler article and configured to hold the inhaler article within the housing space. The movable cap is in the housing space and is movable within the housing space along a longitudinal axis of the housing. The movable cap has a protrusion. The protrusion of the movable cap is configured to be inserted into the inhaler article when the inhaler article is introduced into the holder. The movable cap is configured to move relative to the piercing element. When the inhaler article is introduced into the housing space of the holder, the inhaler article is pushed into the holder. When the inhaler article is pushed into the housing space, the protrusion of the movable cap is inserted into the upstream end of the inhaler article. At the same time, the inhaler article is pushed into the housing relative to the movable cap. The movable cap moves downward. When the movable cap moves, the piercing element extends through the movable cap, and the capsule inside the inhaler article comes into contact with the piercing element and is pierced by the piercing element. The inhaler article is then removed and the movable cap returns to a rest position. The movable cap can be returned to the rest position by a spring. After the capsule has been punctured, the position of the inhaler article inserted into the holder is shown in Figure 2 below.

[0108] The protrusion of the movable cap can be inserted into the upstream end of the inhaler article through the elastic element at the upstream end of the inhaler article.

[0109] The method includes inserting an inhaler article into a housing space of a holder for an inhaler article as described herein. The inhaler article includes a body (the body extends along the inhaler longitudinal axis from the mouthpiece end to the distal end), a length of the body, and a capsule disposed within the inhaler article body. The inhaler article and sleeve are then moved toward the piercing element until the piercing element penetrates the capsule. Air is then drawn into a second opposite end of the housing space of the holder to form a swirling inhalation airflow. This swirling inhalation airflow is then transmitted into the inhaler article while the inhaler article is disposed within the holder for the inhaler article. The spent inhaler article may then be removed from the holder. When the spent inhaler is removed from the holder, the elastic element closes sufficiently to prevent the capsule from falling out of the used inhaler article. The spent inhaler article can be safely discarded. An unused inhaler article can then be inserted into the holder and the method repeated.

[0110] The inhaler article associated with the holder described above is configured to receive a swirling inhalation airflow directly into the distal end of the inhaler article. The swirling inhalation airflow is initiated when a user "inhales" on the downstream end of the inhaler article inserted into the holder. This creates a negative pressure inside the inhaler article. As a result of this negative pressure, air enters the holder through the air inlet. The air then travels through an air passage in the holder. When inserted into the holder, the air passage in the holder directs air into the inhaler article at a tangential angle to the longitudinal axis of the inhaler article. This tangential air generates a swirling airflow within the inhaler article when the inhaler article is inserted into the holder. This swirling airflow rotates and / or agitates the capsule within the inhaler article. This capsule agitation improves the flow of powder from the activated capsule and increases the efficiency of powder entrainment in the airflow delivered to the user.

[0111] The elastic element may be made of any material suitable for opening and closing. For example, the elastic element may be made of silicone. The elastic element may be made of latex. The elastic element may be made of rubber. The elastic element may be made of plastic. The elastic element may be made of paper. The elastic element may be made of aluminum foil. The elastic element may be made of layered PLA laminated onto a paper layer. The elastic element may be made of cardboard. The elastic element may be made of silicone, latex, or rubber. The elastic element may be made of silicone, latex, rubber, or a combination thereof.

[0112] The elastic element may be attached to the inhaler article. The elastic element may be attached to the inhaler article by any means. For example, the elastic element may be attached to the inhaler article by adhesion, frictional engagement, heat sealing, or any means.

[0113] The elastic material may be cut into disks from a ribbon of material suitable for forming the elastic elements. The ribbon of elastic material may be fed from a feeder reel to a take-up reel along a cutting stage. The disks forming the elastic elements may be cut by a cutter in the cutting stage. Further, in the cutting stage, cuts may be made to form elastic elements having cuts and flaps, or a central opening may be cut in the elastic element disk, or both a cut and a central opening may be cut in the elastic element.

[0114] The cut discs may be transported to a gluing station by a holder. The adhesive may be introduced to the gluing stage. For example, the adhesive may be applied to the stage. The adhesive may be pressure fed into a ring of adhesive slightly smaller in size than the diameter of the elastic element disc at the gluing stage. The adhesive may be applied to the cut discs at the gluing stage by placing the cut discs in the ring of adhesive. The cut discs with the applied adhesive may then be attached to the upstream end of the inhaler article. The adhesive may be any adhesive known in the art. For example, the adhesive may be a water-based adhesive or a hot melt adhesive. EXAMPLES

[0115] The present invention is defined in the claims. However, below is provided a non-exhaustive list of non-limiting examples. Any one or more of the features of these examples may be combined with any one or more features of the other examples, embodiments, or aspects described herein.

[0116] Example 1: 1. A method of manufacturing an inhaler article having an upstream elastic element that is inserted into a holder to form an inhaler system for delivering dry powder to a user's lungs, the method comprising: transferring a ribbon of elastic material from a feeder reel to a cutting stage; disposing the ribbon of elastic material at the cutting stage; cutting at least one disk of elastic material from the ribbon of elastic material to form at least one disk of cut elastic material; disposing the at least one disk of cut elastic material at a bonding stage; providing at least one ring of adhesive; applying the at least one ring of adhesive to the at least one disk of cut elastic material; disposing the at least one disk of cut elastic material with the ring of adhesive applied to an upstream end of an inhaler article; and attaching the at least one disk of cut elastic material with the ring of adhesive applied to the upstream end of the inhaler article to form an inhaler article having an upstream elastic element attached thereto. Example 2: The method of example 1, wherein the cutting step further comprises making at least two cuts in at least one of the disks of elastic material to form at least four flaps in each cut disk. Example 3: The method of example 1, wherein the cutting step further comprises making at least three cuts in at least one of the disks of elastic material to form at least six flaps in each cut disk. Example 4: The method of example 1, wherein the cutting step further comprises making at least four cuts in at least one of the disks of elastic material to form at least eight flaps in each cut disk. Example 5: The inhaler article of any one of Examples 2-4, wherein the incision extends over a range of about 65% to about 95% of the diameter of the elastic element. Example 6: The method of any one of claims 1-5, further comprising cutting a central opening in at least one disk of elastic material. Example 7: The method of example 6, wherein the central opening has a diameter that is less than 30% of the diameter of the elastic element. Example 8: The method of any one of claims 1-7, further comprising transferring the ribbon of elastic material from the cutting stage to a take-up reel. Example 9: The method of any one of Examples 1 to 8, further comprising the step of inserting the capsule into the inhaler article prior to the attaching step. Example 10: The method according to any one of Examples 1 to 9, wherein the elastic element is made from silicone, latex, plastic, paper, aluminum foil, paper tape, laminated layered materials, such as a PLA layer on a paper layer, or cardboard. Example 11: The method of any one of claims 1-10, wherein the elastic element comprises rubber, silicone, or latex. Example 12: A method according to any one of Examples 1 to 11, wherein the inhaler article comprises a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end, a capsule space within the tubular body between the downstream mouthpiece end and the upstream end, and a capsule space containing a capsule, the upstream boundary of the capsule space being defined by an elastic element, and the affixed elastic element retains the capsule within the capsule space. Example 13: The method of example 12, wherein the downstream mouthpiece end is provided with a blocker element. Example 14: The method according to any one of examples 1 to 13, wherein the tubular body is made of cardboard. Example 15: The method according to any one of Examples 12 to 14, wherein the capsule comprises a nicotine-containing pharma- ceutically active dry powder. Example 16: The method according to any one of examples 1 to 15, wherein the elastic material comprises a color.

[0117] The embodiments will now be further described with reference to the figures.

[0118] The schematic diagrams are not necessarily to scale and are presented for purposes of illustration, not limitation. The drawings illustrate one or more aspects described in the present disclosure. However, it will be understood that other aspects not shown in the drawings fall within the scope and spirit of the present disclosure.

[0119] 1A and 1B show an embodiment of an inhaler article 100 of the present disclosure. FIG. 1A illustrates an inhaler article 100 having an upstream end 120 (also the distal end), a downstream end 130 (also the proximal or mouthpiece end), and a tubular body 121 extending from the downstream end 130 to the upstream end 120 along a longitudinal axis 122. FIG. 1A shows an embodiment of an inhaler article having an elastic element 101 at the upstream end 120 with a cut 104 to form a flap 103. FIG. 1A shows the cut 104 and the flap 103 formed by the cut 104. FIG. 1A and 1B also show a capsule space 123 that contains a capsule 125. FIG. 1B shows an embodiment of an inhaler article having an elastic element 101 at the upstream end 120, the elastic element having a central opening 105. 1A and 1B also show that the inhaler article 100 may have a blocker 131 disposed near the downstream end 130 of the inhaler article 100.

[0120] The tubular body 121 may be made of a carton or wrapping paper rolled into a tube. The elastic element 101 has openings formed by incisions 104 forming flaps 103, as shown in FIG. 1A. These incision flaps 103 form openings in the elastic element 101. In FIG. 1B, a central opening 105 is shown. These openings provide access so that when the inhaler article 100 is placed in the holder 200 and the capsule 125 is actuated, the piercing pin 205 can reach and pierce the capsule 125. At the same time, these openings are smaller than the diameter of the capsule 125, preventing the capsule 125 from falling out of the inhaler article 100 before, during or after use.

[0121] FIG. 2 shows the inhaler article 100 of the present disclosure inserted into a holder 200 forming an inhaler system 300. The inhaler article 100 comprises a capsule 125, a capsule space 123, and a tubular body 121. The holder 200 comprises a housing 201 defining a housing space 216. The housing space 216 comprises an open end 220 and a perforated end 221. When the inhaler article 100 is introduced into the holder 200, into the housing space 216, the inhaler article 100 presses against a movable cap 202 at the distal end of the housing space 216. The movable cap 202 comprises protrusions 210. These protrusions 210 may be part of the movable cap or may be separate from the movable cap. The protrusions 210 are disposed within the housing space 216. When the inhaler article 100 is inserted into the holder 200, the protrusions 210 are configured to be inserted into the tubular body 121 of the inhaler article 100. The movable cap 202 moves downwards relative to the housing 201. As the inhaler article and the movable cap 202 move downwards relative to the housing 201, the piercing pin 205 extends through a resilient element (not shown in FIG. 2, but see FIGS. 3A and 3B) and pierces the capsule 125.

[0122] There is an air inlet 206 through the housing 201 of the holder 200 that allows air to enter the inhaler system 300. Air flows into the inhaler system 300 from the air inlet 206 through the airflow path 301, through the airflow channel 208 through the movable cap 202, and into the capsule space 123 of the inhaler article 100. The airflow channel 208 is tangential to the longitudinal axis 122 of the inhaler article 100 (and the capsule space 123), so that air flowing through the capsule space 123 follows a swirling airflow path 302. In an embodiment, there is one airflow channel 208. In an embodiment, there are two airflow channels 208. In an embodiment, there are more than two airflow channels 208.

[0123] When using such an article, a user inserts the inhaler article 100 into the holder 200 to form an inhaler system 300. Upon inserting the inhaler article 100 into the holder 200, the user presses down on the inhaler article, which causes the movable cap 202 to move relative to the piercing pin 205, which in turn causes the capsule 125 contained in the capsule space 123 of the inhaler article to move into contact with the piercing pin 205, puncturing the capsule 125. Once the capsule 125 has been pierced, the movable cap 202 retracts, for example, under the action of a spring 212. The movement of the movable cap is indicated by arrow 215.

[0124] After the capsule 125 is punctured, the air flows into the system through the air inlet 206, through the airflow passage 208, through the capsule space 123, and out of the system to the user through the downstream end 130 of the inhaler article 100, where the powder released from the punctured capsule 125 is entrained in the airflow path 302, which sends the powder to the downstream end 130 (mouthpiece end) of the inhaler 100, where it is inhaled by the user. This airflow is initiated by the user inhaling at the downstream end 130, the mouthpiece end, of the inhaler article 100. Furthermore, the swirling airflow path 302 provides an agitating or swirling airflow that agitates the capsule 125 inside the capsule space 123, and also improves the release of powder from the capsule 125 during use.

[0125] It may be desirable to generate an effective airflow through the inhaler system 300 and entrain a suitable amount of powder in the airflow to provide a suitable dose of powder to the user. The powder is released from the capsule 125 through a hole introduced into the capsule by the piercing pin 205. This piercing pin 205 also penetrates the upstream end 120 of the inhaler article 100. When the upstream end 120 of the inhaler article 100 is closed, the piercing pin 205 pierces the upstream end 120 of the inhaler article 100. The hole created by the piercing pin 205 in the upstream end 120 of the inhaler article is generally related to the size of the piercing pin 205. Generally, the hole created by the piercing pin 205 is not large enough to allow sufficient airflow through the inhaler system 300 to provide a suitable dose of powder to the user. That is, small holes at the upstream end 120 of the inhaler article 100 of the inhaler system 300 introduce a large resistance to draw (RTD) into the system, resulting in a system in which there is not enough airflow to provide the user with a suitable dose of powder released from the capsule 125. One solution to this RTD problem is to provide an inhaler article 100 with an upstream end 120 that can be opened. A solution to this RTD problem is to provide an inhaler article 100 with a resilient element 101 at the upstream end 120 of the inhaler article 100, which resilient element 101 is opened by an opening force provided by the structure of the holder, e.g., the protrusion 210, to create an open airflow area, improving the RTD of the overall system.

[0126] After using the inhaler system 300, the user can withdraw the inhaler article 100 from the holder 200. After the inhaler article 100 is withdrawn from the holder, the elastic element 101 returns to its pre-use state or approximately its pre-use state. That is, the elastic element 101 opens to an open position in response to an opening force, and closes to a closed position when the opening force is removed. When the elastic element is in the closed position, the elastic element is sufficiently closed such that the capsule is held in the capsule space between the downstream mouthpiece end and the elastic element.

[0127] It may be desirable to ensure that the capsule 125 containing the active ingredient is held within the inhaler article before and after insertion of the inhaler article 100 into the holder 200. Additionally, it may be desirable to prevent powder from spilling out of the inhaler article 100 before and after insertion of the inhaler article 100 into the holder 200. It may be desirable to prevent capsule powder from falling out or spilling out of the inhaler article 100 before and after use. Providing an inhaler article 100 with an open upstream end 120 would not allow the capsule 125 to be held within the capsule space 123 of the inhaler article 100. The present disclosure provides a solution that addresses both the RTD challenge and the retention challenge. The solution is an elastic element at the upstream end of the inhaler article, which can be closed (or relatively closed) to hold the capsule and powder before and after insertion into the holder 200 to form the inhaler system 300, and can be opened during insertion into the holder 200 during use to provide a proper airflow and a proper dose of powder to the user of the inhaler system 300.

[0128] Additionally, it may be desirable to provide a resilient element 101 attached or affixed to the upstream end of the inhaler article 100, the resilient element 101 being sufficiently affixed so that the resilient element 101 cannot be easily removed.

[0129] 2, when inserting the inhaler article into the holder, the user simultaneously moves the movable cap 202 to pierce the capsule 125 and insert the insert of the movable cap 202 into the inhaler article to provide an airflow opening at the upstream end 120 of the inhaler article 100, thereby providing a suitable RTD for proper operation of the inhaler system 300. That is, the hole at the upstream end 120 of the inhaler article 100 is large enough for the inhaler system to function when the insert of the movable cap is inserted into the inhaler article and the elastic element 101 moves or stretches open.

[0130] Furthermore, the elastic element returns (partially or completely) to its pre-insertion state when the inhaler article 100 is removed from the holder 200. When the elastic element 101 returns to its pre-insertion state, the capsule 125 and powder are contained within the inhaler article 100.

[0131] The protrusions 210 are illustrated as pillars that are inserted into the inhaler article in Figure 3. There may be more than one protrusion 210. For example, there may be two protrusions 210. There may be three protrusions 210. There may be four protrusions 210. There may be five protrusions 210. There may be six or more protrusions 210. The protrusions 210 may be annular ring structures. The protrusions 210 may be cone structures that are inserted into a central opening to stretch and open the central opening. The protrusions 210 may be any suitable shape or size to open the elastic element of the inhaler article.

[0132] 3A and 3B illustrate the insertion of an inhaler article 100 having an elastic element 101 with a notched flap 103 into a holder 200. The arrows in Figs. 3A and 3B illustrate the insertion of the inhaler article 100 into the holder 200. Fig. 3A illustrates an inhaler article having an elastic element 101 at its upstream end 120 that is notched to form a flap 103. Fig. 3B illustrates an inhaler article 100 having an elastic element 101 at its upstream end 120 that is notched to form a flap 103, inserted into the holder 200, where the flap 103 is opened by a protrusion 210 of a movable cap (not shown) of the holder 200. Fig. 3B illustrates that when the inhaler article 100 is inserted into the holder 200, the pin 205 pierces the capsule 125 in the capsule space 123 of the inhaler article 100.

[0133] After using the inhaler system 300, the user can withdraw the inhaler article 100 from the holder 200. After the inhaler article 100 is withdrawn from the holder and the insert of the movable cap 210 is withdrawn from the inhaler article 100, the elastic element 101 returns to its pre-use state, or approximately its pre-use state. After use, the flap 103 on the upstream end 120 of the inhaler article 100 returns to a closed state, for example, as shown in FIG. 1A.

[0134] 4A and 4B illustrate the insertion of an inhaler article 100 of the present disclosure into a holder 200 to form an inhaler system 300. The arrows in Fig. 4A and 4B illustrate the insertion of the inhaler article 100 into the holder 200. Fig. 4A illustrates an inhaler article 100 having an elastic element 101 at an upstream end 120, the elastic element 101 having a central opening 105. Fig. 4B illustrates an inhaler article 100 having an elastic element 101 at an upstream end 120 with a central opening 105, inserted into the holder 200, where the central opening 105 is opened to form an airflow opening 140. The central opening 105 is opened by an opening force exerted by a protrusion 210 by inserting an insert of a movable cap 210 through the central opening 105 of the elastic element 101 of the inhaler article 100 to form an airflow opening.

[0135] After using the inhaler system 300, the user can withdraw the inhaler article 100 from the holder 200. After the inhaler article 100 is withdrawn from the holder and the insertion projection 210 of the movable cap (not shown) is withdrawn from the inhaler article 100, the elastic element 101 returns to its pre-use state or approximately its pre-use state. After use, the central opening 105 of the elastic element 101 returns to a closed state, for example as shown in FIG. 1B.

[0136] 5A, 5B, 5C, 5D, 5E, 5F, and 5G illustrate an embodiment of an inhaler article of the present disclosure having an elastic element 101 at its upstream end that is cut to form a flap 103. The number of cuts 104 and the length of the cuts 104 define the shape of the flap 103 formed by the cuts 104. FIG. 5A illustrates a flap 103 that folds back to form an internal opening. FIG. 5A shows that the number of cuts 104 defines the arc 135 and the shape of the flap 103 that the flap folds inward. The number of cuts (3 diametric cuts as shown in FIG. 5B, or 6 radial cuts, or 8 radial cuts as shown in FIG. 5C, or 4 diametric cuts) changes the arc 135. Increasing the number of cuts results in a smaller arc 135. For example, if there are two diametric cuts, four flaps will be formed. For example, as shown in FIG. 5B, when there are three diametric or six radial cuts, six flaps are formed, and for an inhaler article with a diameter of 10 mm, the arc 135 is 3.14 mm. When there are four diametric or eight radial cuts, as shown in FIG. 5C, eight flaps are formed, and for an inhaler article with a diameter of 10 mm, the arc 135 is 2.34 mm. Increasing the number of cuts 104, and therefore the number of flaps 103, reduces the arc 135. Furthermore, the length of the cuts 104 affects the arc 135. Changing the shape of these flaps and changing the arc 135 can affect the degree to which the flaps can open during use. Furthermore, adjusting the length of the cuts 104 and the number of flaps 103 allows the use of different materials for the elastic element 101. For example, increasing the number of flaps makes the elastic material less elastic, allowing the flap 103 to return to its original shape, or nearly its original shape, after opening. In embodiments, the elastic material may be, for example, silicone, latex, rubber, plastic, paper, aluminum foil, paper tape, a layer of paper or laminated PLA on cardboard. If greater elasticity is required, the material may be selected from silicone, latex, rubber, or a combination.In an embodiment, the elastic element may be, for example, less than 0.5 mm thick.

[0137] Additionally, as shown in Figures 5D, 5E, and 5F, the length of the incision can also affect the size and shape of the flap and arc 135. The size of the flap 103, the length of the incision 104, and the shape of the arc 135 can be adjusted in correlation with the material of the elastic element to optimize the ability of the elastic element to close before and after use, and open during use to form a proper airflow path when the inhaler article 100 is inserted into the holder 200 to form the inhaler system 300. Figures 5D, 5, and 5F illustrate the incision 104 forming the flap 103, which extends about 90% of the diameter of the inhaler article (Figure 5D), about 78% of the diameter of the inhaler article (Figure 5E), and about 65% of the diameter of the inhaler article (Figure 5F). Figure 5G is a photograph of one embodiment of an inhaler article of the present disclosure having an elastic element at the upstream end, pre-cut to form flaps, and having six radial incisions, forming six flaps. FIG. 5G is a diagram of one embodiment of an inhaler article 100 having a central opening 105 and cuts 104 forming flaps 103. In an embodiment, the elastic element 101 is cut to form at least four flaps. In an embodiment, the elastic element 101 is cut to form at least six flaps. In an embodiment, the elastic element 101 is cut to form four, six, or eight flaps. Such a number of flaps provides the arc region of the elastic element with good flexibility and tear resistance (when pressed into the holder 200) while providing adequate stiffness to return the article to its original position when removed from the holder 200. In an embodiment, the cuts extend about 65% to 95% of the diameter of the elastic element 101.

[0138] In embodiments, the incisions are the same length, intersect at the center of the elastic element, and are angled similarly to one another so that forces on the flaps are symmetrically distributed when pressed into the holder 200. Providing this symmetry helps prevent the elastic element from tearing when the inhaler article is inserted into the holder, and can contribute to the desired opening and closing of the elastic element.

[0139] 6A, 6B and 6C illustrate an embodiment of an inhaler article of the present disclosure having an elastic element 101 at its upstream end, the elastic element 101 having a central opening 105. FIG. 6A is a view of the central opening 105 of the elastic element 101 mounted on the upstream element 18 at the upstream end 120 of the inhaler article 100. FIG. 6B is another view of an inhaler article 100 of the present disclosure having an elastic element 101 at its upstream end 120, the elastic element having a central opening 105. In an embodiment, the elastic element 101 is mounted on the upstream element 18. The upstream element 18 may or may not be present. FIG. 6C is a view of an elastic element 101 having only a central opening 105. In another embodiment, the elastic element may have a combination of a central opening and a flap. For example, the central opening may be partially cut or weakened. In an embodiment, the diameter of the central hole may be about 30% of the disk diameter or may be less than 30%.

[0140] 7A, 7B, 7C, and 7D are diagrams of an embodiment of an inhaler article 100 of the present disclosure. FIG. 7 is a diagram of an elastic element 101 with a ring of adhesive 108 applied thereto before the elastic element 101 is attached to the upstream end 120 of the inhaler article 100. FIG. 7B is a photograph of an embodiment of the upstream end 120 of the inhaler article 100 before the elastic element 101 is attached. The upstream end 120 of the inhaler article may be the upstream element 18 or may be the upstream end 120 of the tubular body 121. FIG. 7C is a diagram of attaching the elastic element 101 to the upstream end 120 of the inhaler article 100. FIG. 7D shows a diagram of the inhaler article 100 after the elastic element has been attached to the upstream end 120 of the inhaler article 100. In an embodiment, the elastic element may have indicia. For example, the elastic element may be colored. Or, the elastic element may have one or more symbols. Alternatively, the elastic element may have both a color and one or more symbols.

[0141] 8A, 8B, and 8C illustrate a manufacturing apparatus 400 and method for manufacturing an embodiment of an inhaler article 100 having an elastic element 101 affixed to the upstream end 120 of the inhaler article 100. The manufacturing apparatus 400 operates to cut a round disk of elastic material to form an elastic element 101 that fits into the upstream end 120 of the inhaler article 100. FIG. 8A shows a ribbon cutter 403 having a feeder reel 401, a ribbon of elastic material 402, a cutter 403, a cutting stage 405, and a take-up reel 404. In use, as shown in FIG. 8A, the feeder reel 401 contains an uncut ribbon of elastic material 402. The uncut ribbon of elastic material 402 is transferred from the feeder reel 401 to the cutting stage 405. The ribbon of elastic material 402 is positioned in the cutting stage 405. The cutting stage 405 is aligned with the ribbon cutter 403. The cutter 403 cuts a disk of round elastic material to create the elastic element 101. Additionally, the cutter 403 may cut a flaps 103 into the elastic element to form the elastic element 101 with the flaps 103. Alternatively, the cutter 403 may cut a central opening 105 in the disk to form the elastic element 101 with the central opening 105. Alternatively, the cutter 403 may create the slits 104 or the central opening 105 in the elastic element 101 in separate cutting steps. Alternatively, the cutter 403 may create the slits 104 and the central opening 105 in the same cutting operation. After the disk is cut from the ribbon 402, the used ribbon 406 advances to the take-up reel 404. FIG. 8B shows a bonding station 500 having a bonding stage 501 for providing a ring of adhesive to the disk or elastic element as required during the manufacturing process. 8C shows an element holder 600 which, in use, holds three elastic elements which are placed in a gluing stage 502 for applying adhesive to the cut elastic elements during the manufacturing process. Or, stated another way, at least one disc of cut elastic material having a ring of adhesive applied thereto is placed at the upstream end of the inhaler article.

[0142] 9A and 9B illustrate a manufacturing system and method for manufacturing an embodiment of an inhaler article 100 having an elastic element 101 affixed to the upstream end 120 of the inhaler article 100. FIG. 9A shows a cutting process in which a ribbon of elastic material 402 moves from a feeder reel 401 to a cutting stage 405. The ribbon of elastic material is disposed in the cutting stage 405 and a ribbon cutter 403 moves with the ribbon of elastic material 402 to the cutting stage 405. The cutter cuts at least one disk of elastic material from the ribbon of elastic material to form at least one cut disk of elastic material. As shown in FIGS. 9A and 9B, there are three cutters 403. The cutters 403 are modular and may be combined to optimize the manufacturing process. In an embodiment, there may be one cutter 403. In an embodiment, there may be two cutters 403. In an embodiment, there may be three cutters 403. In an embodiment, there may be more than two cutters 403. The ribbon cutter 403 cuts the disk of elastic material from the ribbon of elastic material 402. The cuts can be made by press cutting, knife cutting, laser cutting, or any means. Figure 9B illustrates the step of removing the disk of elastic material from the cutting stage 405. Once the cuts are made, the disk of elastic material can be removed from the cutting stage 405 and proceed to the next step in the manufacturing process. Additionally, the cut ribbon 406 advances to a take-up reel and new uncut ribbon is placed in the cutting stage 405 so the cutting step can be repeated. The cutting step can also include scoring lines in the elastic element to form flaps, or cutting a central opening in the elastic element, or a combination of a central opening and a flap in the elastic element.

[0143] 10A, 10B, and 10C show a manufacturing apparatus and method for manufacturing an embodiment of an inhaler article 100 having an elastic element 101 affixed to the upstream end 120 of the inhaler article 100. FIGS. 10A, 10B, and 10C illustrate the gluing step of the manufacturing process. FIG. 10A illustrates the step of feeding an elastic element to a gluing station 500 to apply at least one ring of adhesive to at least one disc of cut elastic material. FIG. 10B illustrates the step of carrying the ring of adhesive 502. FIG. 10C illustrates the step of applying adhesive to the disc of cut elastic material or elastic element 101. FIG. 10A illustrates the step of placing the disc of cut elastic material 101 at the gluing station 500. The gluing stage 501 has the ring of adhesive 502. The elastic element 101 is placed in the gluing stage 501 by an element holder 600.

[0144] FIG. 10A illustrates the adhesive ring 502 before adhesive is applied to the adhesive ring 502. FIG. 10B illustrates the gluing stage 501 and the adhesive ring 502 after adhesive has been applied to the adhesive ring 502. In other words, as shown in FIG. 10B, the adhesive ring is loaded with adhesive. In an embodiment, adhesive may be applied to the adhesive ring 502 by forcing adhesive from a reservoir of adhesive below the gluing stage 501 into the adhesive ring 502. FIG. 10C illustrates applying adhesive to the adhesive side of the elastic element 101 by pressing the cut elastic element 101 onto the gluing stage 501. The adhesive side of the elastic element is the side that will be attached to the inhaler article 100. FIG. 10C illustrates applying at least one adhesive ring to at least one cut disk of elastic material. The cut disk may be transported to the gluing station by the element holder 600. Adhesive may be introduced into the gluing stage 500. For example, adhesive may be applied to the stage. The adhesive may be pressure fed into a ring of adhesive slightly smaller in size than the diameter of the elastic element disk at the bonding stage 500. In an embodiment, the adhesive may be placed in the ring of adhesive by forcing adhesive into the ring of adhesive from a reservoir of adhesive below the bonding stage. Alternatively, the adhesive may be placed in dots, discontinuous rings, thick rings, thin rings, or any other shape to provide adhesive to the adhesive station. Suitable adhesives may include starch adhesives, e.g., dextrin, casein-based adhesives, polyamide blue, hot melt adhesives, cyanoacrylates, organic adhesives, or any other suitable adhesives.

[0145] 11A, 11B, and 11C illustrate a manufacturing apparatus and method for manufacturing an embodiment of an inhaler article having an elastic element 101 affixed to the upstream end 120 of the inhaler article 100. FIG. 11A illustrates a perspective view of the elastic element 101 having a ring of adhesive 503 applied thereto after the manufacturing process of FIG. 10C. FIG. 11B illustrates a view of the inhaler article 100 positioned adhesive side-on of the elastic element 101 having the ring of adhesive 503 applied thereto. FIG. 11B illustrates the step of placing at least one cut disk of elastic material having a ring of adhesive 502 applied thereto at the upstream end 120 of the inhaler article 100 to affix at least one cut disk of elastic material 101 having a ring of adhesive applied thereto to the upstream end of the inhaler article to form an inhaler article having an affixed upstream elastic element 101. FIG. 11C illustrates an embodiment of an inhaler article having an elastic element 101 affixed to the upstream end 120 of the inhaler article 100 at the end of the manufacturing process. 11C illustrates an embodiment of an elastic element 101 having notches 104 to form flaps 103, an embodiment of an elastic element 101 having a central opening 105, and an embodiment of an elastic element 101 having both notches 104 and a central opening 105 to form flaps 103. The embodiment of an elastic element 101 having both notches 104 and a central opening 105 to form flaps 103 is shown in perspective and top views for clarity. Additionally, the embodiment of FIG. 11C illustrates an elastic element 101 on an upstream element 18. In an embodiment, the upstream element 18 may or may not be present.

[0146] For the purposes of this specification and the appended claims, unless otherwise indicated, all numbers expressing amounts, quantities, percentages, and the like are understood to be modified in all instances by the term "about." Also, all ranges include the maximum and minimum points disclosed, and include any intermediate ranges therein, which may or may not be specifically recited herein. Thus, in this context, the number A is understood as A±10% of A. Within this context, the number A may be considered to include a numerical value that is within the general standard error for the measurement of the property that the number A modifies. The number A may, in some instances used in the appended claims, deviate by the percentages recited above, provided that the amount by which A deviates does not materially affect the basic and novel properties of the claimed invention. Also, all ranges include the maximum and minimum points disclosed, and include any intermediate ranges therein, which may or may not be specifically recited herein.

Claims

1. 1. A method of manufacturing an inhaler article having an upstream resilient element for insertion into a holder to form an inhaler system for delivering dry powder to a user's lungs, the method comprising: transferring a ribbon of elastic material from a feeder reel to a cutting stage; placing the ribbon of elastic material on the cutting stage; severing at least one disk of elastic material from said ribbon of elastic material to form at least one severed disk of elastic material; placing the at least one cut disk of elastic material on a bonding stage; providing at least one ring of adhesive; applying said at least one ring of adhesive to said at least one cut disk of elastomeric material; placing said at least one cut disk of elastomeric material having a ring of adhesive applied thereto at an upstream end of an inhaler article; and affixing the at least one cut disk of elastomeric material having a ring of adhesive applied thereto to the upstream end of an inhaler article to form an inhaler article having an affixed upstream elastomeric element.

2. 2. The method of claim 1, wherein the cutting step further comprises making at least two cuts in the at least one disk of elastic material to form at least four flaps in each cut disk.

3. 2. The method of claim 1, wherein the cutting step further comprises making at least three cuts in the at least one disk of elastic material to form at least six flaps in each cut disk.

4. 10. The method of claim 1, wherein the cutting step further comprises making at least four cuts in the at least one disk of elastic material to form at least eight flaps in each cut disk.

5. The method of any one of claims 2 to 4, wherein the cuts extend between about 65% and about 95% of the diameter of the elastic element.

6. The method of any one of claims 1 to 5, further comprising cutting a central opening in said at least one disk of elastic material.

7. The method of claim 6 , wherein the central opening has a diameter that is less than 30% of a diameter of the elastic element.

8. The method of any one of claims 1 to 7, further comprising transferring the ribbon of elastic material from the cutting stage to a take-up reel.

9. The method of any one of claims 1 to 8, further comprising the step of inserting a capsule into the inhaler article prior to the attaching step.

10. The method of any one of claims 1 to 9, wherein the elastic element comprises rubber, silicone, or latex.

11. 13. The inhaler article, a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end; a capsule space within the tubular body between the downstream mouthpiece end and the upstream end; The capsule space accommodates a capsule, an upstream boundary of the capsule space is defined by the elastic element; The method according to any one of claims 1 to 10, wherein the attached elastic element holds the capsule within the capsule space.

12. The method of claim 11 , wherein the downstream mouthpiece end comprises a blocker element.

13. 13. The method of claim 11 or 12, wherein the tubular body is made of cardboard.

14. The method according to any one of claims 11 to 13, wherein the capsule contains a nicotine-containing pharma- ceutically active dry powder.

15. The method of any one of claims 1 to 6, wherein the elastic material is provided with a colour, one or more symbols, or a combination of a colour and one or more symbols.

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