Method of manufacturing article for dry powder inhaler having upstream resilient element

Abstract

The present disclosure provides a method for manufacturing an inhaler article having an upstream elastic element (101) for insertion into a holder to form an inhaler system for providing dry powder to the lungs of a user, the manufacturing method comprising: moving a strip of elastic material (402) from a feeder reel (401) to a cutting table (405); providing a strip of elastic material to a cutting table; cutting at least one disc of elastic material from the strip of elastic material to form at least one cut disc of elastic material; providing at least one cutting disc of elastic material to the glue table (501); dispensing at least one rubber ring (502); applying at least one rubber ring to at least one cutting disc of an elastic material; and providing at least one cutting disc of elastic material with applied rubber ring to the upstream end (120) of the inhaler article; at least one cutting disk of elastic material having an applied rubber ring is attached to an 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 for making an inhaler article, which is used to be inserted into a retainer to form an inhaler system for delivering an active ingredient in the form of dry powder to a user's lung. Such an inhaler system can have two parts: an inhaler article and a retainer. The inhaler article can hold a capsule filled with dry powder. When combined, the inhaler article and the retainer form an inhaler system. Background Art

[0002] Dry powder inhaler articles are not always well suited to provide an airflow optimized for dry powder medicament delivery during use while also minimizing leakage of dry powder from the inhaler article or loss of capsules from the inhaler article before and after use. Summary of the invention

[0003] It may be desirable to provide a kind of Diskus goods, which closes before and after use and can also be opened during use.It is desirable to provide a kind of Diskus goods, which fully closes before and after use to prevent the loss of the capsule contained in the Diskus goods.It is desirable to provide a kind of Diskus goods, which fully closes before and after use to prevent the loss of the dry powder contained in the capsule contained in the Diskus goods.It is desirable to provide a kind of Diskus goods, which fully opens during use to allow optimal airflow to pass through the Diskus goods during use.It is desirable to provide a kind of Diskus goods with an upstream elastic element, which closes before and after use and opens during use.It is desirable to provide a kind of Diskus goods with an elastic element at the upstream end, to hold capsule or dry powder.

[0004] It may be desirable to provide a Diskus article that holds a capsule, the Diskus article being protected from opening to reveal or release the capsule. For example, it may be desirable to provide a Diskus article that holds a capsule, wherein the capsule is not visible. If the capsule is visible inside the inhaler article, then it may be desirable to open the inhaler article to release the capsule.

[0005] It may be desirable to provide an inhaler article that is protected from removal of a capsule from the inhaler article. A capsule may be released from the inhaler article intentionally or accidentally. It may be desirable to provide a dry powder inhaler article that has an element at the upstream end to prevent the capsule from being released from the inhaler article intentionally or accidentally.

[0006] Appropriate manufacturing methods are desired to ensure that the resilient member is attached to the inhaler article so that the bladder is securely contained within the inhaler article.

[0007] It may be desirable to provide a kind of dry powder inhaler product, which has an improved outward appearance at the upstream end of the inhaler product.For example, an element is added to the upstream end of the inhaler product and can cover the upstream end of the inhaler product. The element added can cover the inconsistency that may appear at the upstream end of the inhaler product, and improve the outward appearance of the upstream end of the inhaler product. The upstream element can provide a pleasing end face. In addition, the upstream element can provide a mark. The mark can indicate source, flavor, intensity or other information to the user. The mark can be a combination of color, symbol or color and symbol.

[0008] It is desirable that the manufacturing method ensures that the resilient member is attached to the inhaler article such that the inhaler article has a pleasing end face.

[0009] Inhaler products can be tubular products with an upstream end and a downstream end. The upstream end can be inserted into a holder. The downstream end (oral end) can be engaged by the user's mouth so that dry powder can be sucked into the user's lungs. Inhaler products contain a dose or multiple doses of dry powder active ingredients. The dry powder can be contained in a capsule inside the inhaler product. The inhaler product can be a disposable product. In order to use the inhaler system, the user can insert the inhaler product into the holder, activate the system to release the dry powder from the capsule, inhale the dry powder, and then remove the used inhaler product from the holder. The activation system can include piercing the capsule.

[0010] It may be desirable that the inhaler article be constructed and arranged to optimize the delivery of dry powder from the inhaler system to the lungs of the user during use. In addition, before and after use, it may be desirable to ensure that the capsule and the dry powder active ingredient are safely contained in the inhaler article. In other words, it may be desirable that the capsule will not fall out of the inhaler article before or after use. It is also desirable that the dry powder contained in the capsule will not fall out of the inhaler article before or after use.

[0011] Provided is an inhaler article, the inhaler article having a resilient element at the upstream end of the inhaler article, wherein the resilient element is in a closed position before being inserted into the retainer, wherein the resilient element opens to the open position in response to an opening force applied to the resilient element when the inhaler article is inserted into the retainer in use, and wherein the resilient element closes to the closed position when the inhaler article is removed from the retainer after use. On the one hand, the upstream end of the pocket cavity of the inhalation article can be a resilient element that forms an openable closed end of the inhaler article.

[0012] Conventional smoking articles do not have elements on the upstream end of the smoking article. The upstream end of a conventional smoking article is the lighting end.

[0013] The upstream end of the conventional smoking article is ignited, and the aerosol released from the combustion of the aerosol-generating substrate is inhaled. Any element at the upstream end of the conventional smoking article will be ignited, and the aerosol released by burning this element at the upstream end will be inhaled.

[0014] In the dry powder inhaler article disclosed herein, the upstream end is not ignited during use. Therefore, the upstream end of the inhaler article can have a utility that is not expected in traditional smoking devices.

[0015] The present disclosure provides a method for manufacturing an inhaler product having an elastic element at the upstream end of the inhaler product. The method of manufacturing includes the following steps: moving an elastic material band from a feeder reel to a cutting station, providing the elastic material band to the cutting station; cutting at least one elastic material disc from the elastic material band; providing at least one cut disc to a glue station; dispensing at least one glue ring; applying the at least one glue ring to the at least one elastic material disc; providing the at least one cut disc with the applied glue ring to the upstream end of the inhaler product; attaching at least one disc with the applied glue ring to the upstream end of the inhaler product to form an inhaler product with an upstream elastic element. The upstream elastic element is attached to the upstream end of the inhaler product.

[0016] The present disclosure provides a method of manufacturing, wherein the inhaler article comprises: a tubular body extending from a downstream mouthpiece end to an upstream end along a longitudinal axis; a capsule cavity, the capsule cavity accommodating a capsule; wherein the upstream boundary of the capsule cavity is defined by an elastic element, and wherein the attached elastic element retains the capsule in the capsule cavity. In an embodiment, the downstream mouthpiece end comprises a barrier element. The barrier element can be a filter. The tubular body can be made of cardboard.

[0017] The elastic element of the present disclosure has the following advantages: it ensures that the capsule in the inhaler product is contained in the inhaler product before use. The elastic element opens to provide an airflow path from the upstream end of the inhaler product to the downstream mouthpiece end of the inhaler product when being inserted into the retainer. When air moves through the inhaler product, the dry powder released from the capsule is entrained in the airflow, and is delivered to the mouthpiece end of the inhaler product to be inhaled by the user. In other words, the elastic element is constructed and arranged to open during use to optimize the dry powder delivery from the inhaler system to the lung of the user. After use, when removing the inhaler product from the retainer, the elastic element is closed to keep the capsule inside the inhaler product. It is advantageous to open to provide enough airflow to deliver pharmaceutically active agents to the lung of the user when the inhaler product is inserted into the retainer during use. It is advantageous to close the inhaler product before use to prevent the capsule from falling out from the inhaler product before use. It is advantageous to close the inhaler product after use to prevent the capsule from falling out from the inhaler product after use. After the inhaler product has been activated, it is advantageous that the inhaler product fully closes after use to prevent the capsule from falling out from the inhaler product after use. The elastic element allows to open and close the upstream end of the inhaler before and after the use of the inhaler product. The elastic element can be opened to provide enough airflows when engaging with the retainer to optimize the dry powder delivery to the user's lungs, and can be closed before and after the inhaler product is inserted into the retainer to prevent the capsule from falling out from the inhaler. The elastic element on the upstream end of the inhaler product provides two advantages: realize enough airflows, and also be protected from the undesirable loss of pharmaceutically active agents from the inhaler product before and after use.

[0018] According to one aspect, the elastic element of inhaler product is a pre-cut elastic element to form a flap. When being inserted in the retainer, the flap of the elastic element is folded to provide an opening, and the opening forms an airflow path from the upstream end of the inhaler product to the downstream mouthpiece end of the inhaler product. When air moves through the inhaler product, the dry powder released from the capsule is entrained in the airflow, and is delivered to the mouthpiece end of the inhaler product to be sucked by the user. In other words, the flap of the elastic element is opened to optimize the dry powder delivery from the inhaler system to the user's lung during use. After use, when removing the inhaler product from the retainer, the elastic element is closed to be maintained at the capsule inside the inhaler product. The elastic element can be pre-cut to form at least 4 flaps. The elastic element can be pre-cut to form at least 6 flaps. The incision can extend between about 65% to about 95% of the diameter of the elastic element. The elastic material provided in the form of a flap at the upstream end of the inhaler article can be opened and closed in a manner suitable for providing an open inhaler article when inserted into the holder during use, and closed before and after use to prevent the capsule from falling out of the inhaler article.

[0019] Open inhaler products provide enlarged airflow path to improve the airflow through inhaler system, and provide higher dose powder to user.If the upstream end of inhaler products is closed before use, the piercing needle introduces a hole in the upstream end of inhaler products.The hole made by the piercing needle in the upstream end of inhaler products is generally related to the size of the piercing needle.In general, the hole made by the piercing needle is not large enough to make it possible to have enough airflow to pass through the inhaler system to provide the powder of appropriate dose to the user.That is to say, due to the narrow orifice relevant to the size of the piercing needle, the aperture in the upstream end of the inhaler products in the inhaler system introduces significant suction resistance (RTD).This will cause the inhaler system to not have enough airflow to provide the powder of appropriate dose discharged from the capsule to the user.A solution to this RTD challenge is to provide an inhaler product with an open upstream end.Provide an inhaler product with an upstream end, the upstream end has a flap or an orifice, and the flap or the orifice is opened in response to the opening force provided by the retainer, which allows a larger opening, and produces an airflow path that is not limited by the pinhole size area in the airflow path.

[0020] The present disclosure provides an inhaler article for inserting into a retainer to form an inhaler system for providing dry powder to the lungs of a user. The inhaler article can be a tubular body extending from a downstream mouthpiece end to an upstream end along a longitudinal axis; a capsule cavity is located in the tubular body between the downstream mouthpiece end and the upstream end; and the capsule cavity accommodates a capsule. An elastic element may be provided upstream of the inhaler article. When the inhaler article is inserted into the retainer, the elastic element opens to an open position in response to an opening force provided by the retainer. When the inhaler article is removed from the retainer, 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, which is closed enough to keep the capsule in the capsule cavity of the inhaler article between the elastic element located 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 present disclosure, the inhaler article can be a tubular body extending from a downstream mouthpiece end to an upstream end along a longitudinal axis, with a capsule cavity located within the tubular body between the downstream mouthpiece end and the upstream end, the capsule cavity accommodating the capsule. In one aspect, the downstream mouthpiece end has a barrier element. In one aspect, the barrier is a filter element. The barrier element is used to ensure that the capsule does not leave the tubular body from the downstream end before, during and after use. When the barrier is a filter, the filter element ensures that the pharmaceutically active powder delivered to the user's lungs is a powder that is small enough to pass through the filter. This ensures that the pharmaceutically active powder is suitable for delivery to the user's lungs.

[0022] According to one aspect, the elastic element is a disk. In one aspect, the elastic element is circular. In one aspect, the elastic element is cut from a band of elastic material to form a disk. The elastic element can be cut from the elastic band by a punch cutter. The elastic element can be cut from the band of elastic material one at a time. That is, the cutter that cuts the elastic material disk from the band of elastic material can have one cutting head. Alternatively, the elastic element can be cut from the band of elastic material two at a time. That is, the cutter that cuts the elastic material disk from the band of elastic material can have two cutting heads. Alternatively, the elastic element can be cut from the band of elastic material three at a time. That is, the cutter that cuts the elastic material disk from the band of elastic material can have three cutting heads. Alternatively, the elastic element can be cut from the band of elastic material more than three at a time. That is, the cutter that cuts the elastic material disk from the band of elastic material can have more than three cutting heads.

[0023] On the one hand, elastic element is the elastic element of applying or attaching.Elastic element can be attached to the upstream end of inhaler goods.Elastic element can be attached to the upstream end of inhaler goods by any process suitable for elastic element being attached to inhaler goods, and described process comprises gluing, heat sealing, pressing, friction fit or other means.Elastic element can be attached to the upstream end of inhaler goods by gluing.Elastic element can be attached to the upstream end of inhaler goods by heat sealing.Elastic element can be attached to the upstream end of inhaler goods by elastic element being pressed into inhaler goods.Elastic element can be attached to the upstream end of inhaler goods by friction fit.Elastic element can be attached to the upstream end of inhaler goods by any suitable means.

[0024] On the one hand, before the elastic element is applied or attached to the upstream end of the inhaler article, the capsule is inserted into the inhaler article. That is, the elastic element is attached to the upstream end of the inhaler article containing the capsule.

[0025] On the one hand, the elastic element is attached to the upstream end of the inhaler product by gluing. On the one hand, the glue station can distribute glue rings. The glue ring can be slightly smaller than the circumference of the elastic material disc. After cutting out the elastic material disc, the elastic material disc can be provided to the glue station with the glue ring distributed. By pressing the cutting disc of the elastic material against the glue ring distributed on the glue station, the glue ring can be applied to the cutting disc of the elastic material. The cutting disc can be transported to the glue station by a retainer. Glue can be introduced into the glue station. For example, glue can be applied to the station. Glue can be pressure-supplied to the glue ring, and the glue ring size is slightly smaller than the diameter of the elastic element disc at the glue station. In an embodiment, glue can be provided to the glue ring by pressing glue from the glue reservoir below the glue station into the glue ring. Alternatively, glue can be provided in dots, discontinuous rings, thick rings, thin rings or any other shape to provide glue to the glue station. Suitable glue can include starch adhesives, such as dextrin, casein-based adhesives, polyamide blue, hot melt adhesives, cyanoacrylates, organic glues or any other suitable glues.

[0026] According to one aspect, the elastic element of the inhaler article is an elastic element that is cut to form a flap. The incision in the elastic material dish can be provided by the same cutter that cuts out the elastic material dish. On the one hand, the incision is made by a punch cutter. These incisions are not always extended to the outer circumference of the elastic material dish. In other words, each incision in the elastic material dish crosses the center of the elastic material dish, but the incision always passes the elastic material dish. When making more than one incision by the center of the elastic material dish, a dish with a sector is formed. A sector is a shape surrounded by two radii at either end of an arc and this arc. Owing to cutting out sectors from elastic material, these sectors form flaps. Flap is a movable sector.

[0027] When being inserted in the retainer, the flap of elastic element is folded to provide opening, and described opening forms the airflow path from the upstream end of inhaler product to the downstream mouthpiece end of inhaler product.When air moves through inhaler product, the dry powder discharged from capsule is entrained in the airflow, and is delivered to the mouthpiece end of inhaler product to be sucked by the user.That is to say, the flap of elastic element is opened to optimize the dry powder delivery from the inhaler system to the lung of the user during use.After use, when removing inhaler product from retainer, elastic element is closed so that capsule is remained on inhaler product inside.

[0028] The elastic element can be cut to have at least 2 otches to form at least 4 flaps. The elastic element can be cut to have at least 3 otches to form at least 6 flaps. The elastic element can be cut to have at least 4 otches to form at least 8 flaps. The otches can extend between about 65% to about 95% of the diameter of the elastic element. The elastic material at the upstream end of the inhaler article that is arranged in the form of flaps can be opened and closed in a way, and the mode is suitable for providing the open inhaler article when being inserted in the retainer during use, and closes to prevent the capsule from falling out from the inhaler article before and after use.

[0029] On the one hand, flap can be opened to the open position by folding the cut flap into the sac cavity of inhaler article in response to the opening force.The opening force can be provided by retainer.That is to say, when the inhaler article is inserted in the retainer, a part of retainer can be fitted in the upstream end inside of the inhaler article.When this part of retainer is fitted in the inhaler article inside, the retainer can force the flap to be folded into the sac cavity.When the flap is folded into the sac cavity of inhaler article, the orifice is opened, and forms an airflow path.According to any one of the inhaler articles among claim 6-9, the elastic element with the incision that wherein has the formation flap is opened to the open position by folding the cut flap into the sac cavity in response to the opening force.Insert inhaler article into the retainer can provide opening force, and this opening force forces the flap of the elastic element of cutting to enter the sac cavity of inhaler article.

[0030] In one aspect, the elastic element can be cut to provide a central aperture in the elastic material disc. The cutout in the elastic material disc can be provided by the same cutter that cuts out the elastic material disc. In one aspect, the cutout is made by a stamping cutter. In one aspect, the central aperture has a diameter that is less than 30% of the diameter of the elastic element.

[0031] The cutter may provide for cutting both the notch (which forms the flap) and the central aperture.

[0032] In one embodiment, the elastic element of inhaler products is an elastic element with a central aperture, and the central aperture is opened to the open position by stretching in response to the opening force. In other words, on the one hand, the elastic element of inhaler products is an annular elastic element of elastomeric material, and the annular elastic element is opened to the open position by stretching in response to the opening force. The central aperture diameter can be less than 30% of the elastic element diameter. The opening force can be provided by retainer. When the inhaler products were inserted in the retainer, the opening force could be provided by moving the tip of the retainer to the central aperture of the upstream end of the inhaler products. The inhaler products are inserted in the retainer and an opening force can be provided, and this opening force forces the central aperture to stretch in response to the opening force and open.

[0033] After the elastic elements have been cut from the strip of elastic material, the strip of elastic material may travel away from the cutting station to be collected by a take-up reel.

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

[0035] On the one hand, when the elastic element is in the open position, is engaged in the retainer, the gained opening or orifice will be provided in the capsule cavity with unrestricted or less restricted airflow.On the one hand, the retainer is configured to provide the inhaler product with a vortex or rotating inhaled airflow.On the one hand, the retainer comprises a housing that limits a housing cavity, is configured to be maintained at a removable cap in the housing cavity for the inhaler product, the removable cap can be moved in the housing cavity along the longitudinal axis of the housing, wherein the removable cap comprises a tip and a piercing end.When the inhaler product is engaged in the retainer, the tip of the removable cap extends into the elastic element at the upstream end of the inhaler product.The piercing end of the inner surface of the bottom of the retainer is attached to extend through the piercing end of the removable cap.When the removable cap moves relative to the piercing element, the inhaler product moves so that it is provided to the piercing element.The piercing element then pierces the capsule in the inhaler product to discharge pharmaceutically active dry powder from the capsule.

[0036] In one aspect, the capsule contains a pharmaceutically active dry powder. The pharmaceutically active dry powder can be nicotine.

[0037] Typically, the capsule will not contain filler materials from the tobacco industry. Typically, the filler materials from the tobacco industry are tobacco, such as small pieces of shredded or shredded tobacco plant leaves or stems. It would not be desirable to provide small pieces of tobacco leaves or stems directly to the user's lungs. Providing small pieces of tobacco leaves or stems to the user's lungs will not provide pharmaceutically active nicotine to the user. Providing small pieces of plant material to the user's lungs will likely be harmful to the user.

[0038] On the one hand, the elastic element may include a mark. In an embodiment, the mark may be a color. In an embodiment, the mark may be one or more symbols. In an embodiment, the elastic material band may be colored. In an embodiment, the elastic material band may include one or more symbols. Or, the elastic material band may include both color and one or more symbols. When the elastic material band includes a color, the cutting disc of the elastic material is colored when being applied to or attached to the upstream end of the inhaler article. When the elastic material band includes one or more symbols, the cutting disc of the elastic material has one or more symbols when being applied to or attached to the upstream end of the inhaler article. Color and symbol are marks. Marks may indicate the source, flavor, strength or other information of goods.

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

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

[0041] As used herein, "having", "comprising", "including", etc. are used in their open sense and generally mean "including (but not limited to)". It should be understood that "consisting essentially of", "consisting of", etc. are included in "comprising", etc.

[0042] The words "preferred" and "preferably" refer to embodiments of the invention that may provide certain benefits under certain circumstances. However, other embodiments may also be preferred under the same or other circumstances. In addition, 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 sense including "and / or" unless the content clearly dictates otherwise. The term "and / or" means one or all of the listed elements or a combination of any two or more of the listed elements.

[0045] Any directions mentioned herein, such as "top", "bottom", "left", "right", "up", "down" and other directions or orientations are described for the sake of clarity and conciseness, but are not intended to limit the actual device or system. The devices and systems described herein can be used in multiple directions and orientations.

[0046] As used herein, "downstream" and "proximal" mean the mouthpiece end of an inhaler article. "Downstream" and "proximal" mean the end of a tubular inhaler article that is intended to be contacted by the user's mouth. "Upstream" and "distal" mean the opposite end of an inhaler article. "Upstream" and "distal" mean the end of a tubular inhaler article that is intended to be inserted into a retainer.

[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 fully closed before and after use to keep the capsule inside the inhaler product. "Closed" also means fully closed before or after use to reduce the loss of pharmaceutically active powder from the inhaler product. The inhaler product may be less closed after use than before use, but can still be considered closed if it provides the function of reducing the loss of the contents of the inhaler product.

[0049] As used herein, the term "use" means the steps of inserting the inhaler article into the holder, initiating airflow through the holder and the inhaler article, and inhaling the pharmaceutically active powder."Use" may optionally include the additional step of removing the inhaler article from the holder.

[0050] An inhaler system is used to provide a pharmaceutically active dry powder to a user's lungs. The present disclosure provides a system, and in particular an inhaler article, which is constructed and arranged to contain an active dry powder before and after use, and to allow the dry powder to leave 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, the user places the downstream end of the inhaler article in the user's mouth and inhales.

[0051] The upstream end of inhaler product is inserted in the retainer during use.When the upstream end of inhaler product is inserted in the retainer, the upstream end of inhaler product is opened.When the upstream end of inhaler product is inserted in the retainer, inhaler product adds retainer to form inhaler system.Inhaler product is inserted in the retainer during use.The upstream end of inhaler product is opened during use to allow air flow through inhaler product and pharmaceutically active dry powder is discharged to the user.When inhaler product is inserted in the retainer, the upstream end of inhaler product is opened.Retainer provides opening force to open inhaler product to inhaler product, thereby discharges pharmaceutically active powder from inhaler product during use.

[0052] In order to prevent the pharmaceutically active dry powder from falling out from the inhaler product before use, the upstream end of the inhaler product is closed before use. After use, after the inhaler product is removed from the retainer, the upstream end of the inhaler product is closed to prevent the pharmaceutically active dry powder from falling out from the inhaler after use. The upstream end of the inhaler product is opened when the inhaler product is inserted into the retainer, and is closed before and after the inhaler product is inserted into the retainer.

[0053] In order to make the upstream end of inhaler products can be closed before use, open during use and then close again after use, the upstream end of inhaler products is a resilient element.The resilient element closes before use, opens during use, and then returns to the closed position after use.The resilient element closes before use, opens when the inhaler products are inserted in the retainer, and then closes again when the inhaler products are removed from the retainer.

[0054] Inhaler products can be any shape or size. For ease of insertion into the retainer, inhaler products can be tubular products. Inhaler products can be tubular bodies extending from the downstream mouthpiece end to the upstream end along the longitudinal axis. Inhaler products can be cylindrical. Inhaler products contain pharmaceutically active powders.

[0055] The size and shape of the inhaler article can be similar to a smoking article or a cigarette. The inhaler article can be a tubular body extending along the longitudinal axis of the inhaler article. The inhaler article can have a substantially consistent external diameter along the length of the elongated body. The inhaler body can have a circular cross-section that can be consistent along the length of the elongated body. The inhaler body can have an external diameter in the range of about 6mm to about 10mm, or about 7mm to about 10mm, or about 7mm to about 9mm, or about 7mm to about 8mm, or about 7.2mm. The inhaler body can have a length (along the longitudinal axis) in the range of about 40mm to about 80mm, or about 40mm to about 70mm, or about 40mm to about 50mm, or about 45mm.

[0056] The inhaler article may be a tubular body extending from a downstream mouthpiece end to an upstream end along a longitudinal axis. Between the downstream mouthpiece end and the upstream end is a central cavity.

[0057] The downstream end of the inhaler product is a mouthpiece end. That is, the downstream end of the inhaler product is intended to engage with the user's mouth to allow the user to inhale the contents of the inhaler product. The downstream end is constructed and arranged to engage with the user's mouth. The size and shape of the downstream end are set to engage with the user's mouth. The downstream end of the inhaler product serves as a conduit to provide pharmaceutically active powder to the user's mouth and lungs. The downstream end of the inhaler product has a certain rigidity or hardness, size and shape to engage with the user's mouth. The downstream end of the inhaler product may have a barrier. The barrier may be an element of the inhaler product providing rigidity or hardness. The rigidity or hardness of the barrier is suitable for being inserted into the user's mouth during the use of the inhaler system. The barrier may have a size and shape to engage with the user's mouth.

[0058] In addition, the barrier may be a filter element. The filter element may have an internal structure that allows smaller particles to flow through the filter element and prevents larger particles from flowing through the filter element. The filter element may be used to filter larger particles of pharmaceutically active powder as they flow out of the inhaler article. The filter element may be used to control the size of the particles of pharmaceutically active powder as they flow out of the inhaler article. The filter element may allow particles of pharmaceutically active powder to flow out of the inhaler article to the user. The filter element may allow particles of pharmaceutically active powder to be small enough to flow out of the inhaler article through the filter element to reach the user. The filter element may be formed of cellulose acetate material. The filter element may be cellulose tow. The filter may be formed of biodegradable material.

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

[0060] Inhaler product has an upstream end. The upstream end has a resilient element. The resilient element of the inhaler product can have an incision, and when the tip is inserted into the resilient element, the incision allows the resilient element to open. These incisions can be referred to as incisions or incisions. These incisions can be described as radial incisions or diameter incisions. Two diameter incisions cause forming four flaps in the resilient element. Two diameter incisions that partially extend across the diameter of the resilient element are identical with four radial incisions that partially extend across the radius of the resilient element. The incision can extend in the scope of 65% to 95% of the diameter of the resilient element.

[0061] When the inhaler product with the elastic element with notch (and flap) is inserted into the retainer, the tip of the retainer pushes the flap into the inside of the inhaler product. When the tip of the retainer pushes the flap into the inside of the inhaler product, the inhaler product opens. The tip of the retainer provides the opening force to open the upstream end of the inhaler product. When the inhaler product opens, the airflow path of the airflow through the inhaler system is provided to improve. When the inhaler product is extracted from the retainer, the tip is extracted from the inhaler product, and the flap returns to its position at the upstream end of the inhaler product. When the opening force is withdrawn, the inhaler product is closed. When the inhaler product is removed from the retainer, the opening force is removed from the upstream end of the inhaler product. When the opening force is removed from the inhaler product, the elastic element returns to the closed position. When removing the opening force, the elastic element is closed to the closed position. Although the elastic element with notch and flap may not be completely closed before or after use, it is partially closed before and after use. It will not open after use.

[0062] The elastic element of inhaler product can have a central aperture, and the central aperture opens to the open position by stretching and opening in response to the opening force. In other words, on the one hand, the elastic element of inhaler product is an annular elastic element of elastomeric material, and the annular elastic element opens to the open position by stretching and opening in response to the opening force. The central aperture diameter can be less than 30% of the elastic element diameter. The opening force can be provided by a retainer. When the inhaler product is inserted into the retainer, the opening force can be provided by moving the tip of the retainer into the central aperture of the upstream end of the inhaler product. The inhaler product is inserted into the retainer and an opening force can be provided, and this opening force forces the central aperture to stretch and open in response to the opening force. In addition, when removing the opening force, the elastic element returns to the closed position. When removing the opening force from the retainer, the opening force is removed from the upstream end of the inhaler product. When removing the opening force from the inhaler product, the elastic element returns to the closed position. When removing the opening force, the elastic element is closed to the closed position. Although the elastic element with the central aperture may not be completely closed before or after use, it is partially closed before and after use. It will not open after use.

[0063] The elastic element of inhaler goods can have the combination of otch and center aperture, and described center aperture opens to open position by stretching and opening in response to opening force.In other words, on the one hand, the elastic element of inhaler goods is the annular elastic element of elastomeric material, and described annular elastic element opens to open position by stretching and opening in response to opening force.The center aperture diameter can be less than 30% of the elastic element diameter.Otch can extend in the scope of 65% to 95% of the diameter of elastic element.Opening force can be provided by retainer.When inhaler goods is inserted in the retainer, opening force can be provided by the tip of retainer being moved to the center aperture of the upstream end of inhaler goods.Inhaler goods is inserted in the retainer and opening force can be provided, and this opening force forces the center aperture to stretch and open in response to opening force.

[0064] When the inhaler goods were removed from retainer, the tip was removed from the inhaler goods, and the elastic element was closed.When the inhaler goods were removed from retainer, the opening force was removed.When the tip was removed from the inhaler goods, the opening force was removed.When the opening force was removed, the elastic element was closed.When removing the inhaler goods from retainer, the opening force was removed from the upstream end of the inhaler goods.When removing the opening force from the inhaler goods, the elastic element returned to the closed position.When removing the opening force, the elastic element was closed to the closed position.

[0065] Between the downstream and upstream ends of the tubular body is a central cavity containing the pharmaceutically active powder. The central cavity 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 cavity can contain the pharmaceutically active powder contained in the capsule. When the cavity contains the pharmaceutically active powder contained in the capsule, the cavity is a capsule cavity.

[0067] The cyst cavity can be the inside of the inhaler product between the downstream barrier element and the upstream elastic element. The downstream barrier element can be connected with the upstream elastic element by a wrapper. The wrapper can form the tubular body of the inhaler product. The tubular body limiting the cyst cavity can be formed by biodegradable materials, for example cardboard or paperboard.

[0068] The sac cavity may have an inner diameter in the range of about 6 mm to about 7 mm, or about 6.5 mm to about 6.7 mm. The sac cavity may have a transverse length in the range of about 15 mm to about 30 mm, or about 20 mm to about 25 mm.

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

[0070] The capsule cavity can promote capsule to rotate stably in the capsule cavity relative to the structure of the capsule. During suction, the longitudinal axis of the capsule can coaxially stably rotate with the longitudinal axis of the inhaler body. The capsule cavity can promote capsule to rotate with certain shaking in the capsule cavity relative to the structure of the capsule.

[0071] Stable rotation refers to that the longitudinal axis of the inhaler body is substantially parallel or coaxial with the rotation axis of the capsule. Stable rotation may refer to that the rotating capsule does not have advancement. Preferably, the longitudinal axis of the inhaler body may be substantially coextensive with the rotation axis of the capsule. The stable rotation of the capsule may provide uniform entrainment of a portion of nicotine particles from the capsule during two or more, or five or more, or ten or more "puffing" or suction of the consumer.

[0072] The capsule can be contained in the inhaler article before consumption. The inhaler article can be contained in the capsule cavity by the elastic member.

[0073] The capsule may be formed of an airtight material that can be pierced or punctured by a piercing element that can be alone or in combination with an inhaler. The capsule may be formed of a metal or polymer material that is used to keep the capsule from contamination and can be pierced or punctured by a piercing element before consuming the nicotine particles in the capsule. The capsule may be formed of a polymer material. The polymer 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 pharmaceutically active particles. The pharmaceutically active particles may include nicotine (also referred to as "nicotine powder" or "nicotine particles") and optional particles containing flavors (also referred to as "flavor particles"). The capsule may contain a predetermined amount of nicotine particles and optional flavor particles. The capsule may contain enough 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 enough nicotine particles to provide about 5 to about 50 inhalations or "puffs", or about 10 to about 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 deliver about 0.2 mg to about 2 mg of nicotine particles to the user's lungs, or deliver about 1 mg of nicotine particles to the user's lungs.

[0075] The nicotine particles can have any effective nicotine concentration based on the specific formulation used. The nicotine particles can have at least about 1%wt of nicotine up to about 30%wt of nicotine, or about 2%wt to about 25%wt of nicotine, or about 3%wt to about 20%wt of nicotine, or about 4%wt to about 15%wt of nicotine, or about 5%wt to about 13%wt of nicotine. Preferably, each inhalation or "puffing" can deliver about 50 to about 150 micrograms of nicotine to the user's lungs.

[0076] The capsule can hold or contain at least about 5 mg of nicotine particles or at least about 10 mg of nicotine particles. The capsule can 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 can hold or contain about 5 mg to about 300 mg of nicotine particles or about 10 mg to about 200 mg of nicotine particles.

[0077] When the flavor particles are blended or combined with the nicotine particles within 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 effective particle size distribution so as to be preferably delivered for inhalation into the lungs of the user. The capsule may include particles other than nicotine particles. The nicotine particles and other particles may form a powder system.

[0079] The capsule can hold or contain at least about 5 mg of dry powder (also referred to as a powder system) or at least about 10 mg of dry powder. The capsule can 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 can 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 can 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 comprised in nicotine particles having a particle size of about 5 microns or less, or in the range of about 1 micron to about 5 microns.

[0081] The particles comprising nicotine may have a mass median aerodynamic diameter of about 5 microns or less, or in the range of about 0.5 microns to about 4 microns, or in the range of about 1 micron to about 3 microns, or in the range of about 1.5 microns to about 2.5 microns. Preferably, the mass median aerodynamic diameter is measured using a cascade impactor.

[0082] The particles containing the aroma may have a mass median aerodynamic diameter of about 20 microns or greater, or about 50 microns or greater, or in the range of about 50 to about 200 microns, or in the range of about 50 to about 150 microns. Preferably, the mass median aerodynamic diameter is measured using a cascade impactor.

[0083] The dry powder may have an average diameter of about 60 microns or less, or in the range of about 1 micron to about 40 microns, or in the range of about 1.5 microns to about 25 microns. The average diameter refers to the average diameter per unit 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 particles of a larger size from passing through the filter. For example, the filter element can allow dry powders having an average diameter of about 60 microns or less to pass through the filter element, while preventing dry powders having an average diameter greater than about 60 microns from passing through. Alternatively, if flavor particles are desired, the filter element can provide a structure that allows particles of up to 200 microns to pass through the filter.

[0085] The nicotine or nicotine particles in the powder system can be pharmaceutically acceptable free base nicotine or nicotine salt or nicotine hydrate. Effective nicotine salt or nicotine hydrate includes, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine monopyruvate, nicotine glutamate or nicotine hydrochloride. The compound that forms a salt or hydrated salt in combination with nicotine can be selected based on its expected pharmacological effect.

[0086] Preferably, the nicotine particles include amino acids. Preferably, the amino acids can be leucine, such as L-leucine. Providing amino acids such as L-leucine to particles containing nicotine can reduce the adhesion of particles containing nicotine, and can reduce the attraction between nicotine particles and therefore reduce the agglomeration of nicotine particles. Similarly, the adhesion with particles containing fragrance can also be reduced, so the agglomeration of nicotine particles and fragrance particles is also reduced. Therefore, even when nicotine particles are combined with fragrance particles, the powder system described herein can also be a free-flowing material and have a stable relative particle size of each powder component.

[0087] Nicotine can be a surface-modified nicotine salt, wherein the nicotine salt particles include coated or composite particles. A preferred coated or composite material can be L-leucine. A particularly effective nicotine particle can be nicotine bitartrate combined with L-leucine.

[0088] The powder system may include a population of flavor particles. The flavor particles may have any effective particle size distribution for selective delivery of an inhalation into the mouth or buccal cavity of a user.

[0089] The powder system can include at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the flavor particle group of the powder system in particles with a particle size of about 20 microns or larger. The powder system can include at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the flavor particle group of the powder system in particles with a particle size of about 50 microns or larger. The powder system can include at least about 40% by weight, or at least about 60% by weight, or at least about 80% by weight of the flavor particle group of the powder system in particles with a particle size of about 50 microns to about 150 microns.

[0090] The particles containing fragrance can include compounds for reducing adhesion or surface energy and the agglomeration caused. The fragrance particles can utilize the compound that reduces adhesion to carry out surface modification to form coated fragrance particles. A preferred compound that reduces adhesion can be magnesium stearate. Provide the compound that reduces adhesion such as magnesium stearate to the fragrance particles, especially the coated fragrance particles, can reduce the adhesion of the particles containing fragrance and can reduce the attraction between the fragrance particles, and therefore reduce the agglomeration of the fragrance particles. Therefore, the agglomeration of fragrance particles and nicotine particles can also be reduced. Therefore, even when nicotine particles are combined with fragrance particles, the powder system described herein can also have the particles containing nicotine and the stable relative particle size of the particles containing fragrance. The powder system can preferably be free-flowing.

[0091] Because active particles may be too small and not affected by the simple airflow of the inhaler, conventional formulations for dry powder suction include carrier particles that are used to increase the fluidization of active particles. Powder systems can include carrier particles. These carrier particles can be sugars that can have greater than about 50 micron sizes, such as lactose or mannitol. Carrier particles can be used to improve the uniformity of dosage by serving as a diluent or a loosening agent in the preparation.

[0092] The powder system used in conjunction with the nicotine powder delivery system described herein can be free of carriers or substantially free of sugars such as lactose or mannitol. The absence of carriers or substantially free of sugars such as lactose or mannitol can allow nicotine to be inhaled and delivered to the user's lungs at an inhalation rate or airflow rate similar to that of a typical smoking style inhalation rate or airflow rate.

[0093] Nicotine particles and flavors can be combined in a single capsule. As described above, the nicotine particles and flavors can each have reduced adhesion, thereby producing a stable particle formulation in which the particle size of each component does not substantially change when 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 the flavor particles can be combined in any effective relative amounts so that the flavor particles are perceived by the user when consumed together with the nicotine particles. Preferably, the nicotine particles and the flavor particles form at least about 90%wt, or at least about 95%wt, or at least about 99%wt or 100%wt of the total weight of the powder system.

[0095] The holder for inhaler products comprises: housing, the housing comprises a housing cavity for receiving the inhaler products; a removable cap, the removable cap enables the inhaler products to engage with a piercing element; a piercing element, a pointed tip, which is inserted into the upstream end of the inhaler products when the inhaler products are inserted into the holder; and an air inlet and an air flow path, the air inlet and the air flow path enable vortex airflow to pass through the inhaler products when the inhaler products are engaged in the holder. The vortex or rotating inhaled airflow can be transmitted to the inhaler products to rotate and agitate the capsule and release the dry powder contained in the capsule. The holder has an open end and a piercing end. The housing cavity is sized to receive the inhaler products. The inhaler products are 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% of the housing length, or about 30% to about 50%. The far end of the piercing element can be fixed to the far end adjacent to the housing or at the far end of the housing. The whole length of the piercing element can be coextensive within the housing length. The piercing element is formed by a rigid material. The rigid material has enough rigidity to pierce, puncture or activate the capsule contained in the inhaler product. The piercing element can be formed by metal. The piercing element can be, for example, formed by stainless steel, such as 316 stainless steel. The piercing element can be formed by a polymer material. The piercing element can be formed by a fiber-reinforced polymer material.

[0097] The piercing element extends through the removable cap. The removable cap is movable relative to the piercing element. When the inhaler article is inserted into the holder and pressed downward, the removable cap moves downward into the holder, thereby exposing the piercing element. When the inhaler article is pressed downward against the removable cap, the piercing element extends into the inhaler article and pierces the capsule. Piercing the capsule activates the capsule. Piercing the capsule activates the inhaler system. Piercing the capsule allows powder to be released from the capsule.

[0098] When the inhaler product is inserted into the retainer, a part of the retainer is inserted into the upstream end of the inhaler product to open the upstream end of the inhaler product. When a part of the retainer is inserted into the upstream end of the inhaler product, the retainer provides the inhaler product with an opening force. In an embodiment, the part of the retainer that is inserted into the upstream end of the inhaler product is a tip. When the inhaler product is inserted into the retainer, the tip of the retainer is inserted into the upstream end of the inhaler product. When the tip of the retainer is inserted into the upstream end of the inhaler product, the tip provides the inhaler product with an opening force. When the tip of the retainer is inserted into the upstream end of the inhaler product, the upstream end of the inhaler product opens. When the tip of the retainer is inserted into the upstream end of the inhaler product, an opening force is applied to the upstream end of the inhaler product. When the tip of the retainer is inserted into the upstream end of the inhaler product as an elastic element, the elastic element opens. When removing the inhaler product from the retainer, the opening force is removed from the upstream end of the inhaler product. When removing the opening force from the inhaler product, the elastic element returns to the closed position. When the opening force is removed, the resilient element closes to the closed position.

[0099] When the inhaler product was inserted in the retainer, the part of the retainer was inserted into the elastic element at the upstream end of the inhaler product to open the elastic element of the inhaler product. When the part of the retainer was inserted into the elastic element of the inhaler product, the retainer provided the opening force to the inhaler product. When the part of the retainer was inserted into the elastic element of the inhaler product, the retainer provided the opening force to the elastic element. When the part of the retainer was inserted into the upstream end of the inhaler product, the retainer provided the opening force to the upstream end of the inhaler product. When removing the inhaler product from the retainer, the opening force was removed from the upstream end of the inhaler product. When removing the opening force from the inhaler product, the elastic element returned to the closed position. When removing the opening force, the elastic element was closed to the closed position.

[0100] The shape and size of the tip can be set to optimize the upstream end that is inserted into the inhaler product.The shape and size of the tip can be set to optimize the elastic element that is inserted into the inhaler product.For example, when the elastic element has a central aperture, the tip can be angled to optimize the expansion of the elastic element that is inserted into the central aperture. Two or more tips can be present.For example, 2 tips can be present. Three tips can be present. Four tips can be present. Five tips can be present. Six tips can be present. There may be more than six tips. Perhaps, the tip can mean the annular ring that is inserted into the upstream end of the inhaler product. Perhaps, the tip can mean the annular ring that is inserted into the elastic element of the inhaler product.

[0101] The housing can be formed of any rigid material. The housing can be formed of a polymer material. The polymer material that can be used to form the housing includes 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 product having a pharmaceutically active dry powder contained in a capsule for delivery to the lungs of a user. An inhaler product containing a capsule is disclosed herein, and the capsule contains a pharmaceutically active powder. In an embodiment, the pharmaceutically active powder contains nicotine, but other pharmaceutically active powders are contemplated in the present disclosure, as described below. When a user inhales from the mouthpiece end (downstream end, proximal end) of the inhaler product, the inhaler product can be used to deliver the pharmaceutically active powder to the user. In order to deliver the pharmaceutically active dry powder contained in the capsule to the user, the pharmaceutically active powder is released from the capsule, the powder is aerosolized, and inhaled by the user. That is, when the user inhales from the mouthpiece end (downstream end, proximal end) of the inhaler product, the powder is released from the capsule and entrained into the airflow generated by the user.

[0103] According to the present disclosure, an inhaler article has a tubular body extending from a downstream mouthpiece end to an upstream end along a longitudinal axis. The interior of the tubular body is a capsule cavity. The capsule cavity contains a capsule containing a pharmaceutically active powder.

[0104] In order to release the pharmaceutically active powder from the capsule contained in the capsule cavity of the inhaler product, the capsule must be opened in a manner that allows the powder contained inside the capsule to be released. In an embodiment, the capsule is pierced. When the capsule is pierced, a hole is introduced into the capsule. This release step or piercing step can also be considered as "activation". According to the present disclosure, when the capsule is pierced by a piercing element, the capsule is activated. In an embodiment, the piercing element is located in a retainer.

[0105] In the case of the inhaler product being inserted into the retainer, the upstream end of the inhaler product is inserted into the retainer. When the inhaler product is inserted into the retainer, the inhaler product can be pressed downwards against the piercing element in the retainer, and the capsule can be pierced by the piercing element. Once inserted, the downstream end of the inhaler product extends from the retainer, and can be approached by the user's mouth. Once the capsule has been pierced or activated, the powder held in the capsule can be discharged from the capsule. The powder from the capsule can then be discharged into the airflow and sucked by the user. The inhaler product is inserted into the retainer to form an inhaler system, and the capsule is pierced by the piercing element of the retainer, and the airflow is triggered by the user, and the airflow passes the inhaler product, and the entrainment powder released from the capsule, and the pharmaceutically active powder is delivered to the user's mouth.

[0106] Retainer is separated from inhaler product, but consumer can utilize inhaler product and retainer, consume the particle of releasing in inhaler product simultaneously.A plurality of these inhaler products can be combined with retainer to form system or kit.Single retainer can be utilized on 10 or more or 25 or more or 50 or more or 100 or more inhaler products, to activate the capsule that (pierces or pierces) each inhaler product holds and reliable activation is provided.

[0107] The holder for inhaler product comprises housing, and this housing comprises housing cavity for receiving inhaler product and is configured to keep inhaler product in housing cavity.Removable cap is located in housing cavity, and can move along the longitudinal axis of housing in housing cavity.Removable cap has tip.The tip of removable cap is configured to insert into inhaler product when inhaler product is introduced into holder.Removable cap is configured to move relative to piercing element.When inhaler product is introduced into housing cavity of holder, inhaler product is pressed down into holder.When inhaler product is pressed into housing cavity, the tip of removable cap is inserted into the upstream end of inhaler product.Meanwhile, inhaler product is pressed down into housing against removable cap.Removable cap moves downward.Piercing element extends through removable cap when removable cap moves, so that the capsule inside inhaler product contacts piercing element and is pierced by piercing element.Then release inhaler product, and removable cap moves back to static position.Removable cap can move back to static position by means of spring. In the following Figure 2 The inhaler article is shown in position inserted into the holder after the capsule has been pierced.

[0108] The tip of the removable cap can be inserted into the upstream end of the inhaler article through the resilient element at the upstream end of the inhaler article.

[0109] As described herein, a method comprises inserting an inhaler product into the housing cavity of a retainer for an inhaler product. The inhaler product comprises a main body, which extends the main body length from the mouthpiece end to the distal end along the inhaler longitudinal axis, and a capsule is arranged in the inhaler product main body. Then, move the inhaler product and the sleeve toward the piercing element until the piercing element pierces the capsule. Then air is drawn into the second opposite end of the housing cavity of the retainer to form a vortex to inhale airflow. Then, when the inhaler product is arranged in the retainer for the inhaler product, the vortex inhaled airflow is transmitted to the inhaler product. Then the consumed inhaler product can be removed from the retainer. When removing the consumed inhaler from the retainer, the elastic element is fully closed to prevent the capsule from falling out from the used inhaler product. The consumed inhaler product can be safely discarded. Then, fresh inhaler product can be inserted into the retainer, and the method can be repeated.

[0110] The inhaler product associated with the above-mentioned retainer is configured to directly receive the vortex suction airflow into the far end of the inhaler product. When the user "sucks" on the downstream end of the inhaler product inserted in the retainer, the vortex suction airflow is caused. This produces negative pressure inside the inhaler product. Due to this negative pressure, air enters the retainer via the air inlet. Then, the air advances through the air path in the retainer. When the inhaler product is inserted into the retainer, the air path in the retainer guides air into the inhaler product at an angle tangent to the longitudinal axis of the inhaler product. When the inhaler product is inserted into the retainer, this tangential air produces vortex airflow in the inhaler product. This vortex airflow rotates and / or stirs the capsule in the inhaler product. This stirring of the capsule improves the flow of powder leaving the activation capsule, and improves 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 silicon. 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 a laminated layer of PLA on a paper layer. The elastic element may be made of cardboard. The elastic element may be made of silicon, latex or rubber. The elastic element may be made of silicon, latex, rubber or a combination thereof.

[0112] The elastic element can be attached to the inhaler product. The elastic element can be attached to the inhaler product by any means. For example, the elastic element can be attached to the inhaler product by gluing, friction fit, heat sealing or by any means.

[0113] The elastic material may be cut into discs from a strip of material suitable for forming the elastic element. The strip of elastic material may be fed from a feeder reel to a take-up reel at a cutting station. The discs that will form the elastic element may be cut by a cutter at the cutting station. Additionally, at this cutting station, cutting may be performed to form the elastic element with a notch and a flap, or a central aperture may be cut into the elastic element disc, or both a notch and a central aperture may be cut into the elastic element.

[0114] The cutting disc can be transported to the glue coating station by a retainer. Glue can be introduced into the glue coating station. For example, glue can be applied to the station. Glue can be pressure-fed to a glue ring, and the glue ring size is slightly smaller than the diameter of the elastic element disk at the glue station. Glue can be applied to the cutting disc by providing the cutting disc to the glue ring at the glue station. Then, the cutting disc with the applied glue can be applied to the upstream end of the inhaler product. Glue can be any glue known in the art. For example, glue can be a water-based glue or a hot melt adhesive.

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

[0116] Example Ex1: A method for manufacturing an inhaler product with an upstream elastic element, wherein the inhaler product is used to be inserted into a holder to form an inhaler system for providing dry powder to the lungs of a user, the manufacturing method comprising: moving an elastic material strip from a feeder reel to a cutting station; providing the elastic material strip to the cutting station; cutting at least one elastic material disc from the elastic material strip to form at least one cut disc of elastic material; providing the at least one cut disc of elastic material to a glue station; dispensing at least one glue ring; applying the at least one glue ring to the at least one cut disc of elastic material; and providing the at least one cut disc of elastic material with the applied glue ring to the upstream end of the inhaler product; attaching the at least one cut disc of elastic material with the applied glue ring to the upstream end of the inhaler product to form an inhaler product with an attached upstream elastic element.

[0117] Example Ex2: The method according to example Ex1, wherein the cutting step further comprises cutting at least 2 cuts in the at least one elastic material disk to form at least 4 flaps in each cut disk.

[0118] Example Ex3: The method according to example Ex1, wherein the cutting step further comprises cutting at least 3 cuts in the at least one elastic material disk to form at least 6 flaps in each cut disk.

[0119] Example Ex4: The method according to example Ex1, wherein the cutting step further comprises cutting at least 4 cuts in the at least one elastic material disk to form at least 8 flaps in each cut disk.

[0120] Example Ex5: The inhaler article according to any of Examples Ex2-Ex4, wherein the cutout extends within a range of about 65% to about 95% of the diameter of the elastic element.

[0121] Example Ex6: The method according to any of the preceding examples, further comprising cutting a central aperture in the at least one elastic material disk.

[0122] Example Ex7: The method according to example Ex6, wherein the central aperture has a diameter that is less than 30% of the diameter of the elastic element.

[0123] Example Ex8: The method according to any of the preceding examples, further comprising moving the elastic material strip from the cutting station to a take-up reel.

[0124] Example Ex9: The method according to any of the preceding examples, further comprising the step of inserting a capsule into the inhaler article before the attaching step.

[0125] Example Ex10: The method according to any of the preceding examples, wherein the elastic element is made of silicon, latex, plastic, paper, aluminum foil, paper tape, laminated layer material (eg, PLA layer on paper layer), or cardboard.

[0126] Example Ex11: The method according to any of the preceding examples, wherein the elastic element comprises rubber, silicon or latex.

[0127] Example Ex12: A method according to any one of the preceding examples, wherein the inhaler product comprises: a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end; a capsule cavity located within the tubular body between the downstream mouthpiece end and the upstream end; the capsule cavity accommodating a capsule; wherein the upstream boundary of the capsule cavity is defined by the elastic element, and wherein the attached elastic element retains the capsule in the capsule cavity.

[0128] Example Ex13: The method according to example Ex12, wherein the downstream mouthpiece end comprises a barrier element.

[0129] Example Ex14: The method according to any of the preceding examples, wherein the tubular body comprises cardboard.

[0130] Example Ex15: The method according to any one of Examples 12-14, wherein the capsule contains a pharmaceutically active dry powder comprising nicotine.

[0131] Example Ex16: The method according to any of the preceding examples, wherein the elastic material comprises a color. BRIEF DESCRIPTION OF THE DRAWINGS

[0132] Several examples will now be further described with reference to the accompanying drawings, in which:

[0133] Figure 1A and Figure 1B An embodiment of an inhaler article of the present disclosure is shown. Figure 1A An embodiment of an inhaler article is shown having a resilient element at the upstream end, the resilient element being cut to form a flap. Figure 1B An embodiment of an inhaler article is shown having a resilient element at the upstream end, the resilient element having a central aperture.

[0134] Figure 2 An inhaler article of the present disclosure is shown inserted into a holder to form an inhaler system.

[0135] Figure 3A and Figure 3BAn inhaler article of the present disclosure is shown inserted into a holder. Figure 3A An inhaler article is shown having a resilient element at the upstream end, the resilient element being cut to form a flap. Figure 3B An inhaler article inserted into a holder is shown having a resilient element at the upstream end cut to form a flap, wherein the flap has been opened by the holder.

[0136] Figure 4A and Figure 4B An inhaler article of the present disclosure is shown inserted into a holder. Figure 4A An inhaler article is shown having a resilient element at the upstream end, the resilient element having a central aperture. Figure 4B An inhaler article inserted into a holder is shown having a resilient element at the upstream end with a central aperture, wherein the central aperture has been opened by the holder.

[0137] Figure 5A , Figure 5B , Figure 5C , Figure 5D , Figure 5E , Fig. 5F and Figure 5G An embodiment of an inhaler article of the present disclosure is shown having a resilient element at the upstream end that is cut to form a flap. Figure 5A The flap is shown folded back to form the interior opening. Figure 5B An embodiment of an inhaler article of the present disclosure is shown having a resilient element at the upstream end cut to form a flap with 6 radial cuts, thereby forming 6 flaps. Figure 5C An embodiment of an inhaler article of the present disclosure is shown having a resilient element at the upstream end cut to form a flap with 8 radial cuts, thereby forming 8 flaps. Figure 5D An embodiment of an inhaler article of the present disclosure is shown having a resilient element at the upstream end cut to form a flap with 6 radial cuts, thereby forming 6 flaps, and in one embodiment the ratio of the length of the cut relative to the diameter of the inhaler article is shown. Figure 5E An embodiment of an inhaler article of the present disclosure is shown having a resilient element at the upstream end cut to form a flap with 6 radial cuts, thereby forming 6 flaps, and in one embodiment the ratio of the length of the cut relative to the diameter of the inhaler article is shown. Fig. 5F An embodiment of an inhaler article of the present disclosure is shown having a resilient element at the upstream end cut to form a flap with 6 radial cuts, thereby forming 6 flaps, and in one embodiment the ratio of the length of the cut relative to the diameter of the inhaler article is shown. Figure 5Gis an illustration of an embodiment of an inhaler article having a central orifice and flaps.

[0138] Fig. 6A , Figure 6B and Figure 6C is an illustrated embodiment of an inhaler article of the present disclosure having a resilient element at the upstream end, wherein the resilient element has a central aperture. Fig. 6A is an illustration of the central orifice of the resilient element at the upstream end of the inhaler article. Figure 6B is another illustration of an inhaler article of the present disclosure having a resilient element at the upstream end, wherein the resilient element has a central aperture. Figure 6C is an illustration of a resilient element 101 having a central aperture 105 .

[0139] Fig. 7A , Figure 7B , Figure 7C and Fig.7D is an illustration of an embodiment of an inhaler article 100 of the present disclosure. Fig. 7A is an illustration of the resilient element 101 with the glue ring 108 applied prior to attaching the resilient element 101 to the upstream end 120 of the inhaler article 100 . Figure 7C is a photograph of an embodiment of the upstream end 120 of the inhaler article 100 prior to attachment of the resilient element 101 . Figure 7C is a diagrammatic representation of the application of a resilient element 101 to the upstream end 120 of an inhaler article 100 . Fig.7D A diagram of the inhaler article 100 is shown after a resilient element has been attached to the upstream end 120 of the inhaler article 100 .

[0140] Fig. 8A , Figure 8B and Figure 8C A manufacturing apparatus for manufacturing an embodiment of an inhaler article having a resilient element attached to the upstream end of the inhaler article is shown. Fig. 8A A tape cutter is shown cutting out a disc of resilient material to create a resilient element. Figure 8B A station is shown where glue rings are provided during the manufacturing process. Figure 8C The holder is shown housing three inhaler articles which are to be provided to the resilient element with the applied glue ring during the manufacturing process.

[0141] Fig. 9A and Fig. 9B A manufacturing apparatus is shown for manufacturing an embodiment of an inhaler article having a resilient member attached to an upstream end of the inhaler article. Fig. 9A The band cutter is shown before elastic elements of elastic material have been cut from the band of elastic material. Fig. 9BThe band cutter is shown after the elastic elements, discs, of elastic material have been cut from the band of elastic material.

[0142] Fig. 10A , Fig. 10B and Fig. 10C A manufacturing apparatus and method for attaching a resilient element to an inhaler article is shown in an embodiment of an inhaler article having a resilient element attached to an upstream end of the inhaler article. Fig. 10A The step of providing the elastic element to the gluing station is shown. Fig. 10B The steps of loading the glue ring are shown. Fig. 10C The step of applying glue to the elastic element is shown.

[0143] Fig.11A , Fig. 11B and Fig. 11C A manufacturing apparatus is shown for manufacturing an embodiment of an inhaler article having a resilient member attached to an upstream end of the inhaler article. Fig.11A A perspective view of the elastic element with the applied glue ring after the manufacturing step of FIG. 10 is shown. Fig. 11B The inhaler article is shown provided to the glue side of the resilient element with an applied glue ring. Fig. 11C An embodiment of an inhaler article having a resilient element attached to the upstream end of the inhaler article is shown.

[0144] The schematic diagrams are not necessarily drawn to scale and are presented for illustrative rather than limiting purposes. The accompanying drawings depict one or more aspects described in the present disclosure. However, it should be understood that other aspects not depicted in the drawings fall within the scope and spirit of the present disclosure. DETAILED DESCRIPTION

[0145] Figure 1A and Figure 1B An embodiment of an inhaler article 100 of the present disclosure is shown. Figure 1A An inhaler article 100 is shown having an upstream end 120 (also distal end), a downstream end 130 (also proximal end or mouthpiece end), a tubular body 121 extending along a longitudinal axis 122 from the downstream end 130 to the upstream end 120 . Figure 1A An embodiment of an inhaler article is shown having a resilient element 101 at an upstream end 120 which is cut 104 to form a flap 103 . Figure 1A The cutout 104 and the flap 103 formed by the cutout 104 are shown. Figure 1A and Figure 1B Also shown is a bladder cavity 123 that houses a bladder 125 . Figure 1B An embodiment of an inhaler article is shown having a resilient element 101 at an upstream end 120 , the resilient element having a central aperture 105 . Figure 1A and Figure 1B It is also shown that the inhaler article 100 can have a barrier 131 located near the downstream end 130 of the inhaler article 100 .

[0146] The tubular body 121 may be made of card paper or wrapping paper rolled into a tube. Figure 1A As shown in FIG. 1 , the elastic element 101 has an opening formed by cutouts 104 forming flaps 103. These cut flaps 103 provide an opening in the elastic element 101. Figure 1B , a central orifice 105 is shown. These openings provide access for a piercing needle 205 to reach and perforate the capsule 125 when the inhaler article 100 is placed in the holder 200 and the capsule 125 is activated. At the same time, these openings are smaller than the diameter of the capsule 125 to prevent the capsule 125 from falling out of the inhaler article 100 before, during or after use.

[0147] Figure 2 Shown is the inhaler article 100 of the present disclosure that is inserted into the holder 200 and forms the inhaler system 300.The inhaler article 100 has a capsule 125, a capsule cavity 123 and a tubular body 121.The holder 200 has a housing 201 that limits a housing cavity 216.The housing cavity 216 has an open end 220 and a piercing end 221.When the inhaler article 100 is introduced into the holder 200, when entering the housing cavity 216, the inhaler article 100 is pushed against the removable cap 202 at the far end of the housing cavity 216.The removable cap 202 has a tip 210.These tips 210 can be a part of the removable cap, or can be separated from the removable cap.The tip 210 is located in the housing cavity 216.The tip 210 is configured to be inserted into the tubular body 121 of the inhaler article 100 when the inhaler article 100 is inserted into the holder 200. The removable cap 202 moves downward relative to the housing 201. When the inhaler article and the removable cap 202 move downward relative to the housing 201, the piercing needle 205 extends through the elastic element ( Figure 2 Not shown, but see Figure 3A and Figure 3B ) and pierces the capsule 125.

[0148] There is an air inlet 206 through the housing 201 of the holder 200, which allows air to enter the inhaler system 300. Air flows into the inhaler system 300 through the air inlet 206 in the air flow path 301, flows into the pocket 123 of the inhaler article 100 through the removable cap 202 through the air flow path 208. Because the air flow path 208 is tangent to the longitudinal axis 122 of the inhaler article 100 (and the pocket 123), the air flowing through the pocket 123 flows in the vortex air flow path 302. In an embodiment, there is one air flow path 208. In an embodiment, there are two air flow paths 208. In an embodiment, there are more than two air flow paths 208.

[0149] When using such an article, the user inserts the inhaler article 100 into the holder 200 to form the inhaler system 300. When the inhaler article 100 is inserted into the holder 200, the user presses the inhaler article downward, which moves the removable cap 202 relative to the piercing needle 205 and moves the capsule 125 contained in the capsule cavity 123 of the inhaler article to contact the piercing needle 205, thereby piercing the capsule 125. Once the capsule 125 has been pierced, the removable cap 202 is retracted, for example, by the action of the spring 212. The movement of the removable cap is indicated by arrow 215.

[0150] After the capsule 125 is pierced, when this air flows into the system via the air inlet 206, through the airflow passage 208, through the capsule cavity 123 and leaves the system via the downstream end 130 of the inhaler product 100 and reaches the user, the powder released from the pierced capsule 125 is entrained in the airflow path 302, and the powder is delivered to the downstream end 130 (mouthpiece end) of the inhaler product 100 and is inhaled by the user. This airflow is triggered by the suction provided by the user at the mouthpiece end (downstream end 130 of the inhaler product 100). In addition, the vortex airflow path 302 provides agitation or vortex airflow, which agitates the capsule 125 inside the capsule cavity 123 and improves the release of powder from the capsule 125 during use.

[0151] It may be expected that effective airflow through the inhaler system 300 can be produced so that the powder of appropriate amount is entrained in the airflow, so that the powder of appropriate dose is provided to the user. The powder is discharged from the capsule by the hole introduced into the capsule 125 by the piercing needle 205. This piercing needle 205 also passes the upstream end 120 of the inhaler article. If the upstream end 120 of the inhaler article 100 is closed, the piercing needle 205 introduces the hole in the upstream end 120 of the inhaler article 100. The hole produced by the piercing needle 205 in the upstream end 120 of the inhaler article is substantially relevant with the size of the piercing needle 205. In general, the hole produced by the piercing needle 205 is not large enough to make enough airflow to pass through the inhaler system 300 to provide the powder of appropriate dose to the user. That is to say, the aperture in the upstream end 120 of the inhaler article 100 in the inhaler system 300 introduces significant suction resistance (RTD) into the system, and produces a system in which airflow is not enough to provide the powder of appropriate dose discharged from capsule 125 to the user. One solution to this RTD challenge is to provide an inhaler article 100 with an openable upstream end 120. A solution to this RTD challenge is to provide an inhaler article 100 with a resilient element 101 on the upstream end 120 of the inhaler article 100 that is opened by an opening force provided by a structure of the retainer (e.g., a tip 210) to create an open airflow area to improve the RTD through the system.

[0152] After using inhaler system 300, the user can extract inhaler product 100 from retainer 200.After inhaler product 100 is extracted from retainer, elastic element 101 recovers to its use front state or almost its use front state.That is to say, elastic element 101 opens to open position in response to opening force, and when removing opening force, is closed to closed position.When elastic element was in closed position, elastic element fully closed so that bag was remained in the capsule cavity between downstream cigarette holder end and elastic element.

[0153] It may be desirable to ensure that the capsule 125 containing active ingredients is maintained in the inhaler product before and after the inhaler product 100 is inserted into the retainer 200. In addition, it may be desirable to prevent powder from overflowing from the inhaler product 100 before and after the inhaler product 100 is inserted into the retainer 200. It may be desirable to prevent the capsule powder from falling out or overflowing from the inhaler product 100 before and after use. The inhaler product 100 with an open upstream end 120 is provided without capsule 125 being maintained in the capsule cavity 123 inside of the inhaler product 100. The present disclosure provides solutions to the RTD challenge and keeps both challenges. The solution is a resilient element at the upstream end of the inhaler product, which can be inserted into the retainer 200 to form the inhaler system 300 before and after closing (or relatively closed) to keep capsule and powder, and during use, during being inserted into the retainer 200, open to provide the user of the inhaler system 300 with suitable airflow and appropriate dose of powder.

[0154] Additionally, it may be desirable to provide a resilient element 101 applied or attached to the upstream end of the inhaler article 100 wherein the resilient element 101 is sufficiently attached to prevent easy removal of the resilient element 101 .

[0155] like Figure 2 As shown in , when inserting the inhaler article into the holder, the user simultaneously moves the removable cap 202, perforates the capsule 125, and inserts the insertion portion of the removable cap 202 into the inhaler article to provide an airflow opening at the upstream end 120 of the inhaler article 100, which provides the appropriate RTD for the proper operation of the inhaler system 300. That is, when the insertion portion of the removable cap is inserted into the inhaler article and the resilient element 101 is moved or stretched open, the hole at the upstream end 120 of the inhaler article 100 is large enough to enable the inhaler system to function.

[0156] In addition, when the inhaler article 100 is removed from the holder 200 , the resilient element returns to its pre-insertion state (partially or completely). When the resilient element 101 returns to its pre-insertion state, the capsule 125 and the powder are contained inside the inhaler article 100 .

[0157] In Fig. 3, tip 210 is shown as the post in the inhaler product of insertion. Two or more tips 210 can be present. For example, two tips 210 can be present. Three tips 210 can be present. Four tips 210 can be present. Five tips 210 can be present. Six or more tips 210 can be present. Tip 210 can be an annular ring structure. Tip 210 can be a tapered structure, thereby the central aperture is stretched to be inserted into and opened. Tip 210 can be any suitable shape or size of the elastic element that opens the inhaler product.

[0158] Figure 3A and Figure 3B An inhaler article 100 having a resilient element 101 with a cut flap 103 is shown inserted into a holder 200 . Figure 3A and Figure 3B The arrow in shows the insertion of the inhaler article 100 into the holder 200 . Figure 3A An inhaler article is shown having a resilient element 101 at an upstream end 120 which is cut to form a flap 103 . Figure 3B An inhaler article 100 is shown inserted into a holder 200 having a resilient element 101 at an upstream end 120 which is cut to form a flap 103 which has been opened by a tip 210 of a removable cap (not shown) of the holder 200 . Figure 3B The needle 205 is shown piercing the capsule 125 in the capsule cavity 123 of the inhaler article 100 when the inhaler article 100 has been inserted into the holder 200 .

[0159] After having used 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 inserted portion of the removable cap 210 is removed from the inhaler article 100, the resilient element 101 returns to its pre-use state or nearly its pre-use state. After use, the flap 103 on the upstream end 120 of the inhaler article 100 returns to the closed state, such as, for example, Figure 1A as shown in .

[0160] Figure 4A and Figure 4B The inhaler article 100 of the present disclosure is shown inserted into a holder 200 to form an inhaler system 300 . Figure 4A and Figure 4B The arrow in shows the insertion of the inhaler article 100 into the holder 200 . Figure 4A An inhaler article 100 is shown having a resilient element 101 at an upstream end 120 , the resilient element 101 having a central aperture 105 . Figure 4B An inhaler article 100 is shown inserted into a holder 200 having a resilient element 101 at an upstream end 120 having a central aperture 105, wherein the central aperture 105 has been opened to form an airflow aperture 140. The central aperture 105 has been opened by an opening force provided by a tip 210 to form an airflow aperture by inserting an insertion portion of a removable cap 210 through the central aperture 105 of the resilient element 101 of the inhaler article 100.

[0161] After having used 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 tip 210 of the removable cap (not shown) is removed from the inhaler article 100, the resilient element 101 returns to its pre-use state or nearly its pre-use state. After use, the central aperture 105 of the resilient element 101 returns to a closed state, such as, for example, Figure 1B as shown in .

[0162] Figure 5A , Figure 5B , Figure 5C , Figure 5D , Figure 5E , Fig. 5F and Figure 5G An embodiment of the inhaler article of the present disclosure is shown having a resilient element 101 at the upstream end, which is cut to form flaps 103. The number of cuts 104 and the length of the cuts 104 define the geometry of the flaps 103 formed by the cuts 104. Figure 5A The flap 103 is shown folded back to form an interior opening. Figure 5A The number of cutouts 104 defining the shape of the arc 135 and the flap 103 is shown, wherein the flap is folded inwardly. Figure 5B 3 diameter cuts or 6 radial cuts as shown in Figure 5C 8 radial cuts or 4 diametric cuts as shown in FIG. 1 ) changes arc 135. Increasing the number of cuts reduces arc 135. For example, in the case where there are two diametric cuts, four flaps will be formed. For example, in the case where Figure 5B In the case of 3 radial cuts or 6 radial cuts as shown in , six flaps are formed, and in an inhaler product with a diameter of 10 mm, the arc 135 is 3.14 mm. Figure 5CIn the case of 4 diameter cuts or 8 radial cuts shown in the figure, eight flaps are formed, and in the inhaler product with a diameter of 10mm, arc 135 is 2.34mm. Increase the number of cuts 104, and therefore increase the number of flaps 103, reduce arc 135. In addition, the length of cuts 104 affects arc 135. Changing the geometric shape of these flaps and changing arc 135 can affect the degree that flaps can be opened during use. In addition, adjusting the length of cuts 104 and the number of flaps 103 can make it possible to use different materials for elastic element 101. For example, providing more flaps can allow elastic material elasticity to be less, and still return to its original shape or almost its original shape after opening flap 103. In an embodiment, the elastic material can be, for example, laminated layer PLA or cardboard on silicon, latex, rubber, plastics, paper, aluminum foil, paper tape, paper layer. When more elasticity is needed, material can be selected from silicon, latex, rubber or combination. In an embodiment, the thickness of elastic element can be, for example, less than 0.5mm.

[0163] In addition, if Figure 5D , 5E 5F , the length of the cutouts may also affect the size and shape of the flaps and arcs 135. The size of the flaps 103, the length of the cutouts 104, and the geometry of the arcs 135 may be adjusted in conjunction with the material of the resilient element to optimize the ability of the resilient element to close before and after use and to open during use to form a suitable airflow path when the inhaler article 100 is inserted into the holder 200 to form the inhaler system 300. Figure 5D , 5 and 5F show the cutout 104 forming the flap 103, wherein the cutout extends about 90% of the diameter of the inhaler article ( Figure 5D ), about 78% of the diameter of the inhaler product ( Figure 5E ) and about 65% of inhaler products ( Fig. 5F ). Figure 5G is a photograph of an embodiment of an inhaler article of the present disclosure having a resilient element at the upstream end that is pre-cut to form a flap with 6 radial cuts, thereby forming 6 flaps. Figure 5G It is the diagram of the embodiment of the inhaler goods 100 with central aperture 105 and the otch 104 that forms flap 103.In an embodiment, elastic element 101 is cut to form at least 4 flaps.In an embodiment, elastic element 101 is cut to form at least 6 flaps.In an embodiment, elastic element 101 is cut to form 4,6 or 8 flaps.The flap of this number provides the arc region of elastic element to provide (when being pushed in retainer 200) good flexibility and tear resistance, and the suitable rigidity that returns to its initial position when goods are removed from retainer 200.In an embodiment, the otch extends the diameter of elastic element 101 approximately 65% ​​to 95%.

[0164] In an embodiment, the cuts are of equal length and cross at the center of the resilient element, and have similar angles between the cuts, thereby providing a symmetrical distribution of forces applied to the flaps when pushed into the holder 200. Providing this symmetry can help prevent tearing of the resilient element when inserting the inhaler article into the holder, and can help with the desired opening and closing of the resilient element.

[0165] Fig. 6A , Figure 6B and Figure 6C is an illustrated embodiment of an inhaler article of the present disclosure having a resilient element 101 at the upstream end, wherein the resilient element 101 has a central aperture 105 . Fig. 6A is an illustration of the central aperture 105 of the resilient element 101 applied to the upstream element 18 at the upstream end 120 of the inhaler article 100 . Figure 6B is another illustration of an inhaler article 100 of the present disclosure having a resilient element 101 at an upstream end 120, wherein the resilient element has a central aperture 105. In an embodiment, the resilient element 101 is applied to an upstream element 18. The upstream element 18 may be present or absent. Figure 6C 1 is a diagram of a separate elastic element 101 having a central aperture 105. In other embodiments, the elastic element may have a combination of a central aperture and a flap. For example, the central aperture may be partially cut or weakened. In an embodiment, the diameter of the central hole may be about 30% of the disc diameter, less than 30%.

[0166] Fig. 7A , Figure 7B , Figure 7C and Fig.7D is an illustration of an embodiment of an inhaler article 100 of the present disclosure. FIG. 7 is an illustration of a resilient element 101 with an applied glue ring 108 prior to attaching the resilient element 101 to the upstream end 120 of the inhaler article 100. Figure 7B is a photograph of an embodiment of the upstream end 120 of the inhaler article 100 before attaching the resilient element 101. 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. Figure 7C is a diagrammatic representation of the application of a resilient element 101 to the upstream end 120 of an inhaler article 100 . Fig.7D Shown is a diagram of an inhaler product 100 after the elastic element has been attached to the upstream end 120 of the inhaler product 100. In an embodiment, the elastic element can have a mark. For example, the elastic element can be colored. Or, the elastic element can have one or more symbols. Or, the elastic element can have both color and one or more symbols.

[0167] Fig. 8A , Figure 8B and Figure 8C A manufacturing apparatus 400 and method for manufacturing an embodiment of an inhaler article 100 having an elastic element 101 attached to the upstream end 120 of the inhaler article 100 is shown. This manufacturing apparatus 400 operates to cut a disc of elastic material to form an elastic element 101 that fits at the upstream end 120 of the inhaler article 100. Fig. 8A A tape cutter 403 is shown having a feeder reel 401, an elastic material strip 402, a cutter 403, a cutting station 405 and a take-up reel 404. In use, as Fig. 8A , a feeder reel 401 contains an uncut elastic material strip 402. This uncut elastic material strip 402 moves from the feeder reel 401 to a cutting station 405. The elastic material strip 402 is provided to the cutting station 405. The cutting station 405 is aligned with a band cutter 403. The cutter 403 cuts the elastic material disc to produce the elastic element 101. In addition, the cutter 403 can cut in the elastic element to form a flap 103, thereby manufacturing an elastic element 101 with a flap 103. Alternatively, the cutter 403 can cut a central aperture 105 in the disc to form an elastic element 101 with a central aperture 105. Alternatively, the cutter 403 can make the cut 104 or the central aperture 105 in the elastic element 101 in a separate cutting step. Alternatively, the cutter 403 can make the cut 104 and the central aperture 105 in the same cutting action. After the disks are cut from the tape 402 , the used tape 406 travels to the take-up reel 404 . Figure 8B A glue station 500 is shown having a glue station 501 to optionally provide a glue ring to a disc or elastic element during the manufacturing process. Figure 8C An element holder 600 is shown holding three resilient elements which, in use, are provided to a glue station 502 to apply glue to cut resilient elements during the manufacturing process. Or, in other words, at least one cut disc of resilient material with an applied glue ring is provided to the upstream end of the inhaler article.

[0168] Fig. 9A and Fig. 9B A manufacturing apparatus and method for manufacturing an embodiment of an inhaler article 100 having a resilient element 101 attached to an upstream end 120 of the inhaler article 100 is shown. Fig. 9A The cutting step is shown, wherein a strip of elastic material 402 is moved from a feeder reel 401 to a cutting station 405. The strip of elastic material is provided to the cutting station 405, and a strip cutter 403 is aimed at the cutting station 405 with the strip of elastic material 402. The cutter cuts at least one disk of elastic material from the strip of elastic material to form at least one cut disk of elastic material. Fig. 9A and Fig. 9BAs shown in FIG. 4 , there are three cutters 403. The cutters 403 are modular and can be combined to optimize the manufacturing process. In an embodiment, there can be one cutter 403. In an embodiment, there can be two cutters 403. In an embodiment, there can be three cutters 403. In an embodiment, there can be more than three cutters 403. The band cutter 403 cuts the elastic material disc from the elastic material band 402. The cutting can be performed by press cutting, knife cutting, laser cutting, or by any means. Fig. 9B The step of removing the disk of elastic material from the cutting station 405 is shown. Once the cutting has been performed, the disk of elastic material can be removed from the cutting station 405 to proceed to the next step in the manufacturing process. In addition, the cut tape 406 is passed to the take-up reel, and a new uncut tape will be provided to the cutting station 405 so that the cutting step can be repeated. The cutting step can also include cutting lines in the elastic element to form flaps, or cutting a central aperture in the elastic element, or a combination of a central aperture and a flap in the elastic element.

[0169] Fig. 10A , Fig. 10B and Fig. 10C A manufacturing apparatus and method for manufacturing an embodiment of an inhaler article 100 having a resilient element 101 attached to an upstream end 120 of the inhaler article 100 is shown. Fig. 10A , Fig. 10B and Fig. 10B The gluing step of the manufacturing process is shown. Fig. 10A The steps of providing an elastic element to a glue station 500 and applying at least one glue ring to at least one cutting disk of elastic material are shown. Fig. 10B The step of loading the glue ring 502 is shown. Fig. 10C The step of applying glue to a cutting disc or elastic element 101 of elastic material is shown. Fig. 10A The step of providing a cut disc 101 of elastic material to a glue station 500 is shown. The glue station 501 has a glue ring 502. The elastic element 101 is provided to the glue station 501 by an element holder 600.

[0170] Fig. 10A The glue ring 502 is shown before glue has been provided to the glue ring 502 . Fig. 10B 1 and 2 show the glue station 501 and the glue ring 502 after glue has been dispensed to the glue ring 502. In other words, Fig. 10B As shown in , the glue ring has been loaded with glue. In an embodiment, glue can be dispensed to the glue ring 502 by pressing glue from a glue reservoir below the glue station 501 into the glue ring 502. Fig. 10CThe step of pressing the cut elastic element 101 onto the glue station 501 to provide glue to the glue side of the elastic element 101 is shown. The glue side of the elastic element is the side that is attached to the inhaler article 100. Fig. 10C Shown is the step of applying at least one glue ring to at least one cutting disk of elastic material.The cutting disk can be transported to the glue coating station by the element holder 600.Glue can be introduced into the glue coating station 500.For example, glue can be applied to the station.Glue can be pressure-supplied to the glue ring, and the glue ring size is slightly smaller than the diameter of the elastic element disk at the glue station 500.In an embodiment, glue can be provided to the glue ring by pressing glue into the glue ring from the glue reservoir below the glue station.Alternatively, glue can be provided in dots, discontinuous rings, thick rings, thin rings or any other shape to provide glue to the glue station.Suitable glue can include starch adhesives, such as dextrin, casein-based adhesives, polyamide blue, hot melt adhesives, cyanoacrylates, organic glues or any other suitable glues.

[0171] Fig.11A , Fig. 11B and Fig. 11C A manufacturing apparatus and method for manufacturing an embodiment of an inhaler article having a resilient element 101 attached to an upstream end 120 of the inhaler article 100 is shown. Fig.11A Shown in Fig. 10C A perspective view of the elastic element 101 with the applied glue ring 503 after the manufacturing steps of FIG. Fig. 11B The inhaler article 100 is shown provided to the glue side of the resilient element 101 with a glue ring 503 applied. Fig. 11B The steps of providing at least one cut disc of elastic material with an applied glue ring 502 to the upstream end 120 of the inhaler article 100 and attaching at least one cut disc of elastic material with an applied glue ring 101 to the upstream end of the inhaler article to form the inhaler article with the attached upstream elastic element 101 are shown. Fig. 11C An embodiment of an inhaler article is shown having a resilient element 101 attached to the upstream end 120 of the inhaler article 100 at the end of the manufacturing process. Fig. 11C An embodiment of the elastic element 101 having a cutout 104 to form a flap 103, an embodiment of the elastic element 101 having a central aperture 105, and an embodiment of the elastic element 101 having both a cutout 104 and a central aperture 105 to form a flap 103 are shown. For clarity, the embodiment of the elastic element 101 having both a cutout 104 and a central aperture 105 to form a flap 103 is shown in perspective and top-down views. In addition, Fig. 11C The embodiment of shows the elastic element 101 on the upstream element 18. In embodiments, the upstream element 18 may be present or absent.

[0172] For the purpose of this specification and the appended claims, unless otherwise stated, all numbers representing amounts, quantities, percentages, etc. should be understood to be modified by the term "about" in all cases. In addition, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges therein, which may or may not be specifically listed in this article. Therefore, in this context, the number A is understood to be A±10%A. In this context, the number A can be regarded as including a value within the general standard error for the measurement of the attribute modified by the number A. In some cases used in the appended claims, the number A may deviate from the percentages listed above, provided that the amount of A deviation will not substantially affect the basic characteristics and novel features of the claimed invention. In addition, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges therein, which may or may not be specifically listed in this article.

Claims

1. A method for manufacturing an inhaler article having an upstream elastic element for insertion into a holder to form an inhaler system for providing dry powder to the lungs of a user, the method comprising: moving a strip of elastic material from a feeder reel to a cutting table; providing the strip of elastic material to the cutting table; cutting at least one disk of elastomeric material from the strip of elastomeric material to form at least one cut disk of elastomeric material; providing at least one cutting disc of said elastic material to a glue station; dispensing at least one adhesive ring; applying the at least one adhesive ring to the at least one cutting disk of the elastomeric material; as well as, providing at least one cut disc of said elastomeric material having an applied glue ring to an upstream end of the inhaler article; At least one cut disc of said elastomeric material with the applied glue ring is attached to the upstream end of the inhaler article to form the inhaler article with the attached upstream elastomeric element.

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

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

4. The method of claim 1, wherein the cutting step further comprises cutting 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 2-4, wherein the cut extends within a range of about 65% to about 95% of the diameter of the elastic element.

6. A method according to any preceding claim, further comprising cutting a central aperture in the at least one disk of resilient material.

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

8. The method of any one of the preceding claims, further comprising moving the strip of elastic material from the cutting station to a take-up reel.

9. A method according to any preceding claim, further comprising the step of inserting a capsule into the inhaler article prior to the attaching step.

10. A method according to any preceding claim, wherein the elastic element comprises rubber, silicon or latex.

11. The method of any one of the preceding claims, wherein the inhaler article comprises: a tubular body extending along a longitudinal axis from a downstream mouthpiece end to an upstream end; a bladder cavity located within the tubular body between the downstream mouthpiece end and the upstream end; The capsule cavity accommodates the capsule; wherein the upstream boundary of the bladder cavity is defined by the elastic element, and An attached elastic element holds the bladder in the bladder cavity.

12. A method according to claim 11, wherein the downstream mouthpiece end comprises a barrier element.

13. A method according to claim 11 or 12, wherein the tubular body comprises cardboard.

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

15. A method according to any one of the preceding claims, wherein the elastic material comprises a colour, one or more symbols or a combination of a colour and one or more symbols.

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