Inhaler article having folded edges of uniform appearance
Patent Information
- Application Number
- JP2024506543
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-08-06
- Filing Date
- 2022-08-03
- Publication Date
- 2025-08-15
- Estimated Expiration
- 2042-08-03
AI Technical Summary
Inhaler articles with deformable tubular elements have varying lengths due to manufacturing tolerances, leading to inconsistent closed distal ends, which can result in uneven visual appearance and require different insertion forces, potentially causing article rupture.
A method and apparatus for manufacturing inhaler articles by aligning the open distal ends of semi-finished articles to the same height, allowing simultaneous and uniform closure, using a holder with movable end surfaces and an inversion mechanism to ensure consistent distal end appearance and reduce rupture risk.
Ensures reproducible, high-speed manufacturing of inhaler articles with uniform closed ends, reducing the risk of rupture and enabling consistent insertion forces.
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Abstract
Description
[Technical field]
[0001] The present disclosure relates to a method for manufacturing an inhaler article. The present disclosure further relates to a package for an inhaler article having a uniformly closed end. The present disclosure further relates to a holder for an equipment for manufacturing an inhaler article. The present disclosure further relates to an equipment for manufacturing an inhaler article. [Background technology]
[0002] In the field of inhaler article manufacturing, it is known to provide a deformable tubular element and to fold the distal end of the deformable tubular element inwardly by about 90 degrees to at least partially close the distal end of the deformable tubular element. Due to manufacturing tolerances in the production of the tubular elements, there may be small differences in length between the individual tubular elements. These differences in the length of the tubular elements may result in the distal portion of the folded semi-finished article having different lengths. This may lead to variations in the closed distal end of the inhaler article. This may lead to a non-uniform visual appearance of the closed distal end of the inhaler article.
[0003] Variations in the closed distal end of the inhaler article may result in differences in the force required by the user to insert the finished inhaler article into the user holder device. This may then lead to applying excessive force and potentially breaking the article. In general, due to the material properties of the paper tubular element, there may be a limit to the maximum bendable length of the paper tubular element. This may mean that the more the tube bends, the more force needs to be applied by the user when inserting the tube into the user holder device. Summary of the Invention [Problem to be solved by the invention]
[0004] It would be desirable to provide a method and apparatus for manufacturing inhaler articles in a reproducible and automated manner. It would be desirable to provide a method and apparatus for manufacturing inhaler articles having a uniform appearance of the closed distal end of the article.
[0005] It would be desirable to provide a method and apparatus for producing inhaler articles at a sufficiently high speed.
[0006] It would be desirable to provide a method and apparatus for manufacturing inhaler articles, which manufacturing method can be carried out on existing manufacturing lines used to manufacture inhaler articles.
[0007] It would be desirable to provide a method and apparatus for manufacturing an inhaler article which reduces the risk of the article exploding when used by a user in a user holder device. [Brief description of the drawings]
[0008] [Figure 1A] 1 illustrates an exemplary inhaler article. [Figure 1B] 1 illustrates an exemplary inhaler article. [Figure 1C] 1 illustrates an exemplary inhaler article. [Figure 2A] 1 illustrates a process for closing the open end of an inhaler article without alignment. [Figure 2B] 1 illustrates a process for closing the open end of an inhaler article without alignment. [Figure 2C] 1 illustrates a process for closing the open end of an inhaler article without alignment. [Figure 2D] 1 illustrates a process for closing the open end of an inhaler article without alignment. [Figure 3A] 1 illustrates a process for aligning an inhaler article. [Figure 3B] 1 illustrates a process for aligning an inhaler article. [Figure 3C] 1 illustrates a process for aligning an inhaler article. [Figure 3D] 1 illustrates a process for aligning an inhaler article. [Figure 3E] 1 illustrates a process for aligning an inhaler article. [Figure 3F] 1 illustrates a process for aligning an inhaler article. [Figure 4A] 1 illustrates a process for closing the open end of an inhaler article without alignment. [Figure 4B] 1 illustrates a process for closing the open end of an inhaler article without alignment. [Figure 4C] 1 illustrates a process for closing the open end of an inhaler article without alignment. [Figure 4D] 1 illustrates a process for closing the open end of an inhaler article without alignment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0009] According to one embodiment of the present invention, a method for manufacturing an inhaler article is provided. The method may include providing a plurality of semi-finished inhaler articles. Each inhaler article may have a longitudinal axis, a proximal end, and an open distal end. The method may include aligning the semi-finished inhaler articles such that the longitudinal axes of the semi-finished inhaler articles are arranged in parallel and the open distal ends of the semi-finished inhaler articles are located at exactly the same height in a direction parallel to the longitudinal axis. The method may include at least partially closing the distal ends of the aligned semi-finished inhaler articles.
[0010] According to one embodiment of the present invention, a method for manufacturing an inhaler article is provided. The method includes providing a plurality of semi-finished inhaler articles, each of which has a longitudinal axis, a proximal end, and an open distal end. The method includes aligning the semi-finished inhaler articles such that the longitudinal axes of the semi-finished inhaler articles are arranged in parallel and the open distal ends of the semi-finished inhaler articles are located at exactly the same height in a direction parallel to the longitudinal axis. The method includes at least partially closing the distal ends of the aligned semi-finished inhaler articles.
[0011] Aligning the semi-finished inhaler articles such that the longitudinal axes of the semi-finished inhaler articles are arranged in parallel and the open distal ends of the semi-finished inhaler articles are located at exactly the same height with respect to a direction parallel to the longitudinal axes may be performed simultaneously. Aligning may be performed simultaneously for multiple articles. At least partially closing the distal ends of the aligned semi-finished inhaler articles may be performed simultaneously. Closing may be performed simultaneously for multiple articles.
[0012] The method may include simultaneously aligning a plurality of semi-finished inhaler articles received in a holder, whereby the longitudinal axes of the articles in the holder are simultaneously disposed parallel and the open distal ends of the semi-finished inhaler articles are located at exactly the same height with respect to a direction parallel to the longitudinal axes. The method may include simultaneously at least partially closing the distal ends of the aligned semi-finished inhaler articles received in the holder.
[0013] The process of aligning the height of the articles can offset or reduce the effect that differences in the length of individual articles due to manufacturing tolerances have on the process of at least partially closing the distal end of the article.Typical manufacturing tolerances for the length of semi-finished inhaler articles can be about + / - 0.5 millimeters.
[0014] The process of height alignment of the semi-finished inhaler article provides a method for reproducibly and automatically manufacturing inhaler articles.The process of height alignment of the semi-finished inhaler article provides a method for manufacturing inhaler articles having a uniform appearance of at least the partially closed distal end of the article.
[0015] A method and apparatus are provided for manufacturing an inhaler article that reduces the risk of the article exploding when used by a user in a user-holder device by providing an article with a uniformly closed end.
[0016] A method is provided for producing inhaler articles at a sufficiently high speed that it can be implemented on existing manufacturing lines used to manufacture inhaler articles.
[0017] As used herein, the term "exactly the same height" can refer to a height difference of less than about 100 microns, preferably less than about 75 microns, and more preferably about 50 microns or less.
[0018] Aligning the open distal ends of the semi-finished inhaler articles at exactly the same height may involve moving one semi-finished inhaler article relative to another to compensate for differences in length of the semi-finished inhaler articles due to manufacturing tolerances.
[0019] Aligning the open distal ends of the semi-finished inhaler articles at exactly the same height may include providing a holder with a plurality of slot elements having movable end faces. The semi-finished inhaler articles may be inserted into each slot element such that the proximal ends of the semi-finished inhaler articles contact the movable end faces of the slots. The holder may then be brought close to the flat face of the alignment element such that the flat face is perpendicular to the longitudinal axis of the semi-finished inhaler article. The holder and alignment element may then be flipped 180 degrees so that gravity moves the open distal ends of the semi-finished inhaler articles downwards to contact the flat face. The movable end faces may then be moved downwards to contact the proximal end 14 of the semi-finished inhaler article. The movement may be achieved by gravity. The position of the movable end faces may then be fixed.
[0020] The method may include, after the step of fixing the position of the movable end surface, flipping the holder 180 degrees so that the aligned semi-finished inhaler articles are in an upright position with the open distal ends at the top.
[0021] The method may include inserting a capsule into each open distal end of the semi-finished inhaler article after inverting the holder 180 degrees so that the semi-finished inhaler articles are in an upright position with the open distal ends at the top.
[0022] The capsule may contain nicotine.
[0023] The capsule may contain a dry powder.
[0024] The inhaler article may comprise a capsule cavity for receiving the capsule. The capsule cavity may define a cylindrical space configured to contain the capsule. For example, the capsule may have an oval or circular cross-section. The capsule cavity may have a substantially uniform or uniform diameter along the length of the capsule cavity. The capsule cavity may have a fixed cavity length. The capsule cavity has a cavity inner diameter perpendicular to the longitudinal axis, and the capsule has a capsule outer diameter. The capsule cavity may be sized to contain an oval capsule. The capsule cavity may have a substantially cylindrical or cylindrical cross-section along the capsule cavity length. The capsule cavity may have a uniform inner diameter. The capsule may have an outer diameter that is about 80 percent to about 95 percent of the inner diameter of the capsule cavity. The configuration of the capsule cavity relative to the capsule may facilitate limited movement of the capsule during activation or penetration of the capsule.
[0025] The capsule cavity may be defined by a deformable element having a diameter in the range of about 6 millimeters to about 8 millimeters, or about 6.6 millimeters.
[0026] The capsule may contain medicamentously active particles. For example, the medicamentously active particles may include nicotine. The medicamentously active particles may have a mass median aerodynamic diameter of about 5 micrometers or less, or within the range of about 0.5 micrometers to about 4 micrometers, or within the range of about 1 micrometer to about 3 micrometers.
[0027] The capsule may contain nicotine particles containing nicotine (also referred to as "nicotine powder" or "nicotine particles"), and optionally, flavor-containing particles (also referred to as "flavor particles"). The capsule may contain a predetermined amount of nicotine particles and, optionally, flavor particles. The capsule may contain sufficient nicotine particles to provide at least 2 inhalations or "puffs", or at least about 5 inhalations or "puffs", or at least about 10 inhalations or "puffs". The capsule may contain sufficient nicotine particles to provide about 5 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 about 0.2 milligrams to about 2 milligrams of nicotine particles to the user's lungs, or about 1 milligram of nicotine particles to the user's lungs.
[0028] The nicotine particles may have any useful concentration of nicotine based on the particular formulation employed. The nicotine particles may have at least about 1 weight percent nicotine up to about 30 weight percent nicotine, or about 2 weight percent to about 25 weight percent nicotine, or about 3 weight percent to about 20 weight percent nicotine, or about 4 weight percent to about 15 weight percent nicotine, or about 5 weight percent to about 13 weight percent nicotine. Preferably, about 50 to about 150 micrograms of nicotine may be delivered to the user's lungs with each inhalation or "puff."
[0029] The capsule may hold or contain at least about 5 milligrams of nicotine particles, or at least about 10 milligrams of nicotine particles. The capsule may hold or contain less than about 900 milligrams of nicotine particles, or less than about 300 milligrams of nicotine particles, or less than 150 milligrams of nicotine particles.
[0030] The capsule may hold or contain from about 5 milligrams to about 300 milligrams of nicotine particles, or from about 10 milligrams to about 200 milligrams of nicotine particles.
[0031] When flavor particles are blended or combined with the nicotine particles in the capsule, the flavor particles may be present in an amount that provides the desired flavor with each inhalation or "puff" delivered to the user.
[0032] The nicotine particles may have any size distribution useful for preferential inhalation delivery into the lungs of the user. The capsule may contain particles other than nicotine particles. The nicotine particles and other particles may form a powder system.
[0033] The capsule may hold or contain at least about 5 milligrams of dry powder (also referred to as a powder system), or at least about 10 milligrams of dry powder. The capsule may hold or contain less than about 900 milligrams of dry powder, or less than about 300 milligrams of dry powder, or less than about 150 milligrams of dry powder. The capsule may hold or contain from about 5 milligrams to about 300 milligrams of dry powder, or from about 10 milligrams to about 200 milligrams of dry powder, or from about 25 milligrams to about 100 milligrams of dry powder.
[0034] The dry powder or powder system may have at least about 40 percent by weight, or at least about 60 percent by weight, or at least about 80 percent by weight of the powder system consisting of nicotine particles having a particle size of about 5 micrometers or less, or in the range of about 1 micrometer to about 5 micrometers.
[0035] The nicotine-containing particles may have a mass median aerodynamic diameter 5 of about 5 micrometers or less, or in the range of about 0.5 micrometers to about 4 micrometers, or in the range of about 1 micrometer to about 3 micrometers, or in the range of about 1.5 micrometers to about 2.5 micrometers. The mass median aerodynamic diameter is preferably measured with a cascade impactor.
[0036] The flavor-containing particles may have a mass median aerodynamic diameter of about 20 micrometers or more, or about 50 micrometers or more, or in the range of about 50 to about 200 micrometers, or in the range of about 50 to about 150 micrometers. The mass median aerodynamic diameter is preferably measured with a cascade impactor.
[0037] The dry powder may have an average particle size of about 60 micrometers or less, or in the range of about 1 micrometer to about 40 micrometers, or in the range of about 1.5 micrometers to about 25 micrometers, where average particle size refers to the average particle size per mass, and is preferably measured by laser diffraction, laser diffusion, or electron microscopy.
[0038] The nicotine in powder system or nicotine particles can be pharma- ceutically acceptable free base nicotine, or nicotine salt or nicotine salt hydrate.Useful nicotine salt or nicotine salt hydrate includes, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine mono-pyruvate, nicotine glutamate, or nicotine hydrochloride.The compound that combines with nicotine to form salt or salt hydrate can be selected based on its expected pharmacological effect.
[0039] Preferably, the nicotine particles comprise an amino acid. Preferably, the amino acid may be leucine, such as L-leucine. Providing an amino acid, such as L-leucine, to the nicotine-containing particles may reduce the adhesive force of the nicotine-containing particles, and may also reduce the attractive force between the nicotine particles, and therefore reduce the aggregation of the nicotine particles.
[0040] Similarly, the adhesive forces to the flavor-containing particles may also be reduced, and therefore the agglomeration of the nicotine particles with the flavor particles is also reduced. Hence, the powder systems described herein may be free-flowing materials and may have a stable relative particle size of each powder component even when the nicotine and flavor particles are combined.
[0041] Preferably, the nicotine may be a surface-modified nicotine salt, in which case the nicotine salt particles include coated particles or composite particles. A preferred coating material or composite material may be L-leucine. One particularly useful nicotine particle may be 5-nicotine bitartrate with L-leucine.
[0042] The powder system may comprise a population of flavour particles, which may have any useful size distribution, optionally for inhalation delivery into the mouth or oral cavity of a user.
[0043] The powder system may have a population of at least about 40 percent, or at least about 60 percent, or at least about 80 percent by weight of the powder system flavor particles that are comprised of particles having a particle size of about 20 micrometers or greater. The powder system may have a population of at least about 40 percent, or at least about 60 percent, or at least about 80 percent by weight of the powder system flavor particles that are comprised of particles having a particle size of about 50 micrometers or greater. The powder system may have a population of at least about 40 percent, or at least about 60 percent, or at least about 80 percent by weight of the powder system flavor particles that are comprised of particles having a particle size in the range of about 50 micrometers to about 150 micrometers.
[0044] The flavor-containing particles may include a compound that reduces adhesion or surface energy and the resulting agglomeration. The flavor particles may be surface-modified with an adhesion-reducing compound to form coated flavor particles. One preferred adhesion-reducing compound may be magnesium stearate. Providing flavor particles, particularly coating the flavor particles, with an adhesion-reducing compound such as magnesium stearate may reduce the adhesion of the flavor-containing particles and may also reduce the attractive forces between the flavor particles and therefore reduce the agglomeration of the flavor particles. Therefore, the agglomeration of the flavor particles with the nicotine particles may also be reduced. Therefore, the powder system described herein may have a stable relative particle size of the nicotine-containing particles and the flavor-containing particles even when the nicotine particles and the flavor particles are combined. Preferably, the powder system may be free-flowing.
[0045] Conventional formulations for dry powder inhalation contain carrier particles that function to increase the fluidization of active particles, because active particles may be too small to be affected by simple airflow through the inhaler.Powder systems may include carrier particles.These carrier particles may be saccharides, such as lactose or mannitol, that may have a particle size of more than about 50 micrometers.Carrier particles may be utilized in formulations to improve dose uniformity by acting as diluent or bulking agent.
[0046] Powder systems utilized with the nicotine powder delivery systems described herein may be carrier-free or substantially free of saccharides such as lactose or mannitol. The absence of carriers or the substantial absence of saccharides such as lactose or mannitol may allow the nicotine to be inhaled and delivered to the user's lungs at an inhalation volume or airflow similar to that of a typical smoking method.
[0047] Nicotine particles and flavors may be combined in a single capsule.As mentioned above, nicotine particles and flavors may each have reduced adhesion, which results in a stable particle formulation in which the particle size of each component does not change substantially when the nicotine particles and flavors are combined.Alternatively, the powder system includes nicotine particles contained in a single capsule and flavor particles contained in a second capsule.
[0048] The nicotine particles and flavor particles may be combined in any useful relative amounts such that the user detects the flavor particles when consumed along with the nicotine particles.
[0049] Preferably, the nicotine particles and flavor particles form at least about 90 percent by weight, or at least about 95 percent by weight, or at least about 99 percent by weight, or 100 percent by weight of the total weight of the powder system.
[0050] The step of inserting a capsule into each open distal end of the semi-finished inhaler article may include providing a filling station adjacent to the semi-finished inhaler article. The filling station may be stationary and may be brought into the vicinity of the semi-finished inhaler article by movement of the holder. The filling station may be movable and may be brought into the vicinity of the semi-finished inhaler article by moving the filling station towards the semi-finished inhaler article.
[0051] The step of aligning the semi-finished inhaler articles such that the longitudinal axes of the semi-finished inhaler articles are arranged parallel and the open distal ends of the semi-finished inhaler articles are located at exactly the same height in a direction parallel to the longitudinal axes may include providing an alignment element adjacent to the semi-finished inhaler articles. The alignment element may be stationary and may be brought into the vicinity of the semi-finished inhaler article by movement of the holder. The alignment element may be movable and may be brought into the vicinity of the semi-finished inhaler article by moving the alignment element towards the semi-finished inhaler article.
[0052] The step of at least partially closing the distal ends of the aligned semi-finished inhaler articles may include providing a closing station proximate to the semi-finished inhaler articles. The closing station may be stationary and may be brought into the vicinity of the semi-finished inhaler articles by movement of the holder. The closing station may be movable and may be brought into the vicinity of the semi-finished inhaler articles by moving the closing station towards the semi-finished inhaler articles.
[0053] One or both of the filling station, alignment element, and closing station may be stationary or movable.
[0054] The distal end portion of the semi-finished inhaler article may comprise a deformable element. The deformable element may be a cardboard tube.
[0055] The term "deformable" should be understood to mean that the shape of the deformable element can be changed. The deformation of the deformable element may include elastic deformation, where the deformable element returns to a closed configuration in the absence of applied force. Alternatively, the deformation of the deformable element may include plastic deformation, where the deformable element is kept in an open configuration after application of a force.
[0056] At least a portion of the deformable element may be formed of a foldable material. The deformable element may comprise fan folds. At least a portion of the deformable element may be formed of a cellulosic material. At least a portion of the deformable element may be formed of paper.
[0057] Advantageously, forming the deformable element from a foldable material allows the deformable element to be reliably broken or opened. The foldable material may also improve assembly of the capsule cavity and provide for rapid assembly of the inhaler article.
[0058] Advantageously, deformable elements formed from cellulosic materials or paper may be substantially biodegradable, reducing the impact of the inhaler article on the environment.
[0059] The deformable element may define at least a portion of a longitudinal sidewall of a cavity of the inhaler article. The cavity may hold a capsule. The deformable element may define a majority of the capsule cavity. The deformable element may define an upstream boundary and a sidewall of the capsule cavity.
[0060] Advantageously, the deformable element may provide a protective cover or hygienic barrier for the retained capsule and inhaler article prior to consumption of the inhaler article.
[0061] The wrapping layer may surround the mouthpiece element and the deformable element. The wrapping layer may join the mouthpiece element, the capsule cavity, and the deformable element with a continuous axial bond. The deformable element may extend beyond the wrapping layer. The deformable element may extend beyond the wrapping layer by about 0.5 millimeters to about 5 millimeters, or about 1 millimeter to about 4 millimeters, or about 2 millimeters to about 3 millimeters. The wrapping layer may be formed from a cellulosic material or paper.
[0062] Advantageously, a wrapping layer formed from a cellulosic material may be substantially biodegradable, reducing the impact of the inhaler article on the environment. Bonding the inhaler article components with a wrapping layer provides for rapid assembly of the inhaler article.
[0063] The capsule cavity and the deformable element may have substantially equal inner diameters within a range of about 6 millimeters to about 8 millimeters.
[0064] The capsule may contain medicamentously active particles. For example, the medicamentously active particles may include nicotine. The medicamentously active particles may have a mass median aerodynamic diameter of about 5 micrometers or less, or within the range of about 0.5 micrometers to about 4 micrometers, or within the range of about 1 micrometer to about 3 micrometers.
[0065] The terms "proximal" and "distal" are used to describe the relative positions of components or portions of components of an inhaler article or system. According to the present invention, the inhaler article has a proximal end. In use, nicotine particles exit the proximal end of the inhaler article for delivery to a user. The inhaler article has a distal end opposite the proximal end. The proximal end of the inhaler article may also be referred to as the mouth end.
[0066] The inhaler article may resemble a smoking article or a cigarette in size and shape. The inhaler article may have an elongate body extending along the longitudinal axis of the inhaler article. The inhaler body may have a substantially uniform outer diameter along the length of the elongate body. The inhaler article may have a circular cross-section that may be uniform along the length of the elongate body. The inhaler body may have an outer diameter within the range of about 6 millimeters to about 10 millimeters, or about 7 millimeters to about 10 millimeters, or about 7 millimeters to about 9 millimeters, or about 7 millimeters to about 8 millimeters, or about 7.3 millimeters. The inhaler article may have a length (along the longitudinal axis) within the range of about 40 millimeters to about 80 millimeters, or about 40 millimeters to about 70 millimeters, or about 40 millimeters to about 50 millimeters, or about 48 millimeters.
[0067] The inhaler article may comprise a mouthpiece element. The mouthpiece element may be located downstream of the capsule cavity and may extend from the capsule cavity to a mouthpiece end of the inhaler article. The mouthpiece element may have a length in the range of about 10 millimeters to about 30 millimeters, preferably about 15 millimeters to about 25 millimeters, more preferably about 20 millimeters to about 22 millimeters. The mouthpiece element may have a diameter in the range of about 6 millimeters to about 10 millimeters, or about 7 millimeters to about 10 millimeters, or about 7 millimeters to about 9 millimeters, or about 7 millimeters to about 8 millimeters, or about 7.1 millimeters.
[0068] The mouthpiece element may have a filtering function. The mouthpiece element may comprise a filter element. The filter element may extend substantially the entire length of the mouthpiece element.
[0069] The deformable element may be configured to deform and expose the capsule cavity. The deformable element may be configured to break or open to expose the capsule cavity. The deformable element may be configured to expose substantially the entire opening of the capsule cavity. The deformable element may be configured to expose the entire opening of the capsule cavity.
[0070] The deformable element may define at least a portion of a longitudinal sidewall of the capsule cavity.The deformable element may define a majority of the capsule cavity.The deformable element may define a closed distal or upstream end of the capsule cavity.
[0071] The deformable element may be formed of a cellulosic material. At least a portion of the deformable element may be formed of paper. The deformable element may provide a barrier to reduce or prevent contaminants or foreign objects from entering the capsule cavity.
[0072] The capsule cavity sidewall may extend parallel to a longitudinal axis of the inhaler article. The deformable element may define a closed distal or upstream end of the capsule cavity and at least a portion of the capsule cavity sidewall.
[0073] The deformable element may define a tubular element having a closed upstream end. The deformable element may define a closed distal or upstream end of the capsule cavity and at least 50 percent of the capsule cavity sidewall. The deformable element may define a closed distal or upstream end of the capsule cavity and at least 75 percent of the capsule cavity sidewall. The deformable element may define a closed distal or upstream end of the capsule cavity and the entire capsule cavity sidewall. The deformable element may define the entire capsule cavity except for a downstream boundary surface defined by the mouthpiece element. The deformable element may be a paper layer extending from the mouthpiece element to the closed upstream end.
[0074] The intake air may flow through the center of the deformable element directly into the capsule cavity when the deformable element is ruptured or opened. The deformable element may have a diameter substantially equal to the inner diameter of the capsule cavity.
[0075] The deformable element may have an outer diameter in the range of about 6 millimeters to about 8 millimeters, or about 7.0 millimeters to about 7.1 millimeters. The deformable element may have an inner diameter in the range of about 6 millimeters to about 7.2 millimeters, or about 6.5 millimeters to about 6.7 millimeters.
[0076] The deformable element may be formed of paper. The deformable element may be formed of one or more layers of paper. The deformable element may be formed of paper having a weight in the range of about 50 grams per square meter to about 150 grams per square meter, or about 75 grams per square meter to about 125 grams per square meter, or about 90 grams per square meter to about 110 grams per square meter.
[0077] The deformable element may have a thickness in the range of about 50 micrometers to about 200 micrometers, or about 100 micrometers to about 150 micrometers, or about 110 micrometers to about 130 micrometers.
[0078] The deformable element, when ruptured or opened, may define an opening having an opening diameter that is at least about 80 percent, or at least about 90 percent, of the diameter of the capsule cavity.
[0079] The deformable element may be easily ruptured to allow inhaled air to enter the capsule cavity. For example, the deformable element may be configured to rupture when a user manually inserts the inhaler article into the user holder device without the use of an additional tool to assist the user in applying force. The deformable element may rupture or open to expose substantially the entire upstream end of the capsule cavity. The deformable element may provide a protective cover or hygienic barrier for the held capsule and inhaler article prior to consumption of the inhaler article.
[0080] The wrapping layer may define a body of the inhaler article. The wrapping layer may surround the mouthpiece element and the deformable element. The wrapping layer may bond the mouthpiece element and the deformable element. The wrapping layer may bond the mouthpiece element and the deformable element with a continuous axial bond. The wrapping layer may be formed from a cellulosic material.
[0081] The deformable element may extend beyond the wrapping layer. The deformable element may extend beyond the wrapping layer by about 0.5 millimeters to about 5 millimeters, or about 1 millimeter to about 4 millimeters, or about 2 millimeters to about 3 millimeters.
[0082] The method may include a step of pre-treating a distal end portion of the aligned semi-finished inhaler article prior to the step of at least partially closing the distal end of the aligned semi-finished inhaler article to obtain a pre-treated portion having reduced structural stability.
[0083] Pre-processing may include providing a pre-processing station, which may include a processing head for creasing, cutting, or scoring the distal end of the deformable tubular element.
[0084] The pre-conditioning step may include crimping the edge of the distal end of the deformable tubular element, such that upon crimping, the edge of the deformable tubular element is folded along one or more lines extending essentially parallel to the axial direction of the inhaler article.
[0085] The pre-treating step may include cutting the edge of the distal end of the deformable tubular element along one or more lines extending generally parallel to the axial direction of the inhaler article.
[0086] The pre-treating step may include scoring the edge of the distal end of the deformable tubular element along one or more lines extending generally parallel to the axial direction of the inhaler article, which may provide discrete cut lines in the deformable element.
[0087] The length of the crimp, score or cut lines may be within the range of 0.5 to 5 millimeters, preferably about 1 to 4 millimeters, and preferably about 2.5 to 3.5 millimeters. Generally, the length of these lines determines the length of the pre-treated portion with reduced structural stability.
[0088] The required length of the pre-treatment section depends on the diameter of the inhaler article.
[0089] A typical inhaler article may have a diameter of 7.2 millimeters. For such articles, the useful length of the pretreatment portion may be at least about 3 millimeters and may be at most equal to the radius (3.6 millimeters). With a pretreatment portion of such dimensions, sufficient closure of the distal end of the deformable tubular element may be achieved.
[0090] During the pretreatment step, the distal end of the deformable tubular element may be provided with 4 to 15 crease, cut or score lines. Preferably, the deformable tubular element may be provided with 6 to 12 crease, cut or score lines. Preferably, the deformable tubular element may be provided with 8 to 10 crease, cut or score lines. The more crease, cut or score lines are provided, the better the deformable tubular element can be folded into a cylindrical form. However, an increase in the number of crease, cut or score lines increases the complexity of the folding process. For a typical paper material used in the manufacture of inhaler articles having a diameter of about 7.2 millimeters, a number of 8 to 10 crease, cut or score lines has been demonstrated to provide the best results.
[0091] Generally, the crease, cut, or score lines may be formed to extend parallel to the longitudinal axis of the deformable tubular element. However, these lines may also be formed to extend at any desired angle relative to the longitudinal axis of the inhaler article. These lines may be formed to extend at an angle of 0 to 45 degrees relative to the longitudinal axis of the inhaler article.
[0092] The step of at least partially closing the distal ends of the aligned semi-finished inhaler articles may include folding the distal end portions of the semi-finished inhaler articles inwardly at least 90 degrees. The distal end portions of the semi-finished inhaler articles may be folded inwardly at an angle of between 90 and 110 degrees.
[0093] In some embodiments, the distal end of the semi-finished inhaler article is completely closed by folding the distal end portion of the semi-finished inhaler article inward at least 90 degrees. Without the step of aligning the semi-finished inhaler article as disclosed herein, some of the shorter semi-finished inhaler articles may disadvantageously not be completely closed due to the folding over of the shorter distal end portion.
[0094] In some embodiments, the distal end of the semi-finished inhaler article is partially closed by folding the distal end portion of the semi-finished inhaler article inward at least 90 degrees so that a central opening in the center of the folded distal end remains open. Without the process of aligning the semi-finished inhaler article as disclosed herein, some of the shorter semi-finished inhaler articles may disadvantageously have a wider opening due to the shorter distal end portion being folded. Without the process of aligning the semi-finished inhaler article as disclosed herein, some of the longer semi-finished inhaler articles may disadvantageously have a smaller opening due to the longer distal end portion being folded. This may result in a non-uniform appearance of the folded distal end.
[0095] The distal ends of all semi-finished inhaler articles received in the holder may be closed simultaneously.
[0096] The distal ends of all semi-finished inhaler articles received in the holder may be closed by applying the same force.
[0097] As used herein, the term "method for manufacturing an inhaler article" may refer to a method for manufacturing a completely finished inhaler article, or it may refer to a method for manufacturing a sub-unit of an inhaler article or a double-length inhaler article.
[0098] The term "inhaler article" as used herein may refer to any type of inhaler article known to those skilled in the art. The term "inhaler article" may refer to an aerosol-generating article that includes an aerosol-generating substrate that is heated to generate and deliver an inhalable aerosol to a user. The term "inhaler article" may refer to a dry powder inhaler.
[0099] The finished inhaler article may comprise a body, a capsule cavity for holding a capsule, a mouthpiece element at a proximal end, and a deformable tubular element having an at least partially closed distal end.
[0100] The present invention further relates to a package comprising a plurality of inhaler articles produced by the methods described herein.
[0101] A package may contain from 5 to 40 inhaler articles, preferably from 10 to 30 inhaler articles, more preferably from 15 to 25 inhaler articles, and most preferably from 18 to 22 inhaler articles.
[0102] At least the partially closed ends of the inhaler articles within the package may have a uniform appearance.
[0103] The difference in diameter of the central opening of the partially closed distal end of the inhaler article within the package may be less than 20%, preferably less than 15%, more preferably less than 10%, more preferably less than 5%, more preferably less than 2%, and most preferably less than 1%.
[0104] The invention further relates to a holder for an installation for manufacturing inhaler articles. The holder comprises a plurality of slot elements, each of which comprises a recess for inserting a semi-finished inhaler article and a movable end face for adjusting the longitudinal position of the semi-finished inhaler article in the recess. The holder comprises releasable fastening means for holding the movable end faces in position. The releasable fastening means may comprise a separate releasable fastening element for each movable end face. The movable end faces may be fastened by a common releasable fastening element of the releasable fastening means.
[0105] The invention further relates to an apparatus for manufacturing inhaler articles comprising a holder as described herein and an alignment element comprising a flat surface.
[0106] The facility may include an inversion mechanism for rotating the holder at least 180 degrees.
[0107] The following provides a non-exhaustive list of non-limiting examples, any one or more of the features of which may be combined with any one or more features of the other examples, embodiments, or aspects described herein.
[0108] Example A: A method for producing an inhaler article, comprising: providing a plurality of semi-finished inhaler articles having a longitudinal axis, a proximal end and an open distal end; aligning the semi-finished inhaler articles such that they are disposed in parallel and that the open distal ends of the semi-finished inhaler articles are located at exactly the same height in a direction parallel to the longitudinal axis; and at least partially closing a distal end of the aligned semi-finished inhaler article. Example B: The method of Example A, wherein aligning the open distal ends of the semi-finished inhaler articles to exactly the same height includes moving a semi-finished inhaler article relative to another semi-finished inhaler article to compensate for differences in length of the semi-finished inhaler articles due to manufacturing tolerances. Example C: The step of aligning the open distal ends of the semi-finished inhaler articles to the exact same height comprises: providing a holder having a plurality of slot elements having movable end faces; inserting a semi-finished inhaler article into each slot element such that a proximal end of the semi-finished inhaler article contacts a movable end surface of the slot; bringing the holder adjacent to a flat surface of the alignment element such that the flat surface is perpendicular to a longitudinal axis of the semi-finished inhaler article; inverting the holder and alignment element 180 degrees so that gravity moves the open distal end of the semi-finished inhaler article downward into contact with a flat surface; moving the movable end surface downwardly into contact with a proximal end of the semi-finished inhaler article; The method of any one of embodiment A and embodiment B, comprising: fixing a position of the movable end surface. Example D: After the step of fixing the position of the movable end surface, The method of embodiment C, comprising the step of inverting the holder 180 degrees so that the aligned semi-finished inhaler articles are in an upright position with the open distal ends on top. Example E: After the step of inverting the holder 180 degrees so that the semi-finished inhaler article is in an upright position with the open distal end at the top, The method of embodiment D, comprising inserting a capsule into each open distal end of the semi-finished inhaler article. Example F: The method of example E, wherein the capsule contains nicotine. Example G: The method of Example E or Example F, wherein the capsule comprises a dry powder. Example H: The method of any of Examples A-G, wherein the distal end portion of the semi-finished inhaler article comprises a deformable cardboard tube. Example I: A method according to any of Examples A-H, comprising, prior to the step of at least partially closing the distal end of the aligned semi-finished inhaler article, pre-treating a distal end portion of the semi-finished inhaler article to obtain a pre-treated portion having reduced structural stability. Example J: The method of any of Examples A-I, wherein the step of at least partially closing the distal end of the aligned semi-finished inhaler article comprises folding the distal end portion of the semi-finished inhaler article inwardly at least 90 degrees. Example K: The method of any of Examples A-J, wherein the distal ends of all of the semi-finished inhaler articles received in the holder are simultaneously closed. Example L: The method of any of Examples A-K, wherein the distal ends of all semi-finished inhaler articles received in the holder are closed by applying the same force. Example M: A package comprising a plurality of inhaler articles made by the method of any of Examples A-L. Example N: A package according to example M, comprising 5 to 40 inhaler articles, preferably 10 to 30 inhaler articles, more preferably 15 to 25 inhaler articles, and most preferably 18 to 22 inhaler articles. Example O: A package according to Example M or Example N, wherein at least the partially closed end of the inhaler article has a uniform appearance. Example P: A package according to any of Examples M, N, and O, wherein the difference in diameter of the central opening of the partially closed distal end of the inhaler article is less than 20%, preferably less than 15%, more preferably less than 10%, more preferably less than 5%, more preferably less than 2%, and most preferably less than 1%. Example Q: A holder for equipment for manufacturing inhaler articles, comprising: a plurality of slot elements, each of which has a recess for inserting a semi-finished inhaler article and a movable end face for adjusting a longitudinal position of the semi-finished inhaler article within the recess; and releasable fastening means for holding the movable end surface in position. Example R: An apparatus for manufacturing inhaler articles, comprising: A holder as described in Example Q; and an alignment element having a flat surface. Example S: The equipment of example R, comprising an inversion mechanism for rotating the holder at least 180 degrees.
[0109] Features described with respect to one embodiment may be equally applied to other embodiments of the invention.
[0110] The invention will now be further described, by way of example only, with reference to the accompanying drawings in which:
[0111] 1A is a schematic cross-sectional view of an exemplary inhaler article 10. The inhaler article 10 includes a body 12 extending along a longitudinal axis of the inhaler article 10 from a proximal end 14 to a distal end 16, a capsule cavity 18, and a capsule 20 held within the capsule cavity 18. The body 12 includes a paper material wrapped around a mouthpiece element 22 that forms a deformable tubular element 24. The deformable tubular element 24 defines the capsule cavity 18 bounded downstream by the mouthpiece element 22 and upstream by an at least partially closed distal end 16 of the deformable tubular element 24.
[0112] 1, the deformable tubular element 24 is formed of paper having a thickness of about 125 micrometers and a basis weight of about 100 grams per square meter. The illustrated inhaler article 10 has a mouthpiece element length of about 20 mm, and the deformable tubular element 24 has a length of about 45 mm and a uniform outer diameter of about 7.2 mm.
[0113] 1B is a front perspective view of an exemplary inhaler article 10 in which the distal end 16 of the deformable tubular element 24 is partially closed, except for the central opening 26. The deformable element 24 is folded upon itself to form overlapping pie-shaped sections, partially closing the distal end 16 of the capsule cavity 18.
[0114] 1C is a front perspective view of an exemplary inhaler article having a deformable tubular element 24 with an open distal end 16. The folded section of the distal end 16 of the deformable tubular element 24 may be opened to expose the capsule cavity 18. To open the distal end 16, the deformable tubular element 24 may be inserted into a suitable user holder device, not described herein. After the folded section of the distal end 16 of the deformable element 24 is opened, an opening is formed to receive the swirling or rotating inhalation airflow.
[0115] 2A-2D show a process for closing the open end of an inhaler article without alignment according to the present invention.
[0116] FIG. 2A shows a semi-finished inhaler article 10 having an open distal end 16 and filled with a capsule 20. The semi-finished inhaler article 10 is disposed in a slot of a holder 30. Due to manufacturing tolerances, the semi-finished inhaler articles 10 are of different lengths. As a result, the heights of the open distal ends 16 of the articles 10 in the holder 30 are different. This is indicated by the three dotted lines in FIG. 2A. The middle line indicates the desired height according to the nominal length of the article 10. The upper and lower dotted lines indicate the difference in height of the longer and shorter articles 10, respectively, due to manufacturing tolerances. A folding head 32, which forms part of the closing station, is also shown in FIG. 2A.
[0117] FIG. 2B shows a subsequent step in which the folding head 32 is moved downward to at least partially close the open distal end 16 of the semi-finished inhaler article 10 by folding the distal end portion of the semi-finished inhaler article 10 inward at least 90 degrees.
[0118] FIG. 2C shows a subsequent step, in which folding head 32 has been moved up again after closing distal end 16 of article 10.
[0119] FIG. 2D shows the partially closed distal end 16 in a top view. The holder 30 is also shown. The sizes of the central openings 26 of the partially closed distal end 16 are different. In other words, the inner diameters of the central openings 26 are different. This is caused by the different heights of the distal end 16 before folding (FIG. 2A), which in turn results in different lengths of the folded distal end portions. Hence, this results in a non-uniform appearance of the distal end 16 of the inhaler article 10, as shown in FIG. 2D.
[0120] 3A-3F show a process for alignment of a semi-finished inhaler article according to one embodiment of the present invention.
[0121] Figure 3A shows a semi-finished inhaler article 10 having an open distal end 16. The semi-finished inhaler article 10 is disposed in a slot of a holder 30. The slot comprises movable end faces 34. The end faces 34 are in their retracted position. As with the embodiment of Figure 2A, different heights of the open distal end 16 due to manufacturing tolerances are indicated by three dotted lines in Figure 3A.
[0122] 3B illustrates the provision of a flat surface of the alignment element 36 adjacent the holder 30. The flat surface is perpendicular to the longitudinal axis of the semi-finished inhaler article 10.
[0123] Figure 3C shows the holder 30 and alignment element 36 inverted 180 degrees. As a result, gravity causes the open distal end 16 of the semi-finished inhaler article 10 to move downward into contact with the flat surface of the alignment element 36. This movement is indicated by the arrow in Figure 3C.
[0124] Figure 3D shows the subsequent step of moving the movable end face 34 downwards into contact with the proximal end 14 of the semi-finished inhaler article 10. This movement is indicated by an arrow in Figure 3D. The position of the movable end face is then fixed by a releasable fixing means 38.
[0125] FIG. 3E shows holder 30 and alignment element 36 flipped 180 degrees back to an upright position.
[0126] As shown in Figure 3F, after removal of alignment element 36, capsule 20 may be inserted into open distal end 16. This movement is indicated by the arrow in Figure 3F. Because article 10 has been inverted back to an upright position, capsule 20 may be inserted by gravity.
[0127] 4A-4D show the step of closing the open end of the semi-finished inhaler article 10 after the alignment step of FIGS. 3A-3F.
[0128] Fig. 4A shows that after alignment, the semi-finished inhaler articles 10 are arranged such that their longitudinal axes are parallel and the open distal ends 16 of the semi-finished inhaler articles 10 are located at exactly the same height with respect to the direction parallel to the longitudinal axes. The exactly the same height locations are indicated by dotted lines in Fig. 4A. The folding heads 32 of the closing station are also shown in Fig. 4A.
[0129] FIG. 4B shows a subsequent step in which the folding head 32 is moved downward to at least partially close the open distal end 16 of the semi-finished inhaler article 10 by folding the distal end portion of the semi-finished inhaler article 10 inward at least 90 degrees.
[0130] FIG. 4C shows a subsequent step, in which folding head 32 has been moved up again after at least partially closing distal end 16 of article 10.
[0131] FIG. 4D shows the partially closed distal end 16 in a top view. The holder 30 is also shown. The size of the central opening 26 of the partially closed distal end 16 does not differ. In other words, the inner diameter of the central opening 26 does not differ. This is achieved by the same height of the distal end 16 before folding (FIG. 4A), which in turn results in the same length of the folded distal end portion. Therefore, it results in a uniform appearance of the distal end 16 of the inhaler article 10, as shown in FIG. 4D.
Claims
1. 1. A method for manufacturing an inhaler article, comprising: providing a plurality of semi-finished inhaler articles having a longitudinal axis, a proximal end, and an open distal end; aligning the semi-finished inhaler articles so that they are disposed parallel and the open distal ends of the semi-finished inhaler articles are positioned at exactly the same height in a direction parallel to the longitudinal axis; and at least partially closing the distal ends of the aligned semi-finished inhaler articles.
2. 2. The method of claim 1, wherein aligning the open distal ends of the semi-finished inhaler articles to the exact same height comprises moving one semi-finished inhaler article relative to another semi-finished inhaler article to compensate for differences in length of the semi-finished inhaler articles due to manufacturing tolerances.
3. aligning the open distal ends of the semi-finished inhaler articles flush with one another; providing a holder comprising a plurality of slot elements having movable end faces; inserting a semi-finished inhaler article into each slot element such that the proximal end of the semi-finished inhaler article contacts the movable end surface of the slot; bringing the holder adjacent a flat surface of an alignment element such that the flat surface is perpendicular to a longitudinal axis of the semi-finished inhaler article; inverting the holder and alignment element 180 degrees so that gravity moves the open distal end of the semi-finished inhaler article downward into contact with the flat surface; moving the movable end surface downward into contact with the proximal end of the semi-finished inhaler article; and fixing the position of the movable end surface.
4. After the step of fixing the position of the movable end surface, 4. The method of claim 3, including the step of inverting the holder 180 degrees so that the aligned semi-finished inhaler articles are in an upright position with the open distal ends at the top.
5. after the step of inverting the holder 180 degrees so that the semi-finished inhaler article is in an upright position with the open distal end at the top; 5. The method of claim 4, including the step of inserting a capsule into each open distal end of the semi-finished inhaler article.
6. 6. The method of claim 5, wherein the capsule contains nicotine.
7. 6. The method of claim 5, wherein the capsule comprises a dry powder.
8. 3. The method of claim 1 or claim 2, further comprising, prior to the step of at least partially closing the distal end of the aligned semi-finished inhaler article, a step of pre-treating a distal end portion of the semi-finished inhaler article to obtain a pre-treated portion with reduced structural stability.
9. 3. The method of claim 1 or claim 2, wherein the step of at least partially closing the distal end of the aligned semi-finished inhaler article comprises folding a distal end portion of the semi-finished inhaler article inward at least 90 degrees.
10. A package containing a plurality of inhaler articles made by the method of claim 1 or claim 2.
11. The package of claim 10, wherein the at least partially closed end of the inhaler article has a uniform appearance.
12. 11. The package of claim 10, wherein the diameters of the central openings of the partially closed distal ends of the inhaler articles vary by less than 20%.
13. 1. A holder for equipment for manufacturing inhaler articles, comprising: a plurality of slot elements, each slot element having a recess for inserting a semi-finished inhaler article and a movable end face for adjusting the longitudinal position of the semi-finished inhaler article within the recess; and releasable fastening means for holding said movable end surface in place.
14. 1. An apparatus for manufacturing inhaler articles, comprising: A holder according to claim 13; an alignment element having a flat surface.
15. 15. The facility of claim 14, comprising an inversion mechanism for rotating the holder at least 180 degrees.