CONTAINER FOR AN INHALER

Abstract

A container for holding, dispensing and/or storing a preferably liquid medicament preparation is proposed, which comprises an inner space for the medicament preparation and an at least partially multi-layered wall structure defining the inner space, the wall structure comprising a first layer with a first through-opening of less than 40 μm. Alternatively or additionally, the wall structure comprises a second and third layer, a second through-opening being provided in the second layer and the third layer covering or closing off the wall structure.

Claims

1-15. (canceled)

16. Container for holding, dispensing and/or storing a liquid medicament preparation, comprising: an inner space for the medicament preparation and a venting device with an at least partially multi-layered wall structure, the wall structure comprising a first layer in which a first through-opening is provided that is in communication with said inner space, wherein the container comprises one or more of the following features: the first through-opening has a diameter of less than 40 μm; and the wall structure further comprises a second layer and a third layer, wherein a second through-opening which is different is size from the first through-opening is arranged in the second layer and the third layer covers or closes off the through-openings of the first and second layers.

17. Container according to claim 16, wherein the first through-opening and the second through-opening are fluidically connected to one another.

18. Container according to claim 16, wherein the first through-opening is at least one of tube-like, produced by laser drilling and the only through-opening in the first layer.

19. Container according to claim 16, wherein the diameter of the first through-opening is less 30 μm and more than 10 μm.

20. Container according to claim 16, wherein the first layer is substantially at least one of flat, film-shaped, plate-shaped, metallic and round.

21. Container according to claim 16, wherein the first layer comprises a convexity or indentation in which the first through-opening is arranged, the second layer also comprising a convexity or indentation, the convexity or indentation of the first layer corresponding to the convexity or indentation of the second layer.

22. Container according to claim 16, wherein the first layer is connected to the second layer by at least one of material bonding, and direct sealing, in an annular connecting portion of the first layer, the first through-opening and the second through-opening being provided in the region of an eyelet formed by the annular connecting portion.

23. Container according to claim 16, wherein the first through-opening and the second through-opening are arranged behind and in alignment with one another.

24. Container according to claim 16, wherein a clearance space is provided between the first layer and the second layer in a region of the first through-opening and the second through-opening.

25. Container according to claim 24, wherein the clearance space is greater than 20 μm

26. Container according to claim 16, wherein the second layer is formed in one piece with a base of the container.

27. Container according to claim 16, wherein the second through-opening has a diameter which is greater than the diameter of the first through-opening.

28. Container according to claim 16, wherein the second through-opening has a diameter which is greater than 50 μm.

29. Container according to claim 16, wherein the third layer: is a sealing film, is arranged and configured to cover or close off the first through-opening and the second through-opening on a side of the first through-opening remote from the inner space of the container, and is fluidically connected to the inner space by means of the first through-opening and the second through-opening.

30. Container according to claim 16, wherein the first layer is arranged inside the container at a bottom surface as an insert, wherein the second layer and the third layer are arranged on a side of the first layer remote from the inner space; wherein the third layer is arranged outside the container: and wherein the first layer and the third layer are arranged on opposing sides of the second layer.

31. Container according to claim 16, wherein an interstice or cavity produced by thermoforming and/or deep drawing is formed between the second layer and the first layer or between the second layer and the third layer in a region of, or fluidically connected to, the first through-opening or the second through-opening

32. Container according to claim 31, wherein the volume of the interstice or cavity is greater than 0.2 μl and less than 10 μl.

33. Container according to claim 16, where the liquid medicament preparation is contained in a collapsible pouch within the interior space of the container.

34. Inhaler, comprising: an inhaler body having a chamber therein, a container disposed in said chamber and having an inner space for holding a liquid medicament preparation, and a dispensing device for fluidically connecting the inner space of the container to a body orifice, wherein the container comprises a venting device with an at least partially multi-layered wall structure, the wall structure comprising a first layer in which a first through-opening is provided that is in communication with said inner space, and wherein the container comprises a second layer and a third layer, wherein a second through-opening which is different is size from the first through-opening is arranged in the second layer and wherein the third layer covers or closes off the through-openings of the first and second layers, and wherein a cutting element configured to cut through the third layer without adversely affecting the first layer is located in said chamber.

35. Method for producing a container for holding, dispensing and/or storing a liquid medicament preparation, comprising: providing the container with an inner space for the medicament preparation and a venting device with an at least partially multi-layered wall structure defining a portion of the inner space, the wall structure comprising a first layer in which a first through-opening is provided, a second layer with a second through-opening which is different from the first through-opening and a third layer covering or closing off the wall structure, comprising the further steps of: providing an inlay with the first through-opening, the first through-opening being provided with a diameter of less than 40 μm, forming the first layer by placing the inlay in a sleeve that forms an outer wall of said container, sealingly connecting the first layer to the sleeve in a region surrounding the first through-opening, and placing the third layer on an outer side of the outer wall of said container.

36. Method according to claim 35, wherein the first through-opening is introduced into the first layer by at least one of: laser drilling, after the first layer has been thermoformed or deep drawn in the region of the through-opening, and before the first layer has been placed or sealed in the sleeve.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0092] FIG. 1 is a side view of a proposed inhaler;

[0093] FIG. 2 is a detail of the proposed inhaler in the region of the relaxed pressure generator;

[0094] FIG. 3 is a detail of the proposed inhaler in the region of the tensioned pressure generator;

[0095] FIG. 4 is a cross-section of a proposed container with a proposed wall structure according to a first embodiment;

[0096] FIG. 5 is a detail of the embodiment according to FIG. 4 in the region of the wall structure;

[0097] FIG. 6 is a schematic detailed view of the first layer;

[0098] FIG. 7 is a detail of the proposed container in the region of the wall structure according to a second embodiment;

[0099] FIG. 8 is a detail of the proposed container in the region of the wall structure according to a third embodiment;

[0100] FIG. 9 is a detail of the proposed container in the region of the wall structure according to a fourth embodiment;

[0101] FIG. 10 is a detail of the proposed container in the region of the wall structure according to a fifth embodiment; and

[0102] FIG. 11 is a detail of the proposed container in the region of the wall structure according to a sixth embodiment.

DETAILED DESCRIPTION OF THE INVENTION

[0103] In the figures, the same reference numerals are used for the same or similar parts, and corresponding or comparable properties and advantages may be achieved even though the relevant description has not been repeated.

[0104] First of all, the backgrounds and the particularly preferred field of use of the present invention are explained in more detail hereinafter with reference to FIGS. 1 to 3.

[0105] FIG. 1 shows a view of a proposed inhaler 1. The inhaler 1 comprises a discharge nozzle 2 indicated by dashed lines in FIG. 1 which is preferably configured to form an aerosol 3 with a medicament preparation 4.

[0106] When the medicament preparation 4, preferably a liquid, is nebulized, the preferably respirable aerosol 3 is formed, which can be breathed in or inhaled by a user or patient (not shown), such as an animal, a human or preferably a large animal, particularly a horse 5. Usually, inhalation takes place at least once a day, more particularly several times a day, preferably at predetermined time intervals, particularly depending on the disease.

[0107] The inhaler 1 preferably has a chamber 6 or dispensing device 7 for fluidically connecting the chamber 6 to a body orifice, preferably a nostril 9, particularly that of a horse 5. The dispensing device 7 is preferably formed in one piece with the chamber 6 or connected thereto. The aerosol 3 may be temporarily stored in a chamber 6 and/or dispensed by the dispensing device 7.

[0108] The user or patient, particularly the horse 5, can inhale the aerosol 3, while air can preferably be sucked in through the chamber 6.

[0109] The chamber 6 is preferably embodied to hold and/or temporarily store the aerosol 3 produced by the inhaler 1. The chamber 6 is preferably arranged, or adapted to be arranged, downstream of the discharge nozzle 2. The chamber 6 may be at least partially tubular, cylindrical, elongate or conical in shape.

[0110] In the embodiment shown, the aerosol 3 is introduced into the chamber 6 in the direction of spraying of the discharge nozzle 2, along a longitudinal extent of the inhaler 1 or in the direction of flow in the region of the discharge nozzle 2 or axially in the direction of the longitudinal axis L of the inhaler 1.

[0111] The chamber 6 and the dispensing device 7 may be formed separately or in several pieces, for example, by a connection in the region of the connecting line 8 indicated by dashed lines. In the embodiment shown, the chamber 6 is formed in one piece with the dispensing device 7, particularly an adapter for a body orifice, particularly the nose or a nostril 9. In this way, depressions or gaps to which impurities might adhere or where they might get in are avoided.

[0112] The chamber 6 is preferably at least substantially rigid in construction. However, the chamber 6 may theoretically also be of flexible and/or telescopic configuration, particularly in order to minimize the space taken up when not in use and/or for carrying. In the embodiment shown the chamber 6 is formed from a dimensionally stable, flexible material and merges fluidically without a gap into the dispensing device 7 to ensure continuous flow guidance. However, it is not impossible that the dispensing device 7 is connected to the chamber 6 by latching and/or clamping or by a bayonet connection, by screwing or the like. However, other design solutions are also possible here.

[0113] The dispensing device 7 preferably comprises or forms a soft end piece. The dispensing device 7 is preferably embodied as a nasal adapter for insertion into the nostrils 9 of a horse 5 or other animal, particularly a large animal, as shown in schematic cross-section in FIG. 1. In particular, the inhaler 1 or the chamber 6 or the dispensing device 7 is embodied so that the aerosol 3 can be introduced preferably into the left nostril 9 of the horse 5. The chamber 6 and/or the dispensing device 7 may be transparent or made of transparent plastics. This makes it possible to monitor the aerosol formation.

[0114] The dispensing device 7 preferably comprises an outlet 10 which engages or can be introduced into the nostrils 9 or a nasal passage 11 of the horse 5 or some other body orifice and can connect the chamber 6 or the dispensing device 7 fluidically with the body orifice. Particularly preferably, the dispensing device 7 is configured such that the outlet 10 always opens into the correct nasal passage 11 and not in a blind passage.

[0115] The chamber 6 preferably has a volume of more than 0.05 l, particularly more than 0.1 l, particularly preferably about 0.1 to 0.4 l. Preferably, the size of the chamber 6 is adapted to the inhaler 1 such that the aerosol 3 formed on actuation of the inhaler 1 can be at least substantially completely received by the chamber 6, particularly without the aerosol 3 or the nebulized medicament preparation 4 being precipitated or deposited on the inner wall of the chamber to any great extent.

[0116] FIGS. 2 and 3 show a detail of the proposed inhaler 1 in the relaxed state and in the tensioned state.

[0117] The inhaler 1 is particularly embodied as a soft-mist inhaler as described at the beginning. This is described in more detail hereinafter with reference to the details in FIGS. 2 and 3.

[0118] The inhaler 1 preferably comprises a container 12 with the medicament preparation 4. The medicament preparation 4 is preferably arranged, or adapted to be arranged, inside the container 12 in a pouch 13.

[0119] Preferably, the container 12 is fixedly, non-detachably or non-removably integrated in the inhaler 1, particularly in such a way that the container 12 cannot be removed, or at least cannot be removed non-destructively or without causing damage. It is thus preferable for the inhaler to be a single-use or disposable product. However, other embodiments are also possible.

[0120] The inhaler 1 may preferably comprise a device for forced ventilation of the container 12. In particular, when it is tensioned or actuated for the first time, the base of the container 12 may be pierced or opened. Alternatively or additionally, it is opened when the container 12 is placed or inserted into the inhaler 1, or as a result of this action. In particular, an axially acting spring 15 arranged in a housing 14 of the inhaler 1 or a carrier of the inhaler 1 for the container 12 or some other opening or perforating element comes to abut on the base 16 of the container, piercing the container 12 or an, in particular, gastight seal on the base by means of a piercing element 17 when brought into contact for the first time, for ventilation purposes.

[0121] The forced ventilation device is thus formed here by the piercing element 17 which is held or formed by the spring 15. The piercing element 17 may also be formed without a spring 15. However, other design solutions are also possible.

[0122] It should be noted that during the piercing or venting, only the outer shell of the container 12 is opened. The pouch 13 preferably remains undamaged during the forced ventilation. As the medicament preparation 4 is taken from the pouch 13 the pouch 13 can collapse and to equalize the pressure ambient air 18 can flow through the venting or piercing opening in the container 12.

[0123] Before the inhaler 1 is used for the first time, the inhaler 1 is preferably tensioned and released several times. This so-called priming causes any air present in a delivery tube 19 and in a pressure generator 20 right up to discharge nozzle 2 to be expelled from the medicament preparation 4. The inhaler 1 is then ready for the inhalation.

[0124] The quantity of medicament preparation 4 delivered per stroke or actuation process is preferably about 10 μl to 50 μl, particularly about 10 μl to 20 μl, most preferably about 15 μl.

[0125] A tensioning element 21, preferably a drive spring, is preferably installed in a pretensioned state in order to achieve a high delivery pressure. In the proposed inhaler 1 the pressurizing and conveying of the medicament preparation 4 during the nebulization process are preferably carried out exclusively by means of energy stored in the tensioning element 21, particularly spring force. The inhaler 1 is thus also preferably configured so that the aerosol formulation is independent of a tensioning process, even if prior tensioning may be a prerequisite for the aerosol formation. Preferably, the inhaler 1 is configured so that the aerosol formation, particularly the dose, the discharge rate and/or the discharge speed, are independent of the tensioning process or are not influenced by the tensioning process. This ensures reliable dosing.

[0126] The inhaler 1 is preferably embodied so that the medicament preparation 4 in the pressure generator 20 in a pressure chamber 22 achieves a pressure of 5 MPa to 60 MPa, particularly 10 MPa to 50 MPa on discharge. Particularly preferably, during the delivery or nebulization of the medicament preparation 4, a pressure of about 50 MPa to 60 MPa, particularly about 10 MPa to 30 MPa is reached at the discharge nozzle 2 or its nozzle openings. The medicament preparation 4 is then converted into the aerosol 3, the droplets of which have an aerodynamic diameter of up to 20 μm, preferably about 3 μm to 10 μm. The nebulizing action or the nebulizing effect is achieved or further assisted by means of preferably intersecting sprays expelled from the discharge nozzle 2.

[0127] The inhaler 1 is preferably embodied such that the aerosol 3 is dispensed at low speed, particularly at a speed of less than 2 m/s, particularly about 1.6 m/s or less (measured in each case at a distance of 10 cm from the discharge nozzle 2). The inhaler 1 is thus preferably embodied as an SMI. The low dispensing speed can be achieved or assisted, in particular, by intersecting sprays of the medicament preparation 4 dispensed from the discharge nozzle 2, and/or by a suitable choice of spring force for the tensioning element 21.

[0128] Particularly preferably, the inhaler 1 is configured such that the aerosol production lasts for more than 0.7 s, preferably substantially 1 s or longer, particularly more than 1.5 s. The time taken to nebulize a dose or for actuation of the inhaler 1 is thus preferably more than 0.75 s, particularly about 1 s or more.

[0129] The inhaler 1 further comprises a delivery device or a pressure generator 20 for delivering and nebulizing the medicament preparation 4, particularly in a predetermined, optionally selectable metered quantity, or for nebulizing metered amounts or amounts capable of being metered. The inhaler 1 is thus able to dispense the medicament preparation 4 in a plurality of defined doses, preferably as an aerosol 3. Preferably, one dose can be dispensed by one actuation of the inhaler 1.

[0130] The inhaler 1 or pressure generator 20 is particularly configured such that the delivery, pressure generation and/or nebulization is carried out without the use of propellant gas, mechanically and/or by the energy or force of an energy storage device, particularly a spring device, particularly preferably by spring force, and in the embodiment shown by a drive spring, helical spring or other tensioning element 21. However, other design solutions are also possible. It is preferable if the nebulization is carried out independently of any manual operation, particularly independently of the speed of actuation of the inhaler 1 or driven exclusively by the energy stored in the tensioning element 21.

[0131] The inhaler 1 or pressure generator 20 comprises a pumping device 24, preferably with a holder 25 for the container 12 and/or with a delivery element, preferably with the delivery tube 19 embodied as a capillary, with an optional valve, particularly a non-return valve 23. The pumping device 24 is thus preferably an assembly of the pressure generator 20 which comprises the delivery tube 19 and means for moving it.

[0132] The pressure generator 20 may further comprise the pressure chamber 22 and/or the discharge nozzle 2, particularly in a transitional region to the chamber 6.

[0133] The pumping device 24 may be movable or drivable, particularly by the tensioning element 21. It is preferable if the pumping device 24 can be driven solely by the tensioning element 21 in order to discharge the medicament preparation 4.

[0134] The container 12 is fixed in the inhaler 1 by means of the holder 25, particularly by a clamping or latching action, so that the delivery tube 19 dips into the container 12. The holder 25 may be configured such that the container 12 can be non-detachably fixed, preferably latched.

[0135] The inhaler 1 comprises an actuating lever 26 for preferably axial tensioning of the tensioning element 21. During the tensioning of the tensioning element 21 the pumping device 24 is preferably moved with the container 12, downwards in the embodiment shown, and the medicament preparation 4—or to be more accurate the next dose—is aspirated out of the container 12 into the pressure chamber 22 of the pressure generator 20 by means of the non-return valve 23.

[0136] During the subsequent relaxation of the tensioning element 21, particularly after operation of an initiating device 27, the medicament preparation 4 is put under pressure in the pressure chamber 22. For this purpose, the pumping device 24 or the delivery tube 19 can be moved back up, with the non-return valve 23 now closed, by relaxation of the tensioning element 21 and can now act as a pressure ram. Preferably, for this purpose, the pumping device 24 with the delivery tube 19 can be moved in a linear or axial manner, particularly exclusively, by the tensioning element 21. This pressure forces the medicament preparation 4 out through the discharge nozzle 2, where it is converted into the preferably respirable aerosol 3, as shown in FIGS. 1 and 2.

[0137] FIG. 4 shows a proposed container 12 according to a first embodiment in cross-section.

[0138] The container 12 preferably forms a reservoir for the medicament preparation 4 which is to be nebulized. Preferably, the container 12 contains a sufficient quantity of medicament preparation 4 or active substance for a plurality of doses of the medicament preparation 4, i.e., to enable a plurality of nebulization or applications. A typical container 12 holds a volume of about 2 to 10 ml.

[0139] It is preferable if the container 12 has a volume which is less than 50 ml, preferably less than 30 ml, particularly less than 20 ml. This provides a compact construction for the inhaler 1 and ensures that the medicament preparation 4 will be used up before its expiry date.

[0140] The container 12 is preferably substantially cylindrical or cartridge-shaped. The container 12 is preferably of rigid construction, while the medicament preparation 4 is held or adapted to be held in the collapsible pouch 13 in the container 12. The container 12 is preferably connectable to a dispensing device, particularly the inhaler 1.

[0141] It is particularly preferable if the container 12 has a rigid outer sleeve 28. The sleeve 28 preferably comprises aluminum or is at least partially, at least substantially or completely made of aluminum or another metal. The sleeve 28 preferably has an (average) wall thickness of more than 50 μm, preferably more than 70 μm. The sleeve 28 may alternatively or additionally also contain plastics, preferably a thermoplastic, particularly polybutylene terephthalate (PBT), or be made from said plastics.

[0142] The container 12 preferably comprises the collapsible pouch 13 which is configured to hold the medicament preparation 4 or contains the medicament preparation 4.

[0143] The container 12 or the sleeve 28 is preferably closed off in airtight or gastight manner by a cover 29, particularly a sealing film, while for operating the device the delivery tube 19 can pierce the cover 29 to provide a fluidic connection on the inside of the pouch 13 for removal of the medicament preparation 4.

[0144] The sleeve 28 preferably surrounds or embraces an inner space 30 of the container 12. The inner space 30 preferably comprises the inner pouch 29 or is configured in some other way for holding, dispensing and/or storing the preferably liquid medicament preparation 4.

[0145] The sleeve 28 is preferably closed off by a stopper 31. The stopper 31 preferably forms a tightly sealing and/or centered guide for a removal connector or the delivery tube 19. The stopper 31 is preferably connected to the sleeve 28 in sealed, particularly airtight manner, and/or non-detachably connected, particularly fitted.

[0146] The container 12 preferably comprises a neck region 32 in which the sleeve 28 is closed off by the stopper 31. In the neck region 32 the container 12 is preferably configured to be held on or in the inhaler 1. In particular, the container 12 comprises in the neck region 32 one or more, particularly annular, grooves, undercuts, projections, indentations, shoulders or other interlocking means for preferably securing the container 12 on or in the inhaler 1 by locking.

[0147] When medicament preparation 4 is taken from the container 12, particularly from the pouch 13, the volume of the pouch 13 decreases and a negative pressure is formed in the inner space 30 of the container 12. To equalize the negative pressure thus formed, the container 12 preferably has a venting device 33.

[0148] The venting device 33 is preferably configured to allow ambient air 18 to penetrate into the inner space 30 and thus allow equalization of pressure.

[0149] The present invention relates particularly to the venting device 33 of the container 12, which particularly preferably comprises, or is formed by, a multi-layered wall structure 34 delimiting the inner space 30.

[0150] The wall structure 34 preferably comprises a first layer 35 in which a first through-opening 36 is provided. It is preferable if the, in particular hydraulic, diameter of the first through-opening 36 is less than 40 μm. This advantageously minimizes the loss of constituents of the medicament preparation 4 through the venting device 33.

[0151] Alternatively or additionally, it is particularly preferred if the wall structure 34 has a second layer 37 with a second through-opening 38. In the embodiment shown, the second layer 37 is formed by the bottom wall of the sleeve 28 or a wall that forms the container 12 or encloses the inner space 30.

[0152] It is also preferable if the wall structure 34 comprises a third layer 39, particularly a sealing layer, sealing film or a third layer 39 configured in some other manner for sealing the inner space 30 or the through-openings 36, 38, particularly in airtight manner.

[0153] A layer in the sense of the present invention is preferably a flat and/or one-piece structure. In particular, the first layer 35 and/or the second layer 37 and/or the third layer 39 is formed in one piece.

[0154] The layers 35, 37, 39 may be coated, particularly with adhesive, and/or may be adhesively bonded to one another. The layers 35, 37, 39 are preferably directly in material contact with one another and/or are joined to one another solely by an adhesive bond, preferably rigidly, fixedly and/or over their surface.

[0155] The first layer 35 and the second layer 37 are preferably fixedly or non-detachably connected, or connectable, to one another. A non-detachable connection is preferably one which allows separation of the first layer 35 from the second layer 37 only by damaging or destroying the first layer 35 and/or the second layer 37. Alternatively or in addition to one or more of the adhesive bonds, one or more of the layers 35, 37, 39 may also be welded together or welded onto one another, particularly by ultrasonic welding, particularly preferably if at least one of the welded layers contains plastics or is formed of plastics, particularly a thermoplastic, particularly PBT.

[0156] FIG. 5 shows a schematic detail of the (forced) venting device 33 or the wall structure 34 of the container 12 according to the embodiment from FIG. 4.

[0157] In the embodiment according to FIG. 5 the first layer 35 comprises only a single, namely the first, through-opening 36, which preferably has a (hydraulic) diameter 44 of less than 40 μm, preferably less than 30μ, and/or greater than 10 μm, preferably greater than 15 μm, particularly at least substantially 25 μm.

[0158] In the embodiment according to FIG. 5 the first layer 35 is formed separately from the second layer 37. The second layer 37 is embodied as part of the sleeve 28.

[0159] The first through-opening 36 has a (hydraulic) diameter 44, which is many times smaller than the (hydraulic) diameter 45 of the second through-opening 38 of the second layer 37, preferably by a factor of more than four, six or ten.

[0160] In the present embodiment, the first layer 35 is provided or arranged with the first through-opening 36 additionally congruent with the second layer 37 and/or the second through-opening 38. This ensures that the first through-opening 36 and the second through-opening 38 are connected fluidically behind one another. As a result, the first layer 35 reduces the minimum diameter of the fluid connection formed by the second through-opening 38, so that the effects described can be obtained.

[0161] The first layer 35 is preferably sealingly connected to the second layer 37 over a large area, particularly preferably materially connected. In particular, more than 20%, preferably more than 30%, particularly more than 40% of the surface of the first layer 35 facing the second layer 37 is connected to or in contact with the second layer 37, particularly materially or adhesively bonded. In this way it is possible to achieve a particularly good, stable, long-lasting and sealed, particularly diffusion-proof, connection of the first layer 35 with the second layer 37. A leak-tight connection of this kind is advantageous so that the intended small (hydraulic) diameter 44 of the first through-opening 36 is not affected or damaged by leaks or diffusion between the first layer 35 and the second layer 37.

[0162] The first layer 35 is particularly preferably spaced from the second layer 37 at least in the region of the first through-opening 36 or the second through-opening 38. This prevents the first through-opening 36 with the small (hydraulic) diameter 44 from being adversely affected, particularly changed in its effective cross-section by deformation or by the ingress of particles.

[0163] Preferably, an interstice 40 is formed between the first layer 35 and the second layer 37. Alternatively or additionally, a cavity 41 is formed between the second layer 37 and the third layer 39.

[0164] The interstice 40 or the cavity 41 may have a volume which is greater than 0.2 μl, preferably greater than 0.5 μl, particularly greater than 1 μl and/or less than 10 μl, preferably less than 6 μl, particularly less than 4 μl. In this way, a sufficient safety gap can be achieved in respect of the interstice 40. With regard to the cavity 41, in the embodiment according to FIG. 5, perforation or piercing of the third layer 39 is possible without affecting the second through-opening 38 or even the first through-opening 36.

[0165] The spacing between the first layer 35 in the region of the first through-opening 36 and the second layer 37 and/or the third layer 39 is preferably more than 20 μm, preferably more than 50 μm, particularly more than 100 μm or 200 μm, and/or less than 3 mm, preferably less than 2 mm, particularly less than 1 mm.

[0166] Preferably, the venting device 33 or the wall structure 34 comprises between the first layer 35 and the second layer 37 a first material connection, particularly a sealing or adhesive bond 42. Alternatively or additionally, the forced venting 33 or the wall structure 34 preferably comprises a material connection, particularly a second adhesive bond 43, between the second layer 37 and the third layer 39.

[0167] The first adhesive bond 42 or the second adhesive bond 43 may be configured as a layer, particularly as a layer of hot melt adhesive, a sealing layer or the like, and/or may be configured with a layer thickness of more than 10 μm, preferably more than 15 μm and/or less than 50 μm, particularly less than 40 μm, particularly preferably about 25 μm. It has been found, surprisingly, that a layer thickness of this order can ensure a good bond with at the same time a low diffusion rate through the adhesive bond 42, 43.

[0168] Preferably, the first layer 35 is configured to be (heat-)sealed to the second layer 37. Alternatively or additionally, the first layer 35 may also be connected to the second layer 37 by welding, ultrasonic welding, soldering, clamping or by other means, preferably to form a leak-tight seal.

[0169] The wall structure 34 according to FIG. 5 is particularly advantageous owing to the fact that the first layer 35 is arranged inside the sleeve 28. As a result the first through-opening 36 is advantageously protected from external influences, particularly by or by means of the second layer 37.

[0170] The third layer 39 is preferably configured to be mechanically removed or destroyed. In particular, the third layer 39 is embodied as a film, plastics film, sealing film, composite film, thin aluminum foil or a combination or the like, which can be pierced, pulled off or otherwise opened. In this way, the fluidic connection between the inner space 30 and the environment formed by the first through-opening 36 and the second through-opening 38 can be opened up.

[0171] The third layer 39 is preferably arranged outside the sleeve 28. This allows easy access to the third layer 39 and enables the venting device 33 to be opened particularly easily and effectively by external action.

[0172] The first layer 35 and/or the second layer 37 preferably comprise(s) a convexity or indentation 46, 47. In this way the cavity 41 may be formed, allowing or favoring the piercing or puncturing of the third layer 39.

[0173] Particularly preferably, the convexity or indentation 46 of the first layer 35 is formed to correspond to the convexity or indentation 47 of the second layer 37. In particular, the first layer 35 is arranged and configured so that the convexity or indentation 47 of the second layer 37 lies in the convexity or indentation 46 of the first layer 35.

[0174] The convexities or indentations 46, 47 of the second layer 37 and first layer 35 are thus preferably at least substantially oriented with one another or arranged inside one another. For this reason the convexity or indentation 46 of the first layer 35 may have a larger diameter than the convexity or indentation 47 of the second layer 37 or vice versa. The diameters of the convexities or indentations 46, 47 thus differ, preferably at least such that the outer diameter of the innermost of the indentations or convexities 46, 47 is less than or equal to the inner diameter of the outermost of the indentations or convexities 46, 47.

[0175] The convexities or indentations 46, 47 can preferably be arranged one inside the other, can be fitted into one another or arranged to correspond to one another so as to be spaced apart when the layers 35, 37 abut on one another in the area surrounding the convexities or indentations 46, 47.

[0176] It is preferable if the first through-opening 36 is provided in the center of the convexity or indentation 46 of the first layer 35 and/or the second through-opening 38 is provided in the center of the convexity or indentation 47 of the second layer 37. However, other solutions are also possible.

[0177] It is preferable if the first through-opening 36 is aligned with the second through-opening 38 and the first through-opening 36 and the second through-opening 38 are both provided in the center of the convexity or indentation 46, 47 of the respective first layer 35 or second layer 37.

[0178] It is particularly preferable if the first layer 35 is of planar configuration, particularly with a layer thickness which is less than 100 μm, preferably less than 70 particularly less than 50 μm, at least in an area surrounding the first through-opening 36.

[0179] It is preferable if the first layer 35 is formed without interruptions, apart from the first through-opening 36. This prevents diffusion taking place through the first layer 35, which could detract from the effect of the small diameter of the first through-opening 36. In particular, the first layer 35 is thus an aluminum foil which comprises a single through-opening, namely the first through-opening 36, particularly preferably in a convex or indented region which may be produced particularly by embossing or thermoforming and/or deep drawing.

[0180] The first through-opening 36 is preferably produced by laser drilling. This allows a particularly precise and uniform shape to be obtained for the through-opening 36 or its diameter 44.

[0181] In FIGS. 4 and 5 the material connections, particularly adhesive layers or adhesive bonds 42, 43, are provided at least substantially over the entire surface of one of the flat sides of the first layer 35 and/or the second layer 37. However, it is alternatively or additionally possible and preferable for this to be interrupted, absent, cut away or recessed in the region of the first through-opening 36 and/or the second through-opening 38. In particular, the adhesive or the respective adhesive bond 42, 43 is provided only in the respective connecting portion 48. In particular, no adhesive coating or adhesive bond 42, 43 is provided in the region of the convexity or indentation 46, 47.

[0182] FIG. 6 shows a first layer 35 in the uninstalled state.

[0183] The first layer 35 is preferably formed as a flat surface or film. In the embodiment shown, the first layer 35 is formed at least substantially of metal, particularly aluminum. Alternatively or additionally, the first layer 35 may also comprise plastics, preferably a thermoplastic, particularly polybutylene terephthalate (PBT), or may be formed at least substantially or completely therefrom.

[0184] The first layer 35 is preferably formed in one piece. The first layer 35 may comprise an adhesive layer, an adhesive coating or the like or be connected thereto, particularly by material bonding.

[0185] The first layer 35 is preferably at least substantially round and/or shaped to fit the base of the container 12 or the sleeve 28. The first layer 35 may have recesses on its edge which preferably correspond to the shape or to obstacles on or in an inner side wall of the container 12 or the sleeve 28. This simplifies the insertion of the first layer 35.

[0186] The first layer 35 is preferably configured to cover the inner base of the sleeve 28 or of the container 12 by more than 50%, preferably more than 65%, particularly more than 80% or at least substantially completely. It has been found that this improves a leak-tight bonding of the first layer 35 to the second layer 37.

[0187] The first layer 35 preferably has an area which is greater than 0.5 cm.sup.2, particularly greater than 1 cm.sup.2, and/or less than 4 cm.sup.2, particularly less than 3 cm.sup.2.

[0188] The convexity or indentation 46 of the first layer 35 preferably takes up less than 30%, particularly less than 20% of the entire area of the first layer 35.

[0189] The convexity or indentation 46 of the first layer 35 is preferably provided in the center of or at least substantially at the center of gravity of the area formed by the first layer 35.

[0190] The first through-opening 36 is provided in the convexity or indentation 46 of the first layer 35 and/or in the center of or at least substantially at the center of gravity of the first layer 35.

[0191] The first layer 35 is preferably formed to be at least substantially symmetrical, particularly mirror-symmetrical and/or rotationally symmetrical, to the first through-opening 36. However, other solutions are also theoretically possible.

[0192] In particular, the first through-opening 36 may theoretically not be in the center and/or the first layer 35 may be of asymmetrical construction, for example, if this is necessary to ensure that the first layer 35 corresponds to the structure of the surface of the second layer 37 or the sleeves 28 or if the second layer 37 is asymmetrical.

[0193] The first layer 35 preferably comprises, on the side remote from the convexity or indentation 46, in particular, a ring-shaped connecting portion 48 for connecting to the second layer 37 or to the sleeve 28 or another wall of the container 12.

[0194] Particularly preferably, the first layer 35 comprises, in the connecting portion 48, a coating 49, particularly for the leak-tight application of the first layer 35 by material bonding. Preferably, the coating 49 is provided only in the connecting portion 48.

[0195] The connecting portion 48 is preferably arranged at the edges of the first layer 35 and/or takes up less than 70%, preferably less than 50%, of the surface of the first layer 35 on the side that carries the coating 49. The coating 49 is preferably provided only on one flat side of the first layer 35, particularly on the flat side of the first layer 35 which is remote from the convexity or the top of the dome or that which faces the indentation 46 in the first layer 35.

[0196] In a method for producing a proposed container 12 which can also be implemented independently, the first layer 35 is sealed into the sleeve 28 or other container blank.

[0197] It is preferably provided that the first layer 35 with the first through-opening 36 forms an inlay which can be arranged, or has been arranged, inside the sleeve 28 or inside the container 12 or in the inner space 30, particularly so as to form a continuous fluidic connection between the inner space 30, the first through-opening 36 and the second through-opening 38, preferably as far as the third layer 39.

[0198] Preferably, after insertion, the first layer 35 is connected to the second layer 37 in the connecting portion 48 and/or by means of the coating 49. The coating 49 may alternatively or additionally also be provided on the second layer 37.

[0199] The coating 49 preferably forms the materially connected or first adhesive bond 42 by sealing, heating, drying, contacting, or the like. For producing a leak-tight bond between the first layer 35 and the second layer 37, the coating is preferably fused on. However, it is also possible for the first layer 35 to be connected to the second layer 37, the sleeve 28 and/or the container 12 by material bonding, interlocking engagement and/or sealing in some other way.

[0200] It is particularly preferable if the first layer 35 is provided with the first through-opening 36 and/or convexity or indentation 46 as an inlay or even before it is installed. For this purpose, the first layer 35 may be stamped out of a film material and/or the convexity or indentation 46 may be introduced, particularly by embossing, vacuum-forming and/or thermoforming and/or deep drawing, and/or the first through-opening 36 may be drilled, particularly by laser drilling.

[0201] The first layer 35 is preferably applied as a lacquer. In particular, the first layer is applied to a flat side facing the convexity or the top of the dome thereof or painted on with nitrocellulose, preferably with a basis weight of more than 0.2 g/m.sup.2, preferably more than 0.5 g/m.sup.2, particularly more than 0.8 g/m.sup.2, and/or less than 3 g/m.sup.2, preferably less than 2 g/m.sup.2, particularly less than 1.5 g/m.sup.2 or about 1 g/m.sup.2. The lacquer coating is preferably also drilled or preferably also comprises the first through-opening 36.

[0202] The first layer 35 comprises, at least in the region of the first through-opening 36 and/or on average, a material thickness which is less than 100 μm, preferably less than 70 μm, particularly less than 55 μm, and/or more than 20 μm, preferably more than 30 μm, particularly more than 35 μm, particularly preferably about 45 μm.

[0203] The first layer 35 is preferably a thermo-weldable aluminum composite film. The first layer 35 is preferably cut from endless strip or endless material, particularly by stamping. This has proved particularly efficient.

[0204] The first layer 35 is preferably sealed into the sleeve 28 by heat-sealing. During the heat-sealing, a bond is preferably formed by the combination of pressure and a supply of heat. The first layer 35 is thus preferably pressed onto the inner sleeve base and at the same time heated, preferably to above 350° Kelvin, particularly above 380°, 400° or 430° and/or below 500° Kelvin. For this purpose, the first layer 35 is preferably held against a sealing punch, particularly by suction, and applied to the inner base of the sleeve 28 by inserting the sealing punch into the sleeve 28. By heating, the first layer 35 can then be bonded to the sleeve 28 or the second layer 37. Preferably, a sealing means, an adhesive or the like previously introduced into the sleeve 28 or applied to the first layer 35 and/or the second layer 37 is melted so as to produce an air-tight joint.

[0205] It is preferable if the first through-opening 36 is drilled before the insertion or sealing. However, it is also possible for the first through-opening 36 only to be made after the installation or sealing of the first layer 35.

[0206] Different embodiments of the proposed venting device 33 or the proposed wall structure 34 will be described in more detail hereinafter with reference to the additional FIGS. 7 to 11, in which the same reference numerals are used for identical or similar parts and the same or similar properties are present and/or the same or similar advantages are obtained, even though the relevant description is not repeated. In the following description, only essential differences are discussed and the explanations provided hereinbefore are of a corresponding supplementary nature wherever this is technically possible.

[0207] FIG. 7 shows a detail of a proposed container 12 with a proposed wall structure 34 according to a second embodiment, in which the first layer 35 is configured differently from the first layer 35 in the first embodiment. In the second embodiment the first layer 35 is arranged in the manner of a housing, a cover or a box above the portion of the second layer 37 with the second through-opening 38.

[0208] In particular, the first layer 35 is of pot-shaped or cylindrical configuration, the first through-opening 36 being particularly preferably provided in the center, in the center of gravity of a cover surface and/or on an axis of symmetry or along an axis of symmetry of the first layer 35.

[0209] The first layer 35 comprises one or more side walls 50 which are arranged at least substantially transversely or perpendicularly to and/or at the end face of the second layer 37 or are connected to the latter.

[0210] FIG. 8 shows a detail of a proposed container 12 with a proposed wall structure 34 according to a third embodiment.

[0211] In this embodiment, the first layer 35 is provided on the side of the second layer 37 remote from the inner space 30. This facilitates the subsequent provision of the first layer 35 or the first through-opening 36.

[0212] Preferably, the convexity or indentation 46 of the first layer 35 is configured such that it can be inserted or arranged in the convexity or indentation 47 of the second layer 37. In particular, the convexity or indentation 46 of the first layer 35 has a diameter which is less than the diameter of the convexity or indentation 47 of the second layer 37.

[0213] The coating 49 is preferably provided on the side facing the convexity of the first layer 35 or the side remote from the indentation 46 of the first layer 35, particularly at the edges. This makes it possible for the convexity or indentation 46 of the first layer 35, particularly in the connecting portion 48, to be sealingly connected to the second layer 37, particularly by material bonding.

[0214] FIG. 9 shows a detail of a proposed container 12 with a proposed wall structure 34 according to a third embodiment.

[0215] In the third embodiment the first layer 35 is of planar configuration at least substantially and/or in the region of the first through-opening 36. Thus, no convexity or indentation 46 is provided.

[0216] The first layer 35 is arranged between the second layer 37 and the third layer 39 in the fourth and also in the third embodiment. In the fourth embodiment the third layer 39 is formed in the manner of a housing, a box and particularly a cylinder or cylindrical section.

[0217] In the embodiment shown, the third layer 39 is preferably directly connected to the second layer 37, particularly by its end faces or one or more side walls 51, and/or receives the first layer 35. Alternatively or additionally the third layer 39 may, however, also be correspondingly connected to the first layer 35 (not shown).

[0218] FIG. 10 shows a detail of a proposed container 12 with a proposed wall structure 34 according to a fifth embodiment. The first layer 35 is arranged here between the second layer 37 and the third layer 39.

[0219] The third layer 39 preferably abuts on the first layer 35 and/or second layer 37 directly or separated only by an adhesive layer.

[0220] In the fifth embodiment, unlike in the previous embodiments, the third layer 39 is configured to be manually removable. For this purpose the third layer 39 preferably comprises a tab 52 or a tab-like projection by means of which the third layer 39 can be pulled away from the first layer 35 and/or the second layer 37.

[0221] FIG. 11 shows a detail of a proposed container 12 with a proposed wall structure 34 according to a sixth embodiment.

[0222] In the sixth embodiment, there is no second layer 37. Instead, the first layer 35 is preferably formed by the sleeve 28, the container 12 or a wall forming the container 12.

[0223] Preferably, the material thickness of the first layer 35, at least in the immediate vicinity of the first through-opening 36, is reduced to preferably less than 200 μm, particularly to less than 150 μm or 100 μm. This permits or favors the introduction of a first through-opening 36 with corresponding diameters.

[0224] In another aspect of the present invention which can also be implemented independently, the proposed container 12, particularly with the inhaler 1, is used to produce the aerosol 3 with a medicament preparation 4 held in the container 12, particularly in the pouch 13.

[0225] In another aspect of the present invention which can also be implemented independently, the proposed container 12 and/or inhaler 1 is used for therapeutic purposes, particularly for holding, dispensing and/or storing a preferably liquid medicament preparation 4.

[0226] In another aspect of the present invention which can also be implemented independently, the proposed container 12 is used in an inhaler 1 or other device for dispensing particularly liquid medicament preparations 4, the third layer 39 being destroyed, perforated and/or removed as the container is inserted, or as a result of it being inserted, so that the medicament preparation 4 can be dispensed, particularly for therapeutic purposes.

[0227] The individual aspects of the various embodiments may be combined with one another in numerous ways. For example, the third layer 39 may be removable and/or spaced apart or pot-shaped in different embodiments.