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WO2025003338A1 - Cartouche pour dispositif d'inhalation - Google Patents

Cartouche pour dispositif d'inhalation Download PDF

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Publication number
WO2025003338A1
WO2025003338A1 PCT/EP2024/068149 EP2024068149W WO2025003338A1 WO 2025003338 A1 WO2025003338 A1 WO 2025003338A1 EP 2024068149 W EP2024068149 W EP 2024068149W WO 2025003338 A1 WO2025003338 A1 WO 2025003338A1
Authority
WO
WIPO (PCT)
Prior art keywords
inner tube
cartridge
outer casing
welded seam
cartridge according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/068149
Other languages
English (en)
Inventor
Jürgen Rawert
Steven Madden
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Invox Belgium NV
Original Assignee
Invox Belgium NV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Invox Belgium NV filed Critical Invox Belgium NV
Priority to AU2024308910A priority Critical patent/AU2024308910A1/en
Publication of WO2025003338A1 publication Critical patent/WO2025003338A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/06—Sprayers or atomisers specially adapted for therapeutic purposes of the injector type
    • A61M11/08—Pocket atomisers of the injector type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/048—Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical
    • B65D77/0486—Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical the inner container being coaxially disposed within the outer container
    • B65D77/0493—Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical the inner container being coaxially disposed within the outer container and retained at a distance of the inner side-wall of the outer container, e.g. within a bottle neck
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/06—Liquids or semi-liquids or other materials or articles enclosed in flexible containers disposed within rigid containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A61M11/007—Syringe-type or piston-type sprayers or atomisers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/02—Membranes or pistons acting on the contents inside the container, e.g. follower pistons
    • B05B11/026—Membranes separating the content remaining in the container from the atmospheric air to compensate underpressure inside the container
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2583/00—Containers or packages with special means for dispensing contents
    • B65D2583/005—Dispensers provided with a replaceable cartridge, recharge or pouch located within the dispenser
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/771—Containers or packages with special means for dispensing contents for dispensing fluent contents by means of a flexible bag or a deformable membrane or diaphragm

Definitions

  • the present invention relates to the field of inhalation devices for medically active liquids.
  • the invention relates to a cartridge for an inhalation device for the generation and administration of a medically active liquid (2) in aerosolized form, the cartridge comprising a dimensionally stable outer casing and a collapsible inner tube.
  • the present invention relates to an inhalation device comprising such cartridge as well as a method for the assembly of such cartridge.
  • Nebulizers or other aerosol generators for liquids have long been known from the art. Amongst others, such devices are used in medical science and therapy. There, they serve as inhalation devices for the application of active ingredients in the form of aerosols, i.e., small liquid droplets embedded in a gas. Such an inhalation device is known, e.g., from document EP 0 627 230 Bl.
  • Essential components of this inhalation device are a reservoir, often in the form of a cartridge, in which the liquid that is to be aerosolized is contained; a pumping device for generation of a pressure being sufficiently high for nebulizing the liquid; as well as an atomizing device in the form of a nozzle.
  • the pumping device By means of the pumping device, the liquid is drawn in a discrete amount, i.e., not continuously, from the reservoir and fed to the nozzle.
  • the pumping device works without propellant and generates pressure mechanically.
  • Cartridges for holding the medically active liquids are, for example, described in US 2004/0143235 Al.
  • the document discloses a container for a medicinal liquid, the container being gas-tight and liquid-tight so that it is storable over many months.
  • the container includes a collapsible foil bag on which a flange, which is stable in respect of shape, is disposed.
  • the flange is designed for fitting onto a discharge connection member.
  • the container can be disposed in a casing which is stable in respect of shape.
  • the medicinal liquid does not come into contact with air and is protected from the effect of light.
  • the medicinal liquid may be dispensed from the foil bag in many partial quantities over a prolonged period of time, with a respective partial amount thereof being converted into an aerosol by means of an atomizer.
  • WO 2009/115200 Al discloses a reservoir for a nebulizer, a nebulizer and a method of filling a reservoir.
  • a fluid chamber of the reservoir is pre-collapsed and filled with an initial amount of fluid which is less than the maximum volume of the fluid chamber.
  • a device may be used to pre-collapse the fluid chamber, wherein the device may have at least manipulating or abutment element.
  • the actual volume of the fluid chamber available during the filling with the fluid is reduced, i.e., it is less than the maximum volume of the fluid chamber. This results in the desired pre-collapsing.
  • a further object of the present invention is to provide a cartridge for an inhalation device that allows for the withdrawal or dispensing of a medically active liquid in a large number of precise consecutive aliquots or doses.
  • the invention relates to a cartridge (1) for an inhalation device for the generation and administration of a medically active liquid (2) in aerosolized form, the cartridge comprising
  • a collapsible inner tube (20) for holding the medically active liquid comprising: an outlet end (21) having an outlet opening (22) and a closed end (23) opposite of the outlet end, wherein the outlet opening and the (the center of the) closed end defining a main axis (X) of the inner tube connecting the outlet opening and closed end of the tube; wherein the closed end of the tube is closed by a welded seam (24) oriented transverse (preferably substantially perpendicular) to the main axis of the inner tube; wherein in the assembled state of the cartridge the collapsible inner tube is located inside the outer casing; characterized in that in the assembled state the deformation element (11) contacts the welded seam such that the welded seam is deformed to deviate from a traversal line to the main axis of the inner tube by the contact between the welded seam and the deformation element.
  • the invention in a second aspect relates to an inhalation device adapted to utilize a cartridge according to the first aspect of the invention.
  • the invention in a third aspect relates to an inhalation system comprising an inhalation device (100) adapted to comprise a cartridge according to invention and a cartridge according to the invention.
  • the invention in a fourth aspect relates to a method for the assembly of a cartridge according to the invention, the method comprising the steps of a] providing an inner tube and a dimensionally stable outer casing comprising at least one deformation element; b] introducing the inner tube into the outer casing, thereby contacting the welded seam of the inner tube with the at least one deformation element and deforming the welded seam of the inner tube; c] filling of the inner tube with the medically active liquid; d] optionally sealing the cartridge after filling.
  • Figure 1 depicts a schematic of a cartridge for an inhalation device.
  • Figures 2A, 2B and 2C depicts a cross-section of a cartridge for an inhalation device according to the present invention.
  • Figure 2A shows the cartridge in an assembled state.
  • Figures 2B and 2C show cross-sections of the parts of the cartridge.
  • Figures 3A, 3B and 3C illustrate the deformation of the welded seam of the inner tube.
  • Figure 4 shows an exemplified inhaler with a cartridge.
  • the invention relates to a cartridge (1) for an inhalation device for the generation and administration of a medically active liquid (2) in aerosolized form, the cartridge comprising
  • the collapsible inner tube for holding the medically active liquid
  • the collapsible inner tube comprising: an outlet end (21) having an outlet opening (22) and a closed end (23) opposite of the outlet end, wherein the outlet opening and the (the center of the) closed end defining a main axis (X) of the inner tube connecting the outlet opening and closed end of the tube; wherein the closed end of the tube is closed by a welded seam (24) oriented transverse (preferably substantially perpendicular) to the main axis of the inner tube; wherein in the assembled state of the cartridge the collapsible inner tube is located inside the outer casing; characterized in that in the assembled state the deformation element (11) contacts the welded seam such that the welded seam is deformed to deviate from an ideal traversal line to the main axis of the inner tube by the contact between the welded seam and the deformation element.
  • welded seam refers to a welded seam present opposite of the outlet end of the inner tube.
  • the inner collapsible tube may comprise additional welded seams, but in preferred embodiments, the inner collapsible tube comprises a single welded seam closing one end of the tube.
  • the welded seam extends transversely with respect to the main axis (X) of the bag.
  • the welded seam is of a rectangular shape, however, the welded seam may be in other shapes, such as a U-shape. In a preferred embodiment, the welded seam is of rectangular shape.
  • the welded seam preferably has a welded height sufficient to effectively close the bag, and allows for a deformation of said seam, without substantially causing a precompression in the non-welded part of the inner collapsible tube.
  • the welded seam preferably has a height of at least 0.1 mm, and up to 5 mm.
  • the height is between 0.1 to 5 mm, preferably between 0.1 and 2 mm, more preferably between 0.3 to 6 mm.
  • the seam is as small as possible, preferably 3 mm height or smaller, more preferably between 0.5 mm to 2 mm.
  • the seam has a height selected from 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, and 2 mm.
  • the collapsible inner tube is made from any suitable material.
  • suitable materials include materials that allow for the generation of a collapsible tube, which allows however, for a still rigid kind of tube.
  • Preferred materials show a stable form and are not substantially deformed when the tube collapses due to the removal of fluid.
  • the collapsible inner tube maintains the general overall shape and essentially constricts on the removal of fluid.
  • the material used for the collapsible inner tube is also dependent on the fluid to be used.
  • the cartridge is for an ethanol-based fluid.
  • the collapsible inner bag is made of or comprises a material impermeable for ethanol.
  • the collapsible inner tube is impermeable for ethanol.
  • Suitable materials include polyethylene, in particular high-density polyethylene, nylon, ethylene vinyl alcohol (EVOH), polyamide and polypropylene, or metals such as aluminum or mixtures of different materials.
  • the collapsible inner tube is made of multiple materials.
  • the tube is made or comprises layers of different materials. If the tube comprises different materials, the tube may be adapted according to the requirements of the fluid. One layer of material may provide sufficient stability of the inner tube, and a second material layer may provide impermeability for the fluid.
  • the invention relates to a cartridge as defined above- wherein the inner collapsible bag comprises at least two distinct material layers. In some embodiments, the inner collapsible tube comprises three or more layers.
  • the collapsible inner bag comprises at least three layers: an outer layer comprising a polymer and/or co-polymer; a central layer comprising a metal layer and an inner layer comprising a polymer and/or or copolymer.
  • outer layer refers to the layer facing the outside of the collapsible tube and the inner layer refers to the layer facing the inside of the collapsible tube.
  • central layer refers to a layer positioned between the inner and outer layer.
  • the collapsible inner tube may be of any suitable general shape.
  • the collapsible tube is essentially tube-shaped.
  • the collapsible tube comprises aside from the welded seam a pouch portion and a collar portion.
  • the pouch portion is generally closed at one end by the welded seam and connects into the collar portion.
  • the collar portion preferably comprises the outlet opening.
  • the collar portion is further adapted to be attached or connected to the outer shell of the casing.
  • the invention relates to a cartridge as defined above, wherein the collapsible tube comprises a pouch portion (26) and a collar portion (27), wherein the collar portion comprises the outlet opening and is adapted to be attached to the shell of the outer casing of the cartridge.
  • the invention relates to a cartridge as defined above, wherein the pouch portion of the collapsible tube comprises polyethylene, in particular high- density polyethylene, nylon, ethylene vinyl alcohol (EVOH), polyamide and polypropylene, or metals such as aluminum or mixtures thereof.
  • the pouch portion comprises multiple material layers, wherein each layer independently comprises polyethylene, in particular high-density polyethylene, nylon, ethylene vinyl alcohol (EVOH), polyamide and polypropylene, or metals such as aluminum or mixtures thereof.
  • the invention relates to a cartridge as defined above, wherein the collar portion of the collapsible tube comprises polyethylene, high density polyethylene, polylactic acid, and/or polyoxymethylene.
  • the selected material should be compatible with the material of the pouch portion.
  • the selection of the material also allows for the selection of the thickness of the walls of the collapsible inner bag, in particular of a pouch portion (26) of the collapsible inner bag.
  • the thickness may be adjusted depending on the requirements of the fluid and inhaler type. It is preferred that the walls of the collapsible inner tube, aside from the welded seam have a thickness of 1 mm or less.
  • the wall of the inner tube has a thickness between 100 and 250 pm. In some embodiments, the thickness is between 125 and 225 pm. In preferred embodiments the thickness is between about 150 and 200 pm. In a particular embodiment, the thickness is about 175 pm.
  • the term deformed to deviate from an ideal traversal line means that the welded seam does not follow a straight line, corresponding to a 180° angle, but deviates from an 180° angle.
  • the deviation may be that the welded seam is curved, angled, bent, warped or otherwise distorted, preferably radially distorted.
  • the deviation can be defined by the deviation from the ideal traverse line to the main axis of the collapsible inner tube.
  • the furthest point of the welded seam may ideally deviate at least 1 mm, preferably 1.5, more preferably 2 mm from the ideal straight traverse line.
  • the welded seam may deviate up to 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm from an ideal straight line at the furthest point.
  • Said deviation is generated by the deformation element.
  • the term “deformation element” refers to any element of the cartridge that interacts or contacts the welded seam of the collapsible inner tube and causes the deformation of the welded seam.
  • Said deformation of the welded seam does not necessarily contribute to a precollapsing of the collapsible inner tube.
  • the invention is particularly suitable for collapsible inner tubes made from more rigid materials.
  • the deformation of the welded seam allows for controlled collapsing of said tube.
  • the problem to be solved is not an undesired increase in pressure inside the inner collapsible tube, but an avoidance of an underpressure as the tube might not fully collapse when fluid is extracted. This problem can be avoided with the deformation of the welded seam.
  • the deformation element is preferably part of the dimensionally stable outer casting.
  • Said outer casting may be a single part or comprise multiple parts.
  • the dimensionally stable outer casing is a single piece, comprising an opening which allows the insertion of the collapsible inner tube and said deformation element.
  • the dimensionally stable outer casing comprises multiple components.
  • the dimensionally stable outer casing may comprise multiple parts, such as a casing as defined above and a cap for securing the collapsible inner tube.
  • the invention relates to a cartridge as defined above, wherein the outer casing comprises or consists of
  • the outer casing may comprise additional components, such as a cartridge extension as described in WO 2011/198151 Al. Said cartridge extension may interact with other part of the inhaler, e.g., in the form of a combined counting and blocking device as described in WO 2023/001750 Al.
  • the deformation element is positioned in the dimensionally stable outer casing in a way that it is possible to deform the welded seam as defined above. As such, in most embodiments the deformation element is present opposite of the opening of the casing. In embodiments, in which dimensionally stable outer casing comprises a bases, it is preferred that the deformation element is provided on the base of the outer casing.
  • the invention relates to a cartridge, wherein the outer casing comprises
  • the outer casing and its parts may be made of any suitable material.
  • the outer casing and its parts are made of the same or partially the same materials as the collapsible inner tube. If the outer casing is made of multiple parts, including but not limited to a shell a cap and a base, these parts may be made of the same or different materials.
  • the invention relates to a cartridge as defined above, wherein the shell and/or base of the outer casing comprises high density polyethylene, polyethylene, polypropylene, polyoxymethylene, metal, e.g., aluminum, acrylonitrile butadiene styrene, or combinations and mixtures thereof.
  • the invention relates to a cartridge as defined above, wherein the cap of the outer casing comprises low density polyethylene, polyethylene, an elastomer, silicones, ethylene propylene diene monomer rubber, metal/elastomer combinations and or combinations and mixtures thereof.
  • An advantage of the present invention is that the volume of the cartridge can be adapted as needed for the requirements of the nebulizer.
  • the volume of the outer casing can be adjusted to accommodate the size of the collapsible inner tube. As long as the volume of the outer casing is sufficient to include the collapsible inner tube, the outer casing may have any volume required by the nebulizer.
  • the outer casing has a volume in the range of between about 0.1 to 200 ml. In particular embodiments the volume of the outer casing is between about 0.5 to about 50 ml. In particular embodiments, the volume of the outer casing is between about 1 mL to 10 ml.
  • the volume of the collapsible inner bag is generally smaller than the volume of the casing so that the collapsible inner tube is able to fit within the outer casing.
  • the volume of the collapsible inner tube is between 0.1 and 0.9 times the volume of the dimensionally stable outer casing. In some embodiments, the volume is about 0.3 to 0.7 times the volume of the outer casing. In some embodiments the volume of the collapsible inner tube is selected from 0.1, 0.2, 0.3, 0.4, 0.5, 0.7, 0.8, and 0.9 times the volume of the outer casing.
  • the inner tube has a volume in the range of from about 2 to about 8 ml, In some embodiments the volume of the inner tube is selected from 2 ml, 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml, 5 ml, 5.5 ml, 6 ml, 6.5 ml, 7 ml, 7.5 ml and 8 ml. In some specific embodiments the volume of the inner tube is about 3 ml.
  • the deformation element may be provided in any suitable form.
  • the deformation element is provided in the form of a protrusion or multiple protrusions.
  • Said protrusions may be of any suitable shape.
  • said protrusions may be in the form of guiding walls.
  • the deformation element may be an indentation, for example in the form of a guiding channel or a groove that receives the welded seam. If the deformation element is provided in the form of a protrusion, it is preferred that said deformation element is oriented parallel to the main axis (X) of the inner tube. In some specific embodiments at least one deformation element is oriented on the main axis (X) of the inner collapsible tube.
  • the deformation element is a protrusion or a set of protrusions.
  • set protrusion is pin-shaped.
  • the invention relates to a cartridge as defined above, wherein the deformation element is provided in the form of at least one pin (15) extending from the base of the outer casing. Said pin may be of any reasonable shape, however, it is preferred that the pin has a generally round shape.
  • the deformation element is provided in the form of a pin, wherein said pin has a circular cross section.
  • the deformation element is a protrusion, e.g., a pin or a plurality of pins as defined above, extending from the bottom of the dimensionally stable casing toward the opening of the dimensionally stable casing.
  • the at least one deformation element is provided in form of at least one pin, it is preferred that the at least one pin is oriented parallel to the main axis (X) of the inner tube.
  • the deformation element is provided in the form of a plurality of pins. Any suitable number of pins may be used. The number and placement of pins allows to adapt and adjust the deformation as needed, depending on the collapsible inner bag. A particularly suitable arrangement is based on three pins. Accordingly, in one embodiment the invention relates to a cartridge as defined above, wherein the deformation element is provided in the form of three pins. In a particular embodiment, said three pins are located on a base plate, as defined above, such that upon contact and deformation of the welded seam one pin is located on one broadside (25) of the welded seam and two pins are located on the opposite broadside of the welded seam.
  • the deformation element does not interact with the non-welded parts of the collapsible inner bag.
  • the deformation element does not substantially contact the collapsible sidewalls of the collapsible tube.
  • the deformation element only contacts the welded seam of the collapsible inner tube.
  • the deformation element is preferably designed to not substantially reduce the inner volume of the collapsible inner tube.
  • the invention relates to a cartridge as defined above, wherein the deformation element upon contact with the welded seam of the collapsible tube does not substantially reduce the inner volume of the collapsible tube.
  • the cartridge according to the present invention is intended for use in an inhalation device for the administration of a medically active liquid.
  • the cartridge, and in particular, the collapsible inner bag comprises a medically active liquid. Said medically active liquid should be administered by inhalation.
  • the cartridge is suitable for any medically active liquid that is administer by inhalation. In some embodiments this might be a liquid active agent. In other embodiments the medically active liquid comprises a pharmaceutically active ingredient and a liquid vehicle. The medically active liquid may be any kind of suitable liquid.
  • the invention relates to a cartridge as defined above, comprising a medically active liquid, wherein the medically active liquid comprises at least one pharmaceutically active ingredient and a liquid vehicle.
  • liquid vehicles suitable for medically active compounds are known to the skilled persons. Such liquid vehicles include solutions, suspensions and emulsions. Preferred liquid vehicles include solvents.
  • the liquid vehicle comprises at least one solvent selected from the group consisting of water, ethanol, polyethylene glycol, liquid fatty acids, oils, in particular natural oils, and semifluorinated alkanes.
  • the liquid vehicle comprises a solvent, wherein the solvent is ethanol.
  • the invention relates to a method for the assembly of a cartridge as defined above, the method comprising the steps of a) providing a collapsible inner tube and a dimensionally stable outer casing comprising a deformation element; b) introducing the inner tube into outer casing, thereby contacting the welded seam of the inner tube with the deformation element of the outer casing and deforming the welded seam of the inner tube; c) filling of the inner tube with a medically active liquid; d) optionally sealing the container after filling.
  • step (d) is not optional.
  • the invention relates to an inhalation device (100) adapted to comprise a cartridge as defined above.
  • the invention relates to a kit comprising an inhalation device (100) adapted to comprise a cartridge as defined above and a cartridge according to any one of the preceding claims.
  • the cartridge may be removably or permanently comprised in the inhalation device.
  • the inhalation device may be any kind of liquid inhalation device.
  • the inhalation device is a soft mist inhalation device, preferably a soft mist inhalation device comprising an impingement type nozzle.
  • the invention relates to a method for the assembly of a cartridge as defined above, the method comprising the steps of a) providing an inner tube and a dimensionally stable outer casing comprising a deformation element; b) introducing the inner tube into outer casing, thereby contacting the welded seam of the inner tube with the deformation element of the outer casing and deforming the welded seam of the inner tube; c) filling of the inner tube with the medically active liquid; d) optionally sealing the container after filling.
  • a cartridge (1) for an inhalation device for the generation and administration of a medically active liquid in aerosolized form comprising
  • a collapsible inner tube (20) for holding the medically active liquid comprising: an outlet end (21) having an outlet opening (22) and a closed end (23) opposite of the outlet end, wherein the outlet opening and the (the center of the) closed end defining a main axis (X) of the inner tube connecting the outlet opening and closed end of the tube; wherein the closed end of the tube is closed by a welded seam (24) oriented transverse (preferably substantially perpendicular) to the main axis of the inner tube; wherein in the assembled state of the cartridge the collapsible inner tube is located inside the outer casing; characterized in that in the assembled state the deformation element (11) contacts the welded seam such that the welded seam is deformed to deviate from a traversal line (L) to the main axis of the inner tube by the contact between the welded seam and the deformation element.
  • a cap (13) adapted to be attached to the outlet opening of the shell; and - a base (14) adapted to be attached to the base opening of the shell.
  • the collapsible tube comprises a pouch portion (26) and a collar portion (27), wherein the collar portion comprises the outlet opening and is adapted to be attached to the shell of the outer casing of the cartridge.
  • the pouch portion of the collapsible tube comprises polyethylene, in particular high-density polyethylene, nylon, ethylene vinyl alcohol (EVOH), polyamide and polypropylene, or metals such as aluminum or mixtures thereof.
  • polyethylene in particular high-density polyethylene, nylon, ethylene vinyl alcohol (EVOH), polyamide and polypropylene, or metals such as aluminum or mixtures thereof.
  • the shell of the outer casing comprises high density polyethylene, polyethylene, polypropylene, polyoxymethylene, metal, e.g., aluminum, acrylonitrile butadiene styrene, or combinations and mixtures thereof.
  • the cap of the outer casing comprises low density polyethylene, polyethylene, an elastomer, silicones, ethylene propylene diene monomer rubber, metal/elastomer combinations and or combinations and mixtures thereof
  • the base of the outer casing comprises high density polyethylene, polyethylene, polypropylene, polyoxymethylene, metal, e.g., aluminum, acrylonitrile butadiene styrene, or combinations and mixtures thereof.
  • the outer casing has a volume in the range of from about 0.1 to about 200 mL, optionally about 0.5 to about 50 ml, further optionally between about 1 mL to 10 ml.
  • the radially curved form of the welded seam comprises a deviation of up to to 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm from an ideal straight line at the furthest point.
  • the medically active liquid comprises at least one pharmaceutically active ingredient and a liquid vehicle.
  • liquid vehicle comprises at least one solvent selected from the group consisting of water, ethanol, polyethylene glycol, liquid fatty acids, oils, in particular natural oils, and semifluorinated alkanes.
  • An inhalation device (adapted to comprise a cartridge according to any of the preceding embodiments) comprising a cartridge according to any one of the preceding embodiments.
  • FIG. 1 shows a schematic of a cartridge (1) for an inhalation device (30) in assembled form.
  • the cartridge (1) comprises a dimensionally stable outer casing (10) which comprises at least an outer shell (12) and a cap (13) closing of the cartridge (1).
  • the collapsible inner tube (20) is not visible in this figure.
  • Figures 2A and 2B show a cross-section of a cartridge (1) for an inhalation device (30) according to the present invention.
  • Figure 2A shows the cartridge (1) in assembled state.
  • the dimensionally stable outer casing (10) of the cartridge (1) comprises a base (14), an outer shell (12) and a cap (13).
  • the base comprises a deformation element (11) in the form of a pin (15).
  • the collapsible inner tube (20) is inserted in the dimensionally stable outer casing (10) secured by the cap (13).
  • the collapsible inner tube comprises an outlet end (2)1 with an outlet opening (22) interacting with the cap (13) of the outer casing.
  • the closed end (23) is closed by a welded seam (24) which is contacted by the deformation element (11) to cause a deviation from a straight line.
  • the main axis (X) of the cartridge is outlined to indicate the deviation of the welded seam.
  • the collapsible inner tube (20) comprises a pouch portion (26) which is filled with the medically active liquid and ends in the welded seam on the one side and a collar portion (27) on the other side. The collar portion marking the outlet end and providing the outlet opening.
  • Figure 2B shows the same embodiment of the cartridge (1) in a disassembled state.
  • the Figure in particular depicts a cross-section of the base (14) of the dimensionally stable outer casing (10) comprising the deformation (11) element in form of a pin (15).
  • the figure allows further a better depiction of the collapsible inner tube (20), still inserted in the shell (12) of the outer casing (10).
  • the collapsible inner tube comprises an out let end (21) with outlet opening (22), closed end (23) with welded seam (24) and pouch portion (26).
  • FIG. 2C shows further depictions the elements of the cartridge in stylized form, not in the form of a cross section.
  • the figure depicts the different components of the cartridge (1) prior to assembly: Base (14) collapsible inner bag (20), shell (12) and cap (13) oriented along the main axis (X) of the cartridge.
  • Figures 3A, 3B and 3C show different angles of the base (14) with the deformation element (11) in the form of a pin (15) interacting with the broadside (25) of the welded seam (24) of the collapsible inner tube (20). All figures show the deformation of the welded seam (24) to a radially curved form deviating from an ideal traversal line (L) to the main axis (X). Figure 3C illustrates and depicts the traversal line (L) to show the deviation.
  • Figure 4 shows an inhaler (30) with an inserted cartridge (1) according to the invention. List of references

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une cartouche (1) pour un dispositif d'inhalation destiné à la génération et à l'administration d'un liquide médicalement actif (2) sous forme aérosolisée, la cartouche comprenant - un boîtier externe (10) dimensionnellement stable et - un tube interne (20) pliable destiné à contenir le liquide médicalement actif, situé à l'intérieur du boîtier externe dans l'état assemblé de la cartouche, le tube interne pliable comprenant une extrémité de sortie (21) ayant une ouverture de sortie (22) et une extrémité fermée (23) opposée à l'extrémité de sortie, l'ouverture de sortie et (le centre de) l'extrémité fermée délimitant un axe principal (X) du tube interne reliant l'ouverture de sortie et l'extrémité fermée du tube, l'extrémité fermée du tube étant fermée par un joint soudé (24) orienté transversalement (de préférence sensiblement perpendiculairement) à l'axe principal du tube interne ; et le boîtier externe comprenant un élément de déformation (11) en contact avec le joint soudé (dans l'état assemblé de la cartouche) de telle sorte que le joint soudé est déformé en une forme incurvée radialement par le contact entre le joint soudé et l'élément de déformation.
PCT/EP2024/068149 2023-06-30 2024-06-27 Cartouche pour dispositif d'inhalation Pending WO2025003338A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024308910A AU2024308910A1 (en) 2023-06-30 2024-06-27 Cartridge for inhalation device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23182849.2 2023-06-30
EP23182849 2023-06-30

Publications (1)

Publication Number Publication Date
WO2025003338A1 true WO2025003338A1 (fr) 2025-01-02

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PCT/EP2024/068149 Pending WO2025003338A1 (fr) 2023-06-30 2024-06-27 Cartouche pour dispositif d'inhalation

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Country Link
AU (1) AU2024308910A1 (fr)
TW (1) TW202502400A (fr)
WO (1) WO2025003338A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0627230B1 (fr) 1990-03-21 2000-02-02 BOEHRINGER INGELHEIM INTERNATIONAL GmbH Dispositif de pulvérisation
US20040143235A1 (en) 1998-02-27 2004-07-22 Boehringer Ingelheim Gmbh Container for a medicinal liquid
WO2009115200A1 (fr) 2008-03-17 2009-09-24 Boehringer Ingelheim International Gmbh Réservoir et nébuliseur
EP2408571A2 (fr) * 2009-03-17 2012-01-25 Boehringer Ingelheim International GmbH Réservoir et pulvérisateur
US20150040890A1 (en) * 2013-08-09 2015-02-12 Boehringer Ingelheim International Gmbh Nebulizer
WO2023001750A1 (fr) 2021-07-20 2023-01-26 Softhale Nv Système de dispositif d'inhalation doté d'un ensemble de comptage et de blocage

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0627230B1 (fr) 1990-03-21 2000-02-02 BOEHRINGER INGELHEIM INTERNATIONAL GmbH Dispositif de pulvérisation
US20040143235A1 (en) 1998-02-27 2004-07-22 Boehringer Ingelheim Gmbh Container for a medicinal liquid
WO2009115200A1 (fr) 2008-03-17 2009-09-24 Boehringer Ingelheim International Gmbh Réservoir et nébuliseur
EP2408571A2 (fr) * 2009-03-17 2012-01-25 Boehringer Ingelheim International GmbH Réservoir et pulvérisateur
US20120132198A1 (en) * 2009-03-17 2012-05-31 Boehringer Ingelheim International Gmbh Reservoir and atomizer
US20150040890A1 (en) * 2013-08-09 2015-02-12 Boehringer Ingelheim International Gmbh Nebulizer
WO2023001750A1 (fr) 2021-07-20 2023-01-26 Softhale Nv Système de dispositif d'inhalation doté d'un ensemble de comptage et de blocage

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AU2024308910A1 (en) 2025-12-04

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