WO2013174752A2 - Système composé d'un inhalateur et d'une capsule - Google Patents

Système composé d'un inhalateur et d'une capsule Download PDF

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Publication number
WO2013174752A2
WO2013174752A2 PCT/EP2013/060272 EP2013060272W WO2013174752A2 WO 2013174752 A2 WO2013174752 A2 WO 2013174752A2 EP 2013060272 W EP2013060272 W EP 2013060272W WO 2013174752 A2 WO2013174752 A2 WO 2013174752A2
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
inhaler
cap
holes
receptacle
Prior art date
Application number
PCT/EP2013/060272
Other languages
German (de)
English (en)
Other versions
WO2013174752A3 (fr
Inventor
Holger Holakovsky
Jessica Frentzel-Beyme
Stephen Terence Dunne
Jens Besseler
Claudius Weiler
Original Assignee
Boehringer Ingelheim International Gmbh
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
Priority claimed from PCT/EP2012/059324 external-priority patent/WO2012163704A2/fr
Application filed by Boehringer Ingelheim International Gmbh filed Critical Boehringer Ingelheim International Gmbh
Priority to JP2015513120A priority Critical patent/JP6365848B2/ja
Priority to US14/402,507 priority patent/US10500355B2/en
Priority to ES13724241.8T priority patent/ES2683972T3/es
Priority to PL13724241T priority patent/PL2852423T3/pl
Priority to DK13724241.8T priority patent/DK2852423T3/en
Priority to EP13724241.8A priority patent/EP2852423B1/fr
Publication of WO2013174752A2 publication Critical patent/WO2013174752A2/fr
Publication of WO2013174752A3 publication Critical patent/WO2013174752A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • 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
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0043—Non-destructive separation of the package, e.g. peeling
    • 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
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/04—Closures with discharging devices other than pumps
    • B65D47/20—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge
    • B65D47/26—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge with slide valves, i.e. valves that open and close a passageway by sliding over a port, e.g. formed with slidable spouts
    • B65D47/28—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge with slide valves, i.e. valves that open and close a passageway by sliding over a port, e.g. formed with slidable spouts having linear movement
    • B65D47/283—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge with slide valves, i.e. valves that open and close a passageway by sliding over a port, e.g. formed with slidable spouts having linear movement between tubular parts
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder

Definitions

  • the present invention relates to a system of a capsule for containing medical formulations for use in an inhaler and an associated inhaler.
  • the invention relates to systems with capsules filled with a powdered pharmaceutical preparation and to inhalers intended to provide a powdered pharmaceutical preparation for inhalation, the powder being contained in a capsule and being inhaled by means of at least a hole in the capsule wall exits the capsule.
  • Capsules are known in the art which are used in certain medical devices, such as powder inhalers.
  • the outer shape of capsules used in such inhalers is often (as in the present specification) that of a closed cylinder with hemispherical ends, the length of the cylinder being greater than its diameter.
  • Such capsules usually consist of two cup-like parts, namely a capsule body and a capsule cap, which are telescopically inserted into each other.
  • Many capsules used in medicine consist of gelatin or hard gelatin.
  • WO2000 / 07572 discloses plastic capsules for use in powder inhalers.
  • the capsules consist of capsule body and capsule cap, which can be connected together to form a stable, closed cavity of defined volume.
  • the capsule may have latching elements which connect the capsule cap firmly with the capsule body.
  • An example of such locking elements are punctiform elevations in the inner shell of the capsule cap, which engage in slightly larger punctiform depressions on the outer surface of the capsule body.
  • Capsule cap and capsule body both consist of the same non-water-soluble, hydrophobic plastic, preferably polyethylene.
  • WO2006 / 074982 A2 discloses a closure concept for capsule cap and capsule body, by which it is possible to provisionally connect the two parts for the transport of the capsule to the filling system via a prefastener, which can be opened non-destructively in contrast to the main closure.
  • the closures are provided in the inner casing of the capsule cap by annular or segmental elevations. gene and matching peripherally formed the outer shell of the capsule body annular recesses.
  • WO2004 / 082750 A1 shows an example of such an inhaler in which a capsule is pierced at its two ends by two opposite needles.
  • the capsule rotates about its transverse axis, being driven by tangentially incoming air. Particles, which are conveyed by the rotation of the capsule from its interior, then move through the air flow to the mouthpiece.
  • US 5896855 shows an inhaler in which a plurality of capsules are stored in a rotatable magazine and which are fed by an optionally motorized mechanism to a vortex chamber where the powder is also discharged by rotating the capsule about its transverse axis from holes at the capsule ends.
  • the capsules are held in place by needles or stoppers at both ends.
  • the capsules are either pierced before insertion into the magazine at their pole ends and these holes are closed by the plugs in the magazine until the respective capsule is fed into the vortex chamber; or the capsules are pierced by just these needles when inserting the capsules in the magazine and the
  • WO04 / 052435 A1 shows various capsule-based powder inhalers in which the atomization takes place using the so-called Bernoulli effect.
  • a shown inhaler has a mouthpiece which is similar to a cap and is placed on a base containing a capsule chamber. On the lower housing part, a cutting device for opening the capsules is provided. To replace the used capsules with new ones, the mouthpiece is folded up or a connector solved training, which is located between the mouthpiece and housing base or between the mouthpiece and an inserted into the housing base and connected to the capsule chamber plate.
  • Another inhaler shown has a rotatably mounted, exchangeable or refillable revolving magazine with a plurality of each equipped with a capsule chambers.
  • the drug to be delivered is stored in a substantially cylindrical capsule and this capsule is inserted into the inhalation chamber of an inhaler.
  • the capsule chamber is adapted to the size of the capsule in that it is also substantially cylindrical, with their length and their diameter are each slightly larger than the corresponding dimensions of the capsule.
  • a capsule inserted into the capsule chamber has enough leeway to be able to carry out vibratory movements both in the axial and in the radial direction, but remains essentially aligned along the axis of the chamber.
  • the capsule chamber has an air inlet in the region of one of the two ends and an air outlet opening in the region of the other end.
  • the air outlet is connected to an inhalation channel leading to the mouthpiece of the inhaler.
  • the capsule chamber, air outlet, inhalation channel and opening in the mouthpiece are arranged along a common axis.
  • the capsule is first opened at usually two points alongside the jacket. As a rule, the openings are located near the two longitudinal ends of the capsule. If an air flow is now generated in the capsule chamber from the air inlet to the air outlet, this leads along the longitudinal axis of the capsule and thereby has two effects: on the one hand, the capsule vibrates, its preferential direction of movement being due to the air flow along the longitudinal axis. On the other hand, the air flowing along the two capsule openings generates a negative pressure relative to the interior of the capsule, so that the powder contained in the capsule is sucked out of the air stream and thereby atomized.
  • the object of the present invention is to provide a capsule-and-inhaler system which is improved over the prior art and in which the reproductive system dusieriana the atomization, in particular the powder application from the capsule is improved.
  • a system should be provided in which irregularities in opening the capsules are reduced or minimized.
  • a feature of the system according to the invention which is formed by a capsule and an inhaler, is that the inhaler has a capsule chamber and the capsule is stored in a capsule holder belonging to the system or the inhaler before the use of the inhaler.
  • the capsule is for use as a reservoir for a pharmaceutical preparation or medical formulation and comprises two capsule elements which are open on one side, namely a capsule body and a capsule cap, which can be telescoped into one another via their openings to form a cavity.
  • Capsule body and capsule cap are characterized in that at least one of the two, preferably both, in addition to the one-sided opening at least each have a prefabricated hole.
  • the capsule receptacle seals at least one hole and / or all holes, which leads or lead after the nesting of the capsule elements in the cavity of the capsule.
  • the capsule receptacle is at least partially disposed in the capsule chamber and removable from the capsule chamber such that the capsule remains in the capsule chamber upon removal of the capsule receptacle
  • a further feature of the present invention is that a capsule cap filled with a pharmaceutical preparation and having a capsule cap and / or capsule body with prefabricated holes is used in an inhaler, wherein the prefabricated holes at the time of insertion of the capsule into a capsule chamber of the Inhalator are concealed and exposed by operating a tension element in the inhaler.
  • the exposure of prefabricated holes offers various advantages over the use of piercers in the inhaler:
  • the prefabricated holes are due to their manufacturing process, eg in plastic injection, in size and shape of capsule to capsule very well reproducible during piercing holes depending on Capsule material, capsule size and material as well as piercing position and geometry of the needles can vary individually and / or lead to irregular hole geometries. Furthermore, a certain recovery of the capsule surface in the region of the puncture site is possible when piercing capsules.
  • the prefabricated holes presented here have a stable shape after their exposure and no protrusions in the capsule material.
  • Such protrusions in the capsule material form for example, when the capsule wall is pressed in by a piercing device and may possibly lead to a slightly reduced application of the preparation from the capsule to the addition of, in particular, pulverulent pharmaceutical preparation and thus during atomization.
  • the atomization of the pharmaceutical preparation itself is thereby reproducible, especially in comparison to inhalers with
  • a further feature of the present invention is that the inhaler for use with capsules with prefabricated holes has a tension element and for the actuation of the tension element ducts or openings are used, which are already necessary due to the operating principle of the inhaler.
  • the tension element is arranged in an air duct of the inhaler.
  • the associated piercing element when using a piercing device, would have to be introduced through one or more openings into the capsule chamber, which during inhalation can lead to additional undesired air flows through these openings.
  • Such openings in addition to the air inlet and air outlet of the capsule chamber are not required in the inhaler according to the invention, unless they are in turn aligned with an improvement of the air flow in the capsule chamber.
  • a tension element for exposing prefabricated holes has a further advantage compared to the use of piercing elements: due to the movement latitude of the capsule in the capsule chamber necessary for the sputtering process, fluctuations in the position of the capsule relative to the piercing tips can occur come when the capsule is pierced in the capsule chamber. This leads to variations in the exact position of the holes in the respective capsule in comparison to several similar capsule-inhaler systems.
  • the use of a pull mechanism for exposing prefabricated holes further has, depending on the design of the tension member the advantage that the same mechanism for the exposure of different hole arrangements can be used on capsules.
  • a pull mechanism for exposing prefabricated holes for example, in cylindrical arrangements of capsule, capsule chamber and traction element several holes on the capsule - in relation to their circumference - are different locations. Size, shape, position, number of holes in a capsule are very variable in this concept, especially in a production of the capsule parts from injection molding processes. At this point the results of the atomization of certain pharmaceutical preparations or specific powders can be deduced. Certain flow simulations may be used to use optimal hole structures for capsules for that particular formulation or powder.
  • the inhaler comprises a body (100) having a chamber, in particular a vibration chamber or preferably a capsule chamber (74) for receiving a preferably powder-filled capsule (71) forms, and the material of this body (100) consists essentially of a thermoforming sheet or a blister foil.
  • a chamber in particular a vibration chamber or preferably a capsule chamber (74) for receiving a preferably powder-filled capsule (71) forms
  • the material of this body (100) consists essentially of a thermoforming sheet or a blister foil.
  • the body is formed of two halves or parts that are joined together by sealing, laminating, gluing or welding.
  • the reservoir containing a medicinal preparation to be nourished or, more specifically, as herein preferably, a capsule holder with a powder-filled capsule is inserted into the chamber before the two halves or parts of the body are connected together.
  • the at least one prefabricated in the capsule hole is closed by a tension element, wherein the tension element forms a capsule receptacle or a capsule receptacle is part of the tension element.
  • This capsule receptacle has substantially the shape of a cylindrical tube, which is dimensioned so that it encloses the cylindrical part of the capsule accurately.
  • the at least one prefabricated hole in the capsule is located in the cylindrical shell region of the capsule and is thus closed during the storage or storage of the capsule in the inhaler through the wall of the capsule holder.
  • the capsule thus stored and filled with powder has two holes at the top and bottom, i. one hole at the beginning and one at the end of the cylindrical jacket area.
  • the capsule consists of a capsule body and a capsule cap, both of which have at least one prefabricated hole, wherein after collapsing capsule body and capsule cap into each other, the holes remain free, i. not covered by the other capsule element.
  • the holes can also be prefilled after filling the capsule and after merging capsule cap and capsule body outside of the inhaler.
  • powder quantities of between 0.1 milligrams and 100 milligrams of a pure active substance or a mixture of active ingredients may be stored for later application.
  • this has a pulling mechanism for exposing the prefabricated capsule holes.
  • the pulling mechanism is preferably designed such that the capsule is located in a capsule receptacle and the capsule receptacle is in a suitable state for transport and storage of the system in the capsule chamber.
  • the capsule holder is pulled out of the capsule chamber, preferably also completely out of the inhaler.
  • a device is provided which prevents the capsule with the capsule holder from being pulled out of the capsule chamber and / or releases the capsule from the capsule holder when the capsule holder is withdrawn.
  • the capsule holder is pulled out through a mouth tube on the inhaler, the mouth tube in this case forms the air outlet from the capsule chamber towards mundschem end of the inhaler.
  • This device for retaining the capsule in the capsule chamber preferably includes a rod or web which simultaneously forms the upper boundary of the capsule chamber. This rod or web penetrates preferably in the storage state of the system, the capsule receptacle on the air inlet of the capsule chamber opposite side.
  • the capsule receptacle preferably has slot-shaped recesses, on the basis of which the capsule receptacle, on withdrawal from the inhaler, can slide past the web and thus separate from it.
  • the component forming the capsule receptacle has a region protruding from the inhaler, on which a gripping surface is formed, on which the user can touch, in order to be able to pull the capsule receptacle out of the inhaler.
  • the component forming the capsule receptacle is particularly preferably designed as a cap which, in the transport state, covers the mouth-side end of the inhaler.
  • the capsule receptacle or the tension element is designed, with the aid of which the holes are sealed or uncovered.
  • the capsule receptacle is formed by the tension element.
  • the capsule holder and the tension element are produced as one or more deep-drawn parts from a blister foil.
  • the capsules in the capsule receptacle in the region of the prefabricated holes are preferably closed by a sealing process on the tension element.
  • the capsule receptacle is designed to be so flexible that the capsule can be released from the capsule receptacle destructively by pressure along the longitudinal axis of the tension element; e.g. as just described, in that upon actuation of the pulling mechanism, a rod or other obstruction restrains the capsule while the capsule retainer can slide past the rod or obstruction due to a suitable slot.
  • a further feature of the invention is that in the case of systems for single use, the components involved in the respective pulling mechanism have devices which cause the respective pulling movement can not be undone destructively.
  • this has the capsule retainer spring arms or other elements, which prevents a non-destructive reinsertion of the capsule receptacle in the capsule chamber in the case of the withdrawn capsule receptacle.
  • the inhaler also has two associated two capsule chambers and two capsule receptacles for the two capsules.
  • the two capsules are optionally filled with different formulations and / or different formulation quantities.
  • Such a system of inhaler and two capsules can be used, for example, in therapies in which two different medical formulations are to be administered simultaneously to a patient.
  • the respective capsule chambers and capsule holders are then adapted in terms of their sizes to their respective capsules.
  • the pull mechanism on the inhaler is designed to simultaneously expose the holes on both capsules with one movement.
  • the system has capsule receptacles extending into mouth tubes of the inhaler and a cap having a gripping surface or a tab for pulling, both preferably capsule receptacles, preferably interconnected in the cap region, are simultaneously withdrawn from the inhaler when pulling on the cap.
  • the system is formed from an inhaler and a composite capsule with at least one prefabricated hole, wherein the capsule is in a transport state of the system in the inhaler and at least partially so of a preferably stretchable and / or flexible film is enclosed, that the film closes the at least one prefabricated hole and / or all holes of the capsule in the transport state of the system.
  • the film is preferably connected to a drawstring or another grip element and / or partly projects beyond the capsule at one end of the capsule (the foil with drawstring or the protruding foil itself is thus the "tension element” in these embodiments)
  • Inhaler has an opening through which the film comes out of the inhaler at its protruding part and / or at its tension band. can be pulled out, the prefabricated holes are exposed on the capsule.
  • such a system of capsule with prefabricated, initially hidden holes and inserted into a capsule capsule or tension element is also suitable for the production of single-dose (disposable) ).
  • a system of capsule with prefabricated, initially hidden holes and inserted into a capsule capsule or tension element is also suitable for the production of single-dose (disposable) ).
  • the composite capsule may be present in two different states: in the first state, the at least one prefabricated hole is closed, in the second it is free.
  • both capsule elements have prefabricated holes and in telescoping nesting two insertion positions to each other (these two insertion positions correspond to the so-called first and second state of the capsule in this embodiment): A first insertion position in which both elements are inserted into each other, that the prefabricated holes are concealed and the cavity of the capsule is closed as a whole, and a second insertion position in which cover the prefabricated holes in the capsule body and capsule cap so that the entire capsule at the point of overlap of both holes has a hole.
  • both capsule elements are cup-shaped: The cavity formed by them, open on one side is bounded laterally by a circumferential capsule shell and with respect to the open side by a closed end.
  • the capsule shell forms a cylindrical or elliptically encircling wall, so that inside the collapsed capsule inside no corners are formed, in which in particular powdered pharmaceutical preparation accumulate and thus could remain at a later application of the powder from the capsule.
  • the undersides of capsule body and capsule cap and thus have both ends the nesting capsule a convex, in particular substantially hemispherical or ellipsoidal shape.
  • the prefabricated holes in capsule cap and capsule body are preferably located in their respective shell region, so that when nesting each other, the shell of the other capsule element covers the respective hole until the insertion position is reached, in which both holes are brought to cover.
  • the capsule cap and capsule body are preferably structured in the capsule sheath region on each of the sides which abut each other in the inserted state. This structuring is preferably designed so that it fulfills different functions.
  • the structures of capsule cap and capsule body have mutual latching elements. When the capsule elements are inserted into one another, this structure preferably causes the capsule cap and the capsule body to latch in relation to one another in at least two positions, in particular the said insertion positions. Locking in the first insertion position ensures that, on the one hand, the holes in the capsules are not random, e.g. be exposed prematurely by vibrations during transport and a defined process such as the pushing together of both elements under exercise of a defined pressure is necessary to expose the holes.
  • the mutually interacting latching elements of capsule cap and capsule body are preferably designed so that the two capsule elements after nesting up to the first insertion can no longer be separated from each other without destroying each other. This will prevent the capsule from accidentally opening.
  • structural elements are additionally present, which serve as a guide when nesting the two capsule elements.
  • the effect of these structural elements on the mutually facing jacket regions of capsule cap and capsule body is that the two capsule elements can be inserted into one another only in defined orientations.
  • the "defined orientation” refers to the rotation of the capsule elements about the longitudinal axis of the capsule, it is So an azimuthal orientation.
  • these structural elements have the shape of at least one groove in the outer / inner circumferential surface of the capsule cap / capsule body and respectively the shape of at least one guide rail in the inner / outer lateral surface of the capsule body / capsule cap.
  • linear guides are preferred, in particular those parallel to the main axis of the capsule.
  • the structural elements guide the movement of the capsule elements when nesting are likewise possible. This would be effected, for example, by a helical guide groove or guide rail.
  • the capsule has an elliptical cross section instead of a cylindrical cross section.
  • the ellipse is one that deviates only slightly from the shape of a circle (the ratio of the longitudinal to transverse axis of the ellipse should be less than 75%, preferably between 90% and 85%).
  • Such an elliptical cross-section forces a defined azimuthal orientation of the two capsule elements when nesting into one another and / or a defined orientation when inserting a resulting capsule into a capsule receptacle.
  • the hole in the outer capsule member is preferably designed as a slot, elliptical or slightly larger than the associated hole in the inner cap member.
  • the narrow diameter of the hole is preferably at least as large as the diameter of the hole in the inner capsule element.
  • the outer capsule element is that which forms the outer wall of the capsule from the capsule body and capsule cap in the nested state in the region of the adjacent capsule shells.
  • Fig. 1 is a schematic representation of a special capsule in different states: a) capsule cap and capsule body before nesting, b) capsule cap and capsule body in a first insertion position and c) capsule cap and capsule body in a second insertion position;
  • Fig. 2 is a schematic representation of a second embodiment of the capsule in different states: a) capsule cap and capsule body before nesting and b) capsule cap and capsule body in a second insertion position;
  • Fig. 3 is a schematic representation of a third embodiment of the capsule, wherein capsule cap and capsule body are shown prior to nesting;
  • Fig. 4 is a schematic cross section of a fourth embodiment of the capsule, wherein in the first half of the capsule capsule capsule body and before the nesting and in the second half of the capsule capsule and capsule body are shown after nesting.
  • Fig. 5 is a schematic cross-section of a fifth embodiment of the capsule, wherein capsule cap and capsule body are shown after nesting in the first half of the capsule capsule and capsule body before nesting and in the second half.
  • Fig. 6 shows a schematic representation of a sixth embodiment of the capsule according to the invention in different states: Fig. 6a shows capsule cap, capsule body and ring before nesting, Fig. 6b shows capsule cap separated from the collapsed components ring and capsule body, Fig. 6c shows capsule cap and capsule body in a second insertion position.
  • Fig. 7 is a schematic representation of a seventh and an eighth embodiment of a capsule: Fig. 7a shows the closed capsule with filling, Fig. 7b shows the position of holes of the capsule according to the seventh and Fig. 7c of the eighth embodiment.
  • FIG. 8 shows the capsule with prefabricated holes, FIG. 8b the capsule stored in an inhaler and FIG. 8c the capsule after displacement from its storage state. FIG into the capsule chamber of the inhaler.
  • Fig. 9 is a schematic representation of the operation of a second embodiment of an inhaler with sliding mechanism and the structure of the system of capsule (similar to the sixth or ninth embodiment) and inhaler:
  • Fig. 9a shows a capsule element with associated annular holder
  • Fig. 9b the tube of Inhalator, in which capsule and ring are used
  • Fig. 9c the closure of the capsule in the tube
  • Fig. 9d is an exploded view of the components or component groups of
  • FIG. 9e the completely assembled system of capsule and inhaler in the transport state
  • FIG. 9g the system in the ready-to-use state.
  • Fig. 10 is a schematic representation of the operation of a first embodiment of an inhaler according to the invention and the structure of the associated system of capsule according to the invention (similar to the eighth or ninth embodiment) and inhaler:
  • Fig. 10a shows the use of a capsule element in a tube
  • FIG. 10b shows the closure of the capsule in the tube in a schematic longitudinal section of the tube rotated by 90 ° with respect to FIG. 10b
  • FIG. 10d shows an exploded view of the components or component groups of the inhaler
  • FIG. 10e shows a schematic longitudinal section of the ready-assembled system of capsule and inhaler in the transport state
  • Fig. 10fb shows a schematic longitudinal section of the system of capsule and inhaler in the application state.
  • Fig. 1 1 is a schematic longitudinal section of a system of two capsules (similar to the eighth or ninth embodiment) and an inhaler according to a second embodiment of the invention.
  • FIG. 12 shows a schematic longitudinal section of a system of capsule and inhaler according to a third embodiment of the invention
  • FIG. 12a is a cross-sectional view of the capsule-and-inhaler system in the transport state
  • FIG. 12b is a sectional view of the capsule-inhaler system in use.
  • the embodiments of the inhalers considered here, which are operated together with one with a capsule, are preferably based on the so-called Bernoulli principle:
  • the inhalers (eg to be seen in FIG. 8c) have a capsule chamber (74), the length of which on the Length of the capsule (71) is adapted that the capsule (71) according to the Bernoulli effect in the air flow and can vibrate.
  • the capsule chamber (74) has for this purpose an inlet (76) for the air and an air outlet.
  • the limitation of the capsule chamber (74) in the direction of the air outlet is preferably formed by a rod (75), sieve and / or by an aerodynamically advantageously shaped component, which represents only a small flow resistance.
  • a mouthpiece (78) follows, at which the user, not shown, inhales and thereby generates the air flow necessary for atomising the capsule contents.
  • Figure 1 shows a schematic representation of a special capsule consisting of capsule cap (1) and capsule body (2), both of which have a cup-like shape and telescopically can be inserted into one another via their openings.
  • the capsules shown in this and the following figures are preferably filled with a powdered pharmaceutical preparation.
  • the capsule cap (1) and the capsule body (2) take the form of a cylinder open on one side with round cross section and convex, almost hemispherical closed other side.
  • Capsule cap (1) and capsule body (2) are both preferably made of polypropylene (PP) or polyethylene (PE), more preferably high-density polyethylene having a density between 950 and 1000 kg / m 3 .
  • PP polypropylene
  • PE polyethylene
  • capsule cap (1) and capsule body (2) are made of different materials, for example capsule bodies made of PP or PE and the capsule cap made of gelatin.
  • the capsule sizes are adapted to the respective inhalers or the dimensions of the capsule chambers contained therein, in which they are to be used. Typical lengths of the assembled capsules are for example 9 mm to 22 mm with outer diameters of 4 mm to 10 mm. Examples of the capsule dimensions can be found in the disclosure of WO2006 / 074982 A2 on page 6 lines 6 to 27. The contents of those lines are hereby incorporated in full.
  • Figure 1 a shows the two separate capsule elements (1) and (2) with the prefabricated holes (6) and (7) before nesting.
  • the telescope-like telescoping pushes the capsule cap (1) onto the capsule body
  • the capsule is filled with the preferably powdered pharmaceutical preparation, e.g. by filling the preparation in the capsule body.
  • the capsule cap (1) is pushed to a first insertion position on the capsule body (2).
  • the arrow marked “p" in the figures indicates the direction in which the capsule elements have been pushed together or pushed together, and is intended to symbolize the pressure that must be applied to this collapse.
  • the capsule body (2) in Figure 1 an outwardly directed circumferential bead (5), which engages in the first insertion position in a first annular bead (4) inside the capsule cap (1).
  • an annular groove in the outer shell region of the capsule body (1) wherein in the insertion position, an annular circumferential projection on the inner shell region of the capsule cap (1) engages in this groove.
  • the locking elements do not necessarily have to be ring-shaped, but can also be formed by rather punctiform elevations in the capsule body and matching recesses in the capsule cap or vice versa.
  • the capsule body on several punctiform, annularly arranged elevations, which engage in a corresponding, preferably annular circumferential groove outside the capsule cap.
  • the jacket areas of the capsule body (2) and capsule cap (1) preferably overlap so that the jacket of the capsule body (2) covers the hole (6) in the capsule cap (1) from the inside and the jacket of the capsule cap (1) covers the hole (7) in the capsule body (2) from the outside.
  • the capsule is completely closed in this first insertion position.
  • capsule cap (1) and capsule body (2) are pushed into one another so far that the respective holes (6) and (7) overlap one another.
  • the capsule In this second insertion position, the capsule is thus "opened” in the sense that powder can be dispensed from inside the capsule
  • the prefabricated hole (6) in the outer shell region of the capsule cap (1) is larger than the hole (7)
  • the size of the inner hole (7) in this preferred case determines the total size of the hole in the collapsed capsule, so that inside the capsule does not come to the inside of the hole to a stage at the application
  • For the second insertion position are on the capsule cap (1) similar catch elements as intended for the first insertion position.
  • the capsule cap (1) in the illustrated example of Figure 1 a second bead (3), in which the bead (5) or another projecting locking element on the inner shell portion of the capsule body (2) can engage.
  • the two holes (6) and (7) are held in their coverage and the capsule elements can not move relative to each other even when moving the capsule.
  • the locking elements required for the first and second insertion position can be realized, for example, by molding in the injection molding of capsule cap (1) and capsule body (2) or by material deformation of the components.
  • a bead (5) running inside the capsule body can be accompanied by an outside circumferential bead.
  • another embodiment of the capsule according to the invention has a micro- or nanostructure or surface coating on the inside of a capsule element.
  • a capsule element which forms the outer wall of the capsule in adjacent capsule shells - the capsule cap (1) in the example of FIG. 1.
  • the microstructure is preferably located on the inside of the jacket surface facing the other capsule element.
  • the microstructure extends over a in an annular region of the inner circumferential surface, wherein this annular region in the presence of the capsule in the first insertion position ( Figure 1 a) is a direct Wall of the cavity of the capsule forms and in the presence of the capsule in the second insertion position ( Figure 1 c) on the outer surface of the other capsule element (the capsule body (2) in the example of Figure 1) is applied.
  • microstructure causes a so-called lotus effect, i. that it reduces the adhesion of certain material to this surface.
  • the type of microstructure must be chosen to provide the lowest adhesive properties for the defined pharmaceutical preparation to be stored in the appropriate capsule type. In this way, no or only very little material from the pharmaceutical preparation, for example powder, adheres to the inner wall of the capsule. This has the effect, in particular in the described annular region, that when the capsule is pushed together from the first to the second insertion position, friction does not result due to material adhering to the wall. Expansion of the microstructure to all inner wall portions of the capsule is also possible and has the effect that no material will remain in the capsule by wall adhesion when the material is applied during a sputtering process.
  • the microstructure is formed by elevations and / or depressions in the surface.
  • the elevations and / or depressions may have the form of points, hemispheres, planar surfaces, wedges, etc. They may be random or ordered, e.g. in rows, circles, zig-zag, meandering etc.
  • the distance between the elevations of the surface structure is in the range of 0.1 to 200 microns, preferably 0.1 to 100 microns.
  • structural dimensions which are smaller than the particle sizes of the powder are preferred.
  • Most preferred are heights of pits in the range of 0.1 to 50 micrometers and pitches of 0.1 to 10 micrometers.
  • microstructures For the attachment of a microstructure to capsule inner walls, preference is given to those methods which do not bring any additional material into the capsules, ie such microstructures as can be shaped alone in the material forming the respective capsule element.
  • the microstructures are preferably already in the respective ones Mold inserts of the injection molding tools so to speak mirror images, so that the capsule elements get these microstructures as well as the prefabricated holes already in the first manufacturing step.
  • such microstructures may be created on the capsule interior walls also by subtractive surface treatment, such as etching or galvanic removal, or by subsequent embossing, such as by means of an expandable stamper inserted into the main opening of the capsule element.
  • FIG. 2 shows a second embodiment of a capsule composed of a capsule cap (1) and a capsule body (2).
  • This embodiment differs from the first only in that capsule cap (1) and capsule body (2) each have a plurality of prefabricated holes (6a) and (6b) or (7a) and (7b). In the first insertion position, not shown, all these holes are closed by the respective other capsule element analogous to the first embodiment. In the second insertion position (FIG.
  • the respective holes (6a) and (6b) of the capsule cap (1) overlap with the holes (7a) and (7b) of the capsule body (2), so that the capsule is opened at several points .
  • two holes (6a, 6b) and (7a, 7b) respectively in capsule cap (1) and capsule body (2) are shown, which result in two openings on the capsule in the second insertion position.
  • any number of holes can be provided.
  • the holes can be distributed over the circumference and length of the capsule depending on the design of the jacket areas of capsule cap (1) and capsule body (2).
  • the resulting open capsule has two holes, which are located on the shell region of the capsule each near the opposite ends of the capsule, so are significantly spaced from each other based on the length of the capsule.
  • FIG. 3 shows a third embodiment of a capsule which can be assembled from a capsule cap (1) and a capsule body (2).
  • This embodiment differs from the first only in that the holes (6) and (7) in capsule cap (1) and capsule body (2) have an elliptical shape instead of a circular one. The longitudinal axes of these ellipses are rotated relative to each other by 90 °. In this way, it is ensured in case of irregularities in pushing together that the coming into the overlap openings always occupy a constant total area. Instead of an elliptical hole shape also appropriately aligned slots can be used at this point.
  • Figures 4 and 5 show capsule body (2) and capsule cap (1) schematically in cross-section before and after nesting for different embodiments.
  • capsule cap (1) and capsule body (2) when nesting of capsule cap (1) and capsule body (2), the respective holes (6) and (7) can be brought to cover clean, the capsule elements must be inserted into each other aligned with respect to their circumference.
  • This requires a structure and counter-structure similar to a key-lock principle at the edges or respective lateral surfaces of capsule cap (1) and capsule body (2).
  • a longitudinal guide is advantageous, which has the effect that, after controlled first nesting of the capsule elements, no unwanted rotation of the capsule elements relative to each other can occur.
  • capsule cap (1) and capsule body (2) are equally designed with a slightly elliptical cross-section. The elliptical shape forces the oriented nesting of the two capsule elements.
  • the outer region of the capsule body (2) has, in addition to the latching elements (not shown), a web (8) extending parallel to the longitudinal axis, the contour of which is also longitudinally inside the capsule cap (1) mounted groove (9). fits.
  • the capsule elements can only be pushed together in the azimuthal orientation, in which the web (8) and the groove (9) engage in one another.
  • the web (8) and groove (9) form a guide over the entire insertion length.
  • a plurality of differently spaced and / or different wide web-and-groove pairs may be arranged on the lateral surfaces of the capsule elements.
  • the structure pair of web (8) and groove (9) shown may also have a curved path, by which a collapse of the capsule elements forces a rotation thereof relative to each other. This can be special in the targeted concealment and exposure of multiple holes in the capsule be beneficial.
  • Fig. 6 shows a schematic representation of another embodiment of a capsule according to the invention consisting of capsule cap (1), capsule body (2) and a ring (22).
  • Capsule cap (1) and capsule body (2) similarly to the embodiment of Figure 1, both also have a cup-like shape and can telescopically be inserted into one another via their openings, with aspects described herein also being valid with reference to Figure 1.
  • an embodiment has been chosen in the illustration of Fig. 6 differing from the other examples of representation, in which the capsule cap (1) in the capsule body (2) is inserted (embodiments with externally deferred cap are also possible).
  • the capsule body (2) with respect to the capsule cap (1) enlarged hole (7) thus forms the outer wall of the capsule in the region of the two superimposed shell portions of the capsule elements, the Kapselmantel Kunststoffe the two capsule elements have analogous to the previous examples interacting structuring ,
  • Fig. 6a shows the two separate capsule elements (1) and (2) with the prefabricated holes (6) and (7) before nesting and prior to assembly with the ring (22).
  • Fig. 6b shows the capsule body (2) after assembly with the ring (22).
  • the ring (22) covers the hole (7) of the capsule body (2).
  • This is preferably the situation in which the pharmaceutical preparation, preferably pulverulent, is filled into the capsule body (2) which is then closed with the capsule cap (1) as shown in FIG. 6c.
  • the capsule cap (1) can be pushed in this concept directly to reach the final insertion position in the capsule body (2).
  • Fig. 6c shows the composite capsule (1 1), in the analogous to the embodiment of Figure 1 capsule cap (1) and capsule body (2) by means of locking elements (3) and (5) are locked together.
  • the respective prefabricated holes (6) and (7) overlap in this composite capsule, but the resulting hole is covered in this state by the ring (22).
  • the capsule (1 1) can be stored or placed in a suitable inhaler.
  • the capsule elements can also be designed in this concept by sealing the prefabricated holes (7) via a further, for example ring-shaped component such that a hole (7) in the capsule body (7) does not necessarily form after assembly.
  • the capsule body (2) has a prefabricated hole (7), the capsule cap (1) to this hole (7) matching hole (6) and the jacket of the capsule cap (1) ends in the collapsed state the capsule above the hole (7) and leaves this free.
  • Fig. 7 shows a schematic representation of another embodiment of a capsule.
  • the capsule is shown as a whole with filling.
  • the capsule is substantially cylindrical with hemispherical upper and lower ends.
  • the closed capsule (71) has in its interior a metered dose of the powder (40).
  • holes 42a and 42b have been placed in the hemispherical top and bottom of the capsule.
  • at least one hole is needed in the bottom and at least one in the lid of the capsule. It is also possible to use more than one hole each in the bottom and lid.
  • the hole sizes preferably have diameters between 0.01 and 5 millimeters, preferably between 0.5 and 1.5 millimeters.
  • the holes are preferably circular, but may also be oval, square or other shape.
  • the holes can be molded in the injection molding process, drilled, stamped or otherwise formed with conventional drills or lasers before the capsule is filled with powder.
  • the holes (72) have been placed in the parallel walls or in the cylindrical shell area of the closed capsule (71).
  • the powder can be stored more easily in the capsule with prefabricated holes, since the capsule can be stored accurately in a cylindrical tube, which then encloses the capsule tightly in the shell region.
  • Figures 7b and 7c show only variants in which the holes (42a, 42b and 72, respectively) are formed either in the hemispherical or in the cylindrical regions of the capsule (71).
  • variants of a capsule (71) with a total of at least two holes (42a, 42b or 72) are possible in which the hole or holes (42a, 42b or 72) on one side of the capsule (71). in the hemispherical area and the hole or holes (42a, 42b or 72) on the other side of the capsule (71) are located in the cylindrical shell region.
  • the least two holes (42a, 42b and 72) may also be arranged offset by 180 ° or other angular units with respect to the circular circumference of the capsule (71).
  • FIG. 8 schematically shows the functioning of a device (70) or inhaler in which a capsule (71) (FIG. 8a) with two prefabricated holes (72a, 72b) is stored in the device in such a way that the holes (72, FIG. 72b) in the storage state (Fig. 8b) are closed, and the capsule (71) for the application of the device from the storage state is moved into a capsule chamber (74).
  • Fig. 8a shows the otherwise closed capsule (71) with prefabricated holes (72a, 72b).
  • the capsule (71) is substantially cylindrical with hemispherical ends. (71a, 71b).
  • the holes (72a, 72b) are located in the parallel walls of the capsule or in the shell region of the capsule respectively near the hemispherical ends.
  • capsules according to other embodiments may also be used in this context, in particular corresponding to the capsule shown in FIG. 7c.
  • Fig. 8b shows the capsule in its storage condition in a device (70).
  • the capsule (71) is held firmly in a tube (73). This prevents the escape of powder from the capsule (71) because the inner wall of the tube covers the holes (72a, 72b).
  • a capsule chamber (74) is formed within the device (70) .
  • the capsule chamber (74) connects directly to the tube (73) and has a slightly larger, preferably circular diameter than the tube (73).
  • the capsule chamber (74) is limited by a rod (75) or by another preferably aerodynamically shaped component in the air outlet region.
  • the device (70) is ready for use, ie it is in the application state.
  • the capsule (71) has been pushed through the inlet (76) into the capsule chamber (74).
  • a piston-shaped slide is inserted into the tube (73) on the side of the capsule (71) opposite the capsule chamber (74).
  • the sliding surface of the slide limited in the application state, the capsule chamber (74) on the opposite side of the air outlet.
  • the user inhales through a mouthpiece (78) in the direction of the arrow (92) in the figure.
  • Air succeeded in the device (70) along the direction of the arrow (91) in the figure through the inlet (76), or through an air guide in the slide, which preferably has the shape of a hollow piston.
  • the capsule (71) vibrates in the capsule chamber (74), the powder being expelled from the capsule (71) via the holes (72a, 72b).
  • the capsule already stored in the vibration chamber or capsule chamber (74) and the capsule (71) is coated with a preferably tubular film.
  • the film is close to the cylindrical shell portion of the capsule (71) and closes the holes (72).
  • the materials of the film and the capsule wall can be selected so that the preferably elastic and / or easily bendable film conforms to the capsule wall by electrostatic attraction.
  • the capsule (71) is preferably not firmly enclosed by the film and on the other side it protrudes clearly beyond the capsule (71) and / or is connected to a drawstring.
  • this film part projecting beyond the capsule end and / or the tension band lies in the air inlet in such a way that a part of the film and / or a tension band protrudes from the inhaler at this point.
  • the foil on this protruding part and / or drawstring is removed through the air inlet of the capsule that does not fit through the air inlet.
  • the capsule (71) in this example, the film or the film tube is only on one side of the web in the air duct.
  • the protruding part of the film or the tension band can also be located in the mouth tube of the inhaler and be pulled out of the system through the mouth tube.
  • the opening through which the film is pulled out of the system can also be closed in the transport state.
  • the mouth tube can be closed by a cap attached to the mouthpiece (78), which must first be removed before the film can be pulled out.
  • a cap can also be connected directly to the drawstring or the film.
  • FIG. 9 shows schematically the structure of another embodiment of an inhaler-capsule system, the operation of the system being similar to that of the system shown in Fig. 8.
  • the partial images 9a to 9f also schematically represent the sequence of assembly of the system.
  • a capsule body (2) with at least one prefabricated hole is inserted into a ring (22) which surrounds the capsule body (2) in FIG The area of his at least one prefabricated hole fits perfectly and thus seals the hole.
  • the ring (22) has on the inside one or preferably a plurality of small projections which, when the capsule body (2) and ring (22) are assembled, define a lower position of the capsule body (2) in the ring (22), so that the capsule body (2 ) can not move down within the ring and / or between the capsule body (2) and ring (22) a fit is formed, through which the capsule body (2) in the ring (22) is retained.
  • the ring (22) relevant features of this embodiment are analogous to the ring (22) from the embodiment of FIG. 6 transferable.
  • Fig. 9b shows how the capsule body (2) in the ring (22) from below into a tube (73) is inserted.
  • the tube (73) forms the capsule receptacle in this embodiment.
  • the ring (22) preferably engages from the inside with the tube (73) in a first detent position, e.g. in that a circumferential bead (22a) or an otherwise shaped latching element engages in a corresponding recess from the inside in the tube (73).
  • the tube (73) is opened at its upper end, so that the capsule body (2), the opening of which, when inserted into the tube (73) facing upward, from above through the upper opening of the tube (73) with powder (40) can be filled.
  • Fig. 9b shows how the capsule body (2) in the ring (22) from below into a tube (73) is inserted.
  • the tube (73) forms the capsule receptacle in this embodiment.
  • the ring (22) preferably engages from the inside with the tube (73) in a first detent position, e
  • 9c shows how - after the filling with powder (40), not shown - the capsule cap (1), which preferably also has at least one prefabricated hole is inserted from above into the tube (73) and so inside the tube (73) closes the capsule body (2), or the capsule (71) in the tube (73) is assembled.
  • the tube (73) encloses the capsule cap (1) preferably with an upper collar (73a), so that the at least one hole (72b) in the capsule cap (1) is covered or sealed by the tube (73).
  • FIGS. 9d and 9e show how the other components of the inhaler - mouthpiece (78) and slide (77) - with the assembly consisting of tube (73), powder-filled capsule (71) and ring (22) are assembled: Mouthpiece (78), which is preferably formed in one piece, contains the capsule chamber (74) and a rod (75) as a limit at the top inside the capsule chamber (74). The mouthpiece is placed on top of the re (73), wherein it locks with the tube (73).
  • latching elements on mouthpiece (78) and tube (73) are formed, for example in the form of a downwardly mounted inside the mouthpiece, annular circumferential bead (78b) in a likewise annular circumferential bead (73b) outside, on top of the Tube (73) engages.
  • annular circumferential bead (78b) is formed, for example in the form of a downwardly mounted inside the mouthpiece, annular circumferential bead (78b) in a likewise annular circumferential bead (73b) outside, on top of the Tube (73) engages.
  • a slide (77) is inserted into the tube (73).
  • the spool (77) includes an inlet (76) through which air may later flow into the capsule chamber (74) upon application of the inhaler.
  • the slide (77) is designed as a hollow piston and / or the inlet (76) is formed by a radially symmetrical passage along the main axis of the slide (77).
  • the slider (77) has at its upper end a taper (77a), which is dimensioned such that it can dip into the ring (22).
  • FIG. 9f shows a schematic longitudinal section of the system of capsule (71) and inhaler in the transport state, which has been put together completely:
  • the capsule (71) is pre-installed in the inhaler such that its prefabricated holes (72a, 72b) from the ring (22) and / or from the interior of the tube (73) (in the illustrated embodiment, with a total of two prefabricated holes (72a, 72b), a hole (72a) is sealed from the ring (22) and a hole (72b) from the inside of the tube).
  • the slide (77) protrudes with its lower end out of the inhaler.
  • the slide is pressed into the device at its end projecting down from the device.
  • the lower end of the slider (77) is widened so that it is pleasant to touch the palm of the user or patient when pressed by hand.
  • pushing in the slide (77) preferably abuts with a ring-shaped contact surface from below against the capsule (71) and pushes them - due to their retention in the ring (22) - initially together with the ring (22) in the direction of the capsule chamber (74 ) until the ring (22) locked in a second detent position.
  • the slide (77) dips into the ring (22) and pushes the capsule (71) out of its precisely fitting holder in the ring (22) with the taper (77a) the capsule chamber (74).
  • the taper (77a) is preferably designed so long that the tapered portion of the slide (77) through the ring (22) and through the collar (73a) of the tube (73) can be pushed through until the top of the slide ( 77) forms the lower boundary of the capsule chamber (74).
  • the upper edge of the slide (77) closes in the embedded pushed state (application state of the inhaler, see Fig. 9g) flush with the upper edge of the tube (73).
  • the gap is preferably sealed by the ring (22) against the ingress of secondary air.
  • the ring (22) consists of an at least partially elastic material and in this inserted state (see FIG. 9g) of the slide (77) seals the slide (77) against the tube (73) below the collar (73a).
  • the inhaler is then ready to operate as shown in Figure 9g: the holes (72a, 72b) are exposed and the capsule (71) in the capsule chamber (74) has the range of motion required for the vibratory motion according to the Bernoulli effect ,
  • at least one, preferably two spring arms (77b) are formed laterally on the slide (77), which in the inserted state engage in corresponding recesses (73s) on the inside of the tube (73). These spring arms (77b) prevent by their engagement inside the tube, a withdrawal of the slide (77) out of the device. The user is thus made clear that this is a device for a single application.
  • FIG. 10 schematically shows the structure of an embodiment according to the invention of a system comprising an inhaler and a powder-filled capsule 71, wherein in particular a capsule according to the embodiments shown in FIG. 7c or FIG. 8 can be used.
  • the partial images 10a to 10e at the same time schematically represent the sequence of an assembly of the system.
  • a capsule body (2) with at least one prefabricated hole from above is inserted into a tube (73), which in this embodiment is essentially only open on one side and forms the capsule receptacle.
  • the tube (73) encloses the capsule body (2) in the region of its at least one prefabricated hole with a precise fit and thus seals the hole in the capsule body (2).
  • the one-sided opening of the capsule body (2) points upwards, i. in the direction from which the capsule body (2) was inserted into the tube (73).
  • the capsule receptacle has, for example, two longitudinal slots (73d) whose function is based on the Spelling of Fig. 10f is explained in more detail.
  • the capsule (71) is preferably inserted oriented in the tube (73) such that the holes (72a, 72b) not in the area of the slots (73d).
  • the techniques described with reference to FIGS. 4 and 5 can be used.
  • capsule (71) and the interior of the capsule receptacle may be slightly elliptical in their short diameter.
  • the capsule (71) or the interior of the capsule receptacle may have corresponding pairs of longitudinal ribs and grooves: for example, a longitudinal groove or longitudinal groove on the outer wall of the capsule (71) in combination with a longitudinally formed web inside the capsule receptacle.
  • Fig. 10b shows the filling of the capsule body (2) within the tube (73) with powder (40), which is filled from above into the one-sided opening of the capsule body (2). Subsequently (Figure 10c) is taken from the same direction, i. in the representation from above, the capsule cap (1) inserted into the tube (73), so that the capsule (71) within the tube
  • FIG. 10d shows how the other components of the inhaler - mouthpiece (78) and rod (75) - with the assembly consisting of tube (73) and powder-filled capsule (71) are assembled: the tube (73) (now in Fig 10d compared to Fig. 10c shown upside down) inserted from above through an opening on the mouthpiece (78) preferably to a lower stop formed by the capsule chamber (74).
  • the side from which the tube (73) is inserted is also the mouth side of the mouthpiece, i. the side on which the patient attaches the lips to use the inhaler.
  • a rod (75) is inserted through a laterally located on the mouthpiece implementation.
  • the rod (75) later forms the upper limit of the mouthpiece (78) located in the capsule chamber
  • the tube (73) has been inserted into the mouthpiece oriented in such a way before insertion of the rod (75) that two slots (73d) provided on the tube bear against the inside of the mouthpiece (78) and thus have room for insertion of the Leave staffs (73).
  • the rod (75) may be inserted into the mouthpiece (78) such that it receives the mouthpiece (78) from an outer wall without interference from the tube (73), mouthpiece (78), preferably across the major axis of the device penetrates to the other.
  • the oriented insertion of the tube (73) into the mouthpiece (78) is preferably predetermined by the external shape of the two components. ben.
  • the illustrative example shows a mouthpiece (78) having a substantially oval or trapezoidal cross-section from the mouth side of the mouthpiece (78).
  • the tube (73) is preferably formed in its upper region, which is remote from the capsule receptacle, in the form of a cap which completely covers the mouthpiece at its mouth-side end.
  • This cap structure of the tube (73) forms the counterpart to the substantially oval or trapezoidal shape of the mouth side of the mouthpiece (78), so that an orientation when merging by the ovality or the preferred axis of a non-circular symmetry is predetermined.
  • the rod (75) forms the upper limit of the capsule chamber (74) inside the mouthpiece (78). Except the rod (75), all other components of the capsule chamber (74) are integrally formed by the mouthpiece (78).
  • the mouthpiece At the lower end of the capsule chamber (74), i. at its end opposite the rod (75) and the mouthpiece opening, the mouthpiece has an inlet (76), which in the illustrated embodiment is formed as a central passage along the main axis of the system.
  • the inhaler shown here preferably consists only of three parts - mouthpiece (78), tube (73) and rod (75), all of which can be inexpensively manufactured in plastic injection molding process, so that a built-in inhaler is very well for Einmai - Application is suitable, ie can be provided as a disposable item after a single use.
  • Fig. 10e shows the system of inhaler and capsule (71) in the assembled state, which here also corresponds to the transport state.
  • the prefabricated holes (72a, 72b) of the capsule (71) are closed by the inner wall of the tube (73).
  • the tube (73) has a corresponding change of the inside diameter: the capsule element with smaller diameter is further inside the tube (73) than the larger diameter capsule element, and the inner diameter of the tube (73) is corresponding to the outer shape of the capsule (71) so that it, too, gradually widens from the inside to the outside.
  • the capsule (71) is thus enclosed in the system without any significant freedom of movement.
  • the tube preferably has spring arms (73f) in its upper region, which in the transport state press against the inner wall of the mouth tube (78d) on the inside the mouth side of the mouthpiece (78) forms the air outlet from the capsule chamber (74).
  • tip tube (78d) and capsule chamber (74) have the same diameter.
  • the tube (73) is then withdrawn from the mouthpiece (78) as shown in Fig. 10f.
  • the slots (73d) in the tube (73) thereby allow the tube (73) to be pulled past the rod (75).
  • the rod (75) inserted into the mouthpiece (78) and extending transversely through the mouthpiece opening causes the capsule (71) to remain in the capsule chamber (74) in the mouthpiece (78) and not be withdrawn with the tube (73) can.
  • the spring arms (73f) previously pressed together in the mouth tube (78d) preferably spread outwards so that the tube (73) does not re-destruct (without aids) in the non-destructive manner Mouthpiece (78) can be used.
  • the tube (73) preferably has a grip aid (73e).
  • this grip aid may be formed by corrugation of the outer side surface in the cap region of the tube (73) or (not shown) by a tab.
  • This tab is preferably located centrally in the top of the cap area of the tube (73), ie on the side opposite the insertion opening for the capsule (71), and includes an opening sized to allow the user to hold a finger (preferably his Index finger) can hook into the opening to then pull the tube (73) out of the mouthpiece (78).
  • Fig. 1 shows a system of one inhaler and two capsules (71). The functions in this embodiment correspond to those of the embodiment of Fig. 10 with the difference that two capsules (71) are provided in individual capsule chambers (74).
  • the inhaler has two capsule chambers (74) with two inlets (76), two rods (75) and two tubes (73) with slots (73d).
  • the walls of the tubes (73) surround the capsules (71) such that the prefabricated holes (72) in the capsules are closed.
  • the two tubes (73) in the illustrated embodiment are preferably connected in a closing region (73k) so as to form part of a cap which closes the opening of the mouthpiece (78) in the transport state analogously to the embodiment of FIG.
  • a grip aid (73 e) is formed, which is shown in Fig. 1 1 in the embodiment as a flap with opening.
  • the inhaler thus has two mouth tubes (78d) which are separated from one another by a central wall (78e). Both mouth tubes (78d) run parallel and open next to each other in a mouthpiece (78) which is preferably designed to be oval on the outside.
  • the two tubes (73) are in the transport state of the device accurately inserted into the two mouth tubes (78 d), wherein a distance (73 g) is provided between the tubes to give space for the middle wall (78 e).
  • the two capsules (71) may be identical or different in terms of their filling and / or external shape.
  • Using a device with two identical capsules (71) has the advantage of being able to spend twice the formulation dose with a single disposable device, thus saving disposable material costs.
  • the use of a device in which two differently filled capsules (71) are stored is particularly suitable for use in therapies in which two active ingredients are administered simultaneously, which may not be stably stored in a common formulation. With such a device ensures that both active ingredients are taken in the correct ratio to each other. It is thus excluded, for example, that a user twice to the same drug instead of two different drugs in a single intake cycle.
  • the capsules (71) and their associated capsule chambers (74), mouth tubes (78d) and tubes (73) may be adapted for this purpose to drug or formulation dose, for example, be different in size or have different diameters and / or lengths.
  • FIGS. 1 -5, 7c or 8a show a schematic sectional view of the construction of a further embodiment according to the invention of a system consisting of an inhaler and a powder-filled capsule (71), wherein in particular a capsule according to the embodiments shown in FIGS. 1 -5, 7c or 8a can be used ,
  • Fig. 12a shows the system of inhaler and capsule (71) in the assembled state, which here also corresponds to the transport state.
  • the prefabricated holes (72a, 72b) of the capsule (71) (not shown) are closed by the inner wall of a cup-shaped capsule receptacle (173a).
  • the capsule receptacle (173a) is part of a tension element (173).
  • one capsule element e.g. the capsule cap (1) has a larger outer diameter than the accessible part of the other capsule element, e.g. of the capsule body (2)
  • the capsule receptacle (173a) preferably has a corresponding change in the inner diameter: the capsule element with a smaller diameter is optionally located on the capsule receptacle, as shown here in FIG.
  • the capsule element in the pulling direction of the tension element (173) the capsule element with a larger diameter.
  • the inner diameter of the capsule receptacle (173a) is correspondingly adapted to the outer shape of the capsule (71), so that it also becomes progressively wider in the same way as the capsule (71). In the transport state, the capsule (71) is thus enclosed in the system without any significant freedom of movement.
  • the tension member (173) is made of a partially flexible and / or moldable material, most preferably a blister sheet which has been patterned in a deep drawing process.
  • the tension member (173) (as shown in Fig. 12) consists of two halves which are preferably already interconnected by a hinge-like location such as a living hinge (173b) (ie, the two halves are preferably formed as one part manufactured the same steps).
  • the tension element (173) consists of a deep-drawn part and / or is preferably in a deep-drawing process produced under heat from a thermoforming sheet or blister film, ie from a film as commonly used in medical technology for blister packs, for example of tablets is used.
  • These blister foils preferably consist of several layers and preferably contain polyethylene and / or aluminum.
  • the two halves are preferably connected in a sealing process at the Switzerlandende of the tension element (173) and in an area between the film hinge (173b) and the capsule receptacle (173a). This results in a suitable rigidity of the tension element (173) and its grip aid (173e).
  • the blister sheets used are preferably coated with an adhesive layer or a sealing wax.
  • the halves are not connected to one another, so that a slot (173d) open to the capsule end of the tension element (173) remains.
  • This slot (173d) extends beyond the capsule receptacle (173a) in the direction of the center of the tension element (173), so that there remains a cavity into which a rod (75) of the inhaler can dip.
  • the tension element (173) in the region of the capsule receptacle (173a) is designed so that in this area the halves are arranged so to speak self-closing, ie, the halves clamp the capsule and hold well in position and are so to speak under a spring bias. Due to the spring elasticity associated therewith, the halves, upon pressure on the capsule 71, can bend away from one another along the longitudinal axis of the tension element 173 and release the capsule 71.
  • a pre-punched and filled capsule (71) in one half of the capsule receptacle (173a) are inserted, whereupon the tension element (173) is folded and the second half of the capsule receptacle (173a) also covers the capsule (71).
  • a slot (173d) remains on the tension element (173) (which, as described above, is closed by sealing, in particular in the area of the grip aid (173e)).
  • the capsule (71) should therefore be oriented in the capsule receptacle (173a) so that the holes (72) are actually fully covered by the capsule capsule receptacle (173a).
  • Prefabricated holes (72) are preferably located on the capsule (71) only on one longitudinal side of the capsule (71) (or distributed less than 180 degrees over the circumference of the capsule (71)).
  • the prefilled capsule (71) can be inserted into the first half of the capsule receptacle in an oriented manner. (173a) - namely with the orientation that the holes (72) in relation to gravity upwards and preferably in the second half of the capsule receptacle (173a inside show - are mounted without loss of powder through the holes.
  • a preceding in the process filling process can proceed as follows:
  • the capsule (71) is filled in a form-fitting capsule carrier in a filling plant, wherein the capsule carrier first receives the capsule body (2).
  • This capsule carrier holds the capsule body (2) during the filling process and closes the holes (72) in the capsule body (2) during filling.
  • the capsule carrier is rotated by 90 ° (the holes pointing upwards, ie in the opposite direction to gravity) and the capsule (71) is moved from the capsule carrier into the pulling element (FIG. 173) inserted or alternatively inserted into the still open tension element, which is then closed and then closed or sealed.
  • the closure of the holes (72) in the capsule (71) by the shells of the capsule receptacle (173a) is improved by a pressing step.
  • a method analogous to FIG. 10 can be used for filling and inserting a pre-perforated capsule (71)
  • the two halves of the tension element (173) are folded together and unfolded or unfolded in the area of the capsule receptacle (or the tension element is bent up in the region of the capsule receptacle (173a) and then folded), so that a capsule element can be inserted and filled therein. Subsequently, the second capsule is pushed onto the first and the capsule holders are bent back again.
  • the capsule (71) can be filled in a form-fitting capsule carrier in a bottling plant. This capsule carrier closes when filling the holes in the capsule body (2). After closing the capsule (71) through the capsule cap (2), then the capsule (71) can be pushed directly into the traction element (173) located vertically above it (so to speak from below with respect to the effective direction of gravity).
  • an alternative method involves the use of a capsule (1) with two different insertion positions, as described for example with reference to Figures 1 to 5.
  • a capsule element is filled and plugged together with the other capsule element so that the holes (6,7) of the two capsule elements not lie one above the other, the capsule (1) is thus completely closed (first insertion position).
  • the capsule (1) is inserted, for example, in one half of the capsule receptacle (173a), and covered during the folding of the tension element (173) by the second half of the capsule receptacle (173a).
  • the capsule receptacle (173) is pressed from one side, for example, on both sides from the outside, so that the two capsule elements slide further into one another on the inner capsule (1) and the holes (6, 7) overlap on the two capsule elements second insertion position is achieved).
  • the capsule receptacle (173a) is deformed so that it conforms to the now shorter capsule (1).
  • the body (100) of the inhaler (where the capsule chamber (74) is formed by the body (100)) consists of two halves, more preferably two deep-drawn parts which divide bodies (100) into two halves along a longitudinal axis (eg FIG 12a instead of a schematic longitudinal section can also be interpreted as showing a deep-drawn part forming the body (100) into which the tension element (173) with capsule (71) is inserted, the actually thin deep-drawn part being bent in the plane of representation into a palate which serves as the interface).
  • the two halves are made of films, in particular thermoforming films or blister films, as they are preferably used in the tension element (173) as described above.
  • tension member (173) and body (100) can be made of the same material.
  • the body (100) also includes the portion of the mouthpiece (78) upon which the lips of the user are placed; However, this lip region of the mouthpiece (78) can also be formed by an additional component that is connected to the body (100).
  • the tension element (173) with capsule (71) is inserted into a half of the body (100) formed, for example, by a deep-drawn part such that the capsule receptacle (173a) engages with the capsule (71) in the capsule chamber (74). is located and the rod (75) between the grip aid (173e) and capsule receptacle (173a) in the slot (173d) immersed on the tension element.
  • the second half of the body (100) so for example, the second deep-drawn part, (preferably mirror-image) placed on the first half and / or plugged.
  • the halves or the two deep-drawn parts are joined together, for example by welding, gluing, laminating or preferably by bonding in a sealing process.
  • a sealing process commonly used in the manufacture of blisters can be used.
  • one possible manufacturing process may include applying a sealant layer (sealing wax) to the halves of the body (100) immediately after the deep-drawing process. The sealing by means of pressure and heat then takes place later during the assembly of the parts.
  • the halves may for example be molded from a thermoforming sheet, which is formed in the region of the joint as Pfalz, so that on the otherwise thin-walled components a support surface for a seal or weld etc. persists.
  • the two halves can also be produced as thick-walled parts without Pfalz in a plastic injection molding process and later welded together preferably in an ultrasonic welding process.
  • the capsule receptacle (173a) is then withdrawn from the mouthpiece (78) as shown in Figure 12b.
  • the slots (173d) on the capsule receptacle (173a) and the tension element (173) as a whole allow the capsule receptacle (173a) to be pulled out past the rod (75) (analogous to the function of the slot (73d) in FIG. 10).
  • the rod (75) inserted into the mouthpiece (78) and extending transversely through the mouthpiece opening causes the capsule (71) to remain in the capsule chamber (74) in the mouthpiece (78) and not be withdrawn with the capsule holder (173a) can.
  • the rod is also preferably divided into two such that one half of the rod (75) is formed by one half of the body (100).
  • the rod (75) is an integral part of the body (100) and is preferably not a single part, so that no additional mounting of the rod (75) is necessary.
  • the two halves of the rod (75) are preferably also connected to one another.
  • the tension element (173) preferably has a grip aid (173e).
  • This grip aid (173e) can be formed, for example, as shown in FIG. 12b, by a flat flap, preferably with an opening or grip hole.
  • This tab is preferably located centrally at the top of the tension element (173) and protrudes out of the inhaler on the side of the mouthpiece (78) in the assembled state of the system (FIG. 12a), so that the user only activates the system to activate the system Pull the tension element (173) on the grip aid (173e) or lug out of the mouthpiece (78).

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Abstract

L'invention concerne un système composé d'un inhalateur et d'une capsule, prévu de préférence pour un usage unique. La capsule contient une préparation pharmaceutique de préférence sous forme de poudre, qui sort de la capsule dans l'inhalateur par au moins un orifice pour être inhalée. Le éléments composant la capsule comprennent un capuchon de capsule et un corps de capsule, dont l'un au moins comporte au moins un orifice préformé. L'orifice préformé de la capsule est fermé de manière étanche lorsque le système est dans un état de transport et est ouvert lorsque le système est dans un état de service. L'orifice est libéré par l'actionnement d'un mécanisme de traction. Avant cela, l'orifice est fermé par un logement de capsule ou par un film. Dans une forme de réalisation, la capsule peut présenter deux états différents, p. ex. dans différentes positions d'insertion des éléments de la capsule. Dans le premier état, l'orifice préformé est fermé, et dans le second état il est ouvert. L'invention concerne également un inhalateur approprié comme produit à usage unique, réalisé à partir d'éléments thermoformés ou d'une feuille à emballage coque.
PCT/EP2013/060272 2011-05-27 2013-05-17 Système composé d'un inhalateur et d'une capsule WO2013174752A2 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2015513120A JP6365848B2 (ja) 2012-05-21 2013-05-17 吸入器及びカプセルで構成されたシステム
US14/402,507 US10500355B2 (en) 2011-05-27 2013-05-17 System composed of inhaler and capsule
ES13724241.8T ES2683972T3 (es) 2011-05-27 2013-05-17 Sistema compuesto de inhalador y cápsula
PL13724241T PL2852423T3 (pl) 2012-05-21 2013-05-17 System z inhalatora i kapsułki
DK13724241.8T DK2852423T3 (en) 2012-05-21 2013-05-17 System of inhaler and capsule
EP13724241.8A EP2852423B1 (fr) 2012-05-21 2013-05-17 Inhalateur et capsule pour inhalateur

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/EP2012/059324 WO2012163704A2 (fr) 2011-05-27 2012-05-21 Inhalateur et capsule conçue pour un inhalateur
EPPCT/EP2012/059324 2012-05-21

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WO2013174752A2 true WO2013174752A2 (fr) 2013-11-28
WO2013174752A3 WO2013174752A3 (fr) 2014-03-20

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Cited By (2)

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CN109330023A (zh) * 2018-11-26 2019-02-15 楚天飞云制药装备（长沙）有限公司 一种过滤胶囊加工方法及设备
RU2748203C1 (ru) * 2021-01-12 2021-05-20 федеральное государственное бюджетное учреждение "Государственный научно-исследовательский испытательный институт военной медицины" Министерства обороны Российской Федерации (ФГБУ "ГНИИИ ВМ" МО РФ) Ингалятор

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US5896855A (en) 1992-12-24 1999-04-27 Rhone-Poulenc Rorer Limited Multi dose inhaler apparatus
WO2000007572A2 (fr) 1998-08-05 2000-02-17 Boehringer Ingelheim Pharma Kg Capsule en deux parties pour preparations pharmaceutiques destinees aux inhalateurs de medicaments en poudre
WO2004052435A1 (fr) 2002-12-12 2004-06-24 Boehringer Ingelheim Pharma Gmbh & Co.Kg Inhalateur de poudre pourvu d'une chambre destinee a recevoir une capsule jetable remplie d'un principe actif
WO2004062716A1 (fr) 2003-01-14 2004-07-29 Boehringer Ingelheim International Gmbh Inhalateur de poudre
WO2004082750A1 (fr) 2003-03-20 2004-09-30 Galephar M/F Systeme d'inhalateur de poudre seche ameliore
WO2006074982A2 (fr) 2005-01-11 2006-07-20 Boehringer Ingelheim Pharma Gmbh & Co. Kg Capsule en deux parties a fermeture prealable destinee a recevoir des preparations pharmaceutiques pour des inhalateurs a poudre

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FR2032436A2 (fr) * 1969-02-27 1970-11-27 Finanz Kompensations Anst
US4076848A (en) * 1976-03-18 1978-02-28 Limur Eleanor De Encapsulated pulverized dehydrated fruit and vegetable product
AU2001250901A1 (en) * 2000-03-27 2001-10-08 Dura Pharmaceuticals, Inc. Containers for individual doses of an inhalable pharmaceutical
US20040173211A1 (en) * 2003-01-14 2004-09-09 Boehringer Ingelheim International Gmbh Powder inhaler
DE102004040928B4 (de) * 2004-08-24 2012-10-31 Georg Menshen Gmbh & Co. Kg Verschluss für einen Behälter
EP1844805A1 (fr) * 2006-04-13 2007-10-17 Boehringer Ingelheim Pharma GmbH & Co.KG Inhalateur

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US5896855A (en) 1992-12-24 1999-04-27 Rhone-Poulenc Rorer Limited Multi dose inhaler apparatus
WO2000007572A2 (fr) 1998-08-05 2000-02-17 Boehringer Ingelheim Pharma Kg Capsule en deux parties pour preparations pharmaceutiques destinees aux inhalateurs de medicaments en poudre
WO2004052435A1 (fr) 2002-12-12 2004-06-24 Boehringer Ingelheim Pharma Gmbh & Co.Kg Inhalateur de poudre pourvu d'une chambre destinee a recevoir une capsule jetable remplie d'un principe actif
WO2004062716A1 (fr) 2003-01-14 2004-07-29 Boehringer Ingelheim International Gmbh Inhalateur de poudre
WO2004082750A1 (fr) 2003-03-20 2004-09-30 Galephar M/F Systeme d'inhalateur de poudre seche ameliore
WO2006074982A2 (fr) 2005-01-11 2006-07-20 Boehringer Ingelheim Pharma Gmbh & Co. Kg Capsule en deux parties a fermeture prealable destinee a recevoir des preparations pharmaceutiques pour des inhalateurs a poudre

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109330023A (zh) * 2018-11-26 2019-02-15 楚天飞云制药装备（长沙）有限公司 一种过滤胶囊加工方法及设备
RU2748203C1 (ru) * 2021-01-12 2021-05-20 федеральное государственное бюджетное учреждение "Государственный научно-исследовательский испытательный институт военной медицины" Министерства обороны Российской Федерации (ФГБУ "ГНИИИ ВМ" МО РФ) Ингалятор

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