Single-Dose Powder Inhalator and Method for the Production Thereof
20170312458 · 2017-11-02
Inventors
Cpc classification
A61M15/0028
HUMAN NECESSITIES
A61M2206/14
HUMAN NECESSITIES
International classification
Abstract
The present invention provides a single-dose powder inhalator and a method for the production thereof. It consists of an inhalator housing, which has a housing part (1), in which there is formed at least one medicament chamber (11) with a dose of a powdered medicament, and wherein the inhalator housing has an outlet opening (13′) and an outlet channel (13), which extends from the medicament chamber (11) to the outlet opening (13′). The outlet channel (13) is advantageously formed in the housing part (1). Also formed in the housing part (1) are an air inlet opening (12′), on a side of the medicament chamber (11) that is facing away from the outlet opening (13′), and an inlet channel (12), wherein the inlet channel (12) extends from the air inlet opening (12′) to the medicament chamber (11).
Claims
1. A single-dose powder inhaler composed of an inhaler housing which has a housing part (1) in which at least one medicament chamber (11) having a dose of a pulverulent medicament is formed, and wherein the inhaler housing has an outlet opening (13′) and an outlet duct (13) which extends from the medicament chamber (11) to the outlet opening (13′), wherein the inhaler housing is comprised of two parts and comprises a housing part (1) and a covering element (2) which, joined together with the housing part (1), forms the inhaler housing, wherein the outlet duct (13) is formed in the housing part (1), and wherein in the housing part (1) an air inlet opening (12′) on a side of the medicament chamber (11) remote from the outlet opening (13′), and an inlet duct (12) which extends from the air inlet opening (12′) to the medicament chamber (11), wherein the outlet duct (13), the medicament chamber (11), and the inlet duct (12) define an axis, are formed, wherein air-guiding, turbulence-inducing and/or deflecting structures (15, 16, 17) are formed in the air inlet duct (12), in the medicament chamber (11) and in the outlet duct (13), and the inlet duct (12) narrows from the air inlet opening (12′) to the medicament chamber (11) in two directions perpendicular to the axis defined by the outlet duct (13), the medicament chamber (11), and the inlet duct (12) and the outlet duct (13) widens from the medicament chamber (11) in the direction of the outlet opening (13′) in two directions perpendicular to the axis defined by the outlet duct (13), the medicament chamber (11), and the inlet duct (12).
2. The single-dose powder inhaler as claimed in claim 1, wherein the housing part (1) is an injection-molded plastics part or preferably is shaped, particularly preferably thermoformed, from a pharmaceutically compliant, preferably single-type plastic film, wherein a covering element (2) the covering element (2) is formed in an extensive and substantially planar manner and bounds the inlet duct (12), the medicament chamber (11) and the outlet duct (13), or is formed in a manner corresponding to the housing part (1), at least in the region of the inlet duct (12) and of the outlet duct (13), and consists of a plastic film, aluminum foil or composite film, and/or at least one inhaler housing component, namely the housing part (1) and/or covering element (2), is transparent.
3. The single-dose powder inhaler as claimed in claim 1, wherein the outlet opening (13′) is formed as a mouthpipe or is connected to a nose nozzle (14), and/or a cross section of the air inlet duct (12) at the medicament chamber (11) is smaller than a cross section of the outlet duct (13) at the medicament chamber (11).
4. The single-dose powder inhaler as claimed in claim 1, wherein at least one loose deagglomerator is arranged in the medicament chamber (11).
5. The single-dose powder inhaler as claimed in claim 1, wherein a film element (3) with a closure tab (30) closes the medicament chamber (11).
6. The single-dose powder inhaler as claimed in claim 5, wherein the film element (3) has at least one pull-off tab (32) which, starting from the closure tab (30), extends out of the air inlet opening or outlet opening (12′, 13′) from one side of the medicament chamber (11) through the opposite air inlet duct or outlet duct (12, 13), or the covering element (2) is formed, on the opposite side from the medicament chamber (11), into a resilient pressure element (22) having at least one piercing element (23) for perforating the closure tab (30) when pressure is exerted on the pressure element (22).
7. The single-dose powder inhaler as claimed in claim 1, wherein the medicament chamber (11) is closed by two plug elements (4), wherein each plug element (4) has a plug portion (40), which is arranged in a portion (120, 130), adjacent to the medicament chamber (11), of the air inlet duct (12) and of the outlet duct (13), and a pull-off tab (42), which extends out of the air inlet opening (12′) and the outlet opening (13′), respectively, or a blocking duct (18) is formed in the housing part (1) on both sides of the medicament chamber (11) at right angles to the air inlet duct (12) and the outlet duct (13), a correspondingly formed fold (21) of the covering element (2) being received in said blocking duct (18) so as to sealingly close the air inlet duct (12) and the outlet duct (13), wherein the powder inhaler (1) has a lifting element enabling the fold (21) to be lifted out of the blocking duct (18).
8. The single-dose powder inhaler as claimed in claim 7, wherein the lifting element is at least one predetermined and marked pressure, bending or pulling point (D, Z) on the inhaler housing, or is a pull tape (5) which extends through the air inlet duct (12) and/or the outlet duct (13) and transversely through the blocking duct (18) between the fold (21) and the housing part (1), and which a grip portion (52) at both ends or a grip portion (52) at one end and is anchored to an anchoring structure (17′) of the inhaler housing at the other end (50), or is formed by the plug elements (4), or is a structure arranged loosely in the medicament chamber, said structure preferably being the deagglomerator.
9. The single-dose powder inhaler as claimed in claim 1, wherein the plastic is biodegradable, and/or contains a marker.
10. The single-dose powder inhaler as claimed in claim 1, wherein the plastic is an antiseptic and/or antimicrobial plastic, or at least the air inlet duct (12), the medicament duct (11) and the outlet duct (13) are provided with an antiseptic and/or antimicrobial coating.
11. The single-dose powder inhaler (1) as claimed in claim 1, wherein the medicament chamber (11) is subdivided into at least two subchambers (11a) by at least one partition wall (11b), or two or more medicament chambers (11) are formed in the housing part (1), which are arranged in parallel alongside one another with an air inlet duct (12) and an outlet duct (13) or are arranged in series with one another, wherein the air inlet duct (12) leads to the first medicament chamber (11) and the outlet duct (13) extends from the last medicament chamber (11) and the medicament chambers (11) are connected to each other by a further duct.
12. The single-dose powder inhaler (1) as claimed in claim 11, wherein in the shaped covering element (2), at least one piercing element (23) for each subchamber (11a) formed in the housing part (1) is provided on the pressure element (22), or a resilient pressure element (22) having the at least one piercing element (23) is provided for each medicament chamber (11) formed in the housing part (1).
13. A method for producing a single-dose powder inhaler as claimed in claim 1, comprising the steps of producing the housing part (1) from plastic by injection-molding or preferably by thermoforming a plastic film, filling the medicament chamber (11) with a dose of a pulverulent medicament, closing the medicament chamber (11) with a film element (3), by two plug elements (4) and/or by a fold (21), received in a blocking duct (18), of the covering element (2), and cutting out the extensive and substantially planar covering element (2) or producing the shaped cover element (2) from plastic by injection-molding or preferably by thermoforming a plastic film, attaching the covering element (2) to the housing part (1), wherein the method is carried out in a single device.
Description
[0033] In the figures:
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[0051] The device according to the invention concerns a powder inhaler that is simple and cost-effective to produce and consists of two housing parts, a shaped housing part and a covering element, which, joined together, form the inhaler housing. The powder inhaler according to the invention can be embodied in the manner of a blister pack, wherein the housing part or the covering element or both are transparent and thus make(s) it possible to see into the powder inhaler, in particular into the medicament chamber. With the inhaler configured in an at least partially transparent manner, it is possible to check the content or the complete emptying of the content in use. In addition, the turbulence during use can be monitored.
[0052] The housing part is formed to provide the air inlet duct, the medicament chamber and the outlet duct and can advantageously be manufactured cost-effectively by a plastic thermoforming film or optionally also be produced in a plastic injection-molding process.
[0053] In order to bound the air inlet duct, the medicament chamber and the outlet duct, a pharmaceutically compliant film, which can be an aluminum foil, composite film or (transparent) plastic film, can simply be attached, for example by sealing, welding or adhesive bonding, as covering element to the housing part.
[0054]
[0055] Formed in the air inlet duct 12 are a plurality of air guiding structures 15 in order to swirl up the air flow drawn in during use before it reaches the medicament chamber 11. Formed in the base of the medicament chamber 11 are turbulence-inducing structures 16 which improve the deagglomeration of the swirled-up powder. A widening of the outlet duct 13 next to the medicament chamber 11 ensures a spacer effect, wherein not only is the flow rate that is increased beforehand by the funnel-shaped inlet slowed down, but also the entrained powder is distributed uniformly. This effect is supported by the guiding structures 17 which additionally give the housing part 1 increased stability in the outlet region.
[0056] Following the production of the housing part 1, which preferably takes place by thermoforming film, but can optionally also take place by injection-molding, the medicament chamber 11 is filled (not illustrated in the figures) with a dose of powder (and optionally also with a loose deagglomerator) and subsequently closed.
[0057] The medicament chamber 11 can be closed in different ways.
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[0059] In general, it is also conceivable for such a film element 3 to also be able to be arranged the other way round, such that the pull-off tab 32 projects out of the inlet opening 12′; however, since the cross section of the outlet duct 13 at the medicament chamber 11 is preferably larger than the cross section of the inlet duct 12, the outlet duct 13 lends itself to pulling off the closure tab 30. The closure tab 30 can be sealed, welded or adhesively bonded to a wall portion or an encircling shoulder of the medicament chamber 11, wherein the connection is embodied in a leaktight but also releasable manner, such that the closure tab 30 can be detached by traction on the pull-off tab 32, without tearing.
[0060] The example illustrated in
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[0063] A further alternative for the closure of the medicament chamber is shown in
[0064] To this end, in the example shown in
[0065] As an alternative thereto, it is possible, as indicated in
[0066] A further possibility for clearing the flow duct through the air inlet duct 12 and outlet duct 13 and opening the medicament chamber 11 consists in detaching plug elements (as described above) in order to lift the folds. Furthermore, a preferably spherical structure which is arranged loosely in the medicament chamber and is thus freely movable and which also acts as a deagglomerator in use, can be used, by lifting, to lift the folds in the blocking ducts.
[0067] In general, a powder inhaler according to the invention can differ from the exemplary embodiments shown, and thus the invention is not limited to the numbers and shapes, shown in the figures, of the air-turbulence-inducing, deflecting and guiding structures 15, 16, 17 and 17′; the structures of the inner wall of a single-dose powder inhaler according to the invention that are formed in the air inlet duct 12, in the medicament chamber 11 and the outlet 13 in order to improve the aerodynamics, resistance and/or deagglomeration can differ as intraluminal flow elements from the shapes illustrated and be formed for example as chicanes, blades, helices, spirals or meanders.
[0068] Furthermore, the flow profile through the medicament chamber can be aerodynamically adjusted to resistance, throughflow and powder by variations in the bore profile with regard to size, shape and edge design (sharp-edged, beveled or rounded) at the inlet and outlet of the medicament chamber. Thus, different factors influence the air flow in terms of speed and course through the powder inhaler and in particular the medicament chamber, these factors influencing the completeness of emptying and deagglomeration and dispersion in the air flow, for example the narrowing cross-sectional profile in the air inlet and the widening cross section in the outlet, wherein the flow duct is preferably narrower on the inlet side of the medicament chamber than on the outlet side.
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[0070] The pressure element 22 is formed by concentric circular wall structures which allow elastic deformation of the plastic film at this point, such that the inwardly integrally formed piercing element 23 can be moved in the direction of the medicament chamber 11 by exertion of pressure in order to pierce the closure tab 30 and returns to its starting position once the pressure has been released. The piercing element can consist of one or more needles or be formed by an angular structure such as a pyramidal spike. If, for the purpose of opening, pressure is exerted on both sides, i.e. pressure on the pressure element 22 and counterpressure on the medicament chamber 11, the closure tab 30, which can consist for example of aluminum foil, is effectively forced open, since the closure tab 30 is placed under tension by the counterpressure on the medicament chamber 11 and cannot yield to the piercing element 23.
[0071] The housing part and the covering part of a single-dose powder inhaler according to the invention can be welded together by heat, but adhesive bonding, clamping connections (wherein the periphery of one housing part is bent around the periphery of the other housing part), latching connections or stitched connections also come into question.
[0072] The powder inhaler according to the invention is provided for single use, and so the inhaler housing cannot be used again after the medicament chamber has been opened and the dose of powder has been inhaled, this also serving to protect against misuse. In addition to good recyclability or biodegradability, the increased volume of packaging waste, which is considered a drawback from the point of view of environmental protection, is also put into perspective, however, by the reduced use of multidose inhalers, the disposal of which is more complicated since residual quantities of the pulverulent medicament are usually contained therein.
[0073] The single-use powder inhaler according to the invention allows economical use for various indications—for instance when only a few uses are necessary, or only as required, for example in the case of migraine, pain, immunomodulators, biopharmaceuticals or the administration of CNS substances. The powder inhaler according to the invention is hygienic and undesired influences such as high air humidity or soiling on account of misuse are largely precluded.
[0074] On account of the cost-effective production, the powder inhaler according to the invention is also suitable for use in the Third World and in crisis areas.
[0075] In fact, the powder inhaler according to the invention is so reasonable to produce that patient-specific medication packs can be realized in an economically justifiable manner. The composition and dosing of the pulverulent medicament (or plurality of medicaments) can thus be filled into the powder inhaler according to the invention in a specific manner tailored to each patient.
[0076] In connection with
[0077] However, it is also conceivable according to the invention for two or more medicament chambers to be formed in the housing part which are arranged in parallel or in series in the flow duct between the air inlet and the outlet. Here, parallel means that in each case at least one air inlet duct leads (from a common air inlet opening or separate air inlet openings) to each of the medicament chambers and in each case at least one outlet duct leads out of each medicament chamber into the outlet formed as a mouthpiece or nose nozzle. When the medicament chambers are arranged in series, the air inlet duct extends as far as a first medicament chamber, from there a further duct extends to the next medicament chamber, and the outlet duct extends from, the last medicament chamber to the outlet opening. In each of the medicament chambers there can be a dose of powder, wherein these can be different active agents which only come into contact with each other on use. Thus, although such a powder inhaler in principle contains more than one dose of powder, this powder inhaler should nevertheless be understood according to the invention as being a “single-dose” powder inhaler since this plurality of doses of powder are inhaled in a combined manner in a single use, after which the powder inhaler can no longer be used.
[0078] The plastic which is used to produce a powder inhaler according to the invention, which is designed as a disposable item, can preferably be a biodegradable plastic.
[0079] Each powder inhaler according to the invention can be at least partially provided with an antiseptic or antibacterial and/or antimicrobial coating. Thus, particularly the air inlet duct, medicament chamber and air outlet duct can be coated in order that no germs are inhaled when the inhalation device is used. However, on account of the easier application, it is also possible for the entire inhalation device to be coated. An example of such a coating is Perlazid® from Rilit, Endingen. Alternatively, an antiseptic or antibacterial and/or antimicrobial plastic can be used to produce the inhalation device.
[0080] A powder inhaler according to the invention can also be marketed for example in outer packaging, which ensures that the powder inhaler is clean or sterile and thus ready for immediate use. Alternatively, it may also be conceivable for the covering element to have an overlap at its ends, by way of which the outlet (optionally also the air inlet) can be closed in the manner of a yogurt cup lid. The overlap can then be pulled off from the opening(s) for example by means of a formed tab. In order to prevent the film from then also being able to be pulled off the housing part, a predetermined breaking point, for example a perforation, can be provided at the connecting point of the overlap.
[0081] Furthermore, the plastic used to produce a powder inhaler according to the invention can have a marker for the identifiability thereof, in order for it to be possible to identify counterfeits, which do not contain the marker.
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[0083] In contrast to conventional powder inhalers, the dose of powder is thus not provided in a capsule or a blister which has to be inserted into an inhaler housing before the powder can be inhaled. A powder inhaler according to the invention is formed so to speak by the blister itself, which contains the powder to be inhaled. The insertion of a powder-containing capsule into an inhaler housing can thus be dispensed with.
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LIST OF REFERENCE SIGNS
[0085] 1 Housing part [0086] 10 Thermoforming film [0087] 11 Medicament chamber [0088] 11a, 11b Subchamber, partition wall [0089] 12, 120 Air inlet duct, portion adjacent to the medicament chamber [0090] 12′ Air inlet opening [0091] 13, 130 Outlet duct, portion adjacent to the medicament chamber [0092] 13′ Outlet opening [0093] 14 Nosepiece [0094] 15, 16, 17 Air-turbulence-inducing, deflecting, guiding structures [0095] 17′ Anchoring device [0096] 18 Blocking duct [0097] 2 Covering element [0098] 21 Fold [0099] 22 Pressure element [0100] 23 Piercing element [0101] 3 Film element [0102] 30 Closure tab [0103] 31 Tape portion [0104] 32 Pull-off tab [0105] 4 Plug element [0106] 40 Plug portion [0107] 41 Tape portion [0108] 42 Pull-off tab [0109] 5 Pull tape [0110] 50 End portion [0111] 51 Tape portion [0112] 52 Pull tab [0113] 100 Manufacturing device [0114] Z Traction force [0115] D Pressure [0116] KD Points