HK1243018B - Single-dose powder inhalator and method for the production thereof - Google Patents

Description

Single-dose powder inhaler and method for producing the same

Technical Field

The present invention relates to a single-dose powder inhaler and to a method for producing the single-dose powder inhaler.

Background Art

Commercially available powder inhalers ("inhalers") are often designed for multiple use and are therefore complex and expensive to produce. They are generally unsuitable for use as disposables. However, multiple use sometimes creates significant hygiene problems because patients incorrectly, rarely, or not at all, clean the inhaler after use. A further problem is the potential loss of the cap. From a hygiene perspective, it is also disadvantageous if the patient uses the inhaler incorrectly, for example by exhaling into the inhaler: with known inhalers, the patient does not always exhale in the intended direction of exhalation, but rather exhales through the inhaler, causing the inhaler to become clogged due to respiratory humidity during multiple uses, as the powdered medicament clumps and becomes lodged in the airways of the inhaler. These deposits and agglomerates, which may also be contaminated by pathological bacteria, can cause inaccurate dosing and further disadvantages, for example, even for nasal use: nasal bacteria should be taken into account, for example, when sinusitis proves resistant to treatment. Affected individuals may repeatedly reinfect themselves (nose, oropharynx) via the inhaler.

WO2007/042822 has described a kind of single dose powder inhaler, and this inhaler has the first housing part and the second housing part that are made of metal, that link together and form the inhaler housing with outlet.The first housing part comprises medicament chamber, and this medicament chamber is held single dose powdered medicament and by being fastened to the foil sealing on the first housing part.This foil stretches out the inhaler housing, thereby makes it can be grasped and open for the user to use, and as a result, discharges powdered medicament from the medicament chamber.The second housing part has collection well and/or dispersion chamber, and the airway that is formed in the inhaler housing leads to outlet by this dispersion chamber.After medicament chamber has been opened, produce air-flow, when inhaling in the gap that still remains after foil is opened between the housing parts at outlet, described air-flow carries and discharges the powdered medicament of collection well or dispersion chamber from medicament chamber.

Starting from this prior art, the object of the present invention is a single-dose powder inhaler which is easy and cost-effective to produce, easy to use and improved with regard to the deagglomeration of the contained powder and the thoroughness of the powder emptying.

Summary of the Invention

This object is achieved by a single-dose powder inhaler having the following features. The single-dose powder inhaler consists of an inhaler housing having a housing portion and at least one medicament chamber containing a dose of powdered medicament, wherein the inhaler housing has an air outlet opening and an air outlet duct extending from the medicament chamber to the air outlet opening, and the air outlet duct is formed in the housing portion, wherein an air-guiding structure, a turbulence-inducing structure and/or a deflecting structure are formed in the air outlet duct, and wherein an air inlet opening on a side of the medicament chamber remote from the air outlet opening and an air inlet duct extending from the air inlet opening to the medicament chamber are formed in the housing portion, wherein the air outlet duct, the medicament chamber and the air inlet duct define an axis, and wherein The inhaler housing may consist of only two parts, namely a housing part and a covering element, which are connected to the housing part to form the inhaler housing, wherein at least one medicament chamber is formed in the housing part, and wherein air-guiding structures, turbulence-inducing structures and/or steering structures are formed in the air inlet duct and in the medicament chamber, and the air inlet duct narrows from the air inlet opening to the medicament chamber in two directions perpendicular to the axis defined by the air outlet duct, the medicament chamber and the air inlet duct, while the air outlet duct widens from the medicament chamber along the direction of the air outlet opening in two directions perpendicular to the axis defined by the air outlet duct, the medicament chamber and the air inlet duct.

The object of producing such an inhaler is achieved by a method having the following features. The method for producing a single-dose powder inhaler as described above comprises the following steps: producing a housing part from plastic by injection molding; filling a medicament chamber with a dose of powdered medicament; closing the medicament chamber using a membrane element via two plug elements and/or via folds of a cover element received in a choke channel; cutting out a broad and substantially planar cover element or producing the cover element from plastic by injection molding; attaching the cover element to the housing part, wherein the method is implemented in a single device.

The development of the device is specified in the following characteristics.

Single dose powder inhaler according to the present invention is made of inhaler housing, and this inhaler housing has housing part, and in this housing part, forms at least one medicament chamber that holds a complete dose or a portion of dosage powdered medicament.Therefore single dose powder inhaler according to the present invention can be said to be the inhaler that can use without the blister mode, that is to say, does not use the blister that separates that is filled with medicament.This inhaler housing has air outlet opening and the air outlet duct that extends to this air outlet opening from this medicament chamber.According to the present invention, not only this air outlet duct also is formed in this housing part, and also forms air inlet opening and air inlet duct at a side away from this air outlet opening of this medicament chamber, and this air inlet duct extends to this medicament chamber from this air inlet opening.Therefore, all relevant parts can be formed in single housing part for powder inhaler, and this housing part only covers with covering element after this medicament chamber is filled with a dose of powder then. In order to support and improve the deagglomeration, uniform dispersion and thorough emptying of powder when using this single dose powder inhaler, in the air inlet duct in this housing part, in the medicament chamber and in the air outlet duct, form air guide structure, turbulence and cause structure and/or turn structure, so that influence enters, passes through the medicament chamber and the air-flow that comes out therefrom.In order to control flow velocity, also provide air inlet duct and narrow from air inlet opening to medicament chamber, and air outlet duct widens along the air outlet opening direction from medicament chamber.As a result, advantageously provide powder inhaler in a housing part and play all structures required for optimal function, thereby make in order to finish powder inhaler, all necessary just also have single further parts, i.e. covering element.In other words, powder inhaler according to the present invention advantageously only consists of two housing parts, can produce these housing parts in addition and it is linked together in a simple manner.Therefore, powder inhaler can make in very cost-effective mode and therefore is suitable for giving a dose of powder (or the combination of several doses of powders) when having the single use of associated hygiene advantage for user. Thus, the powder inhaler according to the invention not only provides the structure required for optimal administration of a powdered medicament by inhalation, but also represents a blister pack of the powdered medicament.

Preferably, this housing portion can be made of plastics cost-effectively and with injection molding process or preferably by shaping, particularly advantageously meet pharmaceutical, preferably single type plastic film by thermoforming and manufacture.Thereby in order to cover housing portion so that constraint air inlet, medicament chamber and air outlet and finish housing portion and form inhaler housing, provide can with broad and substantially planar and unshaped mode easily and cost-effectively forming covering element. " substantially planar and unshaped " is intended to mean that covering element can be completely flat in the simplest and preferred variant at this; Yet, covering element can also be provided to have for example longitudinal curvature along air inlet, medicament chamber and air outlet, so that both stabilization and optimization flow. Alternatively, however, covering element can also be formed in the mode corresponding with housing portion at least in the zone of air inlet and air outlet. Similar to the latter, therefore covering element equally can be made of plastics and with injection molding process or preferably by shaping, particularly advantageously meet pharmaceutical, preferably single type plastic film by thermoforming and manufacture.Therefore the structure of powder inhaler according to the present invention corresponds to the structure of blister pack. In this case, at least one of the two inhaler housings, i.e. the housing part and the covering element can be implemented in a transparent manner, so that the powder existing in the medicament chamber and the giving thereof can be by visual inspection. Preferably, therefore, at least this housing part can be formed into aluminum foil or plastic film by transparent plastic film, so that only air inlet opening and air outlet opening remain open. If covered with plastic film, then this can preferably be made of the plastics identical with the first housing part, so that the powder inhaler can be easily recycled after use. Of course, composite film also can be used as covering element; Yet, this is rather than preferred because its recyclability is poor. Whether it is intended to be a shaped covering element or a substantially planar covering element depends on the material selection for covering element. If covering element is shaped, then preferred material is the thermoforming plastic film corresponding with the housing part, so that the dimensional stability of the shaped covering element.

In addition, the cover element can be advantageously printed to provide the user with information about the contents and uses of the inhaler. This information can be provided in text or preferably with graphics and optionally color support so that it is understandable internationally. If appropriate, the information can also be provided in the film in Braille.

It can also be provided that the housing portion is produced by light-proof plastics or colored plastics. In this way, the different plastics of colors can also provide information about the type and/or amount of the powdered medicament held.

The air outlet opening can be formed as a mouthpiece or connected to a nasal nozzle. In addition to the air inlet duct narrowing from the air inlet opening to the medicine chamber and the air outlet duct widening from the medicine chamber in the direction of the air outlet opening (if a nasal nozzle is present, the air outlet duct can optionally narrow again), the cross-section of the air inlet duct at the medicine chamber can also preferably be kept smaller than the cross-section of the air outlet duct at the medicine chamber in order to control the flow rate.

To support powder deagglomeration during use of the single-dose powder inhaler, at least one loosening disaggregator may be arranged therein. This disaggregator, due to the turbulent airflow generated by the shape of the air inlet duct in the medicament chamber, causes the powder to swirl upward and breaks up powder agglomerates. Preferably, the disaggregator is of sufficiently large size to remain in the medicament chamber and not be able to enter the air inlet duct or the air outlet duct. Optionally, the disaggregator may be embodied with a plurality of holes, i.e., in a breathable manner, so that the airflow is not obstructed, even when the disaggregator is placed in front of the air outlet opening of the medicament chamber.

According to the present invention, provide and the medicament chamber of single-dose powder inhaler is closed after being filled with the powder dose (and optionally also being filled with the deagglomerator), thereby makes it possible to store the filled single-dose powder inhaler until its use.This closure is expected to be opened when the powder inhaler is intended to be used for inhaling the powder contained.For the purpose of closure, different variants are provided according to the present invention.

A variant which is preferred due to ease of handling for the user comprises a film element (peel-off film), for example made of aluminum or plastic, with a closure tab which closes the medicament chamber.

Such membrane elements can have a pull-apart tab connected to the closure tab via a band portion, and the pull-apart tab extends an air inlet opening or an air outlet opening from one side of the medicament chamber, through an opposite air inlet or air outlet. In other words, the band portion extends an air inlet opening from the air outlet side of the medicament chamber, through the air inlet, or preferably extends an air outlet opening from the air inlet side of the medicament chamber, through the air outlet, because the duct cross section is larger on the air outlet side at the medicament chamber. If a traction force is applied to the pull-apart tab, the closure element is pulled apart from the medicament chamber, thereby releasing the powder medicament and allowing it to be removed from the inhaler housing.

As an alternative to pulling the tab apart, in order to open the closing tab of the closed medicament chamber, it can be provided that the covering element is formed with an elastic pressure element on the side opposite the medicament chamber, which pressure element has one or more piercing elements on its inner side (as the side facing the medicament chamber) so that it can preferably perforate the closing tab by exerting pressure on the pressure element.

As an alternative to a membrane element, the medicament chamber can be closed by two plug elements, wherein each plug element has a plug part arranged in the part of the air inlet and air outlet duct adjacent to the medicament chamber. In addition, the plug element has a pull-off tab that projects from the air inlet opening and the air outlet opening. In order to prepare the powder inhaler for inhalation, the plug part is removed from the air inlet and air outlet duct by pulling on the pull-off tab.

In a further, but technically more complex, alternative solution for closing the medicament chamber, laterally constrained chokes are formed in the housing part transversely to or at right angles to the inlet and outlet ducts on both sides of the medicament chamber. These chokes thus impart increased stability to the cover element, and correspondingly formed folds of the cover element are received in these chokes in such a way as to seal the inlet and outlet ducts. In order to allow these folds to be lifted out of the chokes, freeing the inlet and outlet ducts and thus opening the medicament chamber, the powder inhaler has a lifting element, for which various embodiments are again provided according to the invention.

The lifting element of the powder inhaler according to the invention can be at least one predetermined and marked pressure point, bending point or pulling point on the inhaler housing, i.e. on the cover element, so that the fold is lifted out of the choke by applying pressure or traction or bending at a specific point of the inhaler housing.

As its alternative, a drawstring can be provided as a lifting element, said drawstring extending through the air inlet and the air outlet and laterally through the pleat of the covering element and the air blocking path between the housing portion. This drawstring can have a gripping portion at both ends, so that the two ends of the drawstring are pulled simultaneously to raise these pleats. As a preferred alternative owing to easy handling, the drawstring can only have a gripping portion at one end, and the other end is anchored on the anchoring structure of the inhaler housing. This anchoring structure can be configured as an air turning structure or a guiding structure in the air inlet or the air outlet simultaneously.

Furthermore, it is also possible to use the above-mentioned plug elements as lifting elements in that they lift the folds when they are pulled out of the tubing section adjacent to the medicament chamber.

Finally, it is also conceivable to use structures loosely arranged in the medicament chamber for raising the folds, which structures can preferably be deagglomerators. Although the powder inhaler according to the invention is designed for single use, in a preferred cost-effective embodiment using a single type of thermoformed plastic film for the housing part and aluminum foil or plastic film for the covering, these components are very suitable for recycling. Furthermore, it can also be provided that the plastic used for production is preferably biodegradable if it is not available for recycling.

In order to meet higher hygienic requirements, employed plastics are antiseptic and/or antimicrobial plastics. As its alternative, at least the air inlet, medicament chamber and air outlet and also mouthpiece or nose piece can be equipped with antiseptic and/or antimicrobial coating.

To protect against counterfeiting, the plastic may also contain a logo that can be verified on the finished powder inhaler.

Finally, for example, when the simultaneous administration of two or more active ingredients is intended, the chamber can be subdivided into at least two subchambers by at least one partition wall, or two or more chambers can be formed in the housing part, these chambers being arranged in each case side by side, in parallel with an inlet and an outlet, or in series with one another, with the inlet leading to the first chamber and the outlet extending from the last chamber, and the chambers being connected together via further ducts. However, in terms of flow, it may be more advantageous to divide the larger single doses between several chambers in order to achieve a more complete disaggregation and emptying, as well as a more uniform dispersion and thus inhalation of the contained powder.

The single-dose powder inhaler according to the invention can therefore contain a complete dose of powdered medicament in a single medicament chamber or in each case partial doses in two or more subchambers or parallel or series medicament chambers, which are inhaled simultaneously during use.

If a subchamber is sealed by a membrane element, or several chambers are sealed by several membrane elements, the shaped covering element can be equipped with a corresponding piercing element to open these membrane elements. In other words, if the medicament chamber is subdivided into a plurality of subchambers by one or more partition walls, at least one piercing element is provided on the pressure element for each subchamber, so that when pressure is applied to the pressure element, the membrane element of each subchamber is perforated and the powdered substance present therein can be released. If a housing part is provided with several powder chambers, a corresponding number of pressure elements with at least one corresponding piercing element are provided on the shaped covering element.

Advantageously, a method for producing a single-dose powder inhaler according to the present invention can be implemented in a single device. This is therefore a blister machine for film forming, filling and sealing. The method first provides a housing portion that is injection molded or preferably thermoformed from plastic, after which the medicament chamber is filled with a dose of powdered medicament. Simultaneously with the manufacture and/or filling of the housing portion, depending on the embodiment, the covering element is manufactured from film or, preferably, from plastic by injection molding or thermoforming simply by a separation method (such as cutting or stamping of a wide and substantially planar covering element). After the medicament chamber has been sealed with a membrane element, wherein the closure tab is sealed or adhesively bonded to the medicament chamber, the covering element is preferably also attached to the housing portion by sealing, adhesive bonding or by welding (e.g., ultrasonic welding). When the medicament chamber is sealed with a membrane element, the membrane element is provided so that the medicament chamber is opened by pulling the closure tab apart, and before the covering element is attached, the band portion leading to the pull-apart tab is folded or turned downwardly so that the pull-apart tab extends out of one of the openings in the housing portion. As an alternative to a membrane element, the medicament chamber can optionally also be closed by two plug elements and/or by folds of the covering element which are received in the air barrier.

This simple method allows to produce powder inhaler very cost-effectively and further quickly and easily adapt to different variants, thereby making patient-specific embodiment and filling also may be economical.In addition, this powder inhaler that cost-effective production is combined with the optimal release of powder is therefore also suitable for sale or distribution in third world countries.

BRIEF DESCRIPTION OF THE DRAWINGS

Further embodiments and some advantages associated with these and further embodiments will become clearer and better understood from the following detailed description with reference to the accompanying drawings. Substantially identical or similar objects or parts thereof may be provided with the same reference symbols. These figures are merely schematic illustrations of one embodiment of the invention.

In the figure:

FIG1 shows a perspective view of a housing portion of a single-dose powder inhaler according to the invention,

FIG2 shows a plan view of the housing portion of FIG1 ,

FIG3 shows a longitudinal sectional view of the housing portion of FIG1 ,

FIG. 4 shows a perspective view of the housing part of FIG. 1 , wherein the medicament chamber has been closed using a membrane element.

5 shows a perspective view of a powder inhaler according to the invention with the housing part of FIG. 4 , which has been closed using a flat (aluminum) foil as a covering element,

FIG6 shows a longitudinal sectional view of the powder inhaler according to the invention of FIG5 ,

FIG7 shows a perspective view of a powder inhaler formed with an outlet according to the present invention, the powder inhaler being intended for nasal use,

FIG8 shows a perspective view of a housing part in which two plug elements have been provided to close the medicament chamber,

FIG. 9 shows a perspective view of a powder inhaler according to the invention having the housing part of FIG. 8 , which has been closed using a flat (aluminum) foil as a covering element,

FIG10 shows a perspective view of a housing portion in which two air blocking channels are provided to close the medicament chamber and a pull strap is provided to open the medicament chamber,

FIG. 11 shows a perspective view of a powder inhaler according to the invention having the housing part of FIG. 10 , which has been closed using a flat (aluminum) foil as a covering element, the folds of which are received in the choke,

FIG12 shows a schematic cross-sectional side view of a powder inhaler according to the invention, wherein the medicament chamber is closed by folds in the air blocking channel on the covering element, these folds being raised by traction on the covering element,

FIG13 shows a schematic cross-sectional side view of a powder inhaler according to the invention, wherein the medicament chamber is closed by folds in the air blocking channel on the covering element, these folds being raised by pressure on the covering element and the bending element,

FIG. 14 shows a longitudinal section through a powder inhaler according to the invention having a shaped cover element with a pressure element with a piercing element for opening a closure tab,

FIG. 15 shows a longitudinal section through a further powder inhaler according to the invention, which has a shaped cover element, wherein the pressure element has two piercing elements for opening the closure tabs on the two subchambers,

FIG16 shows a perspective view of a thermoformed film with four formed housing parts, to which a covering element is attached before cutting out the powder inhaler,

FIG. 17 shows a schematic diagram of a manufacturing apparatus for producing a powder inhaler according to the present invention.

DETAILED DESCRIPTION

Device according to the present invention relates to a kind of powder inhaler, and this powder inhaler production is simple and cost-effective and is made of two housing parts (a shaped housing part and a covering element) that link together to form inhaler housing.Powder inhaler according to the present invention can be implemented in the mode of blister pack, and wherein, housing part or covering element or both are transparent and therefore make to see powder inhaler inside, particularly see medicament chamber inside.Under the situation that inhaler is configured in at least partially transparent mode, can check the thorough emptying of content and content when using.In addition, can monitor the turbulent flow in use.

The housing portion is formed to provide an air inlet, a medicament chamber and an air outlet and can advantageously be manufactured cost-effectively by thermoforming a plastic film and optionally also produced in an injection moulding process.

To bound the air inlet, medicament chamber and air outlet, a pharmaceutically acceptable film, which may be an aluminum foil, a composite film or a (transparent) plastic film, may be attached as a covering element to the housing part, eg by sealing, welding or adhesive bonding.

Figures 1 to 3 show an example of a housing part 1 for producing a powder inhaler according to the present invention. The housing part 1 formed by a thermoforming film has a semi-funnel-shaped air inlet 12, which extends from an air inlet opening 12' to a medicament chamber 11 formed in a cup-shaped form. On the side away from the air inlet, an air outlet 13 extends from the medicament chamber 11 to an air outlet opening 13', which in this case has a semi-elliptical cross section so that it can be easily received in the mouth.

Several air-guiding structures 15 are formed in the air inlet duct 12 to swirl the inhaled airflow before it reaches the medicament chamber 11 during use. Turbulence-inducing structures 16 are formed in the bottom of the medicament chamber 11, which improve the deagglomeration of the swirling powder. The widening of the air outlet duct 13 adjacent to the medicament chamber 11 ensures a spacing effect, not only slowing down the previously increased flow rate due to the funnel-shaped inlet but also ensuring a more uniform distribution of the entrained powder. This effect is supported by guide structures 17, which also increase the stability of the housing part 1 in the outlet region.

After production of the housing part 1 , which is preferably done by thermoforming a film, but can optionally also be done by injection molding, the medicament chamber 11 is filled with a dose of powder (and optionally also with loose disaggregates) and subsequently closed.

The medicament chamber 11 can be closed in different ways.

Figures 4 to 6 show an embodiment in which a membrane element 3 is used to seal the medicament chamber 11. The membrane element 3 has a closure tab 30, which is dimensioned to seal the medicament chamber 11. A strap portion 31 extends from this closure tab 30 to a pull-out tab 32, which is ribbed for a secure grip. In this embodiment, the strap portion 31 is folded over the closure tab 30 so that the pull-out tab 32 protrudes from the housing part 1 on the side facing away from the folded end. In the illustrated example, the strap portion 31 is turned at the air inlet side of the closure tab 30 and protrudes from the air outlet opening 13' with the pull-out tab 32.

Generally, it is also conceivable that such a membrane element 3 can also be arranged in the opposite manner, so that the pull-off tab 32 protrudes from the air inlet 12 ′; however, since the cross section of the air outlet 13 at the medicament chamber 11 is preferably larger than the cross section of the air inlet 12, the air outlet 13 is suitable for pulling off the closing tab 30. The closing tab 30 can be sealed, welded or adhesively bonded to the wall or circumferential shoulder of the medicament chamber 11, wherein the connection is implemented in a gas-tight but also releasable manner, so that the closing tab 30 can be separated by pulling on the pull-off tab 32 without tearing.

The examples illustrated in Figures 1 to 6 represent a preferred variant of the powder inhaler according to the invention, which, due to the blister-type construction, can be produced very simply and cost-effectively in a single machine and can moreover be operated easily and intuitively by the user.

FIG7 shows by way of example that a powder inhaler according to the invention can be formed with more than just an outlet shaped to be received in the mouth. (Optional) air outlet opening 13 ' (shown in dotted lines) can be adjoined by an air outlet member 14 formed for use with the nose, which can extend as a whole away from the housing portion or can be placed over the air outlet opening 13 '.

Fig. 8 and Fig. 9 show the variant of powder inhaler according to the present invention, wherein before covering element 2 covers air inlet 12, medicament chamber 11 and air outlet 13, medicament chamber 11 is closed by two plug elements 4.Plug elements 4 have plug portion 40 separately, and band portion 41 extends to pull tab 42 from this plug portion.The plug portion 40 of each plug element 4 is arranged in the part 120,130 of the adjoining medicament chamber 11 of air inlet 12 and air outlet 13, and size is determined and is shaped to make it close this part 120,130.The material of plug portion 40 is selected to allow airtightness to be sealed, although this can be overcome by the traction force on the pull tab 42.Alternatively, can between plug portion 40 and pipeline part 120,130, introduce adhesive or sealing device, described adhesive or sealing device allow to remove plug portion 40 non-destructively when traction force occurs on the pull tab 42.

Figures 10 to 13 illustrate further alternative closures for the medicament chamber. Figures 10 and 11 reveal a housing part 1 in which chokes 18 extending transversely to the portions 120, 130 of the inlet 12 and outlet 13 adjacent to the medicament chamber 11 are formed. The substantially planar covering element 2 has integrally formed folds 21 at points corresponding to these chokes 18. These folds fill the chokes 18 and thus block the portions 120, 130 of the inlet 12 and outlet 13, thereby closing the medicament chamber 11. In order to open the medicament chamber 11 closed in this manner and clear the inlet 12 and outlet 13, the folds 21 are raised from the chokes 18. For this purpose, various variants according to the invention are provided.

To this end, in the example shown in Figures 10 and 11, a drawstring 5 is provided, whose tape portion 51 extends from the air outlet duct 13, transversely through the air blocking duct 18 and the medicament chamber 11, and into the air inlet duct 12. The end portion 50 of the drawstring 5 is fastened to an anchoring structure 17' in the air outlet duct 13, which also serves as an air guide. At the other end of the drawstring 5, a tab 52 protrudes from the air inlet duct 12. When the cover element 2 is arranged, the tape portion 51 is pushed into the air blocking duct 18 with the pleats 21. To free up the air inlet duct 12 and the air outlet duct 13, a pulling force is applied to the tape portion 51 at the tab 52, gripping the anchoring structure 17' so that the tape portion 51 can lift the pleats 21 out of the air blocking duct 18. In addition to what is shown, such a drawstring can also be implemented in a non-anchored manner with two tabs, so that the two tabs are pulled in order to raise the folds 21 and clear the inlet and outlet ducts 12 and 13 .

As an alternative, a traction force Z can be applied to the cover element 2, as indicated in Figure 12, in order to raise the folds, as indicated by the double arrow a. However, it can also be provided that a pressure D is applied to the cover element 2 at a specific point, as indicated in Figure 13, in order to raise the folds and/or bend the shell at a point K provided for this purpose.

A further possibility of clearing the flow path through the air inlet 12 and the air outlet 13 and opening the medicament chamber 11 includes separating the plug element (as described above) in order to raise these folds. Alternatively, a preferably spherical structure that is loosely arranged in the medicament chamber and is therefore free to move and also acts as a deagglomerator during use can be used to raise the folds in the air blocking path by raising them. Generally, the powder inhaler according to the present invention can differ from the exemplary embodiment shown, and the present invention is therefore not limited to the number and shape of the air turbulence-inducing structures, deflection structures and guide structures 15, 16, 17 and 17' shown in the figures; the structures formed in the air inlet 12, the medicament chamber 11 and the outlet 13 of the single-dose powder inhaler according to the present invention in order to improve aerodynamics, resistance and/or deagglomeration can be different from the shapes shown as intraluminal flow elements and can be formed, for example, as speed bends, blades, spirals, spirals or meanders.

In addition, the flow profile of the medicament chamber can be aerodynamically adjusted according to resistance, through-flow and powder by changes in the hole profile of size, shape and edge design (sharp edge, bevel or rounding) at the inlet and outlet of the medicament chamber. Therefore, with regard to the speed and distance aspect by powder inhaler and particularly dry powder inhaler, different factors affect the airflow, and these factors affect the emptying thoroughness and depolymerization and dispersion of the airflow, for example the cross-sectional profile of the narrowing of the air inlet and the cross section of the widening of the outlet, wherein, flow channel is preferably narrower at the air inlet side of the medicament chamber than at the air outlet side.

Figures 14 and 15 show a powder inhaler according to the present invention, in which not only the housing part 1 with the medicament chamber 11 is formed, but also the covering element 2. In this embodiment, the corresponding parts of the housing part 1 for forming the air inlet duct 12 and the air outlet duct 13 and the covering element 2 correspond to each other in terms of the opening angle and the air turbulence-inducing structure, deflection structure and guide structure 15, 17 formed. The covering element 2 differs from the housing part 1 only in the part located between the air inlet duct 12 and the air outlet duct 13: instead of the medicament chamber 11, the covering element 2 has a region formed as an elastic pressure element 22. This pressure element has a central piercing element 23 pointing inwardly toward the medicament chamber 11 in Figure 14 and two piercing elements 23 in Figure 15. The piercing elements 23 are located opposite the two subchambers 11a formed in the medicament chamber 11 by the partition wall 11b.

The pressure element 22 is formed by concentric circular wall structures that allow the plastic film to deform elastically at this point, so that the inwardly formed piercing element 23 can be moved toward the medicament chamber 11 by applying pressure to pierce the closure tab 30 and return to its starting position once the pressure has been released. The piercing element can be formed by one or more needles or by angled structures such as pyramidal spikes. If pressure is applied from both sides for the purpose of opening, namely pressure on the pressure element 22 and counterpressure on the medicament chamber 11, the closure tab 30, for example, consisting of aluminum foil, can be effectively forced open because the closure tab 30 is placed under tension by the counterpressure on the medicament chamber 11 and does not lose its resistance to the piercing element 23.

The housing part and the cover part of the single-dose powder inhaler according to the invention can be welded together by heat, but adhesive bonding, clamping connections (wherein the periphery of a housing part is bent around the periphery of the other housing part), snap connections or sewing connections are also in question.

The powder inhaler according to the invention is designed for single use, and therefore the inhaler housing cannot be reused after the medicament chamber has been opened and the powder dose has been inhaled, which also serves to protect against abuse. However, in addition to good recyclability or biodegradability, the increased volume of packaging waste (which is considered a disadvantage from an environmental point of view) is also taken into account by reducing the use of multidose inhalers, which are more complicated to dispose of since residual amounts of powdered medicament are often contained in the multidose inhaler.

The powder inhaler of single use according to the present invention allows to be used economically for a variety of different indications. For example, when only needing to use several times, or only as needed, for example, in the case of migraine, pain, immunomodulators, biopharmaceuticals or CNS substances administration. The powder inhaler according to the present invention is hygienic and eliminates undesirable influences, such as high air humidity or owing to the dirt caused by abuse to a great extent.

Because cost-effective production, so powder inhaler according to the present invention is also suitable for use in the Third World and crisis areas.In fact, the production of powder inhaler according to the present invention is so rational that patient-specific medicine packs can be realized in an economical and rational manner.Therefore, the composition and the dosage of powdered medicament (or multiple medicaments) can be filled in powder inhaler according to the present invention in a specific concrete manner customized for each patient.

In conjunction with Figures 1 to 14 , a single-dose powder inhaler according to the invention is shown with a single medicament chamber containing a single dose of powder. Figure 15 shows a variant of the invention in which the medicament chamber 11 is subdivided into two subchambers 11a by a partition wall 11b, which is formed integrally with the housing part 1 in this case. This allows two different powdered substances or medicaments that need to be stored separately to be brought together during inhalation only after the closure tab has been opened.

However, according to the present invention, it is also conceivable to form two or more medicament chambers in the housing portion, which are arranged in parallel or in series in the flow channel between the air inlet and the outlet. Here, parallel means that in each case at least one air inlet duct (from a common air inlet opening or a separate air inlet opening) is provided to lead to each medicament chamber and in each case at least one air outlet is provided to lead out of each medicament chamber and to introduce into an outlet formed as a mouthpiece or a nasal nozzle. When the medicament chambers are arranged in series, the air inlet duct extends as far as the first medicament chamber, and further ducts extend from there to the next medicament chamber, and the air outlet duct extends from the last medicament chamber to the air outlet opening. In each medicament chamber, a dose of powder can be provided, wherein these can be different active agents that only come into contact with each other during use. Therefore, although this type of powder inhaler can accommodate more than one dose of powder in principle, this powder inhaler should be understood as a "single dose" powder inhaler according to the present invention, because this multi-dose powder is inhaled in a combined manner when used alone, and the powder inhaler can no longer be used thereafter.

The plastic used for producing the powder inhaler according to the invention, which is designed as a disposable article, may preferably be a biodegradable plastic.

Each powder inhaler according to the present invention can be equipped with anticorrosive or antibacterial and/or antimicrobial coating at least in part.Therefore, particularly air inlet, chamber and air outlet can be coated so that when using the inhalation device, do not inhale pathogens.Yet, owing to being more easily applied, so whole inhalation device can also be coated.The example of this type of coating is Perlazid® of Rilit company, Endingen, Germany.Alternatively, can produce inhalation device with anticorrosive or antibacterial and/or antimicrobial plastics.

The powder inhaler according to the present invention can also be sold, for example, in an outer packaging that ensures that the powder inhaler is clean or sterile and is therefore ready for immediate use. Alternatively, it is also conceivable that the covering element has an overlap at its end, in which way the outlet (optionally also the air inlet) can be closed in the manner of a yogurt cup lid. The overlap can then be pulled apart from the opening, for example, by the tabs formed. In order to prevent the film from being able to be pulled apart from the housing portion, predetermined breakpoints, for example perforations, can be provided at the overlapping connection points. In addition, the plastics used to produce the powder inhaler according to the present invention can have a mark so that it can be identified, thereby identifying counterfeit products that do not contain the mark.

Figure 16 discloses a thermoformed plastic film 10, wherein, formed are four housing parts 1 and the medicament chamber 11 each with an air inlet 12 and an air outlet 13. For greater clarity, reference symbols are not provided for all elements of the housing part. The medicament chamber 11 of the housing part 1 is filled and sealed with a closing tab 30 of a membrane element 3. In addition, it can be seen that a wide covering element 2 is attached to each housing part 1, wherein the covering element 2 has a pressure element 22, which has a puncture element 23 relative to the medicament chamber 11. In order to complete the corresponding powder inhaler, all that is necessary now is to separate the corresponding filled blister structure.

Contrary to conventional powder inhalers, the powder dose is not provided in a capsule or blister that must be inserted into the inhaler housing before the powder can be inhaled. Powder inhaler according to the present invention is formed as a blister itself, which holds the powder to be inhaled. Therefore, the capsule that holds the powder can be omitted from being inserted into the inhaler housing.

Figure 17 has summarized the modules of the exemplary manufacturing device 100 for powder inhaler according to the present invention. Of course, other manufacturing devices for implementing method steps according to the present invention can be imagined as well. In the first module M1, the housing part 1 is formed. In the exemplary method variant, for a continuous process, a thermoformed film can be spliced from a rolled product to form an endless film before preheating and transporting to the forming station. As its alternative, a semi-continuous or discontinuous process can also be imagined, wherein, for example, splicing can be omitted. The second module M2 is a filling station, at which the medicament chamber formed is filled with a predetermined type of powder or a predetermined powder mixture or a predetermined amount of powder. If appropriate, powder ingredients and dosages customized for specific patients can also be filled in. In the third module M3, the medicament chamber is sealed by a sealing film, or is sealed using a plug element, and a covering element is attached in a continuous process. In the case of shaped covering elements, these covering elements can be shaped, placed on the thermoformed film with the housing part and sealed in a corresponding manner in the module 1 before preheating by the thermoformed film. In the last module M4 , a further sealing station may follow, after which the powder absorbers made of thermoformed film are separated, preferably punched out, and discharged as finished blisters.

List of Reference Symbols

1 shell part;

10. Thermoforming film;

11 pharmacy;

11A, 11b sub-chambers, partition walls;

12,120 air inlet duct, portion adjacent to the medicine chamber;

12' air intake opening;

13. 130 air outlet duct, portion adjacent to the medicine chamber;

13’ vent opening;

14 nose piece;

15, 16, 17 air turbulence causing structures, steering structures, guiding structures;

17’ anchoring device;

18 blocking the airway;

2 covering elements;

21 folds;

22 pressure element;

23 puncture element;

3 membrane elements;

30 closing tab;

31 band section;

32 Pull open the joint;

4 plug element;

40 plug portion;

41 band part;

42 pull open the joint;

5 drawstrings;

50 terminal part;

51 band part;

52 pull the tab;

100 manufacturing equipment;

Z traction;

D pressure;

KD points.

Claims (19)

1. A single-dose powder inhaler comprising an inhaler housing having a housing portion (1) and at least one medication chamber (11) having a single dose of powdered medication, wherein the inhaler housing has an outlet opening (13') and an outlet passage (13) extending from the medication chamber (11) to the outlet opening (13'), the outlet passage (13) being formed in the housing portion (1), wherein a guiding structure, a turbulence-inducing structure, and/or a deflecting structure are formed in the outlet passage (13), and wherein an inlet opening (12') on the side of the medication chamber (11) away from the outlet opening (13') and an inlet passage (12) extending from the inlet opening (12') to the medication chamber (11) are formed in the housing portion (1), wherein the outlet passage (13), the medication chamber (11), and the inlet passage (12) define an outlet axis, characterized in that The inhaler housing consists of only two parts: a housing part (1) and a cover element (2), which is connected to the housing part (1) to form the inhaler housing. At least one medication chamber (11) is formed in the housing part (1). An air guiding structure, a turbulence-inducing structure, and/or a steering structure are formed in the air intake (12) and the medication chamber (11). The air intake (12) narrows from the air intake opening (12') to the medication chamber (11) in two directions perpendicular to the axis defined by the air outlet (13), the medication chamber (11), and the air intake (12). The air outlet (13) widens from the medication chamber (11) along the direction of the air outlet opening (13') in two directions perpendicular to the axis defined by the air outlet (13), the medication chamber (11), and the air intake (12). 2. The single-dose powder inhaler as claimed in claim 1, characterized in that: the housing part (1) is an injection-molded plastic part, wherein the covering element (2) is formed in a broad and substantially planar manner and constrains the air intake (12), the medication chamber (11) and the air outlet (13), or the covering element (2) is formed in a manner corresponding to the housing part (1) at least in the region of the air intake (12) and the air outlet (13), and the covering element (2) is made of a plastic film, aluminum foil or composite film, and/or at least one inhaler housing part, i.e. the housing part (1) and/or the covering element (2), is transparent. 3. The single-dose powder inhaler as claimed in claim 1 or 2, characterized in that: the air outlet (13’) is formed as a mouth tube or connected to a nasal nozzle (14), and/or, the cross section of the air inlet (12) at the drug chamber (11) is smaller than the cross section of the air outlet (13) at the drug chamber (11). 4. The single-dose powder inhaler as claimed in claim 1 or 2, characterized in that: at least one loosening and deagglomerating device is arranged in the drug chamber (11). 5. The single-dose powder inhaler as claimed in claim 1 or 2, characterized in that: the membrane element (3) with a closing tab (30) closes the drug chamber (11). 6. The single-dose powder inhaler as claimed in claim 5, characterized in that: the membrane element (3) has at least one pull-out tab (32) that originates from the closing tab (30) and extends from one side of the drug chamber (11) through the air inlet or outlet opening (12', 13') into the air inlet or outlet passage (12, 13); or the cover element (2) is formed as a resilient pressure element (22) on the side opposite to the drug chamber (11), the pressure element having at least one puncture element (23) for perforating the closing tab (30) when pressure is applied to the pressure element (22). 7. The single-dose powder inhaler as claimed in claim 1 or 2, characterized in that: the medication chamber (11) is closed by two plug elements (4), wherein each plug element (4) has a plug portion (40) arranged in the portion (120, 130) of the air inlet (12) and the air outlet (13) adjacent to the medication chamber (11), and a pull-out tab extending from the air inlet opening (12') and the air outlet opening (13') respectively, or, an air choke ( 18) Formed in the housing part (1) on both sides of the drug chamber (11) at right angles to the air inlet (12) and the air outlet (13), the corresponding pleats (21) of the covering element (2) are received in the air-blocking passage (18) in such a way as to seal the air inlet (12) and the air outlet (13), wherein the powder inhaler has a lifting element through which the pleats (21) can rise out from the air-blocking passage (18). 8. The single-dose powder inhaler as claimed in claim 7, characterized in that: the lifting element is at least one predetermined and marked pressure point, bend point or pull point on the inhaler housing, or the lifting element is a pull strap (5) that extends through the air inlet (12) and/or the air outlet (13) and laterally through the air choke (18) between the pleat (21) and the housing portion (1), and has gripping portions (52) at both ends or has gripping portions (52) at one end and is anchored to the anchoring structure (17’) of the inhaler housing at the other end (50), or the lifting element is formed by these plug elements (4), or the lifting element is a structure loosely arranged in the drug chamber. 9. The single-dose powder inhaler as claimed in claim 2, characterized in that: the plastic is biodegradable, and/or the plastic contains a label. 10. The single-dose powder inhaler as claimed in claim 2, wherein the plastic is a corrosion-resistant and/or antimicrobial plastic, or at least the air inlet (12), the drug chamber (11) and the air outlet (13) are equipped with corrosion-resistant and/or antimicrobial coatings. 11. The single-dose powder inhaler as claimed in claim 1 or 2, characterized in that: the medication chamber (11) is subdivided into at least two sub-chambers (11a) by at least one partition wall (11b), or, two or more medication chambers (11) are formed in the housing portion (1), wherein the medication chambers are arranged side by side with each other, in parallel with the air inlet (12) and the air outlet (13), or in series with each other, wherein the air inlet (12) leads to the first medication chamber (11), and the air outlet (13) extends from the last medication chamber (11), and the medication chambers (11) are connected together via further conduits. 12. The single-dose powder inhaler as claimed in claim 11, characterized in that: in the cover element (2), in each case, at least one puncture element (23) for each sub-chamber (11a) formed in the housing portion (1) is provided on the pressure element (22), or, in each case, in the cover element (2), a resilient pressure element (22) having the at least one puncture element (23) is provided for each drug chamber (11) formed in the housing portion (1). 13. The single-dose powder inhaler as claimed in claim 2, wherein the housing portion (1) is formed of a pharmaceutically compliant plastic film. 14. The single-dose powder inhaler as claimed in claim 2, wherein the housing portion (1) is formed from a single type of plastic film. 15. The single-dose powder inhaler as claimed in claim 13 or 14, wherein the housing portion (1) is thermoformed from the plastic film. 16. The single-dose powder inhaler as claimed in claim 8, wherein the structure is a depolymerizer. 17. A method for producing a single-dose powder inhaler as claimed in any one of claims 2 to 16, comprising the steps of: producing a housing portion (1) from plastic by injection molding; filling a drug chamber (11) with a dose of powdered drug; sealing the drug chamber (11) using a membrane element (3) by means of two plug elements (4) and/or by means of pleats (21) of a cover element (2) received in an airway (18); and cutting out a broad and substantially planar cover element (2) or producing the cover element (2) from plastic by injection molding; and attaching the cover element (2) to the housing portion (1), wherein the method is carried out in a single device. 18. The method as claimed in claim 17, wherein the housing portion (1) is produced by thermoforming a plastic film. 19. The method as claimed in claim 17, wherein the covering element (2) is produced by thermoforming a plastic film.