EP2467184A1

EP2467184A1 - Inhalation device and method for inhaling an active ingredient from a capsule

Info

Publication number: EP2467184A1
Application number: EP10740557A
Authority: EP
Inventors: Christian Friebel; Bernd W. MÜLLER; Hartwig Steckel
Original assignee: Gamptec GmbH
Current assignee: Gamptec GmbH
Priority date: 2009-08-18
Filing date: 2010-08-02
Publication date: 2012-06-27
Also published as: DE102009037840A1; DE102009037840B4; EA201290065A1; AU2010285290A2; AU2010285290A1; CA2771443A1; JP2013502247A; WO2011020554A1; EA032404B1; CN102573970A

Abstract

The invention relates to an inhalation device for inhaling at least one active ingredient contained in a capsule, comprising: - a swirl chamber (15) for accommodating a capsule and for swirling the capsule content, - at least one air introduction channel (13), and at least one air discharge channel (14), wherein the air introduction channel (13) and the swirl chamber (15) and the air discharge channel (14) are in fluid connection and wherein the air introduction channel (13) and the air discharge channel (14) extend at least partially in opposite directions. The invention further relates to methods for inhaling an active ingredient contained in a capsule.

Description

Inhalation device and method for inhaling an active ingredient from a

capsule

The invention relates to an inhalation device and a method for inhaling at least one active ingredient contained in a capsule.

In general, various so-called capsule-based inhalers for inhalation of one or more active substances are known. The one or more powdery active ingredients may be present as such individually, unbound or bound to a carrier. One capsule generally contains in each case a therapeutically required dose of active substance. The capsule is placed in an inhaler and opened there before an inhalation process. During inhalation, a flow of air extending longitudinally through the inhaler in a flow direction is created. With this air flow contained in a capsule drug can be transported at least partially into the lungs of the user.

In the case of pulmonary administration of a pulverulent active ingredient, the active ingredient, which is present either separately or bound to a carrier, is separated from the carrier by inhalation and passes finely distributed into the lung. This ensures that the active substances in the air stream can reach their site of action in the lungs. The fine division and / or separation of the active ingredients or of the active substance is also called dispersion or deagglomeration.

Known powder inhalers may be active or passive devices. In passive devices, inhalation takes place exclusively via a breath of an inhaling person. In contrast, active devices use, in addition to the breath, a mechanism that promotes dispersion and / or deagglomeration in response to actuation of the inhaler. For example, in the case of inhalation, a pressure reservoir can additionally be opened, the pressure of which releases it encouraging deagglomeration. Active inhalation devices usually have a complicated and therefore expensive construction. Furthermore, a distinction is made between so-called reservoir inhalation devices and predosed systems.

Reservoir inhalation devices include a reservoir from which a single dose is withdrawn and delivered to a patient during an inhalation procedure.

Such devices typically have a complicated structure and place high demands on the so-called single-dose powder technology, particularly since such reservoir systems can contain up to 200 unit doses and are accordingly in use for a long time. On the one hand, such a system0 must ensure that a given number of doses can be delivered and, on the other hand, that a dose is always dosed independently of the time of collection. In addition, it must be apparent to a patient whether other doses are still available in such an inhalation device. Also, such reservoir devices involve complicated development and testing of the formulation, as well as an elaborate construction, and therefore their production is associated with high costs. Furthermore, such reservoir devices often can not be reused.

In so-called pre-dosed inhalation devices, a powder formulation for application is already present in a separate manner, for example as a capsule or in so-called o blisters. A distinction can be made between so-called multidose inhalers and so-called single-dose inhalers.

Multi-dose inhalers include several separate single doses provided, e.g. separated on a blister strip or a blister disc. The blister is either integrated into a 5 inhalation device or can be inserted as needed. Thus, these devices often provide a mechanism for further transport of the blister after inhalation of a single dose.

Such devices again have a complicated structure and place high demands on the production of the blister strips. Also, the production is high

Costs connected. Furthermore, such mono-dose multidose systems usually can not be used again. Single-dose inhalers can take exactly one single dose, eg in one capsule. The user inserts a single capsule into the inhalation device prior to an inhalation procedure.

For example, EP 1 245 243 A1 discloses a pen-shaped capsule inhaler having a rotatable cutting / perforating device for perforating or cutting a capsule. Inhalation devices are known from WO 2007/093149 A1 and US Pat. No. 5,651,359, in which a capsule is guided against fixed knives for opening and the ends of the capsule are completely cut off. US 4,013,075 discloses an inhalation device in which a capsule is opened by rotatable blades and the air flow is performed vertically through the inhalation device.

Furthermore, EP 0 666 085 A1 discloses an inhalation device in which a capsule in a rotatable receptacle is guided past two knives and air is passed through the opened capsule clamped. US 4,889,114 discloses a tubular capsule inhaler through which an airflow is directed vertically.

Further, US 3,991,761 discloses a capsule inhaler in which a capsule is laterally perforated via spring loaded pins. Finally, WO 2007/098870 A1 discloses a capsule inhalation device in which an opening device movable relative to the housing is provided on the mouthpiece.

Overall, the inhalation devices known from the prior art are often difficult to handle and clean. In most cases, they have a complex structure with 5 many components. In addition, in known inhalation devices a

Capsule often not completely emptied.

Against this background, it is an object of the invention to provide an improved inhalation device which at least partially overcomes the above disadvantages.

These objects are achieved by the subject-matter of the independent claims. Preferred embodiments are specified in the subclaims. An inhalation device according to the invention may comprise a swirl chamber for receiving a capsule and swirling capsule contents, at least one air inlet channel, and at least one Luftausleitkanal, wherein the Lufteinleitkanal and the vortex chamber and the Luftausleitkanal are in fluid communication, and wherein the Lufteinleitkanal and the Luftausleitkanal at least partially in opposite directions run. Intake air can be introduced into the vortex chamber through the air inlet channel and can be diverted through the air outlet channel. In general, one or more air inlet ducts and / or air outlet ducts can be provided according to the invention. However, in each case only one air inlet channel and one air outlet channel are preferably provided, since in this way a defined and reproducible air flow can be achieved with simple means. The at least partially opposite arrangement and design of the air inlet duct and the Luftausleitkanals causes a particularly advantageous air flow, since in an inhalation process, the air is guided around the circumference.

The invention also provides a method of inhalation with an inhalation device according to the invention. The method comprises the steps of: inserting a capsule into a capsule receptacle of a swirl chamber arranged and formed in a swirl chamber

Inhalation device; Opening the capsule with a cutting device, sucking air through a mouthpiece via an air inlet channel and an air outlet channel, the capsule being vibrated and rotated by the air flow within the vortex chamber; so that the capsule is emptied.

Further advantageous embodiments are given below.

The air introduction channel may comprise any geometries and be formed at least partially in the lower part of the inhalation device. In the inhalation device according to the invention, the air introduction channel can be at least partially tangential to the

Swirl chamber run. The inhalation device according to the invention may also comprise a mouthpiece in fluid communication with the air outlet channel.

Furthermore, an air inlet opening for the air introduction channel can be formed at any position in the lower part. Also, in the inhalation device of the present invention, the air introduction passage may include an inlet disposed in a portion of the inhalation device outside of the areas intended to be held by a user upon inhalation, preferably adjacent to or near the mouthpiece.

When the outside air is introduced from the direction of the mouthpiece, that is to say from the front of the inhaler, an inhaling patient can not normally close the air inlet opening and thus the air induction channel during normal grasping and holding of the inhalation device with his hand and / or individual fingers. Thus, an error-free function of the inhalation device is ensured.

In principle, the air flow can be introduced from any desired sides and positions into the vortex chamber. The air introduction channel of the inhalation device according to the invention may also have an outlet which opens into a lower region of the vortex chamber and / or laterally into the vortex chamber. Thus, air sucked from the outside can be introduced into the vortex chamber from below and / or laterally. This can produce a favorable flow of air to the capsule. The air flow then acts on the air inlet facing, in particular lower end of a arranged in the vortex chamber capsule.

Partly, the air flow also flows in the extension of the air inlet duct circular along a vertical inner rounding of the vortex chamber. The air flow introduced from below raises the capsule, thus supplying energy from below and causing the capsule to vibrate and rotate. As a result, the capsule can be lifted and carried from below via an airflow vortex acting as an air cushion.

Also, in the inhalation device of the present invention, the air exhaust passage may have an inlet fluidly connected to an upper portion of the swirl chamber, and an outlet, and the Luftausleitkanal extend between the inlet and the outlet arc or S-shaped.

The transition from the vortex chamber into the Luftausleitkanal may, following the vortex chamber initially perpendicular to the top and then arc and / or S-shaped in the direction of the mouthpiece. Thus, the inhalation of the air flow can initially be removed or sucked upwards out of the vortex chamber. As a result, additional forces are released and the turbulent flows are amplified. The capsule is so advantageous sucked on the one hand with the air flow upwards, as in the manner of o Windhose, and supported by the air flow from below, as about an air cushion.

Thus, a deagglomeration can be further improved and ensure complete emptying of the capsule. The bow-shaped or s-shaped air flow in the direction of the mouthpiece enhances the above effects through additional flow fields. The particles contained in the Luftstrom5 are virtually deflected by 180 °, wherein they collide against the lateral upper end of the vortex chamber and against the boundary walls of the Luftausleitkanals, which in turn leads to a force on the particles. This in turn further aggravates turbulence and deagglomeration. o The transition between vortex chamber and air outlet channel can be kept free. Also, in the inhalation device according to the invention at the beginning of the inlet of the Luftausleitkanals be arranged a grid. The grid prevents any fragments formed during the cutting of a capsule from entering the air outlet channel and thus from entering the lungs of a patient. In addition, the active ingredients and carriers partially impinge against the grid, which in turn advantageously the

Deagglomeration promotes.

The Luftausleitkanal may comprise a uniform cross-sectional area. Also, in the inhalation device according to the invention, the Luftausleitkanal in the direction o downstream of the vortex chamber becomes larger and / or smaller

Have cross-section. Thus, the Luftausleitkanal tapers and / or widened over its cross-sectional area. With a taper of the cross section, the flow velocity of the air flow can be increased. An expansion of the cross section slows down the flow velocity of the air flow. Thus, advantageously, the flow cross-section widens toward the mouthpiece in order to provide a high volume flow with a comparatively low flow velocity during the transition to the patient.

When the air flow exits the vortex chamber into the air outlet channel, the cross section is tapered, so that high flow velocities occur at the same volume flow at this point. The impulse effect is particularly great in this area, which in turn enhances deagglomeration.

0

Furthermore, in the inhalation device according to the invention, one or more recesses and / or protruding structures can be arranged and / or formed in the air inlet channel and / or in the air outlet channel and / or in the vortex chamber. The recesses and / or structures increase a deagglomeration in the air inlet duct and / or in the air outlet duct and / or in the vortex chamber. In this case, the recesses and / or protruding structures may be formed, for example, as baffles, supernatants of any geometry and / or so-called baffles, at which the active substance and carrier substances are abutted and deflected via the air flow. Such an embodiment of the air inlet channel and / or o Luftausleitkanals and / or the vortex chamber advantageously enhances a turbulence of the air flow and leads to an additional impulse effect on the active ingredients and carriers. This in turn improves powder dispersion.

The inhalation device according to the invention may also comprise at least one additional channel surrounding the air outlet channel at least partially for generating an additional air flow. This additional channel can be arranged and designed in such a way that the additional air stream surrounds the stream of air containing fluidized substances. For this purpose, the Luftausleitkanal and the at least one additional channel at least partially parallel to each other, wherein the additional channel directs an air flow o from above and / or laterally or circumferentially around the edge of Luftausleitkanals.

Thus, the desgglomeration and Verwirbelungseffekte described can be further improved and reduce the drug deposition on the oropharynx. A capsule can only be inserted into the vortex chamber. This can be an advantage, for example, if the capsule was opened via an external cutting device or a protective film was peeled off.

In the case of the inhalation device according to the invention, the swirl chamber can also comprise a receptacle for receiving a capsule. The capsule receptacle may have the same dimensions of a capsule or may be larger than the capsule.

In addition, in the case of the inhalation device according to the invention, the receptacle can be designed such that a capsule is held positively and / or non-positively. Advantageously, the capsule is set in a defined position.

The air flow supplied through the air introduction duct moves an inserted capsule in the swirl chamber during an inhalation process and places the capsule in intensive motion in the form of predominantly rotation and vibration. The vortex chamber can have any geometry. In a freely movable capsule significantly turbulent flow fields arise as for example in a dormant capsule. As a consequence of this, larger forces occur which, on the one hand, promote the emptying of the capsule and, on the other hand, the deagglomeration and / or dispersion of the active ingredient to be inhaled. The air flow thus favors next to the

Acceleration and movement of the capsule also accelerate and move the active ingredient (s) and carrier (s).

A capsule can already be opened as described, for example, after removal of a protective film or opening via an external cutting mechanism in the inhalation device according to the invention are inserted.

Alternatively, it may be opened in the inhalation device. For this purpose, the inhalation device according to the invention can be provided with a cutting device for opening a capsule. This can be arranged in the upper part. In the case of a cutting device integrated in the inhalation device, no transport losses of the active substances from an opened capsule are advantageously incurred. Da-Oi, the cutting device of the inhalation device according to the invention may comprise at least one movable cutting element. Particularly advantageous is the use of two mutually parallel cutting elements. As cutting elements, for example, knives or blades can be used. As a result, capsule fragment formation can be advantageously avoided and smooth cutting or stitching edges can be achieved compared to pins. Also, the disadvantages of other Öffhungsmittel be prevented, such as a fragmentation and / or a closure of a perforated capsule surface by fragments and / or by the active substance contained therein.

The cutting elements can be designed to be insertable into the upper part of the inhalation device. Preferably, they are firmly fixed in the upper part, such as glued, mechanically coupled or integrally formed when manufactured in the upper part. With a mechanical coupling, the blades are advantageously interchangeable.

In general, the at least one cutting element of the inhalation device according to the invention can be made of any metals or their alloys, but also of other suitable materials, such as ceramics. For example, as the material, a high-alloyed steel may be used, which is, for example, surface-treated by means of a nitriding process. For example, the blades can be cut precisely using spark erosion technology. The cutting elements preferably consist of a steel grade approved for pharmaceutical applications; for example AISI 316L. Advantageously, the capsule ends are cut on both sides with two parallel cutting elements. For this purpose, the cutting edges can be designed and arranged such that they do not cut off the capsule ends but merely partially or completely cut them at the capsule ends. This avoids irregular cutting edges and catching capsule ends. Also advantageous is the air flow is not hindered by about separated capsule ends. Through the incisions, the powder contained in the capsule can be emptied into the vortex chamber. Thus, the cutting guide is closely related to the air flow. The knives can be equipped with any suitable cutting edges. For example, the knives may be formed with rounded, one-sided, double-edged blades having a radius of curvature of 1.28 cm. Preferably, they are formed with a straight, two-sided, two-sided cutting edge and a cutting angle of 80 ° or 5 a straight, single-sided, two-sided cutting edge and a cutting angle of 67 ° or with straight, two-sided cutting and a cutting angle of 0 °. Particularly suitable is a straight, single-sided, single-sided or double-edged cutting edge with a cutting angle of 35 °. o Basically, in an inhalation device according to the invention, the capsule to a

Cutting device to be moved. Advantageously, however, the cutting elements are moved against the fixed and stationary capsule. Since a capsule is fixed in the capsule holder, a movement of the capsule during the opening process is avoided and the capsule is always in the same position. Thus, the cutting guide and interface on the capsule can be reproduced as desired and miscarriage is avoided.

Also, the at least one cutting element of the inhalation device according to the invention can first cut the capsule with the tips of its cutting edges. When the tips of the cutting element first touch the capsule surface, it is advantageous to avoid deformation of the capsule and to achieve exact cuts. To the

Opening a capsule, the cutting elements are brought from above to the capsule, which is then cut vertically from above. The incision angle can be 0 ° - 90 ° to the longitudinal axis of the capsule. It is preferably 10 °, particularly preferably 0 °. 5 The capsules can basically consist of any materials. However, gelatin capsules, for example, require relatively high opening forces. In addition, gelatin capsules tend to become brittle and / or splinter, especially at low humidity. At high humidity, however, gelatin capsules soften and consequently tend to deform.

0

Capsules based on hydroxypropylmethylcellulose have proven particularly suitable for an inhalation device according to the invention. This material is characterized by the fact that it is particularly easy to open and hardly to one Fragmentation tends. Also, this material maintains its described properties over a wide range of humidity, so that the risk of capsule deformation or fragmentation is low.

Furthermore, the inhalation device according to the invention may comprise an actuating element for actuating the cutting element. The actuating element is advantageously arranged separately from the air guide in the upper part of the inhalation device. Thus, a positive connection of all air-conducting components is ensured, so that no leaks can occur and the cutting device has no adverse effect on the air flow during inhalation.

In addition, the inhalation device according to the invention may comprise a spring element to keep the cutting device biased in a retracted position. The actuating element can be guided via at least one guide element. This ensures precise guidance of the actuating element and thus of the cutting element (s). The guide element may be formed as a guide rail, guide groove or any other suitable guide mechanism. Advantageously, the knife guide and cutting angle can be reproduced as desired. In general, the actuator can be any suitable

Handling mechanisms are actuated. For example, the actuating element may comprise a thread which cooperates with a thread arranged in the upper part. For cutting a capsule, the actuating element is then rotated, that is screwed into the inhalation device, wherein the cutting element is guided against the capsule 5 and cuts it at the ends.

Furthermore, the at least one cutting element in the retraction position can be accommodated completely in the upper part. Advantageously, a risk of injury is reduced by the knife. It is also ensured that the air flow is not obstructed by the cutting device during an inhalation process.

The actuating element can be actuated against the force of the spring element in an actuating position such that the at least one cutting element has at least one cutting element Guide element can be brought into the vortex chamber such that a capsule is opened without touching the lower part. Overall, the cutting device of the inhalation device according to the invention advantageously ensures a maximum of reproducibility of the incision by the cutting element (s).

5

Since fragmentation and deformation of the capsule during the cutting process is avoided, the emptying process upon inhalation is also reproducible, which in turn enables uniform dose delivery. Furthermore, an almost complete drug depletion is ensured from the capsule. Also, only a minimum of active ingredient remains in the inhalation device. In addition to the dimensions and design of the air-conducting components, the cutting device also optimizes the separation of the active substance from the carrier material or the dispersion of the active substance (s). Thus, dose fluctuations, such as, in the worst case, no or under dosage, are avoided.

5

Furthermore, the inhalation device according to the invention can comprise an upper part and a lower part, which are coupled to one another. For this purpose, for example, a snap or snap closure or any other suitable mechanism can be used. o Basically, any opening mechanism can be provided. Also, in the inhalation device according to the invention, the upper part and the lower part can be pivotably connected, preferably such that the upper part is movable between an open position for removing or receiving a capsule and a closed position for inhalation. For this purpose, for example, a hinge assembly 5 can be used. Thus, the inhalation device between a defined

Opening position for removing or receiving a capsule and for inhalation in a defined closed position to be pivoted. The pivot positions can be defined and fixed, for example, additionally by snap-in connections. o Furthermore, the inhalation device according to the invention may comprise a securing mechanism, which is able to prevent actuation of the actuating element in the open position. This may be, for example, a locking pin. Additionally or alternatively, the inhalation device according to the invention may comprise a further securing mechanism, which is able to prevent inhalation during operation of the actuating element. For this purpose, for example, the actuating element may be mechanically coupled to the securing mechanism. A 5 incorrect dosage can be avoided so advantageous.

Also, an inhalation device according to the invention may comprise any specific device resistances. Preferably, the inhalation device according to the invention comprises a specific device resistance of 0.027 to 0.050 kPa ^{o> 5 »} L / min, resulting in flow rates of 40 to 75 L / min at 4 kPa pressure drop across the inhalation device (1); preferably from 0.031 to 0.044 kPa ⁰ ^'5 L / min, resulting in flow rate 45-65 liter / min at 4 kPa pressure drop over the

Inhalation device (1); more preferably from 0.036 to 0.040 kPa ° ' ^{5 »} L / min, resulting in flow rates of 50-55 L / min at 4 kPa pressure drop across the inhalation device.

These medium to high device resistances are advantageously perceived as more comfortable by many patients, which has a positive effect on patient compliance. It is also possible in this area for all patient groups to achieve the flow rates required for inhalation.

The air flows thus obtained result in lower air velocities and longer residence times of the powder in the highly turbulent zones of the inhaler compared to low resistance devices, resulting in improved separation of active agent and carrier. Likewise, the capsule is for a long time in the turbulent air flow, which has a beneficial effect on their emptying. Thus, the disadvantages of inhalers operating at low and very high resistances are advantageously overcome. Overall, the preferred embodiments provide a flexible and compact

Inhalation device and a method for inhalation ready. The inhalation device according to the invention is designed in particular as a single-dose capsule inhaler. Advantageously, an inhalation device according to the invention is easy to handle and clean by a patient. Likewise, the inhalation device according to the invention comprises only a few components and has a simple structure, so that it is inexpensive to manufacture. In addition, it can be operated with commercially available capsules. These capsules advantageously provide a comparatively low requirement for powder technology and are inexpensive to produce.

The capsule can be opened at any position for emptying. However, when the capsule is open at the ends, the capsule openings are advantageously located in a rotating capsule at the location of the highest centrifugal forces. The

The consequence of such a combination of opening position and movement of the capsule, compared to systems with resting capsule and other opening positions, significantly increased forces. The forces in turn promote or maximize the emptying of the capsule and the deagglomeration of the active ingredient to be inhaled or an active ingredient dispersion. Overall, it is advantageous to achieve an almost complete emptying of the capsule. Also, the active ingredient is advantageously fluidized in such a way that only a few powder residues remain in the air-guiding parts of the inhalation device and / or the capsule and the greatest possible separation of active substance and carrier material takes place.

The deagglomeration and / or dispersion are also associated with a capsule opening and the dimensions and design of the air-conducting components. According to the invention, all these factors are optimized. Both the intensive movement of the capsule and the dimensioning of the air-conducting parts ensure maximum turbulence in the inhalation device according to the invention. This in turn advantageously causes a reproducible capsule emptying over a defined air flow.

The invention will now be explained with reference to preferred embodiments with reference to the accompanying exemplary figures. Elements that correspond in the various figures bear the same reference numerals. Showing: Fig. 1 is a longitudinal sectional view of an inventive

Inhalation device;

Fig. 2 a is a longitudinal sectional view of the upper part of the inhalation device

Fig. 1;

FIG. 2b shows a plan view of the upper part from FIG. 2a from below; FIG.

Fig. 3 a. a cross-sectional view of the lower part of the inhalation device

Fig. 1;

3b is a plan view of the lower part of Figure 3a from above ..;

4 is a cross-sectional view of the inhalation device according to the invention;

and

Fig. 5 is a longitudinal section through a lower part of another invention

Inhalation device. As used hereinbelow, phrases such as top, bottom, front, back, right, and left refer to an inhalation device located in front of the viewer, with the mouthpiece facing the user and the top facing up. Fig. 1 shows an inhalation device 1 according to the invention, which is designed as a capsule-based powder inhaler. The inhalation device 1 comprises an upper part 3 and a lower part 5; both are coupled to each other via a hinge arrangement 7. The upper part 3 is pivotable relative to the lower part 5 between a Öffhungsstellung (not shown) and a closed position.

In the open position, a user may insert a capsule into a vortex chamber 15 or remove a deflated capsule therefrom. The capsule contains an active ingredient to be inhaled or agents which are associated with a carrier or excipients can. In the vortex chamber 15, an inserted capsule moves over the airflow caused during inhalation, rotating and / or vibrating. In the open position, all components are easily accessible, so that the inhalation device 1 can be easily cleaned.

5

In Fig. 1, the inhalation device is in its closed position. The upper part 3 comprises a housing 23 in which a separating device 11 is arranged. Before beginning an inhalation procedure, a user opens an inserted capsule with the cutting device 11 (see Figs. 2a, 2b and 3). For this purpose, the cutting device 11 o comprises an actuating element 25, which is designed here as a pin-shaped knob and two mutually parallel cutting elements 27, which are formed in the embodiment shown as a knife. The knob 25 is coupled via a fastening means, such as a screw or a pin to the upper part 3. In addition, the cutting device 11 is provided with a spring element 37, 5 which biases the knob 25 and thus the knife 27 in an initial position. The spring element may be any spring, for example a compression spring or a spiral spring. In the starting position, the knives 27 are arranged within the housing 23. In order to prevent a risk of injury in the opened state, the upper part 3 can be designed such that it can not be fully swung open, but only so far that it is easily possible to remove or insert a capsule and / or to clean the inhalation device 1. Alternatively or additionally, a securing mechanism (not shown) may be provided which prevents actuation of a cutting device 11 in the Efrhungsstellung.

The knives 27 may be equipped with any cutting edges 29, for example with a rounded, one-sided, two-sided cutting edge with a radius of curvature of 1, 28 cm; preferably with a straight, two-sided, double-edged cutting edge and a cutting angle of o each 80 ° or with a straight, single-sided, double-edged cutting edge and a cutting angle of 67 ° or with a straight, double-edged cutting edge and a cutting angle of 0 °. Knives 27 with a straight, single-sided, single-sided or double-edged cutting edge and a cutting angle of 35 ° have proven particularly suitable. Also, the knives 27 may have any suitable dimension. Knives with a width of 3 mm, a thickness of 0.6 mm and a length of 35 mm have proven to be particularly suitable.

5

To open a capsule, a user moves the operating knob 25 and thus the knife 27 against the spring force vertically downwards in the direction of the lower part 5 and thus to the capsule in a working position. For this purpose, two of the diameter size adapted openings in the underside of the upper part 3 are formed, through which the knife 27 move into the o lower part 5 into a capsule inserted into the capsule 15. Here, first meet the tips 33 of the cutting edges 29 on the capsule surface of a capsule and then cut both capsule ends and through.

The operating knob 25 is guided for displacement over two guide elements 39 arranged on both sides. As a guide any known guide mechanisms can be provided. In the embodiment shown here (see Figures 1 and 2a), the guide elements are designed as slide rails 39, between which the actuating knob 25 is vertically displaceable. Also, a plurality of slide rails 39 may be attached to certain circumferential positions of the upper part 3. In the embodiment shown here, the slide rails 39 are formed around the upper part 3 around the circumference.

In this case, the sleeve-like portion of the actuating knob 25 is bordered by an outer slide 39 from the outside and by an inner slide 39 from the inside. This in turn ensures a uniform, precise guide 5 of the anchored knife 27. Alternatively, the actuating button 25 may also include a training, such as a spring, the spring in the manner of a groove Guide is engaged with a spring guide.

The incision angle is defined by the arrangement of the knives 27 and can be configured as desired. Cutting angle of 90 °; preferably 10 °; more preferably 0 °; relative to the longitudinal axis of the capsule are particularly suitable. When a capsule is cut in, the knives 27 move through the capsule, beyond the lower end of the capsule, into two in the underside of the capsule holder 9 Recesses 35. The recesses 35 correspond to the blade size or may be formed slightly larger and prevent contact of the tips 33 of the blades 29 with the lower part 5. After opening a capsule leaves a user the actuating button 25. The spring 37 exerts a force on the actuating button 25, moves it and thus the knife 27 in the starting position. The knives 27 are then completely recessed in the housing 23.

In addition, a further securing mechanism (not shown) may be provided which prevents inhalation when pressed down button 25, such as a blockage of the air ducts. Thus, a misuse of the inhalation device 1 or a misdosing can be avoided.

A part of the underside of the upper part 3 closes when the inhalation device 1 is closed both an upper end of the vortex chamber 15 and partly the upper side of an air outlet channel 14 in the mouthpiece 21 via a

Positive connection with the lower part 5. Since the remaining part of the air inlet duct 13 and / or the Luftausleitkanals 14 are formed in the lower part 5, is closed at

Inhalation device 1 ensures a seal of the air ducts 13 and 14. When the inhalation device 1 is closed, the connection between the vortex chamber 15 and the air outlet channel 14 is thus established.

In addition, a further securing mechanism, for example a snap closure (not shown), secure the positive connection between upper part 3 and lower part 5. This also prevents an opening of the inhalation device 1 during a

Inhalation process.

Alternatively, the air inlet channel 13 and / or the Luftausleitkanal 14 can be completely arranged and formed in the lower part 5, so that no cover on the upper part 3 takes place. A cleaning of the channels 13, 14 then takes place for example through the mouthpiece 21st Fig. 3a, 3b and 4 show the lower part 5 in further detail. In the lower part 5 of the Lufteinleitkanal 13, the Kapselaufhahme 9 and the lower part of the vortex chamber 15 are arranged and formed. The dimensions of the vortex chamber 15 are arbitrarily ausgestaltbar. For example, as dimensions of the vortex chamber 15, a height of 7 to 9 mm has proven suitable; 8 mm being particularly suitable. In the bottom of the vortex chamber 15, the capsule receptacle 9 is formed. The dimensions of the capsule receptacle 9 are adapted to a capsule size such that a capsule can be fixed therein. Thus, a capsule can not move or slip during cutting, so that a maximum of reproducibility for the incision is ensured by the knife 27.

The air introduction channel 13 extends laterally from the front side of the inhalation device 1 into the vortex chamber 15. Suitable cross-sectional areas of the air inlet channel 13 are, for example, 11.8 mm ² . 17.7 mm ² or particularly suitable 23.6 mm ^{2 have} proven particularly suitable.

The air inlet of the air inlet channel 13 can be arranged and formed at arbitrary positions in the region between mouthpiece 21 and capsule receptacle 9 in the lower part 5. In the illustrated embodiment, the air inlet of the air inlet channel 13 between the mouthpiece 21 and upper part 3 is formed. One from the front of the

Inhalator upcoming arrangement offers the advantage that it is impossible for an inhaling person to close the air inlet channel 13 in a normal gripping and holding the inhalation device 1. In an inhalation process, the air flow through the air inlet passage 13 via a

Air inlet laterally introduced into the lower region of the circular vortex chamber 15. The air stream acts partially on the air inlet facing, in particular lower end of a capsule and flows partially in extension of the air inlet duct 13 circular along the vertical outer surface of the vortex chamber 15. The air stream raises a capsule and conveys it from the capsule receptacle 9 in the upper region of the

Swirl chamber 15. There, the air flow puts the capsule in vibration and rotation. The game for the capsule in the capsule receptacle 9 is so great that it does not jam or otherwise it can wedge. The resulting suction ensures via the rotation and vibration of the capsule, the emptying of the powder in the surrounding vortex chamber 15th

At the transition between vortex chamber 15 and Luftausleitkanal 14, a grid 17 is arranged. On the one hand, the grille 17 promotes powder splitting and, on the other hand, possibly prevents fragments formed during the cutting of a capsule from entering the grinder

Luftausleitkanal 14. The grid 17 may have any dimensions. Suitable have a free area of 51 mm ² ; particularly suitable 36 mm ² ; particularly suitable 21 mm ² and a web width of 1.30 mm; particularly suitable 0.86 mm, especially suitable from 0.42 mm.

Starting from the grid 17 of the mouthpiece 21 leading Luftausleitkanal 14 is arranged and formed. The Luftausleitkanal 14 extends after the vortex chamber 15 vertically upward. This is followed by an arcuate transition region which extends to the mouthpiece 21. Lufteinleitkanal 13 and Luftausleitkanal 14 thus extend at least partially parallel and opposite to each other. The air flow introduced via the air inlet channel 13 is sucked upwards into the air outlet channel 14 after flow of the vortex chamber 15. There, the air flow is deflected by almost 180 ° and thus at least partially opposite to the air guide in the air inlet duct 13 through an arcuate portion of the Luftausleitkanals 14.

In this case, the air flow leads one active substance or several active substances to the mouthpiece 21. There, the air flow leaves the inhalation device 1 and can be taken up in the lungs of a patient. The vibrating and rotating capsule is sucked up by the air flow and lifted from below in the manner of a cushion.

Further, the longitudinal region of the Luftausleitkanals 14 tapers or widened over its cross section. During the transition from the vortex chamber 15 into the air outlet channel 14, the flow cross-section tapers, so that an equal volume flow with a high flow velocity is present here during inhalation. The mouthpiece 21 widens the cross-section, so that the outflowing air flow a high

Volume flow at low flow velocity includes. Fig. 5 shows a longitudinal section through a lower part 5 of another inhalation device 1 according to the invention with additional channels 41. The additional channels 41 extend partially parallel to Luftausleitkanal 14 and direct an air flow from above around the edge of the Luftausleitkanals 14. About the additional channels 41 can be at generate an additional air flow, which envelops the turbulence-containing air stream. Thus, the desgglomeration and Verwirbelungseffekte described can be further improved and reduce the drug deposition on the oropharynx. Other embodiments and variations of the present invention will become apparent to those skilled in the art within the scope of the following claims.

Claims

claims

1. Inhalation device (1) for inhalation of at least one active substance contained in a capsule comprising:

a swirl chamber (15) for receiving a capsule and for swirling capsule contents,

- At least one air inlet duct (13), and

- At least one Luftausleitkanal (14), wherein the Lufteinleitkanal (13) and the

Whirl chamber (15) and the Luftausleitkanal (14) are in fluid communication, and wherein the Lufteinleitkanal (13) and the Luftausleitkanal (15) extend at least partially in opposite directions.

2. inhalation device (1) according to claim 1, wherein the Lufteinleitkanal (13) at least partially tangential to the vortex chamber (15).

3. Inhalation device (1) according to claim 1 or 2, with a with the Luftausleitkanal (14) in fluid communication standing mouthpiece (21).

The inhalation device (1) according to any one of the preceding claims, wherein the air introduction passage (13) has an inlet disposed in a portion of the inhalation device (1) outside the areas provided for holding / grasping by a user upon inhalation is, preferably adjacent to or near the mouthpiece (21).

5. Inhalation device (1) according to one of the preceding claims, wherein the air introduction channel (13) has an outlet which opens into a lower region of the vortex chamber (15) and / or laterally into the vortex chamber (15).

6. Inhalation device (1) according to one of the preceding claims, wherein the Luftausleitkanal (14) has an inlet which is connected to an upper region of the vortex chamber (15). is in fluid communication, and has an outlet, and the Luftausleitkanal (14) extends between the inlet and the outlet arc or S-shaped.

7. Inhalation device (1) according to any one of the preceding claims, wherein at the beginning of the inlet of the Luftausleitkanals (14), a grid (17) is arranged.

8. Inhalation device (1) according to one of the preceding claims, wherein the Luftausleitkanal (14) in the direction downstream of the vortex chamber (15) has an increasing and / or decreasing cross-section.

0

9. Inhalation device (1) according to one of the preceding claims, arranged in the Lufteinleitkanal (13) and / or in Luftausleitkanal (14) and / or in the vortex chamber (15) one or more recesses and / or protruding structures and / or formed are.

5

10. Inhalation device (1) according to one of the preceding claims, with at least one the Luftausleitkanal (14) at least partially surrounding additional channel (41) for generating an additional air flow. 0 1. An inhalation device (1) according to any one of the preceding claims, wherein the

Whirl chamber (15) has a receptacle (9) for receiving a capsule.

12. Inhalation device (1) according to claim 11, wherein the receptacle (9) is designed to hold a capsule positively and / or non-positively.

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13. Inhalation device (1) according to one of the preceding claims, with a cutting device (11) for opening a capsule.

14. Inhalation device (1) according to claim 13, wherein the cutting device (11) o at least one movable cutting element (27).

15. Inhalation device (1) according to claim 14, wherein the at least one cutting element (27) first intersects with the tips (33) of its cutting edges (29) the capsule.

16. Inhalation device (1) according to claim 14 or 15, with an actuating element (25) for actuating the cutting element (27).

17. Inhalation device (1) according to any one of claims 13 to 16, with a spring element (37) to keep the cutting device (1 1) biased in a retracted position.

18. Inhalation device (1) according to one of the preceding claims, with an upper part (3) and a lower part (5), which are coupled together.

19. Inhalation device (1) according to claim 18, wherein the upper part (3) and the lower part (5) are pivotally connected, preferably such that the upper part (3) between an open position for removal or reception of a capsule and a closed position to Inhalation is movable.

20. Inhalation device (1) according to claim 19 as far as dependent on claim 16, with a securing mechanism which is able to prevent actuation of the actuating element (25) in the open position.

21. Inhalation device (1) according to any one of the preceding claims, with a further securing mechanism, the inhalation in operation of the

Can prevent actuator (25).

22. An inhalation device (1) according to one of the preceding claims with a specific device resistance of 0.027 to 0.050 kPa ° '^5> L / min, resulting in flow rates of 40-75 L / min at 4 kPa pressure drop across the inhalation device (1); preferably from 0.031 to 0.044 kPa ^{o> 5} L / min, resulting in flow rates of 45-65 L / min at 4 kPa pressure drop across the inhalation device (1); more preferably from 0.036 to 0.040 kPa ° ' ⁵ »L / min, resulting in flow rates of 50-55 L / min at 4 kPa pressure drop across the inhalation device (1).

23. A method for inhaling at least one active substance contained in a capsule comprising the steps:

- Inserting a capsule in a swirl chamber (15) arranged and formed capsule receptacle (9) of an inhalation device (1) according to one of the preceding claims;

- Opening the capsule with a cutting device (11) according to any one of claims 12 to 18;

Sucking air through a mouthpiece (21) via an air inlet channel (13) and an air outlet channel (14) according to one of claims 1 to 9,

in which

the capsule is vibrated and rotated by the flow of air within the vortex chamber (15); so that the capsule is emptied.