HUT64242A - Inhalator and method for inhaling - Google Patents

Abstract

A process is disclosed for dosing a preferably powdery inhalation composition. The composition is brought from a reservoir into an inhalation stream generated by the inhaling person and channeled in such a way that the inhalation stream swirls at the same time, dissolving and distributing the composition in the stream. The inhaler for applying the process has a dosing element (25) movably mounted within limits in an outlet (24) of the reservoir (21) in such a way that a lateral dosing recess (26) is located, in one of its extreme positions, within the reservoir (21) and in its other extreme position within the inhalation channel (11). The dosing element is actuated by the inhaling person by means of a spring element (30) or closing cap for the mouth (12) of the inhalation channel (11). Each displacement of the dosing recess (26) from the reservoir (21) into the inhalation channel (11) releases a dose of composition for inhalation. The inhaler has a vibrating mechanism that keeps the powdery composition loose and flowable. In addition, the inhaler may have a locking mechanism (3) that stops dosing when inhalation is not sufficiently strong and/or a dose counting mechanism.

Description

Inhalation is a well-known method of delivering, for example, a drug for absorption to the airways and lungs. A variety of different inhalers for carrying out the process have been introduced on the market to deliver a liquid or powder formulation, either by pressure or propellant, to the oral cavity or in front of the oral cavity and then inhaled into the respiratory tract. The actual active dose thus depends not only on the actual dose that can be recovered from the inhaler, but also on the particle size and the inhalation strength. The larger the particles are, the more likely they are to be separated from the air stream and deposited not in the airways but in the oral cavity; the weaker the airflow the inhaled patient generates, the more particles are released from the airflow and deposited in the oral cavity.

To ensure that the actual active dose is the same for each inhalation, the inhaler should be designed to first emit an equal amount of dose each time, secondly to keep the particle size of the formulation in the air stream as constant as possible. the patient has defined inhalation! to force. This is the case, for example, with the inhaler device disclosed in the same patent application as the patent application 02500 / 90-4 CH. The inhaler is provided with a reservoir in the form of a solution or suspension in the form of a liquid, and a dose of a given amount is manually sprayed into a inhalation passage through a nozzle. A locking mechanism ensures that dosing and spraying are only possible if the inhaler is a specific, possibly adjustable, inhalation! it exerts a force, that is, only if it generates a large flow of air to the oral cavity in the inhalation passage which is capable of delivering a sufficient dose of the composition to the respiratory tract. The process and inhaler disclosed in said patent are for use only in liquid formulations, that is to say, for solid formulations, only when dissolved or suspended in a solvent or propellant.

It is an object of the present invention to provide a method and inhaler device for delivering a powder formulation to a patient's inhaled air stream without the use of a solvent or propellant. Distribute the preparation as evenly as possible over the inhaled air. The dosing process should be triggered manually by the inhaler; only one dose can be delivered per actuation, so that the inhaler can easily control the inhalation, knowing that he receives only one dose each inhalation.

The object is solved by the method according to the invention as well as by the independent process claim for the administration of an inhalation composition for inhalation (preferably in powder form) and by the inhalation device according to the invention described in the independent claim for the device.

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In the process of the invention, the air stream created during inhalation (inhaled air) is diverted into an inhalation passage and a dose of the composition from the reservoir is delivered to the inhalation passage so that swirling uniformly distributes the composition in the air flowing through the inhalation passage. Swirling is created by a hammer body located in the inhalation passage, which is shaped such that swirl occurs behind the hammer body. In this way, a dose of formulation is delivered to this swirling area by the air stream. In the case of powder formulations, the pre-vibration ensures that the powder is loose and, as far as possible, consists of particles of uniform size that can be easily captured by the swirling air stream; if the composition is a liquid, solution, or suspension, it is sprayed under pressure into a vortex air stream.

Inhalation required for inhalation! The force of the inhaler according to the invention is provided by being provided with a locking mechanism which allows metering only when the airflow generated by inhalation in the inhalation passage of the inhaler reaches a certain value. The inhaler may also have an embodiment in which the inhalation force required for dosing can be adjusted by the inhaler. The advantages of such a locking mechanism are described in detail in the aforementioned patent application filed by the same Applicants, which are believed to be known herein.

Inhalers without a locking mechanism are designed for inhalers who cannot be expected to generate a strong airflow or who are not expected to coordinate initiation of dosing and inhalation.

In these devices, the inhalation port through which the patient inhales the composition is closed with a cap and dosing is triggered by removal of the cap. Replenishment will only occur if the closure cap is replaced and then removed from the opening. Thus, the inhaler can only inhale a single dose of formulation at each inhalation.

The invention and the inhaler according to the invention will now be described in more detail with reference to the drawings. The attached swarm is a sigh

Figure 1 illustrates the principle of airflow engulfing a dose of formulation; the

Figure 2 is a sectional view of a possible embodiment of the inhaler device according to the invention with a manual and locking mechanism at rest; the

Figure 3 is a diagram of the inhaler device of Figure 2 in a dosing position, i.e., when a dose is administered for inhalation;

the

Figure 4 is a sectional view of another embodiment of the inhaler device according to the invention with the lever actuated at rest; the

Figure 5 is a drawing of the inhaler of Figure 4 in a dispensing position; the

Fig. 6 is a sectional view of another embodiment of the inhaler device according to the invention in a rest position without a locking mechanism with a dose-triggering closure; the

Fig. 7 is a drawing showing the resting or dosing position of another possible embodiment of the inhaler of Fig. 6 with a closure cap; the

Figures 10 and 11 are two drawings of another possible embodiment of the inhaler according to the invention, similar to Figures 8 and 9; the

Figures 12 and 13 are two drawings of another possible embodiment of the inhaler according to the invention, similar to Figures 8 and 9; the

Figure 14 is a sectional view of a portion of another embodiment of the inhaler device for vibrating the composition; the

Figure 15 is a partial drawing of a portion of another embodiment of the inhaler of the present invention for returning the dispensing member to a rest position; the

Figures 16, 17 and 18 are drawings of containers of other possible embodiments of the inhaler device of Figures 12 and 13; the

Figures 19 and 20 are diagrams of various possible embodiments of the tank level indicator; the

Figures 21 and 22 are drawings of another embodiment of the inhaler according to the invention, wherein the dose of composition is sprayed into the air stream; the

Figures 23 and 25 are cross-sectional views of another embodiment of the inhaler device according to the invention in a resting or dosing position; the

Figures 24 and 26 are plan views of the inhaler of Figures 23 and 25 respectively; the

26 is a side elevational view of the inhaler device of FIGS. 23 and 25 (viewed from the rear of the device to the mouth opening); the

Figure 27 is a top plan view of another embodiment of the inventive inhaler; the

Fig. 28 is a perspective view of one half of the inhaler device of Fig. 27 with respect to the division plane; the

29-34. Figures 23-26 of the inhaler device according to the invention; Figs. the

35-37. Figures 3 to 5 are partial sections of the mouthpieces of a possible embodiment of the inhaler according to the invention; the

38-40. FIGS. 4A are partial drawings of various possible embodiments of the injection molded cavity; the

41-43. Figures 1 to 5 are drawings of various possible embodiments of the container of the inhaler according to the invention; the

44-47. Figs. 4A are partial drawings of various embodiments of sealing the dispensing device of the present invention between a dispensing member and a container; the

48-50. Figures are diagrams illustrating various methods of vibrating the air stream; the

51-55. Figures 1 to 5 are detailed diagrams showing various possible methods for generating mechanical vibration in the inhaler device of the present invention.

Figure 1 schematically shows an air stream L in the inhalation, into which an obstruction body W, for example cylindrical, extends perpendicular to the flow direction. A turbulent flow field forms behind the trough body W and this turbulence sucks in the material in the feed cavity D, which is then trapped by the air stream. The sharper the surface of the body of W facing the flow direction, and the steeper the surface of the body downstream, the stronger the vortex formation behind the body of W. A cylindrical body - such as as shown in the figure, it produces a smaller swirl than, for example, a wobble body W whose back surface is perpendicular to the direction of flow. However, the cylindrical wedge body W has the advantage over all other shaped wedge bodies that there is a seal between it and the container which allows movement of the W wedge body relative to the container; the delivery mechanism of the invention takes advantage of this advantage.

Figures 2 and 3 show an embodiment of the inhaler according to the invention. This is a device that can only deliver a dose of the product if the user is inhaled! exerts power. As a locking mechanism, a ball is used which is placed in a passageway at an acute angle to the direction of gravity. At rest (no or only very weak airflow), the ball locks the feed operation. If the airflow is strong enough, the ball in the passage will move out of position and allow dosing.

The two most important parts of the inhaler according to Figures 2 and 3 are an inhalation device 1 and a metering device 2. It is also the function of the inhaler device 1 to direct the air stream generated during the inhalation. 2 and 3

Embodiment 2 is also provided with a locking mechanism 3, previously mentioned, which is released by the same air stream. The purpose of the delivery device 2 is to deliver a dose of the composition for inhalation into the inhalation passage so that the composition is captured by the air stream and delivered to the patient's respiratory tract. The dispensing device 2 comprises a container 21 for storing a preferably powdered composition and a dispensing mechanism 22.

The inhalation device 1 has an inhalation passage 11, one end of which is an orifice 12 facing the inhaled patient and the other end is an air passage 13, which is preferably narrowed relative to the inhalation passage 11. When inhaled, the patient places his mouth at the mouth 12 and, inhaling, creates a flow of air from the airway 13 to the mouth 12 in the inhalation passage 11.

There is also another passage in the inhalation device 1 (the ball passage 10 containing the ball), which enters the inhalation passage 11 near the mouth opening 12 through the connection opening 15. The ball passage 10 is designed such that, starting from the connecting passage 15, it closes at an acute angle with the gravity space when the inhaler is in the correct inhalation position (i.e., as shown in Figures 2 and 3). An inlet 17 or 17 'is connected to the lower end of the ball passage 10. The diameter of the ball 16 and the ball passage 10 are selected relative to one another so that the ball 16 can move freely in the ball passage 10, but the connection opening 15 and the inlet 17 (or 17 ') are narrower so that the ball 16 You can't get out of a 10-ball flight.

When the inhaler is held in the inhalation position, the inhaler must be in the position indicated in section 16

- 10 balls are driven by gravity to the lower end of the 10 ball passage (Fig. 1 - Resting position). If the patient inhales, an inhalation passage 11 generates an airflow L, but the 10 ball passage generates an airflow L ', which, provided it is strong enough, moves the ball 16 from the bottom of the 10-ball passage toward the upper end (Fig. 3 - Dosing position). As soon as the ball 16 is sufficiently spaced from the bottom of the ball passage 10, the latch 23 of the dispensing mechanism 22 can move downward in a hole 18 into the ball passage 10, and dispensing is possible.

The reservoir 21 is disposed in a line 14 of the inhalation device 1 above the inhalation passage 11 (the metering position of the inhaler), and its bottom is provided with an outlet 24 which opens into the inhalation passage 11. The container 21 is preferably tapered towards the bottom. The dispensing opening 24 is fitted with a dispensing part 25 which is movable from the outside and has a dispensing cavity 26 formed at its lower end. The dispensing part 25 is fitted to the discharge opening 24 and can move sealingly therebetween; the dispensing cavity 26 is located in one end position (rest position) of the dispenser component 25 inside the container 21 and in the other end position (dispensing position) outside the container 21 into the inhalation passage 11. The latch 23 is secured to the underside of the dispenser 25 outside the container 21. As already mentioned, the latch 23 extends through the hole 18 into the sphere of motion of the ball 16 and, depending on the position of the ball 16, prevents or permits dosing.

The metering cavity 26 in the metering component 25 is configured such that, when the metering cavity 26 is in the inhalation passage 11, the metering cavity 25 is viewed from the direction of flow. · · · · * »··« ·· · «· ··

It is behind 11 parts, ie facing the mouth 12. The dispensing cavity 26 is shaped such that the whirling of the air stream is completely permeable, i.e., as flat as possible, narrow or pointed, and has an easily accessible surface. Its volume, which is defined by its inner surface and the continuous surface of the dispensing member 25, is selected to be able to absorb an inhalation dose of the composition.

The dispensing component 25 is embedded in a discharge assembly 33 in the discharge opening 24. The retainer assembly 33 seals the container 21 while also ensuring that the dispensing cavity 26 delivers exactly one dose of composition from the container 21 to its volume. As already mentioned, the triple function of the retaining assembly 33, provided that the dispensing part 25 is cylindrical, is easily accomplished by a cylindrical seal. The seal is preferably rectangular in cross-section, but may also be formed of two superimposed O-rings.

The container 21 is closed at the top by a lid 27, which (in contrast to the discharge opening 24) also has an opening 28 through which the dispensing part 25 can pass, while being closed. Preferably, the portion of the dispensing component 25 passing through the orifice 28 is smaller than the portion passing through the orifice 24. The dispensing component 25 is also embedded in the opening 28 of the lid 27 in a mounting assembly 33 'which is also a seal for the container 21. Since the portion of the dispensing component 25 through the opening 28 of the cover 27 is preferably also cylindrical, the fastening assembly 33 'may also be an O-ring or similar sealing member.

At the upper end of the dispenser portion 25 is a head portion 29 which is rigidly attached to a resilient member. THE ·

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The resilient force of the resilient member 12, acting against the force of gravity, holds the dispenser component 25 at rest and returns it from the extended position to the rest position. The resilient member may be, for example, a hemispherical resilient accordion 30 that is rigidly attached or merely rests on the cover 27; it is provided on the inside with a locking member 31 which, like a rigid fastener, secures the head 29 to the bellows 30. The actuation of the dispenser 25 is achieved by manually applying pressure to the bellows 30 in the direction of the inhalation passage 11 and releasing the pressure to regain its original shape and return the dispenser 25 to its rest position.

The range of movement of the dispenser 25 is limited, for example, so that the latch 23 is in contact with the lower wall of the inhalation passage 11 in one direction and the lower wall of the container 21 in the other direction.

Because the composition is preferably in powder form, the interior of the container 21 is shaped such that the composition can easily flow down toward the discharge port 24. Therefore, there is no bottom sealing surface inside the container 21: the lower wall of the container 21 and, for example, the taper of the dispensing part 25 are inclined downwards.

In order to ensure that the powder can freely bounce downward (toward the drain opening 24 and the dispensing cavity 26), it is advisable to design the dispensing device 2 so that the powder is vibrated automatically before and / or during operation, and thus gravitationally. force can roll off more easily. In the example shown in Figures 2 and 3,

13 results in that the bellows 30 is deformed by hand to a certain extent due to its shape, whereby it automatically snaps into its end position and when released, automatically bounces back to its untensioned position; its movement is not smooth. As a result of the two jerky movements, the powder in the reservoir 21 is vibrated twice each time it is inhaled, so that it remains in a loose state and is subject to gravity.

If the patient wishes to inhale, the inhaler is lifted with its mouthpiece 12 to the mouth, breathing deeply while pressing one of the fingers with the accordion 30. This creates the airflow L and L '. Due to the airflow L ', the ball 16 moves upward in the 10-ball passage. If the airflow L 'is strong enough, the ball 16 passes below the latch 23 and the latch 23, and with it the metering member 25, can move downward under the pressure of the finger until the latch 23 reaches the lower end position and the dispensing cavity 26 do not enter the inhalation passage 11 (dispensing position). The aforementioned shock movement of the bellows 30 ensures that as the dispensing member 25 moves downward, the composition vibrates and moves the dispensing cavity 26, moving toward the discharge opening 24. At the end position of the dispenser 25, the composition in the dispenser cavity 26 is sucked out by the swirling air stream L and carried with it to the inhalation airway of the inhaler. Relieving pressure on the bellows 30, the dispensing member 25 rises again; then, at the end of the inhalation, the bullet 16 in the 10-ball passage rolls back into place and the device returns to the rest position.

Patients who are unable to breathe properly! force the inhaler with 12 mouthpieces of the device • · · · · · · · · ·

They may also hold the mouth 14 in their mouths so that the ball passage 10 is inclined towards the connection opening 15 so that the ball 16 will leave its place under the influence of gravity, and so may be dispensed.

Preferably, the lower end of the ball passage 10 is closed by a plug 19 which may be provided with an inlet 17 '. This simplifies the assembly of the device, since the ball 16 only needs to be inserted into the 10-ball passage when the device is ready and then the plug 19 has to be replaced. The plug 19 must be dimensioned such that the center of the resting ball 16 is farther from the connection opening 15 than the axis of the latch 23. By designing a closure cover or slider, or by designing the plug 19, it is possible to adjust the cross-section of the inlet 17 or 17 'by the inhaler. In the case of a person of very good strength, a minimum cross-sectional opening is sufficient, or even completely absent, and the inlet opening 11 of the inhalation passage 11 serves as the inlet opening of the balloon passage. In addition, the ball 16 may be made of heavier metal or may be made of ferromagnetic material and the plug 19 may be provided with a magnet.

In the embodiment of the inhaler according to the invention shown in Figs. The removable insert includes a container 21, a lid 27, a dispenser 25 with a latch 27, and a bellows 30 attached to the head 29. The cartridge is inserted into the pipe 14 to the dispenser cavity 26 facing the mouth opening 12, 11 and 23 lock the inhaler · «· * · Λ« V • · · · · · · 0 * • Λ ^«β · · Enter hole 18 between passage and 10-ball passage. In order for the insert to be easily and correctly inserted into the conduit 14, the dispensing part 25 is preferably gripped so that it cannot pivot in the container 21; for example, between the container 21 and the bellows 30 there is provided an anti-rotation machine element, the container 21 having a vertical groove and the conduit 14 having an inwardly fitting rib, the latter being also a wall of the airway 13. Thus, the insert can only be placed in a certain position in the conduit 14, so that the rib is in the groove. If the wall of the container 21 is slightly elastic (at least around discharge port 24) and / or shaped, the insert inserted into the opening of the inhalation passage 11 will be adequately secured in place by the forces applied and / or closed.

It is definitely advantageous for the inhalation device 2 to have a dispensing device in the form of a replaceable cartridge, since it is not necessary to dispose of the device once the composition is exhausted and because the volume of the container having regard to the expiry date of the composition prevents aging of the composition.

Figures 4 and 5 show another embodiment of the inhaler device according to the invention, which in its most important parts and mode of operation is similar to that of Figures 2 and 3. Therefore, like parts have the same reference numerals.

The bellows 30, to which the dispensing component 25 is fixed, similar to the embodiment of Figures 2 and 3, is not actuated by finger pressure, but by a lever 41 secured to the conduit 14 by a pin 42. When the 41.1 end of the arm 41 is lifted, the other 41.2 end tumbles against the accordion 30 and squeezes it.

As shown in Figures 3 and 4, the arm 41 may be hollow and thus at least partially surround the bellows 30. In addition, the bellows 30 may have grooves 43 and at least one rib on the inner surface of the arm 41, which are frictionally engaged when the arm 41 is actuated. The friction in the bellows 30 generates a vibration which extends to the container 21 and also causes the composition to vibrate.

6-11. The various possible embodiments shown in FIG. 1B are advantageous for the patient who has only a small inhalation. they are capable of exercising power who have movement coordination problems or who have difficulty operating the inhaler with one hand or one finger! position. They do not have a locking mechanism, so the dosing device does not have to be activated during inhalation. But also in these embodiments, inhalation from resting position! position the inhaler, eg. by opening a closure cap which otherwise closes the mouth opening. By opening the cap, the dispensing part becomes operable or moves directly into the dispensing position. The main advantage of these embodiments is that only one dose is delivered from the inhaler with each inhalation. Between two doses, the cap must be closed at the mouth, that is, the inhalation must be interrupted and the device restored to its resting position.

6-11. Embodiments of the embodiments of Figures 1 to 4, like the above-described embodiments, have the further advantage of having a closure cap that the mouth opening of the inhalation passage is closed so that it cannot become dirty and cannot be lost because the cap is attached to the device.

These embodiments are also shown in part views, partly in section, each in the rest position (Figures 6, 8 and 10) and in the dispensing position (Figures 7, 9 and 11).

In the embodiments shown in Figures 6 and 7, the inhalation passage 11.1 is angled: the portion of the inhalation passage 11.1 into which the composition is dispensed, similar to the shapes previously described, is perpendicular to the direction of movement of the dispensing member 25 to the orifice 12. The viewer portion, on the other hand, is parallel to the direction of movement of the dispensing member 25, so that in the inhalation position of the device (shown), the dispensing member 25 is moved horizontally. In order for the inhalation passage 11.1 to be easy to clean despite its angular shape, it is desirable to provide access to the mouth opening portion 12 by means of an opening 64 and a lid 65.

The inhaler is provided with a closure cap 62 which is pivotable about a spindle 61 and is connected to the dispenser 25 by a lever mechanism. In the drawings, only the lever part 63 directly connected to the dispensing part 25 is shown. When the closure cap 62 is pulled out of the mouth 12, the dispensing member 25 is moved into the dispensing position during the lifting 63. When the closure cap 62 is closed to the mouth opening 12, the dispensing member 25 is a resilient member (see FIG.

15) or the upper t · of the lever 63 and the feeder 25

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a curved component integrated between the ends of the unit returns to its rest position.

Figures 8 and 9 show a further embodiment of the inhaler according to the invention with a closure cap. The upper portion of the container 21 and the dispensing part 25.2 is similar to the one shown in FIGS. and therefore, these parts are not shown.

The inhalation device 1.2 has no locking mechanism; it consists of only one inhalation passage 11.2 and the associated conduit 14 receiving the reservoir 21. An inhalation passage 11.2 is provided with an upper opening 91 into which the outlet 24 of the container 21 opens and a lower opening 92 opposite the upper opening 91 which is at least as large as the cross-section of the dispensing part 25.2. The mouth opening 12 is closed by the closure cap 62.2; the cap 62.2 extends further along the lower wall of the inhalation passage 11.2 to a point beyond the lower opening 92. To expose the mouth opening 12, the closure cap 62.2 is a

11.2 Pull down and completely remove parallel to inhalation passage in the direction of arrow R. When the dispensing member 25.2 is at rest, it extends through the inhalation passageway 11.2 into the lower opening 92 and is locked above the closure cap 62.2 in place. Removing the cap 62.2 removes locking and allows the dispenser component 25.2 to be moved into the dispenser position through the lower opening 92. The actuation of the dispenser component 25.2 can be conceived simply by pressing its head with the finger (not shown). There is no need for a separate resilient element to return the dispenser 25.2 to the rest position: the closure cap 62.2 must be reinstalled to return the dispenser 25.2 to the rest position.

In order to vibrate the contents of the container 21, the lower wall of the inhalation passage 11.2 and the tongue extension of the closure cap 62.2 are provided with ribs 93 facing each other and perpendicular to the direction of movement of the cap 62.2. As a result of the interconnected ribs (Fig. 8), when moving the closure cap 62.2, the ribs of one component jump from the grooves between the ribs of the other component to the adjacent grooves, causing the whole inhaler to vibrate.

Figures 10 and 11 show another solution for locking the dosing operation with a closure cap 62.3. Again, the inhalation passage 11.3 is provided with a lower opening 92 into which the dispensing part 25.3 extends. Again, the closure cap 62.3 is shaped such that it extends completely through the bottom of the inhaler. The inhalation passage 11.3 is placed over the mouthpiece 12 as close as possible to the closure cap 62.3 with a flexible overlap. The side wall of the inhalation passage 11.3 is provided at the same location with the mouth opening 12 and the inside of the closure cap 62.3 with ribs 100 approximately perpendicular to the arcuate direction of movement of the closure cap 62.3. The interlocking ribs 100 vibrate the entire inhaler when the closure cap 62.3 is turned away from it.

Figures 12 and 13 show an embodiment of the inhaler according to the invention in which the dispensing component is not only restored to the rest position by the closure condition (as in the embodiments of Figures 8-11) but also brought into the dispensing position that is, the dosing itself is triggered directly by the removal of the closure cap. Since, in this case, the upper end of the dispensing part 25.4 extending from the container 21 in the opposite direction of the inhalation passage, the dispensing part 25.5 is only sealed with a deflection cone 120 over the container 21. The closure cap 62.4 is similar in shape to the closure cap 62.3 of Figures 10 and 11 and also fits elasticly over the wall of the inhalation passage. Opposite the lower opening 92 in the inhalation passage, the closure cap 62.4 also has a hole 121 which is so recessed on the outside that the guide eye 122 engaging therein, which engages with the lower end of the dispensing member 25.4, is not pulled out. from 121 holes.

When the closure cap 62.4 is pivoted from the mouth 12 for opening, the dispenser 25.4 is pulled into the dispensing position by the guide eye 122 held in the hole 121 (Fig. 13). Replacing the closure cap 62.4 a

The closure cap 62.4 again pushes the dispenser component 25.4, which is larger in cross-section than the smallest diameter of the hole 121, into its rest position.

In this embodiment, the vibration is solved by a handle 124 consisting of a rib 125 on the dispensing part 25.4 and a latch 126 thereon; the lug 126 may be secured to the container 21.4 or to the inner wall of the inhalation passage (around the discharge port 24).

In this embodiment, the range of movement of the dispensing part 25.4 is limited by the leading eye 122, whose leg 123 is held in the hole 121 of the closure cap 62.3, and on the other by the cone base 120 on the dispensing part 25.4. · * · «·· • · · · * trained 127 buffers.

Figure 13 is a partial view, partly in section, of

14.4 wire. Thus, a longitudinal opening 128 extending along the entire length of the container 21.4 is visible and allows the level of the composition in the container 21.4 to be controlled. For example, a scale 130 may be provided adjacent the longitudinal opening 128. 19 and

Referring to Figure 20, these level signaling solutions will be described.

The container 21.4 of the exemplary embodiment of Figures 12 and 13 may have other shapes than the containers of the examples described above, since the upper portion may be of any shape, provided that the actuation is not above. For example, it might be open (like

12 and 13) closed with a closure cover 129. Thus, for example, the container 21.4 may be refillable. The sealing lid 129 may also serve as a container for antifouling material. Figures 16, 17 and 18 further describe containers having only one opening for the dispensing component.

Figure 14 shows yet another embodiment of the inhaler device according to the invention in which the dispensing part 25.5 is to be actuated from above. In this case, the vibration is provided by a 124.4 handle mounted between a resilient member (e.g., an accordion 30.5) and a reservoir 21.5. For example, the bellows 30.5 is internally mounted with a toothed plate 141 and a pin 142 extends from the upper wall of the container 21.5 to the tooth; when the accordion 30.5 is squeezed, the pin 142 will jump from one to another in a row. There is a gap between the header of the dispenser 25.5 and the bellows 30.5 (or serrated plate 141). This ensures that the vibration starts earlier than 25.5

Movement of the dispensing component 22 and the dispensing cavity 26 fills before it reaches the discharge port 24. In fact, when the bellows 30.5 is compressed, the handle 124.5 first starts to operate, and the feeder part 25.5 comes into motion only when the gap between the bellows 30.5 (or toothed plate 141) and the feeder part 25.5 is closed. Movement is limited by the shoulder 141a of the serrated plate 141.

Given that in this embodiment, the 30.5 accordion a

The dispenser 25.5 cannot be returned to its rest position, a spring member 143 is inserted between the dispenser 25.5 and the upper wall of the container 21.5, which is also compressed when the bellows 30.5 is compressed and regains its original shape when depressurized to the bellows 30.5. 25.5 returns the feeder part to its rest position.

Fig. 15 shows another design spring element which is also suitable for returning the dispenser component 25.6 to a rest position. The spring element is mounted in the passage 11.6 and may, for example, take the form of a spring projection 151 which terminates at the bottom of the dispensing part 25.6; while the dispensing member 25.6 moves to the dispensing position, the spring projection 151 is retracted from the rest position.

Figures 16, 17 and 18 show containers of various possible embodiments. The individual shapes are the mode of preparation, the mode of filling, the mode of closure, the economy, etc. they differ from each other.

Figure 16 shows a container 21.7 having a wall 161 open at each end before being closed; the end of the roller 161 being further away from the inhalation passage is closed by a sealing lid 129.7 and the end facing the inhalation passage is sealed by a locking piece 162 integrating a sealing fixture 33.7.

Figure 17 illustrates a drawn or blown (e.g. glass) envelope 171 having a closure piece 162.8 with a sealing fixture 33.8 at the top (on the opposite side of the inhalation passage) and at the bottom (at the end facing the inhalation passage). closed.

18, a flange 181 is thermally welded to the sealing member 162.9 of the container. The flange 181 is thermally welded to a protective wall 182 of laminated material or film. The container may be reinforced with 183 columns (closed or partially divided) placed inside. With the exception of the 162.9 closure, which is relatively rigid, all other components are moderately flexible.

Figures 19 and 20 show various solutions of the tank level markings. A common feature of these is that they do not monitor the actual level of the composition in the reservoir, but rather calculate the number of doses dispensed using a device that is in communication with the dispensing device. Considering that, in the case of a removable container, the counting device also needs to be replaced, so as a disposable device it should be simple and inexpensive; in some cases, due to its construction, it may be compulsorily discarded: the construction of a counter device that precludes its being refitted to a refilled container.

In the dose counter structure of Fig. 19, a yarn 191 having an outflow section 192 of a different color is wound onto a ratchet wheel 194 as it passes through a sighting window 194. The ratchet wheel 193 is forcibly engaged with the metering device: it rotates one tooth further with each metering operation. The yarn 191 is thus gradually wound up, and finally, a different color run-out section 192 appears in front of the observation window 194, indicating that the composition in the container is about to run out. Such a structure may be located, for example, inside the hollow arm 41 (Figures 4 and 5).

Figure 20 shows another type of dose counter structure. In this structure, a nut 202 is wound on a spindle 201 and is visible from the outside. The nut 202 is provided with a projection 203 which slides in a guide groove 204. The spindle 201 is in forced engagement with the dispensing device: it turns slightly further with each dispensing operation, while the nut 202 moves toward the expiration symbol 205 in the container.

21 and 22, the inhalation device 1 is similar to that of the embodiment of Figures 2 and 3. However, the dispenser 2.10 has a pressurized container filled with propellant gas, which is, of course, filled with a composition. The tank is provided with an outlet valve which can be operated manually as is the case with propellant cylinders. The pressurized container is positioned in the conduit 14 such that a

The sprayer opening 211 in the inhalation passage 11.10 faces the mouth 12 and the actuating button 212 rests on the bottom of the inner wall of the inhalation passage 11.10. When the reservoir is pushed in the direction of the inhalation passage 11.10 (Fig. 22), the outlet valve • · 9 9 9 · * • ♦ 9 · V · 4 4 * • ♦ 4 · · •••• «4 ·» 444

25 is actuated by actuating button 212 and the valve sprays a dose of formulation into the inhaled swirling air stream.

In the above embodiments of the inhaler device according to the invention, the dispensing cavity 26 may also be arranged such that the dispensing member has an angle of 180 degrees about its longitudinal axis. Alternatively, it can be arranged to rotate from two positions (0 or 180 degrees) at different angles between 0 and about 45 degrees.

Possible embodiments of the inhaler according to the invention are shown in Figs. Fig. 4a. These differ from the shapes described above in that the dispensing member is not substantially perpendicular to the air stream, but substantially parallel thereto, i.e., when the inhaler is used, the dispensing member moves approximately horizontally.

23-26. Figures 23, 24 show the dosing position (the dispensing component in the dosing position) and Figures 25, 26 show the dosing position (the dosing component in the dosing position). Figures 23 and 25 are sectional views and Figures 24 and 26 are top views.

As shown in the figures, the devices have a substantially rectangular or cylindrical housing 500 in which a tubular dispenser part 525 is disposed horizontally such that it is movable axially between the rest position and the dispenser position. The feeder part 525 may also be a solid rod. At the top of the housing 500 is a 512 mouthpiece. At the other end of the housing 500 is an actuating cap 550 which is slidable between a closed position (Fig. 25) and an open position (Fig. 23). The t

• ·

- 26,525 metering parts are kinematically coupled to the operating cap 550; the attachment point being about the middle of the top portion 552 of the operating cap 550. Thus, when the operating cap 550 is moved between its two end positions, the dispensing member 525 moves with it between its two end positions.

In the front half of the housing 500 there is formed a funnel-shaped container 521 which terminates in a discharge opening 524; the discharge opening 524 is blocked by the longitudinal movement portion 525. The container 521 is closed at the top by a lid 527.

At the rear of the housing 500 is a dose counter mechanism including a counter gear 580, a latch 581, a driving pin 582, a stop pin 583, and a moving cam 584; the latter being mounted on the dispenser part 525 and moving with it. Each time the dispensing member 525 moves from its rest position (Fig. 25) to its dispensing position (Fig. 23), the cam 584 will strike the latch 581 and continue to rotate it with one tooth. At the end of each complete revolution, the latch 581 rotates the counting gear 580 with one tooth using the drive pin 582. The counter gear 580 is provided with a scale that can be read through the window 553 on the operating cap 550.

The tubular dispenser portion 525 is resiliently secured to a portion of the front and rear of the container 521 by mounting in a retaining assembly 533 and 533 '; 44-47. Figures 4 to 5 are described in more detail. In the dispensing part 525, a dispensing cavity 526 is formed, the location of which is selected so that the dispensing part 525 is in place.

- it falls into the mouthpiece 512 at rest position 27 and is placed below the discharge opening 524 in the feed position of the dispenser part 525. For details of the dispensing cavity 526, see Figures 38-40. Figure 4a.

The mouthpiece 512 has an outlet 513 at its front and two or more air inlets 514 on its sides. The air inlet passages 514 are directed to the dispensing cavity 526 when the dispensing part 525 is at rest and thereby create the vortex discussed above. The shape and arrangement of the air inlets 514 are described in more detail in FIGS. 4 to 8.

At the bottom of the housing 500, a corrugation 505 is formed which engages a cam 554 formed at the end of a vibrating spring tongue 555 extending from the top of the operating cap 550. The spring tongue 555, as clearly shown in Figure 26A, is separated from the rest of the operating cap 550 by two slits 556 formed in the sidewall of the cap 550 and the top portion 552. Sliding the actuator cap 550 from one end position to the other end position causes the spring tongue 555 to vibrate mechanically, which, through the actuator cap 550, extends to the dispenser part 525. Another cam 557 formed approximately in the center of the spring tongue 555 also transmits vibration to the housing 500 so that the inhalation composition in reservoir 521 is vibrated. Vibration induction is discussed in more detail in pages 48-55. Figures.

23-26. The treatment of the inhaler according to the embodiment of FIG. 1B is essentially the same as the inhaler devices already described. Before inhalation, the dispenser 525 should be moved from its rest position as shown in Figure 25 to the dosing position as shown in Figure 23. 550 operating caps. Due to the force of gravity, which is exerted by the vibration generated in the container 521 and by the displacement of the dispensing part 525, the dispensing cavity 526 is filled with an inhalation volume corresponding to its volume. Then the dosing part should be returned to its resting position - which is also inhalation! position - and lift the device to the mouth. Inhalation causes airflow in the air inlet passages 514 of the mouthpiece 512 to swirl around the dispensing cavity 526. The inhalation formulation is swirled out of the dispensing cavity 526 and finely dispersed in the air stream. Finally, the air stream, together with the inhalation formulation mixed with it, enters the patient's airways through the mouthpiece 513 of the mouthpiece 512.

FIG. 1 to 4, which is optimized for plastic injection molding technology. The figure shows the device without the operating cap in the plane of division. The figure shows that the housing 600 and the mouthpiece 612 are made in one piece. In addition to the upper air inlet passage 614, the mouthpiece 612 is provided with an inlet passage 615 which projects into the mouthpiece 612 near the outlet port 613 and may contribute to further optimize airflow conditions by appropriate sizing.

It is also shown in Fig. 28 that, as in other embodiments, the container 621 is substantially double-conical, i.e., a narrowing 628 is formed above the discharge opening 624. Thus, the narrowing 628 and the discharge opening 624 or the dispensing part (no • · ♦ ·· ♦

299), pockets 629 are formed which are filled with an inhalation composition; Thus, proper filling of the metering cavity and thus accurate metering is assured even when the inhaler is inclined.

Two grooves 633 are provided for the fittings for securing the dispenser component (not shown).

The vibration-inducing mechanism differs slightly from Figs. 23-26. 6b, since the tongue 655 is not part of the operating cap (not shown), but of the housing 600 and is provided with a corrugation 605, while the operating cap has a cam which abuts the corrugation 605. However, the working principle of the two vibration generating mechanisms is the same. The base of the tongue 655 is connected to the portion of the housing 600 surrounding the container 621 by a stem 670 having an opening 671; the stem 670 transmits the vibration caused by the tongue 655 directly to the container 621. At the upper end of the housing 600 there is also another tongue 690 with a cam 691 at its free end, which is located in a corrugation formed on the operating cap (not shown in Fig. 28) and also acts on the container 621. This vibration is led by a shaft 692 to the container 621.

Figure 27 is a top plan view of some of the different details of the inhaler. A further vibration-generating mechanism is shown which is in direct contact with the portion of the housing 600 forming the container 621. One part of the vibration generating mechanism is the corrugation 693 formed on the operating cap 650 and the other part is the cam 694 on the outside of the container 621. The container 621 is also provided with undercuts 695 and 696 which also help the container 621 to vibrate. If the various vibration-inducing mechanisms and modes of vibration are found in the a • • ♦ ♦ ♦ <<<<<<<

Selected and combined with the properties of the 30 individual inhalation formulations, if necessary combined, it is possible to dispense even problematic, propensity-responsive inhalation formulations and deliver very small doses (less than 0.1 mg) accurately and reliably.

29-34. Figs. The mouthpiece 712 shown in Figures 29 and 30 is provided with four rectangular air inlets 713-716. This embodiment is particularly suitable for the rectangular metering cavity of Figure 38. Figures 31 and 32 show a mouthpiece 722 having two upwardly sloping inclined passageways 723 and 724 and a downwardly inclined air intake passage 725. The mouthpiece 722 is designed for the oblique dispensing cavity of Figure 39, but can of course also be used for other embodied dispensing cavities. Finally, the spout 732 shown in Figures 33 and 34 is provided with two lateral air passages 733 and 734 perpendicular to the longitudinal axis and an upper oblique air inlet 735. The shape and arrangement of the air inlets, which also takes into account the shape of the metering cavity formed on the metering member, ensures optimum emptying of the metering cavity and mixing the inhalation formulation into the air.

Figures 35-37 are sectional views of various possible embodiments of a mouthpiece 512. 35, the front end of the tubular or rod-shaped dispenser portion 525 is provided with a streamlined tip 745 extending almost to the outlet of the mouthpiece 512. The tip 745 provides further vortexing to disperse the possibly undistributed additives of the inhaled formulation mixed with air.

• · · «·» ·

Β «« * «« «♦ ♦» - »» »

The same purpose is shown in Figs. 36 and 37 for the trough bodies 746 and 747, which are positioned slightly forward of the feed cavity 526 at rest. Of course, the shape of the tip 745 and the tine body 746 or 747 may be influenced by flow conditions and other requirements.

38-40. Figures 5 to 9 show some embodiments of the dispensing cavity formed on the dispenser part 525. The dispensing cavity 750 shown in Figures 38 and 40 is substantially rectangular in shape and is delimited by two rectangular walls 751 and 752, so that the actual cavity itself has an eighth shape. The dotted lines in Figure 38 illustrate that walls 751 and 752 may be further subdivided into four separate walls. The dispensing cavity 760 of Figure 39 consists of two diagonal recesses 761 and 762. Both embodiments 750 and 760 are relatively short in the longitudinal direction of the dispenser portion 525, so that the normally flexible fastener assembly 533 of the dispenser portion 525 cannot penetrate the cavity, regardless of the position of the dispenser portion 525; This ensures accurate, constant dosing.

41-43. Figure 5B shows a container 521 in one embodiment; the cap is removed. Fig. 41 is a top plan view, Fig. 42 is a section perpendicular to the longitudinal direction of the dispensing part 525, and Fig. 43 is a cross-sectional view of the container 521.

It can be seen that the container 521 is provided on both sides of the dispensing part 525 with a slanting surface 771 and 772 extending almost to the dispensing cavity 526. The extending surfaces 771 and 772 guide the inhalation composition optimally into the dispensing cavity 526. In addition, the 521 tank 524 drains · · · · · · ··············································•

The aperture 32 has a larger dimension in the longitudinal direction of the dispensing part 525 than the dispensing cavity 526, so that the latter is held under the discharge aperture 524 for a longer period of time during its movement and can be properly charged.

44-47. Figures 3 to 5 show some possible embodiments of the mounting assembly required for the proper operation of the dispenser part 525.

The fastening assembly shown in Fig. 44 is split

781 and 782 are composed of O-rings. In the case of Fig. 45, the assembly comprises two superimposed O-rings 783a and 783b on each side. 46, two adjacent O-rings 784a and 784b are formed on each side. In the case of Fig. 47, the assembly consists of only one O-ring 785 on each side, but these are also supported by an inclined shoulder 786 of the dispensing member 525. A common feature of the solutions is that, on the one hand, the assembly exerts only a relatively mild pressure on the surface of the dispenser part and, on the other hand, that it does not substantially dampen the vibration of the dispenser part due to the vibration generating mechanism.

It has already been mentioned that all embodiments of the dispensing component may be in the form of a tubular or a rod-shaped component. The tubular shape is more advantageous in that it is more vibrational! in terms of degrees of freedom, the characteristics of the inhalation formulation can be better considered than design.

Figure 48 illustrates a tubular dispenser component 825 which is hollow throughout and is provided with additional passageways 826 and 827 at its free end to modify flow conditions. If necessary, the inside of the front end of the tube may be widened (see lines 828 and 829). The rear end of the tube is extended by a short, smaller diameter 830 stub. This allows the tube, i.e. the dispenser part 825, to be gripped with the top portion 552 of the operating cap 550 so that the two are axially in a forced relationship, but the dispenser part 825 can nevertheless freely oscillate.

The tubular metering portion 835, opened at its rear end, is closed at the front by a tip 837 with a single orifice 836. The rear end of the dispenser 835 is provided with a flange 838 which fits into the recess 839 in the recess 552 of the cap 552 of the operating cap 550. Inside the dispenser part 835 is a resilient plate 840 which is acoustically vibrated by the air flowing in the dispenser part 835; with proper dimensioning, this vibration also helps fill the dispensing cavity 526.

In the embodiment of Figure 50, a disc 841 is disposed at the open end of the mouthpiece 512 which extends into the front end of the tubular dispenser portion 845. Alternatively, or additionally, there may be a plate 850 or the like between the dispenser portion 845 and the mouthpiece 512 which, by vibration of the air stream, also makes a tapping movement on the dispenser portion 845. This facilitates the emptying of the dispensing cavity 526 and allows the vortex to more easily grab the inhalation formulation.

Further vibration-inducing methods are described in Figures 51-55. Figure

- 34 described.

Figure 51 is a sectional view of the container 521 and the dispensing part 525 below it. Between the cover 527 and the dispenser part 525, a roller spring 860 is mounted movably. The lower end of the roll spring 860 is supported by a corner 861. When a vibration-generating mechanism vibrates the reservoir 521 and / or the dispensing part 525, the roller spring 860 starts to about dance and breaks the inhalation composition, aiding the exact filling of the dispensing cavity 526.

52, the handle 521 is diagonally suspended in the container 521, which engages in tapping action upon vibration. Thus, the blade-shaped head 871 of the handle 870 almost dips the inhalation formulation into the dispensing cavity 526.

Figure 53 is a detail of the section shown in Figure 25. This figure shows, in magnification, the corrugation 505 formed on the housing 500 and the spring tongue 555 forming part of the operating cap 559, with the cam 554 at the end. As shown, the corrugation 505 consists of different types of teeth that cause different types of vibrations. This allows the same inhaler to be used for inhalation compositions with different properties.

In the case of Fig. 54, instead of the cam 554, a riveted head rivet 880 is loosely secured to the tongue. Finally, Fig. 55 shows an embodiment in which the teeth of the corrugation 505 and the cam 554 of the spring tongue 555 are asymmetric, resulting in vibrations of different spectra in the two directions of movement. Obviously, not only at the bottom of the 500 houses, but also at the top, to vibrate

or you can place corrugations on its sidewalls. In addition to or instead of the stem 612 shown in Figure 28, additional cams similar to cam 694 protruding from the inner wall of container 621 and, for example, a cam such as cam 696 located outside the container 621, can cooperate to provide vibration shapes defined in container 621. created.

Finally, it should be noted that the corrugation on the housing or the actuator cap may provide a linear pattern, allowing for further vibration variations.

Claims (48)

Patent claims CLAIMS 1. A method of administering an inhalation composition, preferably a powder inhalation composition, comprising directing an inhaled air stream into an inhalation passageway and swirling at least a portion of the inhalation passageway, and delivering a dose of the composition from the reservoir to the inhalation passageway. swirling in the air stream moves and mixes it in the air stream. 2. The method of claim 1, wherein the administration is triggered by manual operation of a patient who inhales the composition. Method according to claim 1 or 2, characterized in that the composition is vibrated before and / or during actuation of the dispensing device. 4. A method according to any one of claims 1 to 4, wherein the actuation of the dispensing device is locked until the patient inhales the composition to produce a certain amount of airflow. 5. The method of claim 4, wherein the dispensing device is inhaled to unlock the dispensing device. · Si force can be set. 6. The method of claim 4 or 5, further comprising inhibiting actuation of the dispensing mechanism by a forced locking mechanism which is released by inhalation airflow when it reaches a certain strength, thereby enabling the dispensing mechanism to be actuated. Inhalation airflow is weaker and the locking mechanism automatically prevents re-dosing. 7. The method of claim 6, wherein said forced locking mechanism comprises a ball, said ball being movably disposed in a ball passage that closes at least one portion of said gravitational direction and is passed through an air stream. 8. A method according to any one of claims 1 to 4, wherein the locking mechanism is capable of being released by the patient inhaling the composition, if necessary, without inhalation. 9. The method of any one of claims 1 to 4, wherein a dose of the composition is delivered to the inhalation passage when the inhaler is brought from a resting state to an inhalation and a further dose is delivered only when the inhaler is returned from the inhalation state to the resting state. and then return to the inhalation state. 10. The method of claim 9, wherein a dose of the composition is dispensed into the inhalation passage when the inhalation passage is opened for inhalation, and a further dose is dispensed only when the inhalation passage is closed and then reopened. . 11. A method according to claim 1 or 2, characterized in that the composition is sprayed through a nozzle by pressurizing the eddy section of the air stream behind the dispensing part. An inhaler device for carrying out the method according to claim 1 or 2, preferably for inhalation of a powder inhaler, characterized in that it comprises an inhalation passage (11) into which a patient-generated air stream is directed and a reservoir (21). storing the inhalation composition in a loose state with a delivery mechanism (22) for delivering the inhalation composition from the reservoir (21) to the inhalation passageway (11) in portions, the delivery mechanism (22) being configured so that the inhalation composition half of it is airborne, it has. An inhaler according to claim 12, characterized in that the dispensing mechanism (22) has a dispensing part (25) with a side dispensing cavity (26) near one end, the dispensing part (25) being the emptying of the container (21). slot (24) for movement between two borders • · 4 · · · 4,444 · · · «« · · · · · · · ··· ····················································· 39 being able to enter the dispensing cavity (26) into the container (21) at one end position of the dispensing component (25) and outside the container (21) into the inhalation passage (11) outside the container (21). . 14. An inhaler according to claim 13, characterized in that the dispensing component (25) is also inserted through another opening (28) facing the discharge opening (24) of the container (25) (thus limiting its freedom of movement), and the head portion of the dispensing component (25) extending beyond said opening (28) is connected to an actuating and / or resilient structure. An inhaler according to claim 14, characterized in that a flexible bellows (30) is attached to the head portion of the dispensing part (25) and the flexible bellows (30) is used as both a manual actuator and a flexible structure. 16. An inhaler according to claim 14, characterized in that an elastic accordion used as a resilient structure is attached to the head of the dispenser component and a lever fixed to the operating member which is mounted on the inhaler so that when rotated it can deform. 17. A 12-16. An inhaler according to any one of the preceding claims, characterized in that it has a locking mechanism (3) by means of which the dispensing is prevented, V ♦ • 4 ♦ ♦ · ··· ·· · ·· - 40 if the inhalation airflow rate is below a certain level. 18. An inhaler according to claim 17, wherein the locking mechanism has a ball that is movably disposed in a passageway, the passageway being an inhalation device. In its position, it closes at an acute angle with the direction of gravity and is at least in one section passed by an air stream, and the latch (23) of the metering mechanism (22) extends into the ball passage and can be locked in one end position by the locking mechanism. An inhaler according to claim 12, characterized in that the mouth opening (12) of the inhaler is closed by a closure cap (62) and the closure cap (62) is in forced engagement with the dispensing member (25). An inhaler according to claim 19, characterized in that the closure cap (62) is movably secured to the device and is in forced engagement with the head of the dispenser (25) through a lever assembly (60) such that the closure cap (62) ), when moving from a closed position to an open position, the head of the dispensing component (25) is forced to move towards the container (21). An inhaler according to claim 13, wherein the dispensing member extends as far as possible into the opening (92) formed in the wall of the inhalation passage opposite the discharge port (24). 22. An inhaler according to claim 21, wherein the end of the dispensing member provided with a dispensing cavity (26) is in forced engagement with the closure cap of the mouth opening. 23. A 12-22. An inhaler according to any one of claims 1 to 5, characterized in that it has a gap-inducing mechanism, the parts of which are moved relative to one another and which, when the inhaler is actuated or rested, causes the composition in the container to vibrate. 24. A 12-23. An inhaler according to any one of claims 1 to 5, wherein the dispensing device is a replaceable insert. 25. A 12-24. An inhaler according to any one of claims 1 to 4, characterized in that it has a refillable container with a closure lid (129) on the side opposite the discharge opening (24). 26. An inhaler according to claim 25, characterized in that the closure lid (129) is designed to also serve as a container for antifouling material. 27. A 12-26. An inhaler according to any one of claims 1 to 4 - 42 - ........... characterized in that it has a dose counter structure. 28. An inhaler device, preferably a powder inhaler, comprising an inhalation mouthpiece (512) into which a patient-induced air stream is directed, an inhalation container (521) and a dispensing device (525, 526) wherein the inhalation composition may be dispensed into the inhalation passageway from the reservoir (521), wherein the dispenser is provided with a barrel or tubular dispenser portion (525) having a dispensing cavity (526) on its outer surface, wherein the dispensing member (525), by means of a forced operating cap (550) thereof, a longitudinal rest position (in which the metering cavity (526) is in the mouthpiece) and a metering position (in which the metering cavity (526) is below the reservoir (521)); and that air inlets (514) in the mouthpiece (512) which direct the air stream generated by the inhaler to the metering cavity (526) of the dosing portion (525) at rest, so that the swirling air stream is washed away and entrapped by the metering cavity (526). An inhaler according to claim 28, characterized in that the container (521) includes an elongated housing (500) and that an operating cap (550) is movably mounted on the housing (500) between two end positions, and the actuator cap (550) is the actuator for the metering component (525). 30. An inhaler according to claim 28 or 29, characterized in that it is provided with a counting device (580 ... 584) for forced dose counting, which is operatively engaged and stepped by the operating cap (550). 31. A 28-30. An inhaler according to any one of claims 1 to 4, characterized in that the container (521) is substantially horn-shaped and has two laterally extending surfaces (771, 772) with respect to the longitudinal direction of the dispensing component (525). is introduced into the metering cavity (526) when the metering component (525) is in the metering position. 32. A 28-31. An inhaler according to any one of claims 1 to 5, characterized in that the container (521) is provided with a narrowing (628) directly above the dispensing part (525), which forms pockets (629) for inhalation with the dispensing part (525). 33. A 28-32. An inhaler according to any one of claims 1 to 5, characterized in that the container (521) is provided with an elongate discharge opening (524) closed by the dispensing part (525), the longitudinal dimension of the dispensing part (525) being larger than the dispensing cavity (526). so that when the dispensing member (525) is moved, the dispensing cavity (526) is located longer than its size below the discharge opening (524). 34. A 28-33. An inhaler according to any one of claims 1 to 4, characterized in that it is provided with a vibration-generating mechanism (505, 554, 555) actuated by moving the dispensing part (525), which vibrates in the container (525) and / or the dispensing part (525). An inhaler according to claim 34, characterized in that the vibration-generating mechanism is provided with a spring tongue (555) formed on the housing (500) or the operating cap (550) and cooperating with the spring tongue (555) and operating on the operating cap (550). or corrugated (505) formed on the housing (500). 36. An inhaler according to claim 35, characterized in that a vibration-generating mechanism (670) is provided to the container (521) by a vibration-generating mechanism. 37. A 34-36. An inhaler according to any one of claims 1 to 5, characterized in that it has two or more vibration-generating mechanisms (505, 555; 690 ... 692; 693, 694) which produce different types of vibrations at different points of the device. 38. A 34-37. An inhaler according to any one of claims 1 to 4, characterized in that the air stream is provided with acoustic vibration plates (840, 841) inside the tubular dispenser component (525). • · • · * · · «· ··· - 45 - ........ '· 39. A 34-38. An inhaler according to any one of claims 1 to 5, characterized in that the mouthpiece (512) has discs (850) for tapping movement on the dispensing member (525). 40. A 34-39. An inhaler according to any one of claims 1 to 5, characterized in that the vibration generating mechanism generates different types of vibrations depending on the direction of movement of the dispensing component (525). 41. A 34-40. An inhaler according to any one of claims 1 to 5, characterized in that the container (521) is provided with a loosely fixed cutting device (860, 870) which, when subjected to mechanical vibration to the container, irregularly jumps, dances, knocks or vibrates the clots in the inhalation composition. and assisting in filling the dispensing cavity (526) of the inhaler component (525) with the inhalation composition. 42. An inhaler according to claim 41, characterized in that the cutting device comprises a roller spring (860) which has a lid (527) at one end and a resting member (525) preferably at the other end. is supported by a saru (861). An inhaler according to claim 41, characterized in that the cutting device has a handle (870) which is fixed loosely, * or vibratively in the diagonal position in the container (521), and its lower, preferably blade-like head (870). 871) lies on the dispenser part. 44. A 28-43. An inhaler according to any one of claims 1 to 5, characterized in that the mouthpiece (512) is provided with a dummy body (746, 747) in the vicinity of the dosing cavity (526) which causes swirling around the dosing cavity (526). 45. A 28-44. An inhaler according to any one of claims 1 to 4, wherein the mouth (512) of the dispensing member (525) is provided with a streamline tip (745) for swirling the inhaled suspension suspended in the air stream. 46. A 28-45. An inhaler according to any one of claims 1 to 5, characterized in that the dispensing component (525) is movably secured on both sides of the container (521) in a mounting fixture (533) without substantially damping the vibration to the dispensing component (525). 47. A 28-46. An inhaler according to any one of claims 1 to 5, characterized in that the dispensing component (525) is movably secured on both sides of the container (521) in a mounting fixture (533) such that the fixture assembly (533) under slight pressure - lying down. Τ · * V 48. An inhaler according to claim 46 or 47, wherein the dispensing portion (525) is configured such that the dispensing cavity (526) is nowhere large in the direction of movement of the dispensing portion (525), so that the retaining assembly (533) can enter the dispensing cavity (526).