EP2991714A2

EP2991714A2 - Inhaler for a metered dose aerosol

Info

Publication number: EP2991714A2
Application number: EP14720631.2A
Authority: EP
Inventors: Björn O. SÖRENSEN
Original assignee: CHV Pharma & Co KG GmbH
Current assignee: CHV Pharma & Co KG GmbH
Priority date: 2013-05-03
Filing date: 2014-05-02
Publication date: 2016-03-09
Also published as: JP2016518201A; WO2014177703A3; DE102013104549A1; DE102013104549B4; CA2909583A1; US20160101244A1; WO2014177703A2

Abstract

The invention relates to an inhaler for delivering a metered dose aerosol, in which a permeable flat structure is positioned directly in front of a narrow channel.

Description

Inhaler for a metered dose inhaler

description

Field of the invention

The invention relates to an inhaler for a

Metered aerosol, which has a housing for receiving a

Active substance container includes.

Background of the Invention Inhalers for metered dose aerosols are known. These usually include a housing for receiving a

Drug container. Such a drug container contains a propellant and the active ingredient. Furthermore, the active ingredient container comprises a valve, wherein upon actuation of the valve, a defined amount of the active ingredient is dispensed.

In the most common inhalers, the valve is actuated by the user pressing on the drug container inserted into the housing of the inhaler. Such a

Inhaler is shown in DE 601 32 666 T2.

The housing typically includes a nebulizer nozzle through which an aerosol is dispensed into a mouthpiece of the housing which the user can breathe.

The problem with known inhalers, on the one hand, is that they have a relatively short spray of high pressure Release particle velocity. This requires good coordination of the actuation of the spray and the

Inhalation of the aerosol cloud. As a rule, part of the active ingredient is not inhaled.

Various approaches are known to mitigate this problem. In particular, attachable, relatively large-volume containers are known from practice, in which the aerosol cloud is to collect, so that the user can inhale them. These containers are however

impractical and have the disadvantage that depending on

used aerosol settles more or less aerosol on the vessel wall. The patent US 4, 706, 663 A suggests on the

Inhaler to set up an essay, which is closed with a net. So the particle speed is to be reduced. Such approaches have in the

Past due to separating particles led to the fact that the emitted dose (total emitted dose) is subject to strong fluctuations.

In general, a high standard deviation in the

dispensed drug amount a problem that many have known from practice inhalers. It is believed that it is also conventional, comprising a spray nozzle

Inhalers to Abseheidüngen of the active ingredient in the region of the nozzle comes, which entails fluctuations in the amount of active ingredient delivered. OBJECT OF THE INVENTION In contrast, the object of the invention is to reduce the aforementioned disadvantages of the prior art.

It is a particular object of the invention to provide a simply constructed inhaler in which, compared to known inhalers, the particle velocity is reduced and / or the accuracy of the emitted

Amount of active ingredient is improved.

Further, the invention relates to an inhaler whose handling is improved.

Summary of the invention

The object of the invention is already by a

Inhaler for dispensing a metered dose inhaler according to one of the independent claims. Preferred embodiments and further developments of

Invention are the subject of the dependent claims

remove .

The invention relates to an inhaler for a

Metered aerosol, ie a device by means of one

Liquid, especially a suspension, can be delivered with an active ingredient as an aerosol cloud. In which Active ingredient is usually a drug. For the purposes of the invention, however, it is not excluded that the inhaler may also be used to dispense other substances,

For example, for the dispensing of stimulants, can be used.

The inhaler comprises a receptacle for the outlet of a drug container. Such a receptacle is usually designed as a kind of bore, in which a tube-shaped outlet of the introduced into the housing drug container can be performed.

Furthermore, the inhaler comprises a channel, which extends from the receptacle for the outlet of the drug container to a Zerstäuberauslass.

The atomizer outlet is understood to mean that the aerosol enters the mouthpiece of the inhaler at this component.

The atomizer outlet includes one for the aerosol

permeable fabric. In particular, the atomizer outlet comprises a fleece, a net or a fabric.

The channel leading to the permeable sheet placed between the outlet of the drug container and the atomizer outlet tapers

in sections.

The channel thus includes a bottleneck. This constriction is formed in particular with a diameter between 0, 1 and 1 mm, preferably between 0, 3 and 0, 7 mm. The constriction, which is located near the permeable sheet, causes the velocity of the fluid to increase sharply in the region of the constriction. The inventor suspects that in this way it is prevented that particles in larger quantities on the

pervious fabrics or settle on the walls of the channel. Much more could be achieved that

Speed of the particles of aerosol cloud is reduced, which manifests itself in particular in a larger and better inhalable aerosol cloud. At the same time, however, the standard deviation in the amount of active ingredient delivered could even be reduced compared to inhalers known from practice.

It has been found that when using the

Inhalator for a suspension a diameter of

Constriction of 0, 4 to 0, 6 mm in particular of 0, 5 mm is optimal.

When using the inhaler for a solution, a somewhat smaller diameter is optimal, in particular from 0.2 to 0.3 mm, particularly preferably 0.25 mm. In

Advantageously, the bottleneck is through two

converging and tapered channel sections are formed, which are arranged at an angle to each other. For a particularly efficient delivery has in particular an angle between 100 ⁰ and 130 °, preferably between 110 ° and 120 °, found to be suitable. Preferably, the angle of the two corresponds

Channel sections of the same angle in which the

Main extension direction of the mouthpiece to a

Rotation symmetry axis of the drug container runs. The constriction preferably extends approximately in the same inclination as a central axis of the mouthpiece.

The permeable sheet preferably has a mean pore diameter between 10 and 100 μιη,

more preferably between 30 and 50 μπι on.

The diameter of the opening of the atomizer outlet, that is to say the diameter of the permeable sheet, is preferably between 0.5 mm and 3 mm, more preferably between 1 and 2 mm. When using a membrane, which is in particular designed as a nonwoven and use of the inhaler for a solution, average pore diameter of 50 to 70 μιτι, in particular of about 60 ym have proven ideal. The permeable sheet preferably has an open area between 10 and 60%, more preferably between 25 and 45%.

The invention further relates to an inhaler for a metered dose inhaler, in particular as described above, which has a receptacle for the outlet of a Active substance ehälters and a channel, which of the

Recording to a Zerstäuberauslass includes includes.

The atomizer outlet comprises the above-mentioned permeable fabric, which closes the channel by means of which the outlet of the active substance container is connected.

This channel has a length of less than 8 mm, preferably less than 5 mm.

It has been found that a particularly short, preferably a fairly thin channel, a

uniform drug release entails. Presumably, this effect is due to the fact that when operating the inhaler in the channel to a pressure build-up and to an acceleration of the forming aerosol particles. This will, especially in conjunction with a

Diameter of the permeable sheet of less than 3 mm, a deposit of active ingredient largely avoided. It has been found that the inventive

Inhaler is particularly suitable for suspensions. In a preferred embodiment of the invention, the channel has a volume of less than 10 mm ³ , preferably less than 5 mm ³ , and particularly preferably less than 3 mm ³ . The invention further relates to an inhaler for a metered dose inhaler, in particular as described above, which comprises a container housing for receiving a

Active agent container and a Zerstäuberauslass includes, which opens into a mouthpiece.

The mouthpiece according to the invention has an extension on an opposite side to an opening for inhaling the aerosol.

In particular, the mouthpiece is at least 10 mm above the opening at the back.

Through the extension better handling is possible because the inhaler so balanced in the hand of the

User is lying.

It is also conceivable to use the volume created by the extension for the integration of further components, in particular for the integration of a counter.

DESCRIPTION OF THE DRAWINGS The subject matter of the invention is described below with reference to the drawings FIG. 1 to FIG. 7 will be explained in more detail with reference to schematically illustrated embodiments.

Fig. 1 shows a schematic perspective view of an embodiment of the housing of an inhaler 1. In this view, the active substance container is not

used. The inhaler 1 comprises a mouth piece 2 with an opening 3 through which the user inhales the delivered aerosol. The mouthpiece 2 is in an angle deviating from 90 ⁰ , in this embodiment at an angle of 110 ⁰ to 120 ° to a container housing 4, which at least in

Inner tubular with circular cross-section

is formed and above an opening 5 for insertion of the drug container (not shown).

The mouthpiece 2 also has the back, so

opposite the opening 3, an extension 6, which serves the better balance when using the inhaler.

Fig. FIG. 2 shows a perspective cutaway view of the device shown in FIG. 1 illustrated inhaler. 1

Evident in this view is a protruding into the mouthpiece 2 receptacle 7, which has a channel 9, in which the outlet of a drug container (not

shown) is pushed.

A sprayer outlet 8, from which the aerosol cloud is released when the inhaler is actuated, can also be seen.

The design of the receptacle 7 as a nozzle, which is formed in this embodiment substantially circular cylindrical, has the advantage that the mouthpiece 2 remains a large volume.

This volume, which is also present on the back side of the nozzle opening, can be used, for example, to integrate further Components, in particular a counter, can be used.

The embodiment shown here allows a

particularly simple production of the inhaler 1,

for example, as a plastic injection molded part, in which the receptacle 7 is an integral part of the housing.

Fig. FIG. 3 is a schematic sectional view of the FIG

Inhalator 1, wherein in this view, the drug container 10 is shown, which is inserted into the container housing 4.

The Wirkstoffbehäl ter 10 has a collar 11 and a tubular outlet 12.

The tubular outlet 12 is in the channel 9th

pushed. Now, the drug container 10 continues

depressed, the outlet 12 slides in the

Drug container 10 and there will be a valve (not

shown), over which a defined

Amount of active ingredient is delivered. The function of such drug container for dispensing MDIs is known in the art.

In this embodiment, the outlet 12 jams in the channel 9 and thus secures the drug container 10 used from falling out. It is also conceivable, however, to provide the container housing 4 with further clamping means (not shown), which in particular can engage on the collar 11.

The atomizer outlet in the mouthpiece is in

Directed substantially in the direction of the opening of the mouthpiece 2. About this outlet, the exact configuration is explained in detail below, the

Aerosol cloud in the mouth piece. Fig. 4 is a detailed view of the device shown in FIG. 3 too

recognizing channel between the outlet 12 of the

Drug container and the atomizer outlet.

The channel is divided into a first channel section 13 and a second channel section 14, which in one

Angle of 110 ⁰ to 120 ° to each other are arranged.

First and second channel sections 13, 14 taper and are essentially this embodiment

truncated cone-shaped.

Both channel sections 13,14 taken together have a length of less than 5 mm and a maximum diameter of less than 2 mm. Between the channel sections 13,14 a constriction 15 is formed, which in this embodiment

Sectionally substantially circular cylindrical

is formed and coaxial with the channel section 14th

is arranged and thus arranged according to a central axis of the mouthpiece. In this bottleneck, which has a diameter of less than 0, 7 mm in this embodiment, there is a significant increase in speed of the

Outlet 12 exiting active ingredient.

In Fig. 4, only the plastic parts of the inhaler are shown, which are integral parts of the housing, which can be manufactured in one piece by injection molding.

Fig. 5 shows the in Fig. 4, wherein now a permeable sheet 16, which serves as Zerstäuberauslass, is set in front of the channel section 14.

The permeable fabric may be formed as a net, in particular as a nylon net with a pore diameter of 35-45 μιτι.

The network is secured by means of a ring 17.

This can be glued, welded,

in particular cold welded or clamped.

By means of the ring 17, which is placed in a corresponding recess of the receptacle 7, the

permeable fabrics 16 are particularly easy to use.

The diameter of the permeable sheet 16 according to the invention becomes the same diameter

understood, which overlaps with the channel section 14. It is understood that the laterally existing part of the sheet 16 only serves the attachment by means of the ring 17, but does not form a Zerstäuberauslass. Due to the combination of a short channel with a constriction, which has only a small volume, and the close placement of the fabric 18 at the outlet of the

Active substance container is a pressure build-up in the channel

so that most of the droplet formation may occur behind the atomizer outlet.

It has been found that in a surprisingly simple manner, the speed of the exiting from the inhaler particles can be significantly reduced.

Measurements have shown that the speed of the

Particles could be reduced by more than 40% compared to known, on the market inhalers.

The effect of the invention should be with reference to the

Infrared images Fig. 6 and FIG. 7 are clarified. Fig. Figure 6 shows an infrared uptake of the aerosol cloud of a commercially available inhaler.

In contrast, FIG. 7 shows an infrared absorption of the aerosol cloud of an inhaler according to the invention. To recognize is a substantial larger aerosol cloud. This has a volume of more than 150% of the volume of the in Fig. 6 illustrated aerosol cloud.

Due to the lower particle velocity and the larger aerosol cloud, the inhalation of the aerosol is considerably simplified. At the same time, the standard deviation of the delivered dose could even be improved compared to known inhalers. In particular, a standard deviation of less than 10% could be achieved.

At the same time, it was possible to ensure that the amount of active substance released was essentially the same as that delivered

Quantity of active substance, which is produced by an inhaler having only a nozzle as a sprayer.

Experiments have shown that when using the inhaler for a suspension of the aerosol cloud had a temperature higher by at least 2 ° Celsius. In particular, higher temperatures of up to ⁰ Celsius could be achieved. The speed of the aerosol particles could change

at least 20%, preferably reduced by half. At the same time, an aerosol cloud of more than 1.5 times, preferably up to twice, volume could be generated, without a membrane compared to a standard inhaler.

When using a solution, the number could

respirable particles in the aerosol cloud are increased by up to ten percentage points (from 35% to 45%). List of reference numbers:

1 inhaler

2 mouth piece

3 opening

4 container housing

5 opening

6 extension

7 recording

8 atomizer outlet

9 channel

10 drug containers

11 collar

12 outlet

13 channel section

14 channel section

15 bottleneck

16 permeable fabric

Claims

claims

Inhaler (1) for a metered dose inhaler, comprising a receptacle (7) for the outlet of an active substance container (10), and a channel extending from the receptacle (7) to an atomizer outlet (8),

wherein the atomizer outlet (8) comprises a permeable sheet (16), and wherein the channel tapers in sections between the outlet of the active substance container and the atomizer outlet.

Inhaler (1) for a metered dose inhaler after

preceding claim, characterized in that the channel has at least two channel sections which taper towards a constriction (15).

Inhaler (1) for a metered dose inhaler according to the preceding claim, characterized in that the constriction has a diameter between 0, 1 and 1 mm, preferably between 0, 3 and 0, 7 mm, or between 0, 2 and 0, 3 mm or between 0, 4 and 0, 6 mm.

Inhaler (1) for a metered dose inhaler according to one of the preceding claims, characterized in that the channel is divided into two channel sections (13, 14), which at an angle between 100 ° and 130 °, preferably between 110 ⁰ and 120 ° to each other

are arranged. Inhaler (1) for a metered dose inhaler according to one of the preceding claims, characterized in that the permeable fabric (16) is formed as a net, fleece or fabric.

Inhaler (1) for a metered dose inhaler according to one of the preceding claims, characterized in that the permeable Flächengebi lde (16) has a mean pore diameter between 10 and 100 μιτι, preferably between 30 and 50 microns.

Inhaler (1) for a metered dose inhaler according to one of the preceding claims, characterized in that the permeable sheet (16) has an open area between 10 and 60%, preferably between 25 and 45%.

Inhaler (1) for a metered dose inhaler, in particular according to one of the preceding claims, comprising a receptacle (7) for the outlet of a drug container (10), and a channel which extends from the receptacle (7) to an atomizer outlet (8),

the channel being characterized by a permeable

Sheet (16) is closed, and has a length of less than 8 mm, preferably less than 5 mm.

Inhaler (1) for a metered dose inhaler according to one of the preceding claims, characterized in that the channel has a volume of less than 10 mm ³ ,

preferably less than 5 mm ³ , especially preferably less than 3 mm ³ .

10. inhaler (1) for a metered dose inhaler, in particular according to one of the preceding claims, comprising a container housing (4) for receiving a

Active substance container (10), as well as a

Atomizer outlet (8), which opens into a mouthpiece (2), wherein the mouthpiece on an opening (3) gegenüberl laying side has an extension (6).