DE20218974U1 - Atomizers for liquids - Google Patents

Description

1/1432-Priority

Atomizer for liquids

The present invention relates to a new container which is used as a container for an atomizer for atomizing a pharmaceutical liquid for the application of a medical-pharmaceutical aerosol, whereby the active ingredient formulation is always kept under sterile conditions. The aerosols produced in this way can be applied, for example, nasally, orally, via the ears or onto the skin. Nasal application is preferred. Humectants, drugs and/or wound healing agents can be applied via the atomizer.

For nasal sprays of the type described above, i.e. nasal sprays for continuous and repeated use, it is necessary that the atomizers are absolutely leak-proof so that biological contamination cannot occur through leaks.

For example, there are atomizers in which the active ingredient formulation is always under an overpressure compared to the outside environment. On the one hand, such an overpressure is used to press the active ingredient formulation through the nozzle of the attachment and thus generate the aerosol. In such cases, the use of pump attachments can be dispensed with. On the other hand, the overpressure ensures that no material from the outside can penetrate into the storage container and thus lead to contamination of the active ingredient formulation. If the attachment on such devices is a pump attachment for manually generating the aerosol using pumps, these have the disadvantage that active ingredient formulation can flow out of the valve of the attachment even when the device is at rest, partially precipitating or condensing on the valve and becoming microbiologically contaminated there. At the same time, active ingredient formulation can precipitate on the outlet valve or small amounts of water can condense there during spraying. Finally, the area between the pump attachment and the storage container can be leaky.

All of these effects can lead to biological contamination of the fluid in the reservoir or at the outlet valve and spout.

1/1432-Priority

WO02/34411 discloses an atomizer consisting of a pump attachment with oligodynamic agents that prevent biological contamination in the storage container via the pump attachment. The storage container is an aluminum can. The safety of such a system depends on the joint between the aluminum can and the pump being absolutely tight, even under alternating temperature loads. Due to the manufacturing tolerances of the flanged edge of such an aluminum can, it has so far only been possible to create storage containers whose bottle necks have a flat or slightly convexly curved head-side surface, i.e. the surface of the neck that is perpendicular to the longitudinal axis of the container on the head side. The pump attachment is then placed on this surface. In order to achieve a sufficient sealing effect and to ensure it in the long term, a permanently elastic rubber seal is necessary between the bottle neck and the pump attachment. These have the disadvantage that part of the sealing material can come loose, thereby impairing the pharmaceutical quality of the formulation to be applied. Inert plastics cannot be used as seals because they are too hard and not permanently elastic enough to solve the problem of the manufacturing tolerances of the can flange edges that are currently common and feasible.

The object of the present invention is therefore to provide an atomizer which overcomes the difficulties known from the prior art.

In particular, it is an object of the invention to improve the sealing point between the storage container and the pump attachment.

A further task is to ensure that the pump in such atomizers snaps on properly and sits securely on the storage container.

A further task in such atomizers is to prevent the seal from being displaced from its intended position if the pump is placed at a slight angle when being applied to the reservoir.

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1/1432-Priority

Description of the invention

The object of the invention is achieved by a new, specially developed flange for aluminum containers, in which a sealing line is created at the uppermost edge of the flange, which seals the area between the aluminum can and the pump attachment instead of the previous sealing surfaces. A suitable plastic seal can be formed between the pump attachment and the sealing line.

The storage container according to the invention is a bottle made of aluminum, as shown in Figure 1. Figure 2 shows the bottle neck with the flange according to the invention enlarged. The storage container (101) consists of the bottle neck (102), the bottle belly (103) and the concave bottle bottom (104). The bottle neck has the flange shape according to the invention (105). This is designed in such a way that the uppermost point of the bottle neck (107), which surrounds the bottle opening (108) in a ring shape, is designed as a sealing line.

The flanged edge according to the invention can be described in cross-section as follows. Following the inner wall of the bottle neck from the bottom to the bottle opening, this is bent outwards at the uppermost point of the bottle neck by an angle of 180° - alpha from the longitudinal axis of the container towards the bottom. This means that the last straight section of the inner wall of the bottle neck before the bottle opening and the bent area enclose the angle alpha. Bent in this way, the flange runs diagonally towards the bottom over a distance a before bending again towards the bottom by an angle of 180° minus beta in order to now run a distance b parallel to the longitudinal axis of the container. The angle beta is accordingly enclosed by the distance a and the distance b. At the end of the distance b, this is folded over towards the container as usual. According to the invention, the angle alpha is always smaller than the angle beta. As a result, the bottle flange appears in cross-section like a cylinder cut at an angle to the longitudinal axis, with the high end located at the bottle opening.

1/1432-Priority

This high end forms the sealing line according to the invention, which runs in a ring around the container opening. This increases the tightness between the bottle neck and the seal of the pump attachment.

If necessary, an annular notch running perpendicular to the axis is formed near the bottle opening in order to anchor a cap.

The bottle neck is generally narrower than the bottle belly, its outer diameter is preferably between 15 and 33 mm, particularly preferably between 18 and 21 mm. In another embodiment, it is preferably between 30 and 33 mm. The inner diameter is preferably between 12 and 28 mm, particularly preferably between 14 and 16 mm. In another embodiment, it is preferably between 24 and 26 mm. The bottle height is preferably between 50 mm and 250 mm, particularly preferably between 50 mm and 125 mm, most preferably between 60 mm and 90 mm. The bottle belly preferably has an outer diameter of between 20 mm and 100 mm, particularly preferably between 23 mm and 55 mm.

The wall and neck area of the bottle has a thickness of 0.3 to 0.5 mm, preferably 0.37 to 0.41 mm. The wall thickness of the base area is 0.5 mm to 1.5 mm, preferably 0.8 to 1 mm.

The outside of the bottle can be painted and optionally printed, the inside, including the bottle neck and its upper edge (106) can be coated with an artificial varnish. This is preferably an epoxy phenol. The varnish is advantageous in order to increase the corrosion resistance of the bottle to the active ingredient formulation and at the same time to prevent the active ingredient formulation from taking on a metallic taste.

The present invention also includes atomizers consisting of the aluminum storage containers according to the invention and a pump attachment, which preferably has the following features:

1/1432-Priority

- a snap or crimp closure to be placed on the storage container;

- a pump channel that can pump liquid from the reservoir into a pressure chamber;

- a valve formed between the storage vessel and the pressure chamber;

- a riser pipe leading from the pressure chamber to a nozzle;

- a pressure control valve which is connected to the riser pipe and is preferably formed in the riser pipe;

- a nozzle for atomizing the liquid;

- a trigger element by means of which a piston can be actuated, which builds up the pressure in the pressure chamber necessary for nebulisation;

- Air inlet points outside the pump tube or riser tube and air inlet paths from outside the pump head into the reservoir;

- oligodynamically active substances in and/or along the path taken by the liquid in the pump channel and/or riser pipe between the storage tank and the nozzle;

- means for sterilization along the path taken by the incoming air, i.e. between the air inlet openings and the storage container,

- as well as the storage bottle according to the invention made of aluminum with the flange according to the invention on the bottle neck for forming a sealing line around the bottle opening.

In the atomizers according to the invention, the active ingredient formulation is always under normal pressure; overpressure is not necessary.

The pump attachment is preferably one such as that described in WO 97/18902 and shown in Figure 3. The pump attachment (2) is firmly connected to the bottle neck and the flanged edge (102) according to the invention via the snap closure (3). The inner edge of the snap closure (4) slides over the flanged edge (105) of the bottle neck (102). Between the bottle neck and the pump attachment there is a seal (5) which is made of plastics which release no or only minimal substances, preferably polyethylene. Liquid can be pumped from the storage container into the pressure chamber (10) via a first pump channel (25).

1/1432-Priority

The pressure chamber (10) can be designed as part of the first pump channel (25) in its upper region. A ball valve (11) closes the path of the liquid through the first pump channel (25) into the pressure chamber (10). The pressure chamber (10) is part of the pressure cylinder (8). In the pressure cylinder (8) there is a piston (6) with a further axial pump channel (7). The piston (6) is held in the upper rest position by the spring (9) against a stop. The pressure chamber (10) is located between the piston (6) and the ball valve (11) and is connected to the upper pump channel (7).

The piston (6) has a smaller outer diameter than the inner diameter of the pressure cylinder (8), so that a gap (12) remains between the outer wall of the piston and the inner wall of the cylinder, which gap is sealed by the peripheral sealing body (13) of the piston. In the lower area of the pressure chamber (10), the pressure cylinder (8) has an area (14) with a larger inner diameter, in which the sealing body (13) has no sealing effect.

A trigger element (15) is located on the piston (6) with the upper pump channel (7). From there, a riser pipe (16), which is connected to a pressure control valve (17), leads to a nozzle (18) in order to dispense the liquids to be nebulized through the opening of the nozzle (18). In terms of function, the upper pump channel (7) and the riser pipe (16) form a common riser pipe that connects the pressure chamber with the nozzle.

The pressure control valve (17) is connected to the riser pipe (16) in such a way that it is at least partially flushed by the liquid. The pressure control valve can be installed at any point within the common riser pipe, which is formed from the upper pump channel (7) and the riser pipe (16). In Figure 1, it is formed in the upper region of the riser pipe (16).

If the piston (6) is in the upper rest position, as shown in the drawing, the sealing body (13) seals the pressure chamber (10) against the opening (19) of the storage container.

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1/1432-Priority

The tappet (20) is firmly connected to the piston (6) in the region (21) and has a star-shaped diameter so that a free space remains between the pressure chamber (10) and the upper pump channel (7).

In the rest position, the tappet (20) is far away from the ball valve (11), so that this valve is open towards the storage container when enough negative pressure is generated in the pressure chamber (10) and the valve is closed when the pressure there is sufficiently high.

The liquid takes the following path through the pump attachment: First, it is pumped from the first pump channel (25) from the storage vessel via the open ball valve (11) into the pressure chamber (10) and then enters the pump channel (7).

From there, the liquid passes through the riser pipe (16) with the pressure control valve (17) located there and finally reaches the nozzle (18).

To avoid biological contamination of the liquid in the storage tank, oligodynamically active substances are formed along the path that the liquid takes from the storage chamber to the nozzle.

These substances can be formed, for example, on the spring (9), on the wall of the upper pump channel (7) or the riser pipe (16), in the pressure control valve (17) and/or on the nozzle (18).

To equalize the pressure in the storage container (101) after dispensing liquids, air can flow into the device from outside at the points (23) and then penetrate into the storage container (101), as shown, for example, by the arrow (22) in the drawing.

Means for sterilizing the incoming air are provided along the airway. These include, for example, sterility filters, membranes that are only permeable to air, materials that retain bacteria, oligodynamically active substances, or microbiocidally active substances or combinations thereof. Figure 3 shows an example of a sterility filter (24).

As already mentioned, the pump attachment (2) is firmly connected to the bottle neck (102) via a snap fastener (3).

1/1432-Priority

Figure 4 shows a variant of Figure 1, in which the pressure control valve (17) is designed close to the transition region between the upper pump channel (7) and the riser pipe (16). This arrangement has the result that the region of the riser pipe (16) between the upper end of the upper pump channel (7) and the pressure control valve (17) is considerably shortened compared to that in Figure 3, whereas the region between the pressure control valve (17) and the opening of the nozzle (18) is considerably lengthened. As soon as the pressure control valve (17) is opened, the opening (26) is released and the liquid from the lower region of the riser pipe (16), which lies in front of the pressure control valve (17), can flow past it through the opening (26) into the upper region (26) of the riser pipe (16). The nozzle (18) is covered by a slip-on cap (27).

The advantages of the atomizer according to the invention are

- in the relatively low weight of the device itself compared to the total weight of the filled atomizer,

- in the unbreakability of the storage container, which is particularly important during the application of the pump attachment to the bottle neck,

- that the active ingredient formulation does not suffer any taste changes due to the material of the storage container and

- that the storage container is gas-diffusion-tight, so that the pharmaceutical stability of the active ingredient formulation cannot be reduced by diffusing gas even during longer storage periods

- that the storage bottle is opaque

- in that the flange shape according to the invention creates a sealing line around the bottle neck, which increases the tightness between the storage bottle and the pump attachment.

Claims (10)

1. Bottle made of aluminum ( 101 ) consisting of a bottle bottom ( 104 ), a bottle belly ( 103 ) and a bottle neck ( 102 ), wherein the bottle neck is flanged in such a way that the flange in cross section appears like a cylinder cut obliquely to the longitudinal axis, the high end of which is located at the bottle opening ( 108 ). 2. Bottle made of aluminum according to claim 1, characterized in that the outer diameter of the bottle neck is between 15 and 33 mm, preferably 18 to 21 mm or 30 mm to 33 mm. 3. Bottle made of aluminum according to claim 1 or 2, characterized in that the inner diameter of the bottle neck is between 12 and 28 mm, preferably 14 and 16 mm or 24 mm to 26 mm. 4. Bottle made of aluminum according to claim 1, 2 or 3, characterized in that the wall of the storage container has a thickness of 0.3 to 0.5 mm, preferably 0.37 to 0.41 mm, in the wall and neck area and a thickness of 0.5 mm to 1.5 mm, preferably 0.8 to 1 mm, in the base area. 5. Aluminium bottle according to claim 1, 2, 3 or 4, characterized in that the bottle neck has an annular notch running perpendicular to the axis. 6. Bottle made of aluminium according to claim 1, 2, 3, 4 or 5, characterized in that the storage container including the neck and the upper edge of the neck is painted on the inside. 7. Atomizer according to claim 1, 2, 3, 4, 5 or 6, characterized in that a seal, preferably made of polyethylene, is formed between the bottle neck and the pump attachment. 8. Bottle made of aluminum according to claim 1, 2, 3, 4, 5, 6 or 7, characterized in that the bottle height is 50 mm to 250 mm, preferably 50 mm to 125 mm, more preferably 60 mm-90 mm. 9. Atomizer ( 1 ) for atomizing a liquid of a medical-pharmaceutical liquid kept under sterile conditions and not under pressure, consisting of a) an aluminium storage container ( 101 ) according to one of claims 1 to 8 containing a non-pressurised liquid, and b) a pump attachment ( 2 ) permanently attached to the neck of the storage container for manual atomisation of the liquid by pumping, the pump attachment having the following features: - a snap or crimp closure ( 3 ) for placing on the storage container ( 101 ); - a pump channel ( 25 ) which can pump liquid from the storage container into a pressure chamber; - a valve ( 11 ) formed between the storage vessel and the pressure chamber; - a riser pipe ( 7 , 16 ) leading from the pressure chamber ( 10 ) to a nozzle ( 18 ); - a pressure control valve ( 17 ) connected to the riser pipe; - a nozzle ( 18 ) for atomizing the liquid; - a trigger element ( 15 ) via which a piston ( 6 ) can be actuated, which builds up the pressure necessary for nebulization in the pressure chamber ( 10 ); - air inlet points ( 23 ) outside the riser pipe ( 7 , 16 ) and air inlet paths ( 22 ) from outside the pump attachment into the storage container; - oligodynamically active substances in and/or along the path taken by the liquid in the pump channel and/or riser pipe between the storage tank and the nozzle; - means for sterilization ( 24 ) along the path taken by the incoming air, ie between the air inlet openings and the storage container. 10. Atomizer according to claim 9, characterized in that the pump attachment is a pump attachment as described in WO 97/18902.