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HK1116437A1 - Device for dosing and dry nebulization - Google Patents

Device for dosing and dry nebulization Download PDF

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Publication number
HK1116437A1
HK1116437A1 HK08106603.8A HK08106603A HK1116437A1 HK 1116437 A1 HK1116437 A1 HK 1116437A1 HK 08106603 A HK08106603 A HK 08106603A HK 1116437 A1 HK1116437 A1 HK 1116437A1
Authority
HK
Hong Kong
Prior art keywords
reservoir
nebulization channel
valve
nebulization
channel
Prior art date
Application number
HK08106603.8A
Other languages
Chinese (zh)
Other versions
HK1116437B (en
Inventor
Gerhard Pohlmann
Horst Windt
Oliver Nolte
Wolfgang Koch
Original Assignee
Takeda Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE102005016100A external-priority patent/DE102005016100B3/en
Application filed by Takeda Gmbh filed Critical Takeda Gmbh
Publication of HK1116437A1 publication Critical patent/HK1116437A1/en
Publication of HK1116437B publication Critical patent/HK1116437B/en

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Abstract

A device 1 for dosing and dry nebulization of nebulizable material 12, comprising a nebulization channel 3 which has a first attachment piece 18 and a second attachment piece 6/7, and a source of compressed carrier gas connected to the first attachment piece 18 via a valve 16 for the purpose of sending a carrier gas pressure pulse into the nebulization channel 3. Between the first attachment piece 18 and second attachment piece 6/7 and above the nebulization channel 3 is a reservoir 10 open only towards the nebulization channel 3 which contains the nebulizable material 12. The reservoir 10 is connected to the nebulizaton channel 3 such that it is gas-tight with respect to the environment. When the valve 16 is closed a pressure compensation takes place in the nebulization channel 3 and in the reservoir 10.

Description

Device for dosing and drying atomization
Technical Field
The present invention relates to a device and a method for dosing and dry nebulization of nebulizable material, in particular for dosing and dry nebulization of pharmaceutical preparations in powder form. The invention also relates to the use of such a device for dry nebulization of powdered pharmaceutical preparations, in particular lung surfactants.
Background
Devices for drying atomized nebulizable material are known to the person skilled in the art. In these devices, an aerosolizable material, such as a powdered pharmaceutical product, is acted upon by a compressed or carrier gas provided exclusively within a chamber, and is converted within the chamber into a state known as a dry mist. In this case, the material particles are present in a particularly homogeneous and finely dispersed form across the entire volume of the compressed gas or carrier gas and are subsequently released from the chamber in this state via suitable devices.
Such devices are particularly used to form pharmaceutical preparations for inhalation administration to spontaneously ventilating or ventilated patients. For use with naturally ventilated patients, the devices are typically attached to a suitable mouth or breathing mask. In invasive use, i.e. for ventilating patients, these devices form part of a respirator.
However, in the devices known to date for nebulizing nebulizable material, it has generally been found that a problem is that large quantities of pharmaceutical preparations can be dispensed only to the patient, but at all that there is considerable outlay in terms of equipment, for example the use of expensive mechanical dosing devices. Generally, known devices are suitable for aerosolizing pharmaceutical formulations in the range of from about 1 μ g to about 20 mg. A large number of pharmaceutical preparations as described above, e.g. in the gram range, which are administered to the lungs over a long period of time, are called pulmonary surfactant preparations. Administration of large amounts of the above mentioned pulmonary surfactants is necessary in acute situations.
In conventional dry nebulizers, one problem that is often found is that the loose mass nebulizable material present in the storage container, for example in commercially available medicament vials, tends to coagulate due to its surface properties and/or its moisture content, resulting in blocking of the relatively narrow opening across the cross section of the vial. The above-mentioned agglomeration also occurs in lung surfactant preparations. Such clogging can generally be avoided only by suitable mechanical means to ensure that the nebulizable material is dosed continuously over a considerable period of time. Furthermore, agglomerated particles of nebulizable material, such as lung surfactant preparations, are generally unable to enter the lungs.
Especially in the case of intensive care emergency treatment of patients, it is necessary to ensure that nebulizable material is administered into the lungs in a rapid and high dose into the alveoli and that a constant dose is administered in rapid sequence and over a period of several minutes. However, in the prior art, such administration is possible, but fundamentally there is considerable outlay in terms of equipment.
Disclosure of Invention
The object of the present invention is therefore to achieve a device and its use and method for dosing and dry nebulization by means of the device which overcome the disadvantages known from the prior art.
This object is achieved by a device for dosing and dry nebulization of nebulizable material, a use according to the device for dry nebulization of a powdered pharmaceutical preparation and a method for dosing and dry nebulization of a nebulizable material according to the device. The above-mentioned device includes: an nebulization channel having a first and a second connection, and a source of compressed carrier gas connected to the first connection via a valve for sending pressure pulses of the carrier gas into the nebulization channel. Between the first connection and the second connection and above the nebulization channel, a reservoir which is open only towards the nebulization channel and which serves for accommodating nebulizable material is connected to the nebulization channel, so that the reservoir is gastight with respect to the environment and, when the valve is closed, is pressure-compensated by gas which flows back against the carrier gas pressure pulse towards the nebulization channel and the reservoir. The method comprises the following steps: opening a valve to send a carrier gas pressure pulse into the nebulization channel and create a vacuum in the reservoir; drawing a secondary quantity of nebulizable material from a reservoir or dosing chamber into the nebulization channel; atomizing an auxiliary amount of an aerosolizable material within an aerosolization channel; passing a mixture of compressed gas and material through an atomising channel; and closing the valve for pressure compensation in the nebulization channel and the reservoir.
Within the context of the present invention, dry nebulization of nebulizable material is understood to mean its aerosolization, i.e. its conversion into a state carried by a carrier gas.
According to the invention, a device according to the principle of a jet pump is obtained in which nebulizable material stored in a reservoir is sucked into a nebulization channel by a vacuum in the reservoir and nebulized in this channel by a compressed gas. In which case the vacuum in the reservoir is created by the flow of compressed gas through the connector between the reservoir and the nebulization channel.
The dry nebulizer according to the invention can be used for acute treatment of spontaneously ventilating patients. For this purpose, the second connection of the nebulization channel can be connected via a connection to a device for administration to spontaneously ventilating patients. Examples of such devices are mouth and breathing masks.
When used on ventilated patients, i.e. in invasive use, the dry nebulizer forms part of the respirator. The second connection piece of the nebulization channel is in this case preferably connected to the breathing air intake line of the respirator, in particular to the side port of the respirator.
According to the invention, the duration and/or time of the pressure pulse from the source of compressed carrier gas is preferably controllable so as to be synchronized with the breathing rate of the ventilator in the case of invasive use and with the breathing rate of the patient in the case of use on spontaneously ventilating patients. According to the invention, a synchronous control is ensured whenever the mixture of compressed gas and material, that is to say the combination of nebulizable material and compressed carrier gas, reaches the patient before or during the inhalation cycle, so that it is possible to inhale the dry thin substance directly from the patient. Of course, the control may also be such that the dry mist may be inhaled directly by the patient at every xth breath. The above control is such that the control signal is set depending on the length of the nebulization channel and/or any respirator connection or connection to a device for administration to spontaneously ventilating patients, and also depending on the desired time for the dry mist to enter the breathing tube.
Thus, according to the invention, a device is obtained in which during the pressure pulses from the source of compressed carrier gas, i.e. when the valve is open, a vacuum is present in the reservoir, which vacuum is compensated by gas backflow between the pressure pulses, i.e. when the valve is closed. In an invasive use of the dry nebulizer according to the invention, the return gas may be a breathing gas used in a respirator. In the case of use in spontaneously ventilating patients, it may also be ambient air.
According to the invention, the reservoir is arranged above the nebulization chamber and has a connector to the nebulization channel. The connector is arranged to be air tight with respect to the environment. The connector may include one or more openings. By arranging the reservoir above the nebulization channel, nebulizable material contained in the reservoir is concentrated in the region of the aperture of the reservoir by gravity and forms a mass there, which prevents emptying into the nebulization channel without outputting pressure pulses, due to the surface properties of the nebulizable material and the choice of a suitable diameter for the aperture. The friction effect of the particles of the nebulizable material plays an important role here. There is no particular limitation on the connection of the reservoir to the nebulization channel, as long as nebulizable material can be inhaled into the nebulization channel when the valve is open to the source of compressed carrier gas and the reservoir does not empty into the nebulization channel when the valve is closed.
When a low pressure is applied at the opening of the reservoir, nebulizable material on the one hand and the gas stored in the reservoir on the other hand are sucked into the nebulization channel. As a result, agglomeration of the agglomerates above the reservoir opening can occur. According to the invention, however, such condensation is broken up by pressure compensation between the pressure pulses in the device, since ambient air and/or breathing air flowing back into the nebulization channel also passes through the mass in the reservoir to create pressure compensation in the reservoir.
The device according to the invention is arranged in such a way that, when the valve is closed, pressure compensation takes place in the nebulization channel and in the reservoir. This is in particular obtained by the fact that the source of compressed carrier gas is connected to the first connection of the nebulization channel via a valve in such a way that the above-mentioned pressure compensation can take place. According to a preferred embodiment, the pressure compensation is made possible by the fact that the nebulization channel is closed in a sufficiently gas-tight manner at its first connection piece. This ensures that pressure compensation takes place at least in the nebulization channel and in the reservoir for the most part and not, for example, via the first connection.
In this manner, according to the invention, a uniform loose mass of nebulizable material can be obtained after each pressure compensation, as a result of which a stepwise increasing compaction of the material is avoided and a uniform dosing over a considerable period of time is ensured. Thus the device according to the invention readily allows the nebulizable material to be dosed in large quantities in a highly reproducible manner and preferably without mechanical parts. Furthermore, during pressure compensation, lumps can be loosened and the nebulizable material can be de-agglomerated, if appropriate. The mixture of compressed gas and material may thus contain predominantly particles, preferably individual particles, which correspond to the size of the predominant particles of the nebulizable material. If the nebulizable material is in the form of a powdered pharmaceutical preparation, in particular a pulmonary surfactant, primary particles of the pharmaceutical preparation in the reservoir may be present in the mixture of compressed gas and material. To this extent, the device according to the invention, which preferably completely removes mechanical parts, allows an optimal dispersion of the nebulizable material even down to the predominant particle size.
The size of the primary particles of nebulizable material preferably corresponds to the Mass Mean Airflow Diameter (MMAD), which is the above-mentioned location at which the particles can thus enter the lungs, i.e. act in the alveoli of the lungs. The MMAD of the microparticles that are able to enter the lungs is of a size in the range of 1 to 5 μm. Thus, according to the invention, the desired MMAD range of the particles in the mixture of compressed gas and material is from 1 to 5 μm, preferably from 1 to 3 μm.
The invention thus provides a device, its use and a method by which a constant dosing of nebulizable material is ensured over a considerable period of time and, due to the above-mentioned large number of grams of pharmaceutical preparation, can also be administered to a patient by inhalation over a relatively short period of time, for example less than 15 minutes.
The device according to the invention thus preferably doses the amount of material to be atomized solely on the basis of the amount of compressed gas output per pressure pulse and the duration of the pressure pulse. Furthermore, no mechanical dosing device is required in the device according to the invention.
In an advantageous embodiment of the device according to the invention, the ingredient chamber is arranged between the reservoir and the nebulization channel. Due to a suitable choice of the volume and the aperture of the dosing chamber towards the nebulization channel, dosing of the dose of nebulizable material per output pressure pulse can advantageously take place without any restrictions with regard to the opening of the reservoir itself towards the dosing chamber. In a particularly advantageous manner, the diameters of the aperture and of the reservoir and also of the dosing chamber situated below the aperture are matched to one another in such a way that the quantity of nebulizable material present in the dosing chamber is nebulized within the pressure pulse.
The source of compressed gas in the device according to the invention can be connected to the nebulization channel via a controllable valve. The controllable valve is here particularly preferably a solenoid valve, which controls the time and duration of the pressure pulse in the nebulization channel in a manner known to the person skilled in the art. The above-mentioned valves are controlled in a manner adapted to the patient's breathing or ventilation rate, and in a preferred embodiment of the device according to the invention, the control signal for the valves is emitted by a pressure sensor, which in invasive use is located inside the respirator.
According to the invention, pressure compensation takes place between the pressure pulses in the nebulization channel and in the reservoir and, if appropriate, in the dosing chamber. This pressure compensation can take place by introducing ambient air by suitable means in the device. In an advantageous embodiment of the device, however, this pressure compensation takes place by introducing breathing air or ventilation air into the nebulization channel and the reservoir in a direction opposite to the direction of the pressure pulse. In this way, a closed and preferably sterile system can be provided in an advantageous manner, in which contamination by microorganisms or contaminants in the ambient air can be safely avoided.
The compressed gas can advantageously be introduced into the nebulization channel via a capillary, the capillary particularly preferably having an internal diameter of from 0.8 to 1mm, very preferably approximately 1 mm. In a particularly advantageous embodiment of the invention, the outlet of the capillary is arranged in the nebulization channel in the region below the connection between the reservoir or the dosing chamber and the nebulization channel. In this way, a device is obtained in which the swirling of the compressed gas, which is advantageously formed from the capillary tube, supports the swirling of the nebulizable material in the nebulization channel and thus produces a dry mist. Furthermore, the vortex can break up possible agglomerates of the nebulizable material, so that almost all the primary particles of the nebulizable material are present in the obtained mixture of compressed gas and material.
The second connection piece of the nebulization channel of the device according to the invention is connected to the respirator connection piece (in invasive use) or to the connection piece which is connected to a patient who is suitable for administration to the natural ventilation (in the case of non-invasive use) in such a way that a dry mist, i.e. a mixture of compressed gas and material, is delivered to the patient without said mixture striking a contact obstacle or other obstacle. In this configuration of the device, the dry mist can pass unimpeded into the ventilation gas of the respirator and can mix there with the ventilation gas. In this way a situation can be prevented where nebulizable material carried by the carrier gas hits obstacles, stays on them and thus cannot reach a position of action in the lungs. Adhesion of the nebulized material, for example to the inner wall of a respirator attachment (for example a respirator side port or a breathing tube) or of a mouthpiece, can be safely suppressed, in particular by the parallel and exactly specific concentric arrangement of the nebulization channel and preferably of the dispensing mouthpiece with the respirator attachment or with the attachment to a device which is suitable for application to spontaneously ventilating patients.
In the device according to the invention, preferably 30 to 180ml of compressed gas per pressure pulse can be introduced into the nebulization channel. In this way, a quantity of compressed gas is obtained which is particularly advantageous for nebulizing a desired quantity of nebulizable material and which is sufficient for nebulizing a quantity of nebulizable material which can be taken up by the lungs of a patient in question. While the amount of nebulization by the volume of compressed carrier gas is sufficiently small to exclude the possibility of side effects on the respiration or ventilation of the patient.
In a further advantageous embodiment of the device according to the invention, a predetermined quantity of powdered material, preferably 10 to 50mg, more preferably 10 to 30mg, can be atomized per pressure pulse. In this way, a device is obtained which in a very simple manner allows the nebulization of a homogeneous dose of powdered material in an amount which is advantageously adapted to the absorption capacity of the lungs of the patient.
A reservoir suitable for the nebulizable material is connected to the device and is preferably a conventional vial suitable for injectable preparations. Its outer diameter is typically in the range of 2 cm. Before the vial is fitted on the device according to the invention, its closure, which is usually a rubber stopper, is removed. In a further preferred embodiment according to the invention, the reservoir contains 0.5 to 3g, particularly preferably 1 to 2g, of nebulizable material. This also means that the amount of material to be nebulized by the device can be adapted in a very advantageous manner to the dosage and duration of administration required by the intensive care body in the inhalation administration of powdered pharmaceutical preparations.
Within the meaning of the present application, nebulizable material is understood to be a material, at least some of which is converted into a state carried by a carrier gas during operation of the device according to the invention.
The nebulizable material is preferably a pharmaceutical preparation which can be administered in particular by inhalation. The pharmaceutical preparation is advantageously in powder form, for example in the form of a micro-powder. According to a preferred embodiment, the pharmaceutical preparation comprises a surfactant, in particular a pulmonary surfactant. Pulmonary surfactants are a mixture of substances contained in the lungs of all vertebrates. It has surface active properties and reduces the surface tension in the alveolar region of the lung to such an extent as to avoid collapse of the final airway region during exhalation. The essential component in pulmonary surfactant is eggWhite matter, marked as SP-A, SP-B, SP-C. Pulmonary surfactants included in the nebulizable material are particularly advantageous as reconstituted surfactants, such as described in WO 95/32992. It is a mutant of human SP-C (also designated as rSP-C). The most preferred pulmonary surfactants are(INN: Iusaultide, and also denoted rSP-C (FF/I)). rSP-C (FF/I)) is described in WO 95/32992. In addition to the surfactants described on the basis of the recombinant surfactant protein C (rSP-C), the pharmaceutical preparations may contain further pulmonary surfactants from the SP-A and SP-B groups. In addition, it may also contain phospholipids and other additives well known to the skilled person.
Particularly preferably, the pharmaceutical preparation is a powdered pulmonary surfactant preparation prepared as described in EP-B-877602. In the process of EP-B-877602, an organic solution or suspension containing a pulmonary surfactant and possibly other components is subjected to spray drying. In this contextIs the most preferred pulmonary surfactant.
Thus, the powdered pharmaceutical preparations comprising in particular pulmonary surfactants are in particularIs a particularly preferred use of the device.
Pulmonary surfactants are useful in the prevention and early treatment of acute lung diseases. This use is described in WO 01/76619. For example, diseases treated by pulmonary surfactants are, for example, asthma, pulmonary fibrosis, pneumonia, bronchitis, Chronic Obstructive Pulmonary Disease (COPD) and various Respiratory Distress Syndrome (RDS), Adult Respiratory Distress Syndrome (ARDS), and Infant Respiratory Distress Syndrome (IRDS). For the treatment of ARDSThe use of the atomizing device of (a) is a particularly preferred field of use.
According to a third aspect of the invention, a method for dosing and dry nebulization of nebulizable material is obtained by means of the above-described device. The method comprises the steps of introducing a pressure pulse into the nebulization channel in order to generate a vacuum in the reservoir which is suitable for the nebulizable material, resulting in the inhalation of an auxiliary quantity of the nebulizable material into the nebulization channel, and the aerosolization of this auxiliary quantity inside the nebulization channel. After the mixture of compressed gas and nebulizable material has passed through the dispensing mouth into the breathing tube or the like, pressure compensation takes place after completion of each pressure pulse, wherein air introduced from the outside and/or breathing air flows back from the breathing tube or the like into the nebulization channel and the reservoir.
According to the invention, during this pressure compensation, the gas flows through the mass of material which is located above the opening of the reservoir and, if appropriate, of the dosing chamber and where it is possible for the mass of material to compact and coagulate, and the coagulated mass can therefore loosen and coagulate.
If the dosing chamber used during the aforementioned pressure pulse is completely emptied, the mass of coagulated material located above the opening of the reservoir falls into the dosing chamber and forms a mass of the dosing chamber opening into the nebulization channel. In this way, by particularly simple means, a targeted dosing of the pharmaceutical preparation inside the device is obtained.
In another preferred embodiment of the method according to the invention, by repeating the above steps, the contents of the reservoir are all nebulized and dispensed to the patient within a defined period of time, preferably less than 15 minutes, more preferably less than 10 minutes. In this way, the method is made available which particularly advantageously meets the need for intensive care or emergency treatment of patients, where rapid administration of high-dose pharmaceutical preparations is necessary.
Brief description of the drawings
The invention is described in more detail below by way of example and with reference to the accompanying figures 1 to 5. The device shown in the drawings represents only an advantageous embodiment of the invention and is not intended to limit the basic meaning of the invention in any way.
In the drawings:
figure 1 shows a schematic view of a first embodiment of the device according to the invention;
FIG. 2 shows a side view in partial section of a first embodiment of the device according to the invention;
fig. 3 shows the device according to the invention in a state in which a pressure pulse is output into the nebulization chamber;
fig. 4 shows the state of the device according to the invention in the time period between two pressure pulses;
fig. 5 shows a schematic side view in partial section of a second embodiment of the device according to the invention.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
In fig. 1, a partially sectioned perspective view of a device 1 is shown, in which an atomising channel 3 is provided inside a nozzle block 2. At its first end (on the left in fig. 1), the nozzle block 2 comprises a capillary seat 4 in which a capillary holder 14 supporting a capillary 13 is fitted. The capillary holder 14 is in turn connected to a connection line 15 leading to a solenoid valve 16, which solenoid valve 16 is controlled by a control system schematically indicated by reference numeral 17. The flow of compressed gas from the compressed air connection line 18 into the capillary tube 13 is controlled by a control system 17. At its second end (on the right in fig. 1), the nebulization channel 3 opens into a dispensing mouth 5 whose cross section increases continuously in the direction away from the capillary 13. The dispensing nozzle 5 in turn leads to a connecting piece 2a which is an integral part of the nozzle block 2, on which a respirator connecting piece 6 is fitted or which is fitted connected to a connecting piece 7 for application to a spontaneously ventilating patient device. The device 1 further comprises a support seat 9 above the nebulization channel adapted to support a reservoir 10. The rim 11 of the reservoir 10 fits into a support seat 9 provided in the nozzle block 2, the opening 19 of the reservoir 10 being located above the dosing chamber 8 having a tapering conical shape. Located above this opening 19 is a mass of pharmaceutical product 12 which is agglomerated to such an extent that few particles 12 of nebulizable material enter the dosing chamber 8.
Fig. 2 shows a partially sectioned side view of the device 1 shown in fig. 1, but with the difference compared to the view in fig. 1 that the ingredient chamber 8 has been filled. In this state of the device 1, the dosing chamber 8 is filled with material falling through the opening 19 until the material in the reservoir 10 is compacted to such an extent that no further material 12 can slip into the dosing chamber 8. At the moment shown in fig. 2, the control system 17 does not send any signal to the solenoid valve 16, so that no compressed air enters the nebulization chamber 3 through the valve 16 and the capillary tube 13.
Fig. 3 shows a partially sectioned side view of the device 1 at a moment after the control system 17 has issued an opening signal to the solenoid valve 16. Before this moment, compressed air enters the nebulization chamber 3 via the solenoid valve 16 and the capillary tube 13. Inside the nebulization chamber 3, a vacuum is created by the flow of compressed air in the reservoir 10 and in the dosing chamber 8, by means of which vacuum at least the mass material 12 present inside the dosing chamber 8 is brought into the flow of compressed air, which is indicated by the empty arrows. In the nebulization channel 3, the nebulizable material 12 is aerosolized by the compressed air, and the dry mist indicated by the solid arrows and also the empty arrows is guided into the respirator attachment piece 6 and the attachment piece 7. The dry mist generated in this way can be conveyed by the breathing air or ventilation gas into the lungs of the patient.
Fig. 4 shows a partially sectioned side view of the first embodiment of the device 1 at the moment in which the control system 17 does not send an opening signal to the solenoid valve 16, as a result of which the flow of compressed gas from the compressed-air source (not shown) into the nebulization channel 3 is also interrupted. Due to the pressure gradient, for example between the breathing air intake line of the respirator or of the device for administration to spontaneously ventilating patients and the breathing air intake line of the device 1, ventilation air or breathing air flows into the nebulization channel 3 and through the ingredient chamber 8 into the reservoir 10. The loosening of the agglomerates and the breaking up of any agglomerates is caused by the air flow (indicated by arrows 22) through the respective mass materials in the dosing chamber 8 and the reservoir 10, so that the nebulizable material 12 capable of flowing is present in the device 1 after pressure compensation has taken place.
Fig. 5 shows an embodiment of the device 1 according to the invention, in which the device 1 is arranged concentrically with respect to a cylindrical breathing tube 21. Also in this embodiment, after the opening of the solenoid valve 16, the compressed air flows through the compressed air connection line 18 and the capillary tube 13 into the nebulization channel 3, which solenoid valve 16 is controlled by the control system 17. Also in this case, directly above the open end of the capillary tube 13 is an opening of the ingredient chamber 8, above which the reservoir 10 is positioned in a support seat 9 provided for it. In this embodiment, the longitudinal axis of the nebulization channel 3 lies on the longitudinal axis of the breathing tube 21 and parallel to a plurality of respiratory air inlets 23 through which respiratory air is conveyed by a source (not shown) through the breathing tube 21. Finally, at its end remote from the device 1, the breathing tube 21 ends in a schematically shown mouth 24 around which the patient can place his or her lips in order to inhale the breathing air to which the dry mist has been added.

Claims (34)

1. Device (1) for dosing and drying an atomized nebulizable material, comprising:
an nebulization channel (3) having a first and a second connection and to which a source of compressed carrier gas is connected via a valve (16) for sending carrier gas pressure pulses into the nebulization channel;
the method is characterized in that:
between the first and second connections and above the nebulization channel, a reservoir (10) which is open only towards the nebulization channel and which serves for accommodating nebulizable material (12) is connected to the nebulization channel, so that the reservoir is gastight with respect to the environment and, when the valve is closed, is pressure-compensated by gas which flows back towards the nebulization channel and the reservoir counter to the direction of the pressure pulse of the carrier gas.
2. The apparatus of claim 1, wherein: the second connection of the nebulization channel is designed as a dispensing mouth (5).
3. The apparatus of claim 1, wherein: an ingredient chamber (8) is arranged between the reservoir and the nebulization channel.
4. The apparatus of claim 1, wherein: the valve (16) is a controllable valve.
5. The apparatus of claim 1, wherein: a capillary tube (13) is arranged in the nebulization channel, through which capillary tube (13) the carrier gas flows into the nebulization channel when the valve is open.
6. The apparatus of claim 5, wherein: the capillary has an inner diameter of 0.8 to 1 mm.
7. The apparatus of claim 1, wherein: the gas that flows back towards the nebulization channel and the reservoir counter to the direction of the carrier gas pressure pulse is respiratory air or ventilation air.
8. The apparatus of claim 2, wherein: the second connection of the nebulization channel is connected to a respirator connection (6).
9. The apparatus of claim 8, wherein: the duration and/or timing of the carrier gas pressure pulse may be controlled via a valve (16) such that it is synchronized with the breathing rate of the ventilator.
10. The apparatus of claim 2, wherein: the second connection of the nebulization channel is connected to a connection (7) of a device for administration to spontaneously ventilating patients.
11. The apparatus of claim 10, wherein: the duration and/or timing of the carrier gas pressure pulse may be controlled via a valve (16) such that it is synchronized with the respiratory rate of the patient breathing via the device for administration to spontaneously ventilating patients.
12. The apparatus of claim 8, wherein: the nebulization channel and the dispensing nozzle are connected concentrically to the respirator connection piece.
13. The apparatus of claim 10, wherein: the nebulization channel as well as the dispensing mouth are connected concentrically to the connection piece of the device for administration to spontaneously ventilating patients.
14. The apparatus of claim 1, wherein: each pressure pulse may introduce 30-180ml of carrier gas into the nebulization channel.
15. The apparatus of claim 1, wherein: each pressure pulse may atomize a predetermined amount of the aerosolizable material.
16. The apparatus of claim 1, wherein: 10-50mg of nebulizable material can be nebulized per pressure pulse.
17. The apparatus of claim 1, wherein: the reservoir (10) is a conventional vial for an injectable product.
18. The apparatus of claim 1, wherein: the reservoir (10) contains 0.5 to 3g of nebulizable material.
19. The apparatus of claim 1, wherein: a source of compressed carrier gas is connected to the first connection via a valve (16), whereby pressure compensation takes place in the nebulization channel and the reservoir when the valve is closed.
20. The apparatus of claim 19, wherein: the connection of the compressed carrier gas via the valve (16) to the first connection of the nebulization channel is substantially gas-tight.
21. Use of a device according to one of the preceding claims 1 to 20 for dry nebulization of powdered pharmaceutical preparations.
22. Use according to claim 21, characterized in that: the pharmaceutical preparation comprises a pulmonary surfactant.
23. Use according to claim 22, characterized in that: pulmonary surfactants are recombinant surfactant protein C based surfactants.
24. Use according to claim 23, characterized in that: recombinant surfactant protein C is iusuultide.
25. Method for dosing and drying atomized material by means of a device (1) according to claim 1, comprising the steps of:
-opening a valve (16) to send a carrier gas pressure pulse into the nebulization channel (3) and to generate a vacuum in the reservoir (10);
-drawing an auxiliary quantity of nebulizable material (12) from the reservoir into the nebulization channel;
-atomizing an auxiliary amount of nebulizable material in the nebulization channel;
-passing the mixture of compressed gas and material through an atomising channel; and
-closing the valve (16) for pressure compensation in the nebulization channel and the reservoir.
26. The method of claim 25, wherein: when the valve (16) is closed for pressure compensation, gas flows back into the reservoir and flows through the nebulizable material (12) located in the reservoir (10).
27. The method of claim 26, wherein: as the gas flows through the nebulizable material (12), the nebulizable material loosens and, if appropriate, depolymerizes.
28. Method according to one of claims 25 to 27, characterized in that: the contents of the reservoir (10) are almost completely nebulized over a defined period of time.
29. Method according to one of claims 25 to 27, characterized in that: the contents of the reservoir (10) are almost completely nebulized in a time period of less than 15 minutes.
30. Method for dosing and drying atomized material by means of a device (1) according to claim 3, comprising the steps of:
-opening a valve (16) to send a carrier gas pressure pulse into the nebulization channel (3) and to generate a vacuum in the reservoir (10);
-drawing a secondary quantity of nebulizable material (12) from a reservoir or dosing chamber (8) into the nebulization channel;
-atomizing an auxiliary amount of nebulizable material in the nebulization channel;
-passing the mixture of compressed gas and material through an atomising channel; and
-closing the valve (16) for pressure compensation in the nebulization channel and the reservoir.
31. The method of claim 30, wherein: when the valve (16) is closed for pressure compensation, gas flows back into the reservoir and flows through the nebulizable material (12) located in the reservoir (10).
32. The method of claim 31, wherein: as the gas flows through the nebulizable material (12), the nebulizable material loosens and, if appropriate, depolymerizes.
33. Method according to one of claims 30 to 32, characterized in that: the contents of the reservoir (10) are almost completely nebulized over a defined period of time.
34. Method according to one of claims 30 to 32, characterized in that: the contents of the reservoir (10) are almost completely nebulized in a time period of less than 15 minutes.
HK08106603.8A 2005-04-08 2006-04-07 Device for dosing and dry nebulization HK1116437B (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102005016100.6 2005-04-08
DE102005016100A DE102005016100B3 (en) 2005-04-08 2005-04-08 Device for metering and dry fogging
PCT/EP2006/003155 WO2006108558A1 (en) 2005-04-08 2006-04-07 Device for dosing and dry nebulization

Publications (2)

Publication Number Publication Date
HK1116437A1 true HK1116437A1 (en) 2008-12-24
HK1116437B HK1116437B (en) 2011-10-28

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ES2727000T3 (en) 2019-10-11

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Effective date: 20170407