WO2008049433A1

WO2008049433A1 - Hand-held drug inhaler for administration of pharmaceutical or technical products

Info

Publication number: WO2008049433A1
Application number: PCT/DK2007/000460
Authority: WO
Inventors: Anders Leonhard Jensen; Tage Wenzel Debess
Original assignee: Trendtech A/S
Priority date: 2006-10-27
Filing date: 2007-10-29
Publication date: 2008-05-02

Abstract

This invention relates to a hand-held medicine inhaler working with refill unit and manually established compression, ensuring that the inhalation product is delivered into the lung tissue of the patient with defined particle size and dynamic sequence on inhalation.

Description

HAND-HELD DRUG INHALER FOR ADMINISTRATION OF PHARMACEUTICAL OR TECHNICAL PRODUCTS

FIELD OF THE INVENTION The present invention concerns a device for pulmonary administration of certain drugs where pharmacological possibilities allow for pulmonary or muscular absorption of the active matter.

BACKGROUND Today it is a known fact that diabetics have to inject themselves to get the vital insulin. On the basis of a blood test and a standard chart the patient defines the amount of drug that he/she needs to inject into the blood vessel in order to secure the required balance and to obtain a situation where the severe or less severe diabetes, including type 2 diabetes, is in control and does not affect the patient's health in general.

Poorly treated diabetes may in worst-case lead to disablement, as the blood circulation system of the diabetic increases in severity so amputation of body parts might be necessary. However, by delivering the correct and sufficient amount of insulin, the diabetic is able to lead an almost normal life. As mentioned, there are several degrees of diabetes, which consequently require various feedings of insulin.

The present invention relates to an apparatus for pulmonary administration of certain drugs where pharmacological possibilities allow for pulmonary or muscular absorption of the active matter and can advantageously be used for pulmonary treatment. The apparatus according to the present invention will also be an alternative in less severe diabetic cases, where insulin inhalation would be a fine alternative to tablet treatment. In addition, the present inven- tion can advantageously be used for other pulmonary treatments. In pulmonary treatment in general, there are very high demands as to particle size in the vaporization process when inhaling the drug as well as to the particle velocity. Both parameters are considered and dealt with by the present invention. Furthermore, the invention considers the special requirements to the drug storage that are often a matter of concern.

By a normal breath 0.5 litre of air is inhaled. The necessary drug delivery is as mentioned based on each individual diabetic's medical history, but a dosage can be assumed to lie between 0.1-5 ml for one drug delivery per treat- ment by inhalation. Also, it can be assumed that a neutral position between the isotonic water content / drug dosage in the inhalation phase must be adjusted, as an either too concentrated or too weak dosage might provoke a detrimental effect on the lungs (irritation / "drowning"). This aspect is also considered by the present invention.

The present invention considers this aspect, as one drug delivery can either be inhaled in several inhalations or in one single inhalation - in both cases the drug is 100 per cent delivered to the lung volume. Multiple inhalation or single inhalation can be adjusted by means of the established backpressure, which must be high to particulate, but low to provide tactic delivery, by inhalation.

Thus, all in all, there is a great need for new equipment, which treats the above mentioned parameters.

Present Stage

There has not been found any patent specifications, which could be novelty- defeating to the present invention.

Strict efforts from numerous manufacturers are being made to bring a drug inhalation device to the market. The market in question is growing signifi- cantly and can be characterised as being dominated by an oligopoly of relatively large companies. Pharmaceutical products have a very long lead-time, from idea to launching, not least while covered by pharmaceutical legislation. The present invention is deemed to be in a pole position in comparison with other players.

For example one or more devices produced by the Danish company 'Novo' are based on vaporization of the drug with a particle size of less than 5 μm together with the application of a battery-powered compressor unit to estab- lish the necessary evacuation pressure.

The company Generex also applies a standard pressure aerosol containing insulin. Pfeizer has announced a tube-like inhaler for the inhalation of particulate insulin. Most recently Bang & Olufsen Medicom has introduced an inha- lation-released inhaler also based on pressure aerosol.

The known inhalers are, however, disadvantageous for a number of reasons:

- The application of the vaporization temperature might impact the drug. - The application of transparent plastic tubes in connection with particulate drugs might cause dosing variability depending on humidity and static electricity.

- The application of pressure aerosols might cause a too high drug velocity resulting in the drug being delivered in the throat instead of in the lung tissue.

- Another drawback of several of the inhalers mentioned is volume. These devices are relatively large and are not easy to integrate into daily activities; during travels, etc.

Further, some patients also suffer from reduced lung capacity increasing the requirements to an inhalation device. Further, there is an ever-growing demand for e.g. diabetic treatment on grossly every market, and therefore the production price of the inhaler device is of great importance to third countries, where also the poor standard of hy- giene and ease of use are major challenges to overcome.

OBJECT AND SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a device for pulmonary inhalation which at least partly overcomes some or all of the above mentioned problems.

This is achieved by the invention as defined by the independent claims, and other advantageous embodiments of the invention are defined by the dependent claims. The benefits and advantages of the present invention are explained and discussed in the detailed description.

The present invention is an inhaler device consisting of an air compressor, which is an integrated part of a refill-system. Depending on the person's lung capacity, the inhaler enables an inhalation sequence given by the following steps: a delivery of pure air in phase one, and as phase two the subsequent vacuum created by inhalation will release a drug inhalation by a predetermined backpressure ensuring that the medicated air is delivered directly into the lung volumes for maximum uptake and distribution in the lungs. The inhalation sequence is finalized by phase three consisting of pure air.

The system is flexible and the patient can make his/her own inhalation sequence, whereby a maximum effect of the medicated air is achieved. The drug inhalation can be made as one inhalation or as several minor inhalations. Further, on an inspection dial the patient will be able to see when the medicine has been depleted and will thus be able to adjust this inhalation sequence of prescribed dosage.

The distinctive feature is the hand-held design of the drug inhaler. The inhaler consists of only low-cost parts, which are easy to mass-produce.

The conceptual framework of the present invention is of great importance, as the product approaches many different segments and markets.

The device is designed with a replaceable refill unit with sterile content and a basic unit, which are both described in more details in the following.

The refill unit: The refill units will come in sterile packing.

The refill unit contains the drug in pharmaceutical dissolution, suspension or dispersion or the like. Another variant of the described allows the administration of particulate pharmaceuticals, here the atomizer (106) is replaced by a mesh structure or a static mixer. The refill unit is easy to replace using only few movements. Furthermore, printing on the refill unit is possible allowing the producer to print logo, strength, etc.

A spring-restrained needle valve (108), which is essential to the present in- vention, is placed in the refill unit.

The refill unit has a displaceable umbrella unit (105), which is displaced by a well-defined inhalation pressure on its back side, alternatively aerodynamic vacuum on the front side, and which has an axial mechanical connection to the opening/closing mechanism of the needle valve (109) in the refill unit. The atomizing nozzle in the refill unit, static mixer or the like ensures that the drug in question by a well-defined backpressure is delivered into the lung volume of the patient with the required degree of vaporization, which is the core objective of this invention.

The refill unit can either be constructed with a pair of bellows, an ordinary reservoir of aluminium foil coated with a layer of Barex or similar, or it can be a plastic or glass tube. All three alternatives are equipped with a floating plunger, and the designs ensure that the manufacturer's demands to storage are considered, i.e. durability, protection from sunlight and air.

The basic Unit

The basic unit has been designed as a hand-held unit (101 ), containing a hollow plunger tube (104) with o-ring sealings against the movable parts (115), where the refill unit is inserted.

The one end of the plunge tube has a valve function (116) in order to obtain the requested compression establishment. The cylindrical pressure chamber (113) is surrounding this. Furthermore, the basic unit consists of a dismount- able tip (103), which is dismounted when replacing the depleted unit and mounted when inserting a new refill unit. The dismountable tip maintains the inserted refill unit in place.

The compression is established by pumping the movable part of the body (plunger tube) (101 ) back and forth a couple of times. In this process the basic tube (104) of the refill unit acts as a plunger and the sealing function is obtained by means of the o-rings (118).

The spherical valves mounted into the slide way (125) work as intake valve against the surrounding environment and as relief valve against the pressure chamber (116), respectively. The release function is activated by the valve (114), which is placed in the unit's centreline. When the pressure is released, the excess pressure is led from the pressure chamber directly to the end face of the refill unit, where it works as a stationary pressure on the sliding plunger (112), which is released once the user makes sufficient inhalation for the needle valve to lift.

The volume of the refill unit can be adjusted to fit all relevant feeding rates and the pressure equalization provides a 100 per cent accurate evacuation of the drug. Thus, the accuracy of the feeding rate is deemed to be perfect.

In case the pharmaceutical manufacturer wants a large or smaller drug volume, this is easily adjusted, as the refill unit will probably be produced of a low-cost plastic material.

The pumping unit is equipped with an adjustable marking dial (120) for ON / OFF, limiting the travelling of the release pin during establishment and release, respectively, of pressure against the end face of the refill unit.

Establishment of effective thrust is made when the user pumps an adequate number of times with the movable pressure chamber of the inhaler until the required excess pressure is obtained. Subsequently, the pressure chamber is turned in a given angle, whereby it is locked into the correct position. The inhaler is now ready for drug inhalation.

The following inhalation sequence is considered:

1. Clean air

2. Medicated air 3. Possibly several inhalations of step 2 *)-

4. Clean air. *) The medicated air might also be inhaled in one single inhalation.

Finally, great efforts have been made in order to make the inhalation unit tamper-proof. This feature can be extended to the mouth piece bayonet lock, so that an axial pressure must be established before the dismounting.

Storage

The complete unit is very compact and can easily fit into a pocket or a bag, which eases daily use.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following, preferred embodiments of the invention will be described referring to the figures, where

figure 1 shows a sectional view of an embodiment of a drug inhaler according to the invention,

figure 2 shows a detailed view of a mouth piece with an umbrella shaped re- lease unit,

figure 3 shows a detailed sectional magnification of a needle release construction,

figure 4 illustrates a sequence of operation,

figure 5 shows another embodiment of the invention. Dotted lines indicate the envisaged displacement of the pressure chamber, and

Figure 6: Medication refill might be:

- Plastic tube with pharmaceutical drug and floating plunger - Glass tube with pharmaceutical drug and floating plunger Bellow (sp) with pharmaceutical drug and floating plunger Bellow with pharmaceutical drug and thrust washer

- Capsule with pharmaceutical drug and thrust washer - Needle valve and umbrella, backstop spring and valve guide

- Specially developed mixing unit / vaporization unit for pharmaceutical products

Figure 7 is the drug inhaler seen from section A - A.

Figure 8 shows the switch washer for the release of back pressure. Section B - B.

Figure 9 is a schematic view of a multi-dosage refill unit with regulation screw for stop pin and magnifier for dosage position as well as treatment confirmation.

DESCRIPTION OF EMBODIMENTS

This invention relates to a hand-held medicine inhaler working with refill unit and manually established compression, ensuring that the inhalation product is delivered into the lung tissue of the patient with a defined particle size and in a dynamic sequence on inhalation.

The inhaler according to one embodiment of the invention consists in general of the following parts:

• Refill unit (104) with displaceable umbrella (105)

• Center section / press plunger 102

• Dismountable mouth piece (103)

• Moveable pressure chamber (113) with valve functions • Moveable safety device (121 ) for release of backpressure Referring mainly to figure 1 , the inhaler is designed with one replaceable refill unit (104) constituting a container for the pharmaceutical product (135). The replacement of the refill container (104) is very simple and requires only a few grips. A needle valve and a spray nozzle (132, 106), which is an essen- tial part of this invention, is placed in the refill unit. The refill unit is further e- quipped with a displaceable umbrella shaped unit (105), which can be displaced by a well-defined inhalation pressure on its backside, alternatively on the front side, and which is mechanically and axially connected by a number of connection pins (129) to the opening/closing mechanism of the needle valve.

The atomizer or spray nozzle (106) in the refill unit (104) ensures by the drug flow through the drug and dilution reservoir (135) that the drug by a defined backpressure is delivered to the patient's lung volume with the requested degree of atomisation which is a major advantage of the invention.

The refill unit can for instance be constructed of a pair of bellows, as an ordinary reservoir of aluminium foil coated with a layer of Barex or similar, or it can comprise a plastic or glass tube. All the mentioned alternatives are equipped internally with a floating plunger (112). The inhaler which is designed as a hand-held unit further comprises a hollow plunger tube or inner corpus (102) into which the refill unit is inserted and with o-ring sealings (115) against the movable parts. The one end of the plunger tube (102) comprises a valve function (116) in order to obtain the required level of air pressure. The cylindrical pressure chamber (113) is surrounding this plunger tube or inner corpus. Furthermore, the device comprises a dismountable mouth piece (103), which keeps the inserted refill unit in place.

The required compression is established by pumping the movable part of the device (the assembly of the plunger tube and outer corpus) back and forth a couple of times. In this process the refill unit (104) acts as a piston, and the sealing function is obtained by means of the o-rings. The spherical valves (124, 116) mounted in the pass-way tube (125) and in the inner corpus (102) work as an intake valve (124) from the surrounding environment, and as a relief valve (116) against the pressure chamber or reservoir (113), respec- tively. The release function is activated by the valve (114), which is placed in the refill unit's centreline. When the pressure is released, the excess pressure is led from the pressure chamber (113) directly to the end face of the refill unit (104), where it works as a stationary pressure on the floating plunger (112), which is, however, not released until the user makes a suffi- cient inhalation for the needle valve (132) to lift.

The volume of the refill unit can be adjusted to fit all relevant feeding rates, and the pressure equalization provides a 100 per cent accurate evacuation of the drug. Thus, the accuracy of the feeding rate is deemed to be perfect.

The pumping unit constituted by the movable pressure chamber is in its end equipped with a adjustable marking dial (25) for ON / OFF, limiting the travelling of the release pin or connector rod (119) during establishment and release, respectively, of pressure against the end face of the refill unit. Estab- lishment of effective thrust is made when the user pumps an adequate number of times with the movable pressure chamber (101) of the inhaler until the required excess pressure is obtained. Subsequently, the pressure chamber is turned in a given angle, whereby it is locked into position. The inhaler is then ready for drug inhalation. The following inhalation sequence is considered:

- Clean air,

- Medicated air,

- repetition of step 2*) - possibly several inhalations

- Clean air.

*) The medicated air might also be inhaled in one single inhalation. Description of refill unit with displaceable umbrella

The construction is variable but by way of example a number of alternatives are listed below. The selection of material does not affect the described con- ceptual framework. The construction of the refill unit will be based on the manufacturer's demands as to cost of production, durability, etc.

- Plastic tube / paper tube with pharmaceutical drug and floating plunger

- Glass tube with pharmaceutical drug and floating plunger of either rubber or plastic

- Bellows with pharmaceutical drug and floating plunger

- Capsule with pharmaceutical drug and thrust washer

Plastic tube - (in general) (104) Floating plunger / thrust washer (112) Pharmaceutical drug (135) Backstop with o-sealing (111) Needle valve with guide and backstop spring (109) Special Mixer / Vaporizing unit / atomizing spray nozzle (106) Displaceable umbrella (105) for lift/opening of needle valve

When the established backpressure presses against the innermost end face of the refill unit, the floating plunger will be pushed up through the inner tube, and now the patients' inhalation sequence is decisive for the actual delivery function of the drug into the lungs.

The application of a needle valve is deemed essential for the intended result, due to the fact that the closing area of the needle valve is very small enabling the established backpressure to be maintained even with a small spring pressure (107). The needle valve and its release function are needed to establish a standing pressure. The release function occurs from the slight pressure variation that occurs on the umbrella shaped element (105) when the user inhales. This variation draws the umbrella towards the user's mouth, and the pin connector (129) moves the needle (132) via the internal guide tube (130).

The pharmaceutical drug is delivered through a micron filter (108) or static powder mixer via a nib holed hollow needle (132) to an atomizing nozzle (106) or powder particulate, for obtaining fine particle content of the delivered drug.

The functionality of this invention stems from the fact that pressurized air only works on the medicinal dose which in turn is sprayed into the normal pressure primary air that the user draws in trough the holes in the back plate (110) of the mouth piece (103) By using this method two advantages are found: The high pressure allows for small particles while the normal inhalation allows for tactical pulmonary delivery of the drug.

Insertion / Removal of Refill Unit The refill unit is a sterile part, which is inserted in the hollow centre tube (102), sealed with an o-ring (115) and maintained in place via the threaded back plate (110) in the mouth piece (103). In another variation this can also be a bayonet lock with a minimum of 3 backstop tabs.

After insertion a threaded nut located free around the piston rod is screwed into the inner part (111) thread, whereby the piston is restricted from leaving the tube.

The refill units are disposable, and new units are inserted as required. From this is gained that all critical components i.e. nozzles, filters, valves, needle etc. are changed prohibiting dysfunction, clogging and wear and tear.

When idle, the inhaler is pressure-less and tamper-proof. To make ready for use the following procedure is used:

Establishment of compression in compression chamber, (referred to as backpressure)

Subsequently transfer of pressure to act on refill unit - Total release/delivery of pressure, thereby total drug dosage as prescribed.

The umbrella shaped unit (105) is shaped as sketched in the figures and the back plate (110) will have nib holes or slits as radian structure to facilitate permeability.

The mixture of medicated and pure air is delivered at the mouth piece outlet opening by means of backpressure, adjusted to each patient's individual need.

Description of Center Section piston

This part is made out of suited plastic. The cylindrical part is closed to the left by an o-ring sealing (115) against the movable pressure chamber.

The piston is an integrated part of the refill unit to be placed in the inner body (102) tube in the centreline with external projection and sealing (110). The end face of the press plunger has a flange / bayonet lock (110). When secured by nut 111 the device presents a complete and securely assembled unit. Description of Dismountable Mouth piece with threaded or bayonet Lock (103)

The tip of the mouth piece is conically shaped ensuring an outer diameter and shape, which feels pleasant for the user to put into the mouth. The larg- est diameter has a grooved surface to ensure a good grip. The refill unit, e.g. a plastic tube with pharmaceutical drug and floating plunger, is kept in place by the mouth piece.

Description of Movable Pressure Chamber with Valve Function The pressure chamber (113) is a closed chamber, which is formed by the outer body 101 combined with inner body 102 that are securely glued together. A cylindrical bore receives the replaceable piston and the refill unit. Air intake occurs in the air inlet duct (125) which is equipped with a micron filter unit (126). In the one end a one way valve (124) prevents return air. With the valve (114) blocked by control pin (121) pressure will build in (113) through one way valve (116). When the refill unit is extracted from the cylindrical inner corpus an air intake occurs, and when pushed back the pressure is increased.

A safety plug, which is not shown in the figure, ensures that the user cannot establish excess pressure.

Locking of (101) Relative to (103)

This is relevant when the backpressure is established and released towards the end face of the refill unit (104). At (121), displaced 90 degrees, a locking respective operating mode can be made.

Movable Safety Device for Release of Backpressure (120)

The spring-loaded push dial (121 ) has two settings by a 90 degrees turn of the dial. When turned the dial travels 2.5 mm in height (see figs. 7 and 8). When the pumping function has been made the dial is set to "OFF". When the release function for backpressure is set, the dial is set to "ON". The high pressure is hereby transferred to the floating piston (112) and acts as a standing pressure. O-ring sealing (120) is integrated in the above, retaining the pressurized air within the inner corpus.

The Augmented Release Mechanism

When ready for medication, the user will now place the mouth piece in the mouth and start inhaling - hereby supplying pressure on umbrella shaped unit acting as a trigger (105) moving towards the mouth. Via the connecting pin(s) (129) the inner guide tube which holds the needle also moves against the spring (107) whereby the pressurized medication will evacuate through hollow needle (132) and fine mist nozzle (106). Due to medium or high pressure the medication dissolves into non pressurized primary air reducing travel speed of particles to normal inhalation velocity. If inhalation is not sufficient for delivery, the spring will close the needle valve immediately. New inhalation will reopen the valve. This can be repeated until all medication has been supplied to the lung tissue. Hereby is ensured that the drug is finely particu- late and mixed with air ensuring a tactical fine particulate administration at normal inhalation velocity.

In figure 5 is further shown how a simple dosage device permits multi dosage application. Stop pin/flange (29) is led forwards by means of the roller wheel on the regulation screw (30) to the desired quantity read off by means of the enlargement window (magnifier) (28). It is hereby achieved that the floating plunger (112), here provided with appropriate carving, cannot be led any further than to the stop. Legend:

101. Outer corpus serves as outer shell and compression build-up reser- voir.

102. Inner corpus (plunger tube / centre tube) confines inner shell of reservoir and supports valves, it snaps into 101 where it is glued or welded to an airtight seal.

103. Mouth piece (tip) serves as contact item with users' mouth and en- cases interior mechanism.

104. Refill unit and locking tube (centre piston) fit into inner corpus 102 and is screwed into mouth piece 103 whereby it fixates core technology i.e. release function, filter and spray nozzle.

105. Inhalation augmented umbrella shaped unit for releasing the needle valve.

106. Atomising spray nozzle (special mixer / vaporizing unit) e.g. with dual feed tubes and 28 degree angle.

107. Spring for spring loading of umbrella 105 and thereby via connector pin needle valve. 108. 5 micron particle filter filtrates and particulates medical liquid.

109. Counter hold for spring 107 (back stop spring).

110. Threaded and punch-holed (back plate) for surrounding air inlet connector is an integral part of 104 and screws into 103.

111. Distal end-stop for refill unit 104 is loosely fitted around 104 and screws into inner corpus 102 by means of with 110 interconnecting wing-bolt arrangement.

112. Floating, air augmented rubber piston (plunger / thrust washer).

113. Reservoir (pressure chamber) for build-up air compression.

114. Augmentation air pin (or spherical) valve directed toward mouth piece is sealed into refill unit 104. 115. O-ring type of seal placed in grove for sealing the refill unit 104's piston action.

116. Augmented air one-way valve directed toward reservoir 113 is sealed into inner corpus 102. 117. Air connector tube is an integral part of inner tube 102 and receives inlet tube of 114 by means of an o-ring fitted sleeve connector.

118. Sealing pad that when pressed onto inner corpus effectively seals compression build-up from entering 117.

119. Connector rod is an integral part of safety dial and transfers pushing force from said dial.

120. O-ring seal retains pressurized air within 102.

121. Ridge rail types of safety dial - see description for function.

122. O-ring fitted sleeve connector to seal conveyed compressed air towards floating piston 12. 123. Compression chamber where compression generated by refill unit 104 movements is built up and excess pressure is transferred to compressed air reservoir 113 via valve 116.

124. Air-inlet one-way valve permits surrounding air to enter compression chamber. 125. Air inlet pass-way tube (slide way) that on distal end draws air from surroundings on refill unit104's return movements.

126. 5 micron airs filter to ensure against foreign particle clocking of valves and nozzle.

127. Filtration type paper filter glued onto face of 110 prevents eventual solid particles from entering user's airways during the primary air inhalation.

128. Mounting for drug filter 108 equipped with needle valve land is an integral part of refill unit 104.

129. Connecting pin/ pins transfers) the inhalation augmented force to the guide tube (130) holding the needle valve and the needle.

130. Movable guide tube holding the needle valve and the needle. 131. O-ring seal between static drugs filter 118 with integrated needle valve land and the dynamic guide tube holding needle.

132. Proprietary needle design whereby the needle is closed pointed and extends to a wider hollowed out diameter whereby a number of cavi- ties can be made to offer conveying of air and drug vapours into the needle's interior hollow part and further into the atomising nozzle 133 connected hereto.

133. Spray nozzle that can be of the type of two or more feeding channels, integral atomising chamber and fine spray ejection orifice. 134. Fixed mounting bracket between movable guide tube and needle to ensure that the release action occurs when inner tube 130 is moved by the connecting pin 129. 135. Medical drug reservoir (dilation chamber).

It should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word 'comprising' does not exclude the presence of other elements or steps than those listed in a claim.

Claims

CLAIMS:

1. An inhaler for pulmonary administration of a drug to a person characterized by comprising at least one refill unit comprising the drug confined by at

5 least one movable floating piston for partial or full evacuation of said drug through at least one needle valve to one or more atomisation nozzles, where said needle valve(s) is(are) activated at least partially by the person's inhalation, and which piston is moved by a positive pressure from at least one compression chamber via at least one valve. 0

2. An inhaler according to claim 1 , further comprising at least one umbrella shaped unit connected to said needle valve(s) and slidably connected to said refill unit(s) whereby said umbrella shaped unit(s) control(s) the position of said needle valve(s). 5

3. An inhaler according to claim 2, where said umbrella shaped unit is placed in the mouth piece of said inhaler so that an inhalation of the person moves said umbrella shaped unit. 0

4. An inhaler according to one or more of the claims 1-3, where said compression chamber is further connected via one or more valves to a manually operated pump for creating a positive pressure in said compression chamber.

5. An inhaler according to one or more of the claims 1-4, where said pump is5 constituted by said refill unit movably mounted in a tube at least partly surrounded by said compression chamber.

6. An inhaler according to one or more of the claims 1-5, where said atomising nozzle comprises two or more feeding channels, an atomising chamber o and fine spray ejection orifice.

7. An inhaler according to one or more of the claims 1-6, where said refill unit further comprises at least one particle filter placed in front of said needle valve(s) for filtrating said drug.

8. An inhaler according to one or more of the claims 1-6, where said refill unit further comprises at least one mesh and static mixer for powdered placed in front of said needle valve(s) for filtrating said drug.