CA3123725A1

CA3123725A1 - Inhaler

Info

Publication number: CA3123725A1
Application number: CA3123725A
Authority: CA
Inventors: Lars Arvidsson; Fredrik Gunnarsson; Orest Lastow; Henrik Svedberg; Richard Johnson
Original assignee: Iconovo AB
Current assignee: Iconovo AB
Priority date: 2019-02-15
Filing date: 2020-02-14
Publication date: 2020-08-20
Also published as: EP3924023A1; WO2020165390A1

Abstract

The invention pertains to a dry powder inhaler comprising at least one air inlet at a distal end zone of said inhaler, at least one air outlet at a proximal end zone of said inhaler, and an air channel between said at least one air inlet and said at least one air outlet; at least one medicament reservoir; a dosage mechanism for arranging at least one dose of a medicament from said at least one medicament reservoir between the air channel and the air outlet such that said at least one dose may be delivered upon inhalation at said air outlet. The dosage mechanism comprises a dose disc with at least one cavity, wherein the dose disc may be rotated between a dose collecting position wherein the cavity is positioned in the medicament reservoir, and a dose administering position wherein the cavity is in communication with said air channel. The inhaler further comprises at least one agitator located inside the at least one reservoir, comprising an interactor. The interactor interacts with the dose disc or cavity, such that the dose disc rotation transfers energy to the agitator, which will release energy as movement during the dose disc movement from the dose collecting position to the dose administering position.

Description

INHALER
FIELD OF THE INVENTION
This invention pertains in general to the field of medicament inhalers, and more particularly to dry powder inhalers. Even more particularly, the invention pertains to a medicament inhaler comprising an agitator comprising an interactor.
BACKGROUND OF INVENTION
Inhalers have been widely used in the pharmaceutical field for treatment of respiratory and/or other diseases. Numerous drugs, medications and other substances are inhaled into the lungs using the inhalers for rapid absorption of the drug etc. in the blood stream and for local action in the lung.
Inhaled drugs fall into two main categories, one being in the form of liquids, including suspensions, and the other being powders. The choice of liquids or powders depends on the characteristics of the drugs, medications, etc. to be inhaled.
The most common type of inhaler is the pressurized metered-dose inhaler. In this type of inhaler medication is most commonly stored in solution in a pressurized canister that contains a propellant, although it may also be a suspension. The canister is attached to a plastic, hand-operated actuator. On activation, the metered-dose inhaler releases a fixed dose of medication in aerosol form.
Another kind of inhaler is a nebulizer, which supplies medication as an aerosol created from an aqueous formulation.
The kind referred to herein is yet another type, in the form of a dry powder inhaler. A dry powder inhaler releases a pre-metered, capsuled, dose or a device-metered dose of powdered medication that is inhaled through the inhaler.
Inhalers with a device-metered dose of powdered medication are normally inhalers with a medication reservoir containing powdered medication, from which metered doses are withdrawn through the use of different dose metering arrangements, the doses then being inhaled.
Dry powder inhalers need to deliver a particle size that is predominantly below 5 microns, and preferably between 1 micron and 3.3 microns, for maximum effectiveness. However, such small particles are often very cohesive due to high surface

2 energy. Agglomeration may be worsened by moisture and / or when the medication comprises more than one active substance, since the different active substances may have such properties as to form agglomerations with each other or with pharmaceutical carriers etc. Agglomeration of small particles is a problem which results in the active particles leaving the inhaler as large agglomerates.
EP0237507 relates to a device in powder inhalators intended to be used for local administration of drugs to the respiratory tract and lungs of a patient.
Not only moisture can cause the dry powder to clump together, also static electricity could make the dose stick to the walls and parts of the dose metering system.
This can make the dose amount inconsistent or cause part of the dose stick in a dose administering location. This may lead to users receiving uneven amounts of medicament per dose, and in extreme cases, it could even at least partially clog the inhaler.
As such, there exists a need for an improved dry powder inhaler device in which effective and satisfactory dispersion of the dry powder is obtained and which inhaler efficiently facilitates deaggregation and dispersion and provides an even medicament amount per dose.
SUMMARY OF INVENTION
Accordingly, the present invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination and solves at least the above mentioned problems by providing a dry powder inhaler comprising: at least one air inlet, at least one air outlet, and an air channel between the at least one air inlet and the at least one air outlet; at least one medicament reservoir; a dosage mechanism for arranging at least one dose of a medicament from the at least one medicament reservoir between the air channel and the air outlet such that the at least one dose may be delivered upon inhalation at the air outlet, wherein the dosage mechanism comprises a dose disc with at least one cavity, wherein the dose disc may be rotated between a dose collecting position wherein the cavity is positioned in the medicament reservoir, and a dose administering position wherein the cavity lies underneath the air channel; at least one agitator located inside the at least one reservoir, comprising an interactor, wherein said interactor interacts with the dose disc orcavity, such that the dose disc rotation transfers energy to the agitator,

3 which will release energy as movement during the dose disc movement from the dose collecting position to the dose administering position.
Further advantageous embodiments are disclosed below and in the appended patent claims.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other aspects, features and advantages of which the invention is capable will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which Fig. 1 is a cross sectional view along a longitudinal axis of an inhaler in the dose administering position according to one embodiment of the present invention;
Fig. 2 is a perspective and cross sectional view of the inhaler in Fig. 1, wherein air inlets are omitted from Fig. 2 for clarity;
Fig. 3 is a cross sectional view along a longitudinal axis of the inhaler in Fig. 1 wherein the air and air/medicament flows through the inhaler are disclosed;
Fig. 4 show a detailed view of an agitator located inside a reservoir above the dose disc according to one embodiment for use in the inhaler in Fig. 1;
Fig. 5 show a detailed view agitator located inside a reservoir above the dose disc according to one embodiment for use in the inhaler in Fig. 1;
Fig. 6 show a detailed view agitator located inside a reservoir above the dose disc according to one embodiment for use in the inhaler in Fig. 1;
Fig. 7 show a detailed view agitator located inside a reservoir above the dose disc according to one embodiment for use in the inhaler in Fig. 1;
Fig. 8 show a detailed view of an embodiment of the agitator for use in the inhaler in Fig. 1;
Fig. 9 show a detailed view agitator located inside a reservoir above the dose disc according to one embodiment for use in the inhaler in Fig. 1;
Fig. 10 shows partial views of the embodiments of the agitator in in Fig. 4 (10a) and Fig. 8(10b); and Figs. lla-d shows detailed partial views of different axis supports.

4 DETAILED DESCRIPTION OF EMBODIMENTS
The following description focuses on embodiments of the present invention applicable to a medicament inhaler 100, and in particular to a dry powder drug inhaler with more than one medicament reservoir, such as two medicament reservoirs.
However, it will be appreciated that the invention is not limited to this application but may be applied to many other inhalers having an inlet and an outlet, as well as a medicament reservoir.
Fig. 1 and 2 illustrate a dry powder drug inhaler 100. The dry powder drug inhaler 100 comprises air inlets 101 and an air outlet 102. The outlet 102 is arranged in a zone of a proximal end 128 of the dry powder drug inhaler 100 while the inlets 101 are arranged at a zone in an opposite distal end 129 of the dry powder drug inhaler 100.
The outlet 102 is arranged centrally along the longitudinal axis of the dry powder drug inhaler 100. The inlets 101 may be arranged at the periphery of the dry powder inhaler 100 in a radial position in relation to the longitudinal axis of the dry powder drug inhaler 100, such that the inlets 101 lead inhaled air transversally and radially towards the central portion of the dry powder inhaler 100.
Although not illustrated in Figs. 1 and 2, the inlets 101 may also be positioned with a direction that is parallel to the central axis of the dry powder inhaler 100.
The number of inlets and outlets may be different from what is disclosed in Figs. 1 and 2. The number of inlets may for example be adjusted in accordance with needs and specific inhaler design such that a number of smaller air inlets, for reducing pressure fall over the inhaler, are arranged circumferentially on the dry powder inhaler 100. In a similar manner the number of air outlets may be adjusted in accordance with needs and specific inhaler design.
The different parts of the dry powder inhaler 100 may be manufactured in a suitable material, such as injection moldable plastics, such as thermoplastics.
The dry powder inhaler 100 comprises three major parts in the form of (i) an upper proximal reservoir housing 103 with an inhalation chimney 112, (ii) a dosage mechanism 118 comprising a dose disc 104 having at least one cavity 108, a mixing and deaggregation chamber 106 adjacent to the at least one cavity 108, and a conduit 116 extending distally from the chamber 106, and (iii) a lower distal twister 105 which in some embodiments may comprise a floor disc 114. The reservoir housing 103 and the twister 105 cooperate so as to house the dosage mechanism 118 and the floor disc 114 in between housing 103 and twister 105. The chimney 112 of the reservoir housing 103 cooperates with the conduit 116 of the dosage mechanism 118 such that the dose disc 104 may be rotated between a dose administering position and a dose collecting position when the reservoir housing 103 is rotated. The floor disc 114 is connected to twister 105 so that floor disc 114 only moves when twister 105 is rotated as will be described

5 further below. This may be accomplished by connecting the floor disc 114 and the twister 105 via interconnecting grooves and ribs, or letting the twister 105 extend longitudinally around the floor disc 114 as disclosed for example in Fig. 1.
Preferably, the rotation of the dose disc 104 has two end positions corresponding to the dose administering position and the dose collecting position in its relation with the reservoir housing 103 in a known manner.
The dose administering position is illustrated in Fig. 1 and 2. In the dose administering position, the inlets 101 are in communication with the mixing and deaggregation chamber 106 via air channels 107. The air channels 107 direct the flow of air from inlets 101 initially downwards onto cavities 108 in the dose disc 104. Hence, in the dose administering position the cavities 108 may lie underneath and in line with the air channels 107, in particular in line with a longitudinal section 130 of the air channels 107. In addition, in the dose administering position the cavities 108 may be arranged flush with a transversal section 132 of a respective air channel 107 and may be arranged partially in line with a longitudinal section 130 of a respective air channel 107. The combination of an air flow A from channels 107 and the medicament M from cavities 108 then flows radially to the chamber 106 via the transversal section of the air channel 132 as will be described further below with respect to Fig. 5 and 6. When the dose disc 104 is rotated into a dose collecting position (not shown), the chamber 106 and the cavities 108 are rotated away from communication with the inlets 101 and air channels 107. Instead, the cavities 108 are rotated into medicament reservoir 109 and medicament reservoir 110 disclosed in Fig. 2, wherein the cavities 108 may collect a medicament housed in the reservoirs 109 and 110. The medicament contained in the medicament reservoir 109 may be a medicament different from the medicament contained in the medicament reservoir 110. Due to the presence of two reservoirs 109 and 110, the inhaler 100 may deliver two substances in one inhalation, the two substances otherwise being incompatible meaning that these two substances would not be possible to be comprised in one joint reservoir. Thus, the dry powder inhaler device 100 can effectively and satisfactorily disperse two dry powders and can administer a medicament comprising two or more substances which are incompatible in a mixture or are preferably stored in separate reservoirs for other reasons.

6 For single medicament delivery, only one medicament reservoir 109 is required. If so, the dry powder inhaler 100 only comprises one medicament reservoir 109 or the same medicament is filled in the two medicament reservoirs 109.
It is possible to arrange the dose disc 104 and the cavities 108 thereof such that when a first set of two cavities 108 lie underneath the air channels 107, i.e.
in a dose administering position, a second set of two cavities 108 are positioned in the medicament reservoirs 109. In this arrangement the inhaler has two medicament reservoirs, two air inlets, and one dose disc with four cavities.
Additionally, the distribution of the cavities 108 on the dose disc 104 is such that the dose disc 104 may be rotated in one direction only meaning that when the second set of two cavities 108 lie underneath and in line with the air channels 107, the first set of cavities 108 are positioned in the medicament reservoirs 109, 110 respectively. It is also possible for the dose disc 104 to be rotated in a first direction so that cavities 108 lie underneath the air channels 107 in a dose administering position, and then for the dose disc 104 to be rotated in the opposite direction into the dose collecting position, and thereafter again for the dose disc to be rotated in the first direction back into the dose administering position. When the dose disc 104 is rotated in a first direction into the dose administering position and the opposite direction into the dose collecting position, the dose disc 104 may have rotational stops in the dose administering position and the dose collecting position, respectively, to ensure accurate alignment of the cavities 108 under air channels 107 and positioning in the medicament reservoirs 109, 110 respectively.
It is also envisioned that an inhaler provided with more than two, such as three, four, five, or six, reservoirs 109 with the same arrangement of inlets, outlets, air channels, dose disc, cavities etc., is within the ambit of the present invention. For example, the inhaler 100 may have three medicament reservoirs 109, three air inlets 101, and a dose disc with three cavities 108. Alternatively, the inhaler 100 may have four medicament reservoirs 109, four air inlets 101, and a dose disc with four cavities 108. It is preferred however that the inhaler 100 have two air inlets 101, two air channels 107, one air outlet 102, two medicament reservoirs 109, 110, and one dose disc 104 with two cavities 108.
The air channels 107 have a first proximal conformation 134 as disclosed in the embodiment in Fig. 1. The proximal conformation 134 is such that the air channels 107 start at inlets 101 and extend downstream (during inhalation) in a central and transversal direction, where after they bend downwards at a right angle (90 degrees) to longitudinal sections 130 of the air channel 107 extending in a longitudinal and distal direction

7 before connecting to transversal sections 132 of the air channel 107 via a second distal convention 131. In this way, when medicament lies in the cavities 108, the medicament is arranged flush with the transversal sections of the air channel 132 and the air flow direction will facilitate initial deaggregation of the medicament from the cavities 108.
This facilitates that the medicament in the cavities 108 will be dispersed into the air flow and enters into the chamber 106.
The reservoirs 109 may be provided with medicament scrapers 113 as illustrated in Figs. 4 to 9. The scrapers 113 are suspended at the bottom of the reservoirs 109 such that they bear upon the dose disc 104. The scrapers 113 will pass over the cavities 108 of the dose disc 104 so that excessive medicament is removed from the cavities 108 to ensure correct dose volume. The scrapers 113 will also aid in compacting medicament in the cavities 108, which will improve retention of medicament in cavities 108 when the dose disc has been rotated into the dose administering position. Since the scrapers 113 are suspended at the bottom of the reservoirs 109 they will scrape the upper proximal surface of the dose disc 104, when the dose disc 104 is rotated between the dose administering position and dose collecting position. Preferably, each reservoir 109 has a number of scrapers evenly distributed along the bottom of the reservoirs 109, 110. In this way the scrapers do not only aid in obtaining correct dose volume and dose compacting but also aid in distributing medicament at the bottom of the reservoirs 109. The number of scrapers per reservoir 109 could for example be selected in the interval of 1 to 6, such as 2 to 4, such as 3. It is also envisioned that the scrapers are arranged in an uneven distribution in the reservoirs 109 if certain reservoirs are configured such that an uneven distribution of the scrapers will have a beneficial effect on the medicament distribution along the bottom of the reservoirs 109.
The inhaler 100 further comprises at least one agitator 200 located inside the at least one reservoir 109, comprising an interactor 201. The interactor 201 interacts with the dose disc 104 and/or cavity 108, such that the dose disc 104 rotation transfers energy to the agitator 200. The interactor can also interact with the powder.
The agitator 200 will release energy as movement during the dose disc movement, from the dose collecting position to the dose administering position. The released movement energy helps agitating and homogenizing the medicament inside the dosage mechanism and provide a homogeneous dose in the cavity 108.
Referring to figures 4 to 10, the agitator 200 further comprises an axis 202, which is arranged radially inside the reservoirs 109, between the inner wall 109a and

8 outer wall 109b of said reservoirs 109. In this way, the interactor 201 can be attached to said axis 202 and comprise means for mixing the medicament. Such means may be in the form of pegs 203, wheels 206, wings or flaps or other shapes suitable for dispersing the medicament.
Referring to figures 4 and 10a, the axis 202 is fixedly attached to the inner wall 109a and/or the outer wall 109b inside the reservoirs 109. The agitator 200 further comprises the interactor 201 in form of a peg 203 attached to the axis 202.
The peg 203 protrudes perpendicularly to the axis 202 towards the dose disc 104, and the peg 203 is longer than the perpendicular distance from the axis 202 to the dose disc 104.
The peg 203, or the peg 203 and the axis 202, is made from an elastic material such as rubber or elastic plastic, and interacts with the dose disc 104 and/or cavity 108 during dose disc movement to retain and release energy as movement.
During dose disc 104 movement, the peg 203 will be forced to flex by the movement of the dose disc 104, whereby it will retain energy, which will be released burst-wise, as a snapping motion against the dose disc 104. This snapping motion of the peg 203 will transfer the energy retained by the interactor 201 to the medicament, the medicament reservoir 109 and dose disc 104, and will help dislodge and evenly disperse the medicament, thus helping to load a homogeneous dose in the cavity 108.
This burst-wise release of energy not only agitates and mixes the medicament in contact with the peg 203, but facilitates a homogenizing effect for a large part of the medicament reservoir 109.
By having a second peg 203 attached to the axis 202, protruding perpendicularly to the axis 202, towards the distal end of the inhaler, this second peg 203 will also flex, providing an even more efficient release of the retained energy, thus helping to disperse the medicament.
Referring to for instance figure 7, the agitator 200 further may comprise axis supports 204 fixedly attached to the inner wall 109a and the outer wall 109b of the medicament reservoir 109. The axis support 204 comprises an indentation 205 wherein the axis 202 is being held, such that it is allowed to rotate along its central axis, perpendicular to the inner wall 109a and outer wall 109b.
Referring to the example of figure 7, the interactor 201 further comprises a wheel 206 projecting radially from the axis 202, wherein the wheel 206 comprises mixing means 207, here cogs 208, protruding radially from the wheel 206, and wings 209, and the radius of the wheel 206 is the distance from the axis 202 to the dose disc 104 or the radius being such that the cogs 208 rests upon the dose disc 104 in such

9 manner that the wheel will rotate from friction with the dose disc 104, thus helping to disperse the medicament.
The cogs 208 and/or wings 209 may be made from an elastic material, such as rubber or elastic plastic, such that they can flex and burst-wise release energy as movement.
It has been found that interactors 201 comprising a wheel 206 are very efficient at dispersing the medicament and providing even loading of the medicament in the cavity 108.
In the example of figure 11b, the axis support 204 may further comprise the an elastic member 210, in fig. 1 lb illustrated by an elastic 0-ring 211 placed in the circular indentation 205 and around said axis 202. The axis 202 is fixedly attached to the elastic member 210, for instance by friction. Rotating the axis 202 around its central axis will build up energy in the interactor 201, and the interactor 201 will release said energy by rotating the axis 202 along its central axis in the counter direction (if energy was retained by clockwise rotation, energy will be released as counter-clockwise rotation).
Referring to the example of figure 5, the interactor 201 comprises at least one peg 203 attached to the axis 202 and axis supports 204 may comprise an elastic member 210, here an 0-ring 211. The at least one peg protrudes perpendicularly to the axis 202 towards the dose disc 104, and the peg 203 is significantly longer (such as 25 to 50 %
longer) than the perpendicular distance from the axis 202 to the dose disc 104. The axis 202 is locked in a position by the 0-ring 211, such that the peg 203 scrapes against the dose disc 104 and vibrates and jumps during rotation of the dose disc 104.
When the peg 203 tip reaches the dose cavity 108, the peg 203 will snap into the cavity 108, creating further movement within the reservoir 109, whereby the medicament is dispersed even loading of the medicament in the cavity 108 is provided.
Referring to the example of figure 9, the interactor 201 further comprises a wheel 206 projecting radially from the axis 202 and circular axis supports 204. When the dose disc is rotated, the wheel 206 will rotate, thus dispersing the medicament and provide even loading of the medicament in the cavity 108.
If the axis supports 204 were to comprise an elastic member 210, such as an 0-ring, the wheel 206 would rotate and apply tension to the elastic member 210 during dose disc 104 movement, and intermittently release the built up tension by rotating in counter direction, thus effectively disperse the medicament and provide even loading of the medicament in the cavity 108.

Referring to figures 11c and d, the axis supports 204 may be U-shaped or comprise elongated indentations 205, holding the axis 202 such that the axis 202 is allowed to both rotate along its central axis and also slide along the indentation 205 towards or away the dose disc 104 in a direction in a direction parallel to the rotational 5 axis of the dose disc 104.
Referring to the example of figure 6, the interactor 201 further comprises a wheel 206 projecting radially from the axis 202 and the axis supports 204 are U-shaped or comprises elongated indentations 205. Here the wheel 206 comprises cogs 208 protruding both radially and at right angles to the plane of the wheel 206 to promote

10 mixing.
Since the axis supports 204 comprises elongated indentations 205, the axis 202 is allowed to move along the indentation 205, towards or away the dose disc 104 in a direction in a direction parallel to the rotational axis of the dose disc 104.
The radius of said wheel 206 is in the range from shortest perpendicular distance between the axis 202 and the dose disc 104 to the longest perpendicular distance between the axis 202 and the dose disc 104, such that dose disc 104 movement will rotate the wheel 206.
When the interactor 201 interacts with the dose disc 104, cavity 108 or powder, the dose disc 104 movement will retain and release energy as movement.
However, due to the elongated indentation 205, the wheel 206 may also jump towards and away from the dose disc 104. Thus, more modes of movement are allowed, which will help to disperse the medicament and provide even loading of the medicament in the cavity 108.
This is especially the case when cogs 208 are made from an elastic material, or the an elastic member 210, such as a such as a flat spring 212, is placed in the elongated indentation 205. The flat-spring 212 will thus retain energy if the axis 202 is pushed in the direction away from the dose disc 104, and releases said energy by pushing the axis 202 towards the dose disc 104. The flat-spring 212 will also ensure that the wheel 206 interacts with the wheel 206 by pushing it towards it.
Referring to the example of figure 9 and 11d, the interactor 201 comprises a wheel 206 projecting radially from the axis 202 and the axis supports 204 are U-shaped or comprises elongated indentations 207. The wheel 206 comprises cogs 208 protruding at right angles to the plane of the wheel 206, and the radius of the wheel 206 is the shortest perpendicular distance between the axis 202 and the dose disc 104.
During movement of the dose disc 104, the dose disc 104, cavity 108 or powder will interact with the wheel 206, making it rotate and jump towards and away from the dose disc 104, through the allowed axis movement along the indentation in the axis support 204.

11 This movement will help disperse the medicament and providing even loading of the medicament in the cavity 108.
To summarize, figures lla-d shows various exemplary embodiments of the axis supports 204.
The axis supports 204 in Fig. 1 la features a circular indentation 205 for holding the axis 202 of the agitator 200, allowing the axis 202 to rotate freely around its central axis.
Fig llb shows an axis support 204 with a circular indentation 205 for holding the axis 202 of the agitator 200, also comprising an elastic member 210 placed in the indentation 205, here an 0-ring 211 fixedly attached to the axis support 204 and axis 202. The 0-ring 211 builds up tension if the axis 202 rotates along its central axis, and rotates the axis 202 back to its initial position when tension is released.
Fig llc shows a U-shaped axis supports 204, comprising an elongated indentation 205 for holding the axis 202. Thus, not only allowing the axis 202 to rotate around its central axis, but also to move along the indentation 205.
Fig lld shows an axis support 204 with an elongated indentation 205 for holding the axis 202 of the agitator 200, also comprising an elastic member 210. Here a flat spring 212, fixedly attached to one end of the axis support 204. The slat spring 212 builds up tension if the axis 202 moves along the indentation 205 towards the flat spring 212, and pushed the axis 202 back to its initial position when tension is released.
Furthermore, referring to the example of figure 7, the interactor 201 may comprise extra pegs 203, cogs 207, wings 209 or protrusions, such as the wings located on the wheel 206 of figure 9, helping to dissipate the built up energy in the interactor 201, thus more effectively dispersing the medicament.
The agitator 200 may be made from any suitable material. Suitable materials include injection moldable plastics, such as thermoplastics, preferably flexible plastics, such as nylons, polyethylene (PE), polypropylene (PP), polystyrene (PS) and polyvinyl chloride (PVC) or other suitable flexible materials such rubber and synthetic rubber.
The skilled reader will appreciate that the disclosed invention is not limited to inhalers featuring shown in figure 1, but may be implemented in any inhaler with a rotating movement to enhance loading homogeneous doses of medicament in a cavity 108.
The cavity 108 may have circular shape or a substantially circular shape having a diameter substantially corresponding the diameter or the air channel 107, in particular the longitudinal section 130 and/or the transversal section 131.

12 This arrangement means for example that the reservoirs 109, 110 may comprise a dry powder medicament in the form of a micronized formulation or a carrier based formulation, or mixtures thereof The inhaler 100 may then for example comprise a dry powder medicament in form of a micronized formulation in the first reservoir 109 and a free-flowing dry powder medicament in form of a carrier based formulation in the second reservoir 110.
Depending on the medicament to be administered, and the formulation thereof, the cavities 108 may take the form of a single circular shape when viewed from directly above or below the inhaler 100 as illustrated by the semi-circular shape of cavities 108 in Fig. 2. Other medicaments which tend to aggregate more may form an undesirable "plug" in the cavity 108 which is not readily dispersible during inhalation.
Then it may be preferable to make several cavities 108 each having a relatively smaller diameter than a single circular shape as illustrated in Figs. 8. The several smaller cavities will continue to lie underneath one of the air channels 107 which remains unchanged in size and shape. An inhaler with several smaller cavities lying underneath one air channel 107 also allows for delivery of a smaller amount of powder. This feature also adds the possibility to combine or adapt the inhaler 100 for deliverance of micronized formulations and/or carrier based formulations.
The chimney 112 does not necessarily have to be directed upwardly; it can just as well be directed downwardly or to the sides, whereby the outlet 102 is instead positioned at the bottom or on the sides, respectively. Additionally, the chimney 112 does not have to be generally tubular, but could be bent or sinus-shaped, depending on where on the inhaler 100 it is preferred to position the outlet 102. For flow characteristics and dose reliability and maintenance, it is however preferred to have it directed upwardly and generally tubular with optional diverters. The general shapes of the conduit 116 and the chimney 112 may also be such as to have differences in cross-sectional area, such as is present in a cone-shaped chimney. In this way, the flow velocity in the conduit and chimney may be regulated so as to help in deaggregation at chosen parts.
During use of the inhaler 100 the user will then simply rotate the upper housing 103 in one direction and thus the dose disc 104 into a dose collecting position if the dose disc is in a dose administering position. Thereafter, the upper housing 103 and the dose disc 104 are rotated preferably into the opposite direction to reach the dose administering position. If the dose disc 104 is already in the dose collecting position then of course the first rotation into the dose collecting position may be omitted. During

13 these rotations, the agitator 200 will disperse the medicament evenly, allowing the scraper 113 to uniformly fill the cavities 108 of the dose disc 104 in the reservoirs 109.
After the dose disc 104 has been rotated into the dose administering position the cavities 108 are filled with medicament and lie underneath the air channels 107. Then the user puts his/her mouth at outlet 102 and inhales. During inhalation air A will enter the inhaler 100 through inlets 101 and flow through air channels 107 to disperse and carry therewith the medicament(s) M from the cavities 108 in a radial direction in accordance with the arrows shown in Fig. 3. The air/medicament flow AM will then enter the chamber 106. In the chamber 106, the air/medicament flows AM from the air channels 107 and cavities 108 will cross each other or coincide with each other, such that deaggregation of the medicaments M will increase which may increase dose uniformity since the need for diverters then is decreased. The flow characteristics, such as jet stream formation, will also increase. This feature allows the possibility to combine or adapt the inhaler 100 for deliverance of micronized formulations and/or carrier based formulations. Of course, it is also possible to combine the feature of crossing or coinciding flows from the two air channels 107 with diverters, even though the need thereof is decreased. Thereafter, the air/medicament flow AM ¨ now comprising air/medicament flows from both air channels 107 and cavities 108, will go up through the conduit 116, the inhaler chimney 112, and finally through outlet 102 into the lungs of the user. A similar sequence of steps is then repeated the next time the inhaler 100 is required i.e. the user rotates the upper housing 103 and thus the dose disc 104 into a dose collecting position to fill the cavities 108 with a medicament(s), then the user rotates the dose disc 104 back into the dose administering position and inhales at outlet 102 as described immediately above. During these movements, the agitator 200 will disperse the medicament evenly, allowing the scraper 113 to uniformly fill the cavities 108 of the dose disc 104 in the reservoirs 109.
The structure of, and functional relationship between, the cavities 108, reservoirs 109 and the separate dose collecting and dose administering positions allows for no risk of multiple dosing by the user. In use the medicaments remain in the cavities 108 until inhalation. If inhalation is not commenced or is no longer required by the user, the cavities 108 carrying the medicaments may be rotated back into the reservoirs 109,110.
Although, the present invention has been described above with reference to specific embodiments, it is not intended to be limited to the specific form set forth herein. Rather, the invention is limited only by the accompanying claims.

14 In the claims, the term "comprises/comprising" does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e.g. a single unit or processor.
Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous.
In addition, singular references do not exclude a plurality. The terms "a", "an", "first", "second" etc. do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

Claims

PCT/EP2020/053846

1. A dry powder inhaler (100) comprising:
at least one air inlet (101) at a distal end zone of said inhaler (100), at least one 5 air outlet (102) at a proximal end zone of said inhaler (100), and an air channel (107) between said at least one air inlet (101) and said at least one air outlet (102);
at least one medicament reservoir (109);
a dosage mechanism (118) for arranging at least one dose of a medicament from said at least one medicament reservoir (109) between the air channel (107) and the 10 air outlet (102) such that said at least one dose may be delivered upon inhalation at said air outlet (102), wherein the dosage mechanism (118) comprises a dose disc (104) with at least one cavity (108), wherein the dose disc (104) may be rotated between a dose collecting position wherein the cavity (108) is positioned in the medicament reservoir (109), and a dose administering position wherein the cavity (108) is in communication 15 with said air channel (107);
at least one agitator (200) located inside the at least one reservoir (109), comprising an interactor (201), wherein said interactor (201) interacts with the dose disc (104) or cavity (108), such that the dose disc (104) rotation transfers energy to the agitator (200), which will release energy as movement during the dose disc movement from the dose collecting position to the dose administering position.

2. The inhaler (100) according to claim 1, wherein said agitator (200) further comprises an axis (202), which is arranged radially inside the reservoir (109) between the inner wall (109a) and outer wall (109b) of said reservoir (109).

3. The inhaler (100) according to claim 2, wherein said axis (202) is fixedly attached to the inner wall (109a) and/or the outer wall (109b) of said reservoir (109).

4. The inhaler (100) according to claim 2, wherein the agitator (200) further comprises axis supports (204) fixedly attached to the inner wall (109a, 110a) and the outer wall (109b) of said reservoir (109), wherein the axis supports (204) comprise an indentation (205) wherein the axis (202) is being held by the axis supports (204) such that the axis (202) is allowed to rotate along its central axis, perpendicular to the inner wall (109a) and outer wall (109b).

5. The inhaler (100) according to claim 5, wherein the indentations (205) are elongated, such that the axis (202) is allowed to move along the indentation (205), towards or away the dose disc (104) in a direction in a direction parallel to the rotational axis of the dose disc 104.

6. The inhaler (100) according to any one of claims 4 to 5, wherein the axis supports (204) further comprise an elastic member (210) placed in the indentation (205), such as a 0-ring (211) rotationally forcing the axis (202) back to its original position, or a flat spring (212), forcing the axis (202) downwards towards the dose disc (104).

7. The inhaler (100) according to any one of claims 3 to 6, wherein the interactor (201) comprises at least one peg (203) attached to the axis (202), protruding perpendicularly to the axis (202) towards the dose disc (104) and the length of the peg (203) is greater than the perpendicular distance from the axis (202) to the dose disc (104), such that said interactor (201) can interact with the dose disc (104) or cavity (108) during dose disc (104) movement.

8. The inhaler (100) according to any of claims 4 to 6, wherein the interactor (201) comprises a wheel (206) projecting radially from the axis (202), wherein the radius of the wheel (206) matches the perpendicular distance from the axis (202) to the dose disc (104), such that dose disc (104) movement will rotate the wheel (206).

9. The inhaler (100) according to any of claims 5 to 6, wherein the interactor (201) comprises a wheel (206) projecting radially from the axis (202), wherein the radius of said wheel (206) in the range from shortest perpendicular distance between the axis (202) and the dose disc (104) to the longest perpendicular distance between the axis (202) and the dose disc (104), such that dose disc (104) movement will rotate the wheel (206).

10. The inhaler (100) according to any one of claims 8 or 9, wherein the wheel (206) comprises mixing means (207) such as cogs (208) or wings (209) protruding radially from the wheel (206) and/or at right angles to the plane of the wheel (206).

11. The inhaler (100) according to any of claims 10 to 9, wherein the agitator (200) is made from a material, selected from the group consisting of injection moldable plastics, thermoplastics, flexible plastics, nylons, polyethylene (PE), polypropylene (PP), polystyrene (PS) and polyvinyl chloride (PVC), rubber and synthetic rubber.