CA2239292C

CA2239292C - Inhalator designed to provide multiple doses of a dry pharmacological powder

Info

Publication number: CA2239292C
Application number: CA002239292A
Authority: CA
Inventors: Manfred Keller; Thomas Eggimann
Original assignee: Jago Research AG
Current assignee: Jagotec AG
Priority date: 1995-12-07
Filing date: 1996-12-05
Publication date: 2003-09-30
Anticipated expiration: 2016-12-05
Also published as: ATE261324T1; NO982516L; DK0995457T3; JP3669710B2; NO982516D0; GR3034282T3; ATE193455T1; WO1997020589A1; DK0865302T3; JP2000501013A; PT995457E; DE59605366D1; CA2392466A1; EP0865302A1; US6182655B1; NO316495B1; EP0995457A1; NZ322422A; USD469527S1; DE59610935D1

Abstract

The inhalator proposed has a casing (100, 150) to which is fitted a special mouthpiece (900) covered by a removable protective cap (950). Disposed insid e the casing are a slide valve guide rail (200), a metering slide valve (300), a closure (400), a slide (500), a funnel (600), a counter (700), a valve cover (800) and a valve guide (850). When the protective cap (950) is pulled off, the metering of the powder is triggered and a dose held in the dose cavity i s conveyed by the metering slide valve (300) to the mouthpiece (900). Only whe n a given minimum inhalation intensity is produced is the closure (400) displaced by the aspirated valve cover (800), thus releasing the dose so tha t it can be inhaled. When the inhalator is used with an electronic module and a controllable nozzle, all data relevant to the inhalation can be determined a nd the flow conditions controlled.

Description

" I F3,1~~~1.~~'i~N
Inhaler for multiple dosed administration of a pharmacological dry powder Area of application of the invention The invention relates to a dry powder inhaler with dosed ad-ministration of a medical preparation upon inhalation by the patient. The dry powder - in loose form or pre-dosed units for dispensing - is contained in a medicament reservoir. The invention concerns the generic type of inhalers in which, upon activation, a defined dose is first of all introduced from the internal medicament reservoir into the inhalation channel by means of a portioning mechanism, and from there the patient draws this defined dose into his airways via a mouthpiece, in a flow of air generated by aspiration.
Inhalation is a proven method of depositing medicinal agents in the lungs or delivering them to the blood. Thus, in addi-tion to the devices for atomizing or nebulizing of liquids, for example by means of air, compressors, ultrasound, lique-fled propellant gases (fluorohydrocarbons, fluorochlorinated hydrocarbons), inhalers for pulverulent preparations with dosed portioning were also developed for the purpose of in-halation.
A defining feature of inhalers is that the active substance particles of the medicament are deposited, by inhalation, i:~
a defined dose and particle size (about 1 - 6 ~~m) either in the central or peripheral lung compartments (topical treat-ment) or as very small particles by means of absorption in the alveolar region into the blood stream of the patient (systemic treatment).
However, micronized particles with the diameter in question here have extremely poor flow characteristics. This problem:

is solved by a number of conventional methods. Thus, powder mixtures are produced with a carrier which generally has a greater particle diameter than the active substance, with the active substance particles depositing themselves on the 5 carrier surface. On the other hand, in the manufacture of soft pellets, a large number of active substance particles are massed together to form respectively larger particles, the pellets. Under the effect of force, the pellets split up again into the individual, smaller active substance parti-10 cles. During inhalation it should be possible with the in-haler to detach the active substance particles from the car-rier or to break the pellets up again into small particles.
Simple swallowing of the medicament is completely undesir-able. For this reason, special functional demands are im-15 posed on inhalers in principle.
Drier art EP-A-0 404 454 and EP-A-0 558 879 disclose inhalers for sin-gle use. Such designs are appropriate only for special ap-20 plications, since on the one hand the patient has no control over the correct use, i.e. the optimum inhalation, and on the other hand a new inhaler has to be used for each inhala-tion, which is costly, inconvenient and not environmentally friendly.

Thus, inhalers with a dry powder as medicament were developed also for multiple use. WO 93/03782 discloses an inhaler witr~
a medicament reservoir and a dosing mechanism, by means of which the medicament is conveyed in doses from the storage 30 container into the inhalation channel and can be sucked from there with the flow of air generated by the patient. This inhaler does not yet satisfy all the requirements. The exact and prescribed use can still not necessarily be sufficientl,,-guaranteed. The dosing accuracy has to be increased; humidity.
35 too easily penetrates into the inhaler, tre deagglomeration and atomization have to be improved, and keeping the inhaler clean is complicated.
US-A-5 239 992 discloses a further inhaler in which a dosing 5 cavity is present in a longitudinally displaceable piston rod and this dosing cavity, first positioned under the.me-dicament reservoir, receives a dose of medicament. The pa-tient has to inhale counter to the force of a spring, so that the piston rod moves and the ready-to-use dose can be 10 sucked by the patient through suction openings in the guide channel of the piston rod. In principle, this inhaler too exhibits the abovementioned inadequacies.
WO 94/05359 describes an inhaler for multiple dosed admini-15 stration of a pharmacological dry powder which is contained within a medicament reservoir provided inside the housing.
On the inhaler a mouthpiece is joined which is closed out-side inhalations by a folding down protective cap. The in-haler further has inside a horizontally movable carriage 20 with a dosing depression. If the protective cap is closed the dosing depression is positioned underneath the funnel-shaped outlet of the medicament reservoir, so that dry pow-der by its gravity should flow into the dosing depression until it is full if the inhaler is in a vertical position.
25 One filling of the depression represents one dose.
After a preceding inhalation a spring arranged above a bel-lows is tensed by closing the protective cap. The bellows is placed on the medicament reservoir, an air permeable mem-30 brane is provided as a separating wall. During opening the protective cap the locking of the tensed spring is released, so an air pressure pulse acts upon the medicament reservoir.
This air pressure pulse ought to guarantee that in each case the dosing depression is properly filled with dry powder.
35 The carriage is moved by further opening o~ the protective cap, so the dosing depression is positioned within a suction channel. With the inhalation the medicament dose is sucked out from the dosing depression through the mouthpiece.

5 The mouthpiece has at one side a flange for joining to the housing of the inhaler and has at the other side a suction pipe outwardly trumped-like opening. A flow channel flows tangentially into the flange which channel is connected with the suction channel, where the medicament dose is available 10 in readiness for inhalation. At the flange tangentially ar-ranged air openings are provided for the purpose of turbu-fence of the medicament containing air stream sucked into the mouthpiece.
15 The spring above the bellows again tenses by closing the protection cap and the carriage goes back into its starting position, so the dosing depression is again positioned un-derneath the funnel-like outlet of the medicament reservoir and the next inhalation cycle can start.

The previously described inhaler and its pertinent mouth-piece shows the following essential disadvantages:
- Independent of the intensity of the inhalation the medica-25 ment from the dosing depression can be sucked out too low that the medicament particles only insufficiently arrive at their intended position within the patient's respira-tory ducts and/or actually only a part of the dose avail-able is sucked out. Thus the patient has no control as to 30 whether the inhalation has been actually done or correctly completed.
- After opening of the protective cap and during inhalation the inhaler has to be positioned vertically, otherwise the 35 dry powder can from the dosing depression flow back into the medicament reservoir or come into the suction channe situated above the dosing depression and deposit there as a loss. A construction feature is missing which obliques the patient to apply the inhaler in the right functional position.
- At least a part of the dry powder of the unused dose can come into the suction channel if the inhalation is incom-pletely finished or not done at all and the inhaler is not held strictly vertically. By the next inhalation cycle it 10 is metered again, therefore inaccuracies of the dosage can emerge. Based on the construction double dosages or dos-ages under the limit can happen.
- The extending bellows sucks in a larger amount of external 15 air with each closing of the protective cap, their mois-ture can arrive successively into the medicament reser-voir. This is disadvantageous for the flowability and the accuracy of metering of the dry powder as known from the literature and the practice.
- A further construction feature is missing which guarantees that the last 5 to 10 nominal doses in the declared meas ure (weight and volume) can be delivered in order to solve the tail-off-problem known of inhalers with a mufti dosage 25 reservoir.
- The mouthpiece has at its flange a tangentially discharg ing channel and openings for acceleration and turbulence of the airstream generated by the patient. This corre-30 sponds with the cyclone principle as used for a long time for the dry powder inhalers available on the market (e. g.
Spinhaler~, Cyclonhaler~).
- The unit of turbulence and the mouthpiece can be cleaned 35 and dried internally relatively ill which under circum-stances can cause microbiological problems.

ect of the invention Thus, i:n summary,, it may be stated that none of the inhalers known to date can be regarded as optimal. The invention is therefore based on the problem of producing an inhaler whose functional characteristics are extensively improved. The design const:ruct:ion is intended to conclusively guarantee the prescribed ~.nhalation position and inhalation intensity. In the inhaler there must be a suitable registration and function covering a properly completed inhalation, an omitted inhalation, or an incomplete inhalation; in any event, a multiple dosage is to be prevented. It is necessary to improve the dosing accuracy upon preparatian of the individual doses from the medicament reservoir, and the deagglome_=;ration and atomization of the medicament during inuhal.ation. The protection against humidity is to be made more effective and the cleaning of the inhaler should be made easier. It must be ensured that a mouthpiece wh~.ch has been removed for cleaning is fitted in place again by t:he patient. The mouthpiece ought to be used as well as in connection with the inhaler to be created as with other inhalers of the present type. Finally, it must be possible for the inhaler to be manufactured efficiently as a mass-produced article and at the same time satisfy all the regulations laid down in drugs legislation.
Summary of the invention The present invention provides inhaler for multiple dosed administration of a pharmacological dry powder with:
a) a housing, 6a b) a medicament reservoir containing the dry powder in loose form or in pre-dosed units far dispensing, c) a mouthpiece covered by a removable protective cap, d) a movable dosing slide with a dosing cavity to be filled i.n the starting position can be ~>ositic7ned underneath a funnel outlet of the medicament reservoir; wherein e') the dosing into the dosing cavity as an operation is connected with the partially starting opening of the protective cap, and f) the transfer of the filled dosing cavity into a channel out of which the patient inhales the dGose o.f medicament:, is connected with the=_ continued opening of the protective cap, characterized in that g) a movable shutter and a movable valve ~;hield are provided in the housing;
h) the filled dosing cavity pushes into the shutter and is closed by the shutter with further opening of the protective cap and transfer of the dosing cavity _i.nto the channel;
i) the valve shield is removable from its home position and comes into movement by the suwt_Lon gen~:rated with the inhalation, in order to push away the shutter with the body parts of the valve shield, to push away the shutter against adjustable lacking means only is possible with a defined minimum intensity of inhalation;
j) only by the displacement. of the shutter the dosing cavity is released and the therefrom released dose of dry powder can be inhaled;
k) means are provided by means of which only after a correctly completed inhalation the dosing s:Lide can be 6b returned to prepare for renewed f=filling w~_th its dosing cavity under the funnel outlet;
1) an integrated mechanical and/or electronic recording unit is present, by means of which at least the correctly performed inhalations are recorded; and m) the recording unit effects a blocking c~f the inhaler after a defined number of vnhalat.ion doses have been used up.
Removal of the protective cap initiates the dosing, with the dose received in the dosing cavity being transported to the mouthpiece by means of the dos--ing slide. Only upon application of a defined minimum inten-sity of inhalation is the shutter moved by the suctioned valve plate, as a result of which the dose is released for inhalation. Only after properly completed inhalation can the 5 dosing slide be returned with its dosing cavity under the funnel outlet for the purpose of, preparing for renewed fill-mg.
In the inside of the inhaler there are blocking means which 10 come into action as soon as the inhaler, upon removal of the protective cap, is situated in a horizontal and/or axial in-clined position going beyond a defined extent. The correct dosing and use position of the inhaler are guaranteed in this way. For the patient's safety, optional blocking means can be 15 fitted which prevent any possibility of the protective cap of the inhaler being closed when the mouthpiece is missing. This ensures that after the mouthpiece has been removed, it is not possible to omit to replace it.
20 In the mouthpiece which can be detached from the housing of the rest of the inhaler there is a labyrinthine atomizing path for powder deagglomeration, in which path there is at least one barrier. For the purpose of reducing the powder flow rate and depositing relatively coarse particles inef-25 fective for inhalation, the atomizing path comprises, up-stream of the channel outlet, a channel section which is of increased volume and which deflects the powder aerosol flow-ing through. The mufti-component mouthpiece can preferably be arranged on the inhaler housing by means of a plug con-30 nection and can be opened out after detachment from the housing, the mouthpiece parts being connected to one another via an integral film hinge. The mouthpiece according to the invention is preferably intended for using with the inhaler according to the invention but it is also suitable in con-35 nection with other inhalers of the same type.

_ g _ In the inhaler there are means which contribute to the regu-lar flow of the pharmacological dry powder ~ahen the protec-tive cap is removed. The generated vibratio:~~s preferably 5 only exert an effect while the dosing cavity is located un-der the funnel outlet. These means are advantageously com-plementary grate sections which are located on components moved relative to one another.
10 The inhaler can be supplemented with an electronic module and a controllable nozzle so that all data relevant to inha-lation can be recorded and the flow conditions regulated.
Completion of a correct inhalation, or an incomplete inhala-tion, can be indicated by an acoustic and/or optical signal.

Brief description of the attached drawings Figure 1A inhaler, side view; closed state (starting po-sition -~ situation A1);

Figure 1B inhaler, rear view;

20 Figure 1C inhaler, front view;

Figure 1D inhaler, plan view;

Figure 1E inhaler: protective cap pulled out (intermedi-ate position ~ situation A2) Figure 1F inhaler: protective cap swung down fully 25 (ready for inhalation -~ situation A4; inhala-tion omitted -~ situation A5;

inhalation incomplete -~ situation A6; inhala-tion complete ~ Situation A~;

30 Figure 2A protective cap, perspective ~.-ew;
Figure 2B protective cap, plan view;
Figure 2C protective cap, side view;
Figure 2D view into the protective cap;
35 Figure 3A lower part of housing, persoe~tive view;

Figure 3B lower part of housing, plan. -,vew;

Figure 3C lower part of housing, side T.=~ew;

Figure 3D lower part of housing, cross-sectional view;

Figure 3E lower part of housing, perspective view with blocking hooks and balls;
Figure 3F lower part of housing according to Figure 3E, plan view;
Figure 4 upper part of housing, perspective view;
Figure 5A mouthpiece, perspective view of the base plate;
10 Figure 5B mouthpiece, side perspective;
Figure 5C one half of mouthpiece, external view;
Figure 5D one half of mouthpiece, internal perspective;
Figure 5E mouthpiece opened out, internal perspective;
15 Figure 6A slide rail, perspective view from below;
Figure 6B slide rail, side perspective;
Figure 7A carriage, perspectiveview from below;

Figure 7B carriage, perspectiveview from above, later-20 ally, from the front;

Figure 7C carriage, perspectiveview from above, front;

Figure 7D carriage, perspectiveview from above, rear;

Figure 8A dosing slide, perspective view from above;
25 Figure 8B dosing slide, perspective view from above, rear;
Figure 8C dosing slide, perspective view from below;
Figure 9A shutter, perspective view from above;
Figure 9B shutter, perspective view from below;

Figure 10A valve shield, perspective view;
Figure lOB valve shield, side perspective;
Figure 11A valve guide, inner perspective;
35 Figure 11B valve guide, outer perspec~,'_ive;
Figure 12A funnel, perspective view from above;
Figure 12B funnel, perspective view from below;
40 Figure 13A funnel holder, perspective view from above;
Figure 13B funnel holder, side perspeo~i~=e;
Figure 13C funnel holder, perspective ~~~iew from below;

Figure 14A funnel lid, perspective view from above;
Figure 14B funnel lid, perspective view from below;
Figure 14C funnel lid with semi-permeable membrane;
5 Figure 15A funnel holder, funnel and funnel lid, side perspective;
Figure 15B funnel holder and fitted funnel, perspective view from above;
10 Figure 16A counter, perspective view of the units wheel;

Figure 16B counter, perspective view of the hundreds wheel;

Figure 16C counter, units wheel, outer perspective;

Figure 16D counter, units wheel, inner perspective;

15 Figure 16E counter, tens wheel, outer perspective;

Figure 16F counter, tens wheel, inner perspective;

Figure 16G counter, hundreds wheel, inner perspective;

Figure 16H counter, hundreds wheel, outer perspective;

Figure 16I counter body, inner perspective;

20 Figure 16J counter body, outer perspective;

Figure 16K counter, cover plate, outer perspective;

Figure 16L counter, cover plate, inner perspective;

Figure 16M counter, drive wheel, outer perspective;

Figure 16N counter, drive wheel, inner perspective;

25 Figure 160 engagement of the dosing slide on the counter, units wheel;

Figure 17A blocking hook, plan view;
Figure 17B blocking hook, perspective view from right;
30 Figure 17C blocking hook, perspective view from left;
Figure 18A inhaler, horizontal longitudinal section ac-cording to Figure 1A on line A-A;
Figure 18B inhaler, vertical longitudinal section accorc;-35 ing to Figure 1D on line B-B;
Figure 18C inhaler, vertical transverse section accordir_l to Figure 1D on line C-C;
Figures 19A
40 to 19D functioning principle of the release of the shutter;
Figure 19A side wings of the carriage with aperture and cam;

Figure 19B closed inhaler according to Figures 1A and 18A
(situation Al);

Figure 19C shutter close to release, with the protective cap not swung down fully (situation A3);

5 Figure 19D shutter released, with protective cap swung down fully in accordance with Figure 1F

(situation A4);

Figures 20A

10 to 20F functioning principle of the inhaler Figure 20A inhaler closed in accordance with Figures 1A, 18A and 19B (starting posit-ion ~ situation A1);

Figure 20B inhaler open in accordance u:ith Figures 1F and 19D (ready for inhalation ~ situation A4);

15 Figure 20C closing the inhaler (inhalation omitted situation A5);

Figure 20D closing the inhaler (inhalation incomplete situation A6);

Figure 20E inhaler closed (after incor._olete inhalation ->

20 situation A8);

Figure 20F inhaler closed (after completed inhalation situation A7);

Figures 21A
25 to 21C functioning principle of tie blocking hooks:
Figure 21A blocking hooks fitted (starring position -situation Bl);
Figure 21B protective cap blocked whe:~. mouthpiece missing (incorrect position ~ situation B2);
30 Figure 21C pivotable protective cap, "_th mouthpiece fit-ted (desired position -~ sv.~~uation B3);
Figures 22A
and 22B functioning principle of t~_e blocking of the 35 inhaler at an inclined pcs-lion:
Figure 22A side position of the block'-_~.a balls on incorre~:t positioning of the inhaler;
Figure 22B blocked inhaler;
40 Figures 23A
to 23G successive construction e= r-nhaler, perspecti-.-views;

Figure 23A lower part of housing with valve valve shield, guide and one mouthpiece hal f;

Figure 23B representation in accordance with Figure23A, with slide rail and carriage added;

5 Figure 23C representation according to Figure23B, with dosing slide added;

Figure 23D representation in accordance u;ithFigure.23C, with shutter added;

Figure 23E representation in accordance with Figure23D, 10 with protective cap added, ithoutlower part w of housing;

Figure 23F representation in accordance with Figure23E, with funnel holder, funnel, funnellid nd a counter added; and 15 Figure 23G representation in accordance with Figure23F, from the rear side.

Exemplary embodiment In the text which follows, the inhaler according to the in-20 vention will be described in greater detail in terms of its construction, as well as its function, with reference to the attached drawings, and possible modifications are mentioned by way of conclusion.
25 The following statement applies to the whole of the descrip-tion following. If, for the purpose of clarity of the draw-ing, reference numbers are included in a figure but are not explained in the directly relevant text of the description, then reference is made to their mention in preceding figure 30 descriptions. In the interest of intellig=-b-lity, the re-peated designation of components in succeed-_ng figures is for the most part omitted if it is clear from the drawings that the components concerned are "recurr=-~.J" components.
35 Figures 1A to 1D
Externally, the inhaler according to the _-invention is made up of the lower part 100 of the housing, ~~~e upper part 150 of the housing, and the protective cap 950. The lower part 100 of the housing and the upper part 150 of the housing have an elongate, semi-monocoque configuration. The upper part has, on its top side, a fairly large opening 151 for 5 receiving a funnel lid 680, and a window 152 through which the status of the counter can be read off. The lower part 100 of the housing and the upper part 150 of the housing are joined to one another such that a housing is obtained which is in principle closed. Grip contours 951 are provided on 10 the outside of the protective cap 950 to permit better grip-ping. Grip contours, preferably designed as grip dimples 113, are also arranged on both sides of the housing, in this case extending over the lower part 100 of the housing and the upper part 150 of the housing.

On the top of the protective cap 950, towards the outer edge, there is an elongate recess, by which means a clear-ance 968 is created together with the adjoining upper part 150 of the housing. By looking into this clearance 968 it is 20 possible to ascertain if the mouthpiece is fitted and the clearance 968 is thus filled, or if the mouthpiece is miss-ing and the clearance 968 is consequently open. Opposite the protective cap 950 - on the rear part of the inhaler - the perforated base 854 of the valve guide enclosed by the lower 25 part 100 of the housing and upper part 150 of the housing can be seen.
In the closed state shown here, the starting position - sub-sequently referred to as Situation A1 - the protective cap 30 950 is fitted flush with the lower part 100 of the housing and the upper part 150 of the housing. Thus, the medical preparation stored in the inhaler is protected quasi her-metically from external humidity.

Figure 1E
The inhaler has to be opened before use; to do this, the protective cap 950 is first of all pulled out in the axial direction. The line along which the protective cap 950 is pulled out is limited by a pair of side arms 960 which are fixed on the protective cap 950 and engage in a longitudi-nally displaceable manner in the inside of the inhaler. With the protective cap 950 pulled out this far, the mouthpiece 900 is already partly visible, which mouthpiece is attached to the lower part 100 of the housing and the upper part 150 of the housing at the front and is enclosed on both sides by the side arms 960. As will be explained later, this step is associated with a temporary vibration for exact dosing of the medicament from the powder reservoir. This intermediate position, with the protective cap 950 pulled out, is here-inafter referred to as situation A2.
Figure 1F
In order to allow the patient access to the mouthpiece 900, i.e. to permit inhalation, the protective cap 950 suspended on the side arms 960 has to be swung down in a further ma-neuver. The mouthpiece 900 with the mouth tube 920 protrud-ing from the base plate 910 is now fully visible. The chan-nel outlet 922 through which the patient inhales the medica-ment is situated on the end face 921 of the mouth tube 920.
In this position, with the protective cap pulled out and swung fully down - subsequently referred to as Situation A4 - the inhaler itself is prepared for inhalation. The dose of medi-cament which has been made ready is in a loosened state. It should be understood that the protective cap 950 can only be swung down when it has first been pulled out to the limit. Lr:4~, dimensioning of the mouthpiece 900, the length of the side arms 960, and the sole possibility of swinging the protective cap 950 downwards, cause the patient by necessity to place the inhaler in the correct position. If the inhaler were used upside down in error, the patient would notice this immedia-5 tely since his nose would hit against the protective cap 950 and he would thus barely be able to apply the mouthpiece 900.
Situation A3 characterizes the state in which the protective cap 950 is in its swing movement and has not yet reached its 10 lowest position.
Figures 2A to 2D
The protective cap 950 consists of the two aforementioned side arms 960 and the actual cap 952. The clearances 968, 15 which provide space for the base plate 910 of the mouthpiece 900, are arranged on that edge of the cap 952 facing towards the mouthpiece 900, centrally on the top side and bottom side.
20 The two side arms 960 each extend laterally into the cap 952. At the front part, which engages in the inhaler, the side arms 960 have a special construction symmetrical to one another. Each side arm 960 has a square, rounded aperture 961, a pin 962 lying below the latter and directed inwards, 25 a recess 963 incorporated from the underside of the side arm and having a cut edge 964, as well as forward bevels 969.
Between the aperture 961 and the cut edge 964 in each side arm 960 there is a further rectangular aperture 970. Offset.
above this aperture 970 there is an outwardly directed dim-30 ple 971. The same type of dimple 972 is arranged in the lower area of the side arm 960 near the entry to the cap 952.

Figures 3A to 3D
The lower part 100 of the housing has, on both sides, a plu-rality of stop cams 101 spaced apart from one another and projecting above the side wall. To the rear, the lower part 5 100 of the housing is strengthened at the end, so that a semicircular bearing ring 102 is obtained. A double wall 103, likewise semicircular and with a radial receiving groove 104, is provided on the base at a distance from the bearing ring 102. Running centrally between the double wall 10 103 is a raised, axial connecting web 115.
Arranged on the base are two parallel bars 106 which extend from the front side 105 and which each have an outwardly facing indentation 116 in the rear area and an obliquely cut 15 aperture 117 in the front area. Together with two columns 118 lying opposite one another at a distance, and a rail 119 extending along the wall of the lower part 100 of the hous-ing, the indentation 116 delimits a depression-like ball socket 108. There is also an indentation 120 provided in the 20 rail 119, and the indentations 116,120 of identical form lie opposite one another. The columns 118 have points 121 which are directed towards one another and which at their deepest point are located in the ball socket 108. On each of the rear columns 118 there is an inwardly pointing hook 122. A
25 raised plug 123 is in each case arranged in front of the front pillars 118, facing towards the front side 105. At the said front side 105, two receiving notches 109 are incorpo-rated, as well as two axially extending longitudinal slots 110 in the base - near each housing wall. A safety cam 125 30 sits to the side at the entrance of each longitudinal slot 110. Between the two bars 106 and the front side 105 there are two U-shaped depressions 124.

Figures 3E and 3F
In the completed state, a blocking ball 130 lies in each ball socket 108 and, with the inhaler in the correct posi-tion, this blocking ball 130 is located at the deepest point 5 between the points 121 of the columns 118. When the inhaler is in an excessively horizontal or axial inclined position, the blocking balls 130 roll into the indentation 116 of the bar 106 or into the indentation 120 of the rail 119 and ef fect a blocking of the inhaler, as described in Figures 22A
10 and 22B.
To ensure that the removed mouthpiece 900 is put back in place before the inhaler is closed, blocking hooks 140 are optionally fitted on the plugs 123. A blocking hook 140 con-15 sists of a spring arm 142 and a lever 143 with a laterally protruding blocking tooth 144 and the catch 145 pointing to the front side 105. The spring arm 142 of a blocking hook 140 passes through the aperture 117, while the lever 143 is pressed outwards by the tensioning of the spring arm 142, so 20 that its blocking tooth 144 protrudes into the course of the longitudinal slot 110 where, in the completed state, the re-spective side arm 960 of the protective cap 900 sits. The function of the blocking hooks 140 is described in detail i~:
Figures 21A to 21C.

Figure 4 Complementing the stop cams 101, the upper part 150 of the housing has plug holes 153 on its side walls. Analogously t..
the lower part 100 of the housing, the upper part 150 of t~
30 housing also has a semicircular bearing ring 154 to the rear, as well as a double wall 155 with a receiving groove 156. The half bearing rings 102 and 154, respectively, and the receiving grooves 104 and 156 combine to form full cir-cles.
On the side walls, mounted ahead of the receiving groove 5 156, there are in each case a support cam 158 and a higher overspring rib 157. The support cam 158 and the overspring rib 157 project towards the center of the upper part 150 of the housing and have a common point of origin on the side wall. Adjacent to the window 152, two parallel supports 159 10 spaced apart from one another are arranged on the housing bottom. In the bottom there is also the recess 151 for the funnel which is to be fitted. On both sides of this recess 151, towards the side walls, a limit cam 164 in each case stands out from the bottom of the housing.

Corresponding to the longitudinal slots 110 in the lower part 100 of the housing, there are also two slots 161 in the front side 160 of the upper part 150 of the housing. In the front side 160 there is additionally a central receiving 20 notch 162, and two elastic clamping prongs 163 extend from the front side 160 in the direction of the mouthpiece 900.
cross-piece 165 stretches between the front side 160 and the base of the clamping prongs 163, and adjacent to the receiv-ing notch 162. To the rear of the front side 160, the clamp-25 ing prongs 163 merge into a vertical U-profile 166, the ver-tical grooves 167 of the U-profiles 166 internally adjoining the front side 160 and facing one another.
Figures 5A to 5E
30 The mouthpiece 900 consisting of the base plate 910 and the mouth tube 920 is advantageously made of two halves which are joined together, for example, by an integral film hinge 923 provided on the end face 921. On the base plate 910, facing the inhaler, there is a full connector plug 911 at the bottom of each half, and a half-cam 912 at the top, which complements the adjacent half- cam 912. Each connector plug 911 has at its front free end, in the lower area, a re-5 cess 930 with an inwardly directed bevel 931.
Incorporated underneath the two half-cams 912 is an engage-ment opening 913 which extends as a shaft 932 right into the mouth tube 920. Deeper in the shaft 932, a recessed groove 10 933 is present in each case laterally in the wall of the mouth tube 920. The channel inlet 914 for the atomizer path 924 of the mouth tube 920 lies below the engagement opening 913. The channel inlet 914 is connected to the channel out-let 922 via the atomizer path 924. A horizontal ramp 935, 15 complementing the second half of the mouthpiece, is in each case arranged on the base plate 910 under the channel inlet 914.
Inside the atomizer path 924, behind the channel inlet 914, 20 there are a plurality of baffles 925 which protrude into the atomizer path 924 for impacting the medicament-containing air stream and causing it to swirl, so that the atomizer path 924 acquires a course which is rich in curves. Nearer the channel outlet 922, the powder aerosol flowing through 25 enters via an S-curve into an enlarged channel section 928 and is here deflected to the channel outlet 922. The purpose of the special configuration of the atomizer path is to deagglomerate the powder and to reduce the flow rate of the powder so as to deposit coarser particles ~,~rhich are ineffec-30 tine for inhalation. At the same time, the impacting of par-ticles of active substance in the pharynx of the patient is thus prevented. The mouth tube 920 is flattened off horizon-tally, at least in the area of the end face 921, so that trv=-patient is induced to employ the correct positioning of the inhaler during use.
Figures 6A and 6B
5 The slide rail 200 has two longitudinal grooves 202 which extend laterally from the end face 201 and parallel to. one another, and which reach to approximately halfway along the slide rail 200. In a continuation of the end face 201, two feet 204 spaced apart from one another extend downwards from 10 the bottom of the slide rail 200. At the top, the slide rail 200 has a ledge-like roof part 210 which protrudes over the end face 201 in the manner of a projecting roof. At the op-posite end from the end face 201, the slide rail 200 ends in a sloping surface 205 which merges ramp-like with the top 15 surface of the slide rail 200, the roof part 210 ending in front of the sloping surface 205.
Figures 7A to 7D
The carriage 500 has two wings 503,523 rising laterally and 20 beginning on the front side 501, with an outwardly directed cam 504 being in each case arranged thereon. The cam 504 is wider in the horizontal than in the vertical, so that an ap-proximately oval shape is obtained. An arcuate aperture 505 is incorporated in the wings 503,523 and runs round the cam 25 504 from below in a part circle. At its rear side 507, the carriage 500 has two laterally rising struts 508,510, the strut 508 having a horizontal shoulder 509. Two pull cams 512 rise from the carriage base 511, while to the rear side 507 the carriage base 511 continues in the form of two elas-30 tic spring tongues 513 which end as spring wedges 514 and can be deflected out to the sides. Between the two spring tongues 513, a longitudinal groove 520 extends centrally through the carriage base 511. A pull catch 521 is present on the front side 501 between the groove 520 and each of the wings 503,523. Towards the front side 501, the wing 523 has a grate section 515 on the inside.
5 Underneath the groove 520, the carriage 500 has two runners 522 on its underside. Also on the underside of the carriage, towards the outside as viewed from the runners 522, there are two pairs of impact ridges 524 which correspond to the two ball sockets 108 in the lower part 100 of the housing.
10 The two impact ridges 524 of one pair are arranged at a dis-tance from one another. A stepped bulge 516 is positioned ahead of each pair of impact ridges 524, in the direction of the front side 501.
15 Figures 8A to 8C
Near its front edge 301, the tongue-like dosing slide 300 has a through-bore, the dosing cavity 302. Starting from the front edge 301, the dosing slide 300 extends firstly as a narrow tongue tip 303 and then widens to the rear part 304.
20 A spring leaf 305, from which a cam 306 rises, is arranged on the outside flank of the rear part 304.
On the underside, the dosing slide 300 has flank ridges 307 which begin immediately behind the dosing cavity 302 and 25 there form limit stop edges 308. The dosing cavity 302 is surrounded by a radial sealing rim 320 on ~~~e underside.
Near the transition to the rear part 304, ~:~ere are two downwardly extending transverse cams 309. On the rear edge 310 of the dosing slide 300 there are two downwardly di-30 rected, profiled catches 321.

Figures 9A and 9B
The shutter 400 has the function of releasing the medicament made ready in the dosing cavity 302 only when there is a suitably forceful inhalation. At the very front, the shutter 5 400 has a sleeve-like closure part 401 wits: the through-opening 402. Behind the closure part 401 there are outer, vertical side ridges 403, beginning with a limit stop 404.
An outwardly directed and ramp-shaped wing 405 is arranged on each side ridge 403. In the direction of the rear part 10 406, the wing 405 is followed by a side bracket 407. At the bottom, on the rear edge 408, the shutter 400 also has an outwardly directed carrier 409. On the bottom, in the area of the wings 405, two base plates 410 extend towards one an-other, leaving a through-gap 411. Towards she rear edge 408, 15 the end of the rear part 406 is provided with a cover 420 which at the top stretches across the two parallel side ridges 403 and begins approximately in the area of the side brackets 407. In the cover 420 there is a -ounded-off groove 421 which extends along the middle and which is open to the 20 center of the shutter 400.
Figures 10A and lOB
The valve shield 800 has the function of inducing the pa tient to generate a defined minimum suctie:, for a correct 25 inhalation. The valve shield 800 consists ef a cylindrical capsule 810 and a plurality of arms attacre~ thereto and having different tasks. The capsule 810 has a flange-like collar 811 surrounding the opening and prc-~ruding outwards.
The bottom 812 of the capsule 810 is conve~,~y curved out-30 wards and has a large number of raised stubs 813 on the out-side.

The further elements of the valve shield 800 are attached perpendicularly onto this collar 811 and in the axial direc-tion. On the collar 811 there is firstly a pair of long ten-tacles 820 which lie opposite one another and which have 5 carriers 821 at their very front. Before the tentacles 820 there are two shorter spring arms 822 with outwardly di-rected wedge profiles 823 at their tips. Behind the tenta-cles 820 there are two further spring arms 825 with out-wardly directed hooks 826. Between these spring arms 825 10 there are two short locking teeth 824 standing close to one another.
Figures 11A and 11B
The capsule-shaped valve guide 850, when fitted into the 15 lower part 100 of the housing and the upper part 150 of the housing, serves to receive the valve shield 800, i.e. its capsule 810. To this extent the valve guide 850 has the function of a slide bearing. Complementing the collar 811 of the valve shield 800, the valve guide 850 has an external 20 limit stop flange 851. Slide ribs 852 in the inside of the valve guide 850 have the purpose of reducing the friction as the valve shield 800 travels out. The perforated bottom 854 has numerous holes 855, so that the stubs 813 of the valve shield 800 find space therein. At the top and bottom of the 25 limit stop flange 851 there are two diametrically opposite notches 856. The holes 855 and the stubs 813 make it possi-ble to design the inhaler virtually closed at the rear and thus to prevent the penetration of dirt particles and the inadvertent displacement of the valve shield 800.

Figures 12A and 12B
The funnel 690 is intended for fitting into the funnel holder 601 (see Figures 13A,13B). The funnel bottom 691 is designed sloping obliquely towards the outlet 692, so that the medicament powder flows in a favorable manner. The out-let 692 is surrounded on the outside by a sealing element 694. On the outside, the funnel 690 has retainer cams 695 5 projecting upwards on two opposite sides, as well as a cen-trally positioned fixing nose 696 which sits on the oblique funnel bottom between the retainer cams 695.
Figures 13A and 13B
10 The box-shaped funnel holder 601 has, on the underside, the holder bottom 603, the front wall 611, the rear wall 612, and the two half-height side walls 613,614 lying between the front and rear walls 611,612. Located in the holder bottom 603 are the funnel outlet 608 and an elongate groove 615. At 15 the very bottom, a sealing member 622 surrounds the funnel outlet 608, so that it is possible to prevent the entry of humidity and the escape of powder from the funnel 690 onto the sliding surfaces of the dosing slide 300.
20 Arranged perpendicularly on the front wall 611 are two an-gled rails 616, and at the top of the rear wall 612 there is a support edge 602, from which a spring arm 617 in each case extends along the two side walls 613,614. A groove 618 fac-ing the respective side wall 613, 614 is provided in each c.
25 the spring arms 617. The side walls 613,614 each have a downwardly open notch 619 approximately at their center on the lower edge. A grate section 621 is provided on one side wall 613 near the rear wall 612. Two elastic lamellae 605 opening in the rear wall 612 extend along the outer flanks 30 of the holder bottom 603, at the vertically movable ends e' which lamellae 605 there are downwardly projecting blockinc cams 609.

Figures 14A to 14C
The funnel lid 680 serves to close the funnel 690. On the underside of the funnel lid 680 there is a chamber 681 which is closed by a semi-permeable membrane 682. The chamber 681 5 is intended to receive a moisture-attracting desiccant pow-der and the moisture can diffuse through the semi-permeable membrane 682.
Figures 15A and 15B
10 When the funnel arrangement is in its completed state, the funnel 690 is fitted into the funnel holder 601, and the funnel 690 is closed by the funnel lid 680. However, the se-quence of assembly of the inhaler need not include the prior completion of the funnel arrangement.

Figures 16A and 16B
The complete counter 700 consists of the units wheel 701, the tens wheel 780, the hundreds wheel 720, the counter body 740, the counter cover plate 760, and two identical drive 20 wheels, which are not shown here. The purpose of the counter 700 is to register the number of doses used or doses still available and to indicate to the patient the inhalation which has just taken place, as long as it was performed cor-rectly. Numbers and, if appropriate, a color marking are 25 provided on the circumference of the counter wheels 701,780 and 720 fixed on the axle 741 of the counter body 740. The current status of the counter is displayed under a lens 742 which sits in the window 152 of the upper part 150 of the housing. The lens 742 is connected to the counter body 740.

Figures 16C and i6D
The units wheel 701 has ten radially distributed cams 703 on its outer surface 702.

Figures 16E and 16F
The tens wheel 780 with its inner toothed ring 781 is itself of a conventional construction.

Figures 16G and 16H .
The hundreds wheel 720 likewise has an inner toothed ring 721 and an outwardly protruding end cam 722.
10 Figures 16I and 16J
The counter body 740 consists of the base plate 743, the lens 742 set on the top at right angles, the axle 741 ex-tending perpendicularly from the base plate 743, as well as the drive-wheel bearing 744.

Figures 16K and 16L
Bearing on the units wheel 701, the counter cover plate 760 is fixed on the axle 741 of the counter body 740. The counter cover plate 760 has an elastic adjusting tongue 761 20 with a wedge cam 762 at the end, which cam 762 moves at all times between two cams 703 of the units wheel 701.
Figures 16M and 16N
The star-shaped drive wheel 790 is fitted on the one hand 25 between the units wheel 701 and the tens wheel 780 and on the other hand between the tens wheel 780 and the hundreds wheel 720. It has six uniformly arranged teeth 791, of which every second tooth 791 has an undercut 792 at its tip on one side of the drive wheel 790.

Figure 160 When a correct inhalation has been completed and the inhale has been closed again by swinging the protective cap 950 up-wards and pushing it in, the actuation of Lhe counter 700 takes place. Only on pushing the dosing slide 300 back into the starting position - Situation A1 - is a cam 703 on the units wheel 701 gripped by the cam 306 situated on the spring leaf 305, and the units wheel 701 thereby turned by 5 one count position.
When the intended number of doses have been taken from the inhaler, the hundreds wheel 720 is in such a position that the end cam 722 has positioned itself at the far top and, on 10 pulling the carriage 500 out, the shoulder 509 (see Figures 7A to 7D) strikes against the end cam 722. Further actuation of the inhaler is thus blocked.
Figures 17A to 17C
15 As an option for increasing the safety of handling of the inhaler, two rotationally movable blocking hooks 140 are provided which can be fastened onto the plugs 123 in the lower part 100 of the housing. The blocking hook 140 is two-armed and is divided into a thin spring arm 142 and a more 20 solid lever 143, the spring arm 142 spreading away from the lever 143. The blocking hook 140 has a bore 146 so that the blocking hook 140 can be fastened onto the plug 123. On the lever 143 there is a blocking tooth 144 protruding out to one side and pointing away from the spring arm 142, as well 25 as a catch 145 pointing forwards and extending the length of the lever 143.

Figures 18A to 18C
In the assembled state, the following arrangement obtains in Situation A1. The lower part 100 of the housing and the up-per part 150 of the housing are joined together. The mouth-5 piece 900 is inserted from the front and the protective cap 950 is fully closed.
The slide rail 200, the carriage 500, the dosing slide 300, the shutter 400 lie in the housing parts 100,150. The valve 10 guide 850 is fitted, and therein the valve shield 800, as well as the complete funnel arrangement - consisting of fun-nel 690, funnel holder 601 and funnel lid 680 - and the counter 700. The valve shield 800 is in its rearmost posi-tion, and the dosing slide 300 is located such that the dos-15 ing cavity 302, positioned under the funnel outlet 608, can fill with medicament. The closure part 401 of the shutter 400 protrudes into the channel inlet 914. The clamping prongs 163 - additionally fixing the mouthpiece 900 - sit in its shaft 932 and engage in the grooves 933. The half-cams 20 912 of the mouthpiece 900, joined together, are locked in the receiving notch 162 in the upper part 150 of the hous-ing. The connector plugs 911 of the mouthpiece 900 pass through the receiving notches 109 in the lower part 100 of the housing, and the ramp 935 of the mouthpiece 900 engages 25 under the front edge of the roof part of the slide rail 200.
The side arms 960 of the protective cap 950 protrude through the slots 110,161 in the lower part 100 of the housing and in the upper part 150 of the housing and embrace the wings 503,523 of the carriage 500. The pins 962 now hang in the 30 apertures 505, while the cams 504 engage in the apertures 961. To fix the protective cap 950 in the starting position, the safety cams 125 are locked into the dimples 972.

The feet 204 of the slide rail 200 engage in the depressions 124 in the lower part 100 of the housing. The angled rails 616 of the funnel holder 601 are driven into the vertical grooves 167 of the U-profiles 166 on the upper part 150 of the housing. The funnel 690 sits with its retainer cams 695 and its fixing nose 696 in the notches 619 and in the 'groove 615, respectively, of the funnel holder 601. The outlet 692 of the funnel 690 with the sealing member 694 is situated in the funnel outlet 608. In addition, the funnel holder 601 is fixed laterally by the limit cams 164 in the upper part 150 of the housing.
The complete counter 700 is held by the supports 159 in the upper part 150 of the housing. The capsule 810 of the valve shield 800 sits to the maximum extent in the valve guide 850, the limit stop flange 851 of the latter sitting in the receiving grooves 104,156 of the lower part 100 of the hous-ing and the upper part 150 of the housing, respectively, and the connecting web 115 coming into engagement with the notch 856.
Figures 19A to 19D
This sequence of figures illustrates the release of the shutter 400 which surrounds the dosing cavity 302 of the dosing slide 300 filled with medicament, upon swinging the protective cap 950 down.
Figures 19A and 19B
In accordance with Situation Al, the carriage 500 is so po-sitioned that its wings 503,523 stand before the funnel holder 601, i.e. the pin 962 of the side arm. 960 of the prc-tective cap 950, engaging in the aperture 505, is ineffec-tive as regards unlocking the unmovable shutter 400. The blocking cams 609 under the funnel holder 601 engage behind the wings 405 projecting laterally on the shutter 400. The dosing cavity 302 is situated underneath the funnel outlet 608 and could already be filled with medicament.

Figure 19C
The protective cap 950 has in the meantime been pulled out completely and the carriage 500 hanging on the side arms 960 has been pulled forward; Situation A2 has been reached. The 10 shutter 400 is still unmovable and, with its closure part 401, surrounds the dosing cavity 302 which has been pushed into the channel inlet 914 of the mouthpiece 900 by means of pulling off the protective cap 950 and filled with medica-ment.

The swinging-down of the protective cap 950 now commenced, i.e. situation A3 is being implemented. However, the protec-tive cap 950 has not yet been swung down fully, so that the pin 962 ascends in the aperture 505 during the swinging-down 20 movement and consequently gradually raises and unlocks the lamella 605 arresting the shutter 400.
Figure 19D
In situation A3 which has been reached - this also applies 25 to Situations A4 to A7 - the protective cap 950 has been swung down fully, as a result of which the pin 962 forces the lamella 605 up. The blocking cam 609 is thus disengaged from the wing 405 on the shutter 400. The shutter 400 is movable, i.e. readiness for inhalation exists in conjunction 30 with situation A3. The swung-down protective cap 950 is fixed in this position by the cooperation of the safety cams 125 in the lower part 100 of the housing and the dimples 971 on the side arms 960.

Figures 20A to 20F
This sequence of figures illustrates a complete inhalation cycle with the mechanical events occurring in the different 5 possible situations.
Figure 20A
In situation Al, the valve shield 800, the carriage 500 and the shutter 400 are located in their rear end position. This 10 is the state of the inhaler after the protective cap 950 is closed following a correctly performed inhalation or prior to the first use. With the protective cap 950 being pushed in, the shutter 400, the valve shield 800 and the dosing slide 300 have been pushed back into the rear end position 15 by the carriage 500. The pull catch 521 of the carriage 500 grips the carrier 409 of the shutter 400. With its spring wedges 514, the carriage 500 presses against the catches 321 of the dosing slide 300, the spring wedges 514 being en-closed to the inside by the locking teeth 824.

The two struts 508,510 of the carriage 500 have pushed the valve shield 800 into its starting position. A cam 703 on the units wheel 701 of the counter 700 has been put forward one unit by the cam 306 on the dosing slide 300. The dosing 25 cavity 302 is now once again situated underneath the funnel outlet 608.
Figure 20B
In situation A9 the inhaler is in a state of readiness for 30 inhalation. By pulling the protective cap 950 out, the valvJ
shield 800 is advanced from the rearmost position. The car-riers 821 on the tentacles 820 have been gripped by the wings 503, 523 and pulled forward slightly, so that the stubs 813 of the valve shield 800 are removed from the holes 855 of the valve guide 850 and create air gaps. The inhaling patient is able to draw breath through these air gaps if no other air inlets are provided on the inhaler. On pulling the protective cap 950 out, the carriage 500 was moved with its grate section 515 past the grate section 621 of the funnel holder, so that a vibration was generated for promoting the flow of the medicament powder from the funr_e1 690 into the dosing cavity 302. The grate sections 515,621 are dimen-sinned and arranged in such a way that whey pulling the pro-tective cap 950 out, vibrations are generated only so long as the dosing cavity 302 is situated under the funnel outlet 608. When the carriage 500 begins to pull ~he dosing slide 300 with it, the grate sections 107 and 515 disengage.
The dosing slide 300 was furthermore gripped via the trans-verse cams 309 by the pull cams 512 of the carriage 500 and moved forwards in the direction of the mouthpiece 900 to such an extent that the dosing cavity 302 '_s now surrounded by the closure part 401 of the shutter 400. The shutter 400 is also released, since the blocking cams 609 underneath the funnel holder 601 have lifted from the wines 405 of the shutter 400 as the protective cap 950 swims down. The wedge profiles 823 of the spring arms 822 of the valve shield 800 stand adjacent to the overspring ribs 157 cf the upper part 150 of the housing.
Pressure is exerted from above on the sprier arms 617 of the funnel holder 601 so that all the compone~:~s lying below are subjected to a certain amount of surface pressure. This in-creases the tightness and prevents the esc~.oe of medicament powder. After the protective cap 950 has ~een swung down, the inhaler is in a state of readiness fcr inhalation, and the easier mobility of the shutter 400 is now desired. When the side arms 960 are swung down, the surface pressure act-ing from above is in part compensated, as the pin 962 as-cending in the aperture 505 presses against the lamellae 5 605. By means of the oval shape of the cam 504 and the ge-ometry of the aperture 961, the cam 504 has a deliberately greater vertical play in the aperture 961 than its horizon-tal play. The reduced surface pressure now affords easier mobility of the shutter 400 upon inhalation.

Figure 20C
In situation A5 - the inhaler is closed again after an omit-ted inhalation - the valve shield 800 remained in its posi-tion, i.e. it was not sucked forwards. When the protective 15 cap 950 is applied, the carriage 500 is pus~_ed back; its spring tongues 513 move away from the catches 321 of the dosing slide 300. The valve shield 800 is again pushed into its rearmost position by the carriage 500; the shutter 400 is locked again. The dosing slide 300 rema-i:_s, however, with 20 its filled dosing cavity 302 in its forward position; it re-mains there as a result of suitable frictic~.
Figures 20D
In situation A6 - inhalation was interruptea when incomplete -25 the valve shield 800 has not yet reached its forward position, as a result of which the shutter 400 was nc~ yet displaced, and the dose of medicament remained enclose.. When the pro-tective cap 950 is applied and the carriage 500 pushed back, the dosing slide 300 remains with its unem.~ied dosing cavity 30 302 at the front. The spring tongues 513 of -~he carriage 500 strike via the spring wedges 514 against tr_~ catches 321 and are thus bent inwards. In this way the spring wedges 514 strike against the locking teeth 824 and t:~_vs push the valvF

shield 800 back, until the further pushing back of the valve shield 800 by the two struts 508 and 510 of the carriage 500 takes place.
5 Figure 20E
After incomplete inhalation and reclosing of the inhaler - situation AS - the filled dosing slide 300 stands forward, while the valve shield 800 and carriage 500 are again situ-ated in the rear starting position.

Figure 20F
In situation A7 - after completed inhalation - the protec-tive cap 950 is swung fully down, as a result of which the pins 962 have lifted the lamellae 605 of the funnel holder 15 601 and the wings 405 of the shutter 400 have been unlocked.
During a correct inhalation, the valve shield 800 has been sucked forwards. The spring arms 822 with the wedge profiles 823 have surmounted the overspring ribs 157 in the upper part 150 of the housing as a result of the valve shield 800 20 moving forwards. The shutter 400 was pushed into its front end position by the advancing valve shield 800, by which means the dosing cavity 302 became free and the medicament was inhaled by the patient.
25 During a correct inhalation the valve shield 800 has been sucked forwards, after its spring arms 822 <<aith the wedge profile 823 have surmounted the overspring ribs 157. It is possible to define the necessary suction effort with the ge-ometry of the wedge profile 823 and of the overspring ribs 30 157, and with the elasticity of the spring arms 822. In the frontmost position of the valve shield 800, the two elastic spring arms 825 with the hooks 826 arranged thereon are driven behind the hooks 122 arranged in the lower part 100 of the housing. This prevents the valve shield 800 from automatically sliding back.
During the reverse movement of the carriage 500, its spring 5 wedges 514 sit clamped between the catches 321 and the lock-ing teeth 824 and cannot therefore escape. As a result, the dosing slide 300 and the valve shield 800 are now pushed back into the starting position - Situation AI - by the spring wedges 514 and the struts 508,510. In so doing, the 10 hooks 826,122 are released from one another.
Figures 21A to 21C
This sequence of figures illustrates the function of the blocking hooks 140 employed in the interaction with the 15 mouthpiece 900 and the side arms 960 of the protective cap 950.
Figure 21A
In the starting position B1, the protective cap 950 is 20 closed, i.e. pushed on; the mouthpiece 900 however is absent when fitting the blocking hooks 140. The spring arms 142 protrude through the apertures 117 in the bars 106, support themselves therein and force the levers 143 outwards. The blocking teeth 144 strike the solid side arms 960 of the 25 protective cap 950.
Figure 21B
Here - in the incorrect position B2 - the protective cap 950 is pulled out and swung down; the carriage 500 is pulled 30 forward, so that the spring arms 142 are pressed back into the apertures 117 by the carriage 500, as a result of which the levers 143 are under increased tensioning. The mouth-piece 900 has been removed, however, for example for a cleaning procedure. The blocking teeth 144 now engage in the apertures 970 present in the side arms 960, since the levers 143 are forced outwards by the pressure of the spring arms 142. In this state, the protective cap 950 cannot be swung 5 up in order to push it in. Thus, the absence of the mouth-piece 900 is made evident, and this precludes a situation where the patient puts the inhaler away without the mouth-piece 900 being fitted and cannot then use the inhaler in an emergency.

Figure 21C
In the desired position B3, the mouthpiece 900 is fitted.
The connector plugs 911 of the mouthpiece 900 project into the receiving notches 109. The bevels 931 of the connector 15 plugs 911 here press the catches 145 of the levers 143 in-wards, counter to the tensioning of the spring arms 142, so that the blocking teeth 144 are drawn out of the apertures 970. The protective cap 950 can thus be swung up again and closed.

Figures 22A and 22B
With correct positioning of the inhaler, i.e. when there is no over-critical inclination in the horizontal or in the ax-ial axis of rotation, the blocking balls 130 position them-25 selves centrally in the ball sockets 108 at the deepest points. In such a position, the protective cap 950 can be pulled out, since the appended carriage 500 is not blocked and can also be moved out.
30 If the inclination is over-critical, then ~'_~.e blocking balls 130 roll from the deepest points onto the _=feral limits 116,120 and now lie higher up because of t~:~ oblique slopes in the ball sockets 108. Outward travel of she carriage 500 is now blocked. The blocking balls 130 now come into colli-sion with the impact ridges 524 and the bulges 516, so that ultimately the protective cap 950 cannot be pulled out. This safety measure guarantees that the inhaler is held in the 5 correct position when it is opened, so that a correct fill-ing of the dosing cavity 302 with medicament powder is en-sured. The inhaler has to be opened in the prescribed posi-tion, but it can be used in any position once it has been opened, that is to say, in particular, also for patients who 10 are lying down. A further control on its use is afforded by the fact that the protective cap 950 can only be swung down-wards.
Figures 23A to 23G
15 This series of figures gives an impression of the successive construction of the inhaler, although this need not neces-sarily correspond with the sequence of assembly in mass manufacture.
20 The valve guide 850 is fitted into the rear of the lower part 100 of the housing and the valve shield 800 is fitted into the valve guide 850. The mouthpiece 900 projects from the front, only one half of the mouthpiece 900 being shown for reasons of improved clarity (Figure 23A). The inhaler is 25 equipped with the slide rail 200 placed near the mouthpiece 900 and with the carriage 500 bearing on the valve shield 800 (Figure 23B). The dosing slide 300 is now placed on the slide rail 200 (Figure 23C). The shutter 400 is added for further completion (Figure 23D). The protective cap 950 with 30 the lateral side arms 960, which are attached to the car-riage 500, is now fitted (Figure 23E). The completely fitted funnel arrangement 600, which is directed towards the pro-tective cap 950, and the counter 700 are shown here in two views (23F, 23G). Finally, the upper part 150 of the housing would have to be fitted.
Further constructional variations can be made to the inhaler which has been described. The following variations are ex-pressly mentioned here:
- Instead of the dimples 972 for arresting the protective cap 950 in the pushed-in state - situation A1 - an out-10 wardly directed cam could in each ease be provided near the entrance to the cap 952 on the upper side of the side arms 960, which cams engage in slots in the front side 160 of the upper part 150 of the housing in the closed state.
In order to detach the protective cap 950 from the mouth-15 piece 900, the protective cap is to be pressed-in in the area of the lateral grip contours 951, as a result of which the cams come out.
In the mouthpiece 900, near the channel outlet 922, it is 20 possible to provide in the enlarged channel section 928 a three-dimensional surface-profiled wall section with a transverse fluting in order to promote the powder deag-glomeration and the deposition of coarser particles inef-fective for inhalation.

- To hold the two halves of the mouthpiece 900 together, complementary connecting elements could be arranged in each case on the inner cut edges of the two halves - for example, a combination of bores and cams - in order for 30 both halves to be joined together again after possible cleaning and drying.
- To embed the funnel arrangement in the inhaler, it might be possible to use a collar made of elastic material whic:~:
35 is pushed onto the funnel holder 601.

- The pharmacological dry powder stored in the funnel 690 can be in loose form on the one hand. However, pre-dosed units for dispensing are also included, for example as ex-truded pellet lane or in pearl chain form. Individually dosed units for dispensing could be arranged in blisters or on tape rolls. It will be appreciated that the medica-ment reservoir and a device for dividing off the individ-ual doses are to be designed in accordance with each other.

- Irrespective of the greater outlay in terms of manufactur-ing technology, the above-described two-part housing, con-sisting of the lower part 100 of the housing and the upper part 150 of the housing, could also be made in one piece.
- The atomizer path 924 in the mouthpiece 900 is designed as a straight or winding channel in which at least one baffle 925 is arranged, and the latter can be an inwardly pro-jecting lamella, a wall, a flow body or a screen.
- Instead of the mechanical counter 700, i-~ is also possible to use a chip with which all relevant dada are recorded, such as number of inhalations performed, time of intake, and flow parameters.
- The flow control realized at present by means of the over-spring rib 157 and the spring arms 822 could also be ob-tained by means of an alterable resistance within the value guide 850.
- To regulate the flow rate, it is advantageous to provide an insert for receiving an optional nozz-'~e within the mouth tube 920, namely at the start of t~:~ atomizer path 924 or mounted upstream of the mouth tub=.
- For specific changing of the flow resist~~_ce in the in-haler during an inhalation, which resist~:-~:ce is obtained by the air gap between the fixed valve a-~;~de 850 and the moving capsule 810 of the valve shield 800, it is possible to configure this air gap, effective at the respective po-sition of the valve shield 800, incrementally by means of physical irregularities on the surface of the capsule 810 5 and/or in the inside of the valve guide 850. For this pur-pose, consideration may be given, for example, to widening or narrowing physical dimensions on the capsule 810 of the valve shield 800 and in the valve guide 850 or grooves whose cross-section changes along their length.

- In the inhaler which has been described, but also in in-halers in general, there is the possibility of recording the inhalations and their flow parameters by means of sen-sor technology. To measure the parameters, use is made of 15 membrane/bending beam technology or a piezoresistive ele-ment in combination with a diaphragm or in combination with the Venturi measurement principle. With IPC logic and sensor technology, open-loop control becomes closed-loop control. This closed-loop control makes it possible to 20 govern an adjustable nozzle via an electronic movement element, which nozzle finally regulates the flow in the inhaler constantly by a resistance change.
- For current supply, a dynamo is provided in the inside of 25 the inhaler and generates an electric current when the protective cap 950 is opened or when air flows through the inhaler during the inhalation, this electric current being stored and being used to supply the electronic components.
30 - The electronic components, as a plug-in, re-usable contro,~
module, can be removed from the inhaler so that a battery operation is possible. The inhalation data are collected by means of an integrated memory chip and made available to the doctor or pharmacist. Exact monitcring of the dose 35 administration is thus possible. The plug-in modules can be recharged on base units for further use and/or can be programmed so that only the contaminated part of the in-haler is to be discarded.
- To better monitor the inhalation procedure, a mechanically and/or electronically generated acoustic and/or optical signal is emitted on completion of a successful or unsuc-cessful inhalation.
- It is also possible to arrange the two complementary grate sections 515,621 on the one hand on the carriage 500 and on the other hand on the lower part 100 of the housing or on the upper part 150 of the housing. So that vibrations occur only when the protective cap 950 is being pulled out - but not when it is being pushed back - one of the two grate sections 515,621 can be taken out of operation on each replacement of the protective cap 950, e.g. on a com-ponent which is also movable.
- The desiccant powder at present accommodated in the funnel lid 680 inside the chamber 681 could also be positioned inside the funnel holder 601.
- The outer contours of the inhaler and the internal weight distribution mean that when it is laid on an essentially horizontal and dimensionally stable support, the inhaler always orients itself with the outlet 608 of the funnel holder 601 pointing downwards.
E

Claims

1. Inhaler for multiple dosed administration of a phar-macological dry powder with:
a) a housing (100,150), b) a medicament reservoir (690) containing the dry powder in loose form or in pre-dosed units for dispensing, c) a mouthpiece (900) covered by a removable protective cap (950), d) a movable dosing slide (300) with a dosing cavity (302) to be filled in the starting position can be positioned underneath a funnel outlet (608) of the medicament reser-voir (690); wherein e) the dosing into the dosing cavity (302) as an operation is connected with the partially starting opening of the protective cap (950), and f) the transfer of the filled dosing cavity (302) into a channel (914) out of which the patient inhales the dose of medicament, is connected with the continued opening of the protective cap (950), characterized in that g) a movable shutter (400) and a movable valve shield (800) are provided in the housing (100,150);
h) the filled dosing cavity (302) pushes info the shutter (400) and is closed by the shutter (400) with further opening of the protective cap (950) and transfer of the dosing cavity (302) into the channel (914);
i) the valve shield (800) is removable from its home posi-tion and comes into movement by the suction generated with the inhalation, in order to push away the shutter (400) with the body parts (820) of the valve shield (800), to push away the shutter (400) against adjustable locking means (157,823) only is possible with a defined minimum intensity of inhalation;

j) only by the displacement of the shutter (400) the dosing cavity (302) is released and the therefrom released dose of dry powder can be inhaled;
k) means (321;500,513,514) are provided by means of which only after a correctly completed inhalation the dosing slide (300) can be returned to prepare for renewed fill-ing with its dosing cavity (302) under the funnel outlet (608);
l) an integrated mechanical and/or electronic recording unit (700) is present, by means of which at least the cor-rectly performed inhalations are recorded; and m) the recording unit (700) effects a blocking of the in-haler after a defined number of inhalation doses have been used up.

2. Inhaler according to Claim 1, characterized in that a) on the protective cap (950) there are two side arms (160) which are articulated on a carriage (500) arranged in a longitudinally displaceable manner in the inhaler, and b) when the protective cap (950) is pulled off, the en-trained carriage (500) draws the dosing slide (300) with it, and c) only after a completed, correct inhalation can the dosing slide (300) be returned by the carriage (500) into the starting position.

3. Inhaler according to Claim 1, characterized in that in the inside of the inhaler there are blocking means (108,116,120,130;500,516,524) which prevent to pull off the protective cap (950) as soon as the inhaler takes up a hori-zontal and/or axial inclined position going beyond a defined extent.

4. Inhaler according to Claim 3, characterized in that the blocking means is at least one ball socket (108) with a complementary bulge (516), impact ridges (524) and a movable blocking ball (130) fitted between them, and in the event of an excessive inclined position the ball (130) blocks the outward movement of the carriage (500).

5. Inhaler according to Claim 1, characterized in that the medicament reservoir consists of a funnel holder (601) and of a funnel (690) which can be fitted therein, space being provided inside the funnel holder (601), or underneath a funnel lid (680), for the incorporation of hygroscopic desiccant powder.

6. Inhaler according to Claim 1, characterized in that the defined minimum intensity of inhalation for releasing the dosing cavity (302) is determined by an adjustable resistance which the valve shield (800) has to overcome directly or indirectly on aspiration.

7. Inhaler according to Claim 6, characterized in that the resistance is formed a) at least by one spring arm (822) with a wedge profile (823) arranged on the valve shield (800), and at least one overspring rib (157) to be surmounted by the wedge profile (823), the overspring rib (157) being situated on a housing part (100,150) of the inhaler; or b) by an obstacle, to be surmounted during the forward movement of the valve shield (800), inside a valve guide (850) which surrounds the valve shield (800); or c) on the distance travelled by the shutter (400).

8. Inhaler according to Claim 1, characterized in that it has a mouthpiece (900) with a channel inlet (914) and a channel outlet (922) provided at a mouth tube (920), an atomizer path (924) lying between the channel inlet (914) and the channel outlet (922), wherein a) a labyrinthine atomizer path (924) is provided in the mouthpiece (900) for powder deagglomeration the labyrinthine atomizer path (924) consisting of a straight or winding channel in which at least one baffle (925) is arranged, which baffle can be an inwardly projecting lamella, a wall, a flow body, a ramp or a screen; and b) the atomizer path (924) in advance of the channel outlet (922) for the purpose of reducing the powder flow rate and depositing coarser particles ineffective for inhalation, has a channel section (928) of enlarge volume which deflects the powder aerosol flowing through it, and it being possible for a three-dimensional surface-profiled wall section to be provided in addition.

9. Inhaler according to Claim 8, characterized in that the channel outlet lies in an upper region of an end face (921) of the mouth tube (920).

10. Inhaler according to Claim 8, characterized in that the mouthpiece (900) is detachable from the housing (100,150) of the rest of true inhaler.

11. Inhaler according to Claim 10, characterized in that the mouthpiece (900) can be arranged on the housing (100, 150) by means of a plug connection (911, 912).

12. Inhaler according to Claim 8, characterized in that the mouthpiece (900) is a multi-part component and can be opened out after detachment from the housing (100,150).

13. Inhaler according to Claim 12, characterized in that the parts of the mouthpiece (900) are connected to one another via an integral film hinge (923).

14. Inhaler according to Claim 13, characterized in that a) the mouthpiece (900) consists of two parts which are symmetrical to one another and b) the integral film hinge (923) is arranged on the outer end face (921) of the mouthpiece (900) and c) it is possible to provide complementary connecting elements (927) on the cut edges of both halves of the mouthpiece.

15. Inhaler according to Claim 1, characterized in that with the recording unit (700) a) additionally relevant data on the use of the inhaler can be recorded and b) the completion of a correct inhalation, or an incomplete inhalation, is indicated by an acoustic and/or optical signal.

16. Inhaler according to Claim 15, characterized in that the recording unit (700) can also be used to record the times and the flow parameters upon use of the inhaler.

17. Inhaler according to Claim 1, characterized in that means are provided which generate vibrations when the protective cap (950) is being pulled off, and only then, while the dosing cavity (302) is situated under the funnel outlet (608), and thus contribute to the uniform flow of the pharmacological dry powder.

18. Inhaler according to Claim 17, characterized in that the vibration-generating means are complementary grate sections (515,621) which are located on components moved relative to one another.

19. Inhaler according to Claim 18, characterized in that on the one hand one grate section (107) is provided on the housing (100,150) or on a funnel arrangement (600) and on the other hand one grate section (515) is provided on a carriage (500) coupled to the protective cap (950).

20. Inhaler according to Claim 1, characterized in that an insert for receiving an adjustable and/or exchangeable nozzle is provided in the channel inlet (914) of the mouthpiece (900); which nozzle serves to set a defined flow characteristic in the inhaler.

21. Inhaler according to Claim 1, characterized in that a) grip contours (951) are provided on the protective cap (950) and b) stop means engaging in the housing (100,150) are provided, which means can be unlocked by pressing the protective cap (950) in the area of the grip contours (951) and c) the protective cap (950) provided with side arms (960) can only be swung downwards after it has been pulled out fully, as a result of which the patient is by necessity led to place the inhaler in the correct position and d) grip contours are provided on the housing (100,150).

22. Inhaler according to Claim 21, characterized in that means (125;971,972) are provided on the one hand on a lower part (100) of the housing or on an upper part (150) of the housing, and on the other hand on the side arms (960) of the protective cap (950), in order to define a pushed-in and a swung-down final position of the protective cap (950).

23. Inhaler according to Claim 1, characterized in that means (140,970) are provided which prohibit the inhaler being closed by pushing back the protective cap (950) when the mouthpiece (900) is not fitted.

24. Inhaler according to Claim 23, characterized in that a) at least one blocking hook (140) is arranged in the inhaler which defines a swung-down position of the protective cap (950) when the mouthpiece (900) is missing;
and b) the blocking hook (140) is locked again on insertion of the mouthpiece (900).

25. Inhaler according to Claim 1 comprising a) a valve guide (850) having a bottom (854) that is perforated with a plurality of holes (855); while b) as a complement to the holes (855), said valve shield (800) has a bottom (812) that has stubs (813) directed outwards and engaging with a positive fit in the holes (855).

26. Inhaler according to any one of Claims 1 to 25, characterized in that in order to set the flow rate of the air which flows through the inhaler and is to be inhaled, an insert for receiving an optional nozzle is provided a) inside the mouthpiece (900), at a channel inlet (914) to an atomizer path (924) or b) upstream of the mouthpiece (900).

27. Inhaler according to Claim 25, characterized in that in order to specifically change the flow resistance in the inhaler during an inhalation, which flow resistance is obtained by the air gap between the fixed valve guide (850) and an outwardly travelling capsule (810) of the valve shield (800), this air gap effective at the respective position of the valve shield (800) is configured incrementally by means of physical irregularities on the surface of the capsule (810) and/or in the inside of the valve guide (850).

28. Inhaler according to any one of Claims 1 to 27, characterized in that a) the inhalations and their flow parameters in the inhaler can be recorded by means of sensor technology and b) the measure values are processed in IPC logic and c) a nozzle which can be adjusted via an electronic movement element is provided in the mouthpiece (900) or upstream of the latter and d) by controlling the nozzle, the flow in the inhaler can be regulated.

29. Inhaler according to Claim 28, characterized in that a) a dynamo and an accumulator are integrated in the inhaler and b) an electric current is generated when the protective cap (950) is pulled off, or is generated by the flow of air during the inhalations, which electric current, fed to the accumulator, can be used for the current supply of the electronic components in the inhaler.

30. Inhaler according to one of Claims 28 and 29, characterized in that a) the electronic components are arranged in a programmable plug-in module which can be fitted into the inhaler and b) an integrated memory chip for storing and setting the inhalation-relevant data is provided therein and c) the plug-in module is supplied from the accumulator or can be charged externally.

31. Inhaler according to Claim 1, characterized in that a) the flow parameters arising in the inhaler during inhalation can be measured by means of sensor technology and b) the measured values are processed in IPC logic and c) a nozzle which can be adjusted via an electronic movement element is provided in the mouthpiece (900) or upstream of the latter and d) by controlling the nozzle, the flow in the inhaler can be regulated.

32. Inhaler according to Claim 31, characterized in that a) a dynamo and an accumulator are integrated in the inhaler and b) an electric current is generated when the protective cap (950) is pulled off, or is generated by the flow of air during the inhalations, which electric current, fed to the accumulator, can be used for the current supply of the electronic components in the inhaler.

33. Inhaler according to Claim 32, characterized in that a) the electronic components are arranged in a programmable plug-in module which can be fitted into the inhaler and b) an integrated memory chip for storing the inhalation-relevant data is provided therein and c) the plug-in module is supplied from the integrated accumulator or can be charged externally.

34. Inhaler according to Claim 1, characterized in that a) the dosing cavity (302) is an opening passing through the dosing slide (300);
b) a slide rail (200) lying underneath of the dosing slide (300) is provided which slide rail (200) extends so far that the dosing cavity (302) is closed from below if the dosing cavity (302) is positioned under the funnel outlet (608);
and c) the shutter (400) has a closure part (401) which closes the dosing cavity (302) pushed into the shutter (400) upwards and downwards.