DE10300984A1 - Capsule for taking up an active ingredient that can be administered by inhalation - Google Patents

Abstract

The invention relates to a novel capsule for receiving an active ingredient that can be administered by inhalation, which is preferably intended for use in a powder inhaler operating according to the Bernoulli principle.

Description

The invention relates to a novel Capsule for taking an active ingredient that can be administered by inhalation, which preferred for use in a Bernoulli principle Powder inhaler is intended.

The literature knows several Powder inhalers based on the Bernoulli principle. They all have in common that the active ingredient to be applied is in a mostly cylindrical Capsule is stored and this capsule is inserted into a capsule chamber of the inhaler becomes.

A suitable powder inhaler is available essentially from a preferably cylindrical capsule chamber, with means for opening the side Capsule is provided, an air inlet opening in the capsule chamber, and an air outlet opening and one, the air outlet downstream mouthpiece. The capsule chamber is often also preferably cylindrical, being a little longer and is slightly wider than the capsule, so the capsule in it can vibrate both vertically and horizontally, but in doing so remains aligned substantially parallel to the chamber axis. The Capsule chamber has an air inlet in the area of one of the two ends and an air outlet opening in the area of the other end. The air outlet leads able to conduct a powder aerosol, to a mouthpiece. To dispense the active capsule content, you can first use the Capsule usually on two Places on the long side Coat opened become. The openings are usually located near the two longitudinal Ends of the capsule. Now there is an air flow from the air inlet in the capsule chamber generated to the air outlet, leads this along the longitudinal axis the capsule and does two things: First, the capsule through the air flow mainly along its long axis emotional. It can also vibrate to a small extent. Secondly, generated at the two capsule openings flowing along Air in front of the capsule openings across from the inside of the capsule, so that the inside of the capsule Powder is entrained by the air flow and atomized in the process.

The DE 3345722 discloses such an inhaler comprising two housing elements with a single capsule chamber that are movable relative to one another in the radial direction.

WO 91/02558 discloses another entry described inhaler, but instead of a single capsule chamber several capsule chambers similar are summarized like a revolver magazine. The open pages of this magazine are through walls limited, with only at one point in these walls the Air inlet or air outlet is located. This magazine is rotatable stored so that a capsule chamber is only in a certain position with the air inlet, the air outlet and the ones for opening the Capsule necessary cutting elements is connected.

The EP 0911047 discloses an inhaler with a) upwardly open, cup-shaped lower part, b) a plate which covers the opening of the lower part and is formed perpendicular to the one capsule chamber, wherein a button movable against a spring is provided on the capsule chamber, the two has ground needles for opening the capsule, c) an upper part with a mouth tube, which can conduct a powder aerosol, is connected to the capsule chamber and d) a lid. The elements a), b) c) and d) are connected to one another by a common hinge element, so that they can be moved against one another in a foldable manner.

In addition, this patent application describes one Capsule holder, the capsule holder being designed as a hole in the plate b) can be and has ribs on the edge. The capsule is in this Capsule holder clamped for the purpose of storage.

The capsules usually used for such inhalers consist of hard gelatin, but they can also consist of a plastic material. In this context, the EP 1100474 directed.

The capsules known from the prior art consist of two cup-like parts which can be telescopically inserted into one another, the capsule cap and the capsule body. The outer shape of such an assembled capsule is that of a closed cylinder with hemispherical ends. The cylinder has a longitudinal axis and a transverse axis. The longitudinal axis is the axis that lies parallel to the generatrix of the cylinder jacket. The longitudinal axis is longer than the transverse axis, so that the longitudinal section of the capsule is oval and the cross section is circular. Some of the capsules have a circumferential gap at the interface between the capsule cap and the capsule body, which arises from the fact that the capsule cap always has a slightly larger outer diameter than the capsule body. In this regard, is on EP 1100474 or refer to PCT / EP0207481. If, for example, cross-sectional drawings of the two capsule parts are placed on top of one another, it can be seen that the two outer contours are not congruent.

Description of the invention

Surprisingly, it has now been found that the capsules known from the prior art vibrate differently as a function of their position in the inhaler when there is an inflow of air, and the minimum air flow rate for generating the capsule vibration depends on whether the capsule surface is otherwise the same. or lower part is located in the direction of the inflow opening. However, such an uncertainty effect is undesirable.

It is therefore an object of the present invention Disposable capsules as a drug reservoir for powder inhalers, especially Creating powder inhalers that take advantage of the Bernoulli effect, which are independent from the positioning, behave the same.

Another object of the invention consists in changing the known capsules in such a way that the active ingredient application independently is from the top-bottom orientation of the capsule in the capsule chamber.

Another aspect of the present Invention is such capsules in Bernoulli powder inhalers use.

Detailed description the invention

The disposable capsules according to the invention have a Along- and a transverse axis, the longitudinal axis being longer than the transverse axis, i.e. the length ratio of the longitudinal axis to the transverse axis, the elongation is greater than 1. According to the invention, the outer contour regarding the capsule one the longitudinal axis of the capsule-dividing mirror plane Sigma h is designed with mirror symmetry. The longitudinal axis is thus perpendicular to the mirror plane Sigma h. This mirror symmetry does not refer to the inner contour of the capsule.

Because of the symmetry Inflow and vibration conditions independently from the direction of entry of the capsules into the inhaler. Both show the same flow behavior above the air inlet opening.

Within the scope of the present invention does not become an abstract under the term "mirror symmetry" or idealized mathematical operation understood, but the transfer this mathematical concept to the physically and technically sensible Possible. As a consequence, the Term "mirror symmetry" tolerances and blurring, which e.g. result from manufacturing reasons.

The term "blur" is understood to mean to what extent an element X that is on one side of the mirror plane the capsule surface is formed identically on the opposite side of the mirror plane is shown on the capsule. The smallest measurable size, on which mirror symmetry is to be used is 0.15 mm, preferably 0.1 mm, stronger preferably 0.05 mm. For example, the capsule surface has point-like projections, a pair of (two) projections is said to be still mirror-symmetrical apply if the one projection has a diameter of 1 mm, the others (mirror-symmetrical) have a diameter of 0.85 mm. In this case is the blur in the sense of the present invention 0.15 mm. Etc.

The term "tolerance" should be understood as a location. The tolerances are preferably 0 to 0.15 mm, preferably 0 up to 0.1 mm, stronger preferably 0 to 0.05 mm.

As an example of the term tolerance should again serve a capsule with a pair of (two) - in this Sense - mirror symmetric Projections. Is there a protrusion on longitude 0 (analogous to earth surveying) then its mirror-symmetrical counterpart may be on the other side the mirror plane up to 0.15 mm from the longitudinal edge, to be mirror-symmetrical to apply. In this case is the tolerance 0.15 mm.

This allows two to form a pair of mirrors Features on the capsule surface a tolerance and uncertainty of deviating from the symmetry each have 0.15 mm, preferably 0.1 mm, more preferably 0.05 mm.

Another tolerance and blur zone can be advertised above and below the mirror plane. This zone can have a width of above and below the mirror plane up to 2.5 mm, preferably up to 1.25 mm. In it you can Find elements, facilities etc. that are not mirror-symmetrical Pendant or no mirror-symmetrically identical pendant on the opposite Side of the mirror plane. That there is a zone of up to 5 mm (2.5 mm above plus 2.5 mm below the mirror plane), the is exempt from mirror symmetry. The background is that In this zone, the interface is preferred for two-part capsules between the two capsule parts, e.g. a weld that naturally not can be made strictly mirror-symmetrical. In that sense can the interface between the individual capsule elements of the Mirror symmetry in the narrowest sense with the tolerances mentioned above also be exempted.

Also from the mirror symmetry one is possible Fine structure of the interface, e.g. the fine structure of a weld. A such a seam is said to be approximate are considered as a line, the height of which corresponds to the height of the weld seam.

Also preferred are on or on the capsule surface trained elements smaller than 0.1 mm, preferably smaller than 50 Micrometers very particularly preferably less than 10 micrometers and the strongest preferably less than 1 micrometer excluded from the mirror symmetry.

Within the scope of the present invention are also features in fractal dimensions regarding the Consideration of symmetry not taken into account.

The capsule consists of at least two sub-elements which are telescopically pushed into one another. In a preferred embodiment there there are exactly two sub-elements, each of these capsule parts representing a cavity with three closed and one open side. The two sub-elements are connected to each other via the open sides. This opening is preferably perpendicular to the longitudinal axis. In this case, the two sub-elements are a capsule body and a capsule cap. The capsules are preferably of a cylinder-like shape.

The sub-elements can by suitable joining processes after the filling process be connected to each other. For this, e.g. Gluing, banding, Shrink fit, friction, laser or ultrasonic welding.

Alternatively or in addition can they Partial elements also by means of clips or snap-in devices get connected. In such an embodiment are located on the inner jacket of the sub-element, which over one of the other sub-elements is pushed, one or more locking means and on the outer jacket of the other, complementary Sub-element corresponding complementary locking means, which are arranged so that they are closing the capsule snap together. Such locking means can be similar to that Push-button principle working protrusions and recesses, which are punctiform and / or the periphery can be formed in a ring shape all around. Prefers are arrangements in which the protrusions or depressions each annular or spiral are arranged around the jacket.

In one embodiment, are on the inner jacket the cap and the outer jacket of the body one or more ring-shaped circumferential projections formed such that when the capsule is closed in each case a projection of the one partial element in a depression of the other sub-element.

In the embodiments with said annular depressions and / or protrusions can this throughout or be interrupted.

The projections and / or are preferred Wells designed so that they are not visible on the outside.

According to the invention, capsules are made up of two sub-elements prefers. In such cases the seam can be parallel to the longitudinal axis or perpendicular to it be trained. Embodiments with vertical are preferred to the longitudinal axis circumferential interface.

In this case, the interface the longitudinal axis between the sub-elements cut in half or at a point away from the center his.

In the case of two sub-elements the seam with respect to the longitudinal axis preferably in the middle or offset from the center by 0 to 12% of the outer length, preferably from the center around 0 to 10% of the outer length, more preferred offset from the center by 0 to 5% of the outer length. In one of the most preferred embodiments the seam lies in the middle or from the middle up to a maximum 3% of the outer length offset. The strongest the interface preferably lies in the mirror plane.

In such a case, along two the longitudinal axis the elements can be pushed into each other by a any joining process such as. Gluing, banding, shrinking, rubbing, laser, or ultrasonic welding be closed.

In embodiments in which the Interface is not in the middle, it can be closed so that the outer jacket at this point is smooth and the joining process, the mirror symmetry the capsule doesn't bother. Otherwise, the provisions on mirror symmetry and tolerances or blurring application.

The closed capsules according to the invention can her outer coat Have surveys. These elevations can serve as spacers when the capsule is placed in the capsule chamber of the inhaler.

The height of the surveys (i.e. the Distance from base to vertex) is preferably 0.1 mm to 5 mm, stronger preferably 0.5 mm to 2 mm.

The surveys can e.g. as ribs with abrupt edges, with soft, wavy transitions or as pins his. Combinations of these are also possible.

The tips or ridges (edges) of this In the most preferred case, elevations have a minimal surface.

In the case of ribs, these can axial (= vertical), i.e. parallel to the longitudinal axis of the capsule in the chamber, horizontal, i.e. perpendicular to the longitudinal axis of the Capsule or skew to the longitudinal axis the capsule. The term "skewed" also includes spirally arranged Ribs. This type of ribs is then also mirror-symmetrical to the plane of symmetry designed.

If the ribs are arranged axially, expediently shows the capsule at least three or more such ribs. It preferably points no more than nine, stronger preferably no more than six such ribs. The length of the Ribs is chosen so that the capsule moves axially in the capsule chamber to lead without this movement being blocked. Preferably extend the ribs over the total amount of Capsule on its outer jacket which is not curved with respect to the longitudinal axis. In this case, the ribs preferably have a triangular cross section, with a tip of the triangle away from the capsule surface has. This embodiment has the advantage that the capsule in the capsule chamber at its axial Movement without great Friction losses led can be. Other geometrical configurations of the ribs are also possible, such as. Ribs with semicircular, rectangular cross section etc.

To pinch the capsule in the axial To prevent arranged ribs, it can be advantageous if the distance between two adjacent pairs of ribs is different (non-equidistant arrangement of the ribs). In this case, the cross-sectional arrangement is asymmetrical.

Are the ribs horizontal (= vertical to the longitudinal axis) arranged, at least two ribs are preferred. In cross section they preferably have smooth transitions, i.e. it is a wave-like surface. But you can also angular etc. be trained. Has a design form with undulating transitions the advantage that the distance between the capsule and the capsule chamber along the longitudinal axis keeps changing. flows Air through such an empty space with a changing cross-section can the Bernoulli effect intensifies and so the emptying of the capsule can be promoted.

Another embodiment of the capsule has an outer surface with a horizontal waveform as just described, whereby on this surface axial, i.e. Ribs are formed perpendicular to the shafts. there these are in turn designed so that the outer edges of the ribs are equidistant to the central longitudinal axis are the capsule, the outer edges the ribs are not wavy Surface, but one (parallel to the longitudinal axis) non-curved surface have.

In the case of pin-shaped elevations can this either be arranged linearly and possibly the ribs replace, or their arrangement is arbitrary. The pens are on in any case aligned so that the axial movement of the capsule is not disturbed can, but the capsule is guided in this movement.

In all of these embodiments however, the bumps are mirror-symmetrical on the outer surface of the Capsule formed, based on the mirror plane defined above is placed.

A preferred capsule, however, has a macroscopically smooth outer surface, i.e. there are no surveys. Under the term “macroscopic smooth "are understood surfaces, which have elevations and depressions of at most 0.5 mm, preferred up to 0.1 mm, stronger preferably up to 0.05 mm.

The capsule according to the invention can in cross section circular, be oval or n-angular with n = 3, 4, 5, 6, 7, 8, 9, 10 or more, preferably 3 to 10. The cross section preferably has a round or oval shape.

In the preferred case it is around a two-part, telescopically pluggable capsule a capsule cap and a capsule body that closed one Cylinder with tapered Ends, preferably hemispherical Ends. The cylinder has a longitudinal axis and a transverse axis on. The longitudinal axis is the axis that is parallel to the generatrix of the cylinder jacket lies. The longitudinal axis is longer than the transverse axis, so the longitudinal cut the capsule is oval, the cross section is circular having.

Such a cylinder preferably has Coming from the center always a constant external cross-section until it tapers steadily, to form the rounded ends.

Such a cylinder has one in parallel to the longitudinal axis unbent Coat.

The cylinder can also be a concave outward, i.e. jacket bent away from the central axis (= longitudinal axis) to have. Such a concave coat comes about, for example, if the outside diameter each of the two capsule parts becomes larger from the tapered end.

In an alternative, less preferred embodiment is the outer contour of the jacket is concavely curved.

Finally, the outer jacket of each of the two capsule parts also coming from the tapered end, initially as Run straight, which is parallel to the longitudinal axis, before it slight curvature accomplished away from the central axis, to then continue as a straight line, but now in one Angle alpha to the central axis is until it finally has reached the open end of the capsule part. In this case, the is similar outer contour the assembled capsule of the concave outer contour described above.

The capsule body - or alternatively the capsule cap - can be attached the inside of its open end is parallel to the inner jacket have circumferential edge that over the edge of the outer jacket protrudes and which can be inserted into the capsule cap and thereby the two elements (capsule cap and capsule body) together combines. This creates a parallel on the inside of the jacket for opening lying, all-round edge, on which the capsule cap is then attached becomes. In other words, the inner shell of this capsule part is pulled higher as the outer jacket, so that at the point of closure between the capsule cap and the capsule body The other capsule part is created on the stage when closed seated.

Such a cylinder-like embodiment of the capsule with a macroscopically smooth outer surface can ideally be assigned to the symmetry group D _∞h with regard to the symmetry properties of the outer surface. In this case, idealized means that deviations due to production technology are not taken into account and that the tolerances and uncertainties as defined above are also used here.

Bodies are assigned to this symmetry group with a vertical two-fold axis of rotation (= longitudinal axis), an infinite number of two-fold axes of rotation perpendicular to it and one that is perpendicular to the longitudinal axis, ie horizontal Mirror plane. Capsules are preferred according to the invention, the outer contour of which can be ideally assigned to this symmetry group in the sense defined above.

The total length of the closed capsule is preferred 26.1 +0.3 mm; 23.3 +0.3 mm; 24.2 ± 0.3 mm; 21.7 ± 0.3 mm; 19.4 ± 0.3 mm; 18.0 ± 0.3 mm; 15.9 ± 0.3 mm; 14.3 ± 0.3 mm; 11.1 ± 0.3 mm.

The outer diameter of the capsule body and the capsule cap from the outside visible area of the closed capsule is preferably: 9.91 mm; 8.53 mm; 7.66 mm; 7.64 mm; 6.91 mm; 6.35 mm; 5.83 mm; 5.32 mm; 4.91 mm.

The dimensions of the capsule according to the invention becomes the standard Based on capsules of so-called size 3, as it is known at least in Germany. With the described telescopic capsules is the outer diameter preferably between 5.57 and 5.83 mm.

The capsules should preferably be used in powder inhalers, for example of the type described at the beginning in the prior art section. The inhalers of the DE 3345722 , WO 91/02558 or the EP 0911047 , These inhalers are inhalers that work on the Bernoulli principle (Bernoulli inhalers). These inhalers have a capsule chamber, the cross section of which is 1.1 to 2.5 times as large as the capsule diameter and whose length is 1.02 to 2 times as long as the length of the capsule.

The capsule chamber has at least two openings on, an access for incoming Air and an air outlet. The air inlet has a smaller cross section than the capsule chamber, so in this area the capsule chamber a relatively high flow rate occurs, which enhances the Bernoulli effect by which the powder in the capsule is ultimately deployed. The air inlet opening will expediently centrally located in the bottom of the chamber.

There can be one on the air outlet side Screen plate or other device such as projecting components, be formed, which prevents a moving in the capsule chamber Slip the capsule into the air outlet and block it or that any resulting capsule fragments are sucked into the mouthpiece become.

The sieve plate can e.g. part one funnel-shaped connector be on the beginning of the inhalation channel leading to the mouthpiece it can be attached that the funnel edge with the sieve plate in one Insert plate engages, which forms the bottom of the mouthpiece. The sieve plate can also be clamped between the funnel edge of the connector and a stop of the insert plate can be exchangeably attached.

There can also be multiple openings as an outlet opening be provided. The one for the outflow is the cross section available from the air from the capsule chamber expediently larger than everywhere the air inlet opening, so that the air loaded with the medicine can flow out as freely as possible. The air outlet will be convenient centrally located in the ceiling of the chamber, but can also be placed on the side of which can be arranged in the ceiling area.

By arranging the two openings should an axial air flow, i.e. vertically, through the capsule chamber.

The capsule chamber instructs at least a point along its long axis (related to the interior of the capsule chamber) an opening for or Connection with a) cutting device with at least two pointed needles or cutting is provided to make one in the Prick or cut open capsule chamber. This cutting device can against the pressure of a spring into the interior of the chamber can be moved and can over a spring-loaded control button to be served.

Because the height of the capsule chamber depends on the length of the Drug capsules are intended, the tips or cutting edges the cutting device preferably in the area of the upper and lower End of the capsule chamber arranged. The side wall of the capsule chamber can face the needles / cutting edges in the area of their upper and lower ends radial bores or elongated Have slits for the implementations serve the needles / cutting. The dimension of these holes / slots is modeled on the cross section of the needles or cutting edges.

In a preferred embodiment shows leadership the needles of the cutting device on a sealing plate. On this way the seal between the in inhalation position located capsule chamber and the cutting device improved. For the spring bearing of the sealing plate the spring can be used which is the reset the actuation button the cutting device.

Finally, another one embodiment a lever system for the actuation the cutting device provided. This lever system is preferred from one attached to the bottom or side of the housing of the inhaler actuating button confirmed from. The lever system can consist of a rocker and a toggle lever, the actuating button acts on one end of the rocker, and the other end of the rocker presses on one end of the toggle lever, whereby the other end of the toggle lever attached to the cutter Cutting device advances. Rocker and toggle are preferred pivoted about axes in brackets that are attached to the housing.

The capsule should be opened near its two ends for inhalation. The hemispherical caps of the capsule should not to be damaged. This is important because the capsule or capsule cap performs a kind of valve function. Due to the pressure conditions, the capsule is drawn against the inflowing air to the inlet opening and closes it. Since the user continues to suck on the mouthpiece, a negative pressure is created in the capsule chamber, by means of which the capsule is entrained with the inflowing air in the direction of the air outlet. The negative pressure now developing at the air inlet causes the capsule to be pulled towards the inlet opening again. The whole process repeats itself in rapid succession as long as the mouthpiece is inhaling and sets the capsule in strong axial vibration.

The one with a capsule according to the invention stocked Powder inhalers, which in the simplest case consist of a capsule chamber, an air inlet, one air outlet, which are connected to a mouthpiece and there is a device for piercing the capsules also subject of the present invention.

It is included in the chamber air mixed with the drug as a powder aerosol through the mouthpiece to the mouth of the user. The mouthpiece, which is generally tubular, optionally something is flattened, axially or at an angle to the axis the chamber arranged or laterally offset to the axis of the chamber.

The mouthpiece of the inhaler can be used as Cap be formed, which is placed on a lower part of the inhaler which contains the capsule chamber. This cap can be placed on the edge of the inhaler housing around a perpendicular to the longitudinal axis of the inhaler horizontal axis be pivoted. Mouthpiece and lower part of the inhaler housing can also through a usual Be plugged together. Due to the solubility or pivoting of the two parts is in any case access overall, on the one hand to the capsule chamber and the cutting device in the lower part of the housing and on the other hand to the internal parts, such as the sieve plate, of the upper part of the housing (the mouthpiece-like Cap) considerably simplified.

To exchange the used capsules for In such an embodiment, the mouthpiece is flipped up fresh or the plug connection between the mouthpiece and the lower housing part is released. The Capsule chamber is then freely accessible, so that the emptied capsule is removed and a filled one is inserted can be. The device is then closed or put together.

The inhaler according to the invention enables the devices known from the prior art a more reliable Application of the drug with lower standard deviation.

Preferred inhalers are those as initially described as embodiments of the DE 3345722 , WO 91/02558 or the EP 0911047 have been described. At this point, the features mentioned in this section are expressly referred to again. The inhaler as described above in connection with the EP 0911047 has been described.

In such inhalers there is only a single capsule chamber for receiving the capsule according to the invention, analogous to the explanations for DE 3345722 or EP 0911047 ,

Other inhalers have a revolver magazine with several, mostly tubular chambers, each with one capsule on. The magazine has one on each of its two open sides Plate covered, one plate covering the air inlet opening and axially, the other plate contains the air outlet opening. Because the magazine within this Plates are rotatably mounted, one of the chambers can between each the two openings be swung in and thus part of the inhalation air passage form. After the end of an inhalation process, the revolver magazine continued to rotate until the next one Chamber comes into the air passage. Here, e.g. one of the two plates are separated from the magazine to the used ones Capsules can be taken out of the chambers or the whole magazine can e.g. to fill up be taken out.

In such a training this Inhalers the revolver magazine is detachably arranged in the inhaler housing. After the capsules in the revolver magazine have been used, you can the complete revolver magazine replaced or new with capsules filled become.

The inhaler housing can be eccentric have arranged pin on which the revolver magazine can be attached is.

To fix the position of the revolver magazine you can do it with the capsule chambers each assigned recesses for one in the inhaler housing Arranged spring-loaded locking bolt provided. The recesses are arranged so that the locking bolt only clicks into place if one of the capsule chambers is exactly between the air inlet and outlet located.

This can ensure that the revolver magazine during the inhalation does not shift. The resilient mounting of the locking bolt should be chosen with regard to the spring constants so that an accidental Rotation of the revolver magazine prevented by the locking, on the other hand with stronger The revolver magazine can be unscrewed from the lock can. Conical designs of the free end of the locking bolt and correspondingly shaped recesses support this.

The locking bolt is preferably arranged coaxially to the air passage channel under the capsule chamber and has a through hole which simultaneously forms the air inlet on the bottom. The locking bolt is preferably arranged centrally in the inhaler housing. After another Embodiment of the invention, the locking bolt is acted upon by a spring, the other end of which rests on a stopper which is detachably fastened in the inhaler housing and which likewise has a central through-hole which is part of the air passage.

In a preferred embodiment are the recesses for the engagement of the locking bolt on the bottom in the base plate of the magazine concentric to the air inlet holes of the capsule chambers arranged and like the coat one with the base facing outwards flat truncated cone. So these recesses are involved around conical or funnel-shaped Extensions to the air inlet holes, the extended area is facing the locking bolt. The resulting from enlargement Bevel roughly the bevels on the head of the locking bolt.

In a preferred embodiment have these recesses at the base of the truncated cone, however still in the base plate, a peripheral stop edge on the as an anti-twist device or stop for the head of the locking bolt serves when it is snapped into the recess. Due to the Said stop edge can therefore be seen with the locking bolt engaged stop turning the magazine.

In another embodiment of this embodiment takes the said stop edge only a part or half of the Circumference of the conical recess, that is, the funnel-shaped extension and is arranged so that it turns the magazine when it is locked Locking bolt locks in one direction, in the other direction but allows because there the weird Wall of the funnel-shaped extension the recess smoothly into the outside of the Base plate merges.

In a further preferred embodiment only one of the recesses has the entire circumference of the recess engaging stop edge, so that in this recess when engaged Locking pin a rotation of the magazine is not possible. Considered this position one then as the end position of a magazine in which all capsules are consumed are. All other recesses point in this embodiment only the one-sided, i.e. one-way anti-rotation lock on, so that the magazine only ever swings in the direction a capsule chamber with an unused capsule until the previously described end position is reached, in which the Lock completely is. The user then knows that the magazine should be filled with fresh capsules when the last one Capsule is used up.

In a further preferred embodiment a tongue can be attached to the locking bolt, which extends up to a stop on the inside of the operating button of the cutting device extends when the locking bolt with the revolver magazine removed occupies its upper stop position. The said tongue works in this position as a lock on the cutting device. When the magazine is inserted, the locking pin pressed down again and thus eliminates the lock of the cutter.

Confirmation of the cutter can can also be coupled with the rotary movement of the capsule magazine, so that with a push of a button, first a capsule chamber into the right one Positioned and then immediately the cutting device attacks.

Will the revolver magazine and the to this adjacent part of the inhaler housing, n-shaped, where n is an integer indicating the number of capsule compartments is, so you leave advantageous the side surfaces of the inhaler housing part and the revolver magazine if the magazine is in the correct one Position is. One can then determine immediately from the outside whether the chamber in the air duct defined by the air inlet and the air outlet lies.

The following is intended to illustrate the invention of drawings closer to be discribed.

1 shows a closed capsule known from the prior art.

2 shows an inhaler in which the capsule according to the invention can be used.

3a to d show a powder inhaler with a revolver magazine in which the capsule according to the invention can be used.

4 shows a powder inhaler with an upper and lower part movable against each other.

The 6 to 13 show different embodiments of the capsule according to the invention.

1 shows a capsule known from the prior art ( 1 ), consisting of a capsule cap ( 2 ) and a capsule body ( 3 ). It can be seen that the outer diameter of the capsule body is smaller than that of the capsule cap over wide areas. This is particularly evident in the region of the down-to-earth hemispherical end of the capsule body.

Out 2 it can be seen how an inhaler can be constructed, in which a capsule chamber according to the invention is integrated. In a lower part ( 5 ) with optional two windows ( 6 ) there is a plate ( 7 ) with the capsule chamber ( 4 ) connected is. To open the capsules in the capsule chamber ( 4 ) is the button with two specially ground needles ( 8th ) against the pressure of the spring ( 9 ) is pressed in, thereby cutting or pricking open the capsule in the chamber at two points. When inhaling through the device using the leadpipe ( 10 ) that with the top ( 11 ) is connected, the air gets into the lower part ( 5 ) and from there at the bottom into the capsule chamber ( 4 ). The device is covered by a cover ( 12 ) closed, the foldable with the lower part ( 5 ), the plate ( 7 ) and the top ( 11 ) is connected, so that dust is closed when the lid is closed cannot penetrate the device. In the plate ( 7 ) there may be optional blind hole-like capsule holders. A sieve plate ( 34 ), which at the lower end of the leadpipe ( 10 ) or the inhalation channel leading to the opening of the mouthpiece and, when the inhaler is closed, the air outlet opening of the capsule chamber ( 4 ) covered. Optional snap hooks on the plate (not shown) 7 ) oriented side of the leadpipe ( 10 ) or the upper part ( 11 ) in the plate ( 7 ) can snap into place. In this case, the plate ( 7 ) correspondingly complementary facilities (recesses or holes). On the plate ( 7 ) projections or snap hooks can also be formed on the side so that the plate ( 7 ) in the lower part ( 5 ) can snap into place. The mentioned devices for locking the mouthpiece ( 10 ) or the upper part ( 11 ) in the plate ( 7 ) or that of the plate ( 7 ) in the lower part ( 5 ) are such that individual elements can easily be separated again. Furthermore, at the location of the cover ( 12 ) above the button when closed ( 8th ), a nose should be designed so that it fits into a recess on the top of the button ( 8th ) engages and the button ( 8th ) blocked so that the button ( 8th ) cannot be pressed when closed. This prevents the capsule from being accidentally punctured if the capsule is inserted prematurely.

3 : Like from 3a . 3b and 3c can be seen, an inhaler with revolver magazine essentially consists of an inhaler housing ( 5 ) with a mouthpiece ( 10 ) on the side of the upper edge of the inhaler housing ( 11 ) around an axis ( 13 ) is pivotally articulated and a revolver magazine ( 14 ) with the capsule chambers ( 4 ) to hold the capsules. The revolver magazine ( 14 ) is eccentric in the inhaler housing ( 5 ) arranged pin ( 15 ) attachable. After attaching the revolver magazine ( 14 ) the mouthpiece ( 10 ) brought into its normal position - as a cap on the housing; the inhaler is functional. A capsule (not shown) can now be 8th ) can be opened. How out 3c visible, the revolver magazine ( 14 ) in this case 6 chambers ( 4 ) to accommodate the capsules, not shown. The bottom of each chamber ( 4 ) has an air inlet hole ( 16 ) on. Furthermore, the revolver magazine ( 14 ) an axial guide ( 17 ) for the pen ( 15 ).

How out 3d visible, the inhaler is adjacent to the one below the inhalation channel ( 18 ) arranged chamber ( 4 ) the cutting device ( 19 ) over the button ( 8th ) is to be operated. This cutting device ( 19 ) has two needles ( 20 ) in the upper or lower part of said chamber ( 4 ) can be inserted radially, the revolver magazine outer wall for easier passage of the needles ( 20 ) breakthroughs or weakened areas at appropriate points ( 21 ) having. The needles ( 20 ) are used to open the in the chamber ( 4 ) capsule located near its upper or lower end. The revolver magazine ( 14 ) also has below the holes ( 22 ) conical recesses ( 23 ) into which a locking bolt ( 24 ) can snap in as soon as the corresponding one of the chambers ( 4 ) coaxial with the air inlet or inhalation channel ( 18 ) of the inhaler housing. The anulating bolt is on its in the recess ( 23 ) engaging end also conical. At the opposite end it is held by a spring ( 26 ) acted on, which is releasably fastened in the inhaler housing ( 27 ) supports. Like the locking bolt, this plug has a central through-hole that acts as an air inlet ( 25 ) serves.

To prepare the inhaler, with the revolver magazine inserted ( 14 ) one of the chambers ( 4 ) by rotating the revolver magazine into a position in which the bottom hole ( 22 ) or the conical recess ( 23 ) coaxial to the air inlet opening ( 25 ) is aligned. The setting of the chamber ( 4 ) is snapped in by the locking bolt ( 24 ) in the recess ( 23 ) facilitated. After the bolt has snapped in, the air inlet opening is aligned ( 25 ) and the bottom opening ( 22 ) the chamber ( 4 ). The capsule cap stands on the bottom opening ( 22 ) and closes it. By pressing the button ( 18 ) against the force of a spring ( 9 ) the cutting edges ( 20 ) radially towards the chamber ( 4 ) moves, first of all the weakened areas ( 21 ) pierce or enter suitable openings in the side wall of the revolver magazine and finally open the capsule at the top and bottom near its end. The tapered caps of the capsules should not be destroyed because they should have a kind of valve function.

If air is now passed through the mouthpiece ( 10 ) is sucked in, the offset from the bottom openings ( 28 ) of the housing ( 5 ) and the air inlet ( 25 ) into the chamber ( 4 ) Incoming air violently vibrates the capsule, whirls up the powder in the capsule, mixes with it and is finally inhaled. The mouthpiece ( 10 ) is generally tubular, but can also be adapted to the shape of the mouth and flattened. In a modification of the embodiment shown, mouthpiece arrangements which are axial or offset at an angle to the axis of the chamber or laterally to the chamber axis are also possible.

The mouthpiece ( 10 ) with an essentially closed insert plate ( 29 ) be provided. This insert plate ( 29 ) can also have openings. Furthermore, the beginning of the inhalation channel ( 18 ) be covered with a sieve, which prevents the capsule or capsule fragments from inhaling into the inhalation channel ( 18 ) get into the mouthpiece. As an alternative to this, wall projections can be provided at the said location, which retain the capsule. The sieve plate is then preferably in the center of the insert plate ( 29 ) arranged, advantageously in the press fit between a stop encompassing the air passage ( 30 ) the plate ( 29 ) and the edge of a funnel-shaped connecting piece ( 31 ), which at the beginning ( 32 ) of the inhalation channel ( 19 ) is attached so that the funnel edge of the insert plate ( 29 ) faces and engages with it. The alternatively provided projections can also be arranged there.

In the 4 reproduced embodiment of the inhaler according to the invention consists of the lower part ( 5 ) and the mouthpiece ( 10 ) that are put together. The lower part contains the air intake duct ( 25 ) with the air inlet into the capsule chamber ( 4 ) connected is. The cutting device ( 19 ) is supported by a spring element ( 9 ) held in their normal position. The mouthpiece ( 10 ) contains the capsule chamber ( 4 ). Protrusions protrude into the extension of the capsule space ( 33 ) that limit the scope of the capsule. A sieve plate ( 34 ) prevents, for example, fragments of the capsule from being inhaled. The inhaler can be pressed against the pressure of a spring element ( 35 ) are pressed together axially, the upper edge of the lower part being in the position ( 36 ) reached. In this position, the knives or tips ( 20 ) the cutting device ( 19 ) through the opening ( 21 ) in the capsule chamber ( 4 ) penetrate and then open the capsule fixed there.

To use the inhaler after 4 become lower part ( 5 ) and mouthpiece ( 10 ) pulled apart, the capsule inserted and the two parts of the inhaler put together. After squeezing in position ( 36 ) against the spring element ( 35 ) the cutting device ( 19 ) pressed and released again. Under the pressure of the spring element ( 35 ) the inhaler goes back into the 4 shown starting position above. Now by inhaling through the mouthpiece ( 10 ) the active ingredient formulation is inhaled from the capsule, not shown.

The 5 and 6 each show a mirror-symmetrical capsule according to the invention ( 1 ) from a capsule cap ( 2 ) and a capsule body ( 3 ). The capsule body has an inward extension on the inside ( 37 ), which is inserted into the capsule cap.

The 7a to d show different locking techniques with locking means on the capsule cap and the capsule body. Both 7a to 7c the smooth side is the outside. In a variant after the 7d the smooth side can be the inside or the outside of the closed capsule.

The 7c has snap-type latching means, with a projection ( 38 ) on one of the capsule elements and a recess ( 39 ) to snap the projection onto the other capsule element.

The closure variant after 7d has a head start ( 40 ) on.

The 8th shows a variant in which the side wall of the capsule cap ( 2 ) suddenly tapered from the open to the closed end ( 41 ). The capsule body can then only be pushed into the capsule cap until it reaches the taper ( 41 ) strikes. The position of the taper is chosen so that the mirror symmetry of the closed capsule is preserved.

9 shows a variant in which the seam between capsule cap ( 2 ) and capsule body ( 3 ) is not in the mirror plane.

10 shows a variant with a closure 7d ,

11 shows a variant with a seam running parallel to the longitudinal axis.

The 12 shows a variant 11 with a clasp after 7d ,

The 13 shows a variant with a seam running perpendicular to the longitudinal axis, which is banded ( 41 ) is.

Claims (17)

, In the use of a group consisting of at least two parts pharmaceutical capsule having a longitudinal axis and a relative shorter the longitudinal axis transverse axis and which is intended for receiving a administered by inhalation pharmaceutical agent formulation in the form of a powder in a powder inhaler, which operates on the Bernoulli principle characterized that the outer contour of the closed drug capsule is mirror-symmetrical with respect to a transverse plane dividing the longitudinal axis, the following features being excluded from the consideration of symmetry: - optional fine structures of the seams which result from the sealing of the seams of the individual parts of the drug capsule and / or - formed on the capsule surface Elements that are smaller than 0.1 mm, preferably smaller than 50 micrometers, very particularly preferably smaller than 10 micrometers. Use of a pharmaceutical capsule according to claim 1, characterized in that located on the capsule surface and features forming a pair of mirrors differ from the symmetry Tolerance and blurring of 0.15 mm, preferably 0.1 mm, more preferably 0.05 mm. Use of a drug capsule according to one of the previous claims, characterized in that the drug capsule bumps on its outer surface having. Use of a medicament capsule according to one of the preceding claims, characterized ge indicates that the drug capsule has no elevations, but has a macroscopically smooth surface. Use of a drug capsule according to one of the previous claims, characterized in that the drug capsule consists of two telescopic, along the longitudinal axis parts that can be inserted into one another. Use of a drug capsule according to one of the previous claims, characterized in that the drug capsule is cylindrical outer contour having. Use of a drug capsule according to one of the previous claims, characterized in that the drug capsule is tapered closed Has ends. Use of a drug capsule according to one of the previous claims, characterized in that the interface of the two drug capsule parts by 0 to 12% of the outer length of the Center is offset, preferably by 0 to 10% of the outer length, more preferred by 0 to 5% of the outer length and the strongest is preferably formed in the middle. Use of a medicament capsule according to one of the preceding claims, characterized in that the medicament _capsule can be assigned to the D _∞h symmetry group with regard to its outer contour irrespective of the interface between the two medicament _{capsule parts and irrespective of} manufacturing _engineering deviations. Use of a drug capsule according to one of the previous claims, characterized in that the powder inhaler consists of at least two housing parts consists of an upper housing part, which with a mouthpiece is connected and a lower housing part with at least one Drug capsule chamber, the drug capsule chamber (s) an air inlet opening and an air outlet has (have) and the air outlet opening (s) over an aerosol could end Connection with the mouthpiece is (are) connected. Use according to claim 10, characterized in that that the drug capsule chamber has a cross section that Is 1.1 to 2.5 times as large like the drug capsule diameter and a length that is 1.02 to 2 times as much is great like the length the drug capsule. Use according to claim 10 or 11, characterized in that that the powder inhaler has a cutting device that is equipped with at least two pointed needles and / or cutting edges, wherein the needles and / or cutting are inserted through openings into the drug capsule chamber (s) can. Use according to claims 10 to 12, characterized in that that the powder inhaler comprises: a) an open top cup-shaped lower part, b) a plate covering the opening of the lower part covered and perpendicular to the one drug capsule chamber of the type described above is formed on the drug capsule chamber a button movable against a spring is provided, the two ground needles or blades to open the drug capsule has, c) an upper part with a leadpipe containing a powder aerosol able to lead is connected to the drug capsule chamber and d) a lid, the elements a), b) c), and d) by a common hinge element are connected to each other so that they can be folded against each other can be. Use according to claims 10 to 13, characterized in that the powder inhaler contains a magazine from drug capsule chambers. Powder inhaler according to one of claims 10 to 114 with a drug capsule according to any one of claims 1 to 9th Drug capsule when closed a longitudinal axis and one regarding the longitudinal axis shorter Has transverse axis and two telescopically, along the longitudinal axis parts which can be pushed into one another, characterized in that that the outer contour the closed drug capsule with respect to a dividing the longitudinal axis Transverse plane is mirror symmetrical, the following features of the Exceptions to symmetry are: - optional fine structures of the Seams, which by closing the seams of the individual parts the drug capsule is formed and / or - Formed on the capsule surface Elements that are smaller than 0.1 mm, preferably smaller than 50 micrometers are very particularly preferably less than 10 micrometers. Medicament capsule according to claim 16, characterized in that the drug capsule has the characteristics of a drug capsule according to one of the claims 2, 3, 4, 6, 7, 8 or 9.