Method for mixing a first and a second pharmaceutical powder substance and use of a container with two chambers

Abstract

The invention relates to a method for mixing a first and a second pharmaceutical powder substance (S1, S2) in an inhalation device (2), by means of which a pharmaceutical substance is delivered by suction of air, the first and the second substance (S1, S2) being accommodated in a container (1) having two separate chambers (K1, K2), the chambers (K1, K2) also being arranged one behind the other along a longitudinal axis (z) of the container (1), and the first and the second substance (S1, S2) being arranged in the container (1). In a first step, a chamber (K1, K2) of the container (1) is opened by piercing, forming a piercing opening (37), the opening by piercing being carried out on opposite sides with respect to the longitudinal axis (z), and in a further step, the container (1) is rotated about an axis of rotation (u) in a receiving chamber (6) of the inhalation device (2) during the inhalation process, which receiving chamber extends transversely to the longitudinal axis (z), according to the invention, the substance (S1, S2) from each chamber (K1, K2) is discharged radially outward from the container (1), and mixing of the two substances (S1, S2) thus discharged is carried out.

Description

TECHNICAL FIELD

[0001] The invention relates to a method of mixing first and second medicament powder substances in an inhalation device, the medicament substances being delivered by inhalation air through the inhalation device, wherein the first and second substances are contained in a container having two separate chambers, wherein the chambers are arranged successively along a longitudinal axis of the container, and wherein, in a first step, the chambers of the container are opened by piercing, forming piercing openings, wherein the piercing openings are made on opposite sides with respect to the longitudinal axis.

[0002] The invention further relates to the use of a container having two chambers (first chamber or second chamber) filled with first and second medicament powder substances, respectively, in an inhalation device having a piercing needle for piercing each chamber of the container, the first chamber further having a first base, the second chamber having a second base, the container further having a partition separating the first chamber from the second chamber, wherein, further, the partition forms the first and second bases (and the first and second chambers extend from the first and second bases, respectively, in opposite directions along a common longitudinal axis of the container, and form a peripheral wall opposite the bases and a top region, each top region being concavely curved and pierceable for delivering the first and second substances from the container by rotating the container about a rotation axis extending transversely to the longitudinal axis. BACKGROUND

[0003] Containers containing medicament powder substances, in particular in the form of capsule-like containers, are known, the contents of which are in particular for inhalation by using an inhalation device. Such containers are usually provided with an opening just before the inhalation process, through which the substance can come out of the container into a suction flow generated during the inhalation process. Such a suction flow is usually only realized as a result of a deep breath taken by a person using the inhaler.

[0004] For opening the container, the inhalation device has a piercing needle which can be moved by intentional actuation of the user from a basic position into an activated position through the wall of the container. The opening produced in the container is made on opposite sides with respect to the longitudinal axis of the container. Such an inhalation device is known, for example, from EP 1 270 034 B1 (US 7284552 B2).

[0005] Other containers are known which have separate chambers arranged successively in the direction of the longitudinal axis of the container. In this respect, reference is made to WO 2020 / 229852 Al (US 2022 / 0213 685 Al). By arranging two separate chambers in the container, it is possible to accommodate two substances in the container, which are only mixed into an active ingredient mixture by the suction flow during discharge from the container and / or during the inhalation process. SUMMARY

[0006] It is an object of the present invention to provide a method and an application which enable a favorable mixing of two substances by means of an inhalation device which is advantageously designed.

[0007] The problem is solved in the method aspect by the fact that, in a further step, during inhalation of air by the user, the container is rotated about a rotation axis in the inhalation process in the accommodation chamber of the inhalation device, which extends transversely to the longitudinal axis, wherein the substances are expelled radially outward from each chamber from the container and the mixing of the two substances expelled thereby is achieved.

[0008] In the application aspect, the problem is solved by the use of a container having two separate chambers, wherein the chambers are arranged one after the other along the longitudinal axis of the container, wherein each chamber has a top region and each top region is (from the inside) concavely curved, pierceable to dispense the first and second substances from the container by rotating the container about a rotation axis which extends transversely to the longitudinal axis.

[0009] Since a container having two separate chambers is used in this way, in which the first and second substances are accommodated, this advantageously leads - after piercing of each chamber - to the mixing of the two initially separate substances only with the start of the inhalation process, respectively with the start of the inhalation air flow initiated by the user in the inhalation process. Depending on the rotation of the container about the rotation axis (which extends essentially transversely to the longitudinal axis of the container) caused by the user during inhalation of air, the two substances can escape due to the centrifugal forces generated relative to the first or second base. Relative to the partition wall in the direction of the longitudinal axis, the substances enter the openings in the top region of the container or the opposite chamber, respectively. The substances are transported outward into the region of the accommodation chamber which accommodates the container and are expelled together and mixed together for inhalation via the outflow channel, which preferably adjoins the accommodation chamber in the flow direction.

[0010] The substances preferably leave the chambers only due to the forces, in particular centrifugal forces, generated during the rotation of the container. The partition wall or base between the chambers in the container prevents the inhaled air from flowing essentially in the direction of the longitudinal axis through the container.

[0011] The top region can be dome-like (at least when viewed from the inside), whereby, due to constructional means, for example by thinning the material and / or due to the selected material from which the top region is made, a piercing with a device-side piercing needle can be implemented. The dome-like curved top (viewed from the inside) is pierced. The rotational force moves the substance towards the top. Due to the curved design, the substance then moves into the opening created by the piercing. Using the piercing needle, it is also possible to form a piercing opening in the region of the apex of the essentially each concave curved top region or dome-like curved top region, which advantageously leads to a complete emptying of the chamber, so that a complete discharge due to the forces generated during the rotation of the first and second substance can be achieved. The substance enters the suction air flow.

[0012] The inhalation device can essentially be designed as known from the already mentioned EP 1 270 034 B1 (US 7284552 B2).

[0013] In the following, further features are explained, including in the description of the enclosed drawings, generally in their preferred association with the essentially described solution or with further features. However, they can also be associated only with the already described individual features or with the described respective other features, or they can independently have significance.

[0014] The piercing opening of the chamber formed by the piercing can pass through overlapping paths when the container rotates around the rotational axis. This superimposition of the paths can only be given in sections with respect to a complete rotation of 360° of the container around the rotational axis, for example due to a slightly wobbling rotational movement of the container, so that the circumferential paths of the piercing openings can cross each other several times. The overlapping paths of the piercing openings allow the substance emerging from the piercing opening, for example the first substance emerging from the first piercing opening, to be distributed into the circumferential path of another piercing opening which is directed in the direction of rotation, for example the second substance emerging from the second piercing opening. This leads to an effective mixing of the two substances which are already in the region of the accommodation chamber, wherein this mixing can advantageously be supported by the overlapping paths during the discharge process and further by the suction air flow present in the accommodation chamber.

[0015] Due to the rotation of the container, the substance can abut against a circumferential wall of the accommodation chamber which extends essentially transversely to the rotational axis and can be captured thereby. Due to the centrifugal force acting on the substance when it leaves the chamber, the radial exit path of the substance relative to the rotational axis is limited. The substance tends to be deflected by the circumferential wall into a direction which essentially corresponds to the direction of rotation of the container, preferably superimposed with a component which essentially acts in the direction of the rotational axis due to the suction air flow, so that a helical or spiral-like flow of the mixed substance along and around the rotational axis can be generated. The substance which can hit the circumferential wall can also be distributed like a spray in the accommodation chamber by limiting its radial outward exit path, which can lead to a further improved distribution and subsequently to a further improved mixing of the two substances.

[0016] The air inhaled by the user during inhalation can flow substantially around the container, in particular in the region of the accommodation chamber. The flow can be in the circumferential direction of the circumferential wall of the accommodation chamber and possibly also in a plane transverse to the longitudinal axis of the container. The basic flow can be in the circumferential direction, which can mean in a plane transverse to the longitudinal axis. An air vortex can be generated around the container, through which the escaping substance particles mix with one another and are transported for inhalation. In this transport, a further advantageous mixing of the two substances, which were initially separated in the container, can be achieved by the vortex of the suction air flow, so that a largely homogeneous mixture of the two substances is supplied to the airways of the user during inhalation. It is considered that only a small proportion to almost no suction air flow into and out of the chamber, or even significantly, leads to the escape of the substances.

[0017] The accommodation chamber can have a bottom with a recess which substantially fits to the contour of the container. In the region of this recess, according to a preferred embodiment, the user can insert an undamaged container, respectively with an unopened chamber, in preparation for the inhalation process. More preferably, in this recess, the container cannot be rotated around the above-mentioned axis of rotation. This preferably leads to a defined orientation of the container to be inserted. The region of rotation of the accommodation chamber can be said to be constituted in a plane above the recess, in which region of rotation the container can be rotated around an axis of rotation which extends transverse to its longitudinal axis.

[0018] According to a preferred embodiment, the piercing of the chamber takes place when the container is located in the recess of the accommodation chamber. The selected dimensions of the recess ensure that the container is guided and supported overall on the bottom and preferably on the sides, so that a precise perforation can be carried out reproducibly using the piercing needle to form the piercing opening sufficiently precisely.

[0019] In a further embodiment, the container can be moved from the recess of the accommodation chamber into a region of rotation of the accommodation chamber, which follows behind in the direction of flow of the air during the inhalation of air in the inhalation device, in which region of rotation the rotation of the container occurs only due to the air flow around the axis of rotation. To this end, the region of rotation, viewed in a plane transverse to the axis of rotation, has an extension which allows the rotation of the container. In this respect, a circumferential wall which is substantially circular in the above-mentioned plane is preferably formed, which limits the range of rotation. This can also result in the diameter dimension of the circumferential wall being exceeded by the longitudinal dimension of the container along the longitudinal axis, for example by a factor of 1.05 to 1.5. Viewed perpendicularly to this diameter dimension, the height of the region of rotation is adapted to the width of the container, viewed perpendicularly to the longitudinal axis of the container, so that the container can rotate freely, and more preferably is exceeded by the width of the container by a factor of about 1.05 to 1.5.

[0020] The accommodation chamber can thus essentially consist of the area of the recess and the rotation area formed close to the recess opening.

[0021] Each chamber of the container can have a chamber wall which is located radially outside the chamber and is also curved with respect to the outer contour, which can correspond to the initially mentioned recessed curved top region. The chamber wall is curved inwards, for example designed dome-like, to guide the substance from both chambers to the piercing opening during the suction process and the associated rotation of the container about the rotation axis. The curved inner surface of the top region has a funnel-like effect, in particular for substance particles which slide radially outwards along the inner wall of the chamber. The preferred arrangement of the piercing opening at the apex of the preferably hemispherical top region, in combination with the effect of the directed guidance of the substance particles towards the piercing opening, supports the complete emptying of the chamber when the container is rotated.

[0022] According to one preferred embodiment, the container can have three parts, namely an intermediate part with at least a portion of the area of the partition and the peripheral wall, and two top parts forming the top region. With respect to each chamber, this preferably results in a two-part structure. The peripheral wall can be formed at least partially in two layers, viewed transversely to the longitudinal axis of the container, due to the superimposition of the sections of the intermediate part and the respective cover part.

[0023] In one possible embodiment, one top part, preferably both top parts, can consist of gelatin material. The gelatin material of the top part is shaped correspondingly recessed curved.

[0024] All parts, namely the top parts and the intermediate part, can also consist of gelatin material.

[0025] In alternative embodiments, one, several or all components can be made of hard plastic material. In this respect, for example also polypropylene (PE) can be used.

[0026] If the top component is made in particular of hard plastic material, a region which is thinned in terms of material thickness can be provided in the region of the piercing opening to be provided.

[0027] Preferred are embodiments in which the intermediate part is made of hard plastic material and the cover part is made of gelatin material. As further preferred, the shaped pieces forming the intermediate part and the top part can be connected to one another in a form-fit manner.

[0028] According to one possible embodiment, the peripheral wall can be designed cylindrically encircling with respect to the longitudinal axis, further optionally, as also preferred, with a diameter which is essentially constant in the longitudinal extent of the container. As further preferred, the recessed curved top region at each end can essentially continuously accommodate this diameter of the cylindrical peripheral wall, such that (in the outer contour) a dome-like end portion is formed, the radius of curvature of which essentially corresponds to the radius of the cylindrical peripheral wall.

[0029] In another embodiment, the container can have a length given in the direction of the longitudinal axis which is greater than a container width (e.g. diameter) given perpendicular to the direction of the longitudinal axis. In this regard, the length of the container can correspond to about 1.5 to 5 times, further about 3 to 3.5 times, the container width.

[0030] With respect to the present disclosure, the ranges or value ranges or multiple ranges given above and below also include all intermediate values, in particular in increments of 1 / 10 of the respective dimension, and if desired also dimensionless. For example, a statement of 1.5 to 5 times also includes a disclosure of 1.6 to 5 times, 1.5 to 4.9 times, 1.6 to 4.9 times, etc., a disclosure of from 1.05 to 1.5 also includes a disclosure of from 1.15 to 1.5, 1.05 to 1.4, 1.15 to 1.4, etc. In one aspect, the disclosure can serve to delimit the specified area limits from below and / or from above, or alternatively, also to disclose one or more single values of the specified area. BRIEF DESCRIPTION OF DRAWINGS

[0031] The application is explained below with reference to the drawings, which show only example embodiments. The drawings show:

[0032] Figure 1 is a perspective view of an inhalation device for carrying out the method and for using the container in a non-use or storage position;

[0033] Figure 2 is an inhalation device according to Figure 1 involving a preparation position for receiving the container;

[0034] Figure 3 is a perspective exploded view of the inhalation device;

[0035] Figure 4 is a cross-section through the inhalation device along Figure 1 line V-V in

[0036] Figure 5 is a cross-section along Figure 4 line VII-VII in

[0037] Figure 6 is a cross-sectional view corresponding to Figure 4 but after insertion of the container into the receiving chamber of the inhalation device;

[0038] Figure 7 is a cross-section along Figure 6 line VII-VII in

[0039] Figure 8 is a subsequent illustration of Figure 6 after the device-side piercing needle has been repositioned to pierce the container;

[0040] Figure 9 is a cross-section along the line IX-IX in Figure 8

[0041] Figure 10 is a subsequent illustration of Figure 8 after the piercing needle has been moved back to the basic position;

[0042] Fig. 11 is a subsequent illustration of Figure 10 after the start of the inhalation air flow caused by the user of the inhalation device and the associated inhalation process;

[0043] Figure 12 is a cross-section along the line XII-XII in Fig. 11 ;

[0044] Figure 13 is an enlarged view of the area XIII in Figure 12

[0045] Figure 14 is a single stand-alone view of the container for use;

[0046] Figure 15 is a cross-section along the line XV-XV in Figure 14 DETAILED DESCRIPTION

[0047] A method for mixing a first medicament powder substance S1 and a second medicament powder substance S2 contained in two separate chambers K1 and K2 of a container 1 is shown and described. Such a container is shown for example in Figure 14 and Figure 15 Mixing is carried out in an inhalation device 2, for example as shown in Figures 1 to 5 The use of the container 1 in the inhalation device 2 is also described and shown in the drawings.

[0048] The inhalation device 2 initially has a housing 3 with a housing wall 4 and a housing bottom 5.

[0049] The housing wall 4 surrounds and delimits a containing chamber 6 formed in the housing 3, which is open towards a housing rim 7 facing away from the housing bottom 5.

[0050] Allocated to the housing rim 7, the housing 3 also has a suction section 8 with a housing cover 9 which can be allocated to the housing rim 7 and which is adapted to the contour of the housing rim 7, and a spout-like extension 10 with a central inhalation channel 11 which extends from the housing cover 9 outwards in the opposite direction to the housing wall 4.

[0051] ​​​The suction section 8 is pivotably mounted on the housing 3 to uncover the accommodation chamber 6. The associated geometric pivot axis y can extend in the direction of the spout-like extension 10. By pivoting the suction section 8 about the rotation axis y, for example, it is possible for the exposure of the accommodation chamber 6 to be made possible, for example by pivoting the suction section 8 back, the accommodation chamber 6 is closed off since it is covered by the housing cover 9 of the suction section 8. In the closed position, the housing cover 9 sits around on the housing rim 7.

[0052] As is shown, for example, in Figure 1 and Figure 4 , the closed position can be defined by a rotationally fixed stop of the suction section 8. To this end, the suction section 8 can have a locking extension 12 which can enter a preferably shape-adapted wall groove 13 in the region of the housing wall 4 in a locking manner.

[0053] The region of the housing cover 9 which covers the accommodation chamber 6 in the closed position can be provided with one opening 14 or a plurality of openings 14. This can result in an overall grid-like opening structure in this region. As a result of these possible plurality of openings 14, the suction channel 11 is connected to the interior of the accommodation chamber 6 in terms of flow in the chamber closed position.

[0054] The suction section 8, in particular the extension 11, can be designed for oral or nasal inhalation.

[0055] In the non-use position of the inhalation device 2, for example according to Figure 1 As is likewise preferred, the suction section 8 can be covered by a cap 15 which can be fixed on the housing 3 by insertion. In order to prepare and carry out inhalation, the cap 15 will be removed.

[0056] The orientation of the suction section 8, in particular of the extension 11, results in a longitudinal orientation of the inhalation device 2 through the longitudinal axis x, in particular in the chamber closed position. The longitudinal axis x preferably extends in the same direction as the pivot axis y of the suction section 8, wherein the accommodation chamber 6 preferably passes centrally through the longitudinal axis x.

[0057] The accommodation chamber 6 essentially consists of two regions. The accommodation chamber 6 firstly forms a rotation region 16 which has a preferably disc-shaped plan view design in which the longitudinal axis x is represented as a point (compare Figure 12 and 13 ). This results in a diameter d which is observed in the rotation region 16 transversely to the longitudinal axis x.

[0058] Towards the plane defined by the circumferential housing edge 7, the rotary region 16 is designed open (chamber opening 17) and is only covered in the chamber closed position by the housing cover 9 of the suction section 8. Opposite this chamber opening 17, viewed in the direction of the longitudinal axis x, there is provided a bottom 18.

[0059] For example with reference to the illustrations in Figure 4 , below the rotary region 16, respectively away from the chamber opening 17, a second region of the accommodation chamber 6 is produced by a recess 19 starting from the bottom 18. Viewed in the direction transverse to the longitudinal axis x, this recess 19 is preferably positioned in the middle of the bottom 18, the length a being chosen to be less than the above-mentioned diameter d in the rotary region 16. For example, this length a can correspond to approximately 0.7 times the diameter d.

[0060] Again transversely to the length a, there is a width b of the recess 19. This can for example correspond to approximately 0.3 times the above-mentioned length a of the recess 19.

[0061] Furthermore, viewed in the direction of the longitudinal axis x and starting from the plane of the bottom 18, there is a depth c of the recess 19, which can for example correspond to approximately 2 times the width b. Viewed in the same direction, there is also a depth c' in the rotary region 16 between the plane of the bottom 18 and the chamber opening 17, which depth c' can for example correspond approximately to the depth c of the recess 19.

[0062] Viewed in the longitudinal extent of the recess 19, a guide 20 for a puncture needle 21 is formed at each end of the recess 19. These puncture needles 21 extend in a plane transverse to the longitudinal axis x and further in this plane from the basic position shown for example in Figure 4 and Figure 5 into the perforation position shown for example in Figure 8 and Figure 9 and can be moved back into the basic position, wherein the needle tip of the puncture needle 21 in the perforation position projects into the space formed by the recess 19.

[0063] For this purpose, the puncture needles 21 are provided at their end corresponding to the accommodation chamber 6 or the recess 19 with an actuation button 22, which in the basic position freely projects beyond the contour of the housing 3. Each actuation button 22 is loaded by a spring 23 into the basic position, for example a cylindrical compression spring according to the illustration. The spring 23 is supported by one end region on the housing side in the region of the guide 20, the other end region acting on the actuation button 22.

[0064] The spring 23 pushes the actuation button 22 and with them the puncture needle 21 into the limited basic position. The displacement of the puncture needle 21 into the perforation position is only possible with the intention and by overcoming the restoring force of the spring 23.

[0065] Assigned to the rotating area 16, the housing wall 4 is provided with two suction channels 24, which are open to the surrounding environment in opposite side areas of the housing wall 4, and the actuation button 22 also protrudes freely in said side areas (suction opening 25). Specifically from... Figure 12 As can be seen in the cross-sectional diagram, the suction channels 24 are diametrically opposite to the longitudinal axis x and enter the rotating region 16. The cross-sectional dimensions and orientation of each suction channel 24 are selected such that it enters the rotating region 16 substantially in an orientation tangential to the rotating region 16, and in particular to the peripheral wall 31 surrounding the rotating region 16.

[0066] This results in fluid connection between suction channel 24, receiving chamber 6 (particularly rotating region 16), and suction channel 11 of suction section 8, wherein both suction channel 24 and suction channel 11 are designed to be open to the environment.

[0067] exist Figure 14 and 15 The capsule-shaped container 1 is shown in detail, in which Figure 15 The cross-sectional view schematically shows the state of the substance being discharged from container 1.

[0068] Container 1 initially and substantially has a cylindrical basic outline with two (at least from the inside) dome or dome-shaped top regions 39. Container 1 may consist of three parts, having a middle part 26 and two top parts (27, 28) forming the dome-shaped top regions 39.

[0069] The intermediate portion 26 can initially be designed as a sleeve with a sleeve wall that essentially forms at least a portion of the substantially cylindrical peripheral wall 28 of the container 1. The central axis of the cylindrical peripheral wall 28 also forms the geometric longitudinal axis z of the container 1.

[0070] Preferably, the partition T is integrally formed and made of the same material as the peripheral wall 28, approximately at the midpoint of the range of the peripheral wall 28 in the direction of the longitudinal axis z. This extends in a transverse plane relative to the longitudinal axis z and forms a first base 29 for the first chamber K1 and a second base 30 for the second chamber K2 on both sides.

[0071] Viewed along the longitudinal axis z, opposite to the separator T or the corresponding base 29 or 30, the chambers K1 or K2 are (initially) closed by one of the top portions 27, each chamber being circumferentially defined by a partial section of the circumferential wall 28. These top portions 27 are dome-shaped, and further designed essentially as hollow hemispheres, each top portion 27 having a radius relative to the dome-shaped curved chamber wall 32 within the top portion 27, which preferably corresponds substantially to the radius of the intermediate portion 26.

[0072] As shown, the curved chamber wall 32 of each top portion 27 can merge into a cylindrical wall portion 33, which preferably comprises the peripheral wall 28 on the side of the central portion. In this regard, a form-fit connection can be provided between the intermediate portion 26 and each top portion 27, for example by engaging a radially inwardly projecting circumferential protrusion 34 of the wall portion 33 in a preferably shape-adapted groove 35 of the intermediate portion 26, which extends around the outside of the peripheral wall 28.

[0073] Furthermore, in the plane in which the partition T extends, a rib 36 can be formed on the outside of the peripheral wall 28, against which a circumferential end edge of the cylindrical wall portion 33 of each top portion 27 can abut as a limiting stop.

[0074] Viewed in the direction of the longitudinal axis z, the cylindrical peripheral wall 28 of the intermediate portion 26 extends substantially into the transition region into the curved, dome-shaped chamber wall 32 of the top portion 27.

[0075] In the direction of the longitudinal axis z, there is a length e of the container 1, which for example can correspond to approximately 2 to 2.5 times a width f or container diameter, viewed perpendicularly to the length e.

[0076] In a possible embodiment, the intermediate portion 26 is composed of a hard plastic, for example polypropylene. The two top portions 27 can also be composed of a gelatinous material.

[0077] Two chambers K1 and K2 are thus created, each of which is comprehensively delimited by the associated base 29 and 30, the associated portion of the cylindrical peripheral wall 28 and the associated dome-shaped chamber wall 32 of the respective top portion 27.

[0078] A first substance S1 is contained in the first chamber K1, and a second substance S2, which is preferably different from the first substance, is contained in the chamber K2. The substances S1 and S2 are preferably powdery. In particular, these are pharmaceutically active substances. The two substances S1 and S2 are to be mixed together during inhalation and, preferably, only at this time, and are transferred to the respiratory tract of the user by the inhalation airflow.

[0079] To this end, in the chamber opening position according to Figure 2 the container 1 can first be inserted into the recess 19 of the accommodation chamber 6, after which the accommodation chamber 6 is closed by pivoting the suction section 8 about the pivot axis y. This results in the arrangement as shown in Figure 6 and Figure 7 .

[0080] In particular from Figure 7As can be seen from the cross-sectional illustrations in the figures, the recess 19 is preferably provided with a comparatively small excess dimension in terms of its length and width compared to the container 1. In this respect, a length a and a width b of the recess 19 can be given, which can correspond to approximately 1.1 to 1.2 times the length e or the width f of the container, for example.

[0081] In this position of the container 1, preferably in the recess 19, the piercing needles 21 are actuated by the user by moving the associated actuation buttons 22 towards each other against the restoring force of the springs 23 (arrow s).

[0082] The piercing needles 21 pierce the container 1 in the region of the top portion 27 of the container 1, thereby forming piercing openings 37 in the region of the dome-shaped curved chamber wall 32. These are essentially and preferably achieved at the apex of the chamber wall 32, which curves in a uniform dome-shaped manner as a result of the wall being penetrated by the respective piercing needles 21 (compare Figure 8 and Figure 9 ).

[0083] Due to the limited displacement, the penetration depth of the piercing needles 21 is preferably chosen such that the partition T separating the chambers K1 and K2 is not penetrated.

[0084] With the repositioning of the piercing needles 21 (arrow s’), which takes place automatically after the user has cancelled the respective action on the actuation buttons 22, the suction device 2 with the container 1 is ready to perform the suction process. The chambers K1 and K2 are each opened by the respective perforation of the top portion 27 to dispense the substances S1 and S2 contained in each case (see Figure 10 ).

[0085] The suction process can be initiated by the suction section 8 being surrounded by the user’s lips, or in the case of nasal cavity use, by the suction section 8 being inserted into a nostril, whereby as a result of the user taking a deep breath, a suction air flow (arrow g) is generated through the suction device 2.

[0086] Hereby, air is sucked from the environment through the suction channel 24 and through the opening 14 and the suction channel 11 of the suction section 8 (arrow g). The container 1 is sucked and lifted from the region of the recess 19 into the rotation region 16, in which, as a result of the air flowing into the rotation region 16 from the suction channel 24 essentially tangentially (arrow g in Figure 12 and 13 ), the container 1 is arranged to rotate about a rotation axis u, which extends essentially transversely to the longitudinal axis z of the container 1 (see arrow r). The housing cover 9 provided with the opening 14 prevents the container 1 lifted in this way from entering the suction channel 11.

[0087] As ideally preferred, the axis of rotation u of the container 1 in the rotation region 16 can essentially coincide with the longitudinal axis x through the center of the accommodation chamber 6, whereby a slight wobbling superimposition of the rotational movement can also occur during the rotation about the axis of rotation u.

[0088] Due to the centrifugal forces generated by the rotation of the container 1, the substances S1 and S2 are expelled from the chambers K1 and K2 through the piercing openings 37 into the rotation region 16 of the accommodation chamber 6, the discharge in the radial direction outwards relative to the axis of rotation u being limited by the peripheral wall 31 of the rotation region 16.

[0089] By the superimposition of the pulses generated by the rotation of the container 1 and the tangential inflow of air into the rotation region 16, a mixing of the two substances S1 and S2 essentially within the rotation region 16 takes place, which supports the effect generated, namely that the piercing openings 37 of the two chambers K1 and K2 pass through the superimposed path during this rotation of the container 1, namely when the container 1 is rotated about the rotation axis u precisely in position along the passage path w delimited by the circumferential piercing openings 37 (see Figure 13 ).

[0090] The rotation of the container 1 in the rotation region 16 can cause a turbulent air flow in the entire region, so that the air entering the rotation region 16 not only flows essentially in the extension of the chamber side peripheral wall 31 around the container 1, but if necessary, superimposed on this flow movement, also essentially in the circumferential direction of the container 1, at least partially on the outside of the wall along the curved peripheral wall 28 around the container 1.

[0091] The chambers K1 and K2 are preferably emptied essentially solely and exclusively due to the forces generated by the rotation of the container 1. The flow through the container 1 is prevented by the arrangement of the partition T to form two separate chambers.

[0092] This can lead to the further positive effect that due to the dome-shaped curved inner wall 38 of the wall portion 33 and the centrifugal forces generated by the rotation of the container 1, residues of the first or second substance S1 or S2 are also driven out of the respective chamber K1 and K2, if necessary, completely emptied by guiding these substances along the curved wall portion 33 to the piercing openings 37, which are preferably provided in the apex region in order to discharge from the chambers (see Figure 15 ).

[0093] Also in the region of the suction channel 11, the suction air g entering the rotation region 16 can cause a suction air vortex in which the substances S1 and S2 are picked up and mixed with one another, so that a homogeneous mixture of the two substances reaches the airways of the user.

[0094] At the end of the inhalation process, after the suction section 8 has been moved into the chamber opening position, the emptied container 1 can be removed from the holding chamber 6. After use, the emptied container 1 lies freely on the floor 18 of the rotating area 16. If desired, the emptied container 1 can also have fallen back into the recess 19.

[0095] List of reference signs

[0096] 1 container

[0097] 2 inhalation device

[0098] 3 housing

[0099] 4 housing wall

[0100] 5 housing bottom

[0101] 6 holding chamber

[0102] 7 housing edge

[0103] 8 suction section

[0104] 9 housing cover

[0105] 10 spout-like extension

[0106] 11 extension

[0107] 12 locking extension

[0108] 13 wall groove

[0109] 14 opening

[0110] 15 cap

[0111] 16 rotating area

[0112] 17 chamber opening

[0113] 18 floor

[0114] 19 recess

[0115] 20 guide

[0116] 21 puncture needle

[0117] 22 actuation button

[0118] 23 spring

[0119] 24 suction channel

[0120] 25 suction opening

[0121] 26 intermediate portion

[0122] 27 top portion

[0123] 28 peripheral wall

[0124] 29 first base

[0125] 30 second base

[0126] 31 peripheral wall

[0127] 32 chamber wall

[0128] 33 wall portion

[0129] 34 protrusion

[0130] 35 recess

[0131] 36 rib

[0132] 37 piercing opening

[0133] 38 inner wall

[0134] 39 top region

[0135] a length

[0136] b width

[0137] c depth

[0138] c' depth

[0139] d diameter

[0140] e length

[0141] f width

[0142] g arrow

[0143] r arrow

[0144] s arrow

[0145] s' arrow

[0146] u rotation axis

[0147] w channel path

[0148] x longitudinal axis

[0149] y pivot axis

[0150] z longitudinal axis

[0151] K1 first chamber

[0152] K2 second chamber

[0153] S1 first substance

[0154] S2 second substance

[0155] T partition

Claims

1. A method for mixing first and second drug powder substances (S1, S2) in an inhalation device (2), wherein the drug substances are delivered by drawing air using the inhalation device (2), wherein, The first and second substances (S1, S2) are contained in a container (1) having two separate chambers (K1, K2), wherein the chambers (K1, K2) are arranged sequentially along the longitudinal axis (z) of the container (1), wherein, in a first step, the chambers (K1, K2) of the container (1) are opened by piercing to form a piercing opening (37), wherein the opening by piercing is performed on opposite sides relative to the longitudinal axis (z), characterized in that, in a further step, during the user's inhalation of air, the container (1) rotates about a rotation axis (u) in the receiving chamber (6) of the inhalation device (2), the receiving chamber (6) extending transversely to the longitudinal axis (z), thereby discharging the substances (S1, S2) from each chamber (K1, K2) radially outward from the container (1), and achieving a mixture of the two substances (S1, S2) thus discharged.

2. The method according to claim 1, characterized in that, During the rotation of the container (1), the puncture opening (37) of the puncture-formed chamber (K1, K2) passes through the overlapping path (w).

3. The method according to any one of the preceding claims, characterized in that, Due to the rotation of the container (1), the substances (S1, S2) abut against the peripheral wall (16) of the containing chamber (6), which extends substantially transversely to the axis of rotation (u), and are thus captured.

4. The method according to any one of the preceding claims, characterized in that, The air drawn in by the suction flows substantially around the container (1).

5. The method according to any one of the preceding claims, characterized in that, The receiving chamber (6) has a bottom (18) with a recess (19) that is substantially adapted to the contour of the container (1).

6. The method according to claim 5, characterized in that, When the container (1) is located in the recess (19) of the receiving chamber (6), the chamber (K1, K2) is punctured.

7. The method according to claim 5 or 6, characterized in that, The container (1) moves from the recess (19) of the receiving chamber (6) into the rotating region (16) of the receiving chamber (6), which is adjacent to the recess (19) in the direction of air flow during the process of air being drawn into the suction device (2), and the rotation of the container (1) about the rotation axis (u) in the rotating region (16) is set by the suction.

8. The method according to any one of the preceding claims, characterized in that, Each chamber (K1, K2) has a curved chamber wall (32) that is radially located outward relative to the chamber (K1, K2) and, after piercing the chamber (K1, K2), the chamber wall (32) guides the powdery substance (S1, S2) to the piercing opening (37).

9. Application of a container (1) having two chambers (K1, K2), i.e., a first chamber (K1) or a second chamber (K2), in an inhalation device (2), the chambers (K1, K2) being filled with a first drug powder (S1) and a second drug powder (S2), respectively, the inhalation device (2) having a puncture needle (31) for piercing each chamber (K1, K2) of the container (1), the first chamber (K1) further having a first base (29), the second chamber (K2) having a second base (30), the container further having a separator (T) separating the first chamber (K1) from the second chamber (K2), wherein the separator... The spacer (T) forms the first base (29) and the second base (30), and the first chamber (K1) and the second chamber (K2) extend from the first base (29) and the second base (30) respectively along the common longitudinal axis (z) of the container (1) in opposite directions, and form a peripheral wall (28) and a top region (39) opposite to the base (29, 30), each top region (39) being concave and pierced so as to provide the first substance (S1) and the second substance (S2) from the container (1) by rotating the container (1) about a rotation axis (u) extending transversely to the longitudinal axis (z).

10. The application according to claim 9, characterized in that, The container (1) has three parts: a middle part (26) and two top parts (27), the middle part having at least one portion of a partition wall (T) and a peripheral wall (28), and the top parts forming the top region (39).

11. The application according to claim 10, characterized in that, The top portion (27) is made of gelatin material.

12. The application according to any one of claims 10 or 11, characterized in that, All parts (26, 27) are made of gelatin material.

13. The application according to claim 10, characterized in that, All components (26, 27) are made of hard plastic material.

14. The application according to claim 10, characterized in that, The middle portion (26) is made of hard plastic material, and the top portion (27) is made of gelatin material.

15. The application according to any one of claims 9 to 14, characterized in that, The container (1) has a basic cylindrical outline with two dome-shaped ends.

16. The application according to any one of claims 9 to 15, characterized in that, The container (1) has a length (e) given in the direction of the longitudinal axis (z), which is greater than the width (f) of the container (1) given perpendicular to the longitudinal axis (z).

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