CN1889861A - Inhaler for basic pharmaceutical agents and method for production thereof - Google Patents

Abstract

The invention relates to a device, for the administration of basic agents, in particular nicotine, to the human or animal body, by means of inhalation, comprising a first preparation containing nicotine base or/and a further basic agent and, furthermore, a second or further preparations, whereby at least one preparation contains at least one volatile acid suitable for inhalation.

Description

Alkaline drug inhaler and its manufacturing method

technical field

The present invention relates to a device for administering alkaline active substances, especially nicotine, to the human or animal body by inhalation. The invention further relates to the manufacturing method by which this device can be obtained, and the use of said device for smoking cessation or, if necessary, for the smoke-free gratification of nicotine cravings.

Background technique

Nicotine inhalers, which deliver nicotine by means of air drawn in during inspiration, have been known for many years (eg US Patent 4 917 120 and US Patent 5 167 242). For many years, nicotine inhalers have also been available on the market in several European countries as smoking cessation products ("Nicorette(R)"; Pharmaci/Pfizer). However, because with the latter inhaler only a small amount of nicotine becomes effective when inhaled, this device has not been widely used. This is due in particular to the fundamental drawbacks of known inhaler technologies and the tolerability achievable with these technologies. In particular, the local irritation of the mucous membranes of the respiratory tract caused by the alkalinity of nicotine is disadvantageous, since this irritation causes an urgent cough, which leads to a reduced absorption of the nicotine vapor released by the inhaler. This way only a very small amount of nicotine is absorbed by the body.

Contents of the invention

It is therefore an object of the present invention to provide a nicotine inhaler which enables nicotine to be absorbed through the respiratory tract with as little irritation as possible and as deep an absorption as possible.

This object is achieved by a device according to the independent claim and its dependent claims, and by a production method according to claim 19 and its dependent claims.

Thus, the device according to the invention is characterized in that it comprises a first formulation comprising nicotine base or/and other volatile, inhalable basic active substances, and that it further comprises a second formulation or formulations, said At least one of said second formulation or said other formulations contains at least one volatile and inhalable acid. The device according to the invention is therefore characterized in that, during inhalation, one or more volatile acid compounds are simultaneously inhaled in addition to the active substance base (eg nicotine base).

The device according to the invention is suitable for administering alkaline substances, especially nicotine, to the human or animal body by inhalation. Suitable basic substances are, for example, selegiline and/or mecamylamine. The combination of nicotine and mecamylamine is particularly preferred for smoking cessation.

As a result of the simultaneous presence of a first formulation containing nicotine base (or other active substance base) with another formulation containing volatile acid, the nicotine base and volatile acid are volatilized during inhalation, causing a mixture of base and acid vapors to form in the device The corresponding nicotine salt (or the corresponding salt of other active substance base). The salt enters the airways in the form of droplets or fine particles with inhaled air. Due to the neutral reaction of the mucous membranes to salt, inhalation of this type is shown to be better tolerated than inhalation achievable with known inhalation devices.

In this regard, it is preferred that said first formulation comprising nicotine base and said second formulation comprising acid are used at separate locations within the device. In this way, the air inlet can be set so that on inhalation, part of the airflow passes through the first formulation, while another part flows through the second formulation, and then the two streams (which contain the volatile nicotine base and acid) combine , which can then be inhaled.

Upon inhalation, the active substance base (such as nicotine base) contained in the first formulation and the volatile acid contained in the second formulation are passively volatilized. The process can optionally be accelerated by the use of heat; methods suitable for this purpose are well known to those skilled in the art.

When using the device according to the invention, aerosols are formed in the inflowing ambient air, especially when there is a high concentration of active substances bases and acids in the vapor. The aerosol formation is due to the lower volatility of the formed nicotine salt, salt mixture or salt droplets. Since nicotine is no longer present as a free base and no longer acts as a base via the external gas phase, the aerosols formed are at the same time responsible for a marked increase in tolerance. As a result, only the particulate deposition of aerosol particles in the alveoli can lead to application and absorption (reabsorption) of the active substance in the lungs. These aerosol droplets, either as a partially water-soluble salt component, or as a solid dispersion, exhibit far better mucous membrane response than devices known in the art may exhibit due to neutral (instead of basic) mucosal responses. out of tolerance. Aerosol formation is beneficial but not essential to achieve the therapeutic effect according to the invention. In general, a high dilution of the supplied vapor, which suppresses the formation of aerosols, is also useful in terms of tolerance.

The size of the aerosol particles formed by the inhalation system according to the invention depends above all on the velocity of the gas flow (flow rate) and the concentration of the individual gaseous components (respectively alkaline active substance and acid) in the mixing zone. The size of aerosol particles is less than 10 μm (average diameter), especially within 5-10 μm, which is beneficial to alveolar absorption.

According to a preferred embodiment, the inhalation device comprises a first air inlet opening, a second air inlet opening and an air outlet opening. These holes are arranged so that the airflow flowing through the first air inlet mainly passes through the first agent, and the airflow flowing through the second air inlet mainly passes through the second or other agent, and these two airflows are then in Merge on its path and leave the device through said vent hole.

The device further preferably has a rectangular recess, groove or channel therein forming the first and second inlet and outlet channels. These airflow paths are respectively open towards the outside through said air inlet and air outlet. The first preparation is arranged in the rectangular recess forming the first air inlet, and the second preparation is arranged in the rectangular recess forming the second air inlet. Preferably, each formulation is placed adjacent to a respective gas inlet.

In general, molar evaporation rates of approximately equimolar ratios of the two components (active substance base, acid) are desired. As stated, if the nicotine-containing formulation and the acid-containing formulation are placed in two separate inlets with combined inlets, the respective release rates can be controlled, especially by the flow in the two slots conditional way. For example, a release rate of 100 μg/10s can be set for the airflow flowing through the first opening and thus the first inlet; The rate will be suitable for said second gas flow.

With regard to the release rate achievable, the inhalation device according to the invention releases from said formulation into the inhaled air during one inhalation lasting 1-10 s, during which an inspiratory velocity of 0.1-1 l/min is achieved 5-250 μg, preferably 10-100 μg, of nicotine base or another basic substance. For example, 100 μg of nicotine base may be administered in one breath lasting 10 s at an inspiratory rate between 0.1 and 1 l/min; this rate of release is suitable for therapeutic purposes.

In order to impair the inhalation process as little as possible, the device preferably has a large channel cross-section throughout its design. This applies in particular when the duct cross-sections of the inlet and outlet holes are formed such that the negative partial pressure in the oral cavity does not exceed 300 Pa during inhalation.

As volatile acid, acetic acid is preferably used; other acids can also be used if they are volatile at room temperature (approx. acid, propionic acid). Combinations of different acids can also be used. Acetic acid, due to its high volatility, is used in lower concentrations and in larger total quantities, and can also be used in combination with additives. Volatile, respirable basic active substances especially mean substances which are volatile at the abovementioned temperatures or which can be transformed into the gas phase.

Furthermore, according to a particular embodiment, the active substance-containing formulation additionally comprises at least one solvent suitable for inhalation (preferably ethanol) or/and at least one volatile auxiliary substance (preferably menthol). Acid-containing formulations may likewise comprise at least one such solvent or/and at least one volatile auxiliary substance. Suitable volatile auxiliary substances are especially pleasant fragrances and flavorings (eg limonene, eucalyptol, peppermint oil, camphor or other substances of the terpenoid type; including combinations of the foregoing).

The present invention further includes a method of manufacturing the above device. These methods usually include the following steps:

Manufacture a shaped part by deep drawing or other processing methods known in the art (such as injection molding), said shaped part comprising a first elongated recess to receive said first formulation, and a first elongated recess to receive said second formulation. Two elongated recesses;

placing a predetermined amount of a first formulation containing nicotine base or another basic active substance into said first recess;

A predetermined amount of the second acid-containing formulation is placed into the second groove.

The device according to the invention can be produced in a simple and cost-effective manner by using shaped parts produced by deep drawing. A preferred material suitable for this purpose is a polyester material with a coating impermeable to alkaline substances, especially nicotine. Primarily suitable for this purpose are copolymers of acrylonitrile and methacrylates (Barex ^(R) ; UK). Preference is given to using a polyethylene terephthalate-Barex laminate.

By means of deep drawing, recesses are provided in the shaped part forming the two air inlet channels. Furthermore, a further recess may be provided which is connected to the two recesses described and forms the outlet channel. The inlet and outlet channels have an essentially cylindrical configuration, but they can also have different geometries.

A shaped part with a recess forms the bottom of the device; the upper part can be formed by a second shaped part with correspondingly provided grooves, or by a planar film or layer as a cover. After being placed in the formulation, the upper part and the lower part are connected to each other in a known manner (eg gluing, welding).

Recesses or shaped parts forming the inlet channels in the shaped part can be accommodated by providing additional protrusions, which can likewise be produced by deep-drawing, so that the vaporization rate of the individual volatile components can be limited geometrically. This method additionally makes it possible to deliver the active substance base and acid preferably in equimolar amounts.

The device is manufactured at least partially, but preferably completely, from a material impermeable to the active substance, especially from a polyester material with the above-mentioned coating, and/or from a metal foil, or a combination of these materials.

Suitable as substrates for the preparation of the above formulations are in principle any material which can be used for the preparation of depots which receive nicotine base or other active substance bases or said volatile acids, and the prepared depots are subjected to vaporization under inhalation conditions Release these substances into the surrounding air. Materials suitable for this purpose are known to those skilled in the art.

Suitable materials are, for example, polymeric materials for the production of active substance depots for transmucosal therapeutic systems. In this process, the active substance (or acid) is dissolved or dispersed in a polymeric matrix (for example polyacrylate), optionally with auxiliary substances, and the resulting slurry is applied to an inert support and Let it dry. From the dried active substance-containing layer, tablets of a certain surface area and layer thickness with a known content of active substance or acid are cut. As mentioned above, these sheets can be inserted into the device according to the invention as the formulation described above. Appropriate layer thicknesses and surface areas of tablet formulations loaded into the airflow space of the device are derived from pharmaceutical practice.

The nicotine preparation inserted into the device according to the invention generally has a content of 10% by weight and the dosage is generally 500 mg. Concentrations and dosages for each case may deviate from the values of these examples; in particular, the active substance content may be from 1 to 80% by weight and dosages from 10 to 1000 mg.

Suitable as polymer matrix are especially polymers selected from the group comprising polyethylene, polypropylene, silicone polymers (polydimethylsiloxane) and poly(meth)acrylates.

Furthermore, the formulations described above can be prepared by using a thermoplastic polymer which is thermally liquefied and the ingredients (basic active substance and/or acid) are dosed into the thermal polymer. The still liquid formulation is applied directly to the place where the deep-draw inhalation device is used for this purpose and allowed to cure.

According to another variant of the invention, a silicone polymer (polydimethylsiloxane) and a crosslinker (for example a platinum-containing crosslinker) are used as matrix. Under cold conditions, the nicotine base or volatile acid component is dosed into the above mixture in liquid form. A predetermined amount of this mixture is applied to each site for this purpose. After sealing the device, it was post-treated with heat, so that a three-dimensional structure of the active substance release formulation was produced.

Active substance-containing or acid-containing formulations are preferably used in the vicinity of the inlet of the respective inlet.

As mentioned above, the material used for the closure means is preferably impermeable to volatile components as described above.

In another preferred embodiment, the inhalation device is covered with a peelable protective layer impermeable to alkaline substances after manufacture. This protective layer will only be removed by the user himself immediately before use. Through the protective layer that has been used, a chamber containing the alkaline active substance and a chamber containing the acid are formed, which are separated from each other and from the surrounding air in a substantially airtight manner. In this way, premature reaction and aging of the components are prevented. Only after the protective layer is removed, gas exchange between the two chambers can take place again.

If necessary, the air inlet and outlet holes are also covered with a protective film.

The device can advantageously be used for smoking cessation or, if necessary, also for the smoke-free gratification of nicotine cravings.

Detailed ways

The invention will be illustrated by means of examples and illustrations in the figures. Unless otherwise indicated, the meaning of the reference numerals is the same in all figures.

Figure 1A shows the commercially available shape (sectional view) of a device (1) according to the invention. The device is formed by an outer wall (2); it has two airflow channels (a, b), approximately in the middle of the airflow channels, which enlarge to form a respective chamber (3a, 3b) and thereafter merge to form an outlet airway (7 ). In the chambers (3a, 3b) there is respectively a nicotine-containing preparation (5) and an acid-containing preparation (4).

Figure 1A shows the state of the device before use. The inlet and outlet holes of the flow channels (a, b) are still closed and the chambers (3a, 3b) are separated from each other by a membrane (13), so mixing of the two components (4, 5) cannot yet take place.

Figure 1B shows the device shown in figure A in operation (again in longitudinal section) after opening the membrane (13) (eg by heat or by squeezing) and the air inlet and outlet holes (A, B, C). The air inlet and outlet holes can be opened eg by breaking or tearing along the perforations (11, 12 in Figure IA) provided in the device (layer (8) not shown in Figure IB).

When inhaling, the air flows through the air inlet (A) and the air inlet (a) on the one hand, and flows through the air inlet (B) and the air inlet (b) on the other hand. Dashed arrows indicate the direction of air flow during inhalation. The two inlet channels (a, b) merge to form an outlet channel (7) with an outlet hole (C). In the region of the inlet duct (a) there is a nicotine-containing formulation (5) immediately after the inlet hole (A) and in the region of the inlet channel (b) there is an acid-containing formulation just after the inlet hole (B) Formulations (4). When the air flows through, nicotine volatilizes from the preparation (5) into the airway (a), while the acidic compound contained in the preparation (4) evaporates into the airway (b). In the region of the outlet duct ( 7 ), the vapors of base and acid mix and approximately neutral to slightly acidic conditions are obtained. An aerosol comprising ambient air and nicotine salts contained therein is formed by inhalation through the vent (C), preferably via the oral cavity.

Figure 1C shows a cross-sectional view in the X-plane of the inhalation device schematically represented in Figure IB. The inlet channels (a, b) are preformed by deep drawing so that they have a concave shape. In the area of the gas channels (a, b) there is respectively an active substance-containing formulation ( 5 ) and an acid-containing formulation ( 4 ). The underside of the device is covered with a flat, nicotine impermeable layer (8).

Figure 2A shows the commercially available shape (longitudinal section) of another embodiment of an inhalation device according to the invention. The inlet and outlet ports (A, B, C) are still closed. The middle areas of the grooves (a, b) are enlarged to form respective chambers (3a, 3b). The chambers ( 3a , 3b ) of the respective preparations ( 4 , 5 ) are arranged side by side and spatially separated from each other so that mixing of the preparations is not yet possible (state before use).

Figure 2B shows a cross-sectional view at plane X of the inhalation device represented in Figure 2A. The inlet channels (a, b) and the chambers (3a, 3b) are formed in the outer wall (2) by deep drawing and are of concave shape. Inside the chambers (3a, 3b) there is respectively an active substance-containing preparation (5) and an acid-containing preparation (4). The underside of the device is covered with a flat, nicotine impermeable layer (8).

Figure 2C is another longitudinal section of the embodiment shown in Figures 2A and 2B. The unit is displayed as ready to use. In order to use the device described in Figure 2A, it is folded before use along a thread (14), which may be provided, for example, in the form of a perforation or a line of weakness, so that the two airflow slots ( a, b) and chambers (3a, 3b) are located on top of each other. The holes for the inlet and outlet channels can be opened, respectively, for example by breaking through the perforations (11, 12) provided for this purpose. A functional inhalation device is thus obtained. Dashed arrows indicate the direction of airflow during inhalation. A tube or mouthpiece (9) can be slid over the two outlet holes (C, C') forming a combined outlet channel (7') and a combined outlet hole (D).

Figure 2D shows a cross-sectional view at plane X of the device shown in Figure 2C in operation. Chambers (3a, 3b), walls (2, 2') and layers (8, 8') formed by deep drawing are located on top of each other.

Figure 2E shows a cross-sectional view at plane Y of the device shown in Figure 2C in operation. Dashed arrows indicate the direction of airflow during inhalation. During inhalation, the gas streams (A, B) flow through separate channels (a, b), past the preparations (4, 5) located in the chambers (3a, 3b). The resulting vapor or aerosol combines in the region of the outlet channel (7') formed by the tube or mouthpiece (9) and leaves the device via the outlet hole (D).

Figures 3A and 3B show another embodiment of the device according to the invention (persistence image display), wherein Figure 3B depicts the tube or mouthpiece (30) into which the cylindrical insertion part (31) can be inserted. The inner space of the insertion part (31) is divided by an axially extending partition wall (32) into two chambers (33, 34) which respectively receive the active substance preparation and the acid component (not shown). The insertion portion is enclosed by a cylindrical barrel (35) (which is shown partially cut away in Figure 3A). In the rear area, holes (36) are provided in the barrel; said holes function as air intake holes. At the rear (38) there is another air inlet (37) which closes the rear of the insertion part (31). Figure 3C shows this rear face in plan view. The number and arrangement of holes can vary.

During the manufacturing process, the nicotine-containing formulation is placed in chambers (33, 34), for example, a carrier material impregnated with nicotine (such as a sponge or filter paper), and a carrier material impregnated with a volatile acid (preferably acetic acid) are placed in the respective chambers (33, 34). chamber; optionally, a flavoring or aroma enhancer may also be added therewith. All openings, ie front end (V) and holes (36, 37) are closed with suitable protective films or foils.

Before use, the protective film is removed and the insertion part (31) is inserted into the mouthpiece (30). By suction on the mouthpiece, air is sucked in through the two rear holes (36, 37). The air flows through both chambers (33, 34) and the carrier, and simultaneously carries away nicotine vapor, acid vapor and optionally added flavorant vapor. These vapors swirl in the area of the mouthpiece before entering the mouth. The combination of nicotine and acid vapor facilitates nicotine inhalation. To this end, it is advantageous to provide the mouthpiece (30) with a plurality of protrusions or teeth (39). The protrusions and teeth are preferably arranged one after the other in several offset rows. The mouthpiece (30) is a substantially cylindrical sleeve open at both ends, which is preferably shorter than the insertion portion (31).

The protrusions or teeth (39) can also be formed as helical shape, S-shaped or spiral baffles to achieve better swirling of the air and better mixing of the gases.

Figure 4A shows a perspective view of another embodiment of a device according to the invention. The device comprises a sleeve-type mouthpiece (30) to which a tube (41) can be rotatably attached, or the tube (41) can be rotatably slid onto it, or the tube (41) can be rotatably inserted where (the direction of the arrow). Preferably, the end of the mouthpiece (40) is shaped so that when the tube (41) is slid onto the mouthpiece, it snaps into place. As depicted in Figure 3, the mouthpiece has a plurality of protrusions (39) facing the mouth opening. The inner space of the mouthpiece (40) is divided into four chambers by two partition walls. The mouthpiece is open at both ends. The opening to be connected to the tube (41) is partially closed. Preferably, at least one sector of the substantially circular cross-section of the mouthpiece is closed, such as the two opposing sectors shown in Figure 4B.

The slide tube (41) is open at both ends and internally divided into four chambers in the same way as the mouthpiece (by means of walls (44, 45)). The nicotine-containing formulation and the acid-containing formulation are respectively located in two opposing chambers.

Embodiments are also provided where the mouthpiece and tube are divided into 2 or 3, or more than 4 interior spaces.

The walls or baffles (44, 45) can also be formed helically, S-shaped or helically in order to achieve a stronger air vortex and thus better gas mixing.

Nicotine-containing tubes (optionally modified with flavoring agents) are prepared by inserting a nicotine-containing carrier material in a first chamber of the tube, and an acid-containing carrier material in the corresponding opposite chamber. All openings are then closed with suitable membranes or foils. Furthermore, the remaining chambers of the tube can be filled with further active substances or fragrances.

In use, the protective film is removed and the tube (41 ) is slid onto the mouthpiece (40), thereby snapping. The tube is rotationally engaged so that the filled chamber can be opened and closed by rotating the tube relative to the mouthpiece (see double arrow). This allows the consumer to adjust the airflow they wish to inhale. If necessary, the open end of the mouthpiece, and the open end of the tube can each be closed with a detachable cap.

FIG. 5 shows (in cross section) a variation of the embodiment described in FIG. 4 . The inner space of mouthpiece (40) and tube (41) is divided into four tubular chambers (51, 52, 53, 54); (50) refer to the cylindrical walls of mouthpiece and tube, respectively.

In this case, it is advantageous for the carrier material impregnated with active substance or acid to be inserted into the tube in the form of a "cartridge". In this case, the tube may form a device with a mouthpiece to which it is permanently (but rotatably) connected, which means that the whole device is reusable. The "cartridges" can be stored independently, and can be manufactured to have different nicotine levels (or to contain different active substances).

FIG. 6 schematically shows another advantageous embodiment of the device according to the invention. The active substance-containing preparation (not shown) is located in the first chamber (61), which forms a large gas space in which the active substance vapor can accumulate. An acid containing formulation that can be combined with a flavoring agent is located in the second chamber (62). Broad arrows indicate the direction of airflow occurring during inhalation. Air is drawn in through the air intake holes (64, 65). These holes may have valves to prevent premature mixing of components (active substances, acids) or/and leakage of components to the outside.

When inhaled through mouthpiece (63), air flows into the device along two different paths: (i) air flows into chamber (61) through side holes (64), and in the process the air pre-sets the vapor pressure. The saturated gas space rushes into the mixing zone in front of the mouthpiece (63). (ii) Simultaneously, air is sucked into the second chamber (62) through the side holes (65). During this process, the gas also rushes auxiliary substances (acids, possibly flavorings) into the mixing zone in front of the mouthpiece (63). In this mixing zone, the two gas streams mix with each other. During this mixing, the desired neutralization of the active substance base takes place.

Claims (24)

1. A device for administering alkaline active substances, especially nicotine, to the human or animal body by inhalation, wherein said device comprises: a first formulation comprising nicotine base or/and another basic active substance; A second or more other formulations, at least one of which comprises at least one volatile acid suitable for inhalation. 2. The device of claim 1, wherein said formulation is administered at a separate location within the device. 3. Device according to claim 1 or 2, characterized in that said first formulation comprises a nicotine base or/and another alkaline active in combination with at least one solvent suitable for inhalation, preferably ethanol. substance. 4. Device according to any one of the preceding claims, characterized in that said volatile acid is contained in the formulation in combination with at least one solvent suitable for inhalation, preferably ethanol. 5. A device according to any one of the preceding claims, wherein said volatile inhalable acid is selected from the group comprising acetic acid, lactic acid, malic acid and propionic acid. 6. Device according to any one of the preceding claims, characterized in that, during inhalation, said device releases nicotine base from said formulation on the one hand, and on the other hand in an approximately equimolar amount Release volatile acids. 7. The device according to any one of the preceding claims, characterized in that, during an inhalation session lasting 1-10 s and reaching an inhalation speed of 0.1-1 l/min, the device starts from the The formulations release 5-250 μg, preferably 10-100 μg, of nicotine base or another basic active substance into the inhaled air. 8. Device according to any one of the preceding claims, characterized in that, during inhalation, aerosol particles are formed in the interior space of the device, the size of said particles being preferably less than 10 [mu]m. 9. Device according to any one of the preceding claims, characterized in that the formulation comprises at least one further volatile and inhalable additive, preferably menthol. 10. Device according to any one of the preceding claims, characterized in that at least one of the nicotine base-containing or acid-containing preparations has a polymer matrix, wherein preferably the active substance or the acid is dissolved or dispersed form is included. 11. The device according to claim 10, wherein said polymer matrix is preferably based on a polymer selected from the group consisting of polyethylene, polypropylene, silicone polymers (polydimethylsiloxane) and poly(meth)acrylates set of polymers. 12. Device according to any one of the preceding claims, characterized in that the device is at least partly, preferably completely, made of a material impermeable to the active substance, in particular coated with acrylonitrile and methacrylic acid Polyester materials of ester copolymers, and/or manufactured from metal foils or combinations of the above materials. 13. Device according to any one of the preceding claims, characterized in that, after manufacture and during storage, the device is covered with a peelable protective layer impermeable to alkaline active substances, whereby the peelable protective layer A chamber containing the active substance and a chamber containing the acid are formed, which are separated from each other and from the surrounding air in an airtight manner. 14. The device according to any one of the preceding claims, characterized in that the device has a first air inlet, a second air inlet and an air outlet, so that the airflow flowing into the first air inlet is mainly The airflow flowing through the first agent and entering the second inlet hole mainly flows through the second or other agent, the two airflows are then merged in their path and exit through the outlet hole device. 15. Device according to claim 14, characterized in that the duct cross-sections of the inlet and outlet holes are formed such that the negative partial pressure in the oral cavity during inhalation is at most 300 Pa, preferably at most 200 Pa. 16. Device according to any one of the preceding claims, characterized in that it comprises at least one shaped part produced by deep drawing, in which there is formed a first inlet channel and a second inlet channel, and The elongated recess of the outlet airway formed by merging these two airways. 17. Device according to claim 16, characterized in that the device has an upper part and a bottom part each formed by deep drawing, the two shaped parts having said recess and being connected to each other in the following manner: by facing each other The provided recess forms a first air inlet channel with an air inlet hole, a second air inlet channel with an air inlet hole, and an air outlet channel with an air outlet hole by combining the two air channels. 18. Device according to any one of the preceding claims, characterized in that said first agent is located in an elongated recess forming a first inlet channel and said second agent is located in a second In the elongated recess of the inlet channel, each agent is preferably placed adjacent to the respective inlet port. 19. A method of manufacturing a device according to any one of claims 1 to 18, the method comprising the steps of: producing a shaped part, preferably by deep drawing, said shaped part comprising a first elongated recess receiving said first formulation, and a second elongated recess receiving said second formulation; placing a predetermined amount of a first formulation containing nicotine base or another basic active substance into said first recess; A predetermined amount of the acid-containing second formulation is placed into the second recess. 20. Method according to claim 19, characterized in that the filled shaped part is covered with a peelable protective layer impermeable to alkaline substances, whereby the active substance-containing chamber and the acid-containing chamber are formed by the peelable layer , the two chambers are separated from each other and from the surrounding air in an airtight manner. 21. The method according to claim 19 or 20, characterized in that, during the manufacture of the shaped part, a further recess connected to the other two recesses and forming an air outlet is formed by deep drawing. 22. A method according to claim 21, characterized in that the filled shaped part is connected to a shaped part as an upper part and having an elongated recess corresponding to the recess of said filled shaped part, whereby by means of the respective, stacked The recessed portion forms a first air inlet channel with an air inlet hole, a second air inlet channel with an air inlet hole, and an air outlet channel with an air outlet hole. 23. Use of an inhalation device according to any one of claims 1 to 18 for smoking cessation or if necessary for smoke-free gratification of nicotine cravings. 24. Use of an inhalation device according to any one of claims 1 to 18 for simultaneous inhalation of an alkaline active substance and one or more volatile acid compounds.

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