JP2007512880A - Inhaler for basic drugs and method for producing the same - Google Patents

Abstract

The invention relates to a device for administering a basic agent, in particular nicotine, by inhalation to the human or animal body, a first preparation containing nicotine base or / and a further basic agent, and further A device comprising a second or further preparation, wherein the at least one preparation contains at least one volatile acid suitable for inhalation.

Description

  The present invention relates to a device for administering a basic active substance, in particular nicotine, to the human or animal body by inhalation. The invention further relates to a manufacturing method for obtaining such a device, as well as the use of the device for smoking cessation or for the fulfillment of nicotine craving without smoking in a necessary situation.

  Nicotine inhalers for administering nicotine via air inhaled during inspiration have become known over the last few years (eg, US Pat. No. 4,917,120 and US Pat. No. 5,167,242). ). Also, over the last few years, nicotine inhalers have been marketed as non-smoking products in several European countries (“Nicorette®”, Pharmacia / Pfizer). The latter nicotine inhaler, however, is not widely used because only a small amount of nicotine is effective when inhaled with this device. This is due in particular to the fundamental deficiencies of known inhaler technologies and tolerability that can be achieved with these technologies. In particular, the local irritation to the airway mucosa caused by the alkaline nature of nicotine is disadvantageous because it causes a cough impulse and consequently reduces the absorption of nicotine vapor released by the inhaler. Thus, only a very small amount of nicotine is absorbed by the body.

  Accordingly, it was an object of the present invention to provide a nicotine inhaler that allows absorption of nicotine through the airways with as little irritation and strength as possible.

  This object is achieved by the device described in the main claim and the subordinate claims and the manufacturing method described in claim 19 and the subordinate claims.

  Accordingly, the device according to the invention comprises a first preparation containing nicotine base or / and other volatile inhalable basic active substances, and in a second preparation or a plurality of further preparations. Wherein the second preparation or at least one of the further preparations further comprises one containing at least one acid that is volatile and suitable for inhalation. Therefore, the device according to the present invention is characterized in that not only the active base substance (for example, nicotine base) but also one or more volatile acid compounds are simultaneously inhaled during inhalation.

  The device according to the invention is suitable for the administration of basic agents, in particular nicotine, by inhalation into the human or animal body. Suitable basic agents are, for example, selegiline and / or mecamylamine. The combination of nicotine and mecamylamine is particularly preferably used for smoking cessation.

  The simultaneous presence of the first preparation containing nicotine base (or other active agent base) and the further preparation containing volatile acid causes nicotine base and volatile acid to volatilize during inhalation and Mixing of acidic and acidic vapors results in the formation of the corresponding nicotine salt (or the corresponding salt of other active agent bases) within the device. This salt enters the respiratory tract with inhaled air in the form of droplets or particles. Due to the neutral response to mucosal salt, this type of inhalation is significantly better tolerated than can be achieved with known inhalation devices.

  In this regard, it is preferred that the first, nicotine base-containing preparation and the second, acid-containing preparation are applied at different locations within the device. By doing so, upon inhalation, some airflows flow over the first preparation, other airflows flow over the second preparation, and then two airflows (the nicotine base and acid volatilized therein). Air inlet channels can be configured so that they can be mixed and then inhaled.

  During inhalation, the active agent base (eg, nicotine base) contained in the first preparation and the volatile acid contained in the second preparation are volatilized passively. This process can be arbitrarily accelerated by the application of heat. Suitable means for this are known to those skilled in the art.

When the device according to the invention is used, an aerosol is formed by the ambient air flowing therethrough. This is especially true when high concentrations of activator base and high concentrations of acid are present in the vapor. The formation of this aerosol is due to the low volatility of the nicotine salt, forming a salt mixture or salt solution droplet. The formation of the aerosol is at the same time a reason for the substantial increase in tolerability, since nicotine is no longer present in free form and can no longer act as alkali via the external gas phase. As a result, only the deposition of aerosol particles in the alveoli can result in the application and absorption (resorption) of the active agent in the lung. These aerosol droplets, either as a salt component partially dissolved in water or as a solid dispersion, are more than possible by devices known in the prior art due to neutral mucosal reactions (rather than alkaline) It is much better tolerated.
Although aerosol formation is useful, it is not essential to achieve a therapeutic result according to the present invention. Overall, a high dilution of the supplied vapor (thus suppressing the formation of aerosols) can be more useful with regard to tolerability.

  The size of the aerosol particles formed by the inhalation system of the present invention depends inter alia on the velocity of the air stream (flow rate) and the concentration of the individual gaseous components (basic active agent and acid, respectively) in the mixing zone. Advantageous for absorption in the alveoli are aerosol particles with a size of less than 10 μm (average diameter), in particular 5-10 μm.

  In a preferred embodiment, the inhalation device includes a first air inlet, a second air inlet and an air outlet. These openings are such that the airflow flowing through the first air inlet is primarily over the first preparation and the airflow flowing through the second air inlet is primarily the second or further preparation. Passing over the object, the two air streams are arranged to mix later in the path and exit the device through the outlet.

  More preferably, the device has longitudinal recesses, grooves or channels therein, thereby forming first and second air inflow channels and air escape channels. These ventilation paths are opened outward through the air inlet and the air outlet, respectively. The first preparation is located in an elongated recess that forms a first air inlet channel, and the second preparation is located in an elongated recess that forms a second air inlet channel. Each preparation is preferably applied near the respective air inlet.

  In general, it is contemplated that the molar evaporation rates of the two components (activator base, acid) are approximately equimolar ratios. As described, when the nicotine-containing preparation and the acid-containing preparation are applied to two separate air supply channels with associated air inlets, the respective release rates are in particular in the two channels. It can be controlled by flow conditions. For example, a release rate of 100 μg / 10 seconds can be provided for the airflow flowing through the first opening and hence the first air supply channel. In this case, if acetic acid is used as the acidic component, a release rate of about 50 mg / 10 seconds is suitable for the second air stream.

  With regard to the release rate that can be obtained, the inhalation device of the present invention has a duration of 1 to 10 seconds, during which one inhalation process reaches 0.1 to 1 l / min. ~ 250 μg, preferably 10-100 μg of nicotine base or another basic agent is released from the preparation during inhalation. For example, 100 μg of nicotine base can be administered during a single breath that lasts 10 seconds and has an inspiration rate of 0.1-1 l / min. This release rate is suitable for therapeutic purposes.

  The device preferably has a wide passage cross-sectional area throughout its structure so as not to disturb the inhalation process as much as possible. In particular, the conduit cross-section of the air inlet and the tube cross-section of the air outlet are set so that the negative differential pressure in the oral cavity during the inhalation process does not exceed 300 Pa. The case is true.

  Acetic acid is preferably used as the volatile acid. Other acids may be used as well (for example, lactic acid, malic acid, if it is volatile at room temperature (about 15-25 ° C.) or can be converted to the vapor phase by thermal shock (up to about 100 ° C.). Propionic acid). Even combinations of different acids can be used. Acetic acid is used in lower concentrations and higher total amounts due to its higher volatility and in combination with additives. Volatile and inhalable basic active agents are understood in particular as agents which are volatile or can be converted into the vapor phase at the temperatures mentioned above.

  Furthermore, according to a specific embodiment, the active agent-containing preparation further comprises at least one solvent suitable for inhalation (preferably ethanol) and / or at least one volatile auxiliary substance (preferably menthol). Including. The acid-containing preparation likewise comprises at least one such solvent and / or at least one volatile aid. Suitable volatile auxiliaries are, in particular, pleasantly flavored and fragrant substances (for example limonene, eucalyptol, mint oil, camphor, or other substances from the terpene group, including combinations of said substances) .

The present invention further includes a method for manufacturing the above device. These methods generally include the following steps.
A vertically elongated first recess for receiving the first preparation and a longitudinal recess for receiving the second preparation by deep drawing or other molding methods known to those skilled in the art (eg injection molding). Producing a molded part including the second recess,
Introducing a predetermined amount of a first preparation comprising nicotine base or other basic active agent into said first recess;
A step of introducing a predetermined amount of the second preparation containing one or more acids into the second recess.

  The device according to the present invention can be manufactured easily and at low cost by using a molded part manufactured by deep drawing. A preferred material suitable for this purpose is a polyester material with a basic agent, in particular a coating impermeable to nicotine. Suitable for this purpose are inter alia copolymers of acrylonitrile and methacrylate (Barex®, BP). A laminated sheet of polyethylene terephthalate and Barex is preferably used.

  Due to the deep drawing, a vertically long recess is provided in the molded part, which forms two air supply channels. Furthermore, a further longitudinal recess may be provided in connection with the two recesses, which forms an air outflow channel. The air inflow channel and air outflow channel are essentially tubular in shape, but they may also be of different shapes.

  The molded part provided with the recess forms the bottom of the device. The upper part may be formed by a second molded part having a correspondingly provided recess or by a flat film or layer serving as a cover. The top and bottom are connected to each other in a known manner (eg adhesive bonding, sealing) after application of the preparation.

The recesses that form the air supply channels in one or more molded parts may be provided with additional bulges (which may also be generated by deep drawing), so that the evaporation rate of each volatile component is geometric. The shape may be limited. This strategy offers the additional possibility of achieving favorable delivery of equimolar amounts of active agent base and acid.
The device is at least partly, however, preferably entirely from a material that is impermeable to the active agent, in particular a polyester material with the coating described above, and / or a metal foil, or a combination of these materials It is made up.

  Suitable as substrates for the preparation of the preparations in principle receive nicotine base or other active agent bases or the stated volatile acids and, under inhalation conditions, these substances to ambient air. Any material that can be used to make a reservoir that releases by evaporation. Suitable materials for this purpose are known to those skilled in the art.

  Suitable materials are, for example, polymeric materials such as those used in the manufacture of active substance reservoirs for transdermal therapeutic systems. In this step, the active substance (or acid) is dissolved or dispersed in a polymeric substrate (eg polyacrylate), optionally with the addition of auxiliary substances, and the resulting mass is placed on an inert support. Coat and dry. A portion of a given surface area and layer thickness with a known content of active agent or acid is separated from the dried active agent-containing layer. As described, these parts can then be inserted as a preparation as described above into the device of the invention. The preferred layer thickness and surface area of the sheet-like preparation introduced into the vent space of the device is derived from pharmaceutical practice.

The nicotine preparation inserted in the device according to the invention typically has a content of 10% by weight and the dose is typically 500 mg. The concentrations and doses used in each individual case may deviate from these exemplary values. In particular, the content of active substance may be 1 to 80% by weight and the dose may be 10 to 1000 mg.
Suitable as polymeric substrates are in particular polymers from the group comprising polyethylene, polypropylene, silicone polymers (polydimethylsiloxane) and poly (meth) acrylates.

  The above preparation can further be made with a thermoplastic polymer, which is liquefied and the components (basic active agent and / or acid) are weighed into the hot polymer. The still liquid preparation is applied in the position intended for this purpose of the deeply drawn inhalation device and left to solidify.

  According to a further variant of the invention, a mixture of a silicone polymer (polydimethylsiloxane) and a crosslinking agent (eg a platinum-containing crosslinking agent) is used as the substrate. The nicotine base or volatile acid component is weighed into the mixture in cold form under cold conditions. A predetermined amount of this mixture is applied to each position intended for this purpose. After closing the device, it is post-treated by applying heat, thereby forming a three-dimensional structure of the active agent release preparation.

The activator-containing or acid-containing preparation is preferably applied near the air inlet of each air supply channel.
The material utilized to close the device is preferably a material that is impermeable to volatile components, as described above.

In a further preferred embodiment, the inhalation device is coated after its manufacture with a peelable protective layer that is impermeable to basic agents. This protective layer is removed by the user himself immediately before use. The applied protective layer forms a compartment containing a basic active substance and a compartment containing an acid, both compartments being isolated from each other in a substantially airtight manner and sealed from ambient air. Is done. In this way, premature reaction and aging of the components are prevented. Only after removing the protective layer can the gas exchange occur again between the two compartments.
If necessary, the air inlet and the air outlet are also covered with a protective film.

The device can be advantageously used for smoking cessation or for non-smoking sufficiency of nicotine cravings in necessary situations.
The invention will now be described by way of example and by means of a schematic representation using the accompanying drawings. The meanings of the reference numbers are the same in all drawings unless otherwise specified.

FIG. 1A shows a device (1) according to the invention in commercial form (cross-sectional view). The device is formed by the outer wall (2). It has two vent channels (a, b) and expands approximately in the middle to form one of the chambers (3a, 3b), respectively, and then merge to form an air escape channel (7). In the chambers (3a, 3b) there are nicotine-containing preparation (5) and acid-containing preparation (4), respectively.
FIG. 1A shows the conditions of the present invention prior to use. The inlets and outlets of the ventilation channels (a, b) are still closed and the chambers (3a, 3b) are mutually connected to the membrane (13 ).

  FIG. 1B shows in FIG. 1A under operating conditions after opening the membrane (13) (eg, by the action of heat or by pushing in) and opening the inlet and outlet (A, B, C). Device (similarly in longitudinal section). The inlet and outlet may be opened (for example, layer (8) in FIG. 1B) by tearing or tearing along perforations (11, 12 in FIG. 1A) provided in the device. Is not shown).

  During intake, air flows on the one hand through the air inlet (A) and the air supply channel (a) and on the other hand through the air inlet (B) and the air supply channel (b). Dashed arrows indicate the direction of air flow during inhalation. The two air supply channels (a, b) are combined to form an air escape channel (7) with an air outlet (C). In the region of the air supply channel (a) there is a nicotine-containing preparation (5) immediately after the inlet (A), and in the region of the air supply channel (b) there is an acid containing immediately after the inlet (B). There is a preparation (4). As air flows through it, nicotine volatilizes from the preparation (5) into the air channel (a) and acidic compounds evaporate from the preparation (4) into the air channel (b). In the region of the air escape channel (7), alkaline and acidic vapors are mixed and approximately neutral to slightly acidic conditions are achieved. Aerosol formed of ambient air and nicotine salt contained therein is inhaled through the outlet (C), preferably through the oral cavity.

  FIG. 1C shows a cross-section at plane X of the inhalation device schematically shown in FIG. 1B. The air inflow channels (a, b) are pre-formed by deep drawing so that they have a recessed shape. In the region of the air channel (a, b) there is an active agent-containing preparation (5) and an acid-containing preparation (4), respectively. The device is covered with a flat, nicotine-impermeable layer (8) on the underside.

  FIG. 2A shows a further embodiment (in longitudinal section) of the inhalation device according to the invention in commercial form. The inlet and outlet (A, B, C) are still closed. The central region of the channel (a, b) is expanded to form the respective chamber (3a, 3b). The chambers (3a, 3b) of the individual preparations (4, 5) are arranged next to each other and spatially separated from each other (before use) so that mixing of the preparations is not yet possible. Status).

  FIG. 2B shows a cross section in plane X of the inhalation device schematically shown in FIG. 2A. The air inflow channels (a, b) and the chambers (3a, 3b) are pre-formed by a deep drawing in the outer wall (2) and have a recessed shape. Inside the chambers (3a, 3b) there are active substance-containing preparation (5) and acid-containing preparation (4), respectively. The device is covered with a flat, nicotine-impermeable layer (8) on the underside.

  FIG. 2C is a further longitudinal cross section of the embodiment shown in FIGS. 2A and 2B. The device is shown ready for use. To use the device described in FIG. 2A, before use, it is folded along a line (14), which can be provided in the form of perforations or weakened lines, and folded along the center. This ensures that the two vent channels (a, b) and the chambers (3a, 3b) lie on top of each other in the longitudinal direction. The openings of the air inflow and air outflow channels may each be opened, for example, by tearing along perforations (11, 12) provided for this purpose. In this way a functional inhalation device is obtained. Dashed arrows indicate the direction of airflow during inhalation. The tube or mouthpiece (9) can be slid over the two outlets (C, C '), thereby forming a combined air outlet channel (7') and a combined outlet (D).

FIG. 2D shows a cross section in plane X of the operable device shown in FIG. 2C. Chambers (3a, 3b) formed by deep-drawn walls (2, 2 ′) and layers (8, 8 ′) are located on top of each other.
FIG. 2E shows a cross section in plane Y of the operable device shown in FIG. 2C. Dashed arrows indicate the direction of airflow during inhalation. During inspiration, the air stream (A, B) flows through separate channels (a, b) and passes over the preparation (4, 5) located in the chamber (3a, 3b). The resulting vapor or aerosol meets in the region of the air outflow channel (7 ′) formed by the tube or mouthpiece (9) and exits the device via the outlet (D).

  3A and 3B show a further embodiment of the device according to the invention (in perspective), in which a tube or mouthpiece (30) into which a cylindrical insert (31) can be inserted. Is described. The internal space of the insert (31) is divided into two chambers (33, 34) by a dividing wall (32) extending in the longitudinal direction, which chambers serve to receive the active agent preparation and the acid component, respectively. Fulfills (not shown). The insert is surrounded by a cylindrical container (35) (in FIG. 3A this is shown partially cut away). In the rear end region, an opening (36) is provided in the container. The opening serves as an air inlet. A further air inlet (37) is provided in the rear face (38), which closes the rear end of the insert (31). FIG. 3C shows a plan view of this rear surface. The number and arrangement of openings can be varied.

  The nicotine-containing preparation is placed in the chamber (33, 34) during manufacture. For example, a carrier material (eg, sponge or filter paper) impregnated with nicotine and a carrier material impregnated with a volatile acid (preferably acetic acid) are placed in separate chambers. Optionally, a flavoring or fragrance may be incorporated together. All openings, ie the front end (V), and the openings (36, 37) are closed with a suitable protective film or foil.

Prior to use, the protective film is removed and the insert (31) is inserted into the mouthpiece (30). By sucking the mouthpiece, air is sucked through the two rear openings (36, 37). This air flows through the two chambers (33, 34) over the carrier material, thereby carrying nicotine vapor, acid vapor, and optionally fragrance vapor. These vapors vortex in the mouthpiece area before entering the oral cavity. Mixing nicotine vapor and acid vapor facilitates inhalation of nicotine. For this purpose, the mouthpiece (30) is advantageously provided with a plurality of protrusions or teeth (39). These are preferably arranged in a plurality of offset rows from next to next. The mouthpiece (30) is a substantially cylindrical sleeve open at both ends. This is preferably shorter than the insert (31).
The protrusions or teeth (39) may be configured as a spiral, S-shaped or spiral baffle, which achieves better air vortex flow and therefore better gas mixing.

  FIG. 4A shows a perspective cross-sectional image of a further embodiment of the device according to the invention. The device includes a sleeve-shaped mouthpiece (30) to which the tube (41) can be rotatably attached or the tube can be rotatably slid, Alternatively, the tube (41) can be inserted rotatably (in the direction of the arrow). Preferably, the mouthpiece end (40) is configured to snap onto when the tube (41) is slid over the mouthpiece. The opening facing the mouth of the mouthpiece is provided with a plurality of protrusions (39) as shown in FIG. The internal space of the mouthpiece (40) is divided into four chambers by two dividing walls. The opening connected to the tube (41) is partially closed. Preferably, at least one sector of the substantially circular cross section of the mouthpiece, eg, two opposing sectors, is closed as shown in FIG. 4B.

The slip-on tube (41) is open at both ends and is divided into four chambers in the same manner as the mouthpiece (by the walls (44, 45)). The nicotine-containing preparation and the acid-containing preparation are each located in two opposing chambers. Also provided are embodiments in which the mouthpiece and tube are divided into two or three, or four or more interior spaces.
The walls or baffles (44, 45) may also be configured in a spiral, S-shape, or spiral, which provides a stronger air vortex and therefore better gas mixing. .

  A nicotine-containing tube is manufactured by inserting a nicotine-containing carrier material into the first chamber of the tube and inserting the acid-containing carrier material into the corresponding opposite chamber (optionally modified with a fragrance. ) Thereafter, all openings are closed with a suitable film or foil. In addition, the remaining chamber of the tube can be filled with additional active agents or fragrances.

  To use, the protective film is removed and the tube (41) is slid into the mouthpiece (40) and snapped on. The tube is rotatably fitted so that the filled chamber can be opened and closed by rotating the tube relative to the mouthpiece (see double arrow). This gives the consumer the possibility to adjust the airflow they wish to inhale. If desired, the open end of each mouthpiece and tube can be closed with a removable cap.

FIG. 5 shows a modification of the embodiment described in FIG. 4 (in cross section). The interior space of the mouthpiece (40) and the tube (41) is divided into four tubular chambers (51, 52, 53, 54). (50) shows the mouthpiece and the cylindrical wall of the tube, respectively.
In this context, it is advantageous to be able to insert the carrier material impregnated with the active agent or acid into the tube in the form of a “cartridge”. In this case, the tube forms a unit with the mouthpiece and can be permanently (but rotatably) connected to it. This means that the entire device is reusable. “Cartridges” can be stored separately and can be manufactured to have different nicotine contents (or to contain different active agents).

  FIG. 6 schematically shows a further advantageous embodiment of the device according to the invention. An activator-containing preparation (not shown) is located in the first compartment (61), which forms a larger gas space in which activator vapor can accumulate. The acid-containing preparation is located in the second compartment (62), optionally in combination with a fragrance. Thick arrows indicate the direction of airflow that occurs during inhalation. Air is sucked in through the inlets (64, 65). They may be equipped with valves to prevent premature mixing of the components (active agent, acid) and / or to prevent the components from leaking out.

  When inhaled through the mouthpiece (63), air flows through the device along two different paths. (I) Air flows into the compartment (61) through the side opening (64), in the process, the gas space presaturated by the vapor pressure is mixed in the front part of the mouthpiece (63) Pour into the area. (Ii) At the same time, air is drawn into the second compartment (62) through the side opening (65). In this process, this air also flows auxiliary substances (acids, and possibly fragrances) into the mixing zone at the front of the mouthpiece (63). In the mixing zone, the two air streams mix with each other. During this mixing process, the desired neutralization of the activator base occurs.

Figure 2 shows a cross section of the device of the invention in commercial form. It is the figure which showed the cross section of the longitudinal direction in the operation state of the device of this invention shown to FIG. 1A. It is the figure which showed the cross section in the surface X of the inhalation device shown to FIG. 1B. Figure 2 shows a longitudinal section of a further embodiment of the device of the invention in commercial form. It is the figure which showed the cross section in the surface X of the inhalation device shown to FIG. 2A. 2A and 2B show further cross sections in the longitudinal direction of the embodiment shown in FIGS. 2A and 2B. 2D shows a cross-section at plane X of the operable device shown in FIG. 2C. FIG. 2D shows a cross-section in plane Y of the operable device shown in FIG. 2C. FIG. FIG. 4 shows a further embodiment of a device according to the invention. 3A and 3B are perspective views and FIG. 3C is a plan view of the rear surface of the device. FIG. 4 shows a further embodiment of a device according to the invention. 4A is a perspective view, and FIG. 4B is a cross-sectional view. It is the figure which showed the cross section of the change aspect of the aspect shown in FIG. FIG. 5 is a schematic diagram illustrating a further advantageous embodiment of the device of the present invention.

Claims (24)

A device for administering a basic active agent, in particular nicotine, to the human or animal body by inhalation, the device comprising:
-A first preparation containing nicotine base or / and other basic active agent,
A second or plurality of preparations, at least one preparation comprising a preparation containing at least one volatile acid suitable for inhalation,
Said device.   Device according to claim 1, characterized in that the preparation is applied at different locations within the device.   1 or 2 characterized in that the first preparation contains nicotine base or / and other basic active agent in combination with at least one solvent suitable for inhalation, preferably ethanol. The device described.   One or more volatile acids are contained in the preparation in combination with at least one solvent suitable for inhalation, preferably in combination with ethanol. The device described.   The device according to any of claims 1 to 4, characterized in that the inhalable one or more volatile acids are selected from the group comprising acetic acid, lactic acid, malic acid and propionic acid.   2. During the inhalation process, the device releases nicotine base on the one hand and one or more volatile acids on the other hand in approximately equimolar amounts from the preparation. The device according to any one of -5.   During the inspiratory process that lasts 1-10 seconds and reaches an inspiratory rate of 0.1-1 l / min, the device receives 5-250 μg, preferably 10-100 μg nicotine base or other basic active agent. 7. A device according to any of claims 1 to 6, characterized in that it is released from the preparation during inhalation.   8. Device according to any one of the preceding claims, characterized in that during inhalation, aerosol particles are formed in the internal space of the device, the size of the particles being preferably less than 10 [mu] m.   9. One or more preparations according to claim 1, characterized in that they contain at least one further additive, preferably menthol, which is volatile and suitable for inhalation. The device described.   10. The nicotine base-containing preparation or acid-containing preparation has at least one polymer matrix containing an active agent or acid, preferably in dissolved or dispersed form. Devices.   11. Device according to claim 10, wherein the polymer matrix is preferably based on a polymer selected from the group comprising polyethylene, polypropylene, silicone polymer (polydimethylsiloxane) and poly (meth) acrylate.   At least partly, preferably entirely, of a material impermeable to one or more active agents, in particular a polyester material coated with a copolymer of acrylonitrile and methacrylate, and / or one or two 12. Device according to any one of the preceding claims, characterized in that it is made of one or more metal foils or a combination of said materials.   The device is coated with a peelable protective layer that is impermeable to one or more basic active agents after manufacture and during storage, thereby providing one or more active agents And a compartment containing one or more acids are formed by the peelable protective layer, both compartments being hermetically separated from each other and sealed from ambient air A device according to any of claims 1 to 12, characterized in that   The device has a first air inlet, a second air inlet and an air outlet, whereby the airflow flowing through the first air inlet mainly flows over the first preparation; and The airflow flowing through the second air inlet mainly flows over the second or further preparation, and the two airflows are then combined in the path and exit the device through the outlet. 14. A device according to any of claims 1 to 13, characterized in that   15. The pipe section of the air inlet and the air outlet is dimensioned so that the negative differential pressure present in the oral cavity during the inhalation process is a maximum of 300 Pa, preferably a maximum of 200 Pa. Device described in.   Formed by combining these two air channels, and at least one molded part made by deep drawing with an elongated recess defining a first air supply channel and a second air supply channel 16. A device according to any of claims 1 to 15, characterized in that it comprises an air outlet channel.   The upper part and the lower part each formed by deep drawing, these two molded parts are provided with recesses and are connected to each other, so that the recesses located opposite each other allow the air inlet A first air supply channel having an air inlet and a second air supply channel having an air inlet are formed, and an air outflow channel having an air outlet is formed by combining the two air channels. The device according to claim 1, characterized in that:   The first preparation is located in the elongated recess that forms the first supply channel, and the second preparation is located in the elongated recess that forms the second supply channel, preferably the preparation Device according to any of the preceding claims, characterized in that the object is applied in the vicinity of the respective air inlet opening. A method for manufacturing a device according to any of claims 1 to 18, wherein the method comprises the following steps:
A molded part, preferably a deep draw, comprising a longitudinally depressed first recess for receiving the first preparation and a longitudinally recessed second recess for receiving the second preparation; The process of producing by,
Introducing a predetermined amount of a first preparation containing a nicotine base or other basic active agent into the first recess,
Introducing a predetermined amount of a second preparation containing one or more acids into the second recess,
Said method.   The filled molded part is coated with a peelable protective layer that is impermeable to basic substances, thereby providing compartments containing one or more active agents and one or more 20. A method according to claim 19, characterized in that the acid-containing compartments are formed by the peelable layer, the compartments being hermetically separated from each other and sealed to ambient air.   21. A deeply drawn further recess, which is connected to two other recesses and forms an air outflow channel during the production of the molded part, is formed by deep drawing. The method described.   The filled molded part serves as an upper part and is connected to a molded part having a longitudinal recess corresponding to the recessed part of the filled molded part, whereby a first air supply having an air inlet 22. A method according to claim 21, characterized in that the channel, the second air supply channel with an air inlet opening and the air outlet channel with an air outlet are formed by respective overlapping recesses. .   Use of the inhaler according to any one of claims 1 to 18 for smoking cessation or for the fulfillment of nicotine cravings in non-smoking situations where necessary.   Use of the inhaler according to any of claims 1 to 18 for simultaneous inhalation of a basic active agent and one or more volatile acid compounds.

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