CN1889861B - Alkaline drug inhaler and its manufacturing method - 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

″；Pharmaci/辉瑞)。然而，由于用后一种吸入器，吸入时只有少量的尼古丁变得有效，所以该装置没有得到广泛使用。这特别是由于已知吸入器技术的基本缺陷和用这些技术可以达到的耐受性。特别地，由尼古丁的碱性导致的对呼吸道粘膜的局部刺激作用是不利的，因为这种刺激作用引起急迫的咳嗽，其导致由吸入器释放的尼古丁蒸气的吸收减少。这样只有非常少量的尼古丁被身体吸收。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). Over the years, nicotine inhalers have also been available on the market in several European countries as smoking cessation products ("Nicorette

"; Pharmaci/Pfizer). However, since with the latter inhaler, only a small amount of nicotine becomes effective when inhaled, this device has not been widely used. This is especially due to the fundamental drawbacks of known inhaler technology and the use of these Tolerance achievable by technology. 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 the absorption of the nicotine vapor released by the inhaler Reduced. 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.

；英国)的共聚物。优选使用聚对苯二甲酸乙二醇酯-Barex层压板。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 acrylonitrile and methacrylate (Barex

; UK) copolymers. 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 (28)

1. give the suction apparatus of human or animal body alkalescence active material by the mode that sucks, wherein said suction apparatus comprises:

Comprise nicotine alkali or/and first preparation of another alkaline active material;

Second or a plurality of other preparation, described second or a plurality of other preparation at least one comprise at least a volatile acid that is suitable for sucking;

It is characterized in that, described suction apparatus has first air admission hole, second air admission hole and venthole, mainly flow through described first preparation so that flow to the air-flow of first air admission hole, and the air-flow that flows to second air admission hole mainly flows through described second or other preparation, these two air-flows merge on its path subsequently, and leave this suction apparatus through described venthole; And be, describedly comprise nicotine alkali and comprise described nicotine alkali or/and the polymer substrate of another alkaline active material or/and first preparation of another alkaline active material has wherein with the dissolving or the form of disperseing, and/or described second or a plurality of other preparation that comprises at least a volatile acid that is suitable for sucking have wherein the polymer substrate that comprises the described volatile acid that is suitable for sucking with the dissolving or the form of disperseing, and the polymer substrate of described first preparation and described second or the polymer substrate of a plurality of other preparations all comprise polyethylene based on being selected from, polypropylene, polymer in the group of silicone polymer and poly-(methyl) acrylate.

2. suction apparatus according to claim 1 is characterized in that, use the position that described first preparation and second preparation or a plurality of other preparation separate in this suction apparatus.

3. suction apparatus according to claim 1 is characterized in that, described first preparation comprises the nicotine alkali that combines with at least a solvent that is suitable for sucking or/and another alkaline active material.

4. suction apparatus according to claim 1 is characterized in that, the described volatile acid that is suitable for sucking combines and is contained in described second preparation or described a plurality of other preparation with at least a solvent that is suitable for sucking.

5. according to claim 3 or 4 described suction apparatus, it is characterized in that the described solvent that is suitable for sucking is an ethanol.

6. suction apparatus according to claim 1 is characterized in that, the described volatile acid that is suitable for sucking is to be selected from the group that comprises acetic acid, lactic acid, malic acid and propionic acid.

7. suction apparatus according to claim 1 is characterized in that, in suction process, nicotine alkali and the volatile acid that is suitable for sucking discharge from described first preparation and described second preparation or described a plurality of other reagent respectively with approximate equimolar amounts.

8. suction apparatus according to claim 1, it is characterized in that, continuing 1～10s and reaching in the suction process of air-breathing speed of 0.1～1l/min, described suction apparatus discharges nicotine alkali or another the alkaline active material of 5～250 μ g from described first preparation to inhaled air.

9. suction apparatus according to claim 8 is characterized in that, described suction apparatus discharges the nicotine alkali of 10～100 μ g or/and another alkaline active material from described first preparation to inhaled air.

10. suction apparatus according to claim 1 is characterized in that, in suction process, forms aerosol particles in the inner space of described suction apparatus.

11. suction apparatus according to claim 10 is characterized in that, the size of described aerosol particles is less than 10 μ m.

12. suction apparatus according to claim 1 is characterized in that, described first preparation and/or described second preparation or described a plurality of other preparation comprise at least a other volatile and additive that is suitable for sucking.

13. suction apparatus according to claim 12 is characterized in that, described other additive is a menthol.

14. suction apparatus according to claim 1 is characterized in that, this suction apparatus is at least in part by for the impervious material manufacturing of described alkaline active material.

15. suction apparatus according to claim 1 is characterized in that, this suction apparatus is fully by for the impervious material manufacturing of described alkaline active material.

16. according to claim 14 or 15 described suction apparatus, it is characterized in that, describedly be selected from for the impervious material of described alkaline active material: be coated with the polyester material of acrylonitrile and methacrylate copolymer, and/or the combination of metal forming or above-mentioned material.

17. suction apparatus according to claim 1; it is characterized in that; after this suction apparatus manufacturing and in storing; with the impervious peelable protective layer of alkaline active material is covered; thereby formed the chamber of containing alkaline active material and the chamber of containing the acid that is suitable for sucking by this peelable protective layer, these two chambers are separated from each other in airtight mode and are isolated with surrounding air.

18. suction apparatus according to claim 1 is characterized in that, the cross-section of pipeline of air admission hole and venthole forms and makes that the negative dividing potential drop in the oral cavity mostly is 300Pa most in suction process.

19. suction apparatus according to claim 1 is characterized in that, the cross-section of pipeline of air admission hole and venthole forms and makes that the negative dividing potential drop in the oral cavity mostly is 200Pa most in suction process.

20. suction apparatus according to claim 1, it is characterized in that, this suction apparatus comprises at least one by the molded component that deep drawing methods is made, and wherein has the microscler recess that forms first air intake duct and second air intake duct and pass through to merge the gas off-take of these two air flues formation.

21. suction apparatus according to claim 20, it is characterized in that, this suction apparatus has top and the bottom that respectively forms by deep drawing methods, these two molded components have described microscler recess and are connected to each other in following mode: by microscler recess positioned opposite to each other, formed first air intake duct with first air admission hole and second air intake duct with second air admission hole, and by the gas off-take with venthole in conjunction with these two air intake ducts.

22., it is characterized in that described first preparation is arranged in the microscler recess that forms first air intake duct according to claim 20 or 21 described suction apparatus, and described second preparation is arranged in the microscler recess that forms second air intake duct.

23. make according to each the method for suction apparatus in the claim 1～22, this method may further comprise the steps:

Make molded component, described molded component comprises the first microscler recess that receives described first preparation, and receives the second microscler recess of described second preparation;

First preparation that contains nicotine alkali or another alkaline active material of scheduled volume is put into the described first microscler recess;

Second preparation of the acid that is suitable for sucking containing of scheduled volume is put into the described second microscler recess.

24. method according to claim 23; it is characterized in that; the molded component of filling is used the impervious peelable protective layer of alkaline active material is covered; thereby form the chamber that contains the chamber of this alkalescence active material and contain the acid that is suitable for sucking by peelable protective layer, these two chambers are separated from each other in airtight mode and are isolated with ambient air.

25. according to claim 23 or 24 described methods, it is characterized in that, in the molded component manufacture process, formed a microscler recess again that is connected and forms air flue with the described first microscler recess with the described second microscler recess by deep drawing methods.

26. method according to claim 25, it is characterized in that, the molded component of filling be connected as top and molded component with microscler recess corresponding with the recess of the molded component of described filling, thereby form first air intake duct by recess separately, stacked with first air admission hole, second air intake duct with second air admission hole, and gas off-take with venthole.

27. be used to give up smoking or be used for the smokeless application of satisfying that nicotine is craved for according to each the suction apparatus in the claim 1～22.

28. be used for sucking simultaneously alkaline active material and one or more volatile acid application of compound according to each the suction apparatus in the claim 1～22.

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