CN1889861B - Inhaler for basic pharmaceutical agents and method for production thereof - Google Patents
Inhaler for basic pharmaceutical agents and method for production thereof Download PDFInfo
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- CN1889861B CN1889861B CN2004800361875A CN200480036187A CN1889861B CN 1889861 B CN1889861 B CN 1889861B CN 2004800361875 A CN2004800361875 A CN 2004800361875A CN 200480036187 A CN200480036187 A CN 200480036187A CN 1889861 B CN1889861 B CN 1889861B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
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- A—HUMAN NECESSITIES
- A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
- A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
- A24F42/00—Simulated smoking devices other than electrically operated; Component parts thereof; Manufacture or testing thereof
- A24F42/20—Devices without heating means
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- A—HUMAN NECESSITIES
- A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
- A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
- A24F42/00—Simulated smoking devices other than electrically operated; Component parts thereof; Manufacture or testing thereof
- A24F42/60—Constructional details
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- A—HUMAN NECESSITIES
- A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
- A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
- A24F42/00—Simulated smoking devices other than electrically operated; Component parts thereof; Manufacture or testing thereof
- A24F42/80—Manufacture
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0003—Details of inhalators; Constructional features thereof with means for dispensing more than one drug
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/06—Inhaling appliances shaped like cigars, cigarettes or pipes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/34—Tobacco-abuse
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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
Technical field
The present invention relates to give the device of human or animal body alkalescence active material, particularly nicotine by the mode that sucks.The invention further relates to the manufacture method that can obtain this device, and described device is used to give up smoking or is used to thirst for the smokeless application of satisfying of nicotine in the case of necessary.
Background technology
For many years, the Nicotine suction device that gives nicotine by means of air-breathing middle inhaled air has been well-known (as United States Patent (USP) 4 917 120 and United States Patent (USP) 5 167 242).For many years, Nicotine suction device also can obtain (" Nicorette as the smoking cessation product on the market of several European countries
"; Pharmaci/ Pfizer).Yet, owing to, have only a spot of nicotine to become effectively during suction, so this device is not used widely with a kind of inhalator in back.This is particularly because the basic defect of known inhalator technology and the tolerance that can reach with these technology.Especially, the local irritant effect to respiratory mucosa that is caused by the alkalescence of nicotine is disadvantageous, because this spread effect causes urgent cough, it causes the absorption of the nicotine steam that discharged by inhalator to reduce.Have only very small amount of nicotine to be absorbed like this by health.
Summary of the invention
So the purpose of this invention is to provide a kind of Nicotine suction device, this inhalator can absorb nicotine through respiratory tract, and causes as far as possible little stimulation and deep as far as possible absorption.
This purpose is the device according to independent claims and its appended claims, and realize according to the preparation method of claim 19 and its appended claims.
Therefore, device characteristic according to the present invention is, this device comprises and contains nicotine alkali or/and first preparation of other volatility, the alkaline active material that can suck, and it further comprises second preparation or a plurality of other preparation, and at least one in described second preparation or described other preparation contains at least a volatilizable and acid that is suitable for sucking.So device characteristic according to the present invention is, during suction, except active material alkali (as nicotine alkali), has also sucked one or more volatile acid compounds simultaneously.
Device according to the present invention is suitable for giving human or animal body alkaline matter, especially nicotine by the mode that sucks.Suitable alkaline matter is that for example selegiline (selegiline) is or/and mecamylamine (mecamylamine).The combination of nicotine and mecamylamine especially preferably is applicable to smoking cessation.
Because containing first preparation of nicotine alkali (or other active material alkali) exists simultaneously with another preparation that contains volatile acid, so nicotine alkali and volatile acid are volatilized when sucking, thereby cause the mixture of alkali and acid vapour to form corresponding nicotine salt (or the corresponding salt of other active material alkali) in this device.This salt enters respiratory tract with the form of drop or particulate with sucking air.Because mucous membrane is to the neutral reaction of salt, so compare with the suction that can reach with known suction apparatus, this class sucks and demonstrates better tolerance.
About this point, preferred described contain first preparation of nicotine alkali and contain the position that second preparation of acid separates in device use.Like this, can the setting air air intake duct, thereby when sucking, a part of airflow passes first preparation, and another part airflow passes second preparation, and these two air-flows (wherein containing the nicotine alkali and the acid of volatilization) merge subsequently, can be inhaled into then.
During suction, be contained in active material alkali (as nicotine alkali) in first preparation and the volatile acid that is contained in second preparation and volatilize passively.Can optionally quicken this process by adopting heating; The method that is applicable to this purpose is known for those skilled in the art.
When using, in the outside air that flows into, form aerosol, especially when active material alkali that in steam, has high concentration and acid according to device of the present invention.The formation of this aerosol is because the lower volatility of nicotine salt, salt mixture or the salt drop that forms.Because no longer there is and no longer plays via outer gas phase the effect of alkali in nicotine with free alkali, so the aerosol that forms also is the reason that significantly improves tolerance simultaneously.As a result, have only aerosol particles can cause active material in lung, to be used and absorb (absorbing again) at the particle deposition of alveolar.These aerosol droplets are perhaps as the salt component that is partially soluble in water, perhaps as solid dispersion, because neutral (replacement alkalescence) mucosa reaction demonstrates and is much better than the tolerance that device as known in the art may demonstrate.It is useful that aerosol forms, but for realizing that result of treatment according to the present invention is not absolutely necessary.Generally speaking, suppressing the high dilution of the supply steam of aerocolloidal formation, also is useful aspect tolerance.
The size of the aerosol particulate that forms by intake system according to the present invention the most important thing is to depend on the concentration of each gaseous component (being respectively alkaline active material and acid) in the speed (flow velocity) of air-flow and the mixed zone.The size of aerosol particulate is lower than 10 μ m (average diameter), helps alveolar especially and absorb in 5～10 μ m.
According to preferred embodiment, suction apparatus comprises first air admission hole, second air admission hole and venthole.These holes are set so that the air-flow of first air admission hole of flowing through mainly passes through described first preparation, and the air-flow of second air admission hole of flowing through is mainly by described second or other preparation, these two air-flows merge on its path subsequently, and through described venthole separating device.
This device further preferably has rectangle recess, groove or ditch within it, thereby forms first and second air intake ducts and gas off-take.These air flow paths are respectively open towards the outside by described air inlet and gas outlet respectively.Described first preparation is arranged in the rectangle recess that forms first air intake duct, and described second preparation is arranged in the rectangle recess that forms second air intake duct.Preferably each preparation is placed the contiguous place of air inlet separately.
Usually, hope reaches the mole evaporation rate of about equimolar ratio of two components (active material alkali, acid).As described, be placed in two air intake ducts that separate if contain the preparation of nicotine and contain sour preparation, it has the air inlet of combination, then can control rate of release separately, especially passes through the mode of the flox condition in two grooves.For example, the rate of release that can set the air-flow of flow through first opening and first air intake duct of flowing through thus is 100 μ g/10s; In the case, if use acetic acid as acid constituents, then approximately the rate of release of 50mg/10s will be suitable for described second air-flow.
About available rate of release, preferably continuing 1～10s and reaching therebetween in the breathing process of air-breathing speed of 0.1～1l/min, suction apparatus according to the present invention discharges 5～250 μ g from described preparation to inhaled air, the nicotine alkali of preferred 10～100 μ g or another alkaline matter.For example, in lasting 10s and the respiration of air-breathing speed between 0.1～1l/min, can give the nicotine alkali of 100 μ g; This rate of release is suitable for therapeutic purposes.
In order to weaken breathing process as few as possible, this device preferably has the big channel cross-section that runs through its structure.This especially is applied to following situation, the cross-section of pipeline of air admission hole and venthole is formed make that the negative dividing potential drop in the oral cavity is no more than 300Pa in breathing process.
As volatile acid, preferably use acetic acid; Also can use other acid, if they are being volatilizable under the room temperature (about 15～25 ℃) or can be transformed into gas phase (for example lactic acid, malic acid, propionic acid) under heat (up to about 100 ℃) influence.Also can use the combination of different acid.Acetic acid also can be used in combination with additive because its high volatile volatile uses with lower concentration and bigger total amount.Volatility, can suck alkaline active material refer in particular to volatile under said temperature, maybe can be transformed into the material of gas phase.
In addition, according to specific embodiment, the preparation that contains active material comprises at least a solvent that is suitable for sucking (preferred alcohol) in addition or/and at least a volatility auxiliary substance (preferred menthol).The preparation that contains acid can comprise at least a this solvent equally or/and at least a volatility auxiliary substance.Suitable volatility auxiliary substance especially makes spices that the people feels pleasure and flavor enhancement (as other material of limonene, eucalyptol, peppermint oil, camphor or terpene; Comprise the combination of aforementioned substances).
The present invention further comprises the manufacture method of said apparatus.These methods generally include following steps:
Make molded component by deep drawing methods or other processing method as known in the art (as injection moulding), 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 described first groove;
Second preparation that contains acid of scheduled volume is put into described second groove.
Device according to the present invention is by using the simply mode and the low-cost manufacturing of molded component of being made by deep drawing methods.The preferred material that is suitable for this purpose is for having alkaline matter, especially the polyester material of the impervious coating of nicotine.That primarily be suitable for this purpose is acrylonitrile and methacrylate (Barex
Britain) copolymer.Preferred PETG-Barex the laminate that uses.
By the means of deep drawing methods, in the molded component that forms two air intake ducts, provide recess.In addition, can provide the other recess that is connected and forms air flue with described two recesses.Air intake duct and gas off-take have cylindrical configuration basically, but they also can have different geometries.
Molded component with recess forms the bottom of device; Top can be by second molded component of the groove that correspondingly provides be provided, or forms by planar film or the layer as lid.After putting into preparation, top and bottom (as splicing, welding) in known manner are connected to each other.
The recess or the molded component arrangement that can form air intake duct in molded component by providing other projection (it can be made with deep drawing methods equally) to make are so that the boil-off rate of each volatile component can be limited geometrically.The method can also realize in addition preferably with equimolar amounts delivery of active substances alkali and acid.
This installs at least in part, but preferably fully by for the impervious material of active material, especially by polyester material, and/or by metal forming with above-mentioned coating, or the combination manufacturing of these materials.
The matrix that is suitable for as the above-mentioned preparation of preparation is any material that can be used to prepare the storage storehouse that receives nicotine alkali or other active material alkali or described volatile acid in principle, and prepared storage storehouse discharges these materials in the air towards periphery by vaporizing under suction condition.The material that is suitable for this purpose it is known to those skilled in the art that.
Suitable material is for example, to be used to prepare the polymeric material through the active material storage storehouse of mucosal treatment system.In this process, active material (or acid) is dissolved in or is scattered in the matrix of polymerization (for example polyacrylate), randomly is added with auxiliary substance, and is coated to the jelly that obtains on the inertia supporter and makes its drying.The sheet of cutting apart the long-pending and layer thickness of the certain surface of active material with known content or acid from the layer that contains active material of drying.As mentioned above, these sheets can be inserted into according in the device of the present invention as above-mentioned preparation.The suitable layer thickness of the Formulation in the airflow space of charging apparatus and surface area are obtained by the pharmacy practice.
Be inserted into the content that generally has 10% weight according to the nicotine formulation in the device of the present invention, and dosage is generally 500mg.The concentration and the dosage that are used for each situation can depart from these embodiment values; Especially, activity substance content can be 1～80% weight, and dosage is 10～1000mg.
Be suitable as polymer substrate, especially be selected from the polymer of the group that comprises polyethylene, polypropylene, silicone polymer (silicone polymers) (dimethyl silicone polymer) and poly-(methyl) acrylate.
And, can prepare above-mentioned preparation by using thermoplastic polymer, thermoplastic polymer is by hydrothermal solutionization, and composition (alkaline active material and/or acid) is quantitatively added in the pyrolytic polymer.Still be used for the position of this purpose, and make its curing for the preparation of liquid directly is coated to the deep-draw suction apparatus.
According to another variant of the present invention, silicone polymer (dimethyl silicone polymer) and crosslinking agent (for example platiniferous crosslinking agent) are as matrix.Under cold environment, nicotine alkali or volatile acid component are quantitatively joined in the said mixture with liquid form.This mixture of scheduled volume is coated on each position that is used for this purpose.After sealing this device, post processing under heating, thus made the three-dimensional structure of active material delivery formulations.
The preparation that contains active material or contain acid preferably uses at the contiguous place of the air inlet of separately air intake duct.
As mentioned above, the material that is used for locking device is preferably as above-mentioned the impervious material of volatile ingredient.
In another preferred embodiment, made suction apparatus after, use the impervious peelable protective layer of alkaline matter is covered.This protective layer will only be removed by user oneself before closing on use.By the protective layer that has used, form the chamber of containing alkaline active material and contained sour chamber, these two chambers are separated from each other in airtight substantially mode and are isolated with ambient air.So, prevented that the antedating response of component is with aging.Have only remove protective layer after, the gas exchange between two chambers just can take place again.
If necessary, air inlet and venthole also cover with diaphragm.
This device can be advantageously used in smoking cessation, or in the case of necessary, also can be used for smokeless the satisfying that nicotine is thirsted for.
The specific embodiment
Will be by the present invention that illustrates of embodiment and accompanying drawing.Except as otherwise noted, the implication of Reference numeral is identical in institute's drawings attached.
Figure 1A shows the commercially available shape (cutaway view) according to device of the present invention (1).This device is formed by outer wall (2); It has two flow channels, and (a, b) big about the centre of this flow channel, it enlarges a chamber that forms separately, and (3a, 3b), and after this merging forms air flue (7).In the chamber (3a, 3b) in, have the nicotine formulation of containing (5) respectively and contain acid supplement (4).
Figure 1A shows the state before this device uses.Flow channel (a, air admission hole b) and venthole are still closed, and the chamber (3a, 3b) tunicle (13) is separated from each other, and therefore the mixing of two components (4,5) can't take place.
Device shown is being opened film (13) (as by heat or by pushing through) and air inlet and venthole (A, B, C) mode of operation after (being similarly profilograph) among Figure 1B demonstration figure A.Air inlet and venthole can be for example by the perforation (11 among Figure 1A, 12) that in device, provides break or tear and be opened (among Figure 1B not display layer (8)).
When air-breathing, air flow through on the one hand air admission hole (A) and air intake duct (a), flow through on the other hand air admission hole (B) and air intake duct (b).Dotted arrow is represented the flow direction of air in the suction process.(a b) merges the gas off-take (7) that formation has venthole (C) to two air intake ducts.Have in the zone of air intake duct (a) just in time air admission hole (A) afterwards contain nicotine formulation (5), and have in the zone of air intake duct (b) just in time air admission hole (B) afterwards contain acid supplement (4).When air flow through, nicotine was from preparation (5) volatilization air intake duct (a), and the acid compound that is contained in the preparation (4) evaporates in the air flue (b).Zone in gas off-take (7), the steam of alkali and acid mixes, and has obtained approximate neutrality to slightly acidic condition.By venthole (C), preferably suck the aerosol of the nicotine salt that comprises surrounding air and wherein comprised that forms via the oral cavity.
Fig. 1 C shows the profile at the place, X plane of the suction apparatus that schematically shows among Figure 1B.(a is b) by deep drawing methods preformed, so that they have recessed shape for air intake duct.(a, zone b) have the active substance preparation of containing (5) respectively and contain acid supplement (4) at air drain.With one flat, nicotine non-permeable formation (8) cover described device below.
Fig. 2 A shows the commercially available shape (vertical section) according to another embodiment of suction apparatus of the present invention.(A, B C) are still and close for air inlet and venthole.Groove (a, b) zone line enlarge the chamber that forms separately (3a, 3b).(3a 3b) is arranged side by side, and spatially is separated from each other, so that the mixing of preparation also can not (be used preceding state) in the chamber of each preparation (4,5).
Fig. 2 B shows the profile of suction apparatus represented among Fig. 2 A at the plane X place.Air intake duct (a, b) and (3a 3b) forms in outer wall (2) by deep drawing methods and is recessed shape in the chamber.(3a has the active substance preparation of containing (5) respectively and contains acid supplement (4) in 3b) in the chamber.With one flat, nicotine non-permeable formation (8) cover described device below.
Fig. 2 C is another vertical section of the embodiment shown in Fig. 2 A and the 2B.This device is shown as the state of preparing use.In order to use the device described in Fig. 2 A, along line (14) that it is folding before using, described line can be for example provides with the form of perforation or weak line, thereby by along middle folding two the airslide (a that make in the vertical, b) and the chamber (3a, 3b) be positioned at over each other.Can be respectively by for example breaking and the hole of opening air inlet and gas off-take along the perforation (11,12) that provide for this purpose.So obtained functional suction apparatus.Dotted arrow is represented the direction of air-flow in the suction process.Pipe or mouthpiece (9) can slippage on two ventholes (C, C '), thereby form associating gas off-take (7 ') and unite venthole (D).
Device in the operation shown in Fig. 2 D demonstration Fig. 2 C is at the profile at plane X place.The chamber that forms by deep drawing methods (3a, 3b), wall (2,2 ') and layer (8,8 ') be positioned at over each other.
Device in the operation shown in Fig. 2 E demonstration Fig. 2 C is at the profile at plane Y place.Dotted arrow is represented the direction of air-flow in the suction process.In suction process, air-flow (A, B) flow through separately road (a, b), through being positioned at chamber (3a, 3b) preparation in (4,5).Steam that obtains or aerosol be by pipe or the regional combination of gas off-take (7 ') that forms of mouthpiece (9), and via venthole (D) separating device.
Fig. 3 A and 3B show another embodiment (demonstration of twilight sunset residual images) according to device of the present invention, and wherein Fig. 3 B has described cylindrical insertion portion (31) and can insert wherein pipe or mouthpiece (30).The inner space of insertion portion (31) is divided into two chambers (33,34) that receive active substance preparation and acid constituents (not shown) respectively by the partition wall (32) that stretches vertically.This insertion portion is surrounded (it is represented as the part incision in Fig. 3 A) by cylindrical tube (35).At Background Region, porose (36) are set in tube; The effect of air admission hole is played in described hole.(38) are provided with another air admission hole (37) in the back, and it has closed the rear portion of insertion portion (31).Fig. 3 C has shown this back with plane.The quantity in hole and layout can change.
In manufacture process, will contain nicotine formulation and be positioned in the chamber (33,34), for example, the carrier material that is soaked with the carrier material (as sponge or filter paper) of nicotine and is soaked with volatile acid (preferred acetic acid) is positioned in separately the chamber; Randomly, also can add flavor enhancement or fumet with it.All openings, promptly front end (V) and hole (36,37) are closed with suitable diaphragm or paper tinsel.
Before the use, remove diaphragm and insertion portion (31) is inserted mouthpiece (30).By aspirating on mouthpiece, air is inhaled into via the hole (36,37) of two back.This air flow through two chambers (33,34) and carrier, and the fumet steam of having taken away nicotine steam, acid vapour simultaneously and selectively having added.These steams enter before the oral cavity eddy current in the zone of mouthpiece.The mixing of nicotine and acid vapour has promoted the nicotine suction.For this reason, offer a plurality of projections of mouthpiece (30) or tooth (39) is favourable.The preferred adjoining land of these projections and tooth is arranged in several offset column.Mouthpiece (30) is the columniform basically sleeve pipe of the equal opening in two ends, and it preferably is shorter than insertion portion (31).
Projection or tooth (39) also can form spirality (helical shape), S-shape or scroll (spiral) baffle plate, thereby reach better eddy current of air and gas better mixing.
Fig. 4 A shows the perspective view according to another embodiment of device of the present invention.This device comprises thimble tube mouthpiece (30), and pipe (41) can be attached on this thimble tube mouthpiece rotatably, or manages (41) and can arrive above it by rotation-sliding, or pipe (41) can rotate insertion wherein (direction of arrow).Preferably, the end of mouthpiece (40) is formed certain shape, so that when pipe (41) slippage was to mouthpiece, it can fasten.As describing among Fig. 3, mouthpiece has a plurality of projections (39) in the face of the hole of mouth.The inner space of mouthpiece (40) is divided into four chambers by two partition walls.Mouthpiece is equal opening at two ends.Will be partially closed with the opening that pipe (41) is connected.Preferably, mouthpiece is fan-shaped being closed of circular cross section substantially at least, for example relative fan-shaped of two shown in Fig. 4 B.
Slippage pipe (41) is equal opening at two ends, and is separated into four chambers in inside in the mode identical with mouthpiece (by the mode of wall (44,45)).Contain nicotine formulation and contain acid supplement and lay respectively in two relative chambers.
Also provide mouthpiece and pipe to be separated into 2 or 3 or more than the embodiment of 4 inner spaces.
Wall or baffle plate (44,45) can also form spirality, S-shape or scroll, thereby reach stronger air-swirl, and therefore reach better gas mixing.
Contained the acid vectors material preparation and contained nicotine pipe (randomly improveing) by in first Room of pipe, inserting to contain the nicotine carrier material and in the chamber on corresponding opposite, to insert with fumet.All then openings are closed with suitable film or paper tinsel.In addition, can fill remaining chamber of pipe with other active material or fumet.
During use, remove diaphragm and will manage (41) slippage to mouthpiece (40), thereby fasten.This pipe is rotated engagement, so that by with respect to mouthpiece swivelling pipe (seeing double-head arrow) time, the chamber of filling can open and close.This makes the consumer can regulate the air-flow of wishing suction.If necessary, the openend of the openend of mouthpiece and pipe can be closed with dismountable cap separately.
Fig. 5 shows a kind of variation of the embodiment of describing among (cross section) Fig. 4.The inner space of mouthpiece (40) and pipe (41) is divided into four tubular chamber (51,52,53,54); (50) refer to the cylindrical wall of mouthpiece and pipe respectively.
In this case, to insert in the pipe with the form of " cartridge case " be favourable to the carrier material that is soaked with active material or acid.In the case, pipe can form have mouthpiece and with its (but rotatably) device of linking to each other for good and all, this means that whole device can reuse.Described " cartridge case " can independently store, and can prepare to have different nicotine content (or to contain different active materials).
Fig. 6 is with diagram expression another advantageous embodiment according to device of the present invention.Contain the active substance preparation (not shown) and be positioned at first Room (61), its formation active material steam can accumulate in the bigger gas compartment wherein.Can be positioned at second Room (62) with the acid supplement that contains of fumet combination.Broad arrow is represented the direction of the air-flow that occurs in the suction process.Air is inhaled into through air admission hole (64,65).These holes can have valve, drain to the outside to prevent that component (active material, acid) from mixing too early or/and prevent component.
When sucking by mouthpiece (63), air is along two different path flow motion devices: (i) in hole (64) flowed into chamber (61) of air by the side, and air is rushed in the pre-saturated gas compartment of vapour pressure the mixed zone of mouthpiece (63) front in this process.(ii) simultaneously, air is inhaled in second Room (62) by the hole (65) of side.In this process, gas is also rushed in auxiliary substance (acid, possible flavor enhancement) mixed zone of mouthpiece (63) front.In this mixed zone, two air-flows are mixed with each other.In this mixed process, the neutralization of the active material alkali of expection 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.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE10356925.1 | 2003-12-05 | ||
| DE10356925A DE10356925B4 (en) | 2003-12-05 | 2003-12-05 | Inhaler for basic active pharmaceutical ingredients and process for its preparation |
| PCT/EP2004/012947 WO2005053444A1 (en) | 2003-12-05 | 2004-11-16 | Inhaler for basic pharmaceutical agents and method for production thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1889861A CN1889861A (en) | 2007-01-03 |
| CN1889861B true CN1889861B (en) | 2010-11-17 |
Family
ID=34638403
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2004800361875A Expired - Fee Related CN1889861B (en) | 2003-12-05 | 2004-11-16 | Inhaler for basic pharmaceutical agents and method for production thereof |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US20070062548A1 (en) |
| EP (1) | EP1699309A1 (en) |
| JP (1) | JP4516970B2 (en) |
| CN (1) | CN1889861B (en) |
| CA (1) | CA2546693A1 (en) |
| DE (1) | DE10356925B4 (en) |
| WO (1) | WO2005053444A1 (en) |
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- 2004-11-16 CA CA002546693A patent/CA2546693A1/en not_active Abandoned
- 2004-11-16 JP JP2006541822A patent/JP4516970B2/en not_active Expired - Fee Related
- 2004-11-16 CN CN2004800361875A patent/CN1889861B/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN86103434A (en) * | 1985-05-24 | 1986-11-26 | 高级烟草制品公司 | The nicotine dispenser of band polymeric reservoir of nicotine |
| US4765348A (en) * | 1986-12-12 | 1988-08-23 | Brown & Williamson Tobacco Corporation | Non-combustible simulated cigarette device |
| US5660169A (en) * | 1990-09-12 | 1997-08-26 | Astra Aktiebolag | Disposable inhaler with pull-off seal |
| GB2388040A (en) * | 2002-05-02 | 2003-11-05 | Robert Jeremy West | Variable dosage nicotine inhaler |
Also Published As
| Publication number | Publication date |
|---|---|
| DE10356925A1 (en) | 2005-07-14 |
| JP2007512880A (en) | 2007-05-24 |
| CN1889861A (en) | 2007-01-03 |
| EP1699309A1 (en) | 2006-09-13 |
| US20070062548A1 (en) | 2007-03-22 |
| CA2546693A1 (en) | 2005-06-16 |
| JP4516970B2 (en) | 2010-08-04 |
| WO2005053444A1 (en) | 2005-06-16 |
| DE10356925B4 (en) | 2006-05-11 |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20101117 Termination date: 20121116 |