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EP1699309A1 - Inhalateur de substances actives pharmaceutiques basiques, et son procede de production - Google Patents

Inhalateur de substances actives pharmaceutiques basiques, et son procede de production

Info

Publication number
EP1699309A1
EP1699309A1 EP04797909A EP04797909A EP1699309A1 EP 1699309 A1 EP1699309 A1 EP 1699309A1 EP 04797909 A EP04797909 A EP 04797909A EP 04797909 A EP04797909 A EP 04797909A EP 1699309 A1 EP1699309 A1 EP 1699309A1
Authority
EP
European Patent Office
Prior art keywords
air
preparation
acid
inhalation
active ingredient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04797909A
Other languages
German (de)
English (en)
Inventor
Michael Horstmann
Karin Ludwig
Christoph Schmitz
Mohammad Sameti
Yves-Thorsten Przybylla
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LTS Lohmann Therapie Systeme AG
Original Assignee
LTS Lohmann Therapie Systeme AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Publication of EP1699309A1 publication Critical patent/EP1699309A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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

Definitions

  • the invention relates to devices for the administration of basic active substances, in particular nicotine, to the human or animal body by inhalation.
  • the invention further relates to manufacturing processes with which such devices can be obtained, as well as the use of the devices mentioned for smoking cessation or for smoke-free breastfeeding of the nicotine craving when necessary.
  • Nicotine inhalers for the administration of nicotine via the breathing air when inhaled have been known for several years
  • nicotine inhalers have also been available on the market as smoking weaning products in some European countries ("Nicorette ® "; Pharmacia / Pfizer).
  • the last-mentioned nicotine inhaler is, however, only slightly widespread, since with this device only small amounts of nicotin are effective during inhalation. This is due in particular to the fundamental deficiencies of known inhaler technologies and the compatibility that can be achieved with them.
  • the local irritant effects on the mucous membrane of the respiratory tract caused by the alkaline properties of nicotine are disadvantageous since they trigger a cough, which results in a reduced absorption of the nicotine vapors emitted by the inhaler. In this way, only very small amounts of nicotine are absorbed into the body.
  • the object of the invention was therefore to provide a nicotine inhaler which enables the most irritant, intensive absorption of nicotine via the respiratory tract. This object is achieved by the devices according to the main claim and the claims dependent thereon, and by the production method according to claim 19 and according to the claims dependent thereon.
  • a device is characterized in that it contains a first preparation which contains nicotine base and / or another volatile, inhalable basic active ingredient, and in that it also contains a second preparation or several further preparations, wherein this second preparation or at least one of the further preparations has a content of at least one volatile acid suitable for inhalation.
  • the devices according to the invention are distinguished in that, when inhaling, in addition to the active substance base (eg nicotine base), one or more volatile acidic compounds are also inhaled at the same time.
  • the devices according to the invention are suitable for the administration of basic active substances, in particular nicotine, to the human or animal body by inhalation.
  • basic active substances in particular nicotine
  • selegiline and / or mecamyla can be considered as basic active ingredients.
  • the combination of nicotine with mecamylamine is particularly preferred for smoking cessation.
  • a first preparation which contains nicotine base (or another active ingredient base) and a further preparation which contains a volatile acid causes the nicotine base and the volatile acid to be volatilized during inhalation, wherein by mixing the basic and acidic vapors in the device to form the corresponding nicotine salt (or the corresponding salt of the others Active ingredient base) comes.
  • This salt reaches the respiratory tract in the form of liquid droplets or in particulate form with the inhaled air. Because of the neutral reaction of the mucous membrane of the salt, this type of inhalation is far better tolerated than is possible with known inhalation devices.
  • the mentioned first preparation containing nicotine base and the second acidic preparation are applied to separate locations within the device. This makes it possible to design the air inflow ducts in such a way that when inhaled, part of the air flow flows over the first preparation and another part of the air flow over the second preparation, and subsequently both air flows (with the volatilized therein) evaporate Nicotine base and acid) combine and can then be inhaled.
  • the active ingredient base eg nicotine base
  • the volatile acid contained in the second preparation are passively volatilized.
  • this process can be accelerated by applying heat; agents suitable for this are known to the person skilled in the art.
  • aerosol formation occurs in the inflowing ambient air.
  • This aerosol formation results from the lower volatility of the nicotine salt, salt mixture or salt solution droplet formed.
  • the formation of aerosols is also the cause of a significantly increased tolerance, since nicotine is no longer available freely and can no longer have an alkaline effect via the gas outer phase.
  • nicotine is no longer available freely and can no longer have an alkaline effect via the gas outer phase.
  • aerosol droplets as salt components partially dissolved in water or as a solid dispersion, have a far better tolerance than is possible with the devices known in the prior art because of the neutral (instead of alkaline) mucous membrane reaction.
  • Aerosol formation is helpful, but is not absolutely necessary for the therapeutic result according to the invention to come about. Overall, a high dilution of the feed vapors - which suppresses aerosol formation - can even be useful in terms of compatibility.
  • the size of the aerosol particles formed by the inhalation system according to the invention depends above all on the speed of the air flow (flow rate) and on the concentrations of the individual gaseous constituents (basic active ingredient or acid) in the mixing zone. Aerosol particles whose size is less than 10 ⁇ m (average diameter), for example 5 to 10 ⁇ m, are advantageous for alveolar uptake.
  • the inhalation device has a first air inlet opening, a second air inlet opening and an air outlet opening. These openings are arranged in such a way that the air stream flowing in through the first inlet opening predominantly flows over said first preparation, and the air stream flowing in through the second inlet opening predominantly flows over said second or further preparation (s) , and wherein the two air flows merge in the further course and emerge from the device through said outlet opening.
  • the device has elongated depressions, channels or channels on the inside, as a result of which a first and second air supply channel and an air outlet channel are formed. These air flow paths open to the outside in each case via the air inlet or outlet openings mentioned.
  • the aforementioned first preparation is located in the elongated recess which forms the first air supply duct
  • the mentioned second preparation is in the elongated recess which forms the second air supply duct. It is preferred that the preparations are applied in the vicinity of the air inlet opening.
  • an approximately equimolar ratio of the molar evaporation rates of the two components is aimed for.
  • the respective delivery rates can be controlled, among other things, via the flow conditions in the two channels.
  • a delivery rate of 100 ⁇ g / lOs can be provided for nicotine with a continuous air flow through the first opening or the first air supply duct; in this case - when using acetic acid as the acid component - a release rate of approx. 50 g / lOs in the second air flow mentioned would be suitable.
  • an inhalation device during an inspiration process, which has a duration of 1 to 10 s and in which an inhalation rate of 0.1 to 1 1 / min is reached, 5 to 250 ⁇ g, preferably 10 releases up to 100 ⁇ g, Ni ⁇ otinbase or another basic active ingredient from the above-mentioned preparation into the inhaled air.
  • an inspiration process which has a duration of 1 to 10 s and in which an inhalation rate of 0.1 to 1 1 / min is reached, 5 to 250 ⁇ g, preferably 10 releases up to 100 ⁇ g, Ni ⁇ otinbase or another basic active ingredient from the above-mentioned preparation into the inhaled air.
  • a breath tens of 10 s and at inhalation rates between 0.1 and 1 1 / min 100 ⁇ g nicotine base are administered; this delivery rate is appropriate for therapy.
  • the device has high passage cross sections in the entire structure. This is particularly the case if the line cross sections of the air inlet openings and the air outlet opening are dimensioned such that the negative differential pressure in the oral cavity during the inhalation process is at most 300 Pa.
  • Acetic acid is preferably used as the volatile acid; other acids can also be used, provided they are volatile at room temperature (approx. 15-25 ° C) or can be converted into the vapor phase by exposure to heat (up to approx. 100 ° C) (e.g. lactic acid, malic acid, propionic acid) , Combinations of different acids can also be used. Due to its high volatility, acetic acid is used in a lower concentration and in a higher total amount, as well as in combination with additives. Volatile, inhalable basic active substances are understood in particular to be those active substances which are volatile at the temperatures mentioned or which can be converted into the vapor phase.
  • the preparation containing the active ingredient additionally contains at least one volatile solvent suitable for inhalation (preferably ethanol) and / or at least one volatile auxiliary (preferably menthol).
  • the acidic preparation can also contain at least one such solvent and / or at least one volatile auxiliary.
  • Volatile auxiliaries which are particularly considered are pleasantly tasting and fragrant substances (for example limes, eucalyptol, mint oils, Camphor, or other terpenes; also combinations of the substances mentioned).
  • the invention also extends to methods for producing the above-mentioned devices. These procedures generally have the following steps:
  • molded part by deep drawing or other molding processes known to the person skilled in the art (e.g. injection molding), the molded part having a first elongated, concave recess for receiving said first preparation and a second elongated, concave recess for receiving said second preparation having;
  • the device according to the invention can be produced in a simple and inexpensive manner using molded parts produced by deep drawing.
  • a polyester material which is provided with a coating impermeable to the basic active ingredient, in particular to nicotine, is preferably suitable for this.
  • a copolymer of acrylonitrile and methacrylate is particularly suitable for this
  • Barex ® (Barex ®; BP).
  • a polyethylene terephthalate Barex laminate film is preferably used.
  • elongated depressions are made in a molded part, which are intended to form the two air supply paths. Furthermore, a further elongated depression can be provided, which is connected to the two mentioned depressions and to form the Air outlet duct is determined.
  • the air supply paths or the air outlet duct are essentially cylindrical, but can also have a different geometry.
  • the molded part provided with the depressions forms the lower part of the device; the upper part can be formed by a second molded part with correspondingly provided depressions, or by a flat film or layer as a cover.
  • the upper and lower parts are connected to one another in a known manner (for example gluing, sealing).
  • the depressions in the molded part or the molded parts, through which the air supply channels are formed, can be designed by attaching additional pockets (also produced by deep drawing) in such a way that the evaporation rate of the respective volatile component can be geometrically restricted. This measure gives an additional possibility to effect the preferred delivery of active ingredient base and acid in equimolar amounts.
  • the device is produced at least partially, but preferably completely, from a material which is impermeable to the active substance (s), in particular from polyester material which is provided with the coating mentioned and / or from metal foil (s), or combinations of the above Materials.
  • polymer materials such as z. B. used in the manufacture of drug reservoirs of transdermal therapeutic systems.
  • the active ingredient or the acid (s)
  • a polymeric base material e.g. polyacrylates
  • auxiliaries optionally with the addition of auxiliaries
  • the resulting mass is coated on an inert base and left to dry.
  • Pieces of a certain area size and layer thickness with a known active ingredient or acid content are separated from the dried active ingredient-containing layer. As described, these can then be introduced into a device according to the invention as the preparations mentioned.
  • the suitable layer thickness and area size of the sheet-like preparations introduced into the air flow space of the device result from pharmaceutical practice.
  • the nicotine preparation introduced into a device according to the invention typically has a content of 10% by weight and the dose is typically 500 mg.
  • the concentration and dose used in individual cases may differ from these example values; in particular, the active substance content can be 1 to 80% by weight and the dose 10 to 1000 mg.
  • Particularly suitable polymer base materials are polymers from the group comprising polyethylenes, polypropylenes, silicone polymers (polydimethylsiloxanes) and poly (meth) acrylates.
  • thermoplastic polymers these being thermally liquefied and the ingredients (basic active ingredient or acid) are metered in while hot.
  • the still liquid preparation is applied directly to the designated point of the deep-drawn inhalation device and allowed to solidify.
  • a further variant according to the invention provides that a mixture of silicone polymers (polydimethylsiloxane) and crosslinking agent (for example a platinum-containing crosslinking agent) is used as the base material. Nicotine base or the volatile acid component are metered in liquid into this mixture in the cold state. A predetermined amount of this mixture is applied to the places of the device provided for this purpose. After the device has been closed, it is post-treated in the heat, which creates a three-dimensional structure of the active substance release preparations.
  • silicone polymers polydimethylsiloxane
  • crosslinking agent for example a platinum-containing crosslinking agent
  • the active substance-containing or acidic preparation is preferably applied in the vicinity of the air inlet opening of the respective air supply duct.
  • a material which is impermeable to the volatile constituents is preferably used to close the device, as described above.
  • the inhalation device is covered with a removable protective layer which is impermeable to the basic active ingredient (s) after manufacture.
  • This protective layer is only removed shortly before use by the user.
  • the applied protective layer forms a compartment containing the basic active ingredient (s) and a compartment containing the acid (s), the two compartments being separated from one another essentially gas-tight and being sealed off from the ambient air. This prevents premature reaction and aging of the ingredients. Only after the protective A gas exchange can take place between the two compartments.
  • the air supply and outlet openings are also covered with a protective film.
  • the devices according to the invention can be used in an advantageous manner for smoking cessation or also for smoke-free breastfeeding of the nicotine craving if necessary.
  • the invention is illustrated by way of example and in a schematic representation with reference to the accompanying drawings. The meanings of the reference symbols are identical in all drawings, unless stated otherwise.
  • FIG. 1A shows a device (1) according to the invention in the commercial form (sectional view).
  • the device is formed by an outer wall (2); it has two air flow channels (a, b) which expand approximately in the middle to form a chamber (3a, 3b) and then merge to form an air outlet channel (7).
  • FIG. 1A shows the condition of the device before use.
  • the inlet and outlet openings of the air flow channels (a, b) are still closed, and the chambers (3a, 3b) are separated from one another by membranes (13), so that the two components (4, 5) cannot yet be mixed.
  • Fig. 1B shows (also in longitudinal section) the device shown in Fig. 1A in the functional state after opening the membranes (13) (e.g. by exposure to heat or puncturing) and the inflow and outflow openings (A, B, C) .
  • the inflow and outflow openings can, for example, be opened or torn open along an attached performance tion (11, 12 in Fig. 1A) can be opened. (Layer (8) is not shown in Fig. 1B).
  • the air flows through the air inlet opening (A) during inhalation through the air supply duct (a) on the one hand and through the inlet opening (B) and the air supply duct (b) on the other hand.
  • the dashed arrows indicate the direction of air flow during inhalation.
  • the two air supply ducts (a, b) unite to form the air outflow duct (7) with the air outflow opening (C).
  • Air channel (a) volatilizes nicotine from the preparation (5), and in the air channel (b) the acidic compound contained in the preparation (4) is evaporated.
  • the alkaline and acidic vapors mix in the area of the air outlet duct (7), and an almost neutral to slightly acidic environment is achieved.
  • the aerosol formed, consisting of ambient air and the nicotine salt contained therein, is preferably inhaled through the oral cavity through the outlet opening (C).
  • FIG. IC shows a cross section in the plane X of the inhalation device shown schematically in FIG. 1B.
  • the air supply ducts (a, b) are preformed concave by deep drawing.
  • the preparation (5) containing the active substance or the preparation (4) containing acid is covered at the bottom by a flat, ni ⁇ otin-impermeable layer (8).
  • FIG. 2A shows (in longitudinal section) a further embodiment of an inhalation device according to the invention in its commercial form.
  • inlet and outlet openings (A, B, C) still closed.
  • the central area of the channels (a, b) is widened to form a chamber (3a, 3b).
  • the chambers (3a, 3b) of the individual preparations (4, 5) are arranged next to one another and spatially separated from one another, so that no mixing can yet take place (state before use).
  • FIG. 2B shows a cross section in the plane X of the inhalation device shown in FIG. 2A.
  • the air supply ducts (a, b) and chambers (3a, 3b) are preformed in a concave manner by deep drawing in the outer wall (2). Inside the chambers (3a, 3b) is the preparation (5) containing the active ingredient or the preparation (4) containing acid.
  • the device is covered at the bottom by a flat, nicotine-impermeable layer (8).
  • FIG. 2C is another longitudinal sectional view of the embodiment depicted in FIGS. 2A and 2B.
  • the device is ready for use.
  • the device shown in FIG. 2A is bent before use along the line (14), which can be designed, for example, as a perforation or weakening line, so that the two air flow channels (a, b) and chambers (3a, 3b ) are positioned one above the other in the longitudinal direction.
  • the openings of the air inlet and outlet channels can be opened, for example, by breaking them open along a perforation (11, 12) provided for this purpose. In this way, a functional inhalation device is obtained.
  • the dashed arrows indicate the direction of air flow during inhalation.
  • FIG. 2D shows a cross section in the plane X of the functional device depicted in FIG. 2C.
  • the chambers (3a, 3b), which are formed by the deep-drawn walls (2, 2 ') and layers (8, 8 "), are positioned one above the other.
  • FIG. 2E shows a cross section in plane Y of the functional device shown in FIG. 2C.
  • the dashed arrows indicate the direction of air flow during inhalation. During inhalation, they are deleted
  • the vapors or aerosols formed combine in the area of the air outlet duct (7 ") formed by the pipe or mouthpiece (9) and leave the device via the outlet opening (D).
  • FIGS. 3A and 3B show (in perspective representation) a further embodiment of the device according to the invention, FIG. 3B representing a tube or mouthpiece (30) in which the cylindrical insert (31) shown in FIG. 3A can be inserted.
  • the interior of the insert (31) is divided into two chambers (33, 34) by a partition (32) running in the longitudinal direction, which are intended for receiving the active substance preparation or the acid component (not shown).
  • the insert is surrounded by the cylinder jacket (35) (partially cut open in FIG. 3A).
  • an opening (36) is provided in the jacket, which serves as an air inflow opening.
  • a further air inflow opening (37) is provided in the end face (38) which closes the rear end of the insert (31).
  • 3C shows this end face in plan view.
  • a nicotinic preparation e.g. B.
  • a substrate soaked with nicotine e.g. sponge, filter paper
  • a substrate soaked with a volatile acid preferably acetic acid
  • an aroma or fragrance substance can also be incorporated. All openings, ie the front end (V) and the openings (36, 37) are closed with a suitable protective film.
  • the protective films are removed before use and the insert (31) is inserted into the mouthpiece (30). Sucking air through the mouthpiece draws air in through the two rear holes (36, 37). This air flows through the two chambers (33, 34) over the carrier materials and takes with it nicotine, acid and possibly fragrance vapors. These vapors are swirled around the mouthpiece before they enter the oral cavity. Mixing nicotine and acid vapor makes it easier to inhale nicotine. For this purpose, it is advantageous if that
  • Mouthpiece (30) is equipped with a plurality of projections or teeth (39). These are preferably staggered in several rows one behind the other.
  • the mouthpiece (30) is a substantially cylindrical sleeve which is open at both ends. It is preferably shorter than the insert (31).
  • the projections or teeth (39) can also be designed as helical, S-shaped or spiral baffles, which causes a greater swirling of the air and thus better gas mixing.
  • FIG. 4A shows a perspective sectional illustration of a further embodiment of the device according to the invention.
  • the device comprises a sleeve-shaped mouthpiece (30) to which a tube (41) is rotatably attached or attached or can be inserted (direction of arrow).
  • the end of the mouthpiece (40) is preferably designed such that the tube (41) snaps into place on the mouthpiece.
  • the mouth-side opening of the mouthpiece is provided with a multiplicity of projections 39.
  • the interior of the mouthpiece (40) is divided into four chambers by two partitions.
  • the mouthpiece is open at both ends.
  • the opening that is connected to the tube (41) is partially closed.
  • at least one sector of the essentially circular cross section of the mouthpiece is closed, for example two opposite sectors, as shown in FIG. 4B.
  • the attachable tube (41) is open at both ends and divided into four compartments inside (in the same way (by walls (44, 45)) as the mouthpiece.
  • the nicotine-containing preparation or the acidic preparation is located in two opposite chambers.
  • Embodiments are also provided in which the mouthpiece and the tube are divided into two or three or more than 4 interior spaces.
  • the walls or baffles (44, 45) can also be of helical, S-shaped or spiral design, which causes a greater swirling of the air and thus better gas mixing.
  • the nicotine-containing tube is produced by introducing the nicotine-containing carrier material into a first chamber of the tube and the acidic carrier material into the corresponding opposite chamber (optionally modified with a fragrance). All openings are closed with a suitable film. It is also possible to fill the remaining chambers of the tube with other active ingredients or fragrances.
  • the protective films are removed and the tube (41) is placed on the mouthpiece (40), where it snaps into place.
  • the tube is rotatably engaged so that the filled chambers of the tube can be opened and closed by turning the tube (see double arrow) relative to the mouthpiece. This gives the consumer the opportunity to regulate the air flow he wants to inhale. If necessary, the open ends of the mouthpiece or tube can be closed with removable caps.
  • FIG. 5 shows (in cross section) a modification of the embodiment described in FIG. 4.
  • the interior of the mouthpiece (40) and the tube (41) is divided into four tubular chambers (51, 52, 53, 54); (50) denotes the cylindrical wall of the mouthpiece or tube.
  • the carrier materials impregnated with the active ingredient or acid can be introduced into the tube in the form of “cartridges”.
  • the tube can form a unit with the mouthpiece and be permanently (but rotatably) connected to it, i. H. the device is reusable overall.
  • the "cartridges" can be stored separately and can be manufactured with different nicotine contents (or with different active ingredients).
  • FIG. 6 shows a further advantageous embodiment of the device according to the invention in a schematic representation.
  • the preparation containing the active substance (not shown) is located in the first compartment (61), which forms a larger gas space in which the active substance vapors can accumulate.
  • the acidic preparation possibly combined with fragrances, is in a second compartment (62).
  • the thick arrows indicate the direction of the air currents when inhaling.
  • the air is sucked in through the inflow openings (64, 65). These can be provided with valves to prevent premature mixing of the ingredients (active ingredient, acid) and / or escape to the outside.
  • air is drawn into the second compartment (62) through the side openings (65). This air also rinses the auxiliary substances (acid, possibly flavoring substances) into the mixing zone in front of the mouthpiece (63). There the two air flows mix with each other. The desired neutralization of the active ingredient base takes place.

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Abstract

L'invention concerne un dispositif pour administrer des substances actives basiques, en particulier de la nicotine, dans le corps d'un être humain ou d'un animal, par inhalation. Ce dispositif comprend une première préparation qui contient une base de nicotine et/ou une autre substance active basique, et comporte en outre une deuxième préparation ou plusieurs préparations supplémentaires, au moins une préparation contenant au moins un acide volatil destiné à être inhalé.
EP04797909A 2003-12-05 2004-11-16 Inhalateur de substances actives pharmaceutiques basiques, et son procede de production Withdrawn EP1699309A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10356925A DE10356925B4 (de) 2003-12-05 2003-12-05 Inhalator für basische pharmazeutische Wirkstoffe sowie Verfahren für dessen Herstellung
PCT/EP2004/012947 WO2005053444A1 (fr) 2003-12-05 2004-11-16 Inhalateur de substances actives pharmaceutiques basiques, et son procede de production

Publications (1)

Publication Number Publication Date
EP1699309A1 true EP1699309A1 (fr) 2006-09-13

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP04797909A Withdrawn EP1699309A1 (fr) 2003-12-05 2004-11-16 Inhalateur de substances actives pharmaceutiques basiques, et son procede de production

Country Status (7)

Country Link
US (1) US20070062548A1 (fr)
EP (1) EP1699309A1 (fr)
JP (1) JP4516970B2 (fr)
CN (1) CN1889861B (fr)
CA (1) CA2546693A1 (fr)
DE (1) DE10356925B4 (fr)
WO (1) WO2005053444A1 (fr)

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US20070062548A1 (en) 2007-03-22
JP2007512880A (ja) 2007-05-24
CN1889861B (zh) 2010-11-17
DE10356925B4 (de) 2006-05-11
CA2546693A1 (fr) 2005-06-16
CN1889861A (zh) 2007-01-03
WO2005053444A1 (fr) 2005-06-16
DE10356925A1 (de) 2005-07-14

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