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WO2013030202A1 - Dispositif et procédé de production d'aérosols aqueux chargés d'un principe actif - Google Patents

Dispositif et procédé de production d'aérosols aqueux chargés d'un principe actif Download PDF

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Publication number
WO2013030202A1
WO2013030202A1 PCT/EP2012/066718 EP2012066718W WO2013030202A1 WO 2013030202 A1 WO2013030202 A1 WO 2013030202A1 EP 2012066718 W EP2012066718 W EP 2012066718W WO 2013030202 A1 WO2013030202 A1 WO 2013030202A1
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WO
WIPO (PCT)
Prior art keywords
compartment
water
adsorbent
aerosol
substrate
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.)
Ceased
Application number
PCT/EP2012/066718
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German (de)
English (en)
Inventor
Helmut Fackler
Elmar Richter
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.)
KRAPF RAINER
Original Assignee
KRAPF RAINER
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 KRAPF RAINER filed Critical KRAPF RAINER
Publication of WO2013030202A1 publication Critical patent/WO2013030202A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
    • A61M11/041—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
    • 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
    • A24F42/10—Devices with chemical 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
    • 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
    • A61M11/041—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
    • A61M11/047—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters by exothermic chemical reaction
    • 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

Definitions

  • the present invention relates to an apparatus and a method for producing drug-loaded aqueous aerosols, comprising as an essential part of a compartment which is loaded with an adsorbent, which adsorbs ontaktierung with water water in an exothermic process, wherein also a part of Water evaporates and into the
  • the present invention relates to devices for inhalation of aerosols, the nicotine or pharmaceutical agents in stable nanoparticles (average diameter ⁇ l-2 ⁇ ) contained th. From the prior art, a variety of devices are known with which aerosols can be produced by atomization of liquid substances.
  • Nicotine quantities or even with drugs can be filled.
  • Inhaler (Can Respir J., 1999, 6 (6), 509) does not meet the requirements, since the aerosol particles obtained are not small enough. Also disclosed are systems which utilize the energy released during chemical reactions, such as e.g. in the reaction of calcium oxide or
  • devices are published whose energy supply is based on the principle of latent heat. rest, for example, releasing heat of crystallization. The energy yield in these systems is relatively low.
  • an adsorbent for water adsorbing water with the release of adsorption wherein due to the released heat of adsorption of a portion of the water in the
  • the device according to the invention thus comprises at least two different compartments, which are spatially separated from one another.
  • the first compartment serves to store an adsorbent which adsorbs water when contacted in an exothermic reaction. Due to the released heat of adsorption, part of the water is converted into the gas phase, for example by the fact that the Adsorptionsmit- When heated with water, it is heated to temperatures above the boiling point of water.
  • the device comprises at least one other
  • Compartment (second compartment), keeps the water ⁇ ent.
  • the optionally present substrate is selected in particular from substances which, for example, can accumulate, admit or absorb a liquid active substance or can be impregnated with solutions, emulsions or dispersions of the active substance.
  • the substrate is formed, for example, from cellulose or modified cellulose (for example hydrophobicized cellulose).
  • a separate storage vessel for the active ingredient is present, this is in fluidic communication with the compartment for the adsorbent, for example via a Venturi nozzle.
  • water from the second compartment is now transferred to the first compartment, i. the compartment containing the adsorbent is transferred, whereby a portion of the water is adsorbed to the adsorbent and a portion of the water introduced into the first compartment is converted to the gas phase by the above-described released adsorption heat.
  • This can e.g. be done by the water is heated by the released heat of adsorption above the boiling point.
  • either the water in the second compartment has an active ingredient which is converted by the resulting water vapor into the aerosol phase.
  • the active ingredient depending on its nature, dissolved in water, as an emulsion, suspension but also as a dispersion.
  • Active ingredient is mixed, for example, the active ingredient may be added in powder or liquid form to the adsorbent.
  • the active substance is applied to a separate substrate which, when the device is activated, is acted upon by the water aerosol generated in the first compartment, whereby the active substance contained in the substrate is involved is transported into the aerosol phase.
  • the generated aqueous aerosol stream can be led into this storage vessel in order to expel the active substance as an aqueous aerosol.
  • an indirect removal from the storage vessel is possible, wherein the active ingredient can be removed from the storage vessel via a Venturi nozzle.
  • the device also has an outlet from which the aqueous aerosol streams laden with active substance can escape.
  • an outlet from which the aqueous aerosol streams laden with active substance can escape.
  • the Device is the outlet at the first compartment ment (the compartment containing the adsorbent), attached to the substrate (if present) or possibly to the storage vessel (if present) or in fluidic communication with the first compartment or substrate.
  • compartments or storage vessels are understood to mean separate spaces separated from each other for storing the respective substances, which are e.g. may have a separate wall.
  • active ingredients are understood to mean substances with which a certain result can be achieved, for example the
  • Active ingredients show pharmaceutically active action, but also a mechanical result, such as a lubricating effect, for example, lubricants (eg mineral oils, synthetic oils, greases, oS 2, etc.) achieve. Decisive here is that the lubricants (eg mineral oils, synthetic oils, greases, oS 2, etc.) achieve. Decisive here is that the lubricants (eg mineral oils, synthetic oils, greases, oS 2, etc.) achieve. Decisive here is that the
  • Active ingredients can be brought in the form of an aqueous aerosol in the gas phase.
  • aerosol is a mixture of fine water droplets as suspended particles and a
  • the water droplets may contain the active ingredient in dissolved, emulsified and / or dispersed form.
  • the size ⁇ mean diameter) of the water droplets ranges according to the invention from 2 nm to 2 ⁇ m, preferably from 50 nm to 2 ⁇ m.
  • water droplets having a size of 0.1 to 1 .mu.m can be produced with the device according to the invention or the method according to the invention.
  • the present invention is thus based on the following general principle, which will be examined in more detail below: In the adsorption of polar substances, such as water on uncoated surfaces of an adsorbent, heat of adsorption is released. It is possible to distinguish between polar (hydrophilic) and nonpolar (hydrophobic) adsorbents.
  • the hydrophilic adsorbents are, for example, silica gel, aluminum oxide,
  • Zeolites and some keys counted. Zeolites are particularly suitable for the separation of polar components such as water. In addition, zeolites have a shape-selective effect due to the ordered pore channel system ( u .a., Defined pore openings). If the surfaces are sufficiently large, it is also possible to produce temperatures that are significantly above 100 ° C.
  • a preferred embodiment of the device according to the invention provides that the compartment, which is the
  • the existing substrate which serves to store the active substance, or also both provided for storing the adsorbent compartment and the substrate comprises at least one projecting into its interior and out of the compartment or the substrate pipe, the wall of which has perforations at least in the part projecting into the compartment for the adsorbent, into the substrate or into the storage vessel.
  • the perforations are designed as recesses or holes through the wall of the tube.
  • the compartment serving for the storage of the adsorbent or the sub- strat can be arranged concentrically around this tube.
  • the drug-loaded aerosols either in the compartment provided for the adsorbent or in the substrate produced can be entered through the perforations into the tube and be discharged there from the compartment or the substrate.
  • the generated aerosol streams can be brought together and discharged from the device.
  • a further advantageous embodiment provides that the compartment serving for storing the adsorbent and / or the substrate is bounded by a plate through which the tube described above is carried out.
  • This plate or wall is impermeable to preferably water, water vapor or the aerosols produced, so that an efficient delimitation of Diff sion space for the aerosols generated, but also the discontinued water or water vapor generated is given.
  • the generated aerosols must thus pave the way into the described tube through the perforation.
  • the tube described above may also have a valve which serves to regulate the aerosol flow.
  • the valve can be designed so that it opens automatically when there is a need for the aerosol stream, this can for example be done so that on the pipe Subdr ck is applied (for example, when a user with his mouth on the opening of the previously described pipe, etc.), otherwise the valve is closed. According to this embodiment, therefore, aerosols can escape from the device only when needed.
  • this compartment can also be subdivided into segments, e.g. by a plastic film, which can gradually decrease or melt or shrink at a temperature rise, are separated from each other. This ensures that the excess water does not flood the entire absorption medium, for example the zeolites, in a short time and releases the active substance massively right at the beginning.
  • Another alternative is film windings, from which the individual Komparti duck are formed, which consist of several layers.
  • water is trapped between plastic sheets, e.g. welded polyethylene films.
  • the middle layer contains a water-absorbent fleece that provides a relatively even distribution of the aqueous phase at start-up by damaging the film.
  • the zeolite filling In the uppermost layer is the zeolite filling with the substrate.
  • There perforated tubes can be stored, through which the aerosol is transported by the air flow during the removal, for example, during "smoking".
  • the device here consists of a metal pressure vessel as a compartment for the adsorbent, which can be used, for example, with embroidery Contains zeolites containing zeolites, furthermore, in this pressure vessel there is at the end a plastic container (compartment for the water) filled with water, which at relatively low temperatures (eg 50 ° C. to 250 ° C., preferably 60 ° C. to 150 ° C.)
  • the water container melts, water passes through, for example, felt material lying on the zeolite material and the desorption of nitrogen is started. This escapes through the nozzle in the front part of the pressure vessel.
  • the heated active ingredient is atomised.
  • the nozzle contains a valve, which can be used to regulate the removal via the air flow during inhalation. If the pressure in the metal container rises, the adsorption of water is suppressed, gas production does not continue unchecked.
  • the device comprises a compartment for the adsorbent which is connected to a further compartment for water.
  • This compartment for water can for example also be designed as a separate water connection or a water supply for the compartment with adsorbent.
  • a water addition in the compartment for the adsorbent is possible.
  • the aqueous aerosols thus formed in the compartment for adsorbents with the addition of water can be discharged from this compartment via an outlet opening.
  • a separate storage vessel may be present, which comprises the active ingredient.
  • the outlet of the compartment for the adsorbent can be connected to the separate container for the active substance, for example via a Venturi nozzle, so that when the device is activated the aerosol Ström, which is expelled from the compartment with adsorbent, via the Venturi nozzle the active ingredient, which is located in the storage container, can entrain.
  • a Venturi nozzle a nozzle for the active ingredient
  • Aerosol technology is already used in the lubricant sector:
  • a specially suitable lubricant is atomised with the aid of the venturi technique and the resulting aerosol is brought to the hollow tool with compressed air via machine-internal supply lines.
  • a further preferred embodiment provides that at least one filter and / or an intermediate between the outlet and the compartment for the adsorbent and / or the substrate or the storage vessel. is arranged.
  • the filter may be formed, for example, of activated carbon or cellulose acetate.
  • the aerosols are again filtered before exiting.
  • the intermediate space which can be arranged, for example, between the filter and the storage compartment of the adsorbent or the substrate, can serve to set dynamic equilibrium conditions in the aerosol, and further structural components of the apparatus can be arranged in this intermediate space, such as For example, the valve described above, which is attached to the pipe.
  • the compartment serving for storing the adsorbent has an inlet area for water originating from the compartment serving for storing the water, the compartment for storing water being arranged at the inlet area.
  • the two compartments ie the compartment which serves to store the adsorbent and the compartment which serves to store the water, are separated from one another by a layer of a porous material, in particular a layer of a nonwoven.
  • This embodiment provides that the two different compartments and thus the two reactants, ie adsorbents and water, are arranged in the immediate vicinity of each other, so that activation of the device is particularly simple.
  • the porous material for example the nonwoven fabric, is suitable for absorbing water, ie water is absorbed by the capillary forces of the water used to store water. To remove partiment and to supply the adsorbents located in the adjacent compartment.
  • Compartment is arranged within the storage of the adsorbent serving compartment.
  • the wall of the compartment serving for the storage of water is formed from a material which is destructible by mechanical action of force or can be melted by the action of external heat, that is, in any case loses its structural integrity that the boundary of this compartment is lost and water leaks from this compartment.
  • the compartment serving to store the water comprises a wall with at least one predetermined breaking point and at least one mechanical means for breaking through the wall at least in the region of the at least one predetermined breaking point.
  • the mechanical means is preferably arranged in the interior of the compartment.
  • the predetermined breaking point can be embodied, for example, in that the wall of the compartment is made thinner at the predetermined breaking point than at the other locations of the wall of this compartment.
  • a preferred mechanical means for breaking the wall may be formed for example in the form of a mandrel or a plunger, so that in flexible design of the compartment of the compartment for storing the water by mechanical pressure on the wall, the means for opening the wall pressed to the breaking point and this can finally be broken so that water can escape from this compartment.
  • the water-containing compartment is under mechanical tension, so that upon activation, ie breaking the wall of this compartment, for example, at the predetermined breaking point or by melting the wall accelerated release of the water takes place because The compartment can now contract due to the mechanical stress and thus can empty.
  • This can for example be realized in that the water is in the compartment under pressure, that the wall of the compartment is designed so that a contraction of the compartments takes place upon breaking a point of the wall or that a mechanical element that a tensile stress, for example, on opposite Widening of the compartment exerts ⁇ eg a tension spring) in the interior of the compartment is present. In this case, it is advisable to flexibly execute the walls of the compartment.
  • a further preferred embodiment provides that between the storage compartment of the adsorbent serving (first compartment) and the storage of water serving compartment (second compartment) is arranged a further (third) compar- timent, which also includes an adsorbent.
  • a further (third) compar- timent which also includes an adsorbent.
  • the third compartment is preferred in the immediate vicinity of the second compartment. Particle arranged and separated from these, for example, by the above-mentioned porous material, such as a nonwoven fabric.
  • this third compartment is used exclusively for the production of water vapor, which is supplied after generation of the first compartment for storing the adsorbent (loaded with active ingredient) and there the actual aerosol loaded with active substances is generated.
  • the device has a casing of all components, for example a cylindrical casing, which may be formed for example of a thermally insulating material or a composite material. Inside this cylinder, all components of the device are thus arranged in this casing.
  • the outlet if appropriate the filter, if appropriate the intermediate space, may optionally be filled with the active substance in this cylinder
  • Substrate the compartment for storing the adsorbent, optionally the third compartment, optionally the nonwoven fabric, as well as subsequently the compartment for storing water are arranged.
  • This arrangement of the components thus enables as short a path as possible (in the abovementioned exemplary arrangement on the right) generation of the aerosol and the removal of the aerosol (left in the exemplary arrangement described above).
  • the sheath on the inner side at least partially comprises a (thermal) insulation, which includes the components of the device.
  • the insulation is only in the range formed in which the compartments are arranged, which have the adsorbent and thus generate heat when contacted with water.
  • the insulation is formed continuously over the entire length of the cylindrical casing.
  • the sheathing and insulation can be identical, but it is also possible that the insulation is a separate component.
  • a bypass is present in the device, which can be formed, for example, in the sheath but also in the insulation.
  • the bypass can be designed as a supply line, the fresh air, for example, on the one or more filled with adsorbent compartments, can pass.
  • the bypass may be formed as a lateral opening in the device, for example as an opening made through the sheath and / or the insulation, which may be arranged in the region of the intermediate space.
  • fresh air i. Air not laden with aerosol is supplied into the area of the device where ready aerosol is already present, so that the aerosol generated can be mixed with fresh air before it is removed from the device.
  • fresh air is drawn into the device when aerosol is withdrawn via the outlet, by a user pulling on the device via the outlet or mouthpiece attached thereto to inhale the generated aerosol.
  • bypass passes by the respective compartments of the device, it may also be the case that the inlet of the bypass is performed through the entire device and also passes to the storage of the water serving compartment.
  • the air flow supplied through the bypass thus runs parallel to the cylindrical casing in all compartments.
  • the air flow through the bypass which is generated when the aerosol is withdrawn via the outlet, can be used in a further advantageous embodiment to activate the possibly existing valve. It may be given that the valve has a means which is arranged in the region of the exiting air flow from the bypass. The valve can be actuated via the air flow leaving the bypass.
  • the agent is designed such that it opposes the emerging from the bypass air flow resistance;
  • the means may be formed as a planar element, on which mechanical pressure is exerted by the air flow emerging from the bypass. This mechanical pressure can be used to actuate the valve.
  • the adsorbent is particularly preferably selected from the group consisting of silica gel, aluminum oxide, clays and / or zeolites, in particular zeolite 3A, zeolite 4A, zeolite 5A, zeolite 13X and mixtures and combinations thereof.
  • zeolites are particularly preferred. In particular, in this case are the
  • Adsorption of water is achieved.
  • those zeolites which can be loaded with an inert gas, in particular nitrogen.
  • the inert gas is introduced into the cavity of the zeolites.
  • These loading processes are known to the person skilled in the art and can be carried out, for example, as follows: Water adsorbed on the zeolite is desorbed at 300 ° C. under reduced pressure. After cooling, the zeolite material is exposed to dry nitrogen, which is then partially adsorbed to the material.
  • a particular embodiment of the invention thus provides that the zeolites contained in the compartment or the compartments are partially or completely loaded with an inert gas, in particular nitrogen.
  • the purpose of this is that, when water is added to these zeolites loaded with inert gas, the inert gas is replaced by water, so that the inert gas, in particular nitrogen, is liberated from the zeolites.
  • the liberated inert gases, in particular nitrogen thus act as a propellant and support the aerosol formation particularly advantageous, so that a particularly efficient aerosol formation is made possible.
  • the amount of adsorbent and thus the size of the compartment or compartments containing the adsorbent is determined in each case according to the application.
  • relatively large amounts of adsorbent in the compartment or the compartments can be stored.
  • Exemplary amounts of adsorbent are between 1 cm 3 and 1,000 cm 3 , but are not limited thereto.
  • the size of the device is based overall on the orders of magnitude of, for example, a commercial conventional cigarette, ie the device is preferably cylindrical and about 5 to 30 cm, preferably 7.5 to 20 cm, more preferably 8 to 12 cm, in particular 10 cm long and 0.5 to 5 cm, preferably 0, 6 to 2 cm, more preferably 0.8 to 1.2 cm, in particular dimensioned 1 cm in diameter, the compartment that contains the adsorbent, or the compartments 10.1 to 10.9 of the Volu ⁇ mens this device can take.
  • the details given are to be understood as examples and not limited thereto.
  • the active ingredient is selected from a) pharmacologically active substances, in particular medicaments and / or nicotine,
  • Suitable substances can be used which are able to be converted into an aqueous aerosol.
  • Suitable substances in particular medicaments, are selected from the following particularly preferred substances, but are not limited thereto:
  • Proteins Polysaccharides, lipids, nucleic acid and combinations or mixtures thereof,
  • Antibiotics antivirals, fungicides, immunosuppressive drugs, non-steroidal anti-inflammatory drugs, surfactants, prostaglandins, mucolytics, antitussives, against Cough medication, throat pain medication, gene therapy vectors, heparin, ergotamine, human growth hormone,
  • Gout anticonvulsants and cold remedies, gynecologics, hepatics, hypnotic / sedative drugs, hypophyseal / hypothelial hormones / - other regulatory peptides and their inhibitors, immunomodulators, ardiaka, coronary drugs, lipid-lowering drugs, gastrointestinal medications, migraine preparations, mineral preparations , Pharyngeal, neuropathic and other neurotropic agents, osteoporosis / calcium / bone metabolism regulators, Parkinson's and other anti-pyramidal drugs, psychotropic drugs, thyroid therapeutics, sera / immunoglobulins and vaccines, sex hormones and their inhibitors, antispasmodics / anticholinergics, antiplatelet agents, tuberculosis drugs, Uméessstoff, urologics, venous therapeutics, vitamins, cytostatics / other antineoplastic agents u. Protectives.
  • the device according to the invention is particularly preferably suitable for producing an aqueous, nicotine-containing aerosol.
  • flavoring substances or flavorings can be mixed with the device according to the invention or the invention.
  • the process according to the invention can be converted into an aqueous aerosol.
  • flavors or flavorings can be mixed with the device according to the invention or the invention.
  • the process according to the invention can be converted into an aqueous aerosol.
  • Flavored substances are understood as substances, as they are covered, for example, in the Flavor Regulation EC No. 1334/2008. Under fragrances are present in accordance with the sense of smell stimulating, chemicals ver ⁇ stood; For example, natural, nature-identical or synthetic fragrances, in particular substances from the organic aldehydes, esters and ethers, may be included.
  • the content of active ingredient is designed for the particular purpose.
  • Pharmaceutically active substances can thus, based on the total amount of adsorbent, be contained in a concentration or total amount in the device that, for example, an aerosol is produced which contains the respective active substance in an effective concentration and thus a sufficient pharmacological effect can be achieved ,
  • Nicotine as well as a variety of drugs have strong hygroscopic properties. The consequence of this is that in the humid environment the lung is watery
  • Aerosol droplets containing nicotine can grow dramatically in fractions of a second and thus can not reach the peripheral lung tissue where resorption occurs. Aerosols in which the maximum of the droplet size distribution on the order of about two microns, are at bends not with the flow (bumps by particle or molecule) carried away, but drift due to the centrifugal force of its mass and "eventually collide with the wall and deposit because they are not hydrophobic in an area of the lung from which only has a ver ⁇ tively low resorption. Therefore, systems based on pure water do not work.
  • hydrophobic substance classes can form very stable aerosols, which are not dramatically adsorbed by moist walls. They are substances that fall under the group of terpenes, liquid at room temperature as well as solid paraffins, fatty acids from C10 to C18 as well as fatty alcohols and cyclic
  • At least one hydrophobic substance in particular selected from the group consisting of paraffin oils, terpenes, terpenoids, alkanecarboxylic acids, alkanecarboxylic acid esters, organic esters, fatty alcohols,
  • Siloxanes and / or mixtures or combinations thereof is contained.
  • the hydrophobic substance can be dissolved, suspended or dispersed, for example, in the compartment containing water. Likewise it is possible that the hydrophobic substance is mixed with the adsorbents, which in the respective Compartments or the compartment are present. Furthermore, it may be possible for the optionally present substrate to contain the hydrophobic substance. The hydrophobic substance is thus entrained in the generation of the aerosol from the resulting water vapor or aerosol droplets and is deposited on the surface of the per se polar water droplets. This leads to a
  • Substance classes are for example:
  • Cyclopentasiloxane (decamethylcyclopentasiloxane) and cyclohexasiloxane (Dodecamethylcyclohexasiloxan) in question.
  • the former is often found in cosmetics such as hair sprays, skin creams, deodorants and the like. and it is also completely odorless.
  • the device contains an evaporation accelerator, in particular selected from the group consisting of 2-oxo acids, in particular pyruvic acid.
  • the evaporation accelerator may also be dissolved, suspended or dispersed in the water of the hydrous compartment.
  • the evaporation accelerator mixed with the adsorbents or applied to the substrate is contained in the device.
  • the evaporation accelerator brings about an efficient conversion of the active ingredient into the aerosol phase, so that it is particularly preferred
  • the device includes both a hydrophobic material and an evaporation accelerator.
  • Preferred evaporation accelerators are selected from the group consisting of 2-oxo acids, in particular pyruvic acid. In order to evaporate e.g. of nicotine with one
  • Boil point of 360 ° C or to promote drugs at significantly lower temperatures evaporation accelerators are used. It is shown experimentally that a small group of 2-oxo acids, such as pyruvic acid, improve the passage of nicotine into the gas phase, while by far the largest Part of organic as well as some inorganic acids such as phosphoric acid affect the evaporation very negative. The best results have so far been achieved with pyruvic acid.
  • Evaporation accelerators can be metered, for example, stoichiometrically or slightly more than stoichiometrically to the active ingredient component.
  • the present invention also relates to a process for producing drug-loaded aqueous aerosols in which water is applied to an adsorbent for water that adsorbs water to release heat of adsorption, wherein a portion of the water is adsorbed by the adsorbent and another portion of the water is evaporated by the heat of adsorption, wherein at least one active ingredient is dissolved, emulsified or suspended in the water and / or mixed with the adsorbent and / or contained in a separate substrate, which is acted upon by the water vapor, wherein the active ingredient dissolves in water vapor and so an aerosol is formed.
  • the process according to the invention is characterized in that water is taken from the water-containing compartment and fed to the compartment containing the adsorbent.
  • the water is partially adsorbed by the adsorbent with heat generation, wherein the heat development is preferably controlled so that temperatures> 100 ° C, more preferably between 100 and 200 ° C, in particular between 140 and 160 ° C, are achieved.
  • the heat development is preferably controlled so that temperatures> 100 ° C, more preferably between 100 and 200 ° C, in particular between 140 and 160 ° C, are achieved.
  • part of the discontinued water is transferred into the vapor and / or aerosol phase.
  • the generated aerosol is carried out via the outlet.
  • the active ingredient may be contained in the water, which is fed into the compartment containing the adsorbent, for example in the form of a solution, emulsion or dispersion.
  • the adsorbent is loaded with an active ingredient. This loading can be designed, for example, such that prior to introduction of the adsorbent into the compartment or compartments provided, the adsorbent is mixed with the active substance, for example in the case of a liquid active substance by mixing this liquid active substance or a solution or emulsion or dispersion thereof the adsorbent.
  • a physical mixing of the adsorbent with this solid active ingredient for example in the form of a Powder, before introducing the Adsorptionsmi els in the space provided compartment.
  • the Device is - loaded with the drug.
  • the loading of the substrate is also preferably carried out before introducing the substrate into the device.
  • the transfer of the water from the compartment provided for this purpose into the compartment or the compartments containing the adsorbent can be carried out in any desired manner according to the process of the invention.
  • the adsorbent-containing and water-containing compartments are arranged in close proximity to each other, it is preferred if the water-containing compartment is equipped with a predetermined breaking point and a mechanical means for breaking this predetermined breaking point.
  • the wall of this water-containing compartment can be broken at the predetermined breaking point and thus leak water from the compartment.
  • the water-containing compartment is disposed within the adsorbent-containing compartments or compartment and has a wall which becomes mechanically unstable upon exertion of pressure or upon application of external heat and bursts, breaks or melts, for example so that water can escape from the compartment.
  • the wall of the water-containing compartments can be formed from a thermoplastic elastomer which becomes mechanically unstable when heated above the melting range.
  • a further alternative envisages that the water from the compartment provided for this purpose can be metered into the compartment for the adsorbent so that both a continuous and metered release of water is possible.
  • This dosage may e.g. by means of a valve or cock placed between the water compartment and the adsorbent compartment.
  • a valve or cock placed between the water compartment and the adsorbent compartment.
  • the removal of the aerosol from the device according to the invention takes place automatically in a basic embodiment of the method according to the invention, ie upon a single activation of the device pressurized aerosol is generated which flows out via the outlet.
  • this tube can be particularly advantageously equipped with a valve that controls the aerosol removal, so that the aerosol only removed when needed can be.
  • the valve is preferably designed such that it opens when generating an air flow through the device according to the invention and automatically closes again after removal of this air flow at removal.
  • FIG. 1 shows a first embodiment of a device according to the present invention
  • FIG. 2 shows a cross section through the device according to the invention shown in perspective in FIG. 1,
  • FIG. 3 shows a detail of the device according to the invention, which represents the water-containing compartment, as well as FIG.
  • FIG. 4 shows a further embodiment of the device according to the present invention in perspective and in section.
  • the reference symbols used in the figures have the following meaning:
  • FIG. 1 shows an embodiment of the device 1 for producing active substance-laden aqueous aerosols according to the present invention, which according to the embodiment shown in FIG. 1 is designed as an inhaler, for example as a smoke-free cigarette.
  • the device 1 is cylindrical and bounded by a casing 14.
  • the sheath 14 is formed continuously over the entire length of the cylinder.
  • the apparatus comprises a (first) compartment 2 containing an adsorbent, for example a zeolite.
  • This compartment 2 is shown in Figure 1 on the left and limited by a plate 6, which is impermeable to the aerosol or water vapor and / or water.
  • the compartment 2 is bounded on the right by a water-wicking web 4; this point represents the water inlet 2a for the compartment 2.
  • a perforated tube 5 In the compartment 2 protrudes a perforated tube 5, wherein the perforations as a dotted Positions are shown in Figure 1.
  • the tube 5 can, as shown in FIG. 1, be centered and fixed by a spacer 19 in the compartment 2.
  • the tube 5 is passed through the plate 6 and thus guarantees the fluidic communication of
  • Compartment 2 via the perforations with the left of the compartment 2 arranged intermediate space 9.
  • a filter 8 may be arranged, via which the generated aerosol emerges at the outlet 7.
  • the case of the filter 8 may represent the mouthpiece with associated outlet 7, as well, it is possible that another sepa rates ⁇ mouthpiece is attached to the outlet.
  • This compartment 3 has a wall which adjoins the nonwoven 4. As shown in FIG. 1, this wall has a plurality of predetermined breaking points 10, via which a respective mandrel 11 is arranged, with which the predetermined breaking point 10 can be broken.
  • the device 1 is activated by pressure on the mandrels 11, wherein the mandrels 11 pierce the predetermined breaking points 10.
  • the nonwoven fabric 4 transfers the absorbed water to the compartment 2, which contains the adsorbent, for example zeolites.
  • the zeolites begin
  • Adsorb water with heat generation ie store it, so that a water vapor development of aerosols begins.
  • the aerosols gradually fill the entire space of the adsorbent-filled compartment 2 and pass through the perforations of the tube 5. Due to the resulting over- pressure during the formation of aerosol, the resulting aerosols are also forced out through the interspace 9 through the filter 8 and finally exit via the outlet 7.
  • at least one active substance for example nicotine
  • This active ingredient may be dissolved, emulsified or dispersed, for example, in the water of compartment 3. It is likewise possible that the active ingredient is mixed with the adsorbents contained in Part 2.
  • adsorption ⁇ medium 2 * is included in the apparatus 1, for example as shown in Figure 1, may be disposed between the spacer 19 and nonwoven fabric. 4
  • the compartment 2 is filled with adsorbents which are drug-loaded, ie mixed with active ingredient, while the adsorbent contained in compartment 2 is free of active ingredient. This design requires a predominantly aerosol development in the compartment
  • the loading of the aerosol with active ingredient then takes place only in compartment 2.
  • this may be present in compartment 2.
  • Figure 2 shows a cross section through the device shown in perspective in Figure 1, in particular, the implementation of the tube 5 is shown in more detail by the plate 6. It can also be seen that in the compartment 3 an opening is present in order to be able to compensate for any resulting overpressure in the device 1 when activated.
  • the exemplary dimensioning of the device 1 is also shown, for example, the length of the device 1 can be 100 mm and 10 mm in diameter ⁇ ser.
  • the compartment 3 is, for example, 15 mm, starting from the right side of the device 1, while the tube 5 for discharging the aerosols can be for example 65 mm long.
  • the compartment 2 may, for example, occupy up to 75 mm of the entire length of the device 1.
  • Figure 3 shows a detailed view of the water-containing compartment 3.
  • Figure 3 also shows a punch tube IIa as further mechanical ele- ment to break the respective frangible Stel ⁇ len.
  • the autonomous energy supply of the device according to the invention for the production of aerosols is based on the principle of the release of heat of adsorption by the addition of water to, for example zeolites with simultaneous desorption of a gaseous
  • Propellant Particularly suitable are zeolites of the type 3A, 4A, 5A and 13X, which are specially prepared in the preparation of the aerosol device 1 according to the desired properties.
  • the preferred type is 4A, since relatively large amounts of nitrogen can be adsorbed thereon.
  • it is desorbed by the zeolite and can function as a propellant for the resulting aerosol. Large molecules such as nicotine are not adsorbed by the zeolite material due to the small mesh size of the selected types.
  • water Upon initiation of the inhaler 1 e.g. by perforation of the water tank 3, water is distributed in the adjacent tile 4 and enters the with
  • the zeolite adsorbs the water, releasing heat. Temperatures of more than 150 ° C. are produced directly on the zeolite particles. Excess water evaporates. ser. Due to the air flow generated during inhalation, the moisture front reaches all zeolite particles in a short time.
  • the active substance or part of the active substance can be present in zeolite particles which act as a porous carrier material. These loaded zeolite particles are located in the zeolite filling between
  • the inhaler is thus constructed in principle as follows.
  • the device 1 consists of an approximately 10 to 12 cm long outer tube 14 with about 8 mm to 12 mm in diameter, which consists of a very good heat insulating material 12 is.
  • the apparatus 1 is divided into three parts:
  • the water tank 3 can easily be under tension, e.g. with the help of a small spring, so that an almost complete emptying during operation is guaranteed.
  • the attached to the water tank starter 11 or IIa is initiated by destroying a predetermined breaking point 10. If the chamber 3 filled with water at the end of the cigarette 1 is opened by a mechanism, for example a mandrel 11, water flows into the water-sucking fleece 4 which is directly in connection with the zeolite filling 2.
  • the zeolite adsorbs water and the resulting heat of adsorption is sufficient to produce water vapor. If the smoker breathes over the cigarette, the water vapor produced at the tip wanders through the zeolite filling and causes a rise in temperature in the cigarette body to approx. 150 ° C. Despite the higher boiling point of nicotine (about 270 ° C) then relevant amounts of nicotine-containing aerosol are in the gas phase.
  • the perforated inner tube 5 is used for rapid removal of the aerosol to the mouthpiece 7,
  • FIG. 4 shows a further embodiment of a device 1 according to the present invention (in perspective in FIG. 4a, in FIG. 4b in FIG Cut) .
  • This device 1 is also cylindrical in shape and limited by a sheath 14 which is formed over the entire length of the cylinder. As shown in Figures 1 to 3, the device 1 has a compartment
  • the compartment 3 may be formed as shown for example in FIG.
  • the device 1 according to FIG. 4 has a substrate 13, which may be formed, for example, from cellulose. This substrate 13 is loaded with active ingredient.
  • Substrate 13 are sealed off from the intermediate space 9 by a vapor-tight and aerosol-tight plate 6, wherein a perforated tube 5 is guided through this plate and protrudes into the substrate 13. According to the already in the previous ones
  • the activation of the device 1 takes place by abandoning the originating from the compartment 3 water through the nonwoven fabric 4 via the inlet 2a in the compartment 2, wherein a vaporization and aerosol formation of the water takes place.
  • the water aerosol can penetrate into the substrate 13 via the opening 13a and receive the active substance there.
  • the active substance-laden aqueous aerosol thus becomes through the perforations in the tube 5 from the compartment 2 or the substrate 13 into the intermediate space
  • the tube 5 projects into the intermediate space 9 and has a nozzle 17 at the end.
  • a valve 16 on the pipe 5 is formed, which can be switched between a closed and an open position, so that only geöffne ⁇ ter position of the valve the aerosol into the intermediate space 9 and thus finally reach the outlet 7 of the device 1 via the filter 8.
  • the device 1 according to FIG. 4 furthermore comprises an insulating layer 12 which is formed between the casing 14 and the compartment 2, the compartment 3 and the nonwoven fabric 4. The insulation 12 prevents resulting heat from being conducted to the outer surface of the shroud 14 and allowing a user to burn on the device 1 when activated.
  • a bypass 15 is passed through the insulating layer 12 and is in fluid communication with the environment of the device 1 via an opening 15a.
  • the valve 16 has an actuating element 18, for example a lever or a spring, via which the valve 16 can be opened.
  • actuating element 18 for example a lever or a spring
  • the valve 16 can be opened.
  • a user removes aerosol, for example by creating a negative pressure by pulling on the outlet 7 (eg with the mouth)
  • the air flow acts on the lever 18 of the valve 16, whereby the lever 18 is deflected and the valve 16 is opened.
  • the aerosol flows out through the tube 5 via the nozzle 17 and mixes with the air volume located in the intermediate space 9. Pull on the outlet 7

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Abstract

L'invention concerne un dispositif et un procédé de production d'aérosols aqueux chargés d'un principe actif, qui comprennent, comme constituant essentiel, un compartiment qui est chargé d'un agent d'adsorption qui, par contact avec l'eau, adsorbe de l'eau dans un processus exothermique, cependant qu'une partie de l'eau s'évapore et passe en phase gazeuse. Dans le cas où l'eau est chargée d'un principe actif ou, par exemple, l'agent d'adsorption est mélangé avec un principe actif, il se forme un aérosol aqueux chargé d'un principe actif. En particulier, l'invention concerne des dispositifs pour l'inhalation d'aérosols qui renferment de la nicotine ou des principes actifs pharmaceutiques dans des nanoparticules stables (diamètre moyen < 1-2 μm).
PCT/EP2012/066718 2011-08-31 2012-08-29 Dispositif et procédé de production d'aérosols aqueux chargés d'un principe actif Ceased WO2013030202A1 (fr)

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DE102011111999.3A DE102011111999B4 (de) 2011-08-31 2011-08-31 Vorrichtung und Verfahren zur Erzeugung von mit Wirkstoff beladenen wässrigen Aerosolen
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US11478807B2 (en) 2014-12-15 2022-10-25 Philip Morris Products S.A. Aerosol-generating system using the venturi effect to deliver substrate to a heating element
US11553734B2 (en) 2018-11-08 2023-01-17 Juul Labs, Inc. Cartridges for vaporizer devices
US12369617B2 (en) 2019-12-19 2025-07-29 Juul Labs, Inc. Metal oxide-based gel nicotine compositions
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