WO2021229574A1 - Compositions pour inhalation et leurs utilisations pour désinfecter les voies respiratoires supérieures - Google Patents

Compositions pour inhalation et leurs utilisations pour désinfecter les voies respiratoires supérieures Download PDF

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Publication number
WO2021229574A1
WO2021229574A1 PCT/IL2021/050544 IL2021050544W WO2021229574A1 WO 2021229574 A1 WO2021229574 A1 WO 2021229574A1 IL 2021050544 W IL2021050544 W IL 2021050544W WO 2021229574 A1 WO2021229574 A1 WO 2021229574A1
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WO
WIPO (PCT)
Prior art keywords
liquid
composition
inhalation
electronic cigarette
evaporation heater
Prior art date
Application number
PCT/IL2021/050544
Other languages
English (en)
Inventor
Miron Hazani
Original Assignee
Corolabs Ltd.
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 Corolabs Ltd. filed Critical Corolabs Ltd.
Publication of WO2021229574A1 publication Critical patent/WO2021229574A1/fr

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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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
    • A—HUMAN NECESSITIES
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    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/40—Constructional details, e.g. connection of cartridges and battery parts
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/40—Constructional details, e.g. connection of cartridges and battery parts
    • A24F40/44—Wicks
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    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/40—Constructional details, e.g. connection of cartridges and battery parts
    • A24F40/46—Shape or structure of electric heating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
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    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
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Definitions

  • the present disclosure generally relates to the field of compositions for administration via inhalation, and uses thereof in disinfection of the upper respiratory airways.
  • the present compositions are alcoholic (ethanolic and/or isopropanolic) and are administered in the form of an aerosol generated by an aerosol generating device.
  • the respiratory tract is structurally divided into the upper and lower respiratory airways.
  • the upper respiratory airways or upper respiratory tract includes the nose and nasal passages, paranasal sinuses, the pharynx, and the portion of the larynx above the vocal folds (cords), and the lower respiratory airways or lower respiratory tract includes the portion of the larynx below the vocal folds, trachea, bronchi, bronchioles and the lungs.
  • the upper respiratory tract is the entrance port for microorganisms entering the lower respiratory tract, e.g., the lungs of a subject.
  • the upper respiratory tract frequently traps these microorganisms and may kill them before they effectively enter the body.
  • the microorganism is able to get a foothold in the upper respiratory tract, it can invade the lower respiratory tract and affect the lungs, and in some cases lead to a severe and potentially life-threatening lower respiratory tract infection (LRTI).
  • LRTI lower respiratory tract infection
  • SARS-CoV-2 severe acute respiratory syndrome coronavirus 2
  • COVID-19 coronavirus disease 2019
  • COVID-19 coronavirus disease 2019
  • mucosae mouth and nose
  • conjunctiva eyes
  • Mycobacteria and related microorganisms like nocardia and corynebacteria are still major causes of difficult to treat infections worldwide. Tuberculosis, leprosy, nocardiosis and diphtheria are among others the most important infections to be mentioned. Different antibiotics with various targets are in use, without solving completely the therapeutic problem.
  • RSV Human respiratory syncytial virus
  • Pneumonia is an infection of one or both of a patient's lungs that can be caused by a number of different pathogens, including viruses, bacteria, and fungi.
  • Symptoms of pneumonia include cough, chest pain, fever, and difficulty breathing. Serious complications of pneumonia can include respiratory failure, sepsis, and lung abscesses.
  • Respiratory viruses, including influenza virus can be the cause of viral pneumonia (i.e., primary viral pneumonia), which also can be present as a co-infection with a bacteria or another virus, or can act as predisposing factors to facilitate or worsen bacterial pneumonia.
  • Influenza virus can cause primary viral pneumonia or predispose a patient to bacterial pneumonia. Influenza is a common cause of pneumonia particularly among young children, the elderly, pregnant women, those with chronic health conditions, and those who live in a nursing home.
  • An alternative approach for dealing with various viral and microbial infections is a preventive approach aiming at reducing the spread and development of pathogenic microorganisms, by killing them before their spread in the body.
  • Ethanol is a well-known anti-viral and anti-microbial agent at concentrations of above 60%, with a strong and broad virucidal activity. Ethanol-based disinfectants are widely used worldwide for hand rubbing and disinfection of surfaces. In order to reduce the evaporation rate and make it easier to apply, ethanol-based hand sanitizers often contain a thickening-gelating carrier.
  • US9585398B2 provides a disinfectant applicable to use for hands and skin, the disinfectant comprising (a) 40 to 90% (w/w) of ethanol, isopropyl alcohol or a mixture thereof; (b) 0.1 to 2% (w/w) of lactic acid; (c) 0.01 to 2% (w/w) of citric acid; and (d) 0.001 to 0.1% (w/w) of a zinc-containing compound which releases zinc ion in solution, relative to the whole disinfectant.
  • US8389583 provides antimicrobial therapy as topical disinfectants.
  • one aspect relates to an alcohol containing antimicrobial composition that includes at least one paraben, a redox compound and an organic acid at a concentration of from about 1.5 percent to about 10 percent by weight, based on the total weight of the composition.
  • Electronic cigarettes are becoming a popular alternative to tobacco smoking because of the many advantages that they offer.
  • One of the main reasons that they are popular is due to the similar sensation the provide, compared to tobacco smoking with paper cigarettes.
  • E-cigarettes are also used to quit smoking and replace paper cigarettes.
  • electronic cigarettes are electronic aerosol-generating devices, which include a heating unit for vaporizing the composition to be inhaled.
  • Conventional electronic cigarettes are made with a mouth piece assembly, a vaporizer assembly, an electric connecting assembly, and an e-liquid storage assembly.
  • the inclusion of a vaporizer assembly is in contrast with other aerosol-generating devices, such as nebulizers and inhalers, which provide cold aerosols, and do not require heating.
  • e-cigarettes are typically smaller than other aerosol-generating devices, and may provide particularly effective delivery of the aerosol to the lungs.
  • WO 2020/194297 relates to the field of aerosol generation devices, and more particularly to electronic cigarettes configured to generation of aerosols from aqueous formulations of nicotine or cannabis products.
  • ultrasonic wave nebulizers were invented in 1965 as a new type of portable nebulizer.
  • the technology inside an ultrasonic wave nebulizer is to have an electronic oscillator generate a high frequency ultrasonic wave, which causes the mechanical vibration of a piezoelectric element. This vibrating element is in contact with a liquid reservoir and its high frequency vibration is sufficient to produce a vapor mist.
  • the present invention is further beneficial for reducing the global spread of various contagious pathogenic microorganisms which upon infecting the lungs, can cause severe and potentially life-threatening diseases.
  • ethanol is a well-known anti-microbial agent which is widely used for hand sanitizing, its use by inhalation for disinfecting the upper respiratory airways poses challenges.
  • ethanol is a highly volatile liquid, which is specifically prone to surface evaporation when air flow is discharge against its surface.
  • a composition that lowers the high evaporation rate of ethanol is needed, while still being suitable for administration by inhalation.
  • the present invention provides a novel method for effective and safe disinfection of the upper respiratory airways.
  • Said method is based on an ethanol-based composition with a lowered ethanol evaporation rate, which upon administration via inhalation leads to deposition of sufficient amounts of ethanol on the surface area of the upper respiratory tract, and maintenance of said deposited ethanol for sufficient time to effectively kill pathogenic microorganisms.
  • the composition is in the form of a gel.
  • the thickening agent is pharmaceutically acceptable for inhalation and is selected from the group consisting of: calcium (II) acetate, glycerol, propylene glycol, poloxamer and saccharide.
  • the thickening agent is selected from the group consisting of: calcium (II) acetate, glycerol, propylene glycol, poloxamer and saccharide.
  • the thickening agent is propylene glycol, vegetable glycerin or both.
  • the composition comprises at least 50% ethanol v/v.
  • the composition comprises at least 1% thickening agent w/w.
  • the composition further comprises isopropanol.
  • the composition further comprises a hydrophilic amine, a quaternary ammonium salt, or both.
  • a hydrophilic amine a quaternary ammonium salt, or both.
  • the method of disinfecting the upper respiratory airways comprises:
  • administering the aerosol via inhalation in step (c) comprises transferring the ethanol and the thickening agent to at least one organ or tissue of the upper respiratory tract of the subject, wherein the at least one organ or tissue is selected from the group consisting of: nose, nostrils, nasal cavity, paranasal sinuses, mouth, pharynx and larynx.
  • the ethanol and the thickening agent are transferred to at least one organ or tissue of the upper respiratory tract of the subject, wherein the at least one organ or tissue is selected from the group consisting of: nose, nostrils, nasal cavity, paranasal sinuses, mouth, pharynx and larynx.
  • said ethanol and thickening agent are deposited on said at least one organ or tissue to form a gel comprising the ethanol and the thickening agent thereon.
  • At least 10% of the ethanol transferred to the organ or tissue remains deposited on said organ or tissue 5 seconds after said deposition. According to some embodiments, at least 15%, at least 20% or at least 25% of the ethanol transferred to the organ or tissue remains deposited on said organ or tissue 5 seconds after said deposition.
  • the aerosol of step (b) comprises droplets having a mass median aerodynamic diameter (MMAD) in the range of 5 microns to 25 microns.
  • MMAD mass median aerodynamic diameter
  • the composition upon administration of the composition via inhalation, the composition manifests antimicrobial activity against at least one pathogenic microorganism present in the upper respiratory tract, wherein the at least one pathogenic microorganism is selected from pathogenic viruses and pathogenic bacteria. According to some embodiments, upon administration of the composition via inhalation, the composition manifests antimicrobial activity against at least one pathogenic microorganism present in the upper respiratory tract, thereby preventing the development of a disease associated with a respiratory tract infection.
  • the pathogenic microorganism is a pathogenic virus.
  • the pathogenic virus is selected from the group consisting of coronavirus, influenza vims, respiratory syncytial virus, and rhinovirus. Each possibility represents a separate embodiment of the present invention.
  • the pathogenic virus is coronavirus.
  • the pathogenic virus is human coronavirus.
  • the human coronavirus is selected from is selected from MERS-CoV, SARS-CoV and SARS-CoV-2. Each possibility represents a separate embodiment of the present invention.
  • the pathogenic microorganism is a pathogenic bacterium.
  • the pathogenic bacterium is selected from the group consisting of streptococcus pneumoniae, haemophilus influenzae, moraxella catarrhalis, staphylococcus aureus, streptococcus pyogene, Legionella pneumophila and mycobacteria species.
  • the pathogenic bacterium is selected from the group consisting of streptococcus pneumoniae, haemophilus influenzae, moraxella catarrhalis, staphylococcus aureus, streptococcus pyogene, and Legionella pneumophila.
  • Each possibility represents a separate embodiment of the present invention.
  • the pathogenic bacterium is a mycobacterium.
  • the composition is administered via inhalation to a subject in need thereof, wherein the subject in need thereof is a subject that is suspected to develop a disease associated with a respiratory tract infection.
  • the disease is selected from the group consisting of COVID-19, influenza, pneumonia, tuberculosis and common cold. Each possibility represents a separate embodiment of the present invention.
  • step (b) comprises applying electric power to the piezoelectric transducer, thereby creating vibrations at an ultrasonic frequency in a transducer plate associated with the piezoelectric transducer, wherein the vibrations result in generating an aerosol from the composition for inhalation in the liquid container.
  • the aerosol generating device comprises a heating unit. According to some embodiments, the aerosol generating device is an electronic cigarette.
  • the liquid deposition mechanism further comprises a biasing element, configured to trigger a dislocation of at least a portion of the liquid drawing element between a first position in the first state of the electronic cigarette and a second position in the second state of the electronic cigarette, wherein the liquid drawing element is spaced apart from the evaporation heater in the first position, and wherein the liquid drawing element is in contact with the evaporation heater in the second position.
  • a biasing element configured to trigger a dislocation of at least a portion of the liquid drawing element between a first position in the first state of the electronic cigarette and a second position in the second state of the electronic cigarette, wherein the liquid drawing element is spaced apart from the evaporation heater in the first position, and wherein the liquid drawing element is in contact with the evaporation heater in the second position.
  • the biasing element comprises a solenoid actuator, a rod and a solenoid plunger head, wherein the rod has a first end and a second end, wherein the second end is connected to the solenoid actuator, and the first end is connected to the solenoid plunger head, wherein the solenoid actuator is configured to dislocate the solenoid plunger head between a first position and a second position, wherein in the second state of the electronic cigarette, the solenoid plunger head is in the second position thereof and is pressing the portion of the liquid drawing element against the evaporation heater, and in the first state of the electronic cigarette, the solenoid plunger head is in the first position thereof and the liquid drawing element is spaced apart from the evaporation heater.
  • the liquid deposition mechanism further comprises a spraying mechanism, located within the cartridge and configured to create a spray from the composition for inhalation, wherein the spraying mechanism is in contact with the liquid drawing element and spaced apart from the evaporation heater in both the first state of the electronic cigarette and the second state of the electronic cigarette.
  • the liquid deposition mechanism further comprises a liquid deposition mechanism housing
  • the spraying mechanism comprises a piezo disc configured to create the spray from the composition for inhalation , wherein the piezo disc is in contact with the liquid drawing element and spaced apart from the evaporation heater in both the first state of the electronic cigarette and the second state of the electronic cigarette, wherein the piezo disc is accommodated within the liquid deposition mechanism housing.
  • a composition for inhalation provided in a dosage form suitable for aerosolization using an aerosol generating device, for use in disinfecting the upper respiratory airways of a subject, the composition comprises ethanol and a pharmaceutically acceptable excipient, wherein the excipient comprises a thickening agent, wherein the composition for inhalation has a viscosity of at least 2 mPa ⁇ S and vapor pressure of no more than 3 kPa at a temperature of 25 C and a pressure of 1 atmosphere.
  • the composition is in a gel form.
  • the thickening agent is pharmaceutically acceptable for inhalation and is selected from the group consisting of: calcium (II) acetate, glycerol, propylene glycol, poloxamer and saccharide. Each possibility represents a separate embodiment of the present invention.
  • the thickening agent is propylene glycol, vegetable glycerin or both.
  • the composition for inhalation comprises at least 50% ethanol v/v.
  • the composition for inhalation comprises at least 1% thickening agent w/w.
  • the composition for inhalation further comprises isopropanol.
  • the composition for inhalation further comprises a hydrophilic amine, a quaternary ammonium salt, or both.
  • the composition for inhalation comprises at least one additive selected from the group consisting of a propellant, an anti-coughing agent and a flavorant. Each possibility represents a separate embodiment of the present invention.
  • the composition for inhalation is for use in disinfecting the upper respiratory airways of a subject, wherein the subject is suspected to develop a disease associated with a respiratory tract infection.
  • disinfecting the upper respiratory airways of the subject comprises treating an infection in the upper respiratory airways.
  • treating the infection in the upper respiratory airways is associated with preventing a disease associated with a respiratory tract infection.
  • the disease is a respiratory disease.
  • the disease associated with a respiratory tract infection is selected from the group consisting of COVID-19, influenza, pneumonia, tuberculosis and common cold. Each possibility represents a separate embodiment of the present invention.
  • the composition upon administration of the composition via inhalation, the composition manifests antimicrobial activity against at least one pathogenic microorganism.
  • the composition upon administration of the composition via inhalation, the composition manifests antimicrobial activity against at least one pathogenic microorganism present in the upper respiratory airways.
  • the at least one pathogenic microorganism is selected from pathogenic viruses and pathogenic bacteria.
  • the pathogenic microorganism is a pathogenic virus.
  • the pathogenic virus is selected from the group consisting of coronavirus, influenza virus, respiratory syncytial virus, and rhinovirus. Each possibility represents a separate embodiment of the present invention.
  • the pathogenic virus is coronavirus.
  • the pathogenic virus is human coronavirus.
  • the human coronavirus is selected from is selected from MERS-CoV, SARS-CoV and SARS-CoV-2.
  • the pathogenic microorganism is a pathogenic bacterium.
  • the pathogenic bacterium is selected from the group consisting of streptococcus pneumoniae, haemophilus influenzae, moraxella catarrhalis, staphylococcus aureus, streptococcus pyogene, Legionella pneumophila and mycobacteria species.
  • the pathogenic bacterium is selected from the group consisting of streptococcus pneumoniae, haemophilus influenzae, moraxella catarrhalis, staphylococcus aureus, streptococcus pyogene, and Legionella pneumophila. According to some embodiments, the pathogenic bacterium is a mycobacterium.
  • an electronic aerosol generating device cartridge comprising a liquid container, wherein the liquid container contains the composition for inhalation in all embodiments thereof.
  • the electronic aerosol generating device cartridge is selected from an electronic cigarette cartridge, electronic vaporizer cartridge an ultrasonic nebulizer cartridge.
  • the electronic aerosol generating device cartridge is selected from an electronic cigarette cartridge, electronic vaporizer cartridge an ultrasonic nebulizer cartridge.
  • the electronic aerosol generating device cartridge further comprises an evaporation heater configured to generate heat and to evaporate alcohol compositions from a surface thereof, and a liquid deposition mechanism configured to transfer portions of the composition from the liquid container to the evaporation heater.
  • the electronic aerosol generating device cartridge has a first state, in which the liquid deposition mechanism prevents fluid communication between the liquid container and the evaporation heater, and a second state, in which the liquid deposition mechanism allows fluid communication between the liquid container and the evaporation heater, wherein the electronic aerosol generating device cartridge is configured to intermittently transition between the first state and the second state.
  • Certain embodiments of the present disclosure may include some, all, or none of the above advantages.
  • One or more technical advantages may be readily apparent to those skilled in the art from the figures, descriptions and claims included herein.
  • specific advantages have been enumerated above, various embodiments may include all, some or none of the enumerated advantages.
  • Figure 1 constitutes a schematic view of an electronic cigarette comprising a cartridge and an actuator, when connected, according to some embodiments.
  • Figure 2 constitutes a schematic view of an electronic cigarette comprising a cartridge and an actuator, when separated, according to some embodiments.
  • Figures 3A and 3B constitute schematic views of an electronic cigarette comprising a cartridge and an actuator, when connected, in a first state of the electronic cigarette ( Figure 3A) and, in a second state of the electronic cigarette ( Figure 3B).
  • Figure 4 constitutes a schematic view of an electronic cigarette comprising a cartridge and an actuator, when connected, according to some embodiments.
  • Figure 5 constitutes a schematic view of an electronic cigarette comprising a cartridge and an actuator, when separated, according to some embodiments.
  • Figure 6 constitutes a schematic view of an ultrasonic nebulizer, according to some embodiments.
  • the present invention provides novel compositions and methods for efficient and safe disinfection of the upper respiratory airways of a subject in need thereof.
  • the compositions and methods are useful for reduction or prevention of the development and spread of pathogenic microorganisms which may be present in the upper airways of the subject, and particularly to reduce or prevent invasion of said pathogenic microorganisms from the upper airways to the lower respiratory system.
  • the present compositions are delivered via inhalation, so as to be deposited at the upper respiratory airways, such that more severe conditions of the lower respiratory tract are prevented or attenuated.
  • compositions and methods can thus be used, according to some embodiments, as a preventive treatment in subjects that are suspected to being infected by a pathogenic microorganism that can induce an infection in the respiratory tract. Such subjects include, for example, those who were exposed to infected patients. Additionally, the present compositions and methods can thus be administered to subjects who show initial signs of infection in the upper respiratory system, as a preventive treatment to prevent, postpone or attenuate development of more severe conditions of the lower respiratory tract.
  • compositions and methods of the current invention are specifically effective in the prevention of COVID-19 disease caused by a human coronavirus, which is a rapidly spreading pandemic nowadays with millions of sick and hundreds of thousands diseased globally.
  • ethanol has a strong and broad antimicrobial activity
  • the compositions and methods of the inventions are advantageous against a wide range of pathogenic microorganisms that can infect the respiratory system.
  • the compositions and methods disclosed herein are not limited to coronaviruses and are also effective and beneficial for reducing the development and spread of a variety of diseases or conditions associated with a respiratory tract infection, such as diseases caused by mycobacterial infections, RSV infections, influenza, and the like.
  • the disinfective approach which includes the dosage form and administration of the current invention are more effective and safer in preventing spread of various diseases than currently known and experimental therapies, which include mainly oral administration by ingestion or administration through injection.
  • a method of disinfecting the upper respiratory airways comprising administering, via inhalation to a subject in need thereof a composition for inhalation comprising ethanol and a pharmaceutically acceptable excipient, wherein the excipient comprises a thickening agent, wherein the composition has a viscosity of at least 2 mPa ⁇ S and vapor pressure of no more than 3 kPa at a temperature of 25 C and a pressure of 1 atmosphere.
  • compositions for inhalation provided in a dosage form suitable for aerosolization using an aerosol generating device, for use in disinfection of the upper respiratory airways, wherein the composition comprises ethanol and a pharmaceutically acceptable excipient, wherein the excipient comprises a thickening agent, wherein the composition for inhalation has a viscosity of at least 2 mPa ⁇ S and vapor pressure of no more than 3 kPa at a temperature of 25 C and a pressure of 1 atmosphere.
  • compositions of the present invention are characterized by high viscosity (e.g. a gel-like composition) and low volatility (as defined by their vapor pressure) compared to ethanol and alcohol compositions.
  • high viscosity e.g. a gel-like composition
  • low volatility as defined by their vapor pressure
  • These physical properties result from the inclusion of the thickening agent.
  • inclusion of various thickening agent, as elaborated below, can result in reduction of the vapor pressure and boiling point of liquid compositions. This phenomenon is illustrated by Raoulfs law.
  • pharmaceutically acceptable carrier or “pharmaceutically acceptable excipient” as used herein refers to any and all solvents, dispersion media, preservatives, antioxidants, coatings, isotonic and absorption delaying agents, surfactants, fillers, disintegrants, binders, diluents, lubricants, glidants, pH adjusting agents, buffering agents, enhancers, wetting agents, solubilizing agents, surfactants, antioxidants the like, that are compatible with pharmaceutical administration.
  • the use of such media and agents for pharmaceutically active substances is well known in the art.
  • the pharmaceutically acceptable excipient is a pharmaceutically acceptable for inhalation.
  • pharmaceutically acceptable for inhalation refers to any carrier, excipient or diluent, which was authorized for use in inhaled compositions by the relevant regulatory authorities.
  • Viscosity can be defined in two ways: kinematic viscosity or absolute viscosity.
  • Kinematic viscosity is a measure of the resistive flow of a fluid under an applied force.
  • the SI unit of kinematic viscosity is mm /sec, which is 1 centistoke (cSt).
  • Absolute viscosity sometimes called dynamic or simple viscosity, is the product of kinematic viscosity and fluid density.
  • viscosity is a measurement of the flow resistance of a fluid under the influence of gravity.
  • the viscous fluid takes longer to flow through the capillary than the low viscosity fluid. If one fluid takes 100 seconds to fully flow and another fluid takes 200 seconds, the second fluid viscosity is twice that of the first fluid on the kinematic viscosity scale.
  • Viscosity is sensitive to changes in the ambient temperature.
  • ethanol has relatively low viscosity of about 1 mPa-S at a temperature of 25 C and a pressure of 1 atmosphere, and the present composition is modified to have higher viscosity of at least twice.
  • the composition has a viscosity of at least 2 mPa ⁇ S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 2.25 mPa-S at a temperature of 25 C'. According to some embodiments, the composition has a viscosity of at least 2.5 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 2.75 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 3 mPa-S at a temperature of 25 C.
  • the composition has a viscosity of at least 3.25 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 3.5 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 3.75 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 4 mPa ⁇ S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 4.25 mPa-S at a temperature of 25 C.
  • the composition has a viscosity of at least 4.5 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 4.75 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 5 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 6 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 7 mPa ⁇ S at a temperature of 25 C.
  • the composition has a viscosity of at least 8 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 9 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 10 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 15 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 20 mPa-S at a temperature of 25 C.
  • the composition has a viscosity of at least 30 mPa ⁇ S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 50 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 75 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 100 mPa ⁇ S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 250 mPa-S at a temperature of 25 C.
  • the composition has a viscosity of at least 500 mPa-S at a temperature of 25 C. According to some embodiments, the composition has a viscosity of at least 1000 mPa-S at a temperature of 25 C.
  • maximum thresholds can also be specified, e.g. 1500 mPa ⁇ S, 2500 mPa ⁇ S, 4000 mPa ⁇ S, or 5000 mPa-S. Each possibility represents a separate embodiment of the invention.
  • vapor pressure means the partial pressure in air at a defined temperature (e.g., 25 °C) and standard atmospheric pressure (760 mmHg) for a given chemical composition. It defines a tendency of the chemical composition to be in the gas phase rather than the liquid or solid state. The higher the vapor pressure the greater the proportion of the material that will, at equilibrium, be found in a gas state. It is also related to the rate of evaporation of a material which is defined in an open environment where material is leaving the system.
  • Vapor pressure is sensitive to changes in the ambient temperature and pressure.
  • ethanol has relatively high vapor pressure of about 7 kPa at a temperature of 25 C and a pressure of 1 atmosphere.
  • the composition has vapor pressure of no more than 3 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 2.8 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 2.6 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 2.4 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 2.2 kPa at a temperature of 25 C and a pressure of 1 atmosphere.
  • the composition has vapor pressure of no more than 2.0 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 1.8 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 1.6 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 1.4 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 1.2 kPa at a temperature of 25 C and a pressure of 1 atmosphere.
  • the composition has vapor pressure of no more than 1.0 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 0.8 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 0.6 kPa at a temperature of 25 C and a pressure of 1 atmosphere. According to some embodiments, the composition has vapor pressure of no more than 0.5 kPa at a temperature of 25 C and a pressure of 1 atmosphere.
  • minimum thresholds can also be specified, e.g. 0.01 kPa, 0.05 kPa or 0.1 kPa. Each possibility represents a separate embodiment of the invention.
  • the thickening agent is selected from the group consisting of: calcium (II) acetate, glycerol, propylene glycol, poloxamer and saccharide.
  • the thickening agent comprises a calcium salt. According to some embodiments, the thickening agent comprises calcium acetate.
  • the thickening agent comprises a polyol.
  • polyol refers to any molecule, which comprises at least two hydroxyl moieties.
  • the thickening agent comprises glycerol. According to some embodiments, the thickening agent is glycerol. According to some embodiments, the thickening agent comprises propylene glycol. According to some embodiments, the thickening agent is propylene glycol. According to some embodiments, the thickening agent comprises glycerol or propylene glycol. According to some embodiments, the thickening agent comprises glycerol and propylene glycol. According to some embodiments, the thickening agent comprises a polyol combination of propylene glycol and vegetable glycerin. According to some embodiments, the polyol combination comprises 20 to 50% propylene glycol and 50 to 80% vegetable glycerin. According to some embodiments, the polyol combination comprises 25 to 35% propylene glycol and 65 to 75% vegetable glycerin. According to some embodiments, the thickening agent comprises a poloxamer.
  • poly(propylene oxide) (PPO) flanked by two hydrophilic chains of poly (ethylene oxide) (PEO), each PPO or PEO chain can be of different molecular weights.
  • Poloxamers are also known by the trade name Pluronics. Particular Poloxamer is Poloxamer 188, a poloxamer wherein the PPO chain has a molecular mass of 1800 g/mol and a PEO content of 80% (w/w). Poloxamers are available in wide range of molecular weights, melting points and hydrophilicity and are commonly used in the pharmaceutical formulations as wetting agents to improve the bioavailability.
  • Poloxamer 188 is a block copolymer of ethylene oxide and propylene oxide and is listed in the NF monograph as poloxamer 188. Poloxamers are available in wide range of molecular weights, melting points and hydrophilicity and are commonly used in the pharmaceutical formulations as wetting agents to improve the bioavailability. They are supplied by BASF (N.J., USA).
  • the Lutrol F68.RTM. used in this invention has molecular weight in the range of 8400 daltons, melting point of 52°C to -54°C and HLB (hydrophilic-lipophilic balance) of 18-29 and the average particle size ranging from 1 micron to 500 microns.
  • the saccharide is a polysaccharide. According to some embodiments, the saccharide is a monosaccharide or disaccharide. According to some embodiments, the saccharide is a monosaccharide. According to some embodiments, the monosaccharide is selected from the group consisting of erythrose, threose, erythrulose, ribose, arabinose, lyxose, ribulose, arabulose, xylulose, lyxulose, mannose, galactose, allose, altrose, talose, gulose, psicose, sorbose, tagatose, and sedoheptulose.
  • the monosaccharide is selected from the group consisting of glucose, fructose, mannose, galactose and combinations thereof. According to some embodiments, the monosaccharide is selected from the group consisting of glucose, fructose and combinations thereof.
  • the thickening agent comprises a sugar alcohol
  • the composition for inhalation comprises at least 40% ethanol v/v. According to some embodiments, the composition for inhalation comprises at least 45% ethanol v/v. According to some embodiments, the composition for inhalation comprises at least 50% ethanol v/v. According to some embodiments, the composition for inhalation comprises at least 55% ethanol v/v. According to some embodiments, the composition for inhalation comprises at least 60% ethanol v/v. According to some embodiments, the composition for inhalation comprises at least 65% ethanol v/v. According to some embodiments, the composition for inhalation comprises at least 70% ethanol v/v.
  • the composition for inhalation comprises at least 1% thickening agent w/w.
  • Typical concentrations of thickening agents depend on the identities thereof.
  • the amounts of polyols, such as vegetable glycerin and/or propylene glycol, which are required for sufficiently high viscosity and low vapor pressure are above 5%.
  • the composition comprises at least 5% polyol. According to some embodiments, the composition comprises at least 7.5% polyol.
  • the composition comprises at least 10% polyol.
  • the composition comprises at least 12.5% polyol. According to some embodiments, the composition comprises at least 15% polyol.
  • the composition comprises at least 20% polyol.
  • the polyol is a combination of propylene glycol and glycerol.
  • the present composition for inhalation further comprises isopropanol.
  • isopropanol also has disinfecting abilities, it can be added to the ethanol of the present composition or to replace it.
  • the present composition comprising ethanol, isopropanol, or both and a pharmaceutically acceptable excipient, wherein the excipient comprises a thickening agent, wherein the composition has a viscosity and vapor pressure as detailed herein.
  • the present composition comprises isopropanol and a pharmaceutically acceptable excipient, wherein the excipient comprises a thickening agent, wherein the composition has a viscosity and vapor pressure as detailed herein.
  • the viscosity of the composition is appropriately modified by the thickening agent to be higher than that of isopropanol.
  • the vapor pressure of the composition is appropriately modified by the thickening agent to be lower than that of isopropanol. Representative values are provided herein, according to some embodiments.
  • the present composition for inhalation further comprises a hydrophilic amine, a quaternary ammonium salt, or both.
  • the present composition for inhalation further comprises a quaternary ammonium salt.
  • the quaternary ammonium salt is selected from the group consisting of: tetrabutylammonium bromide, benzyltriethylammonium chloride, tetrabutylammonium chloride, tetraethylammonium chloride, benzalkonium chloride and tetramethylammonium chloride. Each possibility represents a separate embodiment of the invention.
  • present composition for inhalation further comprises at least one additive selected from the group consisting of a propellant, an anti-coughing agent and a flavorant.
  • the composition of the current invention further comprises at least one additive selected from the group consisting of a propellant, an anti-coughing agent and a flavorant.
  • the composition further comprises at least one additive at a concentration of 0.1-1% w/w. According to some embodiments, the composition further comprises at least one additive at a concentration of 0.1-0.5% w/w. According to some embodiments, the composition further comprises at least one additive at a concentration of 0.1 -0.3% w/w.
  • the additive is approved for use in inhaling compositions.
  • the flavorant is a sweetener.
  • the sweetener is selected from the group of artificial sweeteners including saccharine, aspartame, dextrose, mannitol and fructose.
  • the additive is selected from menthol, eucalyptol, tyloxapol and a combination thereof. According to some embodiments, the additive is selected from menthol, eucalyptol, tyloxapol and a combination thereof, and is present at a concentration of 0.1-0.5% w/w based on the total weight of the composition.
  • % w/w refers to % weight/weight as well known in the art. According to any one of the embodiments of the present invention the term “% w/w may be substituted by the term “% w/v”. the term “% w/v” refers to percent weight/volume as well known in the art. As used herein the term “% v/v” refers to % volume/volume as well known in the art.
  • the composition further comprises at least one preservative.
  • the preservative is selected from the group consisting of benzyl alcohol, propylparaben, methylparaben, benzalkonium chloride, phenylethyl alcohol, chlorobutanol, potassium sorbate, phenol, m-cresol, o- cresol, p- cresol, chlorocresol and combinations thereof.
  • anti-coughing agent refers to an active agent used for the suppression, alleviation or prevention of coughing and irritations and other inconveniencies in the large breathing passages that can, or may, generate coughing.
  • Anti-coughing agent include, but are not limited to antitussives, which are used for which suppress coughing, and expectorants, which alleviate coughing, while enhancing the production of mucus and phlegm. Anti-coughing agents may ease the administration of inhaled aerosols.
  • the at least one anti-coughing agent is selected from expectorants, antitussives or both.
  • the at least one anti-coughing agent is selected from the group consisting of menthol, dextromethorphan, dextromethorphan hydrobromide, hydrocodone, caramiphen dextrorphan, 3-methoxymorphinan or morphinan- 3-ol, carbetapentane, codeine, acetylcysteine and combinations thereof.
  • the pH of the composition of the present invention is in the range of 4 to 10.5.
  • an aerosol upon aerosolization of the composition of the present invention, an aerosol is created, said aerosol has a pH in the range of 4 to 10.5.
  • the composition further comprises at least one buffer.
  • buffer refers to compounds which reduce the change of pH upon addition of small amounts of acid or base, or upon dilution.
  • buffering agent refers to a weak acid or weak base in a buffer solution.
  • the buffer is an acetate buffer.
  • the composition is a liquid or semi-liquid composition.
  • the composition of the current invention is in the form of a liquid mixture.
  • the composition of the current invention is in the form of an isopropanol mixture.
  • the composition of the current invention is in the form of an ethanol mixture.
  • the liquid mixture is selected from liquid solution, liquid suspension and liquid emulsion.
  • the ethanolic mixture is selected from ethanolic solution, ethanolic suspension and ethanolic emulsion.
  • the ethanol mixture comprises at least 40%, 50%, 60%, 70%, 80%, 90%, 95% or at least 98% ethanol.
  • the composition of the current invention is in the form of an ethanol solution.
  • the composition of the current invention is in a solid form.
  • the present composition is in the form of a gel.
  • gel refers to a semi-solid that can have properties ranging from soft and weak to hard and tough. Gels are defined as a substantially dilute system, which exhibits no flow when in the steady-state. A gel has been defined phenomenologically as a soft, solid or solid-like material consisting of two or more components, one of which is a liquid, present in substantial quantity. By weight, gels are mostly liquid, yet they behave like solids. In this way, gels are a dispersion of molecules of a liquid within a solid medium.
  • compositions that does not include, contain or comprise a particular compound or particles e.g. said composition comprises less than 0.1 %, less than 0.01 %, or less than 0.001 % of the such compounds or particles.
  • the thickening agent contributes to the high viscosity and optionally, to the gel state of the present composition.
  • polyols such as vegetable glycerin, propylene glycol or combinations thereof may be used. Such combinations are typically used for inhalation as parts of nicotine compositions (for vaporization/ smoking), however, the present composition is not intended to include nicotine. According to some embodiments, the present composition is substantially devoid of nicotine.
  • the composition disinfecting ingredients consisting essentially of ethanol. According to some embodiments, the composition disinfecting ingredients consisting essentially of isopropanol. According to some embodiments, the composition disinfecting ingredients consisting essentially of ethanol or isopropanol. According to some embodiments, the composition disinfecting ingredients consisting essentially of ethanol and isopropanol.
  • the term “consist essentially of’ is to be construed as a semi-closed term, meaning that no other ingredients which materially affects the basic and novel characteristics of the invention (i.e. having disinfecting characteristics) are included, whereas optional excipients and carriers, e.g. water, may thus be included.
  • compositions for inhalation for use in disinfecting the upper respiratory airways of a subject, the composition comprising ethanol and a pharmaceutically acceptable excipient.
  • the method comprises:
  • step (c) administering the aerosol of step (b) to the subject via inhalation.
  • administering the aerosol via inhalation in step (c) comprises transferring the ethanol and the thickening agent to at least one organ or tissue of the upper respiratory tract of the subject, wherein the at least one organ or tissue is selected from the group consisting of: nose, nostrils, nasal cavity, paranasal sinuses, mouth, pharynx and larynx.
  • the at least one organ or tissue is selected from the group consisting of: nose, nostrils, nasal cavity, paranasal sinuses, mouth, pharynx and larynx.
  • At least 10% of the ethanol transferred to the organ or tissue remains deposited on said organ or tissue 5 seconds after said deposition. According to some embodiments, at least 25% of the ethanol transferred to the organ or tissue remains deposited on said organ or tissue 5 seconds after said deposition. According to some embodiments, at least 10% of the ethanol transferred to the organ or tissue remains deposited in said gel or tissue 5 seconds after said deposition. According to some embodiments, at least 25% of the ethanol transferred to the organ or tissue remains deposited in said gel or tissue 5 seconds after said deposition.
  • the terms “disinfecting” and “disinfection” refer to reducing or substantially eliminating the presence of at least one microorganism from a surface, or otherwise disabling at least one microorganism, i.e., rendering a microorganism incapable of reproducing, by direct contact.
  • microorganism as used herein encompasses both cellular microorganisms, e.g., bacteria and acellular microorganisms, e.g., viruses.
  • upper respiratory airways refer to the major passages and structures of the upper respiratory tract including the nose or nostrils, nasal cavity, paranasal sinuses, mouth, throat (pharynx), and voice box (larynx).
  • the methods and compositions of the invention are for use in disinfecting the upper respiratory airways of a subject, wherein the subject is suspected to develop a disease associated with a respiratory tract infection.
  • the subject is human.
  • the phrase "subject is suspected to develop a disease associated with a respiratory tract infection” refers to a subject that was exposed to a diseased patient that was diagnosed with an infection caused by a contagious microorganism that may be transmitted through the upper respiratory tract, and/or to a subject who presents one or more signs or symptoms indicative of an infection in the respiratory tract.
  • the subject was exposed to a diseased patient that was diagnosed with an infection caused by a contagious microorganism that may be transmitted through the upper respiratory tract.
  • the subject presents one or more signs or symptoms indicative of an infection in the respiratory tract.
  • the subject presents one or more signs or symptoms indicative of an infection in the upper respiratory tract.
  • the subject was exposed to a diseased patient that was diagnosed with an infection caused by a contagious microorganism that may be transmitted through the upper respiratory tract, wherein said subject presents one or more signs or symptoms indicative of an infection in the respiratory tract.
  • a disease associated with a respiratory tract infection refers to a disease that involves or is caused by an infection in the respiratory tract.
  • the disease involves or is caused by an infection in the upper respiratory tract.
  • the disease involves or is caused by an infection in the lower respiratory tract.
  • the disease involves or is caused by an infection in the lungs.
  • the disease is a respiratory disease.
  • the infection is caused by a pathogenic microorganism selected from pathogenic viruses and pathogenic bacteria.
  • the disease associated with a respiratory tract infection is caused by a pathogenic microorganism that initially infects the upper respiratory tract and then invades to the lower respiratory tract and causes a lower respiratory tract infection.
  • the disease associated with a respiratory tract infection is a disease caused by a pathogenic virus.
  • the pathogenic virus is selected from the group consisting of coronavirus, influenza virus, respiratory syncytial (sin-SISH-uhl) virus, rhinovirus poliovirus, measles morbillivirus (MeV), mumps virus, rubella virus, torque teno virus (TTV), adenoviruses, variola virus, and enterovirus D68 (EV-D68).
  • the pathogenic microorganism is a pathogenic virus selected from coronavirus, influenza virus, respiratory syncytial virus, and rhinovirus.
  • the pathogenic microorganism is a pathogenic virus selected from coronavirus and influenza virus.
  • the pathogenic virus is coronavirus.
  • the coronavirus is a human coronavirus.
  • the human coronavirus is selected from betacoronavirus and alphacoronavirus.
  • the betacoronavirus is selected from the group consisting of HCoV-OC43, HCoV-HKUl, SARS-CoV, SARS-CoV- 2 , and MERS-CoV.
  • the betacoronavirus is selected from the group consisting of MERS-CoV, SARS-CoV and SARS-CoV-2.
  • the betacoronavirus is MERS-CoV.
  • the betacoronavirus is SARS-CoV.
  • the betacoronavirus is SARS-CoV-2.
  • the human coronavirus is an alphacoronavirus.
  • the alphacoronavirus is selected from the group consisting of HCoV-NL63 and HCoV- 229E.
  • the pathogenic virus is an influenza virus.
  • influenza virus is selected from the group consisting of influenza A virus subtype H1N1, influenza A virus subtype H1N2, influenza A virus subtype H2N2; influenza A virus subtype H2N3; influenza A virus subtype H3N1; influenza A virus subtype H3N2; influenza A virus subtype H3N8; influenza A virus subtype H5N1; influenza A virus subtype H5N2; influenza A virus subtype H5N3; influenza A virus subtype H5N6; influenza A virus subtype H5N8; influenza A virus subtype H5N9; influenza A virus subtype H6N1; influenza A virus subtype H6N2; influenza A virus subtype H7N1; influenza A virus subtype H7N2; influenza A virus subtype H7N3; influenza A virus subtype H7N4; influenza A virus subtype H7N7; influenza A virus subtype H7N9; influenza A virus subtype H9N2; influenza A virus subtype H1N1, influenza A virus subtype H
  • the disease associated with a respiratory tract infection is a disease caused by a pathogenic bacterium.
  • the pathogenic bacterium is selected from streptococcus pneumoniae, haemophilus influenzae, moraxella catarrhalis, staphylococcus aureus, streptococcus pyogene and Legionella pneumophila.
  • streptococcus pneumoniae haemophilus influenzae
  • moraxella catarrhalis moraxella catarrhalis
  • staphylococcus aureus streptococcus pyogene
  • Legionella pneumophila Legionella pneumophila
  • the pathogenic bacterium is a mycobacterium.
  • the disease is caused by a mycobacterial infection.
  • the disease is caused by a typical mycobacterial infection.
  • the disease is caused by an atypical mycobacterial infection.
  • the disease can be caused by mycobacteria selected from the group consisting of M. tuberculosis; M. avium; M. smegmatis; M. abscessus; M. africanum; M. canetti; M. microti; M. ulcerans; M. avium intracellulare; M. kansasii; M. fortuitum; M. marinum; M. chelonae; and M. leprae.
  • mycobacteria selected from the group consisting of M. tuberculosis; M. avium; M. smegmatis; M. abscessus; M. africanum; M. canetti; M. microti; M. ulcerans; M. avium intracellulare; M. kansasii; M. fortuitum; M. marinum; M. chelonae; and M. leprae.
  • mycobacteria selected from the group consisting of M. tuberculosis
  • the subject is suspected to develop a disease selected from the group consisting of COVID-19 disease, tuberculosis, influenza (such as hemophilus influenza), pneumonia, respiratory syncytial virus (RSV) infection, common cold, Buruli ulcers, leprosy, Hansen's disease, respiratory diphtheria, pertussis, polio, measles, mumps, rubella, , torque teno virus, adenovirus, variola virus, vaccinia virus, rabies virus, ebola virus and enterovirus.
  • influenza such as hemophilus influenza
  • RSV respiratory syncytial virus
  • the subject is suspected to develop a disease is selected from the group consisting of COVID-19 disease, tuberculosis, influenza (such as hemophilus influenza), pneumonia, respiratory syncytial virus (RSV) infection, common cold, Buruli ulcers, leprosy, Hansen's disease, respiratory diphtheria, pertussis, polio, measles, mumps, and rubella.
  • influenza such as hemophilus influenza
  • RSV respiratory syncytial virus
  • the disease is selected from the group consisting of COVID-19, tuberculosis, pneumonia, influenza, common cold and respiratory and syncytial virus (RSV) infection.
  • the term "common cold” refers to a viral infectious disease of the upper respiratory tract that primarily affects the respiratory mucosa of the nose, throat, sinuses, and larynx. According to some embodiments, the common cold is caused by rhinoviruses.
  • the disease is selected from the group consisting of COVID-19, tuberculosis and influenza. According to some embodiments, the disease is selected from the group consisting of COVID-19 and influenza. According to some embodiments, the disease is COVID-19. According to some embodiments, the disease is influenza. According to some embodiments, the disease is pneumonia. According to some embodiments, the disease is caused by a mycobacterial infection. According to some embodiments, the disease is tuberculosis.
  • a pathogenic microorganism may refer to any type of disease caused by said pathogenic microbial agent.
  • diseases such as, but not limited to bronchiolitis and asthma are encompassed. Therefore, according to some embodiments, the disease is bronchiolitis or asthma.
  • the disease is an infectious disease.
  • the infectious disease is an infectious respiratory disease.
  • infectious disease and "infective disease” as used herein are interchangeable and describe clinically evident diseases resulting from the presence of pathogenic microorganism, including pathogenic viruses, pathogenic bacteria, fungi, protozoa, multicellular parasites, and aberrant proteins known as prions. These pathogens are able to cause disease in animals and/or plants. Infectious pathologies are usually qualified as contagious diseases (also called communicable diseases) due to their potentiality of transmission from one person or species to another. Transmission of an infectious disease may occur through one or more of diverse pathways including physical contact with infected individuals. These infecting microorganisms may also be transmitted through liquids, food, body fluids, contaminated objects, airborne inhalation, or through vector-borne spread.
  • Exemplary infective diseases and pathogenic microorganisms causing infective diseases in the scope of the present invention include, but are not limited to, COVID-19 disease, tuberculosis, influenza (such as hemophilus influenza), pneumonia, respiratory syncytial virus (RSV) infection, diphtheria, tetanus, pertussis, polio, hepatitis A virus, hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, hepatitis G virus, measles, mumps, rubella, human papillomavirus (HPV), human immunodeficiency virus (HIV), torque teno virus, adenovirus, herpes zoster virus, variola virus, vaccinia virus, swine fever virus, rabies virus, ebola virus, enterovirus.
  • influenza such as hemophilus influenza
  • RSV respiratory syncytial virus
  • HSV
  • the infective disease is caused by a coronavirus.
  • the coronavirus is a human coronavirus.
  • the human coronavirus is a betacoronavirus.
  • the human coronavirus is selected from MERS-CoV, SARS-CoV and SARS-CoV-2.
  • the human coronavirus is MERS- CoV.
  • the human coronavirus is SARS-CoV.
  • the human coronavirus is SARS-CoV-2.
  • the disease is COVID-19.
  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), formerly known as the 2019 novel coronavirus (2019-nCoV), is a positive-sense single-stranded RNA virus. It is contagious among humans and is the cause of coronavirus disease 2019 (COVID-19). There is no vaccine, but several antiviral drugs are already in clinical trials. SARS-CoV-2 has strong genetic similarity to known bat coronaviruses, making a zoonotic origin in bats likely, although an intermediate reservoir such as a pangolin is thought to be involved. From a taxonomic perspective SARS-CoV-2 is classified as a strain of the species severe acute respiratory syndrome-related coronavirus.
  • SARS- CoV-2 is the cause of the ongoing 2019-20 coronavirus outbreak, a Public Health Emergency of International Concern that originated in Wuhan, China. Because of this connection, the virus is sometimes referred to informally, among other nicknames, as the “Wuhan coronavirus”.
  • the coronavirus is a human coronavirus selected from the group consisting of Human coronavirus 229E (HCoV-229E), Human coronavirus OC43 (HCoV-OC43), Severe acute respiratory syndrome coronavirus (SARS-CoV), Human coronavirus NL63 (HCoV-NL63, New Haven coronavirus), Human coronavirus HKU1, Middle East respiratory syndrome-related coronavirus (MERS- CoV), and Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
  • the human coronavirus is selected from MERS-CoV, SARS-CoV and SARS-CoV-2.
  • the composition upon administration of the composition of the invention via inhalation, the composition manifests antimicrobial activity against at least one pathogenic microorganism that may present in the upper respiratory tract of the subject.
  • the term "antimicrobial activity" refers to a capability of killing microorganisms or inhibiting their growth.
  • the microorganism is a pathogenic microorganism.
  • the pathogenic microorganism is selected from a pathogenic virus and a pathogenic bacterium.
  • the at least one pathogenic microorganism is a pathogenic virus.
  • the pathogenic virus is selected from the group consisting of coronavirus, influenza virus, respiratory syncytial (sin- SISH-uhl) virus, rhinovirus poliovirus, measles morbillivirus (MeV), mumps virus, rubella virus, torque teno virus (TTV), adenoviruses, variola virus, and enterovirus D68 (EV-D68).
  • the pathogenic microorganism is a pathogenic virus selected from coronavirus, influenza vims, respiratory syncytial virus, and rhinovirus.
  • the pathogenic microorganism is a pathogenic virus selected from coronavirus and influenza virus.
  • the pathogenic virus is coronavirus.
  • the coronavirus is a human coronavirus.
  • the human coronavirus is selected from betacoronavirus and alphacoronavirus.
  • the betacoronavirus is selected from the group consisting of HCoV-OC43, HCoV-HKUl, SARS-CoV, SARS-CoV- 2 , and MERS-CoV.
  • the betacoronavirus is selected from the group consisting of MERS-CoV, SARS-CoV and SARS-CoV-2.
  • the betacoronavirus is MERS-CoV.
  • the betacoronavirus is SARS-CoV.
  • the betacoronavirus is SARS-CoV-2.
  • the human coronavirus is an alphacoronavirus.
  • the alphacoronavirus is selected from the group consisting of HCoV-NL63 and HCoV- 229E.
  • the at least one pathogenic microorganism is a pathogenic virus, wherein the pathogenic virus is an influenza virus.
  • influenza virus is selected from the group consisting of influenza A virus subtype H1N1, influenza A virus subtype H1N2, influenza A virus subtype H2N2; influenza A virus subtype H2N3; influenza A virus subtype H3N1; influenza A virus subtype H3N2; influenza A virus subtype H3N8; influenza A virus subtype H5N1; influenza A virus subtype H5N2; influenza A virus subtype H5N3; influenza A virus subtype H5N6; influenza A virus subtype H5N8; influenza A virus subtype H5N9; influenza A virus subtype H6N1; influenza A virus subtype H6N2; influenza A virus subtype H7N1; influenza A virus subtype H7N2; influenza A virus subtype H7N3; influenza A virus subtype H7N4; influenza A virus subtype H7N7; influenza A virus subtype H1N1, influenza A virus subtype H1
  • the at least one pathogenic microorganism is a pathogenic bacterium.
  • the pathogenic bacterium is a mycobacterium.
  • the mycobacterium is selected from the group consisting of M. avium; M. smegmatis; M. abscessus; M. africanum; M. canetti; M. microti; M. ulcerans; M. avium intracellulare; M. kansasii; M. fortuitum; M. marinum; M. chelonae; and M. leprae.
  • the pathogenic bacterium is selected from mycobacteria species, streptococcus pneumoniae, haemophilus influenzae, moraxella catarrhalis, staphylococcus aureus, streptococcus pyogene, Legionella pneumophila, corynebacterium diphtheriae and bordetella pertussis.
  • mycobacteria species streptococcus pneumoniae, haemophilus influenzae, moraxella catarrhalis, staphylococcus aureus, streptococcus pyogene, Legionella pneumophila, corynebacterium diphtheriae and bordetella pertussis.
  • the pathogenic bacterium is selected from the group consisting of M. tuberculosis, M. avium, M. smegmatis, M. abscessus, M. africanum, M. canetti, M. microti, M. ulcerans, M. avium intracellulare, M. kansasii, M. fortuitum, M. marinum, M. chelonae, M.
  • Aerosol generating devices for example, Aerosol generating devices, cartridges and fillings
  • aerosol generating device refer to a device configured to produce a vapor or aerosol from a liquid or solid composition
  • aerosol generating devices are typically used to deliver a solid or liquid (including semi liquid) composition to a subject in need thereof in a inhalable form (i.e. in a substantially gaseous form).
  • Aerosol generating devices include nebulizers and inhalers, which typically produce aerosols by application of mechanical force on the compositions (e.g. by gas flow or vacuum, or by vibrations, such as in ultrasonic nebulizers), and to vaporizers and electronic cigarettes, which typically heating unit(s) and produce aerosols by vaporizing the composition.
  • the composition is delivered through an outlet, wherein in the latter instances (i.e. vaporizers and electronic cigarettes) the vapor is usually at least partially being condensed to form droplets of the composition, through the delivery.
  • the method comprises administering the present composition to the subject via inhalation using an aerosol generating device selected from: nebulizer, inhaler, electronic cigarette and vaporizer.
  • an aerosol generating device selected from: nebulizer, inhaler, electronic cigarette and vaporizer.
  • the method comprises administering the present composition to the subject via inhalation using a nebulizer or an inhaler.
  • the method comprises administering the composition to the subject via inhalation using an inhaler.
  • the method comprises administering the composition to the subject via inhalation using a nebulizer.
  • the nebulizer is an ultrasonic nebulizer.
  • the method comprises administering the present composition to the subject via inhalation using an electronic cigarette or a vaporizer.
  • the aerosol generating device whereby the aerosolization of the composition is achieved is an electronic cigarette.
  • the dosage form containing the composition is suitable for incorporation into an electronic cigarette.
  • compositions of the present invention are suitable for administration by inhalation as an aerosol created upon aerosolization of the composition by an aerosol generating device, which comprises a heating unit configured to vaporize the composition and to form an aerosol therefrom, according to some embodiments.
  • an aerosol generating device which comprises a heating unit configured to vaporize the composition and to form an aerosol therefrom, according to some embodiments.
  • a specialized aerosol generating device configured to create aerosols having droplets having a specific diameter (typically, 6-25 micron).
  • droplets having the diameter profile as provided by the aerosol generating device disclosed herein are highly effective in reaching the upper airways, such that the alcoholic composition of the invention provides effective disinfection thereof.
  • vaporizing refers to a step of heating a condensed material (e.g. a solid, a liquid, a gas-liquid mixture or a solid-liquid mixture) to form gas of vapor therefrom.
  • a condensed material e.g. a solid, a liquid, a gas-liquid mixture or a solid-liquid mixture
  • vaporizing a composition to form an aerosol refers to heating the composition, thereby creating vapors or gas, which is spontaneously or through an external action transforms into an aerosol.
  • an electronic cigarette as presented in WO 2020/194297 is an exemplary device, which is configured to perform the vaporization, aerosolization an administration of the compositions of the present invention.
  • FIG. 1 and Figure 2 constitute schematic illustration of an electronic cigarette 100, according to some embodiments.
  • the terms "electronic cigarette” and “e-cigarette” as used herein, are interchangeable and refer to a device configured to produce a vapor or aerosol from a liquid or solid composition and comprises at least a heating unit for heating the composition, and an outlet for delivering out the formed aerosol composition for a user to inhale, typically through a mouthpiece.
  • Electronic cigarette 100 comprises a cartridge 106 comprising a cartridge housing 102 and a cartridge internal compartment 108.
  • Electronic cigarette 100 further comprises an actuator 114 comprising an actuator housing 104.
  • Electronic cigarette 100 further comprises an outlet 110, an evaporation heater 120, a first trigger 140, a liquid deposition mechanism 160 and a processing unit 190.
  • outlet 110 is formed on cartridge housing 102.
  • electronic cigarette 100 is configured to produce an aerosol 166
  • outlet 110 is configured to deliver aerosol 166 out of electronic cigarette 100. It is to be understood that the objective of electronic cigarettes is generally to produce an aerosol, and to deliver it through the outlet or mouthpiece of the electronic cigarette, through a mouth of an electronic cigarette user to the respiratory system of the user.
  • outlet 110 is connected to a mouthpiece. According to some embodiments, outlet 110 is mechanically connected to a mouthpiece. According to some embodiments, the mouthpiece is detachable. According to some embodiments, evaporation heater 120 is accommodated within cartridge internal compartment 108.
  • electronic cigarettes including electronic cigarette 100 have an elongated shape, e.g. as depicted in Figures 1-5.
  • the term “longitudinal” refer to the direction of elongation of electronic cigarette 100.
  • the term “longitudinal axis” refers to the linear axis along the longitudinal direction.
  • top generally refer, longitudinally, to the side or end of any device or a component of a device, which is closer to outlet 110.
  • top referring to proximity to the mouthpiece or the user using e-cigarette.
  • bottom generally refer, longitudinally, to the side or end of any device or a component of a device, which is farther than outlet 110.
  • liquid deposition mechanism 160 delivers a discrete, known volume of liquid, or a plurality of discrete, known volumes of liquid, intermittently to evaporation heater 120.
  • Evaporation heater 120 is heated to an elevated temperature, which rapidly evaporates the discrete volume of liquid and generates aerosol 166 therefrom, according to some embodiments.
  • liquid deposition mechanism 160 cannot have more than two states, such as intermediate states.
  • each of the states described below may have non-identical forms and/or mechanisms of action.
  • liquid deposition mechanism 160 in a first state of electronic cigarette 100, liquid deposition mechanism 160 is spaced apart from evaporation heater 120, such that liquid is not deposited onto evaporation heater 120, when electronic cigarette 100 is in the first state of operation.
  • liquid deposition mechanism 160 in a second state of electronic cigarette 100, according to some embodiments, liquid deposition mechanism 160 is delivering a discrete volume of liquid onto evaporation heater 120, and the discrete volume of liquid is evaporated and subsequently aerosolized, due to evaporation heater 120 being in an elevated evaporation temperature.
  • liquid deposition mechanism 160 may be spaced apart from evaporation heater 120 and deposit liquid thereon from distance, according to some embodiments.
  • an element of liquid deposition mechanism 160 may approach evaporation heater 120, such that contact is established between evaporation heater 120 and the element of liquid deposition mechanism 160.
  • the contact between evaporation heater 120 and an element of liquid deposition mechanism 160 enables the delivery of a discrete volume of liquid onto evaporation heater 120, and the discrete volume of liquid is evaporated by the heat of evaporation heater 120 and subsequently aerosolized to form aerosol 166.
  • anerosol refers to a dispersion of solid or liquid particles in a gas.
  • anerosol refers to a material that has been vaporized, nebulized, being in a form of spray or jet or otherwise converted from a solid or liquid form to an inhalable form including suspended solid or liquid particles.
  • evaporation and “substantial evaporation” are interchangeable and are intended to mean that at least 50%, at least 60%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, least 97%, least 98%, least 99%, least 99.5% or least 99.9% of the liquid is transformed from liquid to gaseous state.
  • evaporation heater 120 is located longitudinally between outlet 110 and liquid deposition mechanism 160. Specifically, as defined above with respect to directions, evaporation heater 120 is located above liquid deposition mechanism 160, and outlet 110 is located above evaporation heater 120. Therefore, upon operation of electronic cigarette 100 from the first state to the seconds state, liquid deposition mechanism 160 deposits the discrete volume of liquid on the bottom of evaporation heater 120, and vapor is released from the top of evaporation heater 120.
  • evaporation heater 120 is flat and comprises a first surface facing outlet 110 and a second surface facing liquid deposition mechanism 160.
  • electronic cigarette 100 comprises compartment of processing unit assembly 173, accommodated within actuator 114.
  • compartment of processing unit assembly 173 comprises processing unit assembly 174.
  • processing unit assembly 174 comprises processing unit 190.
  • electronic cigarette 100 comprises processing unit 190, accommodated within actuator 114.
  • processing unit 190 is configured to receive signals from first trigger 140.
  • first trigger 140 is configured to generate at least a first trigger activation signal.
  • evaporation heater 120 is configured to generate heat when first trigger 140 generates the first trigger activation signal.
  • second trigger 150 comprises a flow sensor or a pressure sensor 152, configured to detect the flow or the pressure, respectively, in electronic cigarette 100, and to generate signals indicative thereof.
  • flow sensor or pressure sensor 152 comprises a differential pressure sensor.
  • pressure sensor 152 is positioned within actuator 114.
  • electronic cigarette 100 further comprises a second trigger 150, configured to at least trigger activation or deactivation of at least one of evaporation heater 120 and liquid deposition mechanism 160.
  • second trigger 150 is configured to generate a variable second trigger activation signal, varying in at least one of: amplitude, wavelength or frequency of the signals.
  • processing unit 190 is configured to provide varying activation signals to liquid deposition mechanism 160, thereby controlling various parameters of liquid deposition mechanism 160 as a function of the second trigger activation signals generated by second trigger 150. Varying activation signals of liquid deposition mechanism 160 may include, but are not limited to variations in the amount of liquid drawn by liquid deposition mechanism 160 towards evaporation heater 120, or to rate of liquid transfer from liquid deposition mechanism 160 towards evaporation heater 120.
  • the signals produced by flow or pressure sensor 152 are received by processing unit 190.
  • processing unit 190 is configured to receive the flow or pressure signals.
  • the flow or pressure signals are indicative of the usage of electronic cigarette 100. For example, upon inhalation of a user from electronic cigarette 100 through outlet 110, the pressure drops and a reduced pressure signal is sent from flow or pressure sensor 152 to processing unit 190.
  • processing unit 190 is configured to receive the flow or pressure signals and to activate at least one of evaporation heater 120 and liquid deposition mechanism 160 in response thereto.
  • processing unit 190 is configured to receive the flow or pressure signals and to deactivate at least one of evaporation heater 120 and liquid deposition mechanism 160 in response thereto. For example continuing the previous example, upon the user stopping to inhale through outlet 110, the pressure within electronic cigarette 100 will rise again and a respective pressure signal will be sent from flow or pressure sensor 152 to processing unit 190. In response processing unit 190 will terminate the activation of liquid deposition mechanism 160 and evaporation heater 120, according to some embodiments.
  • liquid deposition mechanism 160 is configured to control the operation of evaporation heater 120.
  • processing unit 190 is configured to activate evaporation heater 120 upon receiving first trigger activation signal from first trigger 140.
  • processing unit 190 is configured to deactivate at least one heating element.
  • processing unit 190 is configured to control operation of liquid deposition mechanism 160. According to some embodiments, processing unit 190 is configured to control operation of liquid deposition mechanism 160, such that liquid deposition mechanism 160 delivers a discrete volume of liquid to evaporation heater 120. According to some embodiments, processing unit 190 is configured to operate liquid deposition mechanism 160 to perform a transition from the first state to the second state of electronic cigarette 100. According to some embodiments, processing unit 190 is configured to operate liquid deposition mechanism 160 to perform a transition from the second state to the first state of electronic cigarette 100.
  • processing unit 190 is configured to operate liquid deposition mechanism 160 to perform a transition from the first state to the second state and to perform a transition from the second state to the first state of electronic cigarette 100 consecutively, so as to provide a discrete volume of liquid from liquid deposition mechanism 160 to evaporation heater 120.
  • processing unit 190 is configured to operate liquid deposition mechanism 160 to perform the following sequence of operations consecutively:
  • liquid deposition mechanism 160 (b) maintenance of liquid deposition mechanism 160 in the second state for a predetermined period of deposition time; wherein during the predetermined period of deposition time, liquid deposition mechanism 160 is configured to deliver a discrete volume of liquid to evaporation heater 120;
  • operation (b) is the only operation in which liquid deposition mechanism 160 is configured to deliver a liquid to evaporation heater 120.
  • processing unit 190 is configured to perform the sequence of operations a plurality of times upon receiving the first activation signal.
  • processing unit 190 is configured to activate liquid deposition mechanism 160 upon receiving first trigger activation signal from first trigger 140. According to some embodiments, processing unit 190 is configured to deactivate liquid deposition mechanism 160.
  • liquid deposition mechanism 160 comprises a liquid deposition mechanism housing 178, a liquid container 162, a liquid drawing element 164 and a solenoid mechanism comprising a solenoid actuator 170 connected to a solenoid plunger head 172 through a rod.
  • Figure 3A constitutes a cross sectional view of electronic cigarette 100 in the first state of operation and
  • Figure 3B constitutes a cross sectional view of electronic cigarette 100 in the second state of operation.
  • Liquid container 162 is accommodated within cartridge internal compartment 108 of cartridge 106 and is configured to contain the liquid therein. In contrast with the discrete volume of liquid, which is small and typically sufficient for a single inhalation of aerosol 166 by a user of 100, liquid container 162 is configured to contain bulk amount of the liquid composition, wherein only small discrete volume(s) of the liquid are evaporated during the operation of electronic cigarette 100.
  • liquid drawing element 164 is fluidly attached to liquid container 162. According to some embodiments, liquid drawing element 164 is in constant contact with liquid container 162. According to some embodiments, liquid drawing element 164 is partially accommodated within liquid container 162.
  • liquid is provided in liquid container 162 for deliverance towards evaporation heater 120 via liquid drawing element 164.
  • liquid drawing element 164 comprises a material that is capable of incorporating, taking in, drawing in or soaking liquids, and upon applying physical pressure thereto or being in contact with another material, release a portion or the entire amount/volume of the absorbed liquid.
  • liquid drawing element 164 is affixed to at least one of cartridge housing 102, cartridge internal compartment 108 and liquid container 162. According to some embodiments, liquid drawing element 164 is affixed to at least one of cartridge housing 102, cartridge internal compartment 108 and liquid container 162, such that liquid drawing element 164 is in contact with liquid container 162 and capable of withdrawing liquid therefrom.
  • liquid drawing element 164 is flexible, such that upon physical pressure applied on liquid drawing element 164, it is configured to bend, while still being affixed to at least one of cartridge housing 102, cartridge internal compartment 108 and liquid container 162.
  • liquid drawing element 164 is configured to absorb liquid in an amount which is at least 100% of its weight. According to some embodiments, liquid drawing element 164 is configured to absorb liquid in an amount which is at least 50% of its weight.
  • liquid drawing element 164 is fabricated such that contact of liquid drawing element 164 with evaporation heater 120 for said the predetermined period of deposition time results in the delivery of a discrete volume of liquid to evaporation heater 120. According to some embodiments, liquid drawing element 164 is fabricated such that contact of liquid drawing element 164 with evaporation heater 120 for said the predetermined period of deposition time results in the delivery of a thin layer of liquid to evaporation heater 120. According to some embodiments, the thin layer of liquid e for has thickness in the range of 0.1mm to 0.5mm.
  • liquid container 162 contains the present composition. Therefore, wherever “liquid” is used it is meant the composition for inhalation of the present invention.
  • liquid drawing element 164 comprises cloth, wool, felt, sponge, foam, cellulose, yam, microfiber or a combination thereof, having high tendency to absorb alcohol solutions.
  • the sponge is an open cell sponge.
  • the sponge is a closed cell sponge.
  • liquid drawing element 164 comprises fabric.
  • fibrous and/or woven fabric such as a wick, is a hydrophilic and liquid absorbing material, which may be used as the stationary liquid absorbing element(s), according to some embodiments.
  • liquid drawing element 164 is a hydrophilic liquid drawing element. According to some embodiments, liquid drawing element 164 is a hydrophilic sponge.
  • liquid drawing element 164 pressed against evaporation heater 120 in the second state of electronic cigarette 100.
  • liquid deposition mechanism 160 includes solenoid actuator 170, solenoid plunger head 172 and liquid deposition mechanism housing 178, according to some embodiments.
  • Figure 2 constitutes a view in which actuator 114 and cartridge 106 are separated, such that none of the elements of liquid deposition mechanism 160 is hidden.
  • Liquid deposition mechanism housing 178 is located inside actuator 114 and is configured to accommodate solenoid actuator 170. According to some embodiments, liquid deposition mechanism housing 178 is connected to actuator housing 104. According to some embodiments, solenoid actuator 170 is connected to liquid deposition mechanism housing 178.
  • liquid deposition mechanism housing 178 is rigidly attached to actuator housing 104.
  • solenoid actuator 170 is attached to liquid deposition mechanism housing 178 such that unintentional displacement of solenoid actuator 170 upwards or downward in the longitudinal direction is prevented.
  • liquid deposition mechanism housing 178 is attached to solenoid actuator 170, such that displacement of solenoid actuator 170 upwards or downward in the longitudinal direction is prevented.
  • solenoid actuator 170 is attached to liquid deposition mechanism housing 178 such that unintentional displacement of solenoid actuator 170 in a non-longitudinal direction is prevented.
  • solenoid actuator 170 is attached to liquid deposition mechanism housing 178, such that displacement of evaporation heater 120 in a non-longitudinal direction is prevented.
  • Non-longitudinal directions include any direction, which is not along the longitudinal axis, such as any direction orthogonal or angled with respect to the longitudinal axis.
  • restriction of movement enforced on solenoid actuator 170 by liquid deposition mechanism housing 178 refers to restriction of movement of the main body of solenoid actuator 170, but not of its rod or solenoid plunger head 172, which are moving parts, as detailed herein.
  • solenoid actuator 170 is connected to solenoid plunger head 172. According to some embodiments, solenoid actuator 170 is connected to solenoid plunger head 172 through a rod (not numbered).
  • cartridge 106 further comprises at least one cartridge opening 112 allowing passage there through of solenoid plunger head 172 from actuator 114 to cartridge internal compartment 108.
  • cartridge 106 further comprises at least one cartridge opening 112 allowing fluid communication between actuator 114 and cartridge 106.
  • fluid communication between cartridge 106 and actuator 114 may be required because (a) second trigger 150 may be a pressure sensor (e.g. sensor 152); (b) sensor 152 is located in actuator 114; and (c) sensor 152 senses pressure or flow changes correlating with a user inhalation through outlet 110, which is part of cartridge 106.
  • solenoid refers to a type of electromagnet, the purpose of which is to generate a controlled magnetic field through a coil wound into a tightly packed helix.
  • the electromagnetic solenoids are used for conversion of electric energy to linear movement.
  • solenoid actuator means one or more electric tubular coils and one or more associated armature members; the coils and members being mounted for relative axial movement with respect to each other.
  • solenoid actuator 170 is configured to receive electric current and to generate axial movements upon receiving the electric current. According to some embodiments, the axial movement of solenoid actuator 170 generates an axial movement of its rod along the along an axis perpendicular to each of evaporation heater 120 and liquid drawing element 164. According to some embodiments, the axial movement of solenoid actuator 170 generates a longitudinal axial movement of its rod. According to some embodiments, upon receiving the electric current solenoid actuator 170 is configured to generate longitudinal movement of its rod at a predetermined rate.
  • processing unit 190 is configured to control solenoid actuator 170. According to some embodiments, processing unit 190 is configured to pass current to solenoid actuator 170. According to some embodiments, upon receiving the electric current solenoid actuator 170 is configured to generate longitudinal movement of its rod at a controlled rate, wherein processing unit 190 is configured to control the controlled rate. According to some embodiments, processing unit 190 is configured to pass variable current to solenoid actuator 170, wherein the variable current is dictating the controlled rate.
  • solenoid actuator 170 refers to a linear movement along the longitudinal axis of electronic cigarette 100.
  • solenoid plunger head 172 is functionally connected to solenoid actuator 170.
  • solenoid plunger head 172 moves along the longitudinal axis from a fist location to a second location.
  • the first location is below the second location, as detailed above with respect to directions.
  • solenoid plunger head 172 in the first state of electronic cigarette 100, solenoid plunger head 172 is in the first location, and both solenoid plunger head 172 and liquid drawing element 164 are spaced apart from evaporation heater 120. According to some embodiments, in the first state of electronic cigarette 100, solenoid plunger head 172 is in the first location, and both solenoid plunger head 172 and liquid drawing element 164 not in contact with evaporation heater 120.
  • solenoid plunger head 172 in the second state of electronic cigarette 100, solenoid plunger head 172 is in the second location. According to some embodiments, when solenoid plunger head 172 approaches the second location, its pushes a portion of liquid drawing element 164 towards evaporation heater 120. According to some embodiments, in the second state of electronic cigarette 100, solenoid plunger head 172 reaches the second location, and a portion of liquid drawing element 164 contacts evaporation heater 120. According to some embodiments, when liquid drawing element 164 forms contact with evaporation heater 120, delivery of a discrete volume of liquid from liquid drawing element 164 to evaporation heater 120 is enabled.
  • processing unit 190 is configured to alternately operate solenoid actuator 170, such that solenoid plunger head 172 alternately dislocates between the first and second and configured to alternately deliver discrete volumes of liquid to evaporation heater 120.
  • liquid deposition mechanism 160 is configured to transfer liquid to evaporation heater 120. According to some embodiments, liquid deposition mechanism 160 is configured to deliver a thin film or layer of the liquid to evaporation heater 120.
  • liquid deposition mechanism 160 is configured to deliver a film liquid to evaporation heater 120 having a thickness in the range of 0.1 mm to 3 mm.
  • the film has a thickness in the range of 0.1 mm to 2 mm.
  • the film has a thickness in the range of 0.5 mm to 2 mm.
  • the film has a thickness in the range of 0.75 mm to 1.5 mm.
  • liquid deposition mechanism 160 is configured to deliver a discrete volume of liquid to evaporation heater 120, wherein the discrete volume of liquid has a volume in the range of 2 ⁇ L to 100 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 3 ⁇ L to 50 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 4 ⁇ L to 45 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 5 ⁇ L to 40 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 6 ⁇ L to 35 ⁇ L.
  • the discrete volume of liquid has a volume in the range of 7 ⁇ L to 30 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 8 ⁇ L to 28 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 9 ⁇ L to 25 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 10 ⁇ L to 20 ⁇ L.
  • liquid deposition mechanism 160 is configured to transfer discrete volume of liquid to evaporation heater 120.
  • the liquid comprises the present composition.
  • Prior art liquid deposition mechanisms include liquid containers, which are in constant contact with the respective heater, or which deliver liquid constantly during the electronic cigarette operation through a delivery medium (typically a wick positioned in stationary contact with both the liquid container and the heater).
  • liquid deposition mechanism 160 of electronic cigarette 100 includes liquid container 162, which is configured to deliver liquid to liquid drawing element 164 constantly, but liquid drawing element 164 is separated from evaporation heater 120 in the first state of electronic cigarette 100, such that delivery of liquid is not constant.
  • liquid deposition mechanism 160 or parts thereof is configured to be in transient contact with evaporation heater 120, such that discrete amounts of the liquid are intermittently delivered from liquid deposition mechanism 160 to evaporation heater 120.
  • FIG. 4 and Figure 5 constitute schematic illustration of an electronic cigarette 100, according to some embodiments.
  • Electronic cigarette 100 comprises a cartridge 106 comprising a cartridge housing 102 and a cartridge internal compartment 108.
  • Electronic cigarette 100 further comprises an actuator 114 comprising an actuator housing 104.
  • Electronic cigarette 100 further comprises an outlet 110, an evaporation heater 120, a first trigger 140, a liquid deposition mechanism 160 and a processing unit 190.
  • Electronic cigarette 100 as described in Figures 4-5 differs from electronic cigarette 100 as described in Figures 1-3 mainly in the design of liquid deposition mechanism 160.
  • outlet 110 is formed on cartridge housing 102.
  • electronic cigarette 100 is configured to produce an aerosol 166
  • outlet 110 is configured to deliver aerosol 166 out of electronic cigarette 100. It is to be understood that the objective of electronic cigarettes is generally to produce an aerosol, and to deliver it through the outlet and/or mouthpiece of the electronic cigarette, through a mouth of an electronic cigarette user to the respiratory system of the user.
  • outlet 110 is connected to a mouthpiece (not shown). According to some embodiments, outlet 110 is mechanically connected to a mouthpiece. According to some embodiments, the mouthpiece is detachable.
  • evaporation heater 120 is accommodated within cartridge internal compartment 108.
  • electronic cigarettes, including electronic cigarette 100 have an elongated shape, as depicted in Figures 1-5.
  • the term “longitudinal” refers to the direction of elongation of electronic cigarette 100.
  • the term “longitudinal axis” refers to the linear axis along the longitudinal direction.
  • liquid deposition mechanism 160 delivers a discrete, known volume of liquid, or a plurality of discrete, known volumes of liquid, intermittently to evaporation heater 120.
  • Evaporation heater 120 is heated to an elevated temperature, which rapidly evaporates the discrete volume of liquid and generates aerosol 166 therefrom, according to some embodiments.
  • liquid delivery from liquid deposition mechanism 160 to evaporation heater 120 has benefits, especially when aerosolizing alcohol compositions, and is achieved using a two-state liquid deposition mechanism 160, according to some embodiments
  • liquid deposition mechanism 160 in a first state of electronic cigarette 100, is spaced apart from evaporation heater 120, such that liquid is not deposited onto evaporation heater 120, when electronic cigarette 100 is in the first state of operation.
  • liquid deposition mechanism 160 is delivering a discrete volume of liquid onto evaporation heater 120, and the discrete volume of liquid is evaporated and subsequently aerosolized, due to evaporation heater 120 being in an elevated evaporation temperature.
  • liquid deposition mechanism 160 may be spaced apart from evaporation heater 120 and deposit liquid thereon from distance, according to some embodiments, and as detailed with respect to Figures 4-5.
  • evaporation heater 120 is located longitudinally between outlet 110 and liquid deposition mechanism 160. Specifically, as defined above with respect to directions, evaporation heater 120 is located above liquid deposition mechanism 160, and outlet 110 is located above evaporation heater 120. Therefore, upon operation of electronic cigarette 100 from the first state to the seconds state, liquid deposition mechanism 160 deposits the discrete volume of liquid on the bottom of evaporation heater 120, and vapor is released from the top of evaporation heater 120.
  • evaporation heater 120 is flat and comprises a first surface facing outlet 110 and a second surface facing liquid deposition mechanism 160.
  • electronic cigarette 100 comprises compartment of processing unit assembly 173, accommodated within actuator 114.
  • compartment of processing unit assembly 173 accommodates comprises processing unit assembly 174.
  • processing unit assembly 174 comprises processing unit 190.
  • electronic cigarette 100 comprises processing unit 190, accommodated within actuator 114.
  • processing unit 190 is configured to receive signals from first trigger 140.
  • first trigger 140 is configured to generate at least a first trigger activation signal.
  • evaporation heater 120 is configured to generate heat when first trigger 140 generates the first trigger activation signal.
  • liquid deposition mechanism 160 is configured to control the operation of evaporation heater 120.
  • processing unit 190 is configured to activate evaporation heater 120 upon receiving first trigger activation signal from first trigger 140.
  • processing unit 190 is configured to deactivate at least one heating element.
  • processing unit 190 is configured to control operation of liquid deposition mechanism 160. According to some embodiments, processing unit 190 is configured to control operation of liquid deposition mechanism 160, such that liquid deposition mechanism 160 delivers a discrete volume of liquid to evaporation heater 120. According to some embodiments, processing unit 190 is configured to operate liquid deposition mechanism 160 to perform a transition from the first state to the second state of electronic cigarette 100.
  • transition as used with respect to electronic cigarette 100 and liquid deposition mechanism 160 of Figures 4-5, is not limited to movement. This term may further encompass functional transition from a first state to a second state as follows: liquid deposition mechanism 160 and evaporation heater 120 are spaced apart and liquid deposition mechanism 160 is not operated to deposit liquids onto evaporation heater 120 (first state); and evaporation heater 120 and liquid deposition mechanism 160 remain in the same relative positions, but liquid deposition mechanism 160 is operated to deposit liquid onto evaporation heater 120 (second state).
  • processing unit 190 is configured to operate liquid deposition mechanism 160 to perform a transition from the second state to the first state of electronic cigarette 100. According to some embodiments, processing unit 190 is configured to operate liquid deposition mechanism 160 to perform a transition from the first state to the second state and vise versus, consecutively, to provide a discrete volume of liquid from liquid deposition mechanism 160 to evaporation heater 120. According to some embodiments, processing unit 190 is configured to operate liquid deposition mechanism 160 to perform the following sequence of operations consecutively:
  • liquid deposition mechanism 160 (b) maintenance of liquid deposition mechanism 160 in the second state for a predetermined period of deposition time; wherein during the predetermined period of deposition time, liquid deposition mechanism 160 is configured to deliver a discrete volume of liquid to evaporation heater 120;
  • the phrase "maintenance of liquid deposition mechanism 160 in the second state for a predetermined period of deposition time” means that liquid deposition mechanism 160 is delivering liquid to evaporation heater 120 throughout the predetermined period of time.
  • operation (b) is the only operation in which liquid deposition mechanism 160 is configured to deliver a liquid to evaporation heater 120.
  • processing unit 190 is configured to perform the sequence of operations a plurality of times upon receiving the first activation signal.
  • processing unit 190 is configured to activate liquid deposition mechanism 160 upon receiving first trigger activation signal from first trigger 140. According to some embodiments, processing unit 190 is configured to deactivate liquid deposition mechanism 160.
  • liquid deposition mechanism 160 comprises a liquid deposition mechanism housing 178, a liquid container 162, a liquid drawing element 164 and an ultrasonic mechanism comprising a piezo disc 180.
  • Figure 5 constitutes a cross sectional view of electronic cigarette 100 in the second state of operation, when actuator 114 and 106 are separated
  • Figure 4 constitutes a cross sectional view of electronic cigarette 100 in the second state of operation, when actuator 114 and 106 are joined.
  • Liquid container 162 is accommodated within cartridge internal compartment 108 of cartridge 106 and is configured to contain the liquid therein.
  • Liquid drawing element 164 is in contact with liquid container 162, according to some embodiments. According to some embodiments, liquid container 162 and liquid drawing element 164 are positioned in contact, such that delivery of liquids from liquid container 162 to liquid drawing element 164 is enabled.
  • liquid container 162 is configured to contain bulk amount of the liquid composition, wherein only small discrete volume(s) of the liquid are evaporated during the operation of electronic cigarette 100.
  • liquid container 162 is surrounding liquid drawing element 164 , such that transfer of liquid contained therein of liquid drawing element 164 is enabled through the circumference of liquid drawing element 164 .
  • liquid drawing element 164 is fluidly attached to liquid container 162. According to some embodiments, liquid drawing element 164 is in constant contact with liquid container 162. According to some embodiments, liquid drawing element 164 is partially accommodated within liquid container 162. According to some embodiments, liquid is provided in liquid container 162 for deliverance towards evaporation heater 120 via liquid drawing element 164 .
  • liquid drawing element 164 comprises a material that is capable of incorporating, taking in, drawing in or soaking liquids, and upon applying physical pressure thereto or being in contact with another material, release a portion or the entire amount/volume of the absorbed liquid.
  • liquid drawing element 164 is affixed to at least one of cartridge housing 102, cartridge internal compartment 108 and liquid container 162. According to some embodiments, liquid drawing element 164 is affixed to at least one of cartridge housing 102, cartridge internal compartment 108 and liquid container 162, such that liquid drawing element 164 is in contact with liquid container 162 and capable of withdrawing liquid therefrom.
  • liquid drawing element 164 is configured to absorb liquid in an amount which is at least 100% of its weight. According to some embodiments, liquid drawing element 164 is configured to absorb liquid in an amount which is at least 50% of its weight.
  • liquid drawing element 164 is fabricated such that contact of liquid drawing element 164 with evaporation heater 120 for said the predetermined period of deposition time results in the delivery of a discrete volume of liquid to evaporation heater 120. According to some embodiments, liquid drawing element 164 is fabricated such that contact of liquid drawing element 164 with evaporation heater 120 for said the predetermined period of deposition time results in the delivery of a thin layer of liquid to evaporation heater 120. According to some embodiments, the thin layer of liquid has thickness in the range of 0.1mm to 0.5mm.
  • liquid drawing element 164 comprises cloth, wool, felt, sponge, foam, cellulose, yam, microfiber or a combination thereof, having high tendency to absorb alcohol solutions.
  • the sponge is an open cell sponge.
  • the sponge is a closed cell sponge.
  • liquid drawing element 164 comprises fabric.
  • fibrous and/or woven fabric such as a wick, is a hydrophilic and liquid absorbing material, which may be used as the stationary liquid absorbing element(s), according to some embodiments.
  • liquid drawing element 164 is a hydrophilic liquid drawing element. According to some embodiments, liquid drawing element 164 is a hydrophilic sponge.
  • a liquid deposition mechanism such as liquid deposition mechanism 160 described in Figures 4-5, in which liquid drawing element 164 is intermittently providing discrete volumes of liquid to evaporation heater 120 from a distance, during the second state of operation of electronic cigarette 100 is preferably used with liquid solutions, such as alcohol solutions.
  • liquid drawing element 164 is essentially stationary during both the first state of electronic cigarette 100 and the second state of electronic cigarette 100. According to some embodiments, the distance between liquid drawing element 164 and evaporation heater 120 is substantially constant during both the first state of electronic cigarette 100 and the second state of electronic cigarette 100.
  • liquid deposition mechanism 160 includes liquid drawing element 164 , liquid deposition mechanism housing 178, piezo disc 180 and a piezo slot 184.
  • Figure 5 constitutes a view in which actuator 114 and cartridge 106 are separated.
  • Liquid deposition mechanism housing 178 is located inside cartridge 106 and is configured to accommodate piezo disc 180. According to some embodiments, liquid deposition mechanism housing 178 comprises piezo slot 184, which is configured to accommodate piezo disc 180. According to some embodiments, liquid deposition mechanism housing 178 is connected to actuator housing 104. According to some embodiments, piezo disc 180 is connected to liquid deposition mechanism housing 178.
  • liquid deposition mechanism housing 178 is rigidly attached to actuator housing 104.
  • piezo disc 180 is affixed to piezo slot 184, such that unintentional displacement of piezo disc 180 upwards or downward in the longitudinal direction is prevented.
  • piezo slot 184 is attached to piezo disc 180, such that displacement of piezo disc 180 upwards or downward in the longitudinal direction is prevented.
  • piezo disc 180 is attached to piezo slot 184 such that unintentional displacement of piezo disc 180 in a non-longitudinal direction is prevented.
  • piezo slot 184 is attached to piezo disc 180, such that displacement of piezo disc 180 in a non-longitudinal direction is prevented.
  • liquid deposition mechanism 160 comprises a liquid drawing element positioning compartment 156.
  • liquid drawing element positioning compartment 156 is formed within liquid deposition mechanism housing 178.
  • liquid drawing element positioning compartment 156 is positioned below liquid drawing element 164.
  • liquid drawing element positioning compartment 156 comprises a compartment for installing a positioning mechanism (not shown) for proper positioning of liquid drawing element 164 in the longitudinal axis, according to some embodiments.
  • the positioning mechanism is configured to cause a contact between piezo disc 180 and liquid drawing element 164.
  • liquid drawing element 164 comprises a top surface in contact with piezo disc 180 and a bottom surface in contact with the positioning mechanism.
  • the positioning mechanism is configured to apply pressure on the bottom surface of liquid drawing element 164, such that the top surface of liquid drawing element 164 contacts piezo disc 180.
  • the applied pressure is upwards in the longitudinal direction.
  • the positioning mechanism is configured to apply pressure on the bottom surface of liquid drawing element 164, such that the top surface of liquid drawing element 164 is pressed against piezo disc 180.
  • a piezo gasket 176 is accommodated within piezo slot 184, and is configured to fasten piezo disc 180 to piezo slot 184.
  • piezo gasket 176 comprises a silicone gasket.
  • piezo gasket 176 comprises a rubber gasket.
  • piezo gasket 176 comprises an O-ring.
  • piezo disc 180 is screwed to piezo slot 184.
  • piezo disc 180 is configured to convert electric current to mechanic stress. According to some embodiments, piezo disc 180 is configured to convert electric current to vibrations. According to some embodiments, piezo disc 180 is configured to convert electric current to vibrations having resonant frequency, which creates mist from liquid formulations. According to some embodiments, piezo disc 180 is configured to convert electric current to vibrations having resonant frequency, which creates mist from alcohol formulations. Thus, according to some embodiments, upon driving sufficient current through piezo disc 180 and upon depositing liquid thereon, it creates mist of the liquid.
  • piezo disc 180 has piezo resonant frequency in the range of 100KHz-10MHz. According to some embodiments, piezo disc 180 has piezo resonant frequency in the range of 100-250 KHz. According to some embodiments, piezo disc 180 has piezo resonant frequency in the range of 125-225 KHz. According to some embodiments, piezo disc 180 has piezo resonant frequency in the range of 140- 210 KHz. According to some embodiments, piezo disc 180 has piezo resonant frequency in the range of 150-200 KHz. According to some embodiments, piezo disc 180 has piezo resonant frequency in the range of 165-195 KHz. According to some embodiments, piezo disc 180 has piezo resonant frequency in the range of 175-185 KHz.
  • piezo disc 180 has capacitance in the range of 700- 2000pF. According to some embodiments, piezo disc 180 has capacitance in the range of 700-1700pF. According to some embodiments, piezo disc 180 has capacitance in the range of 800-1600pF. According to some embodiments, piezo disc 180 has capacitance in the range of 950-1450pF.
  • piezo disc 180 has harmonic impedance of not more than 500Ohm. According to some embodiments, piezo disc 180 has harmonic impedance of not more than 450Ohm. According to some embodiments, piezo disc 180 has harmonic impedance of not more than 400Ohm. According to some embodiments, piezo disc 180 has harmonic impedance of not more than 350Ohm.
  • piezo disc 180 has piezoelectric coefficient D 33 of not more than 450 C/N. According to some embodiments, piezo disc 180 has piezoelectric coefficient D 33 of not more than 400 C/N. According to some embodiments, piezo disc 180 has piezoelectric coefficient D 33 of not more than 350 C/N. According to some embodiments, piezo disc 180 has piezoelectric coefficient D33 of not more than 300 C/N.
  • piezo disc 180 is made of a metal. According to some embodiments, piezo disc 180 is made of stainless steel. According to some embodiments, piezo disc 180 is made of SUS304 stainless steel.
  • piezo disc 180 is configured to receive electric current and to generate mist 182 from liquid upon receiving the electric current.
  • piezo disc 180 comprises a top flat surface facing evaporation heater 120 and a bottom flat surface in contact with liquid drawing element 164 .
  • the bottom flat surface of piezo disc 180 is in contact with liquid drawing element 164 during both the first state and the second state of electronic cigarette 100.
  • piezo disc 180 is a perforated disc.
  • piezo disc 180 is a perforated disc, such that fluids may pass therethrough.
  • the bottom surface of piezo disc 180 is in contact with liquid contained in liquid drawing element 164 during both the first state and the second state of electronic cigarette 100.
  • piezo disc 180 upon application of electric current through piezo disc 180, piezo disc 180 converts liquid in contact with the bottom surface there to mist 182, which is released through the perforations of piezo disc 180 from the top surface of piezo disc 180.
  • mist 182 is released from the top surface of piezo disc 180 longitudinally upwards, such that it forms a discrete volume of liquid on the bottom surface of evaporation heater 120.
  • processing unit 190 is configured to control piezo disc 180, by providing current thereto. According to some embodiments, processing unit 190 is configured to control piezo disc 180 such that piezo disc 180 generates, intermittently a plurality of mists 182 at a predetermined rate. According to some embodiments, processing unit 190 is configured to control piezo disc 180 such that piezo disc 180 generates, intermittently a plurality of mists 182 at a rate controlled by processing unit 190.
  • processing unit 190 is configured to control piezo disc 180. According to some embodiments, processing unit 190 is configured to pass current to piezo disc 180. According to some embodiments, upon receiving the electric current, piezo disc 180 is configured to generate mists 182, intermittently at a controlled rate, wherein processing unit 190 is configured to control the controlled rate. According to some embodiments, processing unit 190 is configured to pass variable current to piezo disc 180 wherein the variable current is dictating the controlled rate. According to some embodiments, processing unit 190 is configured to pass variable current to piezo disc 180 wherein the variable current is dictating the mass of mist 182.
  • piezo disc 180 in the first state of electronic cigarette 100, piezo disc 180 is deactivated. According to some embodiments, in the first state of electronic cigarette 100, current is not driven through piezo disc 180. According to some embodiments, in the first state of electronic cigarette 100, processing unit 190 does not provide current to piezo disc 180. According to some embodiments, in the first state of electronic cigarette 100, piezo disc 180 does not generate mist 182.
  • piezo disc 180 in the second state of electronic cigarette 100, piezo disc 180 is activated. According to some embodiments, in the second state of electronic cigarette 100, current is driven through piezo disc 180. According to some embodiments, in the second state of electronic cigarette 100, processing unit 190 provide current to piezo disc 180. According to some embodiments, in the second state of electronic cigarette 100, piezo disc 180 generates mist 182.
  • processing unit 190 is configured is activate and deactivate piezo disc 180 intermittently at a controlled rate, such that a plurality of mists 182 is delivered intermittently to evaporation heater 120.
  • processing unit 190 is configured to alternately operate piezo disc 180, such that piezo disc 180 delivers discrete volumes of liquid to evaporation heater 120, alternately.
  • liquid deposition mechanism 160 is configured to transfer liquid to evaporation heater 120. According to some embodiments, liquid deposition mechanism 160 is configured to deliver a thin film or layer of the liquid to evaporation heater 120. According to some embodiments, liquid deposition mechanism 160 is configured to deliver a film liquid to evaporation heater 120 having a thickness in the range of 0.1 mm to 3 mm. According to some embodiments, the film has a thickness in the range of 0.1 mm to 2 mm. According to some embodiments, the film has a thickness in the range of 0.5 mm to 2 mm. According to some embodiments, the film has a thickness in the range of 0.75 mm to 1.5 mm.
  • liquid deposition mechanism 160 is configured to deliver a discrete volume of liquid to evaporation heater 120, wherein the discrete volume of liquid has a volume in the range of 2 ⁇ L to 100 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 3 ⁇ L to 50 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 4 ⁇ L to 45 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 5 ⁇ L to 40 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 6 ⁇ L to 35 ⁇ L.
  • the discrete volume of liquid has a volume in the range of 7 ⁇ L to 30 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 8 ⁇ L to 28 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 9 ⁇ L to 25 ⁇ L. According to some embodiments, the discrete volume of liquid has a volume in the range of 10 ⁇ L to 20 ⁇ L.
  • liquid deposition mechanism 160 is configured to transfer discrete volume of liquid to evaporation heater 120.
  • the liquid comprises the present composition for inhalation.
  • first trigger 140 may be a touch user interface, according to some embodiments.
  • the user interface may provide options to a user for determining parameters by which processing unit 190 controls liquid deposition mechanism 160 and/or evaporation heater 120.
  • the touch user interface is configured to provide to an electronic cigarette 100 user at least two sensorial options.
  • at least one control parameter of processing unit 190 over liquid deposition mechanism 160 are executed.
  • the at least one control parameter is selected from fluid deposition frequency and fluid deposition duty cycle.
  • the fluid deposition frequency is in the range of 0.5Hz to 100Hz. According to some embodiments, the fluid deposition frequency is in the range of 0.5Hz to 50Hz. According to some embodiments, the fluid deposition frequency is in the range of 0.75Hz to 40Hz. According to some embodiments, the fluid deposition frequency is in the range of lHz to 30Hz. According to some embodiments, the fluid deposition frequency is in the range of 1.5Hz to 25Hz. According to some embodiments, the fluid deposition frequency is in the range of 2Hz to 20Hz. According to some embodiments, the fluid deposition frequency is in the range of 2Hz to 10Hz.
  • the duty cycle is in the range of 5% to 80%.
  • the duty cycle is in the range of 7% to 70%.
  • the duty cycle is in the range of 10% to 60%.
  • the duty cycle is in the range of 12% to 50%.
  • the duty cycle is in the range of 14% to 40%.
  • the duty cycle is in the range of 15% to 35%.
  • the duty cycle is in the range of 20% to 30%.
  • fluid deposition frequency refers to the number of times in which liquid deposition mechanism 160 deposits discrete volume of liquid onto evaporation heater 120 per time unit.
  • fluid deposition frequency refers to the number of times in which electronic cigarette 100 transforms from the first state to the second state of action per time unit.
  • fluid deposition frequency refers to the time ratio between the first state and the second state of electronic cigarette 100. As detailed herein during the second state, a discrete volume of liquid is delivered to evaporation heater 120, and during the first state liquid is not delivered to evaporation heater 120. Thus, the phrase “fluid deposition frequency” refers to the relative duration in which evaporation heater 120 is being deposited with liquid.
  • the at least one control parameter of processing unit 190 over evaporation heater 120 are executed.
  • the at least one control parameter comprises evaporation heater 120 threshold temperature.
  • the threshold temperature is the temperature above which, processing unit 190 stops driving current- or reducing the current driven to evaporation heater 120, for its heating.
  • first trigger 140 is further configured to generate a deactivation signal, such that processing unit 190 is configured to deactivate both evaporation heater 120 and piezo disc 180 upon receiving first trigger deactivation signal from first trigger 140.
  • processing unit 190 is configured to regulate the temperature of evaporation heater 120 in the range of 95°C to 400°C, through control of the operation of both evaporation heater 120 and liquid deposition mechanism 160.
  • processing unit 190 is configured to regulate the temperature of evaporation heater 120 below 400°C, below 350°C, or below 330°C, through control of the operation of liquid deposition mechanism 160 and/or evaporation heater 120.
  • processing unit 190 is configured to receive at least one operation signal and to control operation of liquid deposition mechanism 160.
  • the regulation entails providing variable current to piezo disc 180 as detailed above. Specifically, it is to be understood that deposition of liquid over evaporation heater 120 effects its temperature.
  • actuator 114 and cartridge 106 are reversibly connectable, according to some embodiments.
  • cartridge 106 comprises liquid container 162. According to some embodiments, liquid container 162 is contained within cartridge internal compartment 108 of cartridge 106. According to some embodiments, cartridge 106 comprises outlet 110. According to some embodiments, outlet 110 is formed on cartridge housing 102 of cartridge 106. According to some embodiments, cartridge 106 comprises evaporation heater 120. According to some embodiments, evaporation heater 120 is contained within cartridge internal compartment 108 of cartridge 106. According to some embodiments, cartridge 106 comprises support 122. According to some embodiments, support 122 is connected to cartridge housing 102 of cartridge 106. According to some embodiments, cartridge 106 comprises liquid drawing element 164 . According to some embodiments, liquid drawing element 164 is connected to cartridge housing 102 of cartridge 106.
  • cartridge 106 further comprises at least one cartridge opening 112 allowing fluid communication between actuator 114 and cartridge 106.
  • fluid communication between cartridge 106 and actuator 114 may be required because (a) second trigger 150 may be a pressure sensor (e.g. sensor 152); (b) sensor 152 is located in actuator 114; and (c) sensor 152 senses pressure or flow changes correlating with a user inhalation through outlet 110, which is part of cartridge 106.
  • second trigger 150 may be a pressure sensor (e.g. sensor 152);
  • sensor 152 is located in actuator 114; and
  • sensor 152 senses pressure or flow changes correlating with a user inhalation through outlet 110, which is part of cartridge 106.
  • cartridge 106 comprises cartridge power coupling 196.
  • cartridge power coupling 196 is contained within cartridge internal compartment 108 of cartridge 106.
  • cartridge 106 comprises evaporation heater electric contact 132 and cartridge electric contacts 134.
  • evaporation heater electric contact 132 and cartridge electric contacts 134 are contained within cartridge internal compartment 108 of cartridge 106.
  • cartridge electric contacts 134 are formed as crimp ring terminals.
  • cartridge electric contacts 134 are receiving current derived from battery 194.
  • the current to cartridge electric contacts 134 is monitored by processing unit 190, for achieving the evaporation heater 120 required temperature, as detailed herein.
  • the current to cartridge electric contacts 134 drives from battery 194 through cartridge power coupling 196 and actuator power coupling 198.
  • actuator 114 comprises power source compartment 192.
  • cartridge 106 comprises liquid deposition mechanism 160.
  • actuator 114 comprises flow or pressure sensor 152.
  • actuator 114 comprises power source compartment 192.
  • actuator 114 comprises processing unit assembly 173.
  • actuator 114 comprises compartment of processing unit assembly 174.
  • actuator 114 comprises processing unit 190.
  • electronic cigarette 100 further comprises a communication element (not shown) configured to enable wireless communication of electronic cigarette 100 with servers, databases and personal devices (e.g. computers, mobile phones) among others.
  • the communication element provides wireless communication through Bluetooth, WiFi, ZigBee and/or Z- wave.
  • an electronic cigarette comprising a cartridge and an actuator.
  • the cartridge comprises a first end and a second end.
  • the cartridge comprises an evaporation heater configured to generate heat and to evaporate a liquid from a surface thereof.
  • the cartridge further comprises a liquid drawing element.
  • the cartridge comprises a liquid container.
  • the liquid container contains the composition for inhalation disclosed herein.
  • the cartridge comprises an outlet.
  • the actuator is having a first end and a second end.
  • the actuator comprises a processing unit.
  • the first end of the actuator is connectable with the second end of the cartridge.
  • the electronic cigarette further comprises a first trigger configured to generate a first trigger activation signal.
  • the electronic cigarette further comprises a liquid deposition mechanism comprising the liquid drawing element and the liquid container.
  • the electronic cigarette further comprises the liquid drawing element is spaced apart from the evaporation heater in at least a first state of the electronic cigarette.
  • the electronic cigarette further comprises the liquid deposition mechanism is configured to transfer a discrete volume of an alcohol composition from the liquid drawing element to the evaporation heater in a second state of the electronic cigarette.
  • the liquid drawing element is in contact with the liquid container in both the first state of the electronic cigarette and the second state of the electronic cigarette.
  • the processing unit is configured to receive at least one operation signal and to control operations of at least one of the evaporation heater and the liquid deposition mechanism upon receiving the at least one operation signal.
  • the at least one operation signal comprises the first trigger activation signal.
  • the processing unit is configured to control operations of both the evaporation heater and the liquid deposition mechanism upon receiving the at least one operation signal. According to some embodiments, the processing unit is configured to control the operation of the liquid deposition mechanism to prevent transfer of liquids from the liquid drawing element to the evaporation heater in the first state of the electronic cigarette.
  • the evaporation heater is flat and comprises a first flat surface facing the outlet and a second flat surface facing the fluid deposition mechanism.
  • the liquid deposition mechanism is configured to transfer a discrete volume of an alcohol composition from the liquid drawing element to the second flat surface of the evaporation heater in the second state of the electronic cigarette.
  • the evaporation heater is at least partially permeable to the alcohol composition, and configured to receive the discrete volume of alcohol composition from the liquid drawing element to the second flat surface thereof, and to evaporate the alcohol composition through the first flat surface thereof in the second state of the electronic cigarette, such that the evaporated alcohol composition is released through the outlet.
  • the cartridge comprises a cartridge housing and an evaporation heater support connected thereto.
  • the evaporation heater support is accommodating the evaporation heater, and is made of a low thermal conductivity material.
  • the low thermal conductivity material is selected from the group consisting of ceramics, aluminum silicate, titanium oxide, zirconium oxide, yttrium oxide, molten silicon, silicon dioxide and molten aluminum oxide.
  • the actuator further comprises a power source compartment configured to accommodate a rechargeable battery.
  • the actuator further comprises an actuator power coupling.
  • the cartridge further comprises a cartridge power coupling.
  • the rechargeable battery is configured to provide electric current to the processing unit and to the actuator power coupling.
  • the evaporation heater comprises an elongated heat conductive coil having a first end, a second end and a main body portion extending there between.
  • the evaporation heater comprises an elongated heat conductive coil having a first end, a second end and a main body portion extending there between in a spiraloid path to form a two-dimensional shape.
  • the two-dimensional shape is having a first flat surface facing the outlet and a second flat surface facing the liquid drawing element.
  • the spiraloid path forms inner tracks between portions of the main body of the elongated heat conductive coil.
  • each of the first end and the second end of the elongated heat conductive coil is connected to an evaporation heater electric contact.
  • each of the evaporation heater electric contacts is in electric contact with a cartridge electric contact.
  • the cartridge electric contact is in electric contact with the cartridge power coupling.
  • the rechargeable battery is configured to provide electric current to each of evaporation heater electric contact through the cartridge electric contact, cartridge power coupling and actuator power coupling.
  • each of the first end and the second end of the elongated heat conductive coil is further connected to a heater resistivity measurement contact.
  • each of the heater resistivity measurement contacts is configured to provide a resistivity measurement signal to the processing unit through output resistivity measurement contacts.
  • the resistivity measurement signal is indicative of the temperature of the evaporation heater.
  • the at least one operation signal comprises the resistivity measurement signal.
  • the actuator further comprises a flow or pressure sensor configured to measure the flow or pressure within the electronic cigarette, and to provide a flow or pressure signal indicative thereof.
  • the at least one operation signal comprises the flow or pressure signal.
  • the discrete volume of the alcohol composition has a volume in the range of 2 ⁇ L to 40 ⁇ L.
  • the first trigger is located on the actuator and is selected from the group consisting of a switch, a knob, a dial, a lever, a button, a touch interface, a force sensor, a pressure sensor and a flow sensor.
  • the first trigger comprises a user interface, which provides options to a user for determining at least one control parameter, by which the processing unit controls the liquid deposition mechanism.
  • the at least one control parameter is selected from fluid deposition frequency and fluid deposition duty cycle.
  • the processing unit is configured to control the liquid deposition mechanism in a fluid deposition frequency in the range of lHz to 100Hz. According to some embodiments, the processing unit is configured to control the liquid deposition mechanism in a fluid deposition frequency in the range of lHz to 30Hz. According to some embodiments, the at least one control parameter comprises at least two separate fluid deposition frequencies, wherein each frequency is in the range of lHz to 100Hz. According to some embodiments, the at least one control parameter comprises at least two separate fluid deposition frequencies, wherein each frequency is in the range of lHz to 30Hz. According to some embodiments, the processing unit is configured to control the liquid deposition mechanism in a duty cycle in the range of 10% to 50%.
  • the at least one control parameter comprises at least two separate duty cycles, each in the range of 10% to 50%.
  • the user interface is located on the actuator.
  • the user interface is located on a remote device in communication with the processing unit through internet connectivity.
  • the liquid deposition mechanism further comprises a biasing element, configured to trigger a dislocation of at least a portion of the liquid drawing element between a first position in the first state of the electronic cigarette and a second position in the second state of the electronic cigarette.
  • the liquid drawing element is spaced apart from the evaporation heater in the first position.
  • the liquid drawing element is in contact with the evaporation heater in the second position.
  • the biasing element is positioned between the liquid drawing element and the second end of the actuator.
  • the biasing element is configured to dislocate the portion of the liquid drawing element from the first position in the first state of the electronic cigarette in the direction of the first end of the cartridge, towards the second position in the second state of the electronic cigarette.
  • the biasing element is further configured to trigger dislocation of the liquid drawing element from the second position in the second state of the electronic cigarette in the direction of the second end of the actuator, towards the first position in the first state of the electronic cigarette.
  • the liquid drawing element is flexible and comprises at least first portion and a second portion.
  • the second portion of the liquid drawing element is in contact with the liquid container in both the first state of the electronic cigarette and the second state of the electronic cigarette.
  • the second portion of the liquid drawing element is in contact with an internal compartment of the liquid container in both the first state of the electronic cigarette and the second state of the electronic cigarette.
  • the biasing element is configured to trigger a dislocation of the first portion of the liquid drawing element between the first position in the first state of the electronic cigarette and the second position in the second state of the electronic cigarette.
  • the first portion of the liquid drawing element is spaced apart from the evaporation heater in the first position.
  • the first portion of liquid drawing element is in contact with the evaporation heater in the second position.
  • the biasing element comprises a solenoid actuator, a rod and a solenoid plunger head.
  • rod has a first end and a second end, wherein the second end is connected to the solenoid actuator, and the first end is connected to the solenoid plunger head.
  • the solenoid actuator is configured to dislocate the solenoid plunger head between a first position and a second position.
  • the solenoid plunger head in the second state of the electronic cigarette, the solenoid plunger head is in the second position thereof and is pressing the portion of the liquid drawing element against the evaporation heater, and in the first state of the electronic cigarette, the solenoid plunger head is in the first position thereof and the liquid drawing element is spaced apart from the evaporation heater.
  • the actuator further comprises a liquid deposition mechanism housing.
  • the liquid deposition mechanism housing accommodates the solenoid actuator.
  • the rod extends from the solenoid actuator in the direction of the first end of the cartridge.
  • the solenoid plunger head when the cartridge and the actuator are assembled, the solenoid plunger head resides inside the cartridge, between the solenoid actuator and the evaporation heater.
  • the solenoid actuator is configured to receive electric current and to generate axial movement of the solenoid plunger head upon receiving the electric current.
  • the axial movement is along an axis perpendicular to the evaporation heater, between the first position of the solenoid plunger head in the first state of the electronic cigarette and the second position of the solenoid plunger head in the second state of the electronic cigarette.
  • the processing unit is configured to drive the current to the solenoid actuator and to control the rate of the axial movement of the solenoid plunger head by controlling the current.
  • the liquid drawing element comprises fabric, cloth, wool, felt, sponge, foam, cellulose, yarn, microfiber or a combination thereof. According to some embodiments, the liquid drawing element comprises a wick.
  • the liquid deposition mechanism further comprises a spraying mechanism.
  • the spraying mechanism is located within the cartridge and configured to create a spray from the alcohol composition.
  • the spraying mechanism is in contact with the liquid drawing element and spaced apart from the evaporation heater in both the first state of the electronic cigarette and the second state of the electronic cigarette.
  • the spraying mechanism is located between the liquid drawing element and the evaporation heater.
  • the spraying mechanism in the first state of the electronic cigarette the spraying mechanism does not create a spray.
  • the spray in the second state of the electronic cigarette, the spray is sprayed from the spraying mechanism in the direction of the first end of the actuator and contacts the evaporation heater.
  • the liquid deposition mechanism further comprises a liquid deposition mechanism housing.
  • the spraying mechanism comprises a piezo disc.
  • the piezo disc is configured to create the spray from the alcohol composition.
  • the piezo disc is in contact with the liquid drawing element and spaced apart from the evaporation heater in both the first state of the electronic cigarette and the second state of the electronic cigarette.
  • the piezo disc is accommodated within the liquid deposition mechanism housing.
  • the liquid deposition mechanism housing comprises a piezo slot, and the piezo disc is accommodated within the piezo slot.
  • the piezo disc is configured to convert alcohol current to vibrations having resonant frequency, which creates the spray from the alcohol composition.
  • the resonant frequency is in the range of lOOKHz to 10MHz- KHz.
  • the processing unit is configured to drive the current to the piezo disc and to control the spraying by controlling the current.
  • the piezo disc is made of metal.
  • the piezo disc comprises a first flat surface facing the evaporation heater and a second flat surface in contact with the liquid drawing element.
  • the piezo disc is perforated disc.
  • the piezo disc upon application of electric current through the piezo disc in the second state of the electronic cigarette, the piezo disc is configured to convert the alcohol composition in contact with the second flat surface thereof to the spray, which is released through the perforations of the piezo disc from the first surface thereof.
  • the spray is released from the first surface of the piezo disc in the direction the direction of the first end of the actuator and contacts the evaporation heater.
  • the spraying mechanism in a first state of the electronic cigarette the spraying mechanism does not create a spray.
  • the composition of the present invention is administered via inhalation using an ultrasonic nebulizer.
  • the ultrasonic nebulizer is a piezoelectric nebulizers. Piezoelectric nebulizers are commonly constructed with a piezoelectric transducer submerged within liquid that is to be nebulized.
  • Figure 6 illustrates a schematic diagram of a prior art nebulizer 10.
  • Nebulizer 10 comprises: a liquid reservoir 20 containing liquid 30 (e.g. the ethanol composition) and exhibiting an outlet 40; a piezoelectric transducer 50; and a power source 60. Piezoelectric transducer 50 is submerged within liquid 30 and is in electrical communication with power source 60.
  • liquid reservoir 20 further exhibits an inlet opening arranged to allow for injection of a disinfective composition there into.
  • power source 60 provides alternating-current (AC) power to piezoelectric transducer 50, thereby causing piezoelectric transducer 50 to vibrate at a predetermined frequency.
  • the vibration of piezoelectric transducer 50 nebulizes liquid 30 into an aerosol which exits via outlet 40.
  • the liquid according to some embodiments, is the composition for inhalation of the present invention.
  • an aerosolization filling composition comprising the composition for inhalation as disclosed herein.
  • the filling is for use in the disinfection the upper respiratory airways.
  • the present filling may be specified or approved by the relevant authorities to be used for the disinfection the upper respiratory airways.
  • the aerosolization filling composition is selected from an electronic cigarette, nebulizer cartridge filling composition and an inhaler cartridge filling composition. Each possibility represents a separate embodiment of the present invention. Optional cartridges are presented herein.
  • the an aerosolization filling composition may be used for filling any one of the devices disclosed herein.
  • an aerosol composition for use in disinfection of the upper respiratory airways, wherein the aerosol comprises ethanol, isopropanol or both, and a pharmaceutically acceptable excipient, wherein the excipient comprises a thickening agent, wherein the composition has a viscosity of at least 2 mPa ⁇ S and vapor pressure of no more than 3 kPa at a temperature of 25 C and a pressure of 1 atmosphere, wherein the aerosol comprises droplets having a mass median aerodynamic diameter (MMAD) in the range of 5 microns to 25 microns.
  • MMAD mass median aerodynamic diameter
  • the droplets of the aerosol disclosed herein are having an MMAD within the range of 7 to 20 microns.
  • the MMAD is within the range of 7 to 15 microns.
  • the MMAD is more than 5 microns.
  • the MMAD is in the range of 8 to 12 micron.
  • the aerosol generating devices elaborated herein below provide aerosols having medium droplet size, which was found to be reach the upper respiratory tract for effective disinfection thereof.
  • droplets around 10 micron in diameter are suitable for deposition in the oropharynx and the nasal area; droplets around 3-5 micron in diameter are suitable for deposition in the central airways and droplets between 1-3 microns are suitable for delivery to the alveoli (droplets substantially smaller than 1 micron will also target the alveolar region) and may be useful for delivering pharmaceuticals to the systemic circulation).
  • the disinfection provided by the present invention is directed to the former, and indeed it was found that the upon aerosolization of the composition of the present invention with the aerosol generating device disclosed herein, an aerosol comprising droplet in the range of 5-25 microns is formed.
  • the droplets of the aerosol produced from the composition of the present invention are having an MMAD within the range of 5 to 25 microns. According to some embodiments, the MMAD is within the range of 7 to 20 microns. According to some embodiments, the MMAD is more than 10 microns. According to some embodiments, the droplets of the aerosol produced by the method and aerosol generating device disclosed herein are having an MMAD within the range of 10 to 20 microns. According to some embodiments, the MMAD is within the range of 10 to 15 microns.

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Abstract

La présente invention concerne d'une manière générale le domaine des compositions destinées à être administrées par inhalation, et leurs utilisations dans la désinfection des voies respiratoires supérieures. Spécifiquement, les présentes compositions sont alcooliques (éthanoliques et/ou isopropanoliques) et sont administrées sous la forme d'un aérosol généré par un dispositif de génération d'aérosol.
PCT/IL2021/050544 2020-05-13 2021-05-12 Compositions pour inhalation et leurs utilisations pour désinfecter les voies respiratoires supérieures WO2021229574A1 (fr)

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WO2023152244A1 (fr) * 2022-02-11 2023-08-17 Philip Morris Products S.A. Cartouche pour système de génération d'aérosol et système de génération d'aérosol à distribution de liquide améliorée

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114223947A (zh) * 2022-01-13 2022-03-25 卜鹿生物技术(成都)有限公司 雾化装置
CN114223947B (zh) * 2022-01-13 2024-03-15 卜鹿生物技术(成都)有限公司 雾化装置
WO2023152244A1 (fr) * 2022-02-11 2023-08-17 Philip Morris Products S.A. Cartouche pour système de génération d'aérosol et système de génération d'aérosol à distribution de liquide améliorée

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