WO2020069559A1 - A respiratory passage sprayer and method of use of same - Google Patents

A respiratory passage sprayer and method of use of same

Info

Publication number
WO2020069559A1
WO2020069559A1 PCT/AU2019/051018 AU2019051018W WO2020069559A1 WO 2020069559 A1 WO2020069559 A1 WO 2020069559A1 AU 2019051018 W AU2019051018 W AU 2019051018W WO 2020069559 A1 WO2020069559 A1 WO 2020069559A1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
substance
sprayer
respiratory passage
shaft
Prior art date
Application number
PCT/AU2019/051018
Other languages
French (fr)
Inventor
Raymond Denis PALMER
Original Assignee
Palmer Raymond Denis
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
Priority claimed from AU2018903708A external-priority patent/AU2018903708A0/en
Application filed by Palmer Raymond Denis filed Critical Palmer Raymond Denis
Publication of WO2020069559A1 publication Critical patent/WO2020069559A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0003Details of inhalators; Constructional features thereof with means for dispensing more than one drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/889Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0005Details of inhalators; Constructional features thereof with means for agitating the medicament
    • A61M15/0006Details of inhalators; Constructional features thereof with means for agitating the medicament using rotating means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033Details of the piercing or cutting means
    • A61M15/0035Piercing means
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F27/00Mixers with rotary stirring devices in fixed receptacles; Kneaders
    • B01F27/05Stirrers
    • B01F27/11Stirrers characterised by the configuration of the stirrers
    • B01F27/112Stirrers characterised by the configuration of the stirrers with arms, paddles, vanes or blades
    • B01F27/1125Stirrers characterised by the configuration of the stirrers with arms, paddles, vanes or blades with vanes or blades extending parallel or oblique to the stirrer axis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71Feed mechanisms
    • B01F35/713Feed mechanisms comprising breaking packages or parts thereof, e.g. piercing or opening sealing elements between compartments or cartridges
    • B01F35/7137Piercing, perforating or melting membranes or closures which seal the compartments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0086Inhalation chambers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/08Inhaling devices inserted into the nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/02Gases
    • A61M2202/0208Oxygen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/27General characteristics of the apparatus preventing use
    • A61M2205/276General characteristics of the apparatus preventing use preventing unwanted use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/609Biometric patient identification means

Definitions

  • the present disclosure relates to a respiratory passage sprayer for administration of substances to a subject and a method of use of the respiratory passage sprayer.
  • a device and method to reduce instability and/or decomposition of one or more labile molecule(s) in preparations for administration to animals would be of benefit for the extension of the shelf-life of such preparations.
  • the device and/or method relates to potentially labile substances for administration to a subject facilitates mixture of one or more labile substance with another substance shortly before administration to the subject without exposure to contamination of the mixed substances.
  • a method for delivering a pharmaceutically acceptable mixture of a first substance and a second substance to a respiratory passage of a subject including:
  • a sprayer having a nozzle, a first chamber configured to hold the first substance, a second chamber configured to hold the second substance, and an actuator;
  • the moving of the actuator may include moving a shaft with a sharp end to pierce a seal associated with the first chamber.
  • the moving of the actuator may include signalling a cover to open to release the first substance from the first chamber into the second chamber.
  • the mixing may include moving a plunger through the second chamber and in a direction of the nozzle.
  • the mixing may include rotating at least one vane within the second chamber around a central longitudinal axis of the sprayer to create a vortex.
  • the method may further include inserting a cartridge containing the first substance into the first chamber.
  • the method may further include inserting a tray of powder capsules into the second chamber.
  • the method may further include signalling a user that the first substance level is below a predetermined threshold level.
  • the powdered substance may include a chemical substance selected from the group consisting of a carbohydrate, a carbomer, a carotene, a chemotherapeutic agent, a coenzyme, a cofactor, a curcuminoid, a first messenger, a flavonol, a fullerene, a fungal extract, a ginsenoside, a lipid, a macrolide, a nicotinamide derivative, a nucleic acid, a nucleotide monophosphate, a nucleotide diphosphate, a nucleotide triphosphate, a peptide, a phytoalexin, a plant extract, a protein, a redox cofactor, a second messenger, a senolytic agent, a steroid, a sterol, a stilbenoid, a sugar substitute, a surfactant, a transcription factor, an agonist, an amino acid, an antagonist, an
  • the fungal extract may be an extract of a fungus belonging to a family selected from the group consisting of Cordycipitaceae and Ophiocordycipitaceae.
  • the plant extract may be an extract of a plant belonging to a family selected from the group consisting of Arecaceae, Asteraceae, Fabaceae, and Solanaceae.
  • a respiratory passage sprayer including:
  • a first chamber for holding a first substance
  • a second chamber for holding a second substance, the first chamber being intermediate the nozzle and the second chamber;
  • an actuator including a shaft having a proximal end and a distal end opposite the proximal end along a central longitudinal axis of the shaft, the distal end including a portion configured to breach the first chamber to permit the first substance from the first chamber to enter the second chamber, the shaft including at least one vane spaced from the distal end and projecting from the shaft, the at least one vane being configured to move within the second chamber when the actuator is actuated by a user.
  • the shaft may be configured to rotate during actuation to move the at least one vane in a circular motion about the central longitudinal axis of the shaft.
  • movement of the shaft through the second chamber may cause the at least one vane to rotate about the central longitudinal axis of the shaft.
  • the distal end may include a point configured to puncture a seal attached to the first chamber.
  • the nozzle may be removable from a housing holding the first and second chambers, the first chamber being accessible after removal of the nozzle so that a cartridge or bladder holding the first substance may be inserted into the first chamber.
  • the respiratory passage sprayer may include a level detector for measuring a level selected from the group consisting of: the first substance level in the first chamber, the second substance level in the second chamber, and a mixture of the first substance and the second substance in the second chamber following admixture of the first substance and the second substance in the second chamber.
  • the respiratory passage sprayer may include a channel configured to communicate between the second chamber and the nozzle to deliver a mixture of the first substance from the first chamber with the second substance from the second chamber.
  • the channel may be concentrically located around the shaft.
  • the first chamber may include a coaxial channel configured to permit the delivery of a mixture of the first substance from the first chamber with the second substance from the second chamber, the channel being closed off from the first chamber.
  • Fig. 1 is a cross-section view of one embodiment of a respiratory passage sprayer as herein disclosed.
  • Fig. 2 is a cross-section view of another embodiment of a respiratory passage sprayer as herein disclosed.
  • Fig. 3 is a perspective view of the respiratory passage sprayer as disclosed in
  • the respiratory passage sprayer 100 includes a nozzle 102, a first chamber 104 for containing a first substance (NS), a second chamber 106 for containing a second substance (NS).
  • the respiratory passage sprayer 100 also includes an actuator 108 having a shaft 1 10 with a proximal end 1 12 and a distal end 1 14 opposite the proximal end 1 12 located along a central longitudinal axis 1 16 of the shaft 1 10.
  • a portion 1 18 of the distal end 1 14 of the shaft 1 10 is configured to breach the first chamber 104 to enter the second chamber 106.
  • the distal end 1 14 of the shaft 1 10 can include a point (NS) configured to puncture a seal 122 attached to the first chamber 104.
  • the nozzle 102 is removable from a housing 124 that holds the first chamber 104 and the second chamber 106.
  • the shaft 1 10 includes at least one vane 120 spaced from the distal end 1 14 and projecting from the shaft 1 10, which is configured to move within the second chamber 106 when the actuator 108 is actuated by a user (NS). It will be appreciated that the shaft 1 10 may cause the at least one vane 120 to be rotated in a circular motion about the central longitudinal axis 1 16 when the actuator 108 is actuated by the user (NS).
  • the first chamber 104 is shaped and configured to accommodate a cartridge or bladder 126 holding the first substance.
  • the respiratory sprayer 100 includes a channel 136, which upon actuation, communicates between the second chamber 106 and the nozzle 102 to deliver a mixture (NS) of the first substance from the first chamber 104 with the second substance from the second chamber 106.
  • the actuator 108 includes a spring 109 for reciprocating the actuator 108 from a first position (NS) to a second position (NS) during actuation.
  • the respiratory passage sprayer includes a level detector 328 for measuring a level selected from the group consisting of: the first substance level in the first chamber 104, the second substance level in the second chamber 106, and a mixture of the first substance and the second substance in the second chamber 106 following admixture of the first substance and the second substance in the second chamber 106.
  • the channel 136 can be concentrically located around the shaft 1 10. It will also be appreciated that the first chamber 104 of the respiratory passage sprayer 100 may include a coaxial channel configured to permit the delivery of a mixture of the first substance from the first chamber 104 with the second substance from the second chamber 106, the channel being closed off from the first chamber 104.
  • a respiratory passage should be understood to include a buccal cavity and a nasal cavity.
  • Substances that may be administered using the respiratory sprayer disclosed herein include a carbohydrate, a carbomer, a carotene, a chemotherapeutic agent, a coenzyme, a cofactor, a curcuminoid, a first messenger, a flavonol, a fullerene, a fungal extract, a ginsenoside, a lipid, a macrolide, a nicotinamide derivative, a nucleic acid, a nucleotide monophosphate, a nucleotide diphosphate, a nucleotide triphosphate, a peptide, a phytoalexin, a plant extract, a protein, a redox cofactor, a second messenger, a senolytic agent, a steroid, a sterol, a stilbenoid, a sugar substitute, a surfactant, a transcription factor, an agonist, an amino acid, an antagonist, an antioxidant, an enzyme activ
  • Peptides and proteins that may be administered using the respiratory sprayer disclosed herein include a vaccine, an antibody including an antivenom, a heat- sensitive peptide and/or protein, and a protein that is sensitive to enzymatic degradation including a protein having inherent protease activity.
  • the respiratory passage sprayer may be configured for medicaments of different forms, for example only, powder capsules, liquid capsules, etc.
  • the respiratory passage sprayer may be configured to receive a tray with individual capsules that may be moved or rotated to place a capsule in position for breaching the capsule and delivery of any medicament therein.
  • the wall of the respiratory passage sprayer may include a transparent portion so that a user can easily discern a substance level within the body.
  • the respiratory passage sprayer may include anti-tamper mechanisms as desired.
  • a microchip may be included to facilitate automatic dosing and delivery.
  • the respiratory passage sprayer may include a locking mechanism customised to reduce the likelihood that an unauthorised person will use the sprayer.
  • the respiratory passage sprayer may be configured with a biometric touchpad that may be programmed to register, calibrate the respiratory passage sprayer for use, and/or unlock the respiratory passage sprayer for use upon successful identification of a user’s finger or thumb print.
  • biometrics may include, for example, facial recognition, hand geometry, handwritten biometric recognition, iris recognition, retinal scan, blood vessel matching, and voice analysis.
  • the respiratory passage sprayer may include a transceiver configured to communicate usage and/or storage data to a mobile communications device or remote server.
  • the transceiver may be configured with a peer-to-peer communications technology such as Bluetooth or Wi-Fi Direct.
  • the respiratory passage sprayer may be configured to permit actuation only when a recognised cartridge is inserted.
  • respiratory sprayer disclosed herein may be used to extend the shelf life of pharmaceutical compounds.

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Mixing of substances is known to increase, in some cases, lability of one or more of the constituent molecules in the mixture. In some cases, such admixture of substances may lead, in addition to instability of one or more molecules, to decomposition of labile molecules. Such instability and/or decomposition may be due to concentration effects, enzymatic action, heat, light, a redox reaction, other components in the same solution reacting with labile molecules, physicochemical factors such as pH, and/or solvent effects. It will be appreciated that a lack of stability of a molecule represents a major cause for concern in medical chemistry. The present disclosure relates to a respiratory passage sprayer for administration of substances to a subject and a method of use of the respiratory passage sprayer.

Description

A RESPIRATORY PASSAGE SPRAYER AND METHOD OF USE OF SAME
Field of the Invention
The present disclosure relates to a respiratory passage sprayer for administration of substances to a subject and a method of use of the respiratory passage sprayer.
Background of the Invention
Mixing of substances is known to increase, in some cases, lability of one or more of the constituent molecules in the mixture. In some cases, such admixture of substances may lead, in addition to instability of one or more molecules, to decomposition of labile molecules. Such instability and/or decomposition may be due to concentration effects, enzymatic action, heat, light, a redox reaction, other components in the same solution reacting with labile molecules, physicochemical factors such as pH, and/or solvent effects. It will be appreciated that a lack of stability of a molecule represents a major cause for concern in medical chemistry.
Accordingly, a device and method to reduce instability and/or decomposition of one or more labile molecule(s) in preparations for administration to animals would be of benefit for the extension of the shelf-life of such preparations.
A particular benefit would be derived where the device and/or method relates to potentially labile substances for administration to a subject facilitates mixture of one or more labile substance with another substance shortly before administration to the subject without exposure to contamination of the mixed substances.
Summary
The following is a broad summary of various exemplary embodiments of a respiratory passage sprayer for administration of substances to a subject and a method of use of the respiratory passage sprayer.
According to an embodiment of the invention there is provided a method for delivering a pharmaceutically acceptable mixture of a first substance and a second substance to a respiratory passage of a subject, the method including:
providing a sprayer having a nozzle, a first chamber configured to hold the first substance, a second chamber configured to hold the second substance, and an actuator;
moving the actuator to open the first chamber to release the first substance from the first chamber into the second chamber; mixing the first substance from the first chamber with the second substance in the second chamber to create the pharmaceutically acceptable mixture; and
moving the mixture through a passageway of the sprayer to exit the nozzle of the sprayer.
In another embodiment, the moving of the actuator may include moving a shaft with a sharp end to pierce a seal associated with the first chamber.
In another embodiment, the moving of the actuator may include signalling a cover to open to release the first substance from the first chamber into the second chamber.
In another embodiment, the mixing may include moving a plunger through the second chamber and in a direction of the nozzle.
In another embodiment, the mixing may include rotating at least one vane within the second chamber around a central longitudinal axis of the sprayer to create a vortex.
In another embodiment, the method may further include inserting a cartridge containing the first substance into the first chamber.
In another embodiment, the method may further include inserting a tray of powder capsules into the second chamber.
In another embodiment, the method may further include signalling a user that the first substance level is below a predetermined threshold level.
In another embodiment, the powdered substance may include a chemical substance selected from the group consisting of a carbohydrate, a carbomer, a carotene, a chemotherapeutic agent, a coenzyme, a cofactor, a curcuminoid, a first messenger, a flavonol, a fullerene, a fungal extract, a ginsenoside, a lipid, a macrolide, a nicotinamide derivative, a nucleic acid, a nucleotide monophosphate, a nucleotide diphosphate, a nucleotide triphosphate, a peptide, a phytoalexin, a plant extract, a protein, a redox cofactor, a second messenger, a senolytic agent, a steroid, a sterol, a stilbenoid, a sugar substitute, a surfactant, a transcription factor, an agonist, an amino acid, an antagonist, an antioxidant, an enzyme activator, an enzyme inhibitor, an enzyme, an enzyme complex, and an organosulfur compound.
In another embodiment, the fungal extract may be an extract of a fungus belonging to a family selected from the group consisting of Cordycipitaceae and Ophiocordycipitaceae. In another embodiment, the plant extract may be an extract of a plant belonging to a family selected from the group consisting of Arecaceae, Asteraceae, Fabaceae, and Solanaceae.
In another embodiment of the invention there is provided a respiratory passage sprayer, including:
a nozzle;
a first chamber for holding a first substance;
a second chamber for holding a second substance, the first chamber being intermediate the nozzle and the second chamber; and
an actuator including a shaft having a proximal end and a distal end opposite the proximal end along a central longitudinal axis of the shaft, the distal end including a portion configured to breach the first chamber to permit the first substance from the first chamber to enter the second chamber, the shaft including at least one vane spaced from the distal end and projecting from the shaft, the at least one vane being configured to move within the second chamber when the actuator is actuated by a user.
In another embodiment, the shaft may be configured to rotate during actuation to move the at least one vane in a circular motion about the central longitudinal axis of the shaft.
In another embodiment, movement of the shaft through the second chamber may cause the at least one vane to rotate about the central longitudinal axis of the shaft.
In another embodiment, the distal end may include a point configured to puncture a seal attached to the first chamber.
In another embodiment, the nozzle may be removable from a housing holding the first and second chambers, the first chamber being accessible after removal of the nozzle so that a cartridge or bladder holding the first substance may be inserted into the first chamber.
In another embodiment, the respiratory passage sprayer may include a level detector for measuring a level selected from the group consisting of: the first substance level in the first chamber, the second substance level in the second chamber, and a mixture of the first substance and the second substance in the second chamber following admixture of the first substance and the second substance in the second chamber. In another embodiment, the respiratory passage sprayer may include a channel configured to communicate between the second chamber and the nozzle to deliver a mixture of the first substance from the first chamber with the second substance from the second chamber.
In another embodiment, the channel may be concentrically located around the shaft.
In another embodiment, the first chamber may include a coaxial channel configured to permit the delivery of a mixture of the first substance from the first chamber with the second substance from the second chamber, the channel being closed off from the first chamber.
The reference to any prior art in this specification is not and should not be taken as an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge in Australia or in any other country.
The claims as filed and attached with this specification are hereby
incorporated by reference into the text of the present description.
Embodiments of the invention are now described, by way of example.
Brief Description of the Drawing
Fig. 1 is a cross-section view of one embodiment of a respiratory passage sprayer as herein disclosed.
Fig. 2 is a cross-section view of another embodiment of a respiratory passage sprayer as herein disclosed.
Fig. 3 is a perspective view of the respiratory passage sprayer as disclosed in
Fig. 1 .
Detailed Description
The following detailed description of the invention refer to the accompanying drawing. Alternative embodiments of the disclosure will be apparent to those of ordinary skill in the art from consideration of the specification. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the disclosure being indicated by the claims which follow. It will be understood that the term“comprising” is intended to have a broad, open meaning and not limited to a particular embodiment. It will also be understood that the term“subject” as used herein is intended to include all animals having a respiratory tract, including humans.
Referring to Figs. 1 to 3, the respiratory passage sprayer 100 includes a nozzle 102, a first chamber 104 for containing a first substance (NS), a second chamber 106 for containing a second substance (NS). The respiratory passage sprayer 100 also includes an actuator 108 having a shaft 1 10 with a proximal end 1 12 and a distal end 1 14 opposite the proximal end 1 12 located along a central longitudinal axis 1 16 of the shaft 1 10. A portion 1 18 of the distal end 1 14 of the shaft 1 10 is configured to breach the first chamber 104 to enter the second chamber 106. The distal end 1 14 of the shaft 1 10 can include a point (NS) configured to puncture a seal 122 attached to the first chamber 104. The nozzle 102 is removable from a housing 124 that holds the first chamber 104 and the second chamber 106.
Specifically referring to Fig. 2, the shaft 1 10 includes at least one vane 120 spaced from the distal end 1 14 and projecting from the shaft 1 10, which is configured to move within the second chamber 106 when the actuator 108 is actuated by a user (NS). It will be appreciated that the shaft 1 10 may cause the at least one vane 120 to be rotated in a circular motion about the central longitudinal axis 1 16 when the actuator 108 is actuated by the user (NS). The first chamber 104 is shaped and configured to accommodate a cartridge or bladder 126 holding the first substance.
Specifically referring to Figs. 1 and 2, the respiratory sprayer 100 includes a channel 136, which upon actuation, communicates between the second chamber 106 and the nozzle 102 to deliver a mixture (NS) of the first substance from the first chamber 104 with the second substance from the second chamber 106. The actuator 108 includes a spring 109 for reciprocating the actuator 108 from a first position (NS) to a second position (NS) during actuation.
Specifically referring to Fig. 3, the respiratory passage sprayer includes a level detector 328 for measuring a level selected from the group consisting of: the first substance level in the first chamber 104, the second substance level in the second chamber 106, and a mixture of the first substance and the second substance in the second chamber 106 following admixture of the first substance and the second substance in the second chamber 106.
It will be appreciated that the channel 136 can be concentrically located around the shaft 1 10. It will also be appreciated that the first chamber 104 of the respiratory passage sprayer 100 may include a coaxial channel configured to permit the delivery of a mixture of the first substance from the first chamber 104 with the second substance from the second chamber 106, the channel being closed off from the first chamber 104. A respiratory passage should be understood to include a buccal cavity and a nasal cavity.
Substances that may be administered using the respiratory sprayer disclosed herein include a carbohydrate, a carbomer, a carotene, a chemotherapeutic agent, a coenzyme, a cofactor, a curcuminoid, a first messenger, a flavonol, a fullerene, a fungal extract, a ginsenoside, a lipid, a macrolide, a nicotinamide derivative, a nucleic acid, a nucleotide monophosphate, a nucleotide diphosphate, a nucleotide triphosphate, a peptide, a phytoalexin, a plant extract, a protein, a redox cofactor, a second messenger, a senolytic agent, a steroid, a sterol, a stilbenoid, a sugar substitute, a surfactant, a transcription factor, an agonist, an amino acid, an antagonist, an antioxidant, an enzyme activator, an enzyme inhibitor, an enzyme, an enzyme complex, and an organosulfur compound.
Peptides and proteins that may be administered using the respiratory sprayer disclosed herein include a vaccine, an antibody including an antivenom, a heat- sensitive peptide and/or protein, and a protein that is sensitive to enzymatic degradation including a protein having inherent protease activity.
The foregoing description is by way of example only and may be varied considerably without departing from the scope of the present invention. Reciprocating means other than a spring may be used, for example only, a piston. The respiratory passage sprayer may be configured for medicaments of different forms, for example only, powder capsules, liquid capsules, etc. The respiratory passage sprayer may be configured to receive a tray with individual capsules that may be moved or rotated to place a capsule in position for breaching the capsule and delivery of any medicament therein. The wall of the respiratory passage sprayer may include a transparent portion so that a user can easily discern a substance level within the body. The respiratory passage sprayer may include anti-tamper mechanisms as desired. A microchip may be included to facilitate automatic dosing and delivery.
The respiratory passage sprayer may include a locking mechanism customised to reduce the likelihood that an unauthorised person will use the sprayer. For example only, the respiratory passage sprayer may be configured with a biometric touchpad that may be programmed to register, calibrate the respiratory passage sprayer for use, and/or unlock the respiratory passage sprayer for use upon successful identification of a user’s finger or thumb print. A person skilled in the art will appreciate other forms of biometric measurements may be employed to register, calibrate the respiratory passage sprayer for use, and/or unlock the respiratory passage sprayer for use. Such biometrics may include, for example, facial recognition, hand geometry, handwritten biometric recognition, iris recognition, retinal scan, blood vessel matching, and voice analysis.
The respiratory passage sprayer may include a transceiver configured to communicate usage and/or storage data to a mobile communications device or remote server. The transceiver may be configured with a peer-to-peer communications technology such as Bluetooth or Wi-Fi Direct. The respiratory passage sprayer may be configured to permit actuation only when a recognised cartridge is inserted.
It is to be understood that the terminology employed above is for the purpose of description and should not be regarded as limiting. The described embodiments are intended to be illustrative of the invention, without limiting the scope thereof. The invention is capable of being practised with various modifications and additions as will readily occur to those skilled in the art.
It will also be appreciated that the respiratory sprayer disclosed herein may be used to extend the shelf life of pharmaceutical compounds.
The features described with respect to one embodiment may be applied to other embodiments, or combined with, or interchanged with, the features of other embodiments without departing from the scope of the present invention.
Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims.

Claims

What is claimed is:
1. A method for delivering a pharmaceutically acceptable mixture of a first
substance and a second substance to a respiratory passage of a subject, the method comprising:
providing a sprayer having a nozzle, a first chamber configured to hold the first substance, a second chamber configured to hold the second substance, and an actuator;
moving the actuator to open the first chamber to release the first substance from the first chamber into the second chamber;
mixing the first substance from the first chamber with the second substance in the second chamber to create the pharmaceutically acceptable mixture; and
moving the mixture through a passageway of the sprayer to exit the nozzle of the sprayer.
2. The method of claim 1 , wherein the moving of the actuator includes moving a shaft with a sharp end to pierce a seal associated with the first chamber.
3. The method of claim 1 , wherein the moving of the actuator includes signalling a cover to open to release first substance from the first chamber into the second chamber.
4. The method of any one of the above claims, wherein the mixing includes moving a plunger through the second chamber and in a direction of the nozzle.
5. The method of any one of claims 1 -3, wherein the mixing includes rotating at least one vane within the second chamber around a central longitudinal axis of the sprayer to create a vortex.
6. The method of any one of the above claims, further comprising inserting a cartridge containing the first substance into the first chamber.
7. The method of any one of the above claims, further comprising inserting a tray of powder capsules into the second chamber.
8. The method of any one of the above claims, further comprising signalling a user that the first substance level is below a predetermined threshold level.
9. The method of any one of the above claims, wherein the powdered substance comprises a chemical substance selected from the group consisting of a
carbohydrate, a carbomer, a carotene, a chemotherapeutic agent, a coenzyme, a cofactor, a curcuminoid, a first messenger, a flavonol, a fullerene, a fungal extract, a ginsenoside, a lipid, a macrolide, a nicotinamide derivative, a nucleic acid, a nucleotide monophosphate, a nucleotide diphosphate, a nucleotide triphosphate, a peptide, a phytoalexin, a plant extract, a protein, a redox cofactor, a second messenger, a senolytic agent, a steroid, a sterol, a stilbenoid, a sugar substitute, a surfactant, a transcription factor, an agonist, an amino acid, an antagonist, an antioxidant, an enzyme activator, an enzyme inhibitor, an enzyme, an enzyme complex, and an organosulfur compound.
10. The method of claim 9, wherein the fungal extract is an extract of a fungus belonging to a family selected from the group consisting of Cordycipitaceae and Ophiocordycipitaceae.
1 1. The method of claim 9, wherein the plant extract is an extract of a plant belonging to a family selected from the group consisting of Arecaceae, Asteraceae, Fabaceae, and Solanaceae.
12. A respiratory passage sprayer, comprising:
a nozzle;
a first chamber for holding a first substance;
a second chamber for holding a second substance, said first chamber being intermediate said nozzle and said second chamber; and
an actuator including a shaft having a proximal end and a distal end opposite said proximal end along a central longitudinal axis of said shaft, said distal end including a portion configured to breach said first chamber to permit the first substance from said first chamber to enter said second chamber, said shaft including at least one vane spaced from said distal end and projecting from said shaft, said at least one vane being configured to move within said second chamber when said actuator is actuated by a user.
13. The respiratory passage sprayer of claim 12, wherein said shaft is configured to rotate during actuation to move said at least one vane in a circular motion about the central longitudinal axis of said shaft.
14. The respiratory passage sprayer of claim 12, wherein movement of said shaft through said second chamber causes said at least one vane to rotate about the central longitudinal axis of said shaft.
15. The respiratory passage sprayer of claim 12, wherein said distal end includes a point configured to puncture a seal attached to said first chamber.
16. The respiratory passage sprayer of claim 12, wherein said nozzle is removable from a housing holding said first and second chambers, said first chamber being accessible after removal of said nozzle so that a cartridge or bladder holding the first substance may be inserted into said first chamber.
17. The respiratory passage sprayer of claim 12, further comprising a level detector for measuring a level selected from the group consisting of: the first substance level in said first chamber, the second substance level in said second chamber, and a mixture of the first substance and the second substance in said second chamber following admixture of the first substance and the second substance in said second chamber.
18. The respiratory passage sprayer of claim 12, further comprising a channel configured to communicate between said second chamber and said nozzle to deliver a mixture of the first substance from said first chamber with the second substance from said second chamber.
19. The respiratory passage sprayer of claim 18, wherein said channel is
concentrically located around said shaft.
20. The respiratory passage sprayer of claim 12, wherein said first chamber includes a coaxial channel configured to permit the delivery of a mixture of the first substance from said first chamber with the second substance from said second chamber, said channel being closed off from said first chamber.
PCT/AU2019/051018 2018-10-02 2019-09-23 A respiratory passage sprayer and method of use of same WO2020069559A1 (en)

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