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WO2009029029A1 - Inhalateur pour des substances pulvérulentes ayant un compartiment contenant un agent de dessiccation - Google Patents

Inhalateur pour des substances pulvérulentes ayant un compartiment contenant un agent de dessiccation Download PDF

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Publication number
WO2009029029A1
WO2009029029A1 PCT/SE2008/050948 SE2008050948W WO2009029029A1 WO 2009029029 A1 WO2009029029 A1 WO 2009029029A1 SE 2008050948 W SE2008050948 W SE 2008050948W WO 2009029029 A1 WO2009029029 A1 WO 2009029029A1
Authority
WO
WIPO (PCT)
Prior art keywords
inhaler
substance
transfer member
airflow passage
desiccant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/SE2008/050948
Other languages
English (en)
Inventor
Nicholas John Bowman
David Robert Gale
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AstraZeneca AB
Original Assignee
AstraZeneca AB
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 AstraZeneca AB filed Critical AstraZeneca AB
Publication of WO2009029029A1 publication Critical patent/WO2009029029A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0013—Details of inhalators; Constructional features thereof with inhalation check valves
    • A61M15/0015—Details of inhalators; Constructional features thereof with inhalation check valves located upstream of the dispenser, i.e. not traversed by the product
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A61M15/0025—Mouthpieces therefor with caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0066—Inhalators with dosage or measuring devices with means for varying the dose size
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A61M15/0093—Inhalators mechanically breath-triggered without arming or cocking, e.g. acting directly on the delivery valve
    • 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
    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A61M15/0096—Hindering inhalation before activation of the dispenser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/08—Inhaling devices inserted into the nose
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/062—Desiccants
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/07—General characteristics of the apparatus having air pumping means
    • A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
    • A61M2205/073—Syringe, piston type

Definitions

  • the present invention relates to an inhaler for powdered substance, from which substance is inhalable by a user.
  • a pressurized Metered Dose Inhaler releases a fixed dose of substance in aerosol form.
  • Such an inhaler generally comprises a canister with particulate medicament suspended in propellant gas.
  • powder inhalers which generally release a dose of powdered substance entrained in an air stream, have gained popularity.
  • Powder inhalers commonly comprise a desiccant (drying agent) to reduce the risk of moisture negatively affecting the quality of the powdered substance.
  • the present invention is based on the insight that a powder inhaler can be provided which, similarly to pMDIs, use a propellant gas to provide the substance to the user's airways.
  • the invention is also based on the insight that by using, as said propellant gas, external air which is dried by a desiccant that is kept from following the air stream to the user's airways, a user and environmental friendly alternative can be provided.
  • air may be used as a propellant gas and the inhaler may then be replenished with air from outside the inhaler.
  • an inhaler for powdered substance is provided, such as a pharmaceutical substance or a plurality of pharmaceutical substances which are provided separately or in mixture.
  • the inhaler comprises an airflow passage for guiding substance towards an outlet, such as an inhalation interface in the form of a mouthpiece or nasal adaptor.
  • the inhaler further comprises a substance storing chamber from which substance is provided to the airflow passage.
  • the inhaler also comprises a pressurizable space for establishing an air overpressure in the airflow passage for delivering substance present in the airflow passage to the outlet.
  • a desiccant-containing compartment is provided from which air is enabled to flow to the pressurizable space in order to replenish expelled air and a filter is provided in the desiccant-containing compartment, wherein air flowing from the desiccant-containing compartment to the pressurizable space passes through the filter.
  • the inhaler may be replenished with ambient air, which when entering the inhaler, at an early stage (before reaching the pressurizable space) is dried, therefore reducing the risk of incoming ambient air negatively affecting the quality of the powdered substance.
  • the desiccant-containing compartment may be arranged in fluid communication with the ambient air outside the inhaler in various ways.
  • a filter By providing a filter in the desiccant-containing compartment, the risk of desiccant particles entering the pressurizable space is also reduced.
  • a filter can be designed in various ways. For instance, it may be designed as an element covering a passageway between the desiccant- containing compartment and the pressurizable space. Another alternative would be to provide a filter in the form of a bag or net which encloses the desiccant particles.
  • the desiccant- containing compartment is provided with an opening through which air can flow to the pressurizable space, wherein a one-way valve is provided at the opening to prevent air from flowing from the pressurizable space to the desiccant-containing compartment.
  • a one-way valve is provided at the opening to prevent air from flowing from the pressurizable space to the desiccant-containing compartment.
  • the filter is provided adjacent the opening.
  • there are various ways of designing a filter While from a space- saving perspective it may be advantageous to provide the filter adjacent the opening, an alternative would be to provide the filter more remotely from the opening, but in such way that it has a desiccant-obstructing function.
  • various designs and locations of the filter are conceivable as long as the flow path of the incoming ambient air is such that it reaches the filter before it reaches the one-way valve.
  • the pressurizable space comprises said airflow passage, wherein said opening extends from the desiccant- containing compartment to the airflow passage.
  • the desiccant-containing compartment is arrangable in fluid communication with the airflow passage.
  • the desiccant-containing compartment near the substance storing chamber, in order to protect the substance from moisture ingress. In fact, it is conceivable to provide a well-kept desiccant within the substance storing chamber. However, as an alternative to placing the desiccant-containing compartment near the substance storing chamber, an alternative or a complement would be to have a desiccant containing compartment distanced from the substance storing chamber. According to at least one example embodiment of the invention, the substance storing chamber is located on one side of the airflow passage and the desiccant-containing compartment is located on the other side of the airflow passage.
  • the incoming ambient air replenishing the fired inhaler will suitably enter at the same side of the airflow passage as the desiccant- containing compartment, thus distanced from the substance storing chamber, reducing the risk of moisture from that incoming air ingressing to the substance storing chamber.
  • the inhaler may be designed in various way for enabling the replenishing air to be introduced.
  • the desiccant- containing compartment is via a mouthpiece or nasal adaptor of the inhaler in fluid communication with the atmosphere outside the inhaler, whereby air is enabled to flow from outside the inhaler via the mouthpiece or nasal adaptor and then via the desiccant- containing compartment to the pressurizable space in order to replenish expelled air.
  • the inhaler comprises a transfer member which is displaceable in the substance storing chamber.
  • the transfer member comprises at least one dosing chamber for taking up substance inside the substance storing chamber, the transfer member being displaceable between a substance- keeping position in which the dosing chamber keeps the substance and a substance- evacuating position in which the dosing chamber presents the substance to the airflow passage, wherein, when the transfer member is in said substance-evacuating position, the dosing chamber is evacuated by the air overpressure in the airflow passage.
  • the dosing chamber is arranged to travel from inside the actual substance storing chamber to the airflow passage.
  • the displacement of the transfer member from the substance-keeping position to the substance-evacuating position describes a linear motion, that is, moves in a straight direction.
  • the pressurizable space including the airflow passage, may be closed in various ways for maintaining the overpressure.
  • a one-way valve may be provided for preventing bleeding to the desiccant-containing compartment.
  • the above- mentioned transfer member may also act as or be part of a closure.
  • said transfer member in its substance- keeping position extends through the airflow passage to close said pressurizable space and to maintain the overpressure until the transfer member is displaced to its substance evacuating position.
  • the dosing chamber presents the substance to the airflow passage and the air overpressure.
  • the release of the overpressure causes a stream of air to entrain the substance and deliver it to the outlet (e.g. mouthpiece or nasal adaptor).
  • the dosing chamber in the substance-evacuating position of the transfer member, will be located within the airflow passage so as to form part of the flow path.
  • This may be arranged in various ways, one of which being designing the dosing chamber as a cross hole through the transfer member so that the stream of air will be led through the transfer member to entrain the substance.
  • the inhaler comprises an inhaler housing and an actuator.
  • the actuator comprises an action button protruding from the inhaler housing, the action button being displaceable against a return spring, wherein the overpressure is established when the action button is displaced in the inhaler housing, which overpressure, through the displacement of said transfer member, is used in the flow passage for the discharge of substance.
  • the action button may be adapted to be linearly displaced, e.g. by depression thereof.
  • the actuator may be provided with various other means for establishing the overpressure.
  • the actuator may be provided with a rotating mechanism which, when rotated (e.g. like a tightening screw), reduces the volume of the pressurizable space, thereby establishing the overpressure.
  • the actuator may suitably be operatively connected to the transfer member for displacing it from the substance-keeping position to the substance-evacuating position.
  • the actuator when actuated, causes the overpressure to be established first and then after a brief idling causes the transfer member to be displaced.
  • the actuator when actuated, causes the overpressure to be established and subsequently or simultaneously causes the transfer member to become biased towards the substance- evacuating position.
  • the transfer member can, when desired, be released by a release mechanism, e.g. an inhalation triggered-release mechanism.
  • the above-mentioned release mechanism may be operated by hand, it may suitably be triggered by the user's inhalation in order to coordinate the inhalation with the discharge of the substance from the inhaler.
  • This is reflected by at least one example embodiment of the invention, wherein the established overpressure in the pressurizable space is released by an inhalation-triggered release mechanism when a user inhales through a mouthpiece or nasal adaptor of the inhaler.
  • the inhaler may suitably use one and the same triggering for releasing the overpressure and unlatching the transfer member.
  • a common triggering may facilitate the timing for entraining the substance into the airflow caused by the released overpressure.
  • the overpressure will automatically be released when the release-mechanism unlatches the transfer member upon inhalation by a user.
  • the inhalation effort required by the user for triggering the inhalation-triggered release mechanism may be chosen depending on e.g. age of user and type of therapy.
  • the inspiratory air flow threshold to be overcome may be chosen by appropriate design of e.g. inertia and resistive force acting upon the release mechanism.
  • the inhaler may have several suitable locations for arranging the inhalation- triggered release mechanism.
  • the transfer member could be latched in various ways, e.g. having protrusions or indentations mating with complementary features of the release mechanism.
  • the release mechanism comprises a gripping means which may be closed and open for latching and releasing the transfer member.
  • the release mechanism simply stands in the way of the transfer member, preventing it from further displacement until the release mechanism is out of the way.
  • the action button could optionally be latched to maintain the overpressure until the user inhales. After inhalation, the action button may then become automatically or manually unlatched and return to its starting position. Alternatively, a user could keep the action button depressed with a finger until he or she inhales.
  • the inhaler comprises a biasing mechanism adapted to bias the transfer member towards the substance- evacuating position, the transfer member being latched in the substance-keeping position by said inhalation-triggered release mechanism which, when a user inhales through the mouthpiece or nasal adaptor, unlatches the transfer member, thereby enabling it to move to the substance-evacuating position.
  • the biasing mechanism could be activated electronically or mechanically.
  • the biasing mechanism could provide the force by a manually maintained pressure, e.g. the user pressing and keeping his/her finger on the biasing mechanism (e.g. comprising said actuator with action button) so as to provide the force urging the transfer member to the substance-evacuating position.
  • the biasing mechanism may have some kind of latch for maintaining the bias on the transfer member even after the user has let go of the biasing mechanism.
  • the biasing mechanism may suitably comprise a spring acting on the transfer member.
  • the dosing chamber is located inside the substance storing chamber when the transfer member is latched by the release mechanism in said substance-keeping position and biased towards the substance-evacuating position by the biasing mechanism.
  • the inhaler when the inhaler is primed, i.e. in a loaded state ready for inhalation, the substance is kept safely inside the substance storing chamber, or more specifically, the substance is kept inside the dosing chamber which in turn is located inside the substance storing chamber.
  • This arrangement reduces the risk of contamination.
  • the inhaler may be provided with a feature that allows the biasing of the biasing mechanism to be cancelled if a user changes his/her mind and does not want to use the inhaler at present. The substance will then still be kept safe in the substance storing chamber.
  • the dosing chamber being located in the substance storing chamber when the inhaler has been primed
  • an alternative would be to arrange said substance-keeping position of the transfer member in such way that the dosing chamber is located in an intermediate conduit or the like between the substance storing chamber and the airflow passage, which could still provide a safely shielded location.
  • the priming could comprise introducing substance into the dosing chamber, displacing the transfer member so that the dosing chamber is moved from the substance storing chamber to said intermediate conduit (the transfer member becomes latched after said displacement) and biasing the transfer member towards the substance- evacuating position.
  • the transfer member may be displaced only a short distance before becoming latched so that the dosing chamber, even though moved, still remains located inside the substance storing chamber.
  • the biasing mechanism may be configured in various ways.
  • the biasing mechanism comprises said actuator which is movable towards the transfer member and a spring which is compressible between the actuator and the transfer member, whereby movement of the actuator towards the transfer member, when the transfer member is latched in the substance-keeping position, causes the transfer member to become spring- loaded.
  • Other alternatives to providing a spring between the actuator and the transfer member are conceivable.
  • a hydraulic arrangement such as comprising a piston movable in a cylinder, for transmitting the biasing force. While a simple linear movement of the actuator towards the transfer member is readily envisaged, there may also be alternatives, such as rotating the actuator (e.g. like a tightening screw)
  • the substance storing chamber and the desiccant- containing compartment may be located on respective sides of the airflow passage.
  • the substance storing chamber is located on one side of the airflow passage and the inhalation-triggered release mechanism is located on the other side of the airflow passage, wherein the transfer member extends through the airflow passage.
  • the inhalation-triggered release mechanism and the desiccant-containing compartment may be located on the same side of the airflow passage.
  • the release mechanism may suitably comprise an abutment surface for receiving one end of the transfer member and latching the transfer member in the substance-keeping position.
  • the abutment surface may simply be a surface which stands in the way of the travel direction of the transfer member and suitably mating with an end portion of the transfer member, the abutment surface could alternatively engage with other portions and features of the transfer member as mentioned previously.
  • the release mechanism comprises a movable member being movable from a relaxed position, in which the release mechanism is kept in a latching state, to an energized position in which the release mechanism is caused to be displaced to a releasing state, wherein a first side of the movable member partly defines a first volume which is in fluid communication with the mouthpiece or nasal adaptor, wherein, when a user inhales through said mouthpiece or nasal adaptor, an underpressure is established in said first volume causing the movable member to move from the relaxed position to the energized position.
  • the release mechanism may comprise a return spring for urging the release mechanism to the latching state. Such a return spring may be provided in various configurations.
  • One example is a leaf spring, another example is a coil spring.
  • the release mechanism having a return spring or the like, the energizing force on the movable member will work against the force of the return spring.
  • the design of the return spring and the movable member should be suitably balanced so that when a user inhales above a certain airflow threshold, the force of the return spring is overcome by the movable member and causes the release mechanism to unlatch the transfer member.
  • the movable member is a diaphragm which is flexed to the energized position upon inhalation by a user.
  • the release mechanism comprises a pivotable rocker having an abutment surface for latching the transfer member, wherein the diaphragm is operatively connected to the rocker so that, when the diaphragm is flexed, the rocker is pivoted to said releasing state of the release mechanism.
  • said movable member is a flap which is pivoted to the energized position upon inhalation by a user.
  • a second side of the movable member partly defines a second volume which is in fluid communication with the atmosphere surrounding the inhaler.
  • air will be allowed to flow into the second volume on the other side of the movable member, thereby keeping the second volume at atmospheric pressure even if the second volume is increased upon movement of the movable member, thus avoiding counteracting the movement caused by the underpressure in the first volume.
  • the second volume may be small or, alternatively, even infinitesimal if the movable member would form part of the exterior wall portion of the inhaler housing.
  • the actuator has hitherto been described as being used for one or two functions, namely for creating an overpressure in the pressurizable space and, optionally, for urging the transfer member towards the substance-evacuating position.
  • the actuation of the actuator may also be used for promoting substance to enter the dosing chamber.
  • the actuator when actuated, causes at least a wall portion of the substance storing chamber to move towards the transfer member so that substance is urged into the dosing chamber.
  • the transfer member remains unmovable in the substance-keeping position while substance is urged into the dosing chamber.
  • example embodiments could include other promoting means.
  • the actuator could be connected to one or more pushers inside the substance storing chamber, wherein the substance would be pushed into the dosing chamber upon actuation of the actuator.
  • the above-described example embodiments encompass the actuator to be involved in three different functions, an alternative would be to provide two or three separate actuators for said functions.
  • the substance storing chamber wall consisting of an elastic material, curves in the direction towards the transfer member when the inhaler is actuated.
  • the substance storing chamber wall at least in the dosing chamber region, curves into contact with the transfer member.
  • Press pieces may be provided for curving of the substance storing chamber wall.
  • the press pieces may be provided with cheeks which have impinging surfaces which, in a fully in- turned position of the press pieces, are positioned parallelly to the broadside wall surfaces of the transfer member, if e.g. comprising a flat bar.
  • the transfer member comprises a rod which is displaceable in its longitudinal (lengthwise) direction.
  • a dose will be taken up from the substance storing chamber and then, be moved substantially in a straight uncurved direction to the flow passage.
  • the dosing chamber may be incorporated as an integral part of the rod.
  • the above-described example embodiment discusses a rod which is displaceable in its longitudinal direction, a rotational displacement or pivoting displacement of the rod would also be conceivable depending on the configuration and placement of the substance storing chamber and the airflow passage.
  • the transfer member may comprise component shapes, such as polygonal or circular.
  • a rotatable wheel may take up the substance from the substance storing chamber and then, rotate to present the substance to the airflow passage.
  • the dosing chamber may be designed as a cross hole of the transfer member.
  • the transfer member may have several dosing chambers consecutively located at the transfer member, which during a dispensing action are successively presented to the airflow passage and are, piece by piece, evacuatable by an overpressure in the airflow passage.
  • the dosing chambers suitably in the form of cross holes, would be positioned after each other in the travel direction of the rod, i.e. in its longitudinal extension.
  • the rod may have a circular cross section or polygonal cross section.
  • a part of the transfer member, or the actual rod itself is designed as a flat bar.
  • a flat bar may be advantageous if means are provided for urging substance into the dosing chamber, wherein such means would easily land against the flat bar surface.
  • the inhaler may contain various substances, such as drugs and/or bioactive agents to be inhaled.
  • the bioactive agent may be selected from any therapeutic or diagnostic agent.
  • it may be from the group of antiallergics, bronchodilators, bronchoconsitrictors, pulmonary lung surfactants, analgesics, antibiotics, leukotrine inhibitors or antagonists, anticholinergics, mast cell inhibitors, antihistamines, antiinflammatories, antineoplastics, anaesthetics, anti-tuberculars, imaging agents, cardiovascular agents, enzymes, steroids, genetic material, viral vectors, antisense agents, proteins, peptides and combinations thereof.
  • Examples of specific drugs which can be incorporated in the inhaler according to the invention include mometasone, ipratropium bromide, tiotropium and salts thereof, salemeterol, fluticasone propionate, beclomethasone dipropionate, reproterol, clenbuterol, rofleponide and salts, nedocromil, sodium cromoglycate, flunisolide, budesonide, formoterol fumarate dihydrate, Symbicort (budesonide and formoterol), terbutaline, terbutaline sulphate, salbutamol base and sulphate, fenoterol, 3-[2-(4-Hydroxy-2-oxo-3H- 1 ,3-benzothiazol-7-yl)ethylamino]-N-[2-[2-(4- methylphenyl)ethoxy]ethyl]propanesulphonamide, hydrochloride.
  • Combinations of medicaments may also be employed, for example formoterol/budesonide; formoterol/fluticasone; formoterol/mometasone; salmeterol/fluticasone; formoterol/tiotropium salts; zafirlukast/formoterol, zafirlukast/budesonide; montelukast/formoterol; montelukast/budesonide; loratadine/montelukast and loratadine/zafirlukast.
  • Further combinations include tiotropium and fluticasone, tiotropium and budesonide, tiotropium and mometasone, mometasone and salmeterol, formoterol and rofleponide, salmeterol and budesonide, salmeterol and rofleponide, and tiotropium and rofleponide.
  • Figs. Ia- Id illustrate the operation of an example embodiment of the invention.
  • Fig. 2 illustrates another example embodiment of the invention.
  • Figs. Ia- Id illustrate the operation of an example embodiment of the invention.
  • the inhaler 2 comprises a cylindrical housing 4 from which a substantially radially projecting mouthpiece 6 originates.
  • the inhaler 2 comprises an actuator in the form of an action button 8 arranged at the top of the housing 4 and an opposite surface 10 at the bottom of the housing 4, a general geometrical housing axis x extending therebetween.
  • the housing 4 is formed as a hollow cylindrical body, with a circular horizontal projection in the shown embodiment. Also other shapes, different from this shape with a circular horizontal projection, are conceivable, for example elliptical or multi-cornered/- angled shapes.
  • the circular-cylindrical external inhaler housing 12 is closed at the base by an inhaler bottom 14, which forms the opposite surface 10 for the actuation of the inhaler 2. At the side opposite to this bottom 14, the housing 4 is openly designed.
  • the mouthpiece 6 protrudes therefrom in a substantially radial orientation, more specifically in the shown example embodiment, with the inclusion of an acute angle of about 75 to 80° to the inhaler axis x, which mouthpiece 6 is substantially formed as a hollow cylinder body with an orifice pointing axially outwards with regard to the orientation of the mouthpiece 6.
  • a mouthpiece bottom 16, arranged in the transition region from the housing 4 to the mouthpiece 6, has a central opening 18.
  • the mouthpiece 6 When the inhaler 2 is not in use, the mouthpiece 6 may be covered by a cover, in this example illustrated as a screw cap 20. When the inhaler 2 is to be used, the user removes the screw cap 20.
  • a nasal adaptor instead of the mouthpiece 6.
  • a nasal adaptor instead of sloping downwardly like the illustrated mouthpiece 6, such a nasal adaptor would slope upwardly in relation to the vertical inhaler axis x, thus with the inclusion of an angle to the longitudinal axis x from about 45°.
  • the housing 4 is divided transversely to the axis x by a support 22 attached to the internal wall of the housing 4 on the level of the transition from the housing 4 to the mouthpiece 6.
  • the disc- shaped solid support 22 has a central recess 24, in which a sealing element 26 consisting of a thermoplastic material is inserted. This sealing element 26 is positioned in the recess 24 in a plug-like manner.
  • the sealing element 26 is provided with an airflow passage 28 which is orientated substantially linearly transversely to the axis x, which airflow passage 28, on both sides, is continued going through the support 22.
  • the airflow passage 28 extends on one side of the sealing element 26 through the support 22 to the central opening 18 of the mouthpiece bottom 16.
  • the airflow passage 28 goes, with a widening of its cross-section, to an upper housing section separated by the support 22.
  • the airflow passage orifice 30 is formed on the broad surface of the support 22, which is turned towards the upper housing section.
  • the airflow passage 28 is divided into a passage section on the mouthpiece side and a section on the housing side.
  • the passage orifice 30 is formed.
  • an after-flow opening 34 is provided, which is opposite the passage orifice 30.
  • the after-flow opening 34 forms a connection between the on-the housing-side section of the airflow passage 28 and a lower space provided by a desiccant-containing compartment 36 formed under the support 22.
  • This after-flow opening 34 is covered by a one-way air inlet valve 38 which is switched such that the after- flow opening 34 is only opened upon an airflow from the desiccant-containing compartment 36 through the airflow passage 28 in the direction of the upper housing section.
  • the valve 38 closes this after-flow opening 34.
  • a filter element 33 is provided for reducing the risk of transferring desiccant 37 from the desiccant-containing compartment 36 to the airflow passage 28 when air flows through the after-flow opening 34, and also for reducing the risk of desiccant 37 clogging the valve 38 and preventing it from closing effectively.
  • the airflow passage 28, particularly in the region of the sealing element 26 and the section turned to the mouthpiece 6, is designed essentially smaller than the free cross- section of the mouthpiece 6.
  • the diameter of the internal space of the mouthpiece 6 corresponds to about ten to thirty times the diameter of the airflow passage, the latter of which is tapered, particularly from the sealing element 26 in the direction of the opening 18 on the mouthpiece side, in the region of a slopingly downward-extending section, for the forming of a nozzle-type duct.
  • the sealing element 26 merges, in one piece and materially homogeneous, into a funnel-shaped substance storing chamber 40 facing the upper housing section, the substance storing chamber 40 having upwards, i.e. in the direction of the housing opening at the front side, a widening cross-section.
  • the substance storing chamber 40 consists also of a thermoplastic elastomer or another rubber-type material.
  • the upper end of the substance storing chamber 40 having an expanded diameter, is sealed off by a rolling bellows 42 forming a cover of the substance storing chamber 40.
  • a micronized powdered substance 44 is stored in the substance storing chamber 40, which substance 44 is inhaled in a portioned output by means of the exemplified arrangement.
  • Dosing chambers 46 are provided for the portioned output of the substance 44, three in the illustrated example embodiment.
  • the size of each dosing chamber 46 defines the output substance quantity.
  • the dosing chambers 46 are formed as cross holes of a centrally along the axis x extending transfer member 48, herein illustrated as comprising a connector 50 attached to the upper end portion of a rod 52 formed as a flat bar.
  • the cross holes go through the broad side wall surfaces of the flat bar, whereby this in cross-section has a width/length ratio from 1 :5 to 1 :20.
  • a flat bar thickness of about 0.5 mm is chosen, with a crosswise measured length of about 3 to 3.5 mm.
  • the diameter of the cross holes is chosen, such that a formed dosing chamber 46 hosts from 0.05 mg to 0.1 mg.
  • the rod 52 goes through the substance storing chamber 40 centrally in the direction of extension of the axis x. At the bottom of the substance storing chamber 40, the rod 52 further goes through the sealing element 26 with the crossing of the airflow passage 28 formed therein, as a result of this embodiment, by means of the rod 52, a closure of the airflow passage 28 is firstly attained.
  • the transfer member 48 comprising the rod 52 extends upwardly via the substance storing chamber 40, with the passing through the rolling bellows 42, which is attached to the connector 50 of the transfer member 48.
  • the dosing chambers 46 evenly spaced to each other and consecutively located in the longitudinal extension of the rod 52, are, in an initial position of the inhaler 2 according to the view of Fig. Ia, positioned in the lower third of the substance storing chamber 40, surrounded by the stored substance 44.
  • the distance between the dosing chambers 46 corresponds substantially approximately to the diameter of a cross hole forming a dosing chamber.
  • the connector 50 extending upwardly from the substance storing chamber 40 has a mushroom-shaped head 54. This is captured by towing arms 56 formed on the underside of the action button 8. Between the towing arms 56, a biasing coil spring 58 extends from the action button 8 to the head 54 of the connector 50.
  • the action button 8 extending substantially transversely to the inhaler axis x merges into a cylindrical section formed concentrically with the axis x and with a pot-shaped wall 60 which, with its opening, is downwardly dipping into the housing 4.
  • the external diameter of the wall 60 is adapted to the internal diameter of the cylindrical housing section 12.
  • the action button 8 is with its wall 60 insertable into the housing 4 when guided through the cylindrical section 12, with stop limitation in every end position.
  • the movement area of the action button 8 is sealed off by a rolling bellows 62 which rolls into a gap between the action button 8 and the housing 4.
  • a circumferential nut is provided in the external mantle wall, for housing a piston ring 64 consisting of an elastomeric material, which for sealing goes towards the inner wall of the cylindrical housing section 12.
  • the initial position of the action button 8 is supported by a return coil spring 66 acting on the underside of the action button 8, which spring 66 surrounds the connector 50 of the transfer member 48 and the towing arms 56 of the action button 8, and is supported at its other side by a holder 68 which holds the upper portion of the substance storing chamber 40 and its associated covering rolling bellows 42.
  • the two concentric coil springs 58, 66 are in their relaxed uncompressed state.
  • wedge-shaped connecting protrusions 70 with upwardly pointing bevels 72 of two diametrically opposite supporting arms 74 which support radially inwardly projecting press pieces 76 in the lower free end region.
  • the arms 74 and the radially inwardly pointing impinging surfaces 78 of the press pieces 76 forming cheeks 80 extend in a horizontal projection respectively in a cross- section through the inhaler 2 parallelly spaced to a broadside surface of the rod 52.
  • the impinging surfaces 78 are positioned turned to the broadside surface of the rod 52, whereby the impinging surfaces 78 are evenly formed.
  • the arms 74, further particularly the hinge region 82 on the circular annular support are, with regard to the choice in material and/or with regard to the material thickness, chosen such that a radial pivoting about the hinge region 82 in the direction of the axis x is allowed.
  • the resilient properties of the chosen plastic material are used for the self-acting return of the arms 74 to the original position.
  • the length of the arms 74, measured in the axial direction, is chosen such that the press pieces 76, provided on the end side, extend approximately at the level of the lower third of the storing chamber 40.
  • the action button 8 When a user pushes the action button 8, it is slidingly lowered into the housing 4 along the axis x, as illustrated in Fig. Ib.
  • the housing 4 and, conditioned by the sealing via the piston ring 64, the pot shaped action button 8 form a compressed-air cylinder C, in which, in connection with the lowering of the action button 8, an air overpressure is produced.
  • the internal underside of the action button 8 forms hereby a piston surface.
  • the connecting protrusions 70 are impinged via the front edge of the wall 60 provided with a chamfer, which with a further lowering of the action button 8 results in a pivoting of the arms 74 about the hinge region 82.
  • the press pieces 76 pivot, in a radial and inward direction, around a radius to the hinge region 82 with the curving of the substance storing chamber wall 84 to the filling position according to the view of Fig. Ib, in which the impinging surfaces 78 reach to parallel orientation to each other and to the broadside surfaces of the rod 52, in which position, at the intermediate position of the storing chamber wall sections, substance portions are pushed into the dosing chambers 46.
  • the action button 8 could be held in the depressed position by a latching means. Alternatively, the user could keep his finger on the depressed action button 8.
  • the inhalation-triggered release mechanism 86 comprises a movable member, herein shown as a flap 88, which is mounted to a circular bearing 90 around which it can pivot.
  • the inhalation-triggered release mechanism 86 further comprises a blade spring 92 urging the flap 88 towards the latching state shown in Figs. Ia-Ib.
  • the bearing 90 is provided with a bore which, in the latching state, is in register with a recess in the mounted end portion of the flap 88.
  • the rod 52 extends through the bore and to the bottom of the recess which forms an abutment surface 94.
  • the abutment surface 94 thus prevents the rod 52 from being displaced under the force of the biasing spring 58.
  • the flap 88 extends from the circular bearing 90 substantially along the axis x and its free end portion is pressed by the blade spring 92 against a projection 96 from the inhaler bottom 14.
  • the flap 88, the projection 86 and the inhaler housing define a first volume Vl on the mouthpiece-side of the flap 88 and a second volume V2 on the opposite side of the flap 88.
  • the first volume Vl is in fluid communication with the mouthpiece 6 via a first opening 98 and the second volume V2 is in fluid communication with the atmosphere surrounding the inhaler 2 via a second grille- formed opening 100.
  • the flap 88 When the user inhales through the mouthpiece 6, an underpressure is established in the first volume Vl and causes the flap 88 to pivot around the circular bearing 90 towards the mouthpiece 6 against the force of the blade spring 92. This is illustrated in Fig. Ic.
  • the flap 88 could in its relaxed state completely separate the first volume Vl from the second volume V2, and as the flap 88 starts opening due to the underpressure, the air will also be enabled to flow from the second volume V2 to the first volume Vl across the flap 88 for further assisting the pivoting of the flap 88.
  • the flap 88 may only partially separate the two volumes Vl, V2, wherein, when a user inhales the underpressure and the flow from the second volume V2 will together cause the flap 88 to open.
  • the pivoting of the flap 88 results in that the recess with its abutment surface 94 is displaced from being in register with the bore, thereby presenting the release mechanism 86 in a releasing state.
  • the rod 52 can under the force of the biasing spring 58 (and gravity) move downwardly along the axis x.
  • a filter (not shown) is provided to reduce the risk of desiccant moving past the flap 88 and into the mouthpiece 6.
  • the filled dosing chambers 46 successively go in overlap to the airflow passage 28.
  • the airflow passage 28 has been slidingly closed by the closing solid portion of the rod 52, enabling the producing of the overpressure in the pressurizable space which comprises the compressed-air cylinder C and the on-the housing-side section of the airflow passage 28.
  • the so formed valve is temporarily opened.
  • the cross hole forming the dosing chamber 46 becomes part of the airflow passage 28.
  • the produced air overpressure causes a blow- type exhaustion of the portioned substance from the dosing chamber 46 to jet this portion into the mouthpiece 6. Since the transfer member 48 in the illustrated example embodiment is provided with three dosing chambers 46, it will consequently have three substance- evacuating positions. According to the arrangement of three consecutively provided dosing chambers 46 in the shown example embodiment, the result is, in dependency of the force of the biasing spring 58, a fast momentary compressed-air supported ejection of the substance portion.
  • the action button 8 By terminating a pushing contact of the action button 8 or releasing it if latched, the action button 8, together with the guided transfer member 48, will return to the initial position under the force produced by the return coil spring 66.
  • the arms 74 having the press pieces 76 are also released and, due to the resilient properties of the chosen material, pivot back to the original position illustrated in Fig. Ia.
  • ambient air is fed in. This via said second opening 100 (possibly also via said first opening 98), the desiccant-containing compartment 36 and the after-flow opening 34.
  • the filter 33 is placed before the valve 38, thereby reducing the risk of desiccant 37 entrained in the air stream reaching the valve 38 and the airflow passage 28. The ambient air thus introduced to the pressurizable space will be used in creating an air overpressure in a subsequent dispensing action.
  • the substance material 44 slides self-actingly after the outer force on the storing chamber wall 84 by means of the press pieces 76 has terminated, whereby through the influence of the storing chamber wall 84 through the curving, such a moving-up of substance is supported by flex leveling.
  • the inhaler 2 particularly the housing 4 and the action button 8 with the wall 60 and the holder 68 with the support 22, may consist of a plastic material, further particularly of a hard-plastic material.
  • the transfer member 48 can comprise such a hard-plastic material.
  • the rod 52 may be made of a metallic material.
  • Fig. 2 illustrates another example embodiment of the invention. Features in Fig. 2 which correspond to the features illustrated in Figs. Ia- Id are represented by the same reference signs.
  • the example embodiment illustrated in Fig. 2 resembles to the example embodiment illustrated in Fig. 1, however, there are some differences.
  • the example embodiment illustrated in Fig. 2 does not comprise an inhalation-triggered release mechanism.
  • the transfer member 48 can travel downwardly inside a tubular guide 120 provided in the desiccant-containing compartment 36.
  • the tubular guide 120 is surrounded by desiccant 37 and extends between the sealing element 26 and the inhaler bottom 14.
  • the desiccant-containing compartment 36 is in fluid communication with the outside of the inhaler through an opening 122 in the mouthpiece 6.
  • Air inflow openings 124 are formed in the mouthpiece wall evenly distributed along a periphery line, thereby enabling an airflow through the mouthpiece 6 as the user inhales.
  • the example embodiment illustrated in Fig. 2 does not have a biasing coil spring 58.
  • the towing arms 56, capturing the head 54 are shorter, however, the towing arms 56 have a length which exceeds (e.g. approximately twice or treble) the length of the head 54 in the extending direction of the axis x.
  • an idling is provided between the top of the head 54 facing the action button 8 and the underside of the action button 8.
  • the substance 44 will be pushed into the dosing chambers 46 (as explained for the embodiment illustrated in Figs. Ia- Id), while the transfer member 48 remains in its initial position.
  • the underside of the action button 8 contacts the head 54 of the transfer member 48, for the movement of the transfer member 48 upon further downward displacement of the action button 8.
  • the dosing chambers 46 will then be evacuated as previously explained.
  • air is fed in via the opening 122 and the after- flow opening 34, with a through flow of desiccant 37.
  • the after- flow opening 34 is provided with the previously explained filter 33 and valve 38.
  • the drawings have been provided for non- limiting illustrative purposes. Consequently, alternative embodiments are conceivable.
  • the filter may be provided elsewhere, e.g. as a net around the desiccant, in order to perform said function of reducing the risk of desiccant clogging the valve or entering the air flow passage.
  • the illustrated transfer member could instead of a rod comprise another geometrically-shaped component as previously discussed.
  • release mechanisms may be provided than those illustrated in Figs. Ia- Id.
  • a release mechanism comprising a flap
  • other movable members such as a diaphragm or a sliding piston.
  • other types of biasing mechanisms may be provided instead of the illustrated one which comprises an action button and spring.
  • the size and number of dosing chambers may be varied, and a mechanism may be provided for adjusting how many of the dosing chambers will be presented to the airflow passage during firing of the inhaler.

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Abstract

L'invention se rapporte à un inhalateur pour une substance pulvérulente. L'inhalateur comprend un passage d'écoulement d'air qui sert à guider une substance en direction d'un orifice de sortie, une chambre de stockage de substance à partir de laquelle une substance est transmise au passage d'écoulement d'air, un espace pouvant être mis sous pression pour établir une surpression d'air dans le passage d'écoulement d'air afin de distribuer une substance présente dans le passage d'écoulement d'air à l'orifice de sortie, un compartiment contenant un agent de dessiccation à partir duquel de l'air peut s'écouler vers l'espace pouvant être mis sous pression afin de renouveler l'air expulsé, et un filtre disposé dans le compartiment contenant un agent de dessiccation. L'air s'écoulant du compartiment contenant un agent de dessiccation jusqu'à l'espace pouvant être mis sous pression passe à travers le filtre.
PCT/SE2008/050948 2007-08-24 2008-08-22 Inhalateur pour des substances pulvérulentes ayant un compartiment contenant un agent de dessiccation Ceased WO2009029029A1 (fr)

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US95781907P 2007-08-24 2007-08-24
US60/957,819 2007-08-24

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014161901A1 (fr) * 2013-04-03 2014-10-09 Sanofi Sa Élément de dosage pour un dispositif d'inhalation et ensemble destiné à un dispositif d'inhalation comprenant un élément de dosage
US9179691B2 (en) 2007-12-14 2015-11-10 Aerodesigns, Inc. Delivering aerosolizable food products
US11090294B2 (en) 2009-12-01 2021-08-17 Glaxo Group Limited Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
US11116721B2 (en) 2009-02-26 2021-09-14 Glaxo Group Limited Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl) phenol
CN113613671A (zh) * 2019-03-29 2021-11-05 伊莱利利公司 药物递送系统和方法
JP2022510930A (ja) * 2018-11-30 2022-01-28 アプター フランス エスアーエス 吸気同期式の流体投与装置
US11331442B2 (en) * 2017-10-09 2022-05-17 Pearl Therapeutics, Inc. Drug delivery systems and related methods
US20230029033A1 (en) * 2017-02-14 2023-01-26 Norton (Waterford) Limited Inhalers and Related Methods

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Publication number Priority date Publication date Assignee Title
WO1994027662A1 (fr) * 1993-05-24 1994-12-08 Bon F Del Inhalateur
WO2004009168A1 (fr) * 2002-07-22 2004-01-29 Alfred Von Schuckmann Inhalateur a actionnement manuel pour substances pulverulentes
DE102006029753A1 (de) * 2006-03-10 2007-09-13 Alfred Von Schuckmann Inhalator für pulverförmige Substanzen

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994027662A1 (fr) * 1993-05-24 1994-12-08 Bon F Del Inhalateur
WO2004009168A1 (fr) * 2002-07-22 2004-01-29 Alfred Von Schuckmann Inhalateur a actionnement manuel pour substances pulverulentes
DE102006029753A1 (de) * 2006-03-10 2007-09-13 Alfred Von Schuckmann Inhalator für pulverförmige Substanzen

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9179691B2 (en) 2007-12-14 2015-11-10 Aerodesigns, Inc. Delivering aerosolizable food products
US11116721B2 (en) 2009-02-26 2021-09-14 Glaxo Group Limited Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl) phenol
US11090294B2 (en) 2009-12-01 2021-08-17 Glaxo Group Limited Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
US12396986B2 (en) 2009-12-01 2025-08-26 Glaxo Group Limited Combinations of a muscarinic receptor antagonist and a β-2 adrenoreceptor agonist
WO2014161901A1 (fr) * 2013-04-03 2014-10-09 Sanofi Sa Élément de dosage pour un dispositif d'inhalation et ensemble destiné à un dispositif d'inhalation comprenant un élément de dosage
US20230029033A1 (en) * 2017-02-14 2023-01-26 Norton (Waterford) Limited Inhalers and Related Methods
US11793953B2 (en) * 2017-02-14 2023-10-24 Norton (Waterford) Limited Inhalers and related methods
US11331442B2 (en) * 2017-10-09 2022-05-17 Pearl Therapeutics, Inc. Drug delivery systems and related methods
EP4091652B1 (fr) 2017-10-09 2023-11-29 Pearl Therapeutics, Inc. Dispositif d'administration d'aérosol
US11833292B2 (en) 2017-10-09 2023-12-05 Pearl Therapeutics, Inc. Drug delivery systems and related methods
JP2022510930A (ja) * 2018-11-30 2022-01-28 アプター フランス エスアーエス 吸気同期式の流体投与装置
JP7459096B2 (ja) 2018-11-30 2024-04-01 アプター フランス エスアーエス 吸気同期式の流体投与装置
US11938089B2 (en) 2019-03-29 2024-03-26 Amphastar Pharmaceuticals, Inc. Medication delivery systems and methods
CN113613671A (zh) * 2019-03-29 2021-11-05 伊莱利利公司 药物递送系统和方法

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