WO2002089875A1 - Dispositif - Google Patents

Dispositif Download PDF

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Publication number
WO2002089875A1
WO2002089875A1 PCT/GB2002/002098 GB0202098W WO02089875A1 WO 2002089875 A1 WO2002089875 A1 WO 2002089875A1 GB 0202098 W GB0202098 W GB 0202098W WO 02089875 A1 WO02089875 A1 WO 02089875A1
Authority
WO
WIPO (PCT)
Prior art keywords
deaggregation
powder
medicament
chamber
delivery device
Prior art date
Application number
PCT/GB2002/002098
Other languages
English (en)
Other versions
WO2002089875A8 (fr
Inventor
Philip Braithwaite
Original Assignee
Innovata Biomed Limited
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 Innovata Biomed Limited filed Critical Innovata Biomed Limited
Publication of WO2002089875A1 publication Critical patent/WO2002089875A1/fr
Publication of WO2002089875A8 publication Critical patent/WO2002089875A8/fr

Links

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
    • A61M15/0065—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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/001—Particle size control
    • 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
    • A61M11/001—Particle size control
    • A61M11/003—Particle size control by passing the aerosol trough sieves or filters
    • 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
    • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
    • A61M2205/103—General characteristics of the apparatus with powered movement mechanisms rotating
    • 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
    • A61M2205/75—General characteristics of the apparatus with filters

Definitions

  • This invention relates to a novel deaggregation system, to novel delivery devices related thereto and to novel methods of treatment.
  • DPIs Dry Powder Inhalers
  • the inhaler described in this patent specification comprises a body defining a storage chamber for the substance to be delivered and further defining an inhalation passage through which air is drawn via a mouthpiece.
  • a metering member operates to transfer a volumetric dose of the substance from the storage chamber to the inhalation passage.
  • the metering member is provided with dispensing cups and is moveable between a first position in which a dispensing cup is presented to the storage chamber to receive a dose of the substance to a second position in which a dose of the substance is presented to the inhalation passage.
  • the powder which is located in such dry powder inhalers may typically be a mixture of the medicament itself and a carrier material such as lactose.
  • a carrier material such as lactose.
  • lactose assists the free flow of the drug which might otherwise tend to agglomerate or adhere to the internal surfaces of the inhaler.
  • WO-A-92/05825 describes a dry powder inhaler which includes a dispensing chamber into which the powder is introduced in operation.
  • the dispensing chamber is connected via a duct to a mouth-piece through which the patient may inspire so as to cause air to flow through the chamber, the duct and then the mouthpiece.
  • a stationary plate substantially transverse to the flow direction through the duct.
  • devices such as those described in WO-A-92/05825 rely on one or more plates or baffles within the device to break up, or slow the progress of larger particles.
  • the small particles are able to change direction rapidly with the air flow and therefore pass through the device.
  • a disadvantage of such a device is that its effectiveness depends on the period during which air is drawn through the device and the velocity of the air. There is a need for a device which is effective regardless of the air flow time and the air flow velocity.
  • Air/powder mixture is withdrawn from the cyclone chamber by way of an outlet which is orthogonal to the inlet and lies on the axis of the cylindrical chamber.
  • This arrangement is intended to select the smaller particles for inhalation.
  • a comparable system is described in GB-A-1478138 which shows a powder inhaler provided with air inlets so arranged as to create a vortex within a powder storage chamber in order to trap heavier particles within the storage chamber while allowing lighter particles to escape into a housing for inhalation: this housing has air inlets adapted to create a vortex within the housing, which serves to throw heavier particles near to the wall of the housing than lighter particles so that they can be trapped and held back from leaving the housing.
  • US-5 301 666 discloses a dry powder inhaler comprising a storage chamber and an inhalation passage, a mouthpiece having an inlet and an outlet and defining a flow duct having straight slits which lead into a cyclone chamber.
  • baffle systems and cyclone systems can serve two purposes. Firstly to break down agglomerated particles and secondly to trap agglomerates that have not been broken down.
  • the design of such system for maximum efficiency in either of these respects is made more difficult by the limited nature of the power of suction that a typical patient is capable of applying to the mouthpiece. This difficulty is especially noticeable in the case of a cyclone system because the efficiency of a cyclone separator is dependent on the speed of circulation of the air/powder mixture, a speed which is largely determined by the velocity with which the air/powder mixture enters the cyclone chamber.
  • a powder deaggregation device which comprises a delivery channel provided at an outlet end with a mouthpiece and an inlet end wherein the inlet end is provided with a deaggregation chamber system comprising a moveable deaggregation element wherein the deaggregation element is one which permits the deaggregated powder to pass through the element.
  • the deaggregation chamber may comprise a substantially conical or a frusto conical chamber.
  • a chamber may comprise a powder inlet, e.g. at the cone end of the chamber.
  • the outlet may thus be provided at the end of the chamber distal to powder inlet end.
  • the deaggregation element may be substantially conical or frusto conical in shape.
  • the gap between deaggregation element and the inner walls of the deaggregation chamber may be varied.
  • optimum deaggregation may be achieved by using a gap spacing of from 0.5 to 2.0 mm, preferably 1.0 mm.
  • the deaggregation element is one which permits the deaggregated powder to pass through the element, for example, in the form of a filter.
  • a preferred deaggregation element is a wire mesh, for example, a wire mesh which possesses a mesh size of from 10 to 1000 ⁇ m.
  • the dynamic nature of the deaggregation system of the invention allows particles of the correct size to pass through the system, e.g. on "first pass” or to be deagglomerated on first pass.
  • static deaggregation elements will generally allow a "first pass”.
  • one advantage of the deaggregation system of the invention is that an aggregated particle will be subjected to multiple opportunities to pass through the deaggregation element or be deagglomerated.
  • the dynamics of the deaggregation system also mean that the deaggregation element will remain substantially "clean” and powder retention and/or build up will be minimised.
  • the deaggregation element e.g. the substantially conical deaggregation element may be moveable.
  • the movement of the deaggregation element may movement relative to and/or within the deagglomeration chamber. This, for example, such movement may be linear or, preferably, may be rotary.
  • Such rotary movement may be complete rotation, e.g. a spinning element, or an oscillating rotation.
  • the movement may comprise oscillation through 360° or less e.g. 180°.
  • the rotation of the deaggregation element may comprise a simple oscillating rotation or the deaggregation element may be caused to spin, i.e. revolve.
  • the delivery channel will also comprise the spindle about which the deaggregation element rotates.
  • the inlet end of the deagglomeration chamber may comprise a chamber for receiving a metering member.
  • a metering member Any conventionally known metering member may be used, e.g. a powder blister, capsule, spool, etc.
  • the metering member comprises a spool, such as is described in International Patent Application WO 93/16748 (Technohaler).
  • the metering member is of such dimensions as to be able to pass into the inhalation passage.
  • the metering member may comprise those described in WO 93/16748.
  • the metering member may comprise a spool housed in a spool carrier.
  • the spool carrier acts as a conduit for the spool to communicate with the inhalation passage.
  • the spool will be provided with a flange at each end such that the flanges are in sealing engagement with the inner walls of the conduit and a space exists between the inner walls of the conduit and the non-flanged portion of the spool. In the filled metering member, the space is taken up by a measured dosage of medicament.
  • the plug, flanges and conduit are so dimensioned so as to predetermine the amount of medicament available.
  • the metering member may comprise a medicament container with a closed end and an open end, a cap adapted to abut the open end of the container and a sleeve adapted to overlap the open end of the container and the cap.
  • Reference hereinafter to a spool and spool carrier is intended to encompass a capped cartridge as hereinbefore described.
  • the powder inlet end may also comprise an air inlet.
  • an air inlet may facilitate the aerosolisation of the powder.
  • the deagglomeration system of the invention is advantageous in that, inter alia, the powder, once deaggregated, passes through the deaggregation system.
  • the system provides improved efficiency of deagglomeration and reduces powder retention in the device.
  • a delivery device e.g a medicament delivery device comprising a deaggregation device as hereinbefore described.
  • a delivery device comprising a medicament reservoir, a metering member and a delivery channel characterised in that the delivery device comprises a deaggregation device as hereinbefore described.
  • the delivery device of the invention may comprise any conventionally known medicament device.
  • the deaggregation device of the present invention is especially suited for use as an inhaler, including, for example, a DPI, an insufflator and a nebuliser.
  • oral administration is referred to, it would be well understood by the skilled man that the delivery device may be suitable for use in relation to other routes of administration, e.g. nasal administration.
  • the inhaler of the invention may comprise a DPI.
  • the delivery device of the invention comprises an inhaler
  • air may be drawn through the air inlet and consequently through the powder and mesh filter aerosolising the powder.
  • the entrainment air flow maybe generated by, for example, inhalation by a patient.
  • the entrainment air flow may be generated by an air amplification system such as is described in our copending UK Patent Application No. 0112888.3.
  • the inhaler may optionally include a conventionally known breath actuated mechanism.
  • the deaggregation element of the invention may be actuated separately, simultaneously or sequentially with such breath actuated mechanism.
  • the particle size of the medicament may be varied depending, inter alia, on the type of aerosol being formed.
  • the particle size of the medicament, and the carrier, if one is present, may be varied.
  • the nature of the carrier may also be varied.
  • the particle size of the medicament may be substantially between 1 and 100 ⁇ m. That is, at least 90% w/w of the medicament should have a particle size of between 1 and 100 ⁇ m.
  • the preferred particle size may also depend upon the nature of the medicament being delivered. Thus, for example, for the treatment of respiratory disorders a particle size of 4 to 8 ⁇ m may be preferred, e.g. 6 ⁇ m. However, for the delivery of systematically active medicaments a smaller particle size may be desirable, for example from 1 to 5 ⁇ m, e.g. 3 ⁇ m.
  • a variety of carriers may be used.
  • Certain carriers may be mentioned, by way of example only, such as sugars, e.g. dextran, mannitol and lactose, for example ⁇ -lactose monohydrate.
  • the particle size of the carrier may be across a wide range, between 0.1 and 500 ⁇ m, preferably between 1 and 200 ⁇ m, more preferably between 1 and 100 ⁇ m and especially between 1 and 20 ⁇ m.
  • the carrier may itself comprise a mixture of fine and coarse particles.
  • a method of treating a patient with a respiratory disorder which comprises administering a therapeutically effective amount of a medicament using an inhaler as hereinbefore described.
  • a method of drug delivery to a patient which comprises administering a medicament to a patient suffering a respiratory disorder which comprises administering a therapeutically effective amount of a medicament using an inhaler as hereinbefore described.
  • the inhaler of the invention is advantageous in that, inter alia, it enables the delivery of dispersions of finely divided forms of medicament and avoids some if the disadvantageous of agglomeration experienced with some known DPIs and/or the inhaler delivers an increased respirable fraction to the lungs of a patient.
  • medicaments may be administered by using the inhaler of the invention, such medicaments may have a systemic or non-systemic activity on the patient.
  • medicaments are generally (but not limiting) drugs for the treatment of asthma and chronic obstructive pulmonary disease and respiratory inventions, such as antibiotics, bronchodilators or other anti-asthma drugs.
  • medicaments include, but are not limited to J3 2 -agonists, e.g.
  • fenoterol formoterol, pirbuterol, reproterol, rimiterol, salbutamol, salmeterol and terbutaline
  • non-selective beta-stimulants such as isoprenaline xanthine bronchodilators, e.g. theophylline, aminophylline and choline theophyllinate
  • anticholinergics e.g. ipratropium bromide
  • mast cell stabilisers e.g. sodium cromoglycate and ketotifen
  • bronchial anti-inflammatory agents e.g. nedocromil sodium
  • steroids e.g. beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations thereof.
  • medicaments which may be mentioned include combinations of steroids, such as, beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations of to ⁇ 2 -agonists, such as, formoterol and salmeterol. It is also within the scope of this invention to include combinations of one or more of the aforementioned steroids with one or more of the aforementioned ⁇ 2 -agonists.
  • a method of treating a patient with a respiratory disorder which comprises administering a therapeutically effective amount of a medicament using an inhaler as hereinbefore described.
  • medicaments which may be mentioned include systemically active materials, such as, protemaceous compounds and/or macromolecules, for example, leuprolide and alpha interferon; growth factors, anticoagulants, immunomodulators, cytokines, nucleic acids, hormones, such as insulin human growth hormone and parathyroid hormone.
  • systemically active materials such as, protemaceous compounds and/or macromolecules, for example, leuprolide and alpha interferon
  • growth factors such as, anticoagulants, immunomodulators, cytokines, nucleic acids, hormones, such as insulin human growth hormone and parathyroid hormone.
  • Figure 2 is a schematic cross-section of a deaggregation device of the invention with metering member being inserted;
  • Figure 3 is schematic cross-section of a deaggregation device with metering member inserted and medicament being dispensed
  • Figure 4 is a schematic cross-section of a deaggregation device of the invention with powder being aerolised.
  • a deaggregation device (1) comprises an inhalation channel (2) provided with a powder inlet (3) and a powder outlet (4).
  • the inlet end (3) is positioned adjacent a cone shaped deaggregation chamber (5) and is fitted with a conical, wire mesh (6).
  • the conical deaggregation element (6) fits within the deaggregation chamber (5) to provide a deaggregation cavity (7).
  • the conical end of the deaggregation chamber (5) is provided with a powder inlet (9).
  • the powder inlet (9) comprises an inlet channel (10) and an inlet aperture (11), the inlet aperture (11) being positioned at the end (8) of the deaggregation chamber (5).
  • the surface (12) of the inlet channel (9) opposite the inlet aperture (11) is provided with an air inlet (13).
  • the end (14) of the conical deaggregation chamber (5) distal to the conical end (5) is provided with, an annular shoulder (15) which is adapted to support the conical filter (6).
  • the powder inlet end (3) of the inhalation channel (2) may be provided with a circumferential lip (16) which is adapted to form a snug fit with the shoulder (15).
  • the outlet end (4) of the inhalation channel (2) is provided with a bearing (17) which is adapted to fit into a recess (18) of a shaft (19).
  • the inhalation channel (2) is adapted to act as a rotary spindle.
  • the shaft (19) may also be provided with a top-plate (2) and a second bearing (21) which is adapted to rest in recess (22) of the top-plate (20).
  • the spool (24) is provided with powdered medicament (25).
  • the spool (24) is inserted into the inlet channel (10) until the spool (24) is coincident with the inlet aperture (11) and the air inlet (13).
  • the spindle (2) is rotated by a motor (not shown) and a patient inhales at a mouthpiece (not shown) adjacent the powder outlet end (4). Air is drawn through the air inlet (13) to aerosolise the powder (25). Fine particles of the powder

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Medicinal Preparation (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne un dispositif de désagrégation de poudre. Ce dispositif comprend un canal d'administration présentant une embouchure au niveau d'une extrémité d'orifice de sortie, ainsi qu'une extrémité d'orifice d'admission, celle-ci étant équipée d'un système de désagrégation comprenant un élément de désagrégation mobile. L'invention concerne également un dispositif d'administration de médicament, par exemple, un inhalateur, comprenant un tel système de désagrégation de poudre, ainsi qu'une méthode de traitement associée.
PCT/GB2002/002098 2001-05-10 2002-05-10 Dispositif WO2002089875A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0111330.7 2001-05-10
GB0111330A GB0111330D0 (en) 2001-05-10 2001-05-10 Device

Publications (2)

Publication Number Publication Date
WO2002089875A1 true WO2002089875A1 (fr) 2002-11-14
WO2002089875A8 WO2002089875A8 (fr) 2003-03-06

Family

ID=9914295

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2002/002098 WO2002089875A1 (fr) 2001-05-10 2002-05-10 Dispositif

Country Status (2)

Country Link
GB (1) GB0111330D0 (fr)
WO (1) WO2002089875A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2653181A1 (fr) * 2010-12-17 2013-10-23 Qingtang Chen Embout buccal de médicament en poudre et son utilisation
WO2016108055A3 (fr) * 2014-12-30 2016-10-06 Kokai Tamás Unité pour la micronisation et le dosage d'agents actifs solides

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2709071C (fr) 2007-12-14 2016-11-15 Labogroup S.A.S. Administration de produits alimentaires sous forme d'aerosols

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1478138A (en) 1973-07-18 1977-06-29 Beecham Group Ltd Device for the administration of powders
WO1992005825A1 (fr) 1990-10-02 1992-04-16 United Kingdom Atomic Energy Authority Inhalateur de poudre
EP0539469A1 (fr) 1990-07-13 1993-05-05 Philip Wilson Braithwaite Inhalateur.
WO1993016748A2 (fr) 1992-02-21 1993-09-02 Innovata Biomed Limited Dispositif de dosage
US5301666A (en) 1991-12-14 1994-04-12 Asta Medica Aktiengesellschaft Powder inhaler
EP0605719A1 (fr) * 1992-06-01 1994-07-13 Kawasaki Jukogyo Kabushiki Kaisha Dispositif de traitement des gaz d'echappement
WO1995028192A1 (fr) 1994-04-14 1995-10-26 Dura Pharmaceuticals, Inc. Inhalateur a poudre seche
US5645051A (en) * 1995-04-21 1997-07-08 Dura Pharmaceuticals, Inc. Unit dose dry powder inhaler
GB2354451A (en) * 1999-07-27 2001-03-28 Vectura Ltd Inhalers

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1478138A (en) 1973-07-18 1977-06-29 Beecham Group Ltd Device for the administration of powders
EP0539469A1 (fr) 1990-07-13 1993-05-05 Philip Wilson Braithwaite Inhalateur.
WO1992005825A1 (fr) 1990-10-02 1992-04-16 United Kingdom Atomic Energy Authority Inhalateur de poudre
US5301666A (en) 1991-12-14 1994-04-12 Asta Medica Aktiengesellschaft Powder inhaler
WO1993016748A2 (fr) 1992-02-21 1993-09-02 Innovata Biomed Limited Dispositif de dosage
EP0605719A1 (fr) * 1992-06-01 1994-07-13 Kawasaki Jukogyo Kabushiki Kaisha Dispositif de traitement des gaz d'echappement
WO1995028192A1 (fr) 1994-04-14 1995-10-26 Dura Pharmaceuticals, Inc. Inhalateur a poudre seche
US5645051A (en) * 1995-04-21 1997-07-08 Dura Pharmaceuticals, Inc. Unit dose dry powder inhaler
GB2354451A (en) * 1999-07-27 2001-03-28 Vectura Ltd Inhalers

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2653181A1 (fr) * 2010-12-17 2013-10-23 Qingtang Chen Embout buccal de médicament en poudre et son utilisation
US20130333699A1 (en) * 2010-12-17 2013-12-19 Qingtang Chen Powder medicament mouthpiece and application
JP2014502522A (ja) * 2010-12-17 2014-02-03 ▲陳▼▲慶▼堂 粉末薬物用のマウスピースおよび応用例
EP2653181A4 (fr) * 2010-12-17 2014-08-27 Qingtang Chen Embout buccal de médicament en poudre et son utilisation
US9610413B2 (en) * 2010-12-17 2017-04-04 Leqing Kanghua Medical Supplies Co., Ltd. Powder medicament mouthpiece and application
WO2016108055A3 (fr) * 2014-12-30 2016-10-06 Kokai Tamás Unité pour la micronisation et le dosage d'agents actifs solides
US20180021527A1 (en) * 2014-12-30 2018-01-25 Tamas KOKAI Unit for the micronization and dosage of solid active agents
EP3650007A1 (fr) * 2014-12-30 2020-05-13 Kókai, Tamás Unité pour la micronisation et le dosage d'agents actifs solides

Also Published As

Publication number Publication date
WO2002089875A8 (fr) 2003-03-06
GB0111330D0 (en) 2001-07-04

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