WO2015110832A1 - Inhalateur - Google Patents

Inhalateur Download PDF

Info

Publication number
WO2015110832A1
WO2015110832A1 PCT/GB2015/050163 GB2015050163W WO2015110832A1 WO 2015110832 A1 WO2015110832 A1 WO 2015110832A1 GB 2015050163 W GB2015050163 W GB 2015050163W WO 2015110832 A1 WO2015110832 A1 WO 2015110832A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
chamber
inhaler
deagglomeration
pharmaceutical
Prior art date
Application number
PCT/GB2015/050163
Other languages
English (en)
Inventor
David Stuart Harris
Oliver Harvey
Original Assignee
Team Holdings (Uk) 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 Team Holdings (Uk) Limited filed Critical Team Holdings (Uk) Limited
Publication of WO2015110832A1 publication Critical patent/WO2015110832A1/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
    • A61M15/0086—Inhalation chambers
    • 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
    • A61M15/0003—Details of inhalators; Constructional features thereof with means for dispensing more than one drug
    • 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
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators 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
    • 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
    • A61M11/002—Particle size control by flow deviation causing inertial separation of transported particles
    • 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
    • A61M15/0005—Details of inhalators; Constructional features thereof with means for agitating the medicament
    • 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
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators 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
    • A61M15/0033—Details of the piercing or cutting means
    • A61M15/0035—Piercing means
    • 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
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators 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
    • A61M15/0033—Details of the piercing or cutting means
    • A61M15/0038—Cutting means
    • 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
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/14—Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
    • 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
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/16—Rotating swirling helical flow, e.g. by tangential inflows

Definitions

  • the invention relates to a medical apparatus and method, and in particular to an inhaler for delivering a powdered medicament to a user, and a method for delivering such a powdered medicament.
  • a powdered medicaments or medicines are supplied in pharmaceutical capsules.
  • Such capsules are typically made of gelatine, and contain and protect the medicament.
  • the medicament is typically in the form of an active pharmaceutical ingredient (API) packaged in the capsule together with an inert carrier powder, such as a lactose powder.
  • An API powder is typically of particle size 2 to 5 micrometers, and constitutes between 1 and 5 wt% of the contents of a capsule.
  • the carrier powder is typically of much larger particle size.
  • a lactose carrier powder is typically of particle size 70 to 100
  • capsules of this type are designed for use with a capsule dry powder inhaler (cDPI), for entraining the powder contents of a capsule into an air stream or air flow for inhalation by a patient or user.
  • cDPI capsule dry powder inhaler
  • the invention may thus provide an inhaler, such as a cDPI, for use with a pharmaceutical capsule containing an API and a carrier powder.
  • an inhaler may thus be operable with a pharmaceutical contained in a capsule but may not, for example, be suitable for use with a pharmaceutical contained in a blister or provided in other forms.
  • the inhaler may comprise a pharmaceutical capsule opener for opening the capsule for extraction of the capsule contents.
  • the inhaler may comprise an inhaler inlet, preferably open to the atmosphere to allow air to be drawn into the inhaler.
  • the inlet is upstream of a capsule chamber for, in use, retaining at least a part of an opened pharmaceutical capsule.
  • the inhaler may comprise one or more capsule chambers. If only one is present, then the opened capsule is advantageously retained in, or opening into, the chamber. If more than one capsule chamber is present, then each may retain a part of the opened capsule.
  • a typical capsule may be separated into two capsule portions, by sliding the capsule portions apart. Both capsule portions may be retained in one capsule chamber or, preferably, each capsule portion may be retained in a respective one of two capsule chambers.
  • the (or each) capsule chamber operates, while a user inhales through the inhaler, to allow extraction of the API and the carrier powder from the opened capsule.
  • the inhaler advantageously further comprises a deagglomeration chamber downstream of the capsule chamber for, during inhalation, acting to deagglomerate at least a portion of the API from the carrier particles, such as more than 10%, or 20%, or 30% or more of the API.
  • a deagglomeration chamber downstream of the capsule chamber for, during inhalation, acting to deagglomerate at least a portion of the API from the carrier particles, such as more than 10%, or 20%, or 30% or more of the API.
  • deagglomeration chamber may advantageously be in the form of a swirl chamber, or through-flow or axial-flow cyclone chamber, preferably in the form of a converging axial-flow cyclone.
  • a patient or user inhales air through the inhaler, from the inhaler inlet through the capsule chamber and the deagglomeration chamber, and out through an inhaler outlet downstream of the
  • the inhaler outlet may comprise or be coupled to a mouthpiece.
  • the inhaler when a quantity of inspiratory energy (or power) is applied by a user drawing air through the inhaler, the inhaler is designed such that a first portion of the available energy (or power) is used, or acts, in the capsule chamber to extract the powder from the capsule, and a second portion of the available energy (or power) is used, or acts, in the deagglomeration chamber to encourage detachment of the API from the carrier powder and aerosolisation of the API for inhalation.
  • a first portion of the available energy (or power) is used, or acts, in the capsule chamber to extract the powder from the capsule
  • a second portion of the available energy (or power) is used, or acts, in the deagglomeration chamber to encourage detachment of the API from the carrier powder and aerosolisation of the API for inhalation.
  • a second portion of the available energy (or power) is used, or acts, in the deagglomeration chamber to encourage detachment of the API from the carrier powder and aerosolisation of the API for
  • the efficiency of an inhaler can be expressed in terms of the percentage of the API contained in the capsule which is effectively separated from the carrier powder and aerosolised for delivery to a user's lungs. In a conventional inhaler, efficiencies of 15% to 20% may commonly be achievable, because approximately 15% to 20% of a typical API readily separates from, or falls off, the carrier powder. To increase the efficiency of an inhaler to levels above 15% to 20% is more difficult.
  • the second portion of the inspiratory energy, which is used or absorbed in the deagglomeration chamber for separating the API from the carrier powder is at least one third of the total inspiratory energy.
  • the second portion of the energy may be greater than 0.5, 0.6, 0.7 or even 0.75 of the total inspiratory energy, in order to increase the overall efficiency of the inhaler.
  • a sufficient portion of the inspiratory energy may be used or absorbed in the capsule chamber (or chambers) to extract the powder from the capsule. It is preferred that this first portion is more than 5%, 10%, 15%, 20% or 25% and/or less than 20%, 25%, 30% or 35% of the available energy.
  • any portion of the available energy not used, or absorbed, in portions of the inhaler other than the capsule chamber and the deagglomeration chamber is preferably minimised, for example being less than 5% or 10% or 15% of the available energy. This may be achieved by minimising changes in pressure or momentum of the airflow in any portion of the inhaler other than in the capsule chamber and in the deagglomeration chamber.
  • the inhaler preferably comprises one or more air inlets leading to the capsule chamber or chambers, and directs all air passing through the capsule chamber(s) to the deagglomeration chamber before delivery to the patient using the inhaler.
  • the capsule chamber(s) and the capsule chamber(s) are preferably comprise one or more air inlets leading to the capsule chamber or chambers, and directs all air passing through the capsule chamber(s) to the deagglomeration chamber before delivery to the patient using the inhaler.
  • deagglomeration chamber are preferably connected in series, with no air inlets leading to the deagglomeration chamber without first having passed through a capsule chamber and/or with no air passages bypassing the capsule chamber(s) or the deagglomeration chamber. If more than one capsule chamber is present they may be connected in series or, preferably, in parallel.
  • the structure of the chambers within the inhaler is designed so as to achieve the desired energy split between the chambers, automatically on inhalation.
  • the inspiratory energy is used almost entirely to extract the powder from the capsule rather than in another portion of the inhaler (a separate chamber) to detach the API from the carrier powder.
  • the portion of the inspiratory energy used in the deagglomeration chamber may be expressed as follows.
  • inspiratory energy is applied by a user drawing air through the inhaler inlet, the capsule chamber, the deagglomeration chamber and the inhaler outlet
  • the user When inspiratory energy is applied by a user drawing air through the inhaler inlet, the capsule chamber, the deagglomeration chamber and the inhaler outlet, the user generates an inlet pressure (P,) at the inhaler inlet, an outlet pressure (P 0 ) at the inhaler outlet, and an intermediate pressure (P int ) between the capsule chamber and the deagglomeration chamber.
  • Pin t -Po the inhaler inlet
  • P 0 outlet pressure
  • P int intermediate pressure
  • P int involves an assumption that any pressure drop between the capsule chamber outlet and the deagglomeration chamber inlet is negligible.
  • any energy absorbed in any channel or passage between the capsule chamber and the deagglomeration chamber is to be minimised by the inhaler design, as described above, and as the pressures in the inhaler may vary to some extent during inhalation, this is a reasonable assumption. If any energy absorbed in any such channel passage link were to be assessed in more detail, then a pressure at an exit from the capsule chamber and a pressure at an entrance to the deagglomeration chamber would have to be considered.
  • the inhaler preferably comprises a capsule opener, or capsule opening means or apparatus.
  • This may comprise a means for piercing or cutting the capsule.
  • a conventional pharmaceutical capsule comprises two portions, or halves, slidingly engaged with each other, and the capsule opener advantageously operates by separating the capsule portions or capsule halves.
  • the inhaler comprises two portions which are slidable or movable relative to one another, each inhaler portion gripping one end of the capsule so as to separate the two capsule portions.
  • the capsule portions may be separated by bending the capsule.
  • an inhaler may comprise two capsule chambers, each capsule portion of an opened capsule preferably being retained in a respective capsule chamber.
  • the opened capsule may be held in a fixed position within the or each capsule chamber but is preferably free to move within the or each capsule chamber.
  • Air flow through the capsule chamber or chambers then removes the powder contents from the capsule.
  • an air inlet opens tangentially into the or each capsule chamber so as to set up a rotating flow of air within the capsule chamber, for example causing an opened capsule to tumble or spin so that the contents fall out.
  • the deagglomeration chamber may comprise baffles against which the powder may impact.
  • any change in the momentum of the air flow leaving the or each capsule chamber for example tangentially if the capsule chamber contains a rotating flow of air, is minimised in directing the air flow into the deagglomeration chamber, so as to minimise any pressure drop between an exit from the capsule chamber and an entry to the deagglomeration chamber.
  • Figure 1 is a three-quarter view of an inhaler according to a first embodiment of the invention, ready for inhalation;
  • Figure 2 is a three-quarter view of the inhaler of Figure 1 in an open position for loading with a pharmaceutical capsule;
  • Figure 3 is a three-quarter view of the inhaler of Figures 1 and 2, illustrating the air flow within the inhaler, during use;
  • an open-ended slot 32, 34 is provided into which a pharmaceutical capsule 36 may be urged.
  • a conventional capsule is in the form of two blind-ended, cylindrical capsule portions, each moulded with a hemispherical closure at one end. During manufacture, the capsule is formed by sliding the open ends of two such capsule portions together, one inside the other. The widths of the slots are smaller than the diameter of the capsule, so that a central cylindrical portion of the capsule is gripped, or pinched, by both slots when the inhaler mouldings are closed together.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne un inhalateur (2), qui est destiné à être utilisé avec une capsule pharmaceutique (36) contenant un principe pharmaceutique actif (API) et une poudre porteuse. L'inhalateur (2) comprend un organe d'ouverture de capsule, une chambre de capsule (12) pour retenir une capsule ouverte (36), et une chambre de désagglomération (16) pour détacher au moins une partie de l'API de la poudre porteuse. Lorsqu'un utilisateur inspire à travers une sortie d'inhalateur en aval de la chambre de désagglomération, l'air entre dans la chambre de capsule (12) à travers une entrée d'air (24), circule de la chambre de capsule (12) à la chambre de désagglomération (16) et hors de la sortie. L'inspiration de l'utilisateur génère des pressions d'air Pi au niveau de la sortie, Pint entre la chambre de capsule (12) et la chambre de désagglomération (16) et Po au niveau de la sortie. L'inhalateur (2) est conçu de telle sorte que (Pint-Po)/(Pi- Po)>0,33.
PCT/GB2015/050163 2014-01-23 2015-01-23 Inhalateur WO2015110832A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1401154.8 2014-01-23
GB201401154A GB201401154D0 (en) 2014-01-23 2014-01-23 Medical apparatus and method

Publications (1)

Publication Number Publication Date
WO2015110832A1 true WO2015110832A1 (fr) 2015-07-30

Family

ID=50287459

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2015/050163 WO2015110832A1 (fr) 2014-01-23 2015-01-23 Inhalateur

Country Status (2)

Country Link
GB (1) GB201401154D0 (fr)
WO (1) WO2015110832A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102016005345B3 (de) * 2016-05-03 2017-07-06 Klaus-Dieter Beller Inhalationsvorrichtung, Inhalationsset und Verwendung
WO2018007287A3 (fr) * 2016-07-04 2018-03-01 Alfred Von Schuckmann Dispositif de délivrance d'une substance pouvant être évacuée par l'air
WO2019059826A1 (fr) * 2017-09-19 2019-03-28 Iconovo Ab Inhalateur de poudre sèche comprenant un boîtier ayant une première partie de boîtier et une seconde partie de boîtier
US10449309B2 (en) * 2014-01-30 2019-10-22 Klaus-Dieter Beller Powder inhaler and powder inhalation set
US10456535B2 (en) * 2016-05-23 2019-10-29 Presspart Manufacturing Ltd. Dry powder inhaler
US10493221B2 (en) * 2014-01-30 2019-12-03 Klaus-Dieter Beller Powder inhaler and powder inhalation set
CN111514418A (zh) * 2019-06-12 2020-08-11 李少红 一种自吸式经鼻粉末材料给送装置
CN111989132A (zh) * 2018-04-16 2020-11-24 埃姆弗西斯进出口及分销有限公司 干粉末吸入器

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4446862A (en) * 1979-10-30 1984-05-08 Baum Eric A Breath actuated devices for administering powdered medicaments
US6257232B1 (en) * 1997-03-14 2001-07-10 Astra Akteibolag Inhalation device
US20060237010A1 (en) * 2003-06-16 2006-10-26 Rijksuniversiteit Groningen Dry powder inhaler and method for pulmonary inhalation of dry powder
US20070215149A1 (en) * 2006-01-31 2007-09-20 Oriel Therapeutics, Inc. Dry powder inhalers having spiral travel paths, unit dose microcartridges with dry powder, related devices and methods
US20070240712A1 (en) * 2006-04-05 2007-10-18 Scott Fleming Variable dose inhalation device
US20100300440A1 (en) * 2003-03-20 2010-12-02 Galephar P.R. Inc. Dry powder inhaler system

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4446862A (en) * 1979-10-30 1984-05-08 Baum Eric A Breath actuated devices for administering powdered medicaments
US6257232B1 (en) * 1997-03-14 2001-07-10 Astra Akteibolag Inhalation device
US20100300440A1 (en) * 2003-03-20 2010-12-02 Galephar P.R. Inc. Dry powder inhaler system
US20060237010A1 (en) * 2003-06-16 2006-10-26 Rijksuniversiteit Groningen Dry powder inhaler and method for pulmonary inhalation of dry powder
US20070215149A1 (en) * 2006-01-31 2007-09-20 Oriel Therapeutics, Inc. Dry powder inhalers having spiral travel paths, unit dose microcartridges with dry powder, related devices and methods
US20070240712A1 (en) * 2006-04-05 2007-10-18 Scott Fleming Variable dose inhalation device

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10449309B2 (en) * 2014-01-30 2019-10-22 Klaus-Dieter Beller Powder inhaler and powder inhalation set
US10493221B2 (en) * 2014-01-30 2019-12-03 Klaus-Dieter Beller Powder inhaler and powder inhalation set
DE102016005345B3 (de) * 2016-05-03 2017-07-06 Klaus-Dieter Beller Inhalationsvorrichtung, Inhalationsset und Verwendung
WO2017190835A1 (fr) 2016-05-03 2017-11-09 Klaus-Dieter Beller Dispositif d'inhalation, kit d'inhalation et utilisation dudit dispositif
US10456535B2 (en) * 2016-05-23 2019-10-29 Presspart Manufacturing Ltd. Dry powder inhaler
WO2018007287A3 (fr) * 2016-07-04 2018-03-01 Alfred Von Schuckmann Dispositif de délivrance d'une substance pouvant être évacuée par l'air
CN109475712A (zh) * 2016-07-04 2019-03-15 艾尔弗雷德.冯舒克曼 用于输出可经空气排放的物质的设备
WO2019059826A1 (fr) * 2017-09-19 2019-03-28 Iconovo Ab Inhalateur de poudre sèche comprenant un boîtier ayant une première partie de boîtier et une seconde partie de boîtier
US11607509B2 (en) 2017-09-19 2023-03-21 Iconovo Ab Dry powder inhaler comprising a casing with a first casing portion and a second casing portion
CN111989132A (zh) * 2018-04-16 2020-11-24 埃姆弗西斯进出口及分销有限公司 干粉末吸入器
CN111989132B (zh) * 2018-04-16 2023-06-23 埃姆弗西斯进出口及分销有限公司 干粉末吸入器
CN111514418A (zh) * 2019-06-12 2020-08-11 李少红 一种自吸式经鼻粉末材料给送装置

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