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WO2009128491A1 - Dispositif inhalateur auxiliaire pour un inhalateur-doseur - Google Patents

Dispositif inhalateur auxiliaire pour un inhalateur-doseur Download PDF

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Publication number
WO2009128491A1
WO2009128491A1 PCT/JP2009/057635 JP2009057635W WO2009128491A1 WO 2009128491 A1 WO2009128491 A1 WO 2009128491A1 JP 2009057635 W JP2009057635 W JP 2009057635W WO 2009128491 A1 WO2009128491 A1 WO 2009128491A1
Authority
WO
WIPO (PCT)
Prior art keywords
inhalation
assisting device
aerosol container
pmdi
metered dose
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/JP2009/057635
Other languages
English (en)
Japanese (ja)
Inventor
朋宏 座間
典子 伊藤
尚 本田
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.)
Teijin Pharma Ltd
Original Assignee
Teijin Pharma Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Teijin Pharma Ltd filed Critical Teijin Pharma Ltd
Priority to JP2010508238A priority Critical patent/JP5462152B2/ja
Publication of WO2009128491A1 publication Critical patent/WO2009128491A1/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
    • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • 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
    • A61M15/002—Details of inhalators; Constructional features thereof with air flow regulating means

Definitions

  • the present invention relates to an inhalation assisting device for a metered dose inhaler.
  • pMDI quantitative nebulizers
  • pMDI pressurizedhalmetered dose inhaler
  • Patent Documents 1 to 4 Conventionally, spacers have been used to solve this problem (Patent Documents 1 to 4), but the size is inconvenient to carry, and the deposition of drugs in the spacer over time after spraying is also a problem. Has been. In addition, in order to increase the deposition rate of drugs in the lung, inhalation at a slow inhalation speed is recommended, but there is a problem that it is difficult to control the inhalation speed of the patient.
  • JP-A-2-291869 Japanese National Patent Publication No. 8-508439 Japanese Utility Model Publication No. 5-7246 Japanese Utility Model Publication No. 6-5642
  • An object of the present invention is to provide an inhalation assisting device that facilitates the synchronization of the spraying operation and the inhalation in the pMDI.
  • an object of the present invention is to provide an inhalation assisting device for pMDI that is convenient to carry, does not deposit a drug on the device, and can easily control the inhalation speed.
  • the present inventors have found that by giving ventilation resistance to pMDI, the intake air flow rate is limited and the inhalable time is extended.
  • the inventors have found that the object of the present invention can be achieved by providing ventilation resistance, limiting the flow rate of intake air, and extending the inhalable time, thereby completing the present invention.
  • the present invention relates to the following.
  • An inhalation assisting device for pMDI which is attached to the pMDI so as to cover the pMDI's aerosol container insertion port, and provides ventilation resistance to the pMDI.
  • the inhalation assisting device according to (1) which is breathable.
  • the inhalation aid device according to (2) which is made of a breathable material.
  • Consists of a breathable material or a non-breathable material with holes The inhalation assisting device according to (2), wherein the shape when the pMDI is mounted is a bag shape that can cover the aerosol container insertion port of the pMDI in which the aerosol container is installed, including the aerosol container.
  • the shape at the time of pMDI wearing is a cylindrical shape that can cover the side of the aerosol container and the adapter
  • the cylindrical inhalation assisting device when pMDI is mounted has an inner diameter equal to the outer diameter of the adapter part to which the inhalation assisting device is mounted, and a height that covers at least a part of the pMDI aerosol container and the side surface of the adapter.
  • the inhalation assisting device according to (2) wherein the inhalation assisting device according to (2) has an engaging portion that is configured to extend inward from an end portion of the cylindrical portion as necessary, and can be engaged with an upper end portion of an aerosol container of pMDI.
  • the ventilation resistance to be applied causes a pressure drop (kPa) of greater than 0 and 13 kPa or less to pMDI when an inhalation aid is attached to the pMDI.
  • the inhalation aid device according to any one of (1) to (5), calculated by -Pb).
  • Pa Pressure generated when sucked at 28 L / min
  • Pb Pressure generated when a metered dose inhaler equipped with an inhalation assisting device is sucked at 28 L / min
  • the inhalation assisting device of the present invention which is attached to the pMDI aerosol container insertion port and restricts the flow rate of inhalation air by providing ventilation resistance, thereby extending the inhalable time, in the pMDI, the spray operation and the inspiration are synchronized.
  • This makes it possible to obtain an inhalation aid that is easy to carry, convenient to carry, has no drug deposition on the device, and can easily control the inhalation speed. This achieves a certain effect and improved safety by inhaling the appropriate drug of pMDI.
  • a non-woven material is used as the material of the instrument, it can be expected to avoid antigen mixing into the inhaled air.
  • the device is configured to expand and contract in response to inspiration, it can be seen that the inspiration is visually due to contraction at the time of inspiration. Can assist in inhalation (spray pMDI).
  • the pMDI to which the inhalation assisting device of the present invention can be applied refers to an inhaler in which a certain amount of medicine is sprayed with one push from a medicine can (aerosol container) filled with medicine (FIG. 4).
  • the pMDI is composed of an aerosol container (2) filled with a medicine and an adapter (1) for spraying the medicine in the aerosol container, and the adapter (1) is an aerosol container insertion port into which the aerosol container is inserted.
  • the pMDI inhalation assist device (5a, 5b, 5c) of the present invention is attached to the aerosol container insertion port (4) of pMDI, and provides ventilation resistance when inhaling with the mouth added to the spray port (3).
  • the inhalation assisting device (5a, 5b, 5c) of the present invention is important to have appropriate air permeability. For example, the inhalation resistance is too large to make inhalation difficult, or it is too small to suppress the intake air flow rate. It is necessary not to be not.
  • Appropriate ventilation resistance to be imparted causes a drop in pressure (pressure difference) greater than 0 and less than or equal to 13 kPa on pMDI fitted with an inhalation aid when suctioned at 28 L / min. It causes a pressure drop of 0.5 to 6 kPa.
  • the ventilation resistance provided by the inhalation assisting device can be detected by the following procedure using an apparatus as shown in FIG. That is, a cylinder (13) is prepared, and one port of the tube (13) is connected to a suction device via a tube or the like (note that the other port of the cylinder is a pMDI equipped with an inhalation aid to be measured). Connected). A flow meter is installed between the suction machine and the cylinder (13), and a pressure sensor (17) is incorporated in the cylinder (13). The pressure Pa (kPa) in the cylinder when sucked at a constant flow rate (28 L / min) with a suction machine is measured.
  • pMDI (12) equipped with the inhalation assisting device of the present invention is connected to the mouth of the tube, and the pressure Pb (kPa) in the tube is measured.
  • the pressure drop (Pa ⁇ Pb) caused by mounting the pMDI mounted with the inhalation assisting device of the present invention on the cylinder can be expressed as a pressure difference (kPa).
  • the inhalation assisting device may be made of a breathable material, or may be provided with a breathability by adding a hole or a cut to an impermeable material.
  • the air-impermeable material include polyethylene, polyester, polyvinyl chloride, and latex films.
  • Nonwoven fabric, woven fabric, etc. are mentioned as an example of a breathable material.
  • breathable materials include polyethylene, polyester, polyvinyl chloride, and latex.
  • the woven fabric is composed of nanofibers, it is preferable that when covering the gap between the aerosol container and the adapter, it is stretchable so that it is easy to fix without slipping, and dust and antigen contamination can be avoided during inhalation and inhalation.
  • FIG. 1 is a view showing a first embodiment of the inhalation assisting device of the present invention, which is made of an air-impermeable material.
  • the inhalation assisting device (5a) has a bag-like shape composed of vinyl (6) having a hole (7) and rubber (8).
  • the first inhalation aid (5a) covers the aerosol container insertion port (4) of the pMDI in which the aerosol container (2) is installed, including the aerosol container (2), and the aerosol container insertion port (4) side.
  • the aerosol container (2) and the adapter (1) for the mounting, rubber (8) or the like may be used as shown in FIG. 1, or the elasticity of the instrument itself may be used.
  • an adapter a portion where the aerosol container is not installed in the pMDI is referred to as an adapter.
  • FIG. 2 is a view showing a second embodiment of the inhalation assisting device of the present invention, which is made of a breathable material.
  • the inhalation assisting device (5b) has a cylindrical shape in which the shape when the pMDI is mounted can cover the side surface of the aerosol container and the adapter.
  • the cylindrical portion (9) of the inhalation aid (5b) has an inner diameter equal to the outer diameter of the adapter when pMDI is mounted, and has a height that covers at least a part of the side surface of the aerosol container and the adapter.
  • the inhalation assisting device (5b) is configured to extend inward from the end of the cylindrical portion (9) as necessary, and engages with the upper end of the aerosol container of pMDI (10 ).
  • FIG. 1 is a view showing a second embodiment of the inhalation assisting device of the present invention, which is made of a breathable material.
  • the inhalation assisting device (5b) has a cylindrical shape in which the shape when the p
  • the second inhalation assisting device (5b) is configured such that the pMDI mounting side end portion (11) of the cylindrical portion (9) is fitted into the pMDI in which the aerosol container is installed, and the engaging portion of the inhalation assisting device (5b). (10) is used by pushing and installing until it engages the pMDI aerosol container top.
  • the inhalation assisting device (5b) is formed of a stretchable material in a ring shape
  • the inhalation assisting device (5b) is covered and fixed across the side surfaces of the aerosol container and the adapter so as to cover the gap between the aerosol container and the adapter. You may comprise.
  • the inhalation assisting device (5b) is wound around the side surface of the aerosol container and the adapter so that the gap between the aerosol container and the adapter can be covered with a stretchable material, and a magic tape ( A configuration in which a hook-and-loop fastener such as a registered trademark is provided may be used.
  • FIG. 3 is a view showing a third embodiment of the inhalation assisting device of the present invention, which is made of a breathable material.
  • the inhalation assisting device (5c) has a cylindrical shape when the pMDI is mounted so that the gap between the aerosol container (2) and the adapter (1) can be filled.
  • the inhalation assisting device (5c) has a thickness that fills the gap between the aerosol container and the adapter when pMDI is mounted, and has an appropriate height to fill the gap stably.
  • it is preferably made of a stretchable material.
  • the present invention is applicable to any pMDI.
  • the inhalable time was measured using the inhalation assisting device (5a) shown in FIG.
  • the inhalation assisting device (5a) includes a plastic bag (5 cm ⁇ 5 cm) (6) having holes (7) opened at several tens of points with a needle and a rubber band (8).
  • the inhalation assisting device (5a) was mounted so as to cover the aerosol container insertion port (4) of the pMDI in which the aerosol container (2: Olvesco (registered trademark)) was installed.
  • the pMDI spray port (3) was added to the mouth, and the time from the start of inspiration until the end of inspiration (inhalable time) was measured.
  • Example 1 By installing the inhalation assisting device of the present invention, the inhalable time was extended compared to pMDI not equipped with the inhalation assisting device of the present invention (Example 1). During this extended inhalable time, the pMDI spraying operation can be performed. Therefore, it can be seen from Example 1 that when the inhalation assisting device of the present invention is attached to the pMDI, the inhalable time is extended, and as a result, it becomes easier to synchronize the pMDI spraying operation with the inhalation.
  • Example 2 Pressure difference of inhalation assisting device Nanofront (registered trademark) was used as an inhalation assisting device, and inhalation assisting devices A to F having different inspiratory resistances with materials having different breathability were prepared. As shown in FIG. 2, the inhalation aids A to F have a cylindrical shape that can be covered over the side surfaces of the aerosol container and the adapter and are covered with the aerosol container insertion port.
  • a Teflon (registered trademark) cylinder (inner diameter) is connected to a flowmeter (manufactured by KEYENCE, FD-A50) and a pressure sensor (manufactured by KEYENCE, AP-41). About 30 mm and a length of about 100 mm) were firmly connected so as not to leak air, and the flow rate of the suction machine was adjusted to a predetermined flow rate (15 L / min, 28 L / min, 35 L / min). After that, to prevent air leakage in the Teflon cylinder, firmly attach the pMDI equipped with the inhalation aid of the present invention, and reduce the pressure drop (pressure difference) when sucked with a suction machine. Measurements were made with the attached pressure sensor. The results are shown in Table 2.
  • Example 3 Extension of inhalation time with inhalation assist device Ten subjects who were healthy volunteers were not instructed to inhale, and the time required for inhalation was measured by first inhaling pMDI. Thereafter, the pMDI equipped with the inhalation aids A to F was randomly inhaled, and the time required for inhalation was measured in the same manner. Table 3 shows the measurement results. In Table 3, the units of the numerical values in the columns other than the upper inhalation aid / pressure difference all represent seconds.
  • Example 4 Sensory test on resistance feeling by inhalation assisting device
  • Ten healthy volunteer subjects were equipped with inhalation assisting devices A to F, respectively, using pMDI with no inhalation assisting device as a reference for resistance.
  • the resistance feeling during inhalation of pMDI was arbitrarily described on a straight line, with the level at which the resistance feeling was felt at maximum being 15.
  • the feeling of resistance that I felt acceptable as intake resistance was also described in the same way.
  • Each resistance and allowable resistance are shown in Table 4 as the distance from the lower limit of the straight line.
  • the inhalable time was extended as compared with pMDI alone.
  • the inhalation aids A to E have many responses that are acceptable, the optimum ventilation resistance suggests that the pressure difference during suction at 28 L / min is about 0.5 to 6 kPa. It was done.
  • Example 5 Measurement of particle size distribution when wearing an inhalation assisting device Using pMDI equipped with an inhalation assisting device, particle size distribution was measured by an Andersen Cascade Impactor (manufactured by COPLEY).
  • the inhalation assisting device a cylindrical shape capable of covering the aerosol container and the side surface of the adapter and having a shape covered by the aerosol container insertion port and generating a pressure difference of 9 kPa was used.
  • the fine particle amount and distribution Fine particle dose, Fine Particle fraction
  • the particle size distribution was measured according to USP31 ⁇ 601> AEROSOLS, NASAL SPRAYS, METERED-DOSE INHALARS, AND DRY POWDER INHALERS, and Aerodynamic Size Distribution.
  • an inhalation assisting device that can be attached to the pMDI, that is easy to synchronize the spraying operation and inhalation, that is convenient to carry, that does not deposit medicine on the device, and that can easily control the inhalation speed.

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  • 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)
  • Medicinal Preparation (AREA)

Abstract

L'invention porte sur un dispositif inhalateur auxiliaire qui facilite la synchronisation d'une procédure de pulvérisation avec la respiration dans un inhalateur-doseur. L'invention porte sur un dispositif inhalateur auxiliaire pour un inhalateur-doseur qui est attaché à l'inhalateur-doseur de façon à recouvrir le trou d'introduction de conteneur d'aérosol de l'inhalateur-doseur pour ainsi conférer une résistance à l'aération à l'inhalateur-doseur.
PCT/JP2009/057635 2008-04-17 2009-04-16 Dispositif inhalateur auxiliaire pour un inhalateur-doseur Ceased WO2009128491A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2010508238A JP5462152B2 (ja) 2008-04-17 2009-04-16 定量噴霧式吸入器用吸入補助器具

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2008107849 2008-04-17
JP2008-107849 2008-04-17

Publications (1)

Publication Number Publication Date
WO2009128491A1 true WO2009128491A1 (fr) 2009-10-22

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PCT/JP2009/057635 Ceased WO2009128491A1 (fr) 2008-04-17 2009-04-16 Dispositif inhalateur auxiliaire pour un inhalateur-doseur

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JP (1) JP5462152B2 (fr)
WO (1) WO2009128491A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012072249A1 (fr) 2010-11-30 2012-06-07 Teva Pharmaceutical Industries Ltd. Inhalateurs et capuchons pour boîtiers d'inhalateurs
JP2015221225A (ja) * 2009-12-23 2015-12-10 マップ・ファーマシューティカルズ・インコーポレイテッド 強化排出装置設計
US11376379B2 (en) 2015-12-21 2022-07-05 Kindeva Drug Delivery L.P. Flow governor assemblies for use in medicinal inhalers
US11376378B2 (en) 2015-12-21 2022-07-05 Kindeva Drug Delivery, L.P. Flow governors for use in medicinal inhalers
CN115697445A (zh) * 2020-11-27 2023-02-03 日普制药株式会社 吸入辅助器
US12357776B2 (en) 2015-12-21 2025-07-15 Kindeva Drug Delivery L.P. Medicinal inhalers

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05505968A (ja) * 1990-12-18 1993-09-02 ヘルススキャン・プロダクツ・インコーポレイテッド 所定服用量吸入装置
JP2001511401A (ja) * 1996-06-06 2001-08-14 イノベーティブ・ディバイシィーズ・エルエルシー 定量投与吸入器（ＭＤＩｓ）と一緒に用いる装置
WO2007068896A1 (fr) * 2005-12-12 2007-06-21 Glaxo Group Limited Distributeur à utiliser dans un appareil distributeur de médicament
JP2007528247A (ja) * 2004-03-10 2007-10-11 グラクソ　グループ　リミテッド 投与装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05505968A (ja) * 1990-12-18 1993-09-02 ヘルススキャン・プロダクツ・インコーポレイテッド 所定服用量吸入装置
JP2001511401A (ja) * 1996-06-06 2001-08-14 イノベーティブ・ディバイシィーズ・エルエルシー 定量投与吸入器（ＭＤＩｓ）と一緒に用いる装置
JP2007528247A (ja) * 2004-03-10 2007-10-11 グラクソ　グループ　リミテッド 投与装置
WO2007068896A1 (fr) * 2005-12-12 2007-06-21 Glaxo Group Limited Distributeur à utiliser dans un appareil distributeur de médicament

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015221225A (ja) * 2009-12-23 2015-12-10 マップ・ファーマシューティカルズ・インコーポレイテッド 強化排出装置設計
US9610415B2 (en) 2009-12-23 2017-04-04 Map Pharmaceuticals, Inc. Enhanced eductor design
WO2012072249A1 (fr) 2010-11-30 2012-06-07 Teva Pharmaceutical Industries Ltd. Inhalateurs et capuchons pour boîtiers d'inhalateurs
US9526858B2 (en) 2010-11-30 2016-12-27 Teva Pharmaceuticals Industries Ltd. Inhalers and housing caps for inhalers
US11376379B2 (en) 2015-12-21 2022-07-05 Kindeva Drug Delivery L.P. Flow governor assemblies for use in medicinal inhalers
US11376378B2 (en) 2015-12-21 2022-07-05 Kindeva Drug Delivery, L.P. Flow governors for use in medicinal inhalers
US12357776B2 (en) 2015-12-21 2025-07-15 Kindeva Drug Delivery L.P. Medicinal inhalers
CN115697445A (zh) * 2020-11-27 2023-02-03 日普制药株式会社 吸入辅助器

Also Published As

Publication number Publication date
JP5462152B2 (ja) 2014-04-02
JPWO2009128491A1 (ja) 2011-08-04

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