WO2009139733A1 - Dry powder inhalation device - Google Patents

Dry powder inhalation device Download PDF

Info

Publication number
WO2009139733A1
WO2009139733A1 PCT/TR2009/000064 TR2009000064W WO2009139733A1 WO 2009139733 A1 WO2009139733 A1 WO 2009139733A1 TR 2009000064 W TR2009000064 W TR 2009000064W WO 2009139733 A1 WO2009139733 A1 WO 2009139733A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
inhalation
chamber
shaft
drug
Prior art date
Application number
PCT/TR2009/000064
Other languages
French (fr)
Inventor
Mahmut Bilgic
Original Assignee
Mahmut Bilgic
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 Mahmut Bilgic filed Critical Mahmut Bilgic
Publication of WO2009139733A1 publication Critical patent/WO2009139733A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/001Particle size control
    • A61M11/003Particle size control by passing the aerosol trough sieves or filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033Details of the piercing or cutting means
    • A61M15/0035Piercing means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033Details of the piercing or cutting means
    • A61M15/0041Details of the piercing or cutting means with movable piercing or cutting means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder

Definitions

  • the present invention relates to an inhalation device that has a mechanism providing a well-balanced and facilitated capsule perforation process for utilization of the dry powder drug kept in a perforatable capsule via inhalation.
  • Pharmaceuticals which can be inhaled are generally used to treat diseases in bronchial or pulmonary region such as asthma or chronic bronchitis.
  • breath-activated devices wherein the delivery of dry powder drug to the air passage is provided.
  • dry powder inhalator devices operate via loading of capsule comprising dry powder drug into the device, perforation of the capsule by compression or needles and delivering dry powder to pulmonary region by breathing.
  • beta-2-agonists corticosteroids
  • antibiotics antimuscarinic agents
  • antiallergic agents or anticholinergic agents
  • pulmonary diseases such as asthma and chronic obstructive pulmonary disease.
  • Mechanism according to the invention provides perforation of dry powder capsules by needles and delivery of dry powder drug particles from the capsule to the lungs via the pressure that is generated by breathing.
  • needles are required to penetrate into and out of capsule within a specific depth simultaneously or drug capsules are required to be perforated by other techniques.
  • breaking or perforation process of capsule should be done in a well-balanced way, and should be performed even though the patient is incompliant.
  • children and elderly patients are also included in the patient population who are the user of these drugs and devices.
  • perforation process is mechanically performed via compression of capsule by using fingers and some other special pushing surfaces. Due to the fact that the compression mechanisms placed on both sides of the capsule work separately most of the time; each applied force may be different from the other, the extent of the needle penetration into the capsule may be different or the mechanism may break down. This compression force is designed as a standard for adult, elderly and children patients.
  • the present invention relates to an inhalation device that has a mechanism providing a well-balanced and facilitated capsule perforation process for utilization of the dry powder drug kept in a perforatable capsule via inhalation.
  • the device of the invention provides the required needle compression force on the whole device via a single mechanism so as the required needle compression force can be applied equally in both directions. Although the force applied on the mechanism, which is compressed between fingers and palm of a hand, is low; the movement of needles penetrating into and out of capsule is performed simultaneously in a well-balanced way.
  • inhalation shaft is closed following the load of the capsule.
  • the device compressed between palm and fingers stimulates the needles to perforate capsule simultaneously and allows the patient to make the drug ready for inhalation.
  • the inhalation shaft is opened and the empty capsule is taken out easily.
  • Figure 1 represents the device according to the invention schematically in open position.
  • Figure 2 represents the device according to the invention schematically in closed position.
  • the mechanism according to the invention consists of six components that are listed below and depicted in Figure- 1 and Figure-2 in detail.
  • Pressure Handle Exterior surface of the Inhalation Shaft (1) is designed so as to comply with the mouth shape for sucking and it is connected to the Movable Plate (3) together with the Filter that is present within it and the Blending Chamber (2). As the device is opened, these three parts (1, 2 and 3) are opened simultaneously.
  • the agglomeration of the dry powder during inhalation is prevented by the Blending Chamber (2) which stimulates the collision between the dry powder and the surfaces of the structure.
  • the Filter found on the Movable Plate (3) prevents the inhalation of substances other than the dry powder drug.
  • the Filter and Movable Plate (3) are connected to the Capsule Chamber (4) by a joint.
  • Needle and Buttons (5) are placed at the top of the Capsule Chamber (4) and a spring is placed between them.
  • the Pressure Handle (6) is placed at the bottom of the Capsule Chamber (4) and a spring is placed between them.
  • Inhalation Shaft Blending Chamber and Filtered Plate (1, 2 and 3) are opened by rotating them right.
  • Drug capsule is loaded into the Capsule Chamber.
  • the Inhalation shaft group (1, 2 and 3) is closed again.
  • Pressure Handle (6) and Capsule Chamber (4) are compressed between palm and fingers. Needle Buttons (5) stimulate the needles to penetrate into and out of capsule concurrently. The drug is inhaled.
  • the device having the mechanism according to the invention is preferably used for inhalation of drugs such as beta-2agonists, corticosteroids, anticholinergic agents, antimuscarinics, antiallergics and antibiotics, for local treatment of lungs or pulmonary diseases like asthma and chronic obstructive pulmonary disease.
  • drugs such as beta-2agonists, corticosteroids, anticholinergic agents, antimuscarinics, antiallergics and antibiotics, for local treatment of lungs or pulmonary diseases like asthma and chronic obstructive pulmonary disease.

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

Abstract

The present invention relates to an inhalation device that has a mechanism providing a well-balanced and facilitated capsule perforation process for utilization of the dry powder drug kept in a perforatable capsule via inhalation.

Description

INHALATION DEVICE
DESCRIPTION
The present invention relates to an inhalation device that has a mechanism providing a well-balanced and facilitated capsule perforation process for utilization of the dry powder drug kept in a perforatable capsule via inhalation.
Pharmaceuticals which can be inhaled are generally used to treat diseases in bronchial or pulmonary region such as asthma or chronic bronchitis.
One of the devices which are used for inhalation is breath-activated devices wherein the delivery of dry powder drug to the air passage is provided. Generally, dry powder inhalator devices operate via loading of capsule comprising dry powder drug into the device, perforation of the capsule by compression or needles and delivering dry powder to pulmonary region by breathing.
These kinds of devices are generally used for the administration of beta-2-agonists, corticosteroids, antibiotics, antimuscarinic agents, antiallergic agents or anticholinergic agents for treating pulmonary diseases such as asthma and chronic obstructive pulmonary disease.
Mechanism according to the invention provides perforation of dry powder capsules by needles and delivery of dry powder drug particles from the capsule to the lungs via the pressure that is generated by breathing. In the mechanism according to the invention and similar techniques, needles are required to penetrate into and out of capsule within a specific depth simultaneously or drug capsules are required to be perforated by other techniques.
There are many documents concerning devices for use of capsules containing dry powder drugs, in which devices basically operate via perforation or breaking of the capsules. In document numbered DE 102006006647, a device with a similar operation technique in which the dry powder is kept in a capsule placed inside a housing and made ready for inhalation via cutting off one end of the capsule is described. In this device, the capsule which is taken into device-body via the drawer shaped capsule housing, is perforated mechanically with blades.
In document numbered US2006254583, a device with a similar operation technique in which the dry powder is kept in a capsule placed inside a housing and made ready for inhalation via cutting off one end of the capsule is described. The capsule, which is characterized by being made of hydroxypropyl methyl cellulose (HPMC), is loaded into chamber and the drug is inhaled after perforation of the capsule tips by hand-power.
In document numbered CA2563573, a device with a similar operation technique is described. A dry powder drug, that is kept in the capsule lying in a chamber, is inhaled after perforation of the capsule tips via pressing two buttons on the device by hand-power. In the same document, loading of the capsule into the chamber, air passages and moving parts thereof are also described.
In document numbered GBl 182779, a device with a similar technique is described. A dry powder drug, that is kept in the capsule lying in a chamber, is inhaled after perforation of the capsule tips via pressing two buttons on the device by hand-power.
In these procedures described in the prior art, breaking or perforation process of capsule should be done in a well-balanced way, and should be performed even though the patient is incompliant. Anyway, children and elderly patients are also included in the patient population who are the user of these drugs and devices. In most of the commercial and known techniques, perforation process is mechanically performed via compression of capsule by using fingers and some other special pushing surfaces. Due to the fact that the compression mechanisms placed on both sides of the capsule work separately most of the time; each applied force may be different from the other, the extent of the needle penetration into the capsule may be different or the mechanism may break down. This compression force is designed as a standard for adult, elderly and children patients. While an adult can distribute the required force on the capsule perforation buttons in a well- balanced way; when children and elderly patients can not exhibit the same ability, the needles can not perforate the capsules sufficiently or equally. As a result, adequate drug dose fails to reach to pulmonary region.
The present invention relates to an inhalation device that has a mechanism providing a well-balanced and facilitated capsule perforation process for utilization of the dry powder drug kept in a perforatable capsule via inhalation.
The device of the invention provides the required needle compression force on the whole device via a single mechanism so as the required needle compression force can be applied equally in both directions. Although the force applied on the mechanism, which is compressed between fingers and palm of a hand, is low; the movement of needles penetrating into and out of capsule is performed simultaneously in a well-balanced way.
In the device comprising the mechanism of the invention, inhalation shaft is closed following the load of the capsule. The device compressed between palm and fingers stimulates the needles to perforate capsule simultaneously and allows the patient to make the drug ready for inhalation. For discharging the empty capsule, the inhalation shaft is opened and the empty capsule is taken out easily.
Brief Description of Drawings
Figure 1 represents the device according to the invention schematically in open position.
Figure 2 represents the device according to the invention schematically in closed position.
The mechanism according to the invention consists of six components that are listed below and depicted in Figure- 1 and Figure-2 in detail.
1: Inhalation Shaft
2: Blending Chamber
3: Filter and Movable Plate
4: Capsule Chamber
5: Needle Buttons
6: Pressure Handle Exterior surface of the Inhalation Shaft (1) is designed so as to comply with the mouth shape for sucking and it is connected to the Movable Plate (3) together with the Filter that is present within it and the Blending Chamber (2). As the device is opened, these three parts (1, 2 and 3) are opened simultaneously. The agglomeration of the dry powder during inhalation is prevented by the Blending Chamber (2) which stimulates the collision between the dry powder and the surfaces of the structure. The Filter found on the Movable Plate (3) prevents the inhalation of substances other than the dry powder drug.
The Filter and Movable Plate (3) are connected to the Capsule Chamber (4) by a joint.
Needle and Buttons (5) are placed at the top of the Capsule Chamber (4) and a spring is placed between them. The Pressure Handle (6) is placed at the bottom of the Capsule Chamber (4) and a spring is placed between them.
In order to load the capsule shaped drug; Inhalation Shaft, Blending Chamber and Filtered Plate (1, 2 and 3) are opened by rotating them right. Drug capsule is loaded into the Capsule Chamber. The Inhalation shaft group (1, 2 and 3) is closed again. Pressure Handle (6) and Capsule Chamber (4) are compressed between palm and fingers. Needle Buttons (5) stimulate the needles to penetrate into and out of capsule concurrently. The drug is inhaled.
Following inhalation, Inhalation Shaft, Blending Chamber and Filtered Plate (1, 2 and 3) are opened by rotating them right. The empty capsule is discharged easily and thrown away.
The device having the mechanism according to the invention is preferably used for inhalation of drugs such as beta-2agonists, corticosteroids, anticholinergic agents, antimuscarinics, antiallergics and antibiotics, for local treatment of lungs or pulmonary diseases like asthma and chronic obstructive pulmonary disease.

Claims

1. An inhalation device for utilization of the dry powder drug kept in a perforatable capsule, characterized in that said device has a mechanism wherein the perforation of the capsule comprising the drug is performed by a single movement that can generate the required needle pressure force which can be applied equally in both directions in a well-balanced way; and wherein the single movement is compression of the lower cap chamber, called the Pressure Handle (6), and the Capsule Chamber (4) containing the capsule.
2. A device having a mechanism according to claim 1, characterized in that the device consists of Inhalation Shaft (1), Blending Chamber (2), Filter and Movable Plate (3), Capsule Chamber (4), Needle Buttons (5) and Pressure Handle (6).
3. Inhalation Shaft (1) according to claim 2, characterized in that the Inhalation Shaft has an exterior surface which is designed so as to comply with the mouth shape for sucking and it is connected to the Movable Plate (3) together with the Filter present within it and the Blending Chamber (2).
4. Movable Plate (3) according to claim 2, characterized in that the Movable Plate and Filter present within it are connected to the Capsule Chamber (4) by a joint.
5. Capsule Chamber (4) according to claim 2, characterized in that the Capsule Chamber has the Needle and Buttons (5) on top of it and Pressure Handle (6) on bottom of it together with a spring between them.
6. A working principle of the inhalation device according to any one of the claims between 1 and 5 comprising;
- Opening of Inhalation Shaft, Blending Chamber and Filtered Plate (1, 2 and 3) by rotating them right in order to load the capsule shaped drug,
- Loading of the drug capsule into the Capsule Chamber,
- Reclosing of the Inhalation Shaft Group (1, 2 and 3),
- Compression of Pressure Handle (6) and Capsule Chamber (4) between palm and fingers, and penetration of the needles (5) into and out of the capsule concurrently
7. An inhalation device having the mechanism according to any one of the claims between 1 and 6, characterized in that the device is used for the administration of drugs to the pulmonary region for the treatment of pulmonary diseases particularly such as asthma and COPD or other diseases wherein local pulmonary treatment is needed.
8. An inhalation device having the mechanism according to any one of the claims between 1 and 6, characterized in that the device is used for the administration of beta-2-agonists, anticholinergic agents, antimuscarinics, corticosteroids, antibiotics, anti-allergies alone or in combination to the pulmonary region.
PCT/TR2009/000064 2008-05-16 2009-05-15 Dry powder inhalation device WO2009139733A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2008/03524A TR200803524A2 (en) 2008-05-16 2008-05-16 Inhalation device.
TR2008/03524 2008-05-16

Publications (1)

Publication Number Publication Date
WO2009139733A1 true WO2009139733A1 (en) 2009-11-19

Family

ID=40848402

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2009/000064 WO2009139733A1 (en) 2008-05-16 2009-05-15 Dry powder inhalation device

Country Status (2)

Country Link
TR (1) TR200803524A2 (en)
WO (1) WO2009139733A1 (en)

Cited By (1)

* 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

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1485163A (en) * 1974-03-18 1977-09-08 Isf Spa Inhalers
US4249526A (en) * 1978-05-03 1981-02-10 Fisons Limited Inhalation device
WO1994006498A1 (en) * 1992-09-23 1994-03-31 Fisons Plc Inhalation device
US20030000523A1 (en) * 2001-06-28 2003-01-02 Mauro Citterio Inhaler device
US20070295332A1 (en) * 2004-05-13 2007-12-27 Novartis Ag Inhaler Device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1485163A (en) * 1974-03-18 1977-09-08 Isf Spa Inhalers
US4249526A (en) * 1978-05-03 1981-02-10 Fisons Limited Inhalation device
WO1994006498A1 (en) * 1992-09-23 1994-03-31 Fisons Plc Inhalation device
US20030000523A1 (en) * 2001-06-28 2003-01-02 Mauro Citterio Inhaler device
US20070295332A1 (en) * 2004-05-13 2007-12-27 Novartis Ag Inhaler Device

Cited By (1)

* 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

Also Published As

Publication number Publication date
TR200803524A2 (en) 2009-12-21

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