WO2009139732A1

WO2009139732A1 - Dry powder inhaler

Info

Publication number: WO2009139732A1
Application number: PCT/TR2009/000063
Authority: WO
Inventors: Bilgic Mahmut
Original assignee: Bilgic Mahmut
Priority date: 2008-05-16
Filing date: 2009-05-15
Publication date: 2009-11-19
Also published as: WO2009139732A4; TR200803525A2

Abstract

The present invention relates to an inhalation device that has a mechanism facilitating capsule perforation process for utilization of the dry powder drug kept in a perforatable capsule via inhalation.

Description

DRY POWDER INHALER

DESCRIPTION

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 and the extent of the needle penetration into the capsule may be different. 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 device of the invention provides the required needle compression force on the whole device via a single mechanism and movement. A vertical force applied on the whole product, instead of applying a force on a compression mechanism specifically designed for fingers, is sufficient enough to operate the mechanism. Instead of pushing buttons which are modified and usually not big enough; operating the mechanism by compressing the device, which is easy to grip for every patient, in a vertical direction and even holding the device from the upper side and pushing it on a table or an item are adequate. In said mechanism, Inhalation Shaft is closed after loading the capsule. Compressing the Inhalation Shaft in a vertical direction stimulates the needles to perforate the capsule simultaneously and allows the patient to make the medicament ready for inhalation. For discharging the empty capsule, the Inhalation Shaft is opened easily via its sliding structure and the empty capsule is taken out.

Brief Description of Drawings Figure- 1 represents the device according to the invention schematically in open position.

The mechanism according to the invention consists of ten components that are listed below and depicted in Figure- 1 in detail:

/: Compression Chamber

2: Chamber Spring 3: Capsule Chamber

4: Needle Spring

5: Needle

6: Needle Slide

7: Blending and Screening Chamber

8: Spiral

9: Inhalation Shaft

10: Cap

Exterior surface of the Inhalation Shaft (9) is designed so as to comply with the mouth shape for sucking and it is connected to the Blending and Screening Chamber (7) together with the Spiral (8) that is present within it. These three parts (9, 8 and 7) are opened by sliding together on the slides of the Capsule Chamber (3). Needles (5) and Needle Spring (4) are placed on Needle Slide (6). As the Inhalation Shaft, Spiral, Blending and Screening Chamber, Needle Slide, Needles, Needle Spring, Capsule Chamber (9, 8, 7, 6, 5, 4, and 3) are compressed vertically, the Chamber Spring (2) is compressed between this group and the Compression Chamber (1).

As the compression occurs by the vertical force, the Needle Slide (6) moves horizontally and pushes the Needles (5) through the Capsule Chamber (3) in a way that needles can perforate the capsule. Chamber Spring (2) decompresses as there is no pressure and this allows the Chamber Spring (2) to push the group consisting of Inhalation Shaft, Spiral, Blending and Screening Chamber, Needle Slide, Needles, Needle Spring, Capsule Chamber (9, 8, 7, 6, 5, 4, and 3) back. Drug capsule is perforated and made ready for inhalation via this process. Drug is inhaled. The dry powder drug passes through the Blending and Screening Chamber (7) via the generated air flow. Potential capsule particles are held by the screen. The agglomeration of the dry powder drug that circulates over the Spiral (8) structure via air flow is prevented by collision between the dry powder drug particles and the surfaces of the structure.

The group consisting of Inhalation Shaft (9), Spiral (8), Blending and Screening Chamber (7) is opened by sliding on the slides of the Capsule Chamber (3) and the empty capsule is discharged.

The cap (10) is compressed with a screwed connection in the Compression Chamber (1) in a way that the product can be protected.

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 a part called Needle Slide (6) moves horizontally and pushes the Needles (5) through the Capsule Chamber

(3) in a way that needles can perforate the capsule while compression is generated by applying a single vertical force to the device in order to facilitate capsule perforation process.

2. A device having a mechanism according to claim 1, characterized in that the device consists of Compression Chamber (1), Chamber Spring (2), Capsule Chamber (3), Needle Spring (4), Needles (5), Needle Slide (6), Blending and Screening Chamber (7), Spiral (8), Inhalation Shaft (9), and Cap (10).

3. Inhalation Shaft (9) 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 Blending and Screening Chamber (7) together with the Spiral (8) present within it.

4. Needle Slide (6) according to claim 2, characterized in that the Needles (5) and Needle Spring (4) are placed on the Needle Slide.

5. A working principle of the inhalation device according to any one of the claims between 1 and 4 comprising;

- Compression of the Chamber Spring (2) between the group consisting of Inhalation

Shaft, Spiral, Blending and Screening Chamber, Needle Slide, Needles, Needle Spring and Capsule Chamber (9, 8, 7, 6, 5, 4, and 3), and Compression Chamber (1) following the compression of said group vertically - Horizontal movement of the Needle Slide (6) and pushing of the needles (5) through the Capsule Chamber (3) by the Needle Slide in a way that needles can perforate the capsule as the compression occurs by the vertical force

- Pushing of the group consisting of Inhalation Shaft, Spiral, Blending and Screening Chamber, Needle Slide, Needles, Needle Spring and Capsule Chamber (9, 8, 7, 6, 5,

4, and 3) back by the Chamber Spring (2) following the decompression of the Chamber Spring as there is no pressure, and perforation of the drug capsule, and as a result making the drug ready for inhalation

- Passing of the dry powder through the Blending and Screening Chamber (7) following inhalation and holding of the potential capsule particles by the screen

- Preventing the agglomeration of the dry powder drug that circulates over the Spiral (8) structure via air flow by collision between the dry powder drug particles and the surfaces of the structure

- Opening of the group consisting of Inhalation Shaft (9), Spiral (8), Blending and Screening Chamber (7) via sliding on the slides of the Capsule Chamber (3) and discharging of the empty capsule

6. An inhalation device having the mechanism according to any one of the claims between 1 and 5, 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.

7. An inhalation device having the mechanism according to any one of the claims between 1 and 5, 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.