CA2771443A1 - An inhalation device and a method for inhaling an active ingredient from a capsule - Google Patents

An inhalation device and a method for inhaling an active ingredient from a capsule Download PDF

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Publication number
CA2771443A1
CA2771443A1 CA2771443A CA2771443A CA2771443A1 CA 2771443 A1 CA2771443 A1 CA 2771443A1 CA 2771443 A CA2771443 A CA 2771443A CA 2771443 A CA2771443 A CA 2771443A CA 2771443 A1 CA2771443 A1 CA 2771443A1
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Canada
Prior art keywords
capsule
inhalation device
inhalation
air
swirl chamber
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.)
Abandoned
Application number
CA2771443A
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French (fr)
Inventor
Christian Friebel
Bernd W. Mueller
Hartwig Steckel
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.)
GAMPTEC GmbH
Original Assignee
Gamptec Gmbh
Christian Friebel
Bernd W. Mueller
Hartwig Steckel
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Filing date
Publication date
Application filed by Gamptec Gmbh, Christian Friebel, Bernd W. Mueller, Hartwig Steckel filed Critical Gamptec Gmbh
Publication of CA2771443A1 publication Critical patent/CA2771443A1/en
Abandoned legal-status Critical Current

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    • 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
    • A61M11/002Particle size control by flow deviation causing inertial separation of transported particles
    • 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
    • A61M15/0028Inhalators 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
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • A61M15/0068Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/0081Locking 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
    • 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
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/16Rotating swirling helical flow, e.g. by tangential inflows

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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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

The invention relates to an inhalation device for inhaling at least one active ingredient contained in a capsule, comprising: - a swirl chamber (15) for accommodating a capsule and for swirling the capsule content, - at least one air introduction channel (13), and at least one air discharge channel (14), wherein the air introduction channel (13) and the swirl chamber (15) and the air discharge channel (14) are in fluid connection and wherein the air introduction channel (13) and the air discharge channel (14) extend at least partially in opposite directions. The invention further relates to methods for inhaling an active ingredient contained in a capsule.

Description

An Inhalation Device and a Method for Inhaling an Active Ingredient from a Capsule This invention relates to an inhalation device and a method for inhaling at least one active ingredient contained in a capsule.

Various so-called capsule-based inhalers for inhaling one or more active ingredients are generally known. The usually powdery active ingredient/s can be available as such individually and unbound or bound to a carrier substance. A capsule in general contains one therapeutically required active ingredient dose each. The capsule is inserted in an inhaler where it is opened prior to inhalation. During the inhalation, an air flow passing in a flow direction longitudinally through the inhaler is produced. At least part of the active ingredient contained in a capsule can be transported together with this air flow into the lungs of a user.

When a powdery active ingredient is used for a pulmonary application, either the separately available active ingredient or the active ingredient bound to a carrier substance is separated from the carrier substance during the inhalation and reaches the lungs in a finely divided form. It is thus possible to ensure that the active ingredients in the air flow can reach their site of action in the lungs. The fine division and/or separation of the active ingredients or active ingredient is also referred to as dispersion or deagglomeration.

Known powder inhalers can be active or passive devices. When they are passive devices, the inhalation is effected exclusively by a breath of an inhaling person. In contrast to this, active devices use in addition to a breath a mechanism which in response to an actuation of the inhaler supports a dispersion and/or deagglomeration.
For example, a pressure reservoir can additionally be opened upon inhalation;
the pressure released by it supports the deagglomeration. Active inhalation devices usually have a complex and thus expensive design.

A distinction is also made between so-called reservoir inhalation devices and pre-dosed systems.

Reservoir inhalation devices comprise a reservoir from which an individual dose is taken during an inhalation event and is supplied to a patient. Such devices usually have a complex design and make great demands on the so-called powder technology when an individual dose is separated, in particular since such reservoir systems may contain up to 200 individual doses and are used for a correspondingly long period of time. On the one hand, such a system must ensure that a given number of doses can be dispensed and, on the other hand, also that a dose is always dosed equally irrespective of the dispensing time. In addition, it must be evident to a patient whether further doses are available in such an inhalation device. Such reservoir devices are also accompanied by a complex development and testing of the formulation as well as a complicated design and therefore the production thereof involves high costs.
Furthermore, such reservoir devices often cannot be reused.

So-called pre-dosed inhalation devices already have a divided powder formulation for an application, for example as a capsule or in so-called blisters. A
distinction can here be made between so-called multi-dose inhalers and so-called single-dose inhalers.
Multi-dose inhalers comprise several separately provided individual doses, e.g.
divided on a blister strip or blister disk. The blister is either integrated into an inhalation device or can be inserted, if necessary. Thus, these devices often provide a mechanism serving the further transport of the blister after the inhalation of an individual dose.

Such devices again have a complex design and make great demands on the production of the blister strips. The production also involves high costs. In addition, such single-dosed multi-dose systems usually cannot be reused.
Single-dose inhalers can take up precisely one single dose, e.g. in a capsule.
The user inserts a single capsule in the inhalation device before the inhalation.

For example, EP 1 245 243 Al discloses a pin-like capsule inhaler having a rotatable cutting/perforation device for perforating or cutting a capsule. WO
2007/093149 Al and US 5,651,359 disclose inhalation devices where a capsule is forced against stationary knives to open it and the ends of the capsule are fully cut off. US
4,013,075 discloses an inhalation device where a capsule is opened by rotatable blades and the air flow is passed perpendicularly through the inhalation device.

Furthermore, EP 0 666 085 Al discloses an inhalation apparatus where a capsule is guided in a rotatable support past two knives and air is passed through the opened clamped capsule. US 4,889,114 discloses a tubular capsule inhaler through which an air flow is passed perpendicularly.

In addition, US 3,991,761 discloses a capsule inhaler where a capsule is laterally perforated by spring-loaded pins. Finally, WO 2007/098870 Al discloses a capsule inhalation device where an opening device movable with respect to the housing is provided at the mouthpiece.

All in all, it is often difficult to handle and clean the inhalation devices known from the prior art. They usually have a complex design including many components.
In addition, known inhalation devices often fail to fully empty a capsule.

On this background, it is the object of this invention to provide an improved inhalation device which overcomes at least part of the above drawbacks.

These objectives are achieved by the subject matters of the independent claims.
Preferred embodiments are indicated in the subclaims.

An inhalation device according to the invention can comprise a swirl chamber for receiving a capsule and for swirling the capsule content, at least one air introduction channel and at least one air discharge channel, wherein the air introduction channel and the swirl chamber and the air discharge channel are in fluid communication and wherein the air introduction channel and the air discharge channel extend at least partially in opposite directions. Sucked-in air can be introduced into the swirl chamber through the air introduction channel and can be discharged through the air discharge channel.

According to the invention, one or more air introduction channels and/or air discharge channels can generally be provided. However, it is preferred to only provide for one air introduction channel and one air discharge channel each since it is thus possible to obtain a defined and reproducible air flow by simple means. The arrangement and design of the air introduction channel and the air discharge channel, which extend at least partially in opposite directions, effects a particularly advantageous air passage since the air is passed circumferentially during an inhalation event.

The invention also provides a method for inhalation by means of an inhalation device according to the invention. The method comprises the steps of: introducing a capsule into a capsule support of an inhalation device, which is arranged and formed in a swirl chamber; opening the capsule by means of a cutting device, sucking in air through a mouthpiece via an air introduction channel and an air discharge channel, the capsule being caused to vibrate and rotate as a result of the air flow inside the swirl chamber so as to empty the capsule.

Further advantageous embodiments are indicated below.

The air introduction channel can comprise any geometries and can be formed at least partially in the lower part of the inhalation device. The air introduction channel of the inhalation device according to the invention can extend at least partially tangentially to the swirl chamber.

The inhalation device according to the invention can also comprise a mouthpiece which is in fluid communication with the air discharge channel.

Furthermore, an air inlet opening for the air introduction channel can be developed in the lower part at any position. The air introduction channel of the inhalation device according to the invention can also have an inlet which is arranged in an area of the inhalation device outside the areas provided for holding/gripping by a user during the inhalation, preferably adjacent to or near the mouthpiece.

When the external air is introduced from the direction of the mouthpiece -i.e. coming from the front side of the inhaler -, an inhaling patient usually cannot close the air inlet opening and thus the air introduction channel while gripping and holding the inhalation device in the ordinary way by his hand and/or individual fingers. A
perfect functioning of the inhalation device is thus ensured.

The air flow can basically be introduced into the swirl chamber from any sides and positions. The air introduction channel of the inhalation device according to the invention can also have an outlet which opens into a lower part of the swirl chamber and/or laterally into the swirl chamber. Thus, air sucked in from the outside can be introduced into the swirl chamber from below and/or laterally. An advantageous air flow onto the capsule can be produced in this way. The air flow then acts upon the in particular lower end of a capsule accommodated in the swirl chamber, said end facing the air inlet.

The air flow partially flows in circles, also in extension of the air introduction channel, along a vertical inner curvature of the swirl chamber. The air flow introduced from below lifts the capsule, thus supplying energy from below and causes the capsule to vibrate and rotate. As a result, the capsule can be lifted and be carried from below by an air current eddy acting as an air cushion.

The air discharge channel of the inhalation device according to the invention can also have an inlet which is in fluid communication with an upper area of the swirl chamber and an outlet, and the air discharge channel can extend between the inlet and the outlet in the shape of an arch or S.

The transition from the swirl chamber into the air discharge channel can initially extend, directly next to the swirl chamber, perpendicularly upwards and then in the shape of an arch and/or S towards the mouthpiece. For example, the air flow can initially be passed and/or sucked off from the swirl chamber upwards during an inhalation event. As a result, additional forces are released and the turbulent flows are enhanced. Thus, the capsule is advantageously sucked upwards with the air flow, e.g.
like a whirlwind, and supported from below by the air flow, e.g. in the way of an air cushion.

Thus, a deagglomeration can further be improved and a complete emptying of the capsule can be ensured. The air passage in the shape of an arch or S towards the mouthpiece enhances the above effects by additional flow fields. The particles contained in the air flow are deflected in a way by approximately 180 , thus colliding with the lateral upper closure of the swirl chamber and with the defining walls of the air discharge channel, which in turn results in the application of a force onto the particles. This in turn further enhances swirling and deagglomeration.

The transition between swirl chamber and air discharge channel can be kept free.
Also, a grid can be arranged in the inhalation device according to the invention at the start of the inlet of the air discharge channel. The grid prevents fragments forming when the capsule is cut from entering the air discharge channel and thus from entering a patient's lungs. Moreover, the active ingredients and carrier substances partially collide with the grid, which in turn advantageously supports the deagglomeration.

The air discharge channel can comprise a uniform cross-sectional area. The air discharge channel of the inhalation device according to the invention can also have a cross-section which becomes greater or smaller downstream of the swirl chamber.
Thus, the air discharge channel tapers and/or widens through its cross-sectional area.

The tapering of the cross-section serves for increasing the flow rate of the air flow. A
widening of the cross-section serves for slowing down the flow rate of the air flow.
For example, the flow cross-section widens advantageously towards the mouthpiece to provide a high volume flow having a comparatively low flow rate at the transition to the patient. When the air flow passes out of the swirl chamber and into the air discharge channel, the cross-section is tapered so that at this place high flow rates and an equal volume flow occur. The pulse effect is particularly great in this area, which in turn enhances the deagglomeration.

In addition, one or more recesses and/or protruding structures can be arranged and/or formed in the air introduction channel and/or in the air discharge channel and/or in the swirl chamber. The recesses and/or structures enhance a deagglomeration in the air introduction channel and/or in the air discharge channel and/or in the swirl chamber.
Here, the recesses and/or protruding structures can be made e.g. as dissipaters, projections of any geometries and/or so-called baffles with which the active ingredient/s and carrier substances collide through the air flow and are deflected. Such a design of the air introduction channel and/or air discharge channel and/or the swirl chamber advantageously enhances a swirling of the air flow and results in an additional pulse effect on the active ingredients and carrier substances. This in turn improves the powder dispersion.

The inhalation device according to the invention can also comprise at least one additional channel at least partially surrounding the air discharge channel for generating an additional air flow. This additional channel can be arranged and designed such that the additional air flow encloses the air flow containing swirled active ingredients. For this purpose, the air discharge channel and the at least one additional channel can extend at least partially parallel, the additional channel passing an air flow from above and/or laterally or circumferentially to the edge of the air discharge channel. It is thus possible to further improve the described deagglomeration and swirling effects and reduce the active ingredient deposition at the oropharynx.

A capsule can only be inserted in the swirl chamber. This can be advantageous, for example, when the capsule was opened via an external cutting device or a protection film was peeled off.

The swirl chamber of the inhalation device according to the invention can also comprise a support for receiving a capsule. The capsule support can have the same dimensions as a capsule or also be made larger than the capsule.

In addition, the support of the inhalation device according to the invention can be designed such that a capsule is held in positive and/or frictional engagement.
The capsule is advantageously fixed in a defined position.

During an inhalation event, the air flow supplied through the air introduction channel moves an inserted sphere in the swirl chamber and causes the capsule to move intensely in the form of a preponderant rotation and vibration. The swirl chamber can have any geometries. A freely movable capsule leads to markedly more turbulent flow fields than a resting capsule, for example. As a consequence, greater forces occur which support the emptying of the capsule, on the one hand, and the deagglomeration and/or dispersion of the active ingredient to be inhaled, on the other hand.
The air passage thus supports an acceleration and movement of the capsule and also an acceleration and movement of the active ingredient/s and the carrier substance/s.

As described, a capsule can be inserted in the inhalation device according to the invention when it is already open, e.g. after removing a protection film or opening it by means of an external cutting mechanism.

Alternatively, it can be opened in the inhalation device. For this purpose, the inhalation device according to the invention can be provided with a cutting apparatus for opening a capsule. It can be arranged in the upper part. When the cutting device is integrated into the inhalation device, there are advantageously no transport losses of active ingredients from an open capsule.

To this end, the cutting device of the inhalation device according to the invention can comprise at least one movable cutting member. The use of two parallel cutting members is of special advantage. For example, knives or blades can be used as the cutting members. They advantageously serve for avoiding the formation of capsule fragments and for achieving smooth cutting or stab edges as compared to pins.
The drawbacks of other opening means are also prevented, such as the formation of fragments and/or of a closure of a perforated capsule surface by fragments and/or by the active ingredient contained therein.

The cutting members can be designed so as to be inserted in the upper part of the inhalation device. They are preferably firmly fixed in the upper part, e.g.
adhered, mechanically connected or formed integrally in the upper part during the production thereof. In the case of a mechanical connection, the knives are preferably exchangeable.

In general, the at least one cutting member of the inhalation device according to the invention can be made from any metals or the alloys thereof but also from other suitable materials, such as ceramics. For example, the material used can be a high-alloy steel which is surface-treated or hardness-treated by means of a nitriding method, for example. The blades can be accurately cut using the spark erosion technology, for example. The cutting members preferably consist of a steel grade admitted for pharmaceutical applications; e.g. AISI 316L.

The capsule ends are advantageously cut on both sides by means of two parallel cutting members. For this purpose, the blades can be designed and arranged such that they do not cut off the capsule ends but only cut partially or fully into the capsule ends. As a result, irregular cutting edges and a trapping of capsule ends are avoided.
Another advantage is that the air flow is not impeded by capsule ends which were possibly cut off. The powder contained in the capsule can be emptied into the swirl chamber by the cuts. Thus, the cutting course is also closely correlated with the air passage.

The knives can be equipped with any suitable blades. For example, the knives can be made with a rounded, one-sided double-chamfered blade having a radius of curvature of 1.28 cm. They are preferably made with a straight, two-sided, double-chamfered blade and a blade angle of 80 each or with a straight, one-sided, double-chamfered blade and a blade angle of 67 or with straight, double-chamfered blades and a blade angle of 0 . A straight, one-sided, single-chamfered or double-chamfered blade having a blade angle of 35 is particularly preferred.

The capsules in an inhalation device according to the invention can basically be moved to a cutting device. However, the cutting members are advantageously forced against the fixed and resting capsule. Since a capsule is fixed in the capsule support, a movement of the capsule is avoided during opening and the capsule is always in the same position. Thus, the cutting course and the cutting point at the capsule can be reproduced as desired and miscuts are avoided.

The at least one cutting member of the inhalation device according to the invention can also first cut the capsule with the tips of its blades. When the tips of the cutting member first contact the capsule surface, a deformation of the capsule can advantageously be avoided and accurate cuts can be achieved. In order to open a capsule, the cutting members approach the capsule from above and the latter is then cut vertically from above. The cutting angle can be 0 - 90 to the longitudinal axis of the capsule. It is preferably 10 and more preferably 0 .

The capsules can basically consist of any materials. However, rather high forces are required for opening gelatin capsules, for example. In particular when the humidity is low, gelatin capsules additionally tend to become brittle and/or to split.
However, when the humidity is high, gelatin capsules become soft and hence tend to deform.
Capsules based on hydroxypropylmethyl cellulose have shown to be particularly suited for an inhalation device according to the invention. This material distinguishes itself in that it can be opened particularly easily and hardly tends to form fragments.

This material also retains its described properties over a wide range of humidity so that the risk of a capsule deformation or a fragment formation is low.

The inhalation device according to the invention can also comprise an actuation member for actuating the cutting member. The actuation member is advantageously arranged in the upper part of the inhalation device so as to be separate from the air passage. A positive engagement of all air-conducting components is thus ensured so that no leakages can occur and the cutting device has no disadvantageous influence on the air flow during the inhalation.

In addition, the inhalation device according to the invention can comprise a spring member to keep the cutting device biased in a pull-back position. The actuation member can be guided by at least one guide member. It ensures an accurate guidance of the actuation member and thus of the cutting member/s. The guide member can be designed as a guide rail, guide groove or any other suitable guide mechanism.
Thus, the guidance of the knife and the cutting angles are advantageously reproducible in any way.

In general, the actuation member can be actuated via any suitable manipulating mechanisms. For example, the actuation member can comprise a thread which cooperates with a thread arranged in the upper part. For cutting into a capsule, the actuation member can be turned, i.e. screwed into the inhalation device, the cutting member being forced against the capsule and cutting into the ends thereof.
Furthermore, the at least one cutting member can be fully accommodated in the upper part in the pull-back position. A danger of injury by the knives is thus advantageously reduced. It is also ensured that the air flow is not impeded by the cutting device during the inhalation.

The actuation member can be actuated against the force of the spring member into an actuation position such that the at least one cutting member can be moved into the swirl chamber by means of the at least one guide member so as to open a capsule without touching the bottom part. All in all, the cutting device of the inhalation device according to the invention advantageously ensures a maximum of reproducibility of the cut by the cutting member/s.

Since the fragment formation and capsule deformation are avoided during the cutting step, the emptying step during the inhalation can also be reproduced. This in turn enables a uniform dose dispense. Furthermore, it is also ensured that the active ingredient is also almost fully emptied from the capsule. Only a minimum of active ingredient is left in the inhalation device. The cutting device also optimizes the dimensions and design of the air-conducting components and also the separation of the active ingredient from the carrier material and/or the dispersion of the active ingredient/s. This serves for avoiding dose fluctuations, such as dosage failure or insufficient dosage in the worst case.

The inhalation device according to the invention can also comprise an upper part and a lower part which are connected to each other. For this purpose, a snap-action or locking device or any other suitable mechanism can be used, for example.

Basically any opening mechanism can be provided. The upper part and the lower part of the inhalation device according to the invention can also be pivotably connected, preferably such that the upper part can be moved between an open position to remove or receive a capsule and a closed position for the inhalation. For this purpose, e.g. a hinge arrangement can be used. The inhalation device can be pivoted between a defined open position to remove or receive a capsule and into a defined closed position for the inhalation. The pivot positions can additionally be defined and fixed by nap-in connections, for example.

The inhalation device according to the invention can also comprise a safety mechanism which can prevent an actuation of the actuation member in the open position. It can be a locking pin, for example.

In addition or alternatively, the inhalation device according to the invention can comprise a further safety mechanism which can prevent an inhalation upon actuation of the actuation member. For this purpose, the actuation member can be mechanically linked to the safety mechanism, for example. An inappropriate dosage can be advantageously avoided in this way.

An inhalation device according to the invention can also comprise any specific device resistances. The inhalation device according to the invention preferably comprises a specific device resistance of 0.027 to 0.050 kPa 5=L/min, resulting in flow rates of 40 - 75 L/min with a pressure drop of 4 kPa via the inhalation device (1);
preferably of 0.031 to 0.044 kPa 5=L/min, resulting in flow rates of 45 - 65 L/min with a pressure drop of 4 kPa via the inhalation device (1); more preferably of 0.036 to 0.040 kPaO 5=L/min, resulting in flow rates of 50 - 55 L/min with a pressure drop of 4 kPa via the inhalation device.

These middle to high device resistances are advantageously considered to be more pleasant by many patients, this having a positive effect on a patient compliance. In this range, it is also possible for all patient groups to obtain the flow rates required for the inhalation.

The thus achieved air flows are obtained compared to devices having low resistances in lower air velocities and longer residence times of the powder in the highly turbulent inhaler zones, which results in an improved separation of active ingredient and carrier.
The capsule is also exposed to the turbulent air flow for a prolonged period of time, which has a positive effect on the emptying thereof. Thus, the drawbacks of inhalers which operate at low and very high resistances are advantageously overcome.

All in all, the preferred embodiments provide a flexible and compact inhalation device and an inhalation method. The inhalation device according to the invention is made in particular as a single-dose capsule inhaler.

An inhalation device according to the invention can easily be manipulated and cleaned advantageously by a patient. The inhalation device according to the invention also only comprises some few components and has a simple design so that it can be produced inexpensively. In addition, it can be operated with commercially available capsules. These capsules advantageously make a comparatively low demand on the powder technology and their production is inexpensive.

The capsule can basically be opened for the purpose of emptying at any positions.
However, when the capsule is open at the ends, the capsule openings are advantageously found at the site of maximum centrifugal forces in the case of a rotating capsule. As a result of such a combination of the opening position with the movement of the capsule, the forces are markedly enhanced compared to systems having a resting capsule and other opening positions. The forces support and/or maximize the emptying of the capsule and the deagglomeration of the active ingredient or an active ingredient dispersion to be inhaled. All in all, an almost full emptying of the capsule can advantageously be achieved. The active ingredient is also swirled such that only some few powder residues are left in the air-conducting parts of the inhalation device and/or the capsule and the active ingredient and the carrier material are separated as extensively as possible.

The deagglomeration and/or dispersion are also correlated with a capsule opening and the dimensions and the design of the air-conducting components. All these factors are optimized according to the invention. Both the intense movement of the capsule and the dimensioning of the air-conducting parts ensure a maximum of turbulence in the inhalation device according to the invention. This, in turn, advantageously effects reproducible capsule emptying via a defined air flow.

The invention is now explained by means of preferred embodiments with reference to the enclosed exemplary figures. Members which correspond in the different figures bear the same reference numerals.

Figure I shows a longitudinal section of an inhalation device according to the invention;

Figure 2a a longitudinal section of the upper part of the inhalation device of figure l;

Figure 2b shows a top view of the upper part of figure 2a from below;

Figure 3a shows a cross-sectional view of the lower part of the inhalation device of figure 1;

Figure 3b shows a top view of the lower part of figure 3a from above;

Figure 4 shows a cross-sectional view of the inhalation device according to the invention; and Figure 5 shows a longitudinal section through a lower part of a further inhalation device according to the invention.

Positional designations used hereinafter, such as above, below, front, rear, right and left, relate to the view of the observer onto an inhalation device arranged in front of him, the mouthpiece pointing to the user and the upper part upwards.

Figure 1 shows an inhalation device I according to the invention, which is designed as a capsule-based powder inhaler. The inhalation device 1 comprises an upper part 3 and a lower part 5; both are connected to each other via a hinge arrangement 7. The upper part 3 can be pivoted with respect to the lower part 5 between an open position (not shown) and a closed position.

In the open position, a user can insert a capsule in a swirl chamber 15 or remove an emptied capsule therefrom. The capsule contains an active ingredient or active ingredients to be inhaled which can be combined with a carrier substance or carrier substances. An inserted capsule moves in the swirl chamber 15 via the air flow caused during the inhalation and rotates and/or vibrates. In the open position, all components are easily accessible and therefore it is easy to clean the inhalation device.

Figure 1 shows the inhalation device in its closed position. The upper part 3 comprises a housing 23 in which a cutting device 11 is arranged. Prior to the inhalation, the user opens an inserted capsule by means of the cutting device 11 (see figures 2a, 2b and 3).
For this purpose, the cutting device 11 comprises an actuation member 25 which is here made as a pin-like button as well as two parallel cutting members 27 which are made as knives in the embodiment as shown. The button 25 is linked with the upper part 3 via an attachment means, e.g. a screw or a pin. In addition, the cutting device II
is provided with a spring member 37 which biases the button 25 and thus the knives 27 into an initial position. The spring member can be any spring, e.g. a compression or spiral spring. In the initial position, the knives 27 are arranged within the housing. 23.
In order to prevent the danger of injury in the open state, the upper part 3 can be designed so as not to be fully pivotable but only to such an extent that a removal or an insertion of a capsule and/or a cleaning of the inhalation apparatus I is easily possible.
Alternatively or additionally, a safety mechanism (not shown) can also be provided which prevents an actuation of a cutting apparatus 11 in the open position.

The knives 27 can be equipped with any blades 29, e.g. with a rounded, one-sided, double-chamfered blade having a radius of curvature of 1.28 cm; preferably with a straight, two-sided, double-chamfered blade and a blade angle of 80 each or with a straight, one-sided, double-chamfered blade and a blade angle of 67 or with a straight, double-chamfered blade and a blade angle of 0 . Knives 27 including a straight, one-sided, single-chamfered or double-chamfered blade and a blade angle of 35 have shown to be particularly suitable.

The knives 27 can also have any dimension. Knives having a width of 3 mm, a thickness of 0.6 mm and a length of 35 mm have shown to be particularly suitable.

In order to open a capsule, a user pushes the actuation button 25 and thus the knives 27 against the spring force vertically downwards towards the lower part 5 and thus to the capsule into an operating position. For this purpose, two of the openings adapted to the blade size are formed in the bottom side of the upper part 3 through which the knives 27 move into the lower part 5 to a capsule inserted in the capsule support 15.
The tips 33 of the blades 29 first strike the capsule surface of a capsule and then cut into and through both capsule ends.

The actuation button 25 is slidably guided by two guiding members 39 arranged on both sides. Any known guide mechanisms can be provided as the guidance. In the embodiment shown herein (cf. figures 1 and 2a), the guide members are made as slide rails 39 between which the actuation button 25 is vertically slidable. Several slide rails 39 can also be mounted on certain circumferential positions of the upper part 3. In the embodiment shown herein, the slide rails 39 are formed circumferentially around the upper part 3. In this connection, the sleeve-like section of the actuation button 25 is enclosed by an outer slide rail 39 from outside by an inner slide rail 39 from inside.
The slide rails 39 ensure an accurate guidance and prevent jamming of the actuation button 25. This in turn ensures a uniform accurate guidance of the anchored knives 27.
Alternatively, the actuation button 25 can also comprise a means, such as a spring, which meshes with a spring guidance like a tongue and groove system.

The cutting angle is defined via the arrangement of the knives 27 and can be made as desired. Cutting angles of 90 , preferably 10 , more preferably 0 , based on the longitudinal axis of the capsule, are particularly preferred. While cutting into a capsule, the knives 27 move through the capsule beyond the lower end of the capsule and into two recesses 35 formed in the bottom side of the capsule support 9.
The recesses 35 correspond to the knife size or can be made somewhat larger and prevent a contact of the tips 33 of the blades 29 with the lower part 5.

Having opened a capsule, the user releases the actuation button 25. The spring exerts a force on the actuation button 25and moves the latter and thus the knives 27 into the initial position. The knives 27 are then fully retracted into the housing 23.

In addition, a further safety mechanism (not shown) can also be provided which prevents an inhalation while the actuation button 25 is pressed down, e.g. a blockage of the air channels. An incorrect use of the inhalation device I or an inappropriate dosage can thus be avoided.

When the inhalation device I is closed, part of the bottom side of the upper part 3 closes both an upper closure of the swirl chamber 15 and also partially the top side of an air discharge channel 14 in the mouthpiece 21 by means of a positive fit with the lower part 5. Since the rest of the air introduction channel 13 and/or the air discharge channel 14 are formed in the lower part 5, a seal of the air-conducting channels 13 and 14 is ensured when the inhalation device 1 is closed. When the inhalation device I is closed, a connection between the swirl chamber 15 and the air discharge channel 14 is thus established.

In addition, another safety mechanism, e.g. a snap-action device (not shown) can secure the positive fit between the upper part 3 and the lower part 5. It also prevents an opening of the inhalation device I during an inhalation.

Alternatively, the air introduction channel 13 and/or the air discharge channel 14 can also fully be arranged and designed in the lower part 5 so that there is no cover by the upper part 3. The channels 13, 14 are then cleaned through the mouthpiece 21, for example.

Figures 3a, 3b and 4 show further details of the lower part 5. The air introduction channel 13, the capsule support 9 and the lower part of the swirl chamber 15 are arranged and formed in the lower part 5. The dimensions of the swirl chamber 15 can be made as desired. For example, a height of 7 to 9 mm has shown to be suitable as dimensions of the swirl chamber 15; with 8 mm being particularly suitable. The capsule support 9 is formed in the bottom of the swirl chamber 15. The dimensions of the capsule support 9 are adapted to a capsule size such that the capsule can be fixed therein. For example, a capsule cannot move or slip during cutting and therefore a maximum reproducibility is ensured for the cut by the knives 27.

The air introduction channel 13 extends from the front side of the inhalation device 1 laterally into the swirl chamber 15. Suitable cross-sectional areas of the air introduction channel 13 are 11.8 mm2, for example. 17.7 mm2 or in particular 23.6 mm2 have shown to be particularly suitable.

The air inlet of the air introduction channel 13 can be arranged and designed at any positions in the area between the mouthpiece 21 and the capsule support 9 in the lower part. In the embodiment as shown, the air inlet of the air introduction channel 13 is formed between mouthpiece 21 and upper part 3. An arrangement coming from the front side of the inhaler has the advantage that it is impossible for an inhaling person to close the air introduction channel 13 when the inhalation device 1 is gripped and held as usual.

In the case of an inhalation event, the air flow is introduced through the air introduction channel 13 via an air inlet laterally into the lower region of the round swirl chamber 15. The air flow partially acts on the in particular lower end of a capsule which faces the air inlet and partially flows in circular fashion in extension of the air introduction channel 13 along the vertical outer curvature of the swirl chamber 15. The air flow lifts a capsule and conveys it out of the capsule support 9 to the upper area of the swirl chamber 15 where the air flow causes the capsule to vibrate and rotate. The clearance for the capsule in the capsule support 9 is large such that it cannot clamp or jam in any other way. The resulting suction ensures via the rotary motion and the vibration of the capsule the emptying of the powder into the surrounding swirl chamber 15.

A grid 17 is arranged at the transition between swirl chamber 15 and air discharge channel 14. The grid 17 supports a powder fragmentation, on the one hand, and hinders fragments which might form when the capsule is cut from entering the air discharge channel 14, on the other hand. The grid can have any dimensions. A
free area of 51 mm2, more preferably 36 mm2, most preferably 21 mm2, and a ridge width of 1.30 mm, more preferably 0.86 mm, most suitably 0.42 mm, have proven suitable.
The air discharge channel 14 leading to the mouthpiece 21 is arranged and formed such that it starts from the grid 17. The air discharge channel 14 extends downstream of the swirl chamber 15 vertically upwards. An arch-shaped transition area follows which extends to the mouthpiece 21. The air introduction channel 13 and the air discharge channel 14 thus extend at least partially parallel and in opposite directions.
The air flow introduced through the air introduction channel 13 is sucked off upwards into the air discharge channel l4after flowing through the swirl chamber 15.
This is where the air flow is deflected by almost 180 and is thus guided at least partially opposite to the air passage in the air introduction channel 13 through an arch-shaped area of the air discharge channel 14. The air flow here conveys an active ingredient or several active ingredients to the mouthpiece 21 where the air flow leaves the inhalation device I and can be taken up in the lungs of a patient. The vibrating and rotating capsule is sucked upwards by the air flow and is lifted like an air cushion from below.

Moreover, the longitudinal area of the air discharge channel 14 tapers or widens with respect to its cross-section. At the transition from the swirl chamber 15 to the air discharge channel 14, the flow cross-section tapers so that there is an equal volume flow having a high flow rate during the inhalation. The cross-section widens towards the mouthpiece 21 so that the outflowing air flow comprises a high volume flow with low flow rate.

Figure 5 shows a longitudinal section through a lower part 5 of a further inhalation device I according to the invention with additional channels 41. The additional channels 41 partially extend parallel to the air discharge channel 14 and pass an air current from above circumferentially to the edge of the air discharge channel 14.
During an inhalation event, an additional air flow can be produced via the additional channels 41, said flow enclosing the air flow containing the swirled active ingredients.

Thus, the described deagglomeration and swirling effects can even be improved and the active ingredient deposition at the oropharynx can be reduced.

Further embodiments and variations of the present invention follow for a person skilled in the art from the below claims.

Claims (23)

1. An inhalation device (1) for inhaling at least one active ingredient contained in a capsule, comprising:

- a swirl chamber (15) for receiving a capsule and for swirling capsule content, - at least one air introduction channel (13), and - at least one air discharge channel (14), wherein the air introduction channel (13) and the swirl chamber (15) and the air discharge channel (14) are in fluid communication and wherein the air introduction channel (13) and the air discharge channel (15) extend at least partially in opposite directions.
2. The inhalation device (1) according to claim 1, wherein the air introduction channel (13) extends at least partially tangentially to the swirl chamber (15).
3. The inhalation device (1) according to claim 1 or 2, comprising a mouthpiece (21) which is in fluid communication with the air discharge channel (14).
4. The inhalation device (1) according to any of the preceding claims, wherein the air introduction channel (13) has an inlet which is arranged in an area of the inhalation device (1) outside the areas which are provided for holding/gripping by a user during an inhalation, preferably adjacent to or near the mouthpiece (21).
5. The inhalation device (1) according to any of the preceding claims, wherein the air introduction channel (13) has an outlet which opens into a lower part of the swirl chamber (15) and/or laterally into the swirl chamber (15).
6. The inhalation device (1) according to any of the preceding claims, wherein the air discharge channel (14) has an inlet which is in fluid communication with an upper part of the swirl chamber (15) as well as an outlet and the air discharge channel (14) extends between the inlet and the outlet in the shape of an arch or S.
7. The inhalation device (1) according to any of the preceding claims, wherein a grid (17) is arranged at the start of the inlet of the air discharge channel (14).
8. The inhalation device (1) according to any of the preceding claims, wherein the air discharge channel (14) has a cross-section which becomes larger and/or smaller in the direction downstream of the swirl chamber (15).
9. The inhalation device (1) according to any of the preceding claims, wherein one or more recesses and/or protruding structures are arranged and/or formed in the air introduction channel (13) and/or in the air discharge channel (14) and/or in the swirl chamber (15).
10. The inhalation device (1) according to any of the preceding claims, comprising at least one additional channel (41) at least partially surrounding the air discharge channel (14) to generate an additional air flow.
11. The inhalation device (1) according to any of the preceding claims, wherein the swirl chamber (15) has a support (9) to receive a capsule.
12. The inhalation device (1) according to claim 11, wherein the support (9) is made to hold a capsule in positive and/or frictional engagement.
13. The inhalation device (1) according to any of the preceding claims, comprising a cutting device (11) for opening a capsule.
14. The inhalation device (1) according to claim 13, wherein the cutting device (11) comprises at least one movable cutting member (27).
15. The inhalation device (1) according to claim 14, wherein the at least one cutting member (27) first cuts into the capsule with the tips (33) of its blades (29).
16. The inhalation device (1) according to claim 14 or 15, comprising an actuation member (25) for actuating the cutting member (27).
17. The inhalation device (1) according to any of claims 13 to 16, comprising a spring member (37) to keep the cutting device (11) biased in a pull-back position.
18. The inhalation device (1) according to any of the preceding claims, comprising an upper part (3) and a lower part (5), which are connected to each other.
19. The inhalation device (1) according to claim 18, wherein the upper part (3) and the lower part (5) are pivotably connected, preferably such that the upper part (3) can be moved between an open position to remove or receive a capsule and a closed position for the inhalation.
20. The inhalation device (1) according to claim 19 in so far as dependent on claim 16, comprising a safety mechanism which can prevent an actuation of the actuation member (25) in the open position.
21. The inhalation device (1) according to any of the preceding claims, comprising a further safety mechanism which can prevent an inhalation upon actuation of the actuation member (25).
22. The inhalation device (1) according to any of the preceding claims comprising a specific device resistance of 0.027 to 0.05 kPa0.5.cndot.L/min, resulting in flow rates of 40 - 75 L/min with a pressure drop of 4 kPa via the inhalation device (1);
preferably of 0.031 to 0.044 kPa0.5.cndot.L/min, resulting in flow rates of 45 - 65 L/min with a pressure drop of 4 kPa via the inhalation device (1); more preferably of 0.036 to 0.040 kPa0.5.cndot.L/min resulting in flow rates of 50 - 55 L/min with a pressure drop of 4 kPa via the inhalation device (1).
23. A method for inhaling at least one active ingredient contained in a capsule, comprising the steps of:

- inserting a capsule in a capsule support (9) of an inhalation device (1) according to any of the preceding claims, which support is arranged and formed in a swirl chamber (15);
- opening the capsule by a cutting device (11) according to any of claims 12 to 18;
- sucking in air through a mouthpiece (21) via an air introduction channel (13) and an air discharge channel (14) according to any of claims 1 to 9, wherein the capsule is caused to vibrate and rotate within the swirl chamber (15) such that the capsule is emptied.
CA2771443A 2009-08-18 2010-08-02 An inhalation device and a method for inhaling an active ingredient from a capsule Abandoned CA2771443A1 (en)

Applications Claiming Priority (3)

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DE102009037840A DE102009037840B4 (en) 2009-08-18 2009-08-18 Inhalation device and method for inhaling an active ingredient from a capsule
DE102009037840.5 2009-08-18
PCT/EP2010/004724 WO2011020554A1 (en) 2009-08-18 2010-08-02 Inhalation device and method for inhaling an active ingredient from a capsule

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CN102573970A (en) 2012-07-11
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EA032404B1 (en) 2019-05-31
DE102009037840A1 (en) 2011-02-24
AU2010285290A1 (en) 2012-03-08
EA201290065A1 (en) 2013-01-30
EP2467184A1 (en) 2012-06-27
WO2011020554A1 (en) 2011-02-24
JP2013502247A (en) 2013-01-24

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