Field of the Invention

This invention pertains in general to the field of medicament inhalers, and more particularly to dry powder inhalers, and such dry powder inhalers for one dose administration. The inhaler comprises at least one air inlet and at least one air outlet, and a container comprising a pre-filled dry powder drug, the inhaler having an airflow there through from the at least one air inlet to the at least one outlet during inhalation by a user at said at least one outlet, which airflow will convey said dry powder drug if inhalation by the user is performed after dispersing said dry powder drug from the container.

Background of the Invention

In the pharmaceutical field, with respect to treatment of respiratory and/or other diseases, inhalers have been widely used. Numerous drugs, medications and other substances are inhaled into the lungs for rapid absorption in the blood stream and for local action in the lung with such inhalers.

Inhaled drugs fall into two main categories, in form of liquids, including suspensions, and powders. The choice of category depends on the characteristics of the drugs, medications, etc., to be inhaled.

The most common type of inhaler is the pressurized metered-dose inhaler. In this type of inhaler medication is most commonly stored in solution in a pressurized canister that contains a propellant, although it may also be a suspension. The canister is attached to a plastic, hand-operated actuator. On activation, the metered-dose inhaler releases a fixed dose of medication in aerosol form.

Another kind of inhaler is a nebulizer, which supply medication as an aerosol created from an aqueous formulation.

The kind referred to herein is yet another type, in form of a dry powder inhaler, and specifically a one dose dry powder inhaler. A dry powder inhaler releases a metered or device-metered dose of powdered medication that is inhaled through the inhaler.

Dry powder inhalers need to deliver a particle size that is predominantly below

5 microns, and preferably between 1 micron and 3.3 microns, for maximum effectiveness. Such small particles are, however, very cohesive due to high surface energy. Agglomeration may be worsened by moisture, whereby it is specifically appropriate to keep the metered dose protected from moisture in a container, which is opened, such that the drug/medication therein is revealed, shortly before inhalation. In this context, reveal means that the drug/medication is uncovered, such that it may exit the container. Agglomeration of small particles is a problem which results in the active particles leaving the inhaler as large agglomerates.

WO2008008021 relates to an inhalation system for the administration of a drug in the form of dry powder by inhalation through an airflow path. The system comprises a delivery device, having a mouthpiece through which the powder is inhaled, a dose cassette comprising at least one drug cavity for each dose, comprising a dose to be delivered.

WO2010024759 relates to a an inhaler. The inhaler comprises a base having at least one foil sealed cavity containing medicament. A separating element is attached to the foil for separating the foil from the cavity.

WO2010021589 relates to an inhaler in which an outlet cover is connected to a movable actuator portion located upstream of a sealed medicament-containing cavity. As the outlet cover is removed from the outlet, the actuator portion moves downstream of the cavity and a sealing foil becomes separated from the cavity.

One dose dry powder inhalers, of these kinds, are provided with one metered dose, and this kind of inhaler may for example be used for vaccinations, clinical trials or emergency healthcare, wherein the user not is a day to day user, and the inhaler therefore goes to waste after its only use. These kind of inhalers are, for economical reasons, kept to the minimum with regard to pieces and parts, since the consumption is high and lifetime is low. Therefore, they are normally provided with unprotected inlets/outlets, and perhaps with a cover cap applied over, for example, the outlet. In use, such as in emergencies, the user needs to remove the cap, if there is one, and thereafter reveal the drug. If there is no cap, there is a risk that (i) the inlet or outlet has been fully or partly blocked before use, whereby the delivery of the inhaled drug is impaired and the well being of the patient is jeopardized,(ii) foreign particles entering the device through the outlet or inlet before usage leading to a risk of inhaling foreign particles putting the patient at a risk and (iii) the outlet being soiled or contaminated and being unhygienic. In view of these drawbacks and limitations of the prior art, what is needed is a dry powder inhaler device in which effective and satisfactory dispersion of the dry powder is obtained, while simultaneously facilitating opening of the drug cavity and omitting unnecessary usage steps and handling, and minimizing the risk of clogging and/or soiling of inlets and outlets.

Summary of the Invention

Accordingly, the present invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination and solves at least the above mentioned problems by providing a dry powder drug inhaler comprising: a housing, said housing comprising at least one air inlet and at least one air outlet, and a container comprising a dry powder drug, wherein, upon inhalation by a user at said at least one outlet, an airflow from the at least one air inlet to the at least one outlet will convey said dry powder drug if inhalation by the user is performed after dispersing said dry powder drug from the container; and a strip, said strip forming a part of said container and occluding at least one of said at least one air outlet, such that removal of the strip from the housing reveals said dry powder drug and said at least one of said at least one air outlet.

Further advantageous embodiments are disclosed in the appended and dependent patent claims.

Brief Description of the Drawings

These and other aspects, features and advantages of which the invention is capable of will be apparent and elucidated from the following description of

embodiments of the present invention, reference being made to the accompanying drawings, in which

Fig. 1 is a perspective view from an outlet end of an inhaler according to an embodiment of the present invention;

Fig. 2 is a perspective view from an inlet end of an inhaler according to an embodiment of the present invention;

Fig. 3 is a top view of an inhaler according to an embodiment of the present invention;

Fig. 4 is a cross sectional view along a longitudinal axis of an inhaler according to an embodiment of the present invention; Fig. 5 is a side and close up view of a container in an inhaler according to an embodiment of the present invention;

Fig. 6 is a cross sectional view along a longitudinal axis of an inhaler according to an embodiment of the present invention; and

Fig. 7 is a cross sectional view along a longitudinal axis of an inhaler according to an embodiment of the present invention.

Description of embodiments

The following description focuses on an embodiment of the present invention applicable to a medicament inhaler, and in particular to a dry powder drug inhaler for a one dose administration. However, it will be appreciated that the invention is not limited to this application but may be applied to many other inhalers having an inlet and an outlet, as well as a medicament container.

Figs. 1 to 5 illustrate a dry powder drug inhaler 100. The dry powder drug inhaler 100 comprises a housing 101. The housing 101 comprises an air inlet 102 and an air outlet 103. The outlet 103 is arranged at a first end of the housing 101, while the inlet 102 is arranged at an opposite second end of the housing 101.

The number of inlets and outlets may be different from what is disclosed in

Figs. 1 to 5. The number of inlets may for example be adjusted in accordance with needs and specific inhaler design, such that a number of smaller inlets, for reducing pressure fall over the inhaler, are arranged circumferentially of the housing 101. This is not shown. In a corresponding manner the number of air outlets may be adjusted in accordance with needs and specific inhaler design.

The housing 101 may be manufactured in a suitable material, such as injection moldable plastics, such as thermoplastics.

The inhaler 100 further comprises a container 104, arranged in the housing 101. The container 104 comprises a dry powder drug, such as in the form of a pre-filled drug containing container 104. Upon inhalation by a user at the outlet 103, an airflow from the inlet 102 to the outlet 103 will convey said dry powder drug if inhalation by the user is performed after revealing, i.e. uncovering, the dry powder drug in the container 104.

The container 104 is preferably arranged close to the first end of the housing 101 , i.e. close to the inlet 102. In this way, the drug may be affected directly of air entering the housing 101, such that the drug will have an increased amount of time to be distributed in the air stream before exiting the inhaler 100 at the outlet 103. This results in an improved drug/air profile, increasing the possibility of drug entering an increased area/volume of the lungs of the user.

A strip 105 is arranged on the housing 101. The strip 105 forms a part of the container 104, such that removal of the strip 105 will reveal the drug in the container 104. Also the strip 105 occludes the outlet 103, such that removal of the strip 105 from the housing 101 reveals the outlet 103. In this way the strip 105 forms a protective sheet at the outlet 103, such that the potential user will have a decreased risk of clogging the outlet or getting the outlet 103 dirty during keeping or storage, bearing in mind that the user shall inhale on this outlet 103 during use. Thus, the strip 105 closes the container 104, and extends from the container 104 to the outlet 103 to occlude the latter. The strip

105 then closes the container 104 via a first interaction surface between the strip 105 and a container cavity 104b, where after the strip 105 extends away from the container 104 to the outlet 103 to occlude the outlet 103 via a second interaction surface between the strip 105 and the outlet 103. The strip 105 also occludes the inlet 102, such that the strip 105 forms a protective sheet also at the inlet 102, such that the potential user will have a decreased risk of clogging also the inlet 102 or get the inlet 102 dirty during keeping or storage. The strip 105 then closes the inlet 102 via a third interaction surface between the strip 105 and the inlet 102. The strip 105 then extends away from the container 104 and/or the outlet 103 to occlude the inlet 102 via said third interaction surface between the strip 105 and the inlet 102. In this way the closure of the container 104 may be obtained in a different plane than the closure of the outlet 103 and/or the inlet 102, minimizing risk of clogging outlets/inlets by medicament kept in the container 104.

The strip 105 has a first end 106 in the vicinity of the outlet 103. This first end

106 allows for easy access of the strip 105, by for example providing it with a pull tab 107. Furthermore, the strip runs longitudinally of said housing 101 to said container 104, optionally via the inlet 102. The strip 105 runs on an outer surface of said housing 101 from the outlet 103 to the container 104, optionally via the inlet 102. The strip 105 is arranged double folded at said container 104, such that it attaches to the container 104 centrally. This means that the strip attaches to the container on a side of the container facing away from the second end of the housing 101, i.e. being closer to the center of the housing along a longitudinal axis of the housing 101 and thus the inhaler 100. In this way, when pulling the strip away from the housing 101 , the strip 105 will tear the container 104 in a direction from the centre of the housing 101 towards the second end of the housing 101. Then, the tearing, i.e. the breakage, of the container 104 will reveal the dry powder drug. To facilitate rupture/tearing of the container 104, the container comprises the form of a blister package, wherein the strip 105 attaches to/forms a part of the container 104. In other words, the container 104 comprises a base portion 104a, with the cavity 104b for receiving the drug. Additionally, the container 104 comprises a cover 104c arranged over the container cavity 104b and the drug, and the cover 104c is a part of, i.e. attaches to or is monolithically formed with, the strip 105.

The strip 107 and the container 104 may for example be manufactured in a suitable material for enclosing openings and cavities, and specifically cavities for holding moisture sensitive drugs. One such suitable material is an aluminum foil, such as an aluminum foil laminated with a plastic. It is not necessary that also the strip 107 is made of a moisture barrier of this kind, but for facilitating manufacturing the same foil may be used for the strip 107 as for the container 104.

Before use, the user will hence grab the pull tab 107; pull the strip 105 over the outlet 103; then proceed with turning the inhaler 100 or pulling the strip 105 from below also over the inlet 102; to finally pull the strip 105 away from the housing 101 to break the container 104 and reveal the drug. After this, the user will bring the outlet 103 to his/her mouth, and inhale, such that the drug will disperse into the air stream and be conveyed by the air stream into the respiratory tract of the user.

In an alternative embodiment, in accordance with Fig. 6, the strip 605 runs within the housing 601 of the inhaler 600. In this embodiment the pull tab 607 is positioned at the second end of the housing 601, i.e. in the vicinity of the inlet 602. The strip 605 then also has its first end 606 in said position, where after the strip continues to occlude the inlet 602, then occluding the outlet 603, to finally attach to the container 604. Thus, before use, the user will hence grab the pull tab 607; pull the strip 605 out of the inlet 602; then proceed with pulling the tab 607 and the strip away from the inhaler 600 to reveal the outlet 603 from within; continuing pulling the tab 607 and the strip 605 away from the inhaler 600 to break the container 604 and reveal the drug. After this, the user will bring the outlet 603 to his/her mouth, and inhale, such that the drug will spread in the air stream and be conveyed by the air stream into the respiratory tract of the user. This embodiment allows for revealing of the inlet 602, the outlet 603, and the drug in a one directed motion, which may be beneficial if the user for example has a decreased dexterity. In yet an alternative embodiment, in accordance with Fig. 7, the pull tab 707 is again positioned at the second end of the inhaler 700. The strip 705 continues from the pull tab in a bifurcation; one part of the strip continuing over the container 704, to attach thereto centrally of the housing 701; and another part of the strip 705 continuing to occlude the inlet 702, further along the outside of the housing 701 to the first end to there occlude the outlet 703. Hence, before use, the user will hence grab the pull tab 707; pull the strip 705 out of the inlet 702; then proceed with pulling the tab 707 and the strip away from the inhaler 700 to break the container 704 to reveal the drug; then proceed with turning the inhaler 700 or pulling the strip 705 from below also over the outlet 703. After this, the user will bring the outlet 703 to his/her mouth, and inhale, such that the drug will spread in the air stream and be conveyed by the air stream into the respiratory tract of the user.

Although, the present invention has been described above with reference to specific embodiments, it is not intended to be limited to the specific form set forth herein. Rather, the invention is limited only by the accompanying claims.

In the claims, the term "comprises/comprising" does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e.g. a single unit or processor. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. The terms "a", "an", "first", "second" etc do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.