Patent Description:
Inhalers for drug delivery to a user by inhalation are well-known. Such devices include metered-dose inhalers and dry powder inhalers.

Metered dose inhalers typically comprise a container containing a propellant and a liquid solution or suspension of a medicament. Metered dose inhalers further include a dispensing valve which, when actuated, causes the medicament to be forced out of the container by expansion of the propellant in the form of an aerosol.

Dry powder inhalers, on the other hand, typically comprise a supply of the medicament in dry powder form, and are arranged to permit the user to inhale discrete doses from the supply of powder medicament.

Some dry powder inhalers comprise a bulk reservoir of powder medicament, with a dispensing mechanism being configured to separate a dose of the medicament from the reservoir and make it available for inhalation by the user. Other types of dry powder inhaler comprise a plurality of pre-metered doses of powder medicament in containers, for example in capsules or blisters, and a dispensing mechanism which is configured to open the containers and make the doses of medicament available for inhalation by the user.

One such type of dry powder inhaler comprises a medicament carrier in the form of a blister pack having a plurality of spaced-apart blister pockets containing doses of the medicament. The inhaler comprises a manually-operated dispensing mechanism for moving a medicament dose of the medicament carrier to a dispensing position in the inhaler, and for placing the medicament dose in fluid communication with an air flow path of the inhaler, for example by piercing or peeling open the blisters, ready for inhalation by the user.

An inhaler of this type is described in <CIT>. The dispensing mechanism of this device is operated by a lever, which causes a blister to be moved to the dispensing position of the inhaler and peeled open. Another inhaler of this type is described in <CIT>. The dispensing mechanism of this inhaler is operated by a rotatable mouthpiece cover, the opening of which causes a blister to be moved to the dispensing position of the inhaler and peeled open.

Dry powder inhalers of the type described above may comprise a manifold component which defines a part of an air flow path through the inhaler. In particular, the manifold is arranged to direct air (through an air conduit) from an air inlet of the inhaler to the opened blisters, and to direct air-entrained medicament (through a medicament delivery conduit) from the opened blisters to a mouthpiece of the inhaler. Inhalation-induced air flow through the manifold causes the medicament in the opened blisters to be entrained by the air, which flows through the opened blisters, and across the medicament, so that the air-entrained medicament can be inhaled by the user. By way of example, <CIT> discloses a manifold of this type in which an air bypass hole is provided so that a bleed air flow disruptively impacts the flow of air-entrained medicament.

The present inventors have recognised that, although the operation of the above-described dry powder inhalers may be satisfactory, there is scope to provide improvements, in particular in relation to the design of the manifold component. There is in particular a need for manifold component designs that are able to provide improved control over the air flow through the medicament, and hence the entrainment of the medicament in the air. It is an object of embodiments of the present invention to provide such improvements.

<CIT> US relates to a medicament dispenser device suitable for the delivery of medicament powder from an open blister pocket of at least one blister pack.

The invention provides a dry powder inhaler for delivering medicament to a user from at least one blister pack, the blister pack having a plurality of spaced-apart blister pockets containing doses of the medicament. The inhaler comprises: a housing for accommodating unused and used portions of the blister pack together with a dispensing mechanism for selectively opening the blister pockets; and a manifold component through which air can be drawn in use of the inhaler.

According to the invention, the air outlet opening is arranged to be positioned substantially centrally over the opened blister pocket, and the medicament inlet opening is arranged to be positioned over the opened blister pocket so as to be closer to an edge of the opened blister pocket than the air outlet opening.

Such an arrangement is able to provide for more complete emptying of the medicament from the opened blister pocket. In particular, the provision of the medicament inlet opening close to the edge of the blister pocket can help to prevent medicament being retained at the edge of the blister pocket. In this way, medicament dosing may be more consistent and medicament wastage minimised.

In embodiments, the medicament inlet opening at least partially surrounds the air outlet opening, and optionally the medicament inlet opening may defines an angle of at least <NUM> degrees, optionally at least <NUM> degrees, further optionally at least <NUM> about the air outlet opening.

The air outlet opening may have a circular or elongate shape, which may correspond to the shape of the blister pockets. The medicament inlet opening may have a curved or arcuate shape, for example surrounding the air outlet opening, and at least partially corresponding to the shape of the blister pockets.

In any of the above-identified embodiments, the medicament inlet opening may be divided into a plurality of adjacent openings each arranged to be positioned over a peripheral region of the opened blister pocket. Such an arrangement may be used, instead of a relatively large single medicament inlet, to control the rate at which the medicament is entrained by the airflow.

In the invention, the manifold component may be formed of a material selected from the group consisting of: polyolefins, including polyethylene, in particular high density polyethylene (HDPE), and polypropylene; polyesters, including polyethylene terephthalate; polyamides, including nylons; thermosetting polymers, including urea-formaldehyde, melamine, epoxy resins and polyimides; and mixtures or copolymers thereof.

In the invention, the air inlet opening or openings may define the only points of entry for external air into the manifold component, and optionally into the dry powder inhaler.

In the invention, the medicament delivery conduit may have a circular cross-section. Optionally, the medicament delivery conduit may taper along its length with an increasing cross sectional area in the direction of air flow.

In the invention, the dispensing mechanism may be configured for opening at least two blister pockets at a time, and the manifold component may further comprise a second medicament inlet opening for receiving medicament from the second opened blister pocket, the second medicament inlet being fluidly connected to the medicament delivery conduit or chamber.

The manifold component may further comprise a second air outlet opening for providing air to a second opened blister pocket, the second air outlet opening being fluidly connected to the air delivery conduit, and the second air outlet opening and the second medicament inlet opening being arranged side-by-side to enable simultaneous communication with the second opened blister pocket.

Such an embodiment is suitable for combination therapy in which two different medicaments are simultaneously delivered from respective opened blister pockets, for example where the different medicaments are not suitable for being stored together. The same principle can be used to simultaneously deliver three or more different medicaments.

The different medicaments may be delivered from different blister pockets of the same blister pack or from respective blister pockets of different blister packs. Where a single blister pack is provided, the dispensing mechanism may be configured to simultaneously open at least two blister pockets at a time. Where two (or more) blister packs are provided, the dispensing mechanism may be configured to simultaneously open a blister pocket of each blister pack.

In the invention, the dry powder inhaler may include the dispensing mechanism. The dispensing mechanism may comprises a peeling mechanism arranged to open the blister pockets by peeling a cover layer of the or each blister pack from a base layer of the or each blister pack. The dispensing mechanism may comprise an indexing mechanism arranged to move the or each blister pack so that the or each opened blister pocket is aligned with the air outlet and the medicament inlet openings.

In the invention, the dry powder inhaler may include the blister pack or blister packs, wherein the or each blister pack comprises an elongate base layer defining spaced-apart blister pockets containing medicament doses, and a cover layer adhesively bonded to the base layer to close the blister pockets, and wherein the cover layer is arranged to be peeled from the base layer.

The blister pockets contain medicaments for treating respiratory diseases such as asthma and COPD, for example selected from budesonide, formoterol, beclomethasone, fluticasone, salmeterol, albuterol, salbutamol, indacaterol, tiotropium, ipratropium, glycorpyrronium, umeclidinium, vilanterol, and combinations thereof.

Embodiments of the invention will now be described in more detail and by way of non-limiting examples with reference to the accompanying drawings, in which:.

It should be understood that the detailed description, while indicating exemplary embodiments of the inventive dry powder inhaler, are intended for the purposes of illustration only and are not intended to limit the scope of the invention. Features, aspects, and advantages of the inhaler will become better understood from the following description, appended claims, and accompanying drawings.

The invention provides a dry powder inhaler for delivering medicament from at least one blister pack, each blister pack having a plurality of spaced-apart blister pockets containing doses of the medicament. The inhaler comprises a housing for accommodating unused and used portions of the at least one blister pack together with a dispensing mechanism for simultaneously opening at least one blister pockets at a time; the inhaler also comprises a manifold component through which air can be drawn in use of the inhaler.

The manifold component comprises: an air inlet opening for receiving external air; a medicament inlet opening for receiving air-entrained medicament from the opened blister pocket; and a medicament outlet opening for delivery of the air-entrained medicament from the opened blister pocket to the user. The medicament inlet opening is fluidly connected to the medicament outlet opening by a medicament delivery conduit or chamber formed in the manifold component. The air inlet opening may be fluidly connected to the medicament delivery conduit or chamber in a variety of ways, directly and/or indirectly via the opened blister pocket. The invention provides improvements to the design of the manifold component.

<FIG>, <FIG> and <FIG> show a first dry powder inhaler <NUM>. <FIG> shows a medicament carrier <NUM> for use with the inhaler <NUM>. A dry powder inhaler using the same type of medicament carrier and having a manifold component is described in <CIT>.

As shown in <FIG>, the inhaler <NUM> is a hand-held device having a substantially flat or planar shape with a rounded outer profile. The outer profile of the inhaler is mainly defined by its housing <NUM> which encloses its internal components and receives at least one medicament carrier <NUM> (not shown in <FIG> but shown in <FIG> and <FIG>). Extending from the housing <NUM> is a mouthpiece component <NUM> having a central opening through which the user inhales the powder medicament. The mouthpiece component <NUM> is assembled or joined to the housing <NUM>.

The inhaler also comprises a mouthpiece cover <NUM>, which is rotatably connected to the housing <NUM> for sequential movement about a rotation axis from a first position in which the mouthpiece <NUM> is completely covered to a second position in which the mouthpiece <NUM> is also completely covered, and from the second position to a third position in which the mouthpiece <NUM> is completely uncovered. <FIG> shows the mouthpiece cover <NUM> in its third position.

Also visible in <FIG> is an air inlet <NUM> and a dose counter display <NUM>. The air inlet <NUM>, which can be covered by the mouthpiece cover <NUM>, defines the start of an air flow path that extends from the air inlet <NUM> to the central opening of the mouthpiece <NUM>. The dose counter display <NUM> is coupled to a dispensing mechanism of the inhaler <NUM>, to be described subsequently, so as to provide an indication of the number of medicament doses used or remaining in the inhaler <NUM>.

<FIG> shows a medicament carrier <NUM> for use with the inhaler <NUM> shown in <FIG>. The medicament carrier <NUM> is in the form of an elongate blister strip. The blister strip comprises a semi-rigid base layer <NUM> which is formed with spaced-apart blister openings <NUM> and more flexible cover layer <NUM> which covers the blister openings <NUM> to define spaced-apart blisters <NUM>. The blisters <NUM> each contain a sealed dose of powder medicament.

The cover layer <NUM> of the medicament carrier <NUM> is adhesively bonded to the base layer <NUM> such that the layers <NUM>, <NUM> can be peeled apart to open the blisters <NUM> and liberate the powder medicament without any risk of either layer <NUM>, <NUM> breaking. The base layer <NUM> and the cover layer <NUM> typically comprise plastics/aluminium laminates and are adhesively bonded by a heat seal lacquer. A suitable medicament carrier is described in more detail in <CIT>.

The inhaler <NUM> shown in <FIG> is designed for use with a pair (i.e. two) of the medicament carriers <NUM> shown in <FIG>, as will now be described with reference to <FIG>. It is to be noted, however, that embodiments according to the invention may be used with, or comprise, any number of the medicament carriers <NUM>, including just one.

<FIG> is a view of the inhaler <NUM> shown in <FIG> with certain components removed and including a pair of the medicament carriers 201a, 201b installed. In particular, the mouthpiece <NUM>, mouthpiece cover <NUM>, and part of the housing <NUM> have been removed to reveal a remaining part of the housing <NUM> and the medicament carriers 201a, 201b (shown in schematic form, without all of the blisters), as well as a manifold component <NUM>, to be described subsequently, and parts of the dispensing mechanism. As shown in the drawing, the housing <NUM> provides regions 13a, 13b for accommodating unused portions of the medicament carriers 201a, 201b, which are loosely-coiled. Regions are also provided for accommodating used portions of the medicament carriers 201a, 201b, as will be described below. It is noted that the internal arrangement of the inhaler <NUM> is generally symmetrical, with one medicament carrier 201a being accommodated on one side (left side in the drawing) and the other medicament carrier 201b being accommodated on the other side (right side in the drawing).

The dispensing mechanism, which is only partly shown in <FIG>, comprises an indexing wheel 15a, 15b and a peeling spool 17a, 17b for each of the medicament carriers 201a, 201b. Each medicament carrier 201a, 201b is fed around its respective indexing wheel 15a, 15b with the base layer 203a, 203b having the blisters facing the indexing wheel 15a, 15b. The indexing wheels 15a, 15b are provided with a plurality of recesses about their circumference which are sized and positioned to receive the blisters of the medicament carrier 201a, 201b. When the index wheels 15a, 15b are rotatably driven by the dispensing mechanism, they engage the medicament carriers 201a, 201b, in particular their semi-rigid blisters, so that the next medicament-containing blister of each medicament carrier 201a, 201b can be advanced to a dispensing position of the inhaler <NUM> (adjacent the manifold component <NUM>, at which the medicament is to be presented for inhalation).

Simultaneously, a leading end of the cover layer 207a, 207b of each medicament carrier 201a, 201b is separated from its base layer 203a, 203b and fed around a peeling edge 21a, 21b, which is positioned between used portions of the cover layer 207a, 207b and the base layer 203a, 203b. For this purpose, the leading end of the cover layer 207a, 207b of each medicament carrier 201a, 201b is attached to a respective peeling spool 17a, 17b. The peeling spools 17a, 17b are rotatably driven at the same time as the indexing wheels 15a, 15b, and this causes each cover layer 207a, 207b to be gradually peeled away from its base layer 203a, 203b at the peeling edge 21a, 21b, so that the medicament-containing blister 209a, 209b is opened for inhalation by the user.

As medicament doses are dispensed from the inhaler <NUM>, used portions of the cover layers 207a, 207b are wound onto the peeling spools 17a, 17b. Used portions of the base layers 203a, 203b are accommodated in a separate region of the housing where they are coiled up by rotatably-driven coiling spools 23a, 23b. By way of example, the medicament carriers 201a, 201b may each comprise <NUM> doses of a powder medicament, with a dose from each carrier being dispensed simultaneously.

The manifold component <NUM> and the remaining parts of the dispensing mechanism of the inhaler <NUM> will now be described with reference to <FIG> and <FIG>, which is an exploded perspective view of the inhaler shown in <FIG> with certain components removed. It is to be noted that <FIG> shows an opposite side of the inhaler to that shown in <FIG>, i.e. <FIG> shows the back side of the inhaler <NUM>. In <FIG>, the mouthpiece cover <NUM>, and part of the housing <NUM> have been removed to reveal a remaining part of the housing <NUM> and remaining parts of the dispensing mechanism. <FIG> also shows the mouthpiece <NUM> and part of the manifold component <NUM>.

The manifold component <NUM> shown in <FIG> and <FIG> is a unitary moulded plastics component arranged in the housing <NUM> and which defines an air flow path extending from the air inlet <NUM> (<FIG>) to the mouthpiece <NUM>, with which it interfaces. When a user inhales through the mouthpiece <NUM>, air is drawn in to the air inlet <NUM>, through the air flow path, and out through the mouthpiece <NUM>. The manifold component <NUM> is arranged in such a way that the air flow path is provided with multiple openings adjacent to the dispensing position <NUM> of the inhaler, so that the medicament doses of opened blisters are placed in fluid communication with the air flow path. In this way, when the user inhales through the mouthpiece <NUM>, the powder medicament can be drawn out of the blisters by the turbulent air flow and inhaled.

<FIG> shows the back sides of the indexing wheels 15a, 15b, peeling spools 17a, 17b and coiling spools 23a, 23b, each of which is rotatably mounted in the housing and provided with a gear wheel for driven rotation. The gear wheels form part of a gear train which is driven by opening the mouthpiece cover <NUM> (<FIG>).

For this purpose, the mouthpiece cover <NUM> (not shown in <FIG>) is coupled to a first gear wheel <NUM>, which is arranged to rotate with the mouthpiece cover <NUM> about its rotation axis. In particular, the first gear wheel <NUM> is arranged to rotate forwards and backwards when the mouthpiece cover <NUM> is opened and closed.

The first gear wheel <NUM> is arranged to selectively drive a second gear wheel <NUM> which is mounted coaxially with the first gear wheel <NUM> on a stub shaft 3a. The second gear wheel <NUM> is a drive gear of the dispensing mechanism and directly or indirectly drives the indexing wheels 15a, 15b, peeling spools 17a, 17b and coiling spools 23a, 23b when the mouthpiece cover <NUM> is opened. The coiling spools 23a, 23b are also driven via idler gear wheels <NUM>, <NUM>. The first and second gear wheels <NUM>, <NUM> will now be described in greater detail.

The first gear wheel <NUM> is directly coupled to a hub of the mouthpiece cover <NUM>, which is covered by the housing <NUM> in <FIG>. For this purpose, a front face of the first gear wheel <NUM> is provided with a raised rib 27a, which is received into a corresponding slot of the hub. When the mouthpiece cover <NUM> is opened and closed, the slot engages the rib 27a to transmit torque, so that the first gear wheel <NUM> rotates with the mouthpiece cover <NUM>.

The outer circumference of the first gear wheel <NUM> is provided with a plurality, in this inhaler five, resilient drive pawls 27b which are equally spaced-apart at an angle of <NUM> degrees. It should be noted that other inhalers may comprise a different number of resilient drive pawls 27b. For example, another inhaler comprises four resilient drive pawls which are equally spaced-apart at an angle of <NUM> degrees.

The resilient drive pawls 27b of the first gear wheel <NUM> are arranged to selectively engage corresponding ratchet teeth 29a formed as an internal gear on the second gear wheel <NUM>. In particular, when the first gear <NUM> is rotated forwards upon opening of the mouthpiece cover <NUM>, the resilient drive pawls 27b come into contact with and engage the ratchet teeth 29a of the second gear wheel <NUM> so as to drive it forwards. However, when the first gear <NUM> is rotated backwards upon closing of the mouthpiece cover <NUM>, the resilient drive pawls 27b slide over the ratchet teeth 29a of the second gear wheel <NUM> so that it is not driven.

The second gear wheel <NUM> is provided about its outer circumference with a second plurality of ratchet teeth 29b which function, together with a fixed pawl attached to the housing (not shown), as a means for preventing reverse rotation of the second gear wheel <NUM>.

The second gear wheel <NUM> is also provided about its outer circumference, in a different axial plane, with a set of ordinary gear teeth 29c which engage and drive a first one of the indexing wheels 15b. This indexing wheel 15b drives the other indexing wheel 15a and a first one of the peeling spools 17b. The other indexing wheel 15a drives the other peeling spool 17a. It will be understood that the gear train is sequenced so as to ensure that each of the driven elements rotates in the appropriate direction for dispensing the powder medicament from the blisters of the medicament carriers 201a, 201b.

Further detail relating to the structure and design of a suitable dispensing mechanism can be found for example in <CIT>.

Operation of the dispensing mechanism, will now be described with reference to <FIG>. <FIG> are schematic views showing the inhaler <NUM> and a part of its dispensing mechanism in a first position of the mouthpiece cover <NUM>. <FIG> are schematic views showing the inhaler <NUM> and a part of its dispensing mechanism in a second position of the mouthpiece cover <NUM>. <FIG> are schematic views showing the inhaler <NUM> and a part of its dispensing mechanism in a third position of the mouthpiece cover <NUM>. It is noted that <FIG>, <FIG> and <FIG> show an opposite (back) side of the inhaler to that shown in <FIG>, <FIG> and <FIG> (which is a front side).

Referring now to <FIG>, the inhaler <NUM> is shown with the mouthpiece cover <NUM> in its first position, which is its normal (completely closed) position when the inhaler <NUM> is not in use. In this position, the mouthpiece <NUM> is completely covered by the mouthpiece cover <NUM> and the mouthpiece cover <NUM> is rotated to the maximum extent possible in the counter-clockwise direction (also referred to herein as the backwards direction). In this position, the mouthpiece <NUM> is completely protected from contamination. Such contamination can be unhygienic and can potentially affect the medicament delivery performance of the inhaler <NUM>.

<FIG> is a view showing the first gear wheel <NUM> and second gear wheel <NUM> when the mouthpiece cover <NUM> is in the first position shown in <FIG>. In this position, the resilient drive pawls 27b of the first gear wheel <NUM> are spaced away from, and are not therefore engaged with, the corresponding ratchet teeth 29a formed as an internal gear on the second gear wheel <NUM>.

<FIG> shows the inhaler <NUM> after the mouthpiece cover <NUM> has been moved from the first position to the second position. In this position, the mouthpiece cover <NUM> has rotated clockwise (or forwards) but the mouthpiece <NUM> is still completely covered by the mouthpiece cover <NUM>. Movement of the mouthpiece cover <NUM> from the first position to the second position may enclose an angle of at least <NUM> degrees and, in the illustrated inhaler, encloses an angle of <NUM> degrees.

<FIG> is a view showing the first gear wheel <NUM> and second gear wheel <NUM> when the mouthpiece cover <NUM> is in the second position shown in <FIG>. In this position, the first gear wheel <NUM> has rotated forwards (counter-clockwise in this view) to bring the resilient drive pawls 27b just into contact with the corresponding ratchet teeth 29a of the second gear wheel <NUM>. The second gear wheel <NUM> has not, however, moved, and so the dispensing mechanism of the inhaler <NUM> has not yet been driven.

<FIG> shows the inhaler <NUM> after the mouthpiece cover <NUM> has been moved from the second position to the third position. In this position, the mouthpiece cover <NUM> has rotated further clockwise (or forwards) to completely uncover the mouthpiece <NUM> ready for the user to inhale dispensed doses of the powder medicament. In this position, the mouthpiece cover <NUM> is rotated to the maximum extent possible in the clockwise direction. For reasons that will become apparent from the following description, movement of the mouthpiece cover <NUM> from the second position to the third position encloses an angle of exactly <NUM> degrees. This implies that, in the illustrated inhaler, movement of the mouthpiece cover <NUM> from the first position to the third position encloses a total angle of <NUM> degrees (i.e. <NUM> degrees plus <NUM> degrees).

<FIG> is a view showing the first gear wheel <NUM> and second gear wheel <NUM> when the mouthpiece cover <NUM> is in the third position shown in <FIG>. In this position, the first gear wheel <NUM> has rotated further forwards (counter-clockwise in this view) and in this case the resilient drive pawls 27b have engaged the corresponding ratchet teeth 29a of the second gear wheel <NUM> to drive the second gear wheel <NUM> forwards. This driving of the second gear wheel <NUM> functions to drive the dispensing mechanism so that the next medicament-containing blister of each medicament carrier 201a, 201b is moved to the dispensing position <NUM> of the inhaler <NUM> and so that the cover layers 207a, 207b are peeled away to place the medicament doses in fluid communication with the air flow passage of the manifold <NUM>, ready for inhalation by the user.

The mouthpiece cover <NUM> is configured so that movement from the second position to the third position encloses an angle of exactly <NUM> degrees because this results in the five resilient drive pawls 27b of the first gear wheel <NUM> and the corresponding five ratchet teeth 29a of the second gear wheel <NUM> rotating through <NUM> degrees so that they start and end with the same angular positions, as can be seen by comparing <FIG> and <FIG>, which facilitates resetting the device when the mouthpiece cover <NUM> is subsequently closed.

In particular, when the mouthpiece cover <NUM> is closed after use of the inhaler <NUM>, by rotating the mouthpiece cover <NUM> counter-clockwise from the third position shown in <FIG> to the first position shown in <FIG>, the second gear wheel <NUM> is prevented from rotating backwards (clockwise in the views of <FIG>, <FIG> and <FIG>) owing to the means for preventing reverse rotation 29b and therefore remains in the same angular position. The first gear wheel <NUM> rotates backwards (clockwise in the views of <FIG>, <FIG> and <FIG>) as the mouthpiece cover <NUM> is closed, with the resilient drive pawls 27b sliding back over the ratchet teeth 29a of the second gear wheel <NUM> to the position shown in <FIG> and then back to the position shown in <FIG>.

With the mouthpiece cover <NUM> closed, the five resilient drive pawls 27a of the first gear wheel <NUM> and the corresponding five ratchet teeth 29a of the second gear wheel <NUM> have the positions shown in <FIG>, ready for the next use.

The inhaler <NUM> described above comprises a first gear wheel <NUM> having five resilient drive pawls 27b. It should be noted that the first gear wheel may instead comprise a different number of resilient drive pawls. For example, the first gear wheel may be provided with four resilient drive pawls equally spaced-apart at <NUM> degree intervals (and correspondingly the second gear wheel may be provided with four ratchet teeth equally spaced-apart at <NUM> degree intervals), in which case movement of the mouthpiece cover from the second position to the third position would encloses an angle of exactly <NUM> degrees (<NUM> degrees divided by four).

The inhaler <NUM> described above provides an arrangement in which movement of the mouthpiece cover <NUM> from the first position shown in <FIG> to the second position shown in <FIG> does not result in any actuation of the dispensing mechanism and does not uncover the mouthpiece <NUM>, even partly. As such, actuation caused by unintentional or accidental movement of the mouthpiece cover when the inhaler is not in use can be avoided. Further, such unintentional or accidental movement of the mouthpiece cover does not risk of contamination of the mouthpiece, since the mouthpiece remains completely covered.

The manifold component <NUM> of the inhaler <NUM> will now be described in detail. As noted above, the manifold component <NUM> may be a unitary moulded plastics component arranged in the housing <NUM> and which defines an air flow path extending from the air inlet <NUM> (<FIG>) to the mouthpiece <NUM>, with which it interfaces.

The manifold component <NUM> may be formed of any polymer-based material that is suitable for moulding. Such materials include: polyolefins, including polyethylene, in particular high density polyethylene (HDPE), and polypropylene; polyesters, including polyethylene terephthalate; polyamides, including nylons; thermosetting polymers, including urea-formaldehyde, melamine, epoxy resins and polyimides; and mixtures or copolymers thereof.

<FIG> is an exploded perspective view showing the manifold component <NUM> of the inhaler <NUM> together with a pair of shell-like components 3a, 3b that form the housing <NUM>. The remaining components of the inhaler <NUM> have been omitted from <FIG> for clarity reasons. The manifold component <NUM> is arranged in the housing, in the illustrated orientation, so as to interface with the air inlet <NUM> and the mouthpiece <NUM> (not shown in <FIG>), between which it provides the air flow path. The manifold component <NUM> also interfaces with the opened blisters of the blister packs (not shown in <FIG>).

<FIG> illustrate the manifold component <NUM> in greater detail. <FIG> is a top view of the manifold component <NUM> and <FIG> is a perspective view of the manifold component <NUM>. <FIG> and <FIG> are sectioned views of the manifold component <NUM>; the former being a perspective view (taken from the opposite side to that of <FIG>; also showing hidden detail) and the latter being a top view. The manifold component <NUM> has a number of moulded structures which are described below. <FIG> also illustrates first and second opened blisters 61a, 61b of the respective blister packs, with which the manifold component <NUM> interfaces, in use.

More specifically, the manifold component <NUM> comprises a primary air inlet opening 51a and an auxiliary air inlet opening 51b for receiving external air directly from the air inlet <NUM> of the inhaler. A primary air delivery conduit 53a extends from the primary air inlet opening 51a and an auxiliary air delivery conduit 53b extends from the auxiliary air inlet opening 51b. Both the air inlet openings 51a, 51b and the air delivery conduits 53a, 53b have a substantially rectangular cross-section and are arranged side-by-side, separated by narrow walls.

The air delivery conduits 53a, 53b are separately formed so that the external air from each of the primary and auxiliary air inlet openings 51a, 51b does not mix with the external air from the other of the primary and auxiliary air inlet openings 51a, 51b before reaching the first and second opened blister pockets 61a, 61b, as will be explained below. Furthermore, the primary and auxiliary air inlet openings 51a, 51b preferably define the only points of entry for external air into the manifold component <NUM> (and into the inhaler <NUM>).

An end of the manifold component <NUM> opposing the air inlet openings 51a, 51b is provided with a mounting protrusion <NUM> (<FIG>) which is engaged in a corresponding recess of the housing <NUM>. It should be noted that the mounting protrusion <NUM> does not define any part of the air flow path and is provided only for assembly purposes.

The manifold component <NUM> also comprises a medicament delivery conduit <NUM> which opens out into a medicament outlet opening <NUM> for delivery of air-entrained medicament from first and second opened blister pockets to the mouthpiece <NUM> (not shown in <FIG>), and on to the user. The medicament delivery conduit <NUM> and the medicament outlet opening <NUM> both have a generally circular cross-section. The medicament delivery conduit <NUM> partly tapers along its length, with an increasing cross-sectional area in the direction of air flow.

As illustrated most clearly in <FIG>, the primary and auxiliary air delivery conduits 53a, 53b are arranged in the manifold component <NUM> to be adjacent to the medicament delivery conduit <NUM>. The primary air delivery conduit 53a is separated from the medicament delivery conduit <NUM> by narrow walls. The auxiliary air delivery conduit 53b is fluidly connected to the medicament delivery conduit <NUM> through an opening <NUM>.

Furthermore, it can be seen from <FIG> that the primary and auxiliary air delivery conduits 53a, 53b extend in a direction (vertically in the drawing) that is substantially perpendicular to the direction (horizontally in the drawing) in which the medicament delivery conduit <NUM> extends. In this way, air-entrained medicament can be delivered to the mouthpiece <NUM> in a direction that is substantially perpendicular to the direction in which external air is received from the air inlet <NUM>, so as to accommodate the relative orientations of the mouthpiece <NUM> and air inlet <NUM> of the inhaler <NUM>. This arrangement also allows the air-entrained medicament to pass from the opened blister pockets to the mouthpiece <NUM> without traversing any bends, which could lead to undesirable medicament deposition and build up on the surfaces of the medicament delivery conduit <NUM>.

The manifold component <NUM> also comprises first and second air outlet openings 63a, 63b for providing the external air from the primary air conduit 53a to respective first and second opened blister pockets 61a, 61b, and first and second medicament inlet openings 65a, 65b for receiving air-entrained medicament from the respective first and second opened blister pocket 61a, 61b and providing it to the medicament delivery conduit <NUM>. As can be seen in <FIG> and <FIG>, the first air outlet opening 63a and the first medicament inlet opening 65a are arranged side-by-side to enable simultaneous communication with the first opened blister pocket 61a. The second air outlet opening 63b and the second medicament inlet opening 65b (not shown in <FIG> and <FIG>) are similarly arranged side-by-side to enable simultaneous communication with the second opened blister pocket 61b.

The first and second air outlet openings 63a, 63b are provided in a side wall of the primary air delivery conduit 53a, whereas the first and second medicament inlet openings 65a, 65b are provided in an end wall of the medicament delivery conduit <NUM> (directly facing the medicament outlet opening <NUM>). The second air outlet opening 63b and the second medicament inlet opening 65b are not shown in <FIG> and <FIG>, but have the same size and shape as the corresponding first air outlet opening 63a and first medicament inlet opening 65a. In fact, the second air outlet opening 63b and the second medicament inlet opening 65b are mirror images of the first air outlet opening 63a and the first medicament inlet opening 65a, respectively (see <FIG>).

The air outlet openings 63a, 63b and the medicament inlet openings 65a, 65b are arranged in curved side walls of the manifold component <NUM> (referring to <FIG>). In this way, the blister packs, in which the first and second opened blisters 61a, 61b are provided, are able to slide along the side wall while maintaining substantial contact therewith and providing a substantial fluid (powder and air) seal around the opened blister pockets 61a, 61b.

In use of the inhaler, the user inhales through the mouthpiece <NUM>, which induces an airflow through the manifold component <NUM>. In particular air is drawn into the primary air inlet opening 51a and into the primary air delivery conduit 53a. The air then passes through the first and second air outlet openings 63a, 63b, and into the respective opened blister pockets 61a, 61b where it entrains the medicament. The air-entrained medicament then passes through the first and second medicament inlet openings 65a, 65b, along the medicament delivery conduit <NUM>, and out through the medicament outlet opening <NUM>, from where it is delivered to the user via the mouthpiece <NUM>.

The auxiliary air delivery conduit 53b serves to provide an auxiliary air flow from the auxiliary air inlet 51b to the medicament delivery conduit <NUM>, which auxiliary air flow is independent of the primary air flow and bypasses the open blister pockets 61a, 61b. The auxiliary airflow is generated by the user's inhalation. The auxiliary air flow enters the medicament delivery conduit <NUM> perpendicular to the flow of air-entrained medicament and serves to disruptively impact the air-entrained medicament, to thereby create a more turbulent flow, which helps to deagglomerate the powder medicament and prevent its deposition and build up on the surfaces of the medicament delivery conduit <NUM>.

By providing the auxiliary air delivery conduit 53b with its own air inlet opening for receiving external air (i.e. the auxiliary air inlet opening 51b), the airflow passing through the auxiliary air delivery conduit 53b can be controlled and adjusted (i.e. tuned) independently of the airflow passing through the opened blister pockets 61a, 61b. Such an arrangement allows for the respective airflows to be optimised for any given medicament formulation, for example to provide a greater or lesser auxiliary air flow relative to the primary air flow.

Such an arrangement also provides for a constant airflow resistance of the airflow path through the auxiliary air delivery conduit 53b, regardless of the amount of medicament remaining in the opened blister pockets 61a, 61b. In this way, the performance of the manifold component <NUM>, and in particular the provision of auxiliary air for disruptively impacting the air-entrained medicament flowing through the medicament delivery conduit <NUM>, can be made more consistent throughout use of the inhaler (i.e. throughout the user's inhalation of a dose of the medicament).

<FIG> is a view corresponding to that of <FIG> and showing air flow through the manifold component <NUM>, in use of the inhaler <NUM>. In particular, as has been described, when the user inhales at the mouthpiece <NUM> (not shown in <FIG>), external air is drawn into the air conduits 53a, 53b through the air inlet openings 51a, 51b. As illustrated by arrows having heads in <FIG>, the primary and auxiliary air flows collide with each other in the medicament delivery conduit <NUM>, which creates a more turbulent flow, and which helps to deagglomerate the powder medicament and prevent its deposition and build up on the surfaces of the medicament delivery conduit <NUM>.

<FIG> are schematic cross-sectional views illustrating variant inhalers. These drawings illustrate the manifold component <NUM>, <NUM> of the variant inhalers, the other components of the variant inhalers being essentially the same as those of the inhaler described above. Structures, openings and conduits for use with a first blister pocket 361a, 461a are shown; however, it will be understood that corresponding structures, openings and conduits for a second blister pocket are also provided but not shown.

In <FIG>, the manifold component <NUM> is designed so that the auxiliary air inlet opening 351b and auxiliary air delivery conduit 353b are arrange on an opposite side of the medicament delivery conduit <NUM>, as compared to the primary air inlet opening 351a and the primary air delivery conduit 353a. Such an arrangement may allow for the geometry of the manifold component <NUM> to be optimised or improved, for example with larger conduits and/or reduced air resistance. In other inhalers, a plurality of auxiliary air inlet openings 351b and respective auxiliary air delivery conduits 353b may be arranged around and/or along the medicament delivery conduit <NUM>.

In <FIG>, the manifold component <NUM> is designed so that the auxiliary air delivery conduit 453b is fluidly connected to the primary air delivery conduit 453a, so that the auxiliary air delivery conduit 453b receives air from both the primary air inlet opening 451a and the auxiliary air inlet opening 451b. In this way, the air flow in the auxiliary air delivery conduit 453b may be even more turbulent, thereby enhancing its disruptive effect on the medicament-laden air passing along the medicament delivery conduit <NUM>. The auxiliary air delivery conduit 453b may be provided with one or more one-way valves so as to prevent air from the auxiliary air inlet opening 451b reaching the opened blister pocket 461a via the primary air delivery conduit 453a.

The invention will now be described. <FIG> and <FIG> are views for describing a second dry powder inhaler, which provides a non-limiting embodiment of the invention, in particular illustrating the manifold component <NUM>. More particularly, <FIG> is a perspective view of the manifold component <NUM> showing a surface against which an opened blister pocket passes, including an enlarged view of this surface. <FIG> is a view of the manifold component <NUM> from the opposite side compared to <FIG>, and is sectioned to illustrate structures within the manifold component <NUM>.

The components of the second (inventive) dry powder inhaler other than the manifold component <NUM> are the same as those of the above-described first inhaler, and will therefore not be described in any detail. The dry powder inhaler according to the invention therefore differs only in terms of the detailed design of the manifold component <NUM>.

The manifold component <NUM> is, however, similar in terms of purpose and general structure to those of the manifold components <NUM>, <NUM>, <NUM> of the first inhaler describe above, but is not provided with an auxiliary air inlet opening 51b or an auxiliary air delivery conduit 53b, although such could in principle be provided. Thus, external air flows in to the manifold component <NUM> through a single air inlet opening <NUM>.

In use, the external air flows through an air delivery conduit <NUM> before it passes out of the manifold component <NUM>, through the opened blister pockets (not shown) where it entrains the medicament, then back in to the manifold component <NUM>, and along a medicament delivery conduit <NUM>. The air-entrained medicament then flows out of the manifold component <NUM> through a medicament outlet opening <NUM>, and is delivered to the user's mouth via the inhaler mouthpiece <NUM>.

A bypass opening <NUM> may be provided between the air delivery conduit <NUM> and the medicament delivery conduit <NUM> through which a portion of the external air drawn into the air inlet opening <NUM> may flow, as is known in the art for disruptively impacting the medicament-laden air flowing through the medicament delivery conduit <NUM>.

In use, the air flows from the air delivery conduit <NUM> into the opened blister pockets (not shown) through first and second air outlet openings <NUM>, one for each blister pocket. The medicament-laden air flows from the opened blister pockets to the medicament delivery conduit <NUM> through first and second medicament inlet openings <NUM>, one for each blister pocket. It should be noted that only one of the air outlet openings <NUM> and (a corresponding) one of the medicament inlet openings <NUM> are visible in <FIG>, the others being hidden from view. Similarly, only (the same) one of the air outlet openings <NUM> and one of the medicament inlet openings <NUM> are visible in <FIG>, owing to the sectioning of the manifold component <NUM> in this drawing. However, it will be understood that the unillustrated openings have the same size and shape as the illustrated openings <NUM>, <NUM>, and are arranged to interface with a second one of the opened blister pockets.

As illustrated most clearly in the enlarged portion of <FIG>, according to invention, each air outlet opening <NUM> is arranged to be positioned substantially centrally over the opened blister pocket (not shown), and each medicament inlet opening <NUM> is arranged to be positioned over the opened blister pocket so as to be closer to an edge of the opened blister pocket than the air outlet opening <NUM>. The medicament inlet opening <NUM> also partially surrounds the air outlet opening <NUM>, and in doing so defines an angle of at least <NUM> degrees, optionally at least <NUM> degrees, further optionally at least <NUM> about the air outlet opening <NUM>.

Each air outlet opening <NUM> has an elongate shape, which may correspond to the shape of the periphery of the blister pockets (not shown). Each medicament inlet opening <NUM> has a curved or arcuate shape, in particular surrounding the air outlet opening <NUM>, and also at least partially corresponding to the shape of the periphery of the blister pockets.

In the illustrated embodiment, each medicament inlet opening <NUM> is divided into a four adjacent openings each arranged to be positioned over a peripheral region of the opened blister pocket.

Such an arrangement is able to provide for more complete emptying of the medicament from the opened blister pockets. In particular, the provision of the medicament inlet openings <NUM> close to the edges of the blister pockets can help to prevent medicament being retained at the edge of the blister pockets. In this way, medicament dosing may be more consistent and medicament wastage minimised.

A third inhaler will now be described. <FIG> are views for describing a dry powder inhaler, in particular illustrating the manifold component <NUM>. More particularly, <FIG> is a schematic cross-sectional view of the manifold component <NUM>. <FIG> is a partial plan view of certain features of the manifold component <NUM>.

The components of the third dry powder inhaler other than the manifold component <NUM> are the same as those of the above-described first inhaler, and will therefore not be described in any detail. The third dry powder inhaler therefore differs only in terms of the detailed design of the manifold component <NUM>.

The manifold component <NUM> is, however, similar in terms of purpose and general structure to those of the manifold components <NUM>, <NUM>, <NUM> of the first inhaler, but is not provided with an auxiliary air inlet opening 51b or an auxiliary air delivery conduit 53b, although such could in principle be provided. Thus, external air flows in to the manifold component <NUM> through a single air inlet opening <NUM>. In use, the external air flows through an air delivery conduit <NUM> and, from there, into a medicament delivery conduit <NUM>. The air passing through the medicament delivery conduit <NUM> entrains medicament from the blister pockets <NUM>. The medicament-laden air then flows out through a medicament outlet opening <NUM>, and is delivered to the user's mouth via the inhaler mouthpiece <NUM>.

In this inhaler, the medicament delivery conduit <NUM> forms an elongated chamber having a substantially circular cross-sectional shape. First and second medicament inlet openings <NUM> are arranged at one end of the chamber <NUM>, to be positioned over the respective opened blister pockets <NUM> for receiving medicament from the opened blister pockets <NUM>. Only one of the blister pockets <NUM> and a corresponding one of the medicament inlet openings <NUM> are shown in <FIG>, although both medicament inlet openings <NUM> are shown in <FIG>. The medicament outlet opening <NUM> is arranged at the other end of the chamber <NUM>.

According to this inhaler, the manifold component <NUM> defines a pair of substantially spiral-shaped vanes 681a, 681b which are configured so that, in use of the inhaler, air from the external air inlet opening <NUM> flows transversely over the vanes 681a, 681b and is directed into the circular chamber <NUM> in directions that are substantially tangential to the chamber (see <FIG>) and at an axial position adjacent the medicament inlet openings <NUM>. In this way, the tangential air flow forms a low pressure vortex in the bottom of the chamber <NUM> which is effective for drawing the medicament through the medicament inlet openings <NUM> and mixing the medicament with the air.

Thus, the air delivery conduit <NUM> effectively defines two tangential flow paths which are diametrically opposed to each other, and provide air to the chamber <NUM>. Alternative inhalers may provide three or more tangential air flow paths for creating the low pressure vortex.

According to the third inhaler, the need for air outlet openings for directing air into the opened blister pockets can be avoided, although such can still be provided in certain alternative inhalers. In particular, the low pressure vortex is sufficient for drawing out the medicament. When the air outlet openings are eliminated in this way, the risk of air and medicament leaking from the seal region between the opened blister pockets <NUM> and the manifold component <NUM> can be reduced. This leads to more consistent medicament dosing and may avoid wastage of medicament.

A fourth inhaler will now be described with reference to <FIG>, which is a schematic, exploded, cross-sectional view for describing a dry powder inhaler. <FIG> illustrates a manifold assembly <NUM>, which replaces both the manifold component and the separate mouthpiece component <NUM> of the other embodiments described above.

The components of the fourth dry powder inhaler other than the manifold component/assembly and mouthpiece component are the same as those of the above-described first inhaler, and will therefore not be described in any detail. The fourth dry powder inhaler therefore differs only in terms of the detailed design of the manifold assembly <NUM>, including its mouthpiece <NUM>.

The manifold assembly <NUM> is, however, similar in terms of purpose and general structure to those of the manifold components <NUM>, <NUM>, <NUM> of the first inhaler, but is not provided with an auxiliary air inlet opening 51b or an auxiliary air delivery conduit 53b, although such could in principle be provided. Thus, external air flows in to the manifold assembly <NUM> through a single air inlet opening <NUM>.

In use, the external air flows through an air delivery conduit <NUM> before it passes out of the manifold assembly <NUM>, then through the opened blister pockets <NUM> where it entrains the medicament, back in to the manifold assembly <NUM>, and along a medicament delivery conduit <NUM>. The air-entrained medicament then flows through a medicament outlet opening <NUM>, and is delivered to the user's mouth via a mouthpiece <NUM> of the manifold assembly <NUM>.

In use, the air flows from the air delivery conduit <NUM> into the opened blister pockets <NUM> through first and second air outlet openings <NUM>, one for each blister pocket. The medicament-laden air flows from the opened blister pockets <NUM> to the medicament delivery conduit <NUM> through first and second medicament inlet openings <NUM>, one for each blister pocket. It should be noted that only one of the blister pockets, and a corresponding air outlet opening <NUM> and medicament inlet opening <NUM> are visible in <FIG>, owing to the sectioning of the manifold assembly <NUM> in this drawing. However, the unillustrated openings have the same size and shape as the illustrated openings <NUM>, <NUM>, and are arranged to interface with a second one of the opened blister pockets.

According to this inhaler, the medicament inlet opening <NUM>, the medicament outlet opening <NUM> and the medicament delivery conduit <NUM> of the manifold assembly <NUM> are provided as a first unitary moulded plastics component 725a. The air inlet opening <NUM>, the air outlet opening <NUM> and the air delivery conduit <NUM> of the manifold assembly <NUM> are provided as a second unitary moulded plastics component 725b, which is distinct from the first unitary component 725a.

In this way, the entire medicament flow path of the manifold assembly <NUM> can be provided as a unitary moulded plastics component, without any joins or seams through which the medicament could potentially leak. In this way, medicament leakage can be minimised. This can provide for more consistent medicament dosing, minimise medicament wastage, and avoid contamination of the internal mechanisms of the inhaler.

Design flexibility can be maintained by forming other parts of the manifold assembly <NUM>, including the air delivery conduit <NUM>, as the second unitary component 725b which is assembled or joined to the first component 725a by known techniques, such as by welding or through the use of integrated or separate fasteners. The assembling or joining of these components does not give rise to a risk of medicament leakage because the boundary between the components does not generally form a part of the medicament flow path. It should be noted that <FIG> illustrates the first and second unitary components 725a, 725b spaced-apart before being assembled, and the opened blister pocket <NUM> is illustrated in this drawing purely for explanatory purposes.

In the illustrated inhaler, the first unitary moulded plastics component 725a also defines the mouthpiece <NUM> of the inhaler, which contacts the user's mouth and through which the user is able to inhale the air-entrained medicament from the opened blister pocket <NUM>. In this way, leakage of the medicament as it passes from the medicament delivery conduit <NUM> to the mouthpiece <NUM> can also be avoided.

A fifth inhaler will now be described with reference to <FIG>, which is a schematic, cross-sectional view for describing a dry powder inhaler. <FIG> illustrates the manifold component <NUM>.

The components of the dry powder inhaler other than the manifold component <NUM> are the same as those of the above-described first inhaler, and will therefore not be described in any detail. The fifth dry powder inhaler therefore differs only in terms of the detailed design of the manifold component <NUM>.

The manifold component <NUM> is, however, similar in terms of purpose and general structure to those of the manifold components <NUM>, <NUM>, <NUM> of the first inhaler, but is not provided with an auxiliary air inlet opening 51b or an auxiliary air delivery conduit 53b, although such could in principle be provided. Further, the manifold component <NUM> does not have an air delivery conduit that is separate from a medicament delivery conduit <NUM>. Thus, external air flows in to the manifold component <NUM> through a single air inlet opening <NUM>. In use, the external air flows through a medicament delivery conduit <NUM>, and a portion of the air is directed through the opened blister pockets <NUM>, so that the medicament is entrained in the air, before returning to the medicament delivery conduit <NUM>.

In this inhaler, the medicament delivery conduit <NUM> forms a chamber, with the air inlet opening <NUM> and a medicament outlet opening <NUM> being arranged at opposite ends of the chamber <NUM>. An air flow path extends from the air inlet opening <NUM> to the medicament outlet opening <NUM>.

In use, the air flows from the medicament delivery conduit <NUM> into the opened blister pockets <NUM> through first and second air outlet openings <NUM>, one for each blister pocket. The medicament-laden air flows from the opened blister pockets <NUM> back to the medicament delivery conduit <NUM> through first and second medicament inlet openings <NUM>, one for each blister pocket. It should be noted that only one of the blister pockets, and a corresponding air outlet opening <NUM> and medicament inlet openings <NUM> are visible in <FIG>, owing to the sectioning of the manifold assembly <NUM> in this drawing. However, the unillustrated openings have the same size and shape as the illustrated openings <NUM>, <NUM>, and are arranged to interface with a second one of the opened blister pockets.

The air outlet openings <NUM> and the medicament inlet openings <NUM> are arranged along the medicament delivery chamber <NUM>, positioned between the air inlet opening <NUM> and the medicament outlet opening <NUM>.

According to this inhaler, the medicament delivery chamber <NUM> is provided with at least one deflection baffle <NUM> that is spaced away from the air outlet openings <NUM> and the medicament inlet openings <NUM>. The deflection baffle <NUM> defines a surface that extends obliquely to the air flow path through the medicament delivery chamber <NUM> and is arranged to deflect a portion of the air flowing from the air inlet opening <NUM> to the medicament outlet opening <NUM> so that, in use of the inhaler, the deflected air is diverted through the opened blister pockets <NUM>, via the air outlet openings <NUM> and the medicament inlet openings <NUM>. The diverted air entrains the medicament in the opened blister pockets <NUM>.

A portion of the air flow through the medicament delivery chamber <NUM> is not deflected by the baffle <NUM>, and instead bypasses the opened blister pockets <NUM>. This bypass airflow <NUM> disruptively impacts the medicament-laden air flowing from the opened blister pockets <NUM> to the medicament outlet opening <NUM>, so as to help deagglomerate the powder medicament.

The deflection baffle <NUM>, or a further baffle being spaced away from the air outlet openings <NUM> and the medicament inlet openings <NUM>, may also be arranged to create a low pressure region <NUM> in the medicament delivery chamber <NUM>, adjacent to the medicament inlet openings <NUM>, for drawing the air-entrained medicament from the opened blister pockets <NUM>, via the medicament inlet openings <NUM>.

A sixth inhaler will now be described with reference to <FIG>, which is a schematic, cross-sectional view for describing a dry powder inhaler. <FIG> illustrates the manifold component <NUM>.

The components of the dry powder inhaler other than the manifold component <NUM> are the same as those of the above-described first inhaler, and will therefore not be described in any detail. The sixth dry powder inhaler therefore differs only in terms of the detailed design of the manifold component <NUM>.

The manifold component <NUM> is, however, similar in terms of purpose and general structure to those of the manifold components <NUM>, <NUM>, <NUM> of the first inhaler, but is not provided with an auxiliary air inlet opening 51b or an auxiliary air delivery conduit 53b, although such could in principle be provided. Further, the manifold component <NUM> does not have any air delivery conduit that is separate from a medicament delivery conduit <NUM>. Thus, external air flows in to the manifold component <NUM> through a single air inlet opening <NUM>.

In this inhaler, a medicament delivery conduit <NUM> forms a chamber, with the air inlet opening <NUM> and a medicament outlet opening <NUM> being arranged at opposite ends of the chamber <NUM>. An air flow path extends from the air inlet opening <NUM> to the medicament outlet opening <NUM>.

The chamber <NUM> is provided with first and second medicament inlet openings <NUM>, to be positioned over the respective opened blister pockets <NUM> for receiving medicament from the opened blister pockets <NUM>. Only one of the blister pockets <NUM> and a corresponding one of the medicament inlet openings <NUM> are shown in <FIG>. The medicament inlet openings <NUM> are arranged in a side wall of the chamber <NUM> between the air inlet opening <NUM> and the medicament outlet opening <NUM>.

According to this inhaler, the medicament inlet openings <NUM> are provided at a constricted section <NUM> of the medicament delivery conduit or chamber <NUM>, such that, in use of the inhaler, the Venturi effect provides for a low pressure region <NUM> adjacent to the medicament inlet openings <NUM> for drawing the medicament from the opened blister pockets <NUM> into the medicament delivery conduit or chamber <NUM>. The drawn in medicament is then entrained by the air flowing through the medicament delivery conduit or chamber <NUM>.

In particular, the constricted section <NUM> of the medicament delivery conduit <NUM> defines a cross-sectional area that is at least <NUM>%, optionally at least <NUM>%, smaller than each of an upstream and downstream cross-sectional area of the medicament delivery conduit <NUM>. In this way, the low pressure region <NUM> adjacent the medicament inlet openings <NUM> may be very effective for drawing the medicament from the opened blister pocket.

Such an arrangement may avoid the prior art requirement for the manifold component <NUM> to have an air outlet opening through which external air flows into the opened blister pockets. In particular, the low pressure region <NUM> effectively pulls the medicament from the blister pockets <NUM> and through the medicament inlet openings <NUM>. Accordingly, the manifold component <NUM> may have no air outlet openings through which external air is able to flow into the opened blister pockets <NUM>.

However, in the illustrated inhaler, the opened blister pockets <NUM> are exposed to a source of atmospheric pressure, being higher than a pressure at the low pressure region <NUM>. For this purpose, the manifold component <NUM> may be provided with air outlet openings <NUM> fluidly connected to a source of atmospheric pressure, for example the interior of the inhaler housing. This atmospheric pressure being higher than the pressure of the low pressure region <NUM> helps to drive all of the medicament out of the opened blister pockets <NUM>, without creating a significant air flow through the air outlet openings <NUM> and the opened blister pockets <NUM>.

The medicament delivery conduit <NUM> of the illustrated inhaler is also provided with fins or baffles <NUM> downstream of the constricted section <NUM> for disrupting the airflow through the medicament delivery conduit <NUM>, to thereby improve mixing of the air-entrained medicament. The fins or baffles <NUM> may be arranged at oblique angles for creating a vortex air flow.

As has been explained above, the dry powder inhaler according to the invention comprises two blister packs in the form of first and second blister packs 201a, 201b (<FIG>). The dispensing mechanism is arranged to simultaneously open a blister pocket 61a, 61b of each of the first and second blister packs, and to simultaneously move the first and second blister packs 201a, 201b so that: the first opened blister pocket 61a is aligned with the first air outlet opening 63a and the first medicament inlet opening 65a; and the second opened blister pocket 61b is aligned with the second air outlet opening 63b and the second medicament inlet opening 65b. This allows the inhaler to be used for simultaneous inhalation of different medicaments from the opened blister pockets 61a, 61b.

Additionally or alternatively, the blister pockets 61a, 61b of the first and second blister packs 201a, 201b may have a different shape and/or volume. Additionally or alternatively, the pockets 61a, 61b of the first and second blister packs 201a, 201b may contain a different mass or volume of the respective medicaments, and/or contain respective medicaments having different particle size distributions.

The blister pockets 61a, 61b of the first and second blister packs 201a, 201b may contain different medicaments for simultaneous inhalation where is it preferred that the medicaments do not mix prior to delivery to the user, for example selected from budesonide, formoterol, beclomethasone, fluticasone, salmeterol, albuterol, salbutamol, indacaterol, tiotropium, ipratropium, glycorpyrronium or umeclidinium, vilanterol, and combinations thereof.

The different medicaments for simultaneous inhalation comprise:.

For example, the different medicaments for simultaneous inhalation comprise:.

Non-limiting embodiments of the invention have been described hereinabove with reference to the accompanying drawings. Various changes may be made to these embodiments without departing from the scope of the invention, which is defined by the claims.

For example, the inhalers described hereinabove are for use with blister packs that are peeled open. However, the inhalers may be for use with blister packs that are opened in other ways, for example by piercing or bursting. The blister packs described above are in the form of elongate strips. In other embodiments, the blister packs may be in the form of discs having the blisters arranged about the circumference.

The embodiments described above comprise a specific type of delivery mechanism which is operated by opening a mouthpiece cover. Different types of delivery mechanism may be provided in alterative embodiment, for example, manual lever operated or electrically operated delivery mechanisms.

Although the inhaler described above comprise two medicament carriers, alternative embodiments of the invention may comprise a single medicament carrier, in which case only one half of the dispensing mechanism shown in <FIG> and <FIG> would be need to be provided.

In this case, a single medicament carrier-containing embodiment of the invention may still be configured for simultaneous inhalation of different medicaments by configuring the dispensing mechanism to open two blisters at a time, and providing different blisters of the medicament carrier with different medicaments. For example, the different medicaments for simultaneous inhalation may comprise: budesonide in a first blister and formoterol in a second blister; or beclomethasone in a first blister and formoterol in a second blister; or fluticasone in a first blister and salmeterol in a second blister, or fluticasone in a first blister and albuterol in a second blister, or fluticasone in a first blister and vilanterol in a second blister, or umeclidinium in a first blister and vilanterol in a second blister, or two selected from umeclidinium, fluticasone and vilanterol in a first blister, the remaining medicament from umeclidinium, fluticasone and vilanterol in a second blister. The different medicaments (A and B) could be provided in successive blisters of the blister packs in a repeating arrangement, for example AB AB AB AB. or AB BA AB BA AB.

In this case, the manifold component would need to be adapted slightly, with the air outlet openings and the medicament inlet openings being arranged in the same side wall of the manifold component. This would be necessary to facilitate the interface between the manifold component and the first and second opened blister pockets when the first and second opened blister pockets are adjacent blister pockets in the same (single) blister pack.

Alternatively, the inhaler may comprise a single medicament carrier and be configured to open one blister pocket at a time, for delivery of a single medicament rather than combination therapy.

In the embodiments described above, the manifold component is a unitary (single piece) moulded plastics component. In alternative embodiments, the manifold component may be formed of multiple pieces that are assembled together, and/or may be formed of other materials, and/or may be formed by other processes, for example by machining a solid block of material.

Claim 1:
A dry powder inhaler for delivering medicament to a user from at least one blister pack, the blister pack having a plurality of spaced-apart blister pockets containing doses of the medicament, the inhaler comprising:
a housing (<NUM>) for accommodating unused and used portions of the blister pack together with a dispensing mechanism for selectively opening the blister pockets; and
a manifold component (<NUM>) through which air can be drawn in use of the inhaler, wherein the manifold component (<NUM>) comprises:
an air inlet opening (<NUM>) for receiving external air;
an air outlet opening (<NUM>) for providing the external air from the air inlet opening (<NUM>) into an opened blister pocket, the air inlet opening (<NUM>) being fluidly connected to the air outlet opening (<NUM>) by an air delivery conduit (<NUM>) formed in the manifold component (<NUM>);
a medicament inlet opening (<NUM>) for receiving air-entrained medicament from the opened blister pocket, the air outlet opening (<NUM>) and the medicament inlet opening (<NUM>) being arranged side-by-side to enable simultaneous communication with the opened blister pocket; and
a medicament outlet opening (<NUM>) for delivery of the air-entrained medicament from the opened blister pocket to the user, the medicament inlet opening (<NUM>) being fluidly connected to the medicament outlet opening (<NUM>) by a medicament delivery conduit (<NUM>) formed in the manifold component (<NUM>),
characterised in that the air outlet opening (<NUM>) is arranged to be positioned substantially centrally over the opened blister pocket,
and wherein the medicament inlet opening (<NUM>) is arranged to be positioned over the opened blister pocket so as to be closer to an edge of the opened blister pocket than the air outlet opening (<NUM>).