APPARATUS FOR USE IN DELIVERING RESPIRATORY DRUGS

Abstract

A collapsible inhaler for use with a metered dose inhaler (MDI) dispenser that is operable to dispense a metered dose of medicament therefrom, the inhaler including: an inlet member being adapted to receive an MDI dispenser and having an inlet therein; an outlet member having an outlet therein, a conduit which is pliable and has a distal end associated with the inlet member and a proximal end associated with the outlet member, a support associated with the pliable conduit that is adjustable between an expanded state and a contracted state whereby in the contracted state the inlet member is positioned proximate the outlet member, while in the expanded state the support supports the pliable conduit and combined with the inlet member being spaced from the outlet member that defines a chamber, so that in use a metered dose of medicament can be dispensed from the MDI dispenser through the inlet in the inlet member to mix with air in the chamber and be inhaled by a patient through the outlet in the outlet member, wherein the inhaler further includes a lockout mechanism for inhibiting operation of the MDI dispenser when the support and conduit are in the contracted state and not inhibiting operation of the MDI dispenser when the support and conduit are in the expanded state.

Claims

1. A collapsible inhaler for use with a metered dose inhaler (MDI) dispenser that is operable to dispense a metered dose of medicament therefrom, the inhaler comprising: an inlet member being adapted to receive an MDI dispenser and having an inlet therein; an outlet member comprising an outlet therein, a conduit which is pliable and has a distal end associated with the inlet member and a proximal end associated with the outlet member, a support associated with the pliable conduit that is adjustable between an expanded state and a contracted state whereby in the contracted state the inlet member is positioned proximate the outlet member, while in the expanded state the support supports the pliable conduit and combined with the inlet member being spaced from the outlet member that defines a chamber, so that in use a metered dose of medicament can be dispensed from the MDI dispenser through the inlet in the inlet member to mix with air in the chamber and be inhaled by a patient through the outlet in the outlet member, wherein the inhaler further comprises a lockout mechanism for inhibiting operation of the MDI dispenser when the support and conduit are in the contracted state and not inhibiting operation of the MDI dispenser when the support and conduit are in the expanded state.

2. The inhaler of claim 1, wherein the MDI dispenser comprises an MDI canister containing the medicament and a needle valve for dispensing the medicament there through, wherein the valve opens upon depression of the MDI canister by engagement with a saddle associated with the inlet member.

3. The inhaler of claim 1, wherein the MDI dispenser comprises an MDI canister containing the medicament and a needle valve for dispensing the medicament there through, and further comprises an actuator comprising a saddle and a mouth piece, wherein the valve of the MDI canister opens upon depression of the MDI canister by engagement with the actuator saddle.

4. The inhaler of claim 1, wherein the lockout mechanism inhibits depression of the MDI canister when the support and conduit are in the contracted state and does not inhibit depression of the MDI canister when the support and conduit are in the expanded state.

5. The inhaler of claim 1, wherein the lockout mechanism comprises an elongate member extending from the outlet member to engage and act as a wedge between the MDI canister and the saddle of the inlet member, or the MDI canister and the saddle of the actuator, to inhibit depression of MDI canister when the support and conduit are in the contacted state, and not engage the MDI canister and saddle to not inhibit depression of the MDI canister when the support and conduit are in the expanded state.

6. The inhaler of claim 1, further comprising a mouthpiece associated with the outlet member and wherein the mouthpiece is extendible.

7.-9. (canceled)

10. The inhaler of claim 1, wherein the inlet member and outlet member are adapted to releasably engage each other when the support is in the contracted state, wherein the inlet member releasably engages the outlet member by way of a bayonet fitting.

11.-12. (canceled)

13. The inhaler of claim 1, wherein the inlet member is adapted to receive the MDI dispenser by way of a tube shaped appendage that is complementary in shape to the MDI dispenser such that an at least partial seal is formed in use.

14. The inhaler of claim 1 wherein the inlet member further comprises a mount wherein, the saddle associated with the inlet member to engage the MDI dispenser and enable actuation of the MDI dispenser upon depression is positioned on the mount.

15. The inhaler of claim 1, wherein the inlet member is adapted to receive the MDI dispenser mouth piece by having a complementary shaped recess, the recess comprising an aperture and having a shape complementary a mouthpiece of the MDI such that an at least partial seal is formed in use.

16. The inhaler of claim 1, wherein the inlet member further comprises a first association portion for associating with the distal end of conduit and support.

17. The inhaler of claim 2, wherein the saddle of the inlet member, or saddle of the actuator, engages the MDI dispenser at an angle relative to the conduit, or wherein the recess engages the MDI dispenser at an relative to the chamber such that release of the medicament substantially is parallel an axis of the chamber.

18. The inhaler of claim 1, wherein the outlet member is lenticular having a concave surface facing interior to the chamber, the concave surface having a second association portion for associating with the proximal end of the conduit and support.

19. (canceled)

20. The inhaler of claim 1, wherein the support is a helical spring.

21. The inhaler of claim 20, wherein the spring has a tension such that the conduit in the expanded state is about linear along an axis parallel to the chamber, such that the weight of the outlet member and inlet member do not substantially deform the conduit in the expanded state.

22. (canceled)

23. The inhaler of claim 1, wherein the conduit is cylindrical, and wherein the interior of the conduit is smooth.

24.-30. (canceled)

31. A system for respiratory delivery of a medicament, the system comprising the inhaler of claim 1 and an MDI dispenser, wherein the MDI dispenser contains a medicament composition comprising a pharmaceutically active agent.

32. (canceled)

33. The system of claim 32, wherein the pharmaceutically active agent is selected from the list comprising: a short-acting beta-adrenergic agonist, a corticosteroid, a tocolytic, a long-acting beta-adrenergic agonist or mixtures thereof.

34.-36. (canceled)

37. A method of respiratory administration of a medicament composition to a subject in need thereof, wherein the medicament composition comprises a pharmaceutically active agent, comprising providing the inhaler of claim 1, inserting the MDI dispenser into the inlet member; operating the MDI to dispense a metered dose of the medicament through the inlet of the inlet member into the chamber, wherein the medicament is dispersed within the volume of the chamber; and inhaling the medicament through the outlet out the outlet member.

38. (canceled)

39. The method of claim 37, wherein the pharmaceutically active agent is selected from the list comprising: a short-acting beta-adrenergic agonist, a corticosteroid, a tocolytic, a long-acting beta-adrenergic agonist or mixtures thereof.

40.-42. (canceled)

Description

BRIEF DESCRIPTION OF DRAWINGS

[0061] FIG. 1 is an isometric view of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure.

[0062] FIG. 2 is a side view of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure.

[0063] FIG. 3 is a top plan view of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure.

[0064] FIG. 4 is a sectional side view through plane I of FIG. 1 of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure.

[0065] FIG. 5 is a sectional inverse plan view through II of FIG. 3 of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure.

[0066] FIG. 6 is an isometric view of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure with mouthpiece released.

[0067] FIG. 7 is a sectional side view through plane III of FIG. 6 of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure with mouthpiece released.

[0068] FIG. 8 is an expanded view of detail “J”, a preferred embodiment of lock out the mechanism when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure.

[0069] FIG. 9 is a sectional inverse plan view through plane IV of FIG. 6 of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure with mouthpiece released.

[0070] FIG. 10 is an isometric view of a preferred embodiment of when the conduit and support of the device are in the expanded state according to one aspect of the disclosure with mouthpiece released.

[0071] FIG. 11 is a side view of a preferred embodiment of when the conduit and support of the device are in the expanded state according to one aspect of the disclosure with mouthpiece released.

[0072] FIG. 12 is a plan view of a preferred embodiment of when the conduit and support of the device are in the expanded state according to one aspect of the disclosure with mouthpiece released. The along an axis parallel to the chamber is shown in this drawing by arrow 196.

[0073] FIG. 13 is a sectional view through plane V of FIG. 11 of a preferred embodiment of when the conduit and support of the device are in the expanded state according to one aspect of the disclosure with mouthpiece released.

[0074] FIG. 14 is an expanded view of detail “E”, a preferred embodiment of lock out the mechanism of when the conduit and support of the device are in the expanded state according to one aspect of the disclosure.

[0075] FIG. 15 is an isometric view of a preferred embodiment of when the conduit and support of the device are in the expanded state according to one aspect of the disclosure with mouthpiece released with MDI dispenser depressed.

[0076] FIG. 16 is a sectional side view through plane VI of FIG. 15 of a preferred embodiment of when the conduit and support of the device are in the expanded state according to one aspect of the disclosure with mouthpiece released with MDI depressed.

[0077] FIG. 17 is an expanded view of detail “F”, a preferred embodiment of lockout the mechanism of when the conduit and support of the device are in the expanded state with the MDI depressed according to one aspect of the disclosure.

[0078] FIG. 18 is an isometric, exploded view of a preferred embodiment of the device according to one aspect of the disclosure.

[0079] FIG. 19 is an isometric view and a plan view of a preferred embodiment of when the conduit and support of the device are in the collapsed state, with the mouth piece open, showing bayonet fittings according to one aspect of the disclosure.

[0080] FIG. 20 is a perspective view of a preferred embodiment when the conduit and support are in the contracted state, with the mouth piece extended, showing the preferred arrangement of the outflow vents.

[0081] FIG. 21 is an isometric view of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure. In this embodiment the inlet member is adapted to receive an MDI dispenser by way of a complementary recess having an aperture to frictionally engage the mouth piece of the MDI dispenser.

[0082] FIG. 22 is an isometric view of a preferred embodiment when the conduit and support of the device are in the collapsed state according to one aspect of the disclosure. In this embodiment the inlet member is adapted to receive an MDI dispenser by way of a complementary shaped tube shaped appendage. In this embodiment the MDI dispenser is received when the inhaler is partially disassembled, and is inserted before use.

DETAILED DESCRIPTION

[0083] FIG. 1 illustrates a preferred embodiment of the device when the support and conduit are in the collapsed state 100 according to one aspect of the disclosure. The device 100 comprises an inlet member 102, which is adapted to receive and actuate an MDI dispenser, such as MDI canister 106 or MDI canister and actuator 196, the dispenser is shown in a non-actuated position, an MDI dispenser can be actuated by depression or downward pressure from the operator. The dispenser, such as canister 106 is interchangeable and upon actuation dispenses a metered dose of medicament. The inlet member 102 may take any form suitable to receive the dispenser and allow for transfer of the medicament from the dispenser 106 into the interior of the device. The tube shaped appendage 182 being of such a complimentary size and such that the MDI canister 106 or MDI canister and actuator 196 fits in with enough clearance to be removable, but tight enough to provide an at least partial seal

[0084] Further shown is the outlet member 104, the outlet member being configured to have an outlet for inhaling the medicament. The outlet member 104 as shown is preferably lenticular in shape, but any form suitable can be used. The device contains a vent 110, the vent traverses from exterior the device into the interior of the device and is preferably a one way vent operating in a direction from an exterior to interior of the device. The vent operates to allow air into the device and to flow through upon use through negative thoracic pressure through the mouth piece 122. The vent 110 enables equalization of the concurrent negative pressure in the chamber thus enabling inhalation whilst not allowing substantial leakage of the medicament. The vent 110 is shown as a preferred embodiment as part of the inlet member, although any number of vents may be present at any number of locations throughout the device.

[0085] Shown in FIG. 2 is the mouth piece 122 is preferably covered by a mouth piece cover 108. The mouth piece 122 is shown as retracted and the mouth piece cover 108 is shown as being closed, prone to an exterior surface of the outlet member 104. Most preferably the mouth piece cover 108 is mounted to the inlet member, even more preferably by way of a hinge, and releasably engages with a surface of the outlet member 104. In a further set of embodiments the inlet member 104 is adapted to receive the MDI canister 106 and actuator 196 by having a complementary shaped recess the recess comprising an aperture and having a shape complementary a mouthpiece of the MDI canister 106 and actuator 196. Such an adaptation can be introduced at 188. Thus the mouthpiece of the MDI canister 106 and actuator 196 is received in the recess in fractional engagement where the MDI canister 106 and actuator 196 is readily removable whilst also capable of forming an at least partial seal when in use. In further embodiments the recess is shaped such that the MDI canister 106 and actuator 196 release of the medicament relative to the conduit substantially parallel to an axis of to the conduit. In this set of embodiments the saddle for actuating the MDI canister is associated with the MDI canister 106 and actuator 196.

[0086] FIG. 3 illustrates a top plan view of a preferred embodiment of the device when the support and conduit are in the collapsed state 100 according to one aspect of the disclosure. The view illustrates a preferred construction of the inlet member 104, being joined as two symmetrical halves 150, it is to be understood that this is a convenient means of assembly and as discussed the outlet member may take any form suitable to receive and actuate the canister 106 or MDI canister and actuator 196, and allow transfer of the medicament there through upon actuation.

[0087] FIG. 4 is a sectional side view through plane I of FIG. 2 of a preferred embodiment of the device in the collapsed state according to one aspect of the disclosure. In the collapsed state the inlet member 102 and outlet member 104 are proximate to each other, and as show are abutting. In the collapsed state the support 116 is shown as occupying less volume than in the expanded state. The pliable conduit 136, supported by the support 116 also occupies less volume and is compressed in the collapsed state. The support may take any form capable of supporting the outlet member 102 and pliable conduit 136, in a preferred embodiment the support is a spring 142.

[0088] Further shown in the sectional view is the canister 106 being received in the inlet member 102 by way of a saddle 128. The saddle accommodates a needle valve 126 of the canister 106. The skilled addressee will appreciate that the saddle 128 allows for depression of the canister 106, such that the needle 126 operates to open a valve contained inside thereof and dispense a metered dose of medicament into the device through an inlet 112 of the outlet member 102.

[0089] In some embodiments the device further comprises a lockout mechanism 118 for inhibiting operation of the canister 106 or MDI canister and actuator 196 when the support and conduit are in the contracted state and not inhibiting operation of the canister when the support and conduit are in the expanded state. The canister 106 contains the medicament and has a needle 128 having a valve for dispensing the medicament through. The needle valve opens upon depression of the canister 106 by engagement with the saddle 128. In the collapsed state, this process is inhibited by the lockout mechanism 118.

[0090] A preferred embodiment of the lockout mechanism 118 is shown in FIG. 4 as an elongate member 120 which extends in a manner parallel to axis parallel to the chamber (shown in FIG. 11 as arrow 198) and internal manner, from the outlet member 104. When the support and conduit of the device are in the collapsed state the elongate member 120 engages with the canister 106, preventing depression of the canister, and actuation of the needle valve and dispensation of the medicament. It should be appreciated that many arrangements of matter may serve to perform this function and the elongate member 120 servers only to exemplify one possible way of preforming the intended operation lockout mechanism 118.

[0091] Further shown in FIG. 4 is the mouth piece 122 shown as retracted, with the mouth piece cover 108 in a retaining position prone to the outlet member 104. In further embodiments of the disclosure, the mouth piece 122 is traversed by a one valve 124, preferably this valve may take the form of duck billed valve, which opens in response to negative by application of negative pressure through the mouth piece 122, but remains closed in response to application of positive pressure.

[0092] FIG. 5 illustrates a sectional inverse plan view through plane II of FIG. 3 of a preferred embodiment of the device in the collapsed state according to one aspect of the disclosure. Shown here is the inlet member 102 proximate to the outlet member 104 in the collapsed state. Further shown is the support 116 in a collapse state. Also visible is the mouth piece 122 and one way valve 124 in a retracted position. In some embodiments the mouth piece 122 is biased to be in an extended position by a suitable means, preferable this may take the form of a spring, most preferably a set of springs 170, associated to the outlet member by any suitable means 170. Most preferably when the mouth piece 122 is retracted, the set of springs 170 is extended and under tension ready to act upon the mouth piece 122 on release of the mouth piece cover 108.

[0093] FIG. 6 illustrates an isometric view of a preferred embodiment of the device when the support and conduit are in the collapsed state according to one aspect of the disclosure with mouthpiece 122 released and extended 200. Also shown is the mouth piece cover 108 released, most preferably the mouth piece is attached to the inlet ember 102 by way of a hinge.

[0094] FIG. 7 is a sectional side view through plane III of FIG. 6 of a preferred embodiment of the device in the collapsed state according to one aspect of the disclosure with mouthpiece released 200. This figure shows an embodiment of the disclosure where the mouth piece extended 122 and the mouth piece cover 108 is in a released position, however the lockout mechanism 118, shown in detail J remains engaged with the MDI 106 preventing actuation.

[0095] FIG. 8 details an expanded view of detail “J”, a preferred embodiment of lock out the mechanism when the conduit and support device is in a collapsed state according to one aspect of the disclosure. In the collapsed state, the lockout mechanism is characterized by an inability to actuate the MDI 106. In this embodiment the elongate member 120 attached to the outlet member 104 (not shown) engages with the MDI canister 106 or MDI canister and actuator 196, in this case a surface of a protrusion 174, prevention depression of the MDI canister 106 MDI canister and actuator 196 to act upon the saddle 112, thus preventing opening of the valve within the needle 126. This wedge like action is shown by arrow 190. Shown here the elongate member is performing the function of a wedge between the MDI canister 106 MDI canister and actuator 196, in this instance engagement occurs at the protrusion 174, and saddle 112. It will be appreciate that the lockout mechanism, such as elongate member 120, can act as a wedge when the inlet member 104 is adapted to receive an MDI canister and actuator 196, thus the saddle 128 is located in the MDI canister and actuator 196.

[0096] FIG. 9 illustrates a sectional inverse plan view through a plane IV of FIG. 6 of a preferred embodiment when the support and conduit of the device in the collapsed state according to one aspect of the disclosure with mouthpiece released 200. Shown here, the mouth piece 122 is extended with the mouth piece cover 108 released. In a preferred embodiment the mouth piece 122 is biased to be in an extended position, as shown the extender, preferably a spring, most preferably a set of springs 170, is now therefore in contracted position acting upon the mouth piece 122 to extend it perpendicular to the surface of the outlet member 104.

[0097] FIG. 10 illustrates an isometric view of a preferred embodiment of the device when the support and conduit are in the expanded state 300 according to one aspect of the disclosure with mouthpiece released. In the expanded state, the pliable conduit 132 is expanded by the associated support (not visible) and the inlet member 102 is spaced form the outlet member 104. A chamber 130 is defied by the pliable conduit 132, having a proximal end 136 towards the outlet member 104 and a distal end 134 towards the inlet member 102. Further shown in FIG. 10 is the support 116 acting to support acting on the pliable conduit 132 in a taut manner and supporting the outlet member 104 without significant deformation of the conduit 130 and therefore the chamber 132.

[0098] FIG. 11 displays a side view of a preferred embodiment of the device in the expanded state 300 according to one aspect of the disclosure with mouthpiece released. In some embodiments of the intervention the conduit 132 is tapered, preferably the taper is such that the circumference of the pliable conduit 132 and chamber 130 decreases towards the outlet member 104. In a preferred embodiment of the disclosure the inlet member 102 outlet member 104 and have first and second association portions 140 and 138 respectively for attaching the pliable conduit 132 and support 116. In FIG. 11 the chamber 130 is shown to be substantially linear along a longitudinal axis parallel to the chamber in the expanded state.

[0099] FIG. 12 illustrates a plan view of a preferred embodiment of the device in the expanded state according to one aspect of the disclosure with mouthpiece released. Shown in both FIGS. 12 and 11 is one embodiment for releasable engagement of the inlet 102 and outlet 104 members when the device is in the contracted state. As shown, a pair of is a resiliently deformable protrusions, 176, formed on the inlet member 102 capable of frictional engagement with the outlet member 102.

[0100] FIG. 13 illustrates a sectional view through plane V of FIG. 11 of a preferred embodiment of the device when the conduit 130 and support 116 are in the expanded state 300 according to one aspect of the disclosure with mouthpiece released. Shown here is the support 116 supporting the pliable conduit 132 in the expanded state. In a preferred embodiment the support is a helical spring 142. Also shown is the perimeter of the chamber 130, the perimeter being defined by the pliable conduit 132, inlet member 102 and outlet member 104. Within the chamber is further defined a cavity volume 144 which according to a preferred aspect of the disclosure is around 200 mL. Shown at the proximal end 136 and at the distal end 134 of the pliable conduit 132 is the second association portion of the outlet member 140 and first association portion of the inlet member 138, in a preferred embodiment the support 116 and pliable conduit 132 are associated with thereon.

[0101] When the support 116 and conduit 132 of the device are in the expanded state, the lockout mechanism 118 does not prevent actuation of the MDI canister 106 or MDI canister and actuator 196 and release of the medicament therefrom. In a preferred embodiment an elongate member 120 can perform this action, and as shown in the expanded state the member 120 is no long engaging with the MDI canister 106 or MDI canister and actuator 196, therefore allowing depression and operation thereof.

[0102] FIG. 14 details an expanded view of detail “E”, a preferred embodiment of lockout the mechanism 118 when the conduit and support 116 is in an expanded state according to one aspect of the disclosure. Shown here is the MDI canister 106 or MDI canister and actuator 196 is received in the saddle 128 by way of engagement with the needle 126. Without engagement of the elongate member 120, depression of the MDI canister 106 or MDI allows for actuation of the valve within the needle 128 and dispensation of the medicament through the inlet 112 into the chamber 130.

[0103] FIG. 15 is an isometric view of a preferred embodiment expanded state according to one aspect of the disclosure with mouthpiece released with MDI depressed 400. Shown herein is the depressed MDI canister 106 or MDI canister and actuator 196, the arrow indicating the direction of force. Upon actuation of the MDI canister 106 or MDI canister and actuator 196, a metered dose of medicament is dispensed into the chamber 130 through an inlet 112 of the inlet member 102 according to one aspect of the disclosure. The medicament aerosol mixing with ambient air in the chamber 132, followed by inhalation through the mouth piece 122 of the outlet member 104 by the patient. Subsequently air is interred into the chamber 132 through the at least one vent 110, further carrying and mixing the metered dose of medicament to equalize the pressure caused by inhalation through the use of negative thoracic pressure.

[0104] FIG. 16 is a sectional side view along plane VI of FIG. 15 of a preferred embodiment expanded state according to one aspect of the disclosure with mouthpiece released with MDI depressed 400. Shown here is the inlet 122 of the inlet member 102 which medicament dispensed from the MDI canister 106 or MDI canister and actuator 196 travels through to enter into the camber 130 as defined. The metered dose of medicament mixes with air within the cavity volume 144, before inhalation by the patient. The patient performs inhalation by use of negative thoracic upon mouth piece 122, which in turn opens the duck billed valve 124 enabling the dose of medicament within the chamber 130 to exit through the outlet 144 of the outlet member 104 into the patient's respiratory system. As discussed, the negative pressure thus produced within the chamber 130 can then be equalized by intrusion of air through a vent 110, as stated the vent is preferably a one way vent to prevent escape of medicament prior to inhalation. Any expired air into the mouth piece 122 can be directed out of the device through any number out outflow vents 184. Shown here the MDI canister 106 is received in the saddle 128 by way of engagement with the needle 126. Without the elongate member 120, depression of the MDI canister 106 allows for actuation of the valve within the needle 128 and dispensation of the medicament through the inlet 112 into the chamber 130.

[0105] FIG. 17 is an expanded view of detail “F”, a preferred embodiment of lock out the mechanism 118 when the conduit and support are in the expanded state with the MDI canister 106 or MDI canister and actuator 196 depressed according to one aspect of the disclosure. Shown in detail F is the MDI canister 106 or MDI canister and actuator 196 as actuated, with the lockout mechanism 118 and not inhibiting depression and therefore actuation of the MDI canister 106. In this particular embodiment depression of the MDI 106 leads to actuation of a valve within the needle 126 by engagement with the saddle 128. The body of the MD canister slides over the needle 128, until the protrusion 174 abuts the saddle 128 causing opening of the valve and dispensation of the medicament thought the inlet 112 into the device.

[0106] FIG. 18 is an isometric, exploded view of a preferred embodiment of the device according to one aspect of the disclosure. Shown here is the inlet member 102 comprising in a preferred embodiment a circular mount 148 having the saddle arrangement 128 and alternate support and conduit association point, the load bearing section 141. Also shown in a preferred arrangement are the two halves 150 forming a tube shaped appendage 182 to receive the MDI canister 106 or MDI canister and actuator 196 and forming the circular portion 180 to enclose the circular mount 148. In some embodiments the vent 110 is placed on the inlet member. In some embodiments the MDI canister 106 or MDI canister and actuator 196 is held in place using an annular seal 178. The mouth piece cover 108 is preferably attached by way of a hinge. In some embodiments, the inlet member 102 has a first association portion 138 for attaching the distal end of the support 116 and conduit 132. Most preferably the support is a spring 142, and both spring 142 and the pliable conduit 132 are associated with to a first association portion 138 at the distal end 134 by way of a frictionally engaging o-ring 146. FIG. 18 further shows an embodiment of the mount 148 comprising radial spokes 192 and outer rim 194.

[0107] The pliable conduit 132, inlet member 102 and outlet member 104 define a chamber 130 having a cavity volume 144 in the expanded state. In the expanded state the pliable conduit 132 and outlet member 104 are supported by the support 116, in a preferred embodiment the support is a spring 142. In some embodiments, the proximal end 136 of the conduit and 132 and support 116 are associated with to first association portion 138 the outlet member 104 by way of a frictionally engaging o-ring 146. The support 116 can be associated with the conduit by any means, for example, by tension of the material and spring, the spring can be interwoven within the conduit, a plurality of attaches, such as o-rings associated with the conduit and the spring passing there through can be used, the spring can also be associated with the support by way of adhesive.

[0108] The outlet member 102 is configured to allow a patient to inhale medicament from the device, in a preferred embodiment a mouth piece 122 is provided to perform this function. Even more preferably the mouth piece 122 is traversed by a one way duck bill valve 124, configured to open on application of negative thoracic pressure. Even more preferably the mouth piece 122 is configured to extend out of the outlet member 102. In the embodiment shown, a basing means, in a preferred embodiment a set of springs 170 biases the mouth piece 122 to extend from the outlet member 102, but is held prone to the outer surface of the outlet member 102 by a cover 108. Also shown, is a preferred embodiment of the lockout mechanism 118, taking the form of an elongate member 120, which extends into the chamber 130 to engage with the MDI canister 106 or MDI to prevent actuation when in the contracted state, and not inhibit actuation when in the expanded state.

[0109] FIG. 19 shows an isometric view and a plan view of a preferred embodiment of the device in a contracted state, with the mouth piece open, showing bayonet fittings according to one aspect of the disclosure. Shown in this figure is a preferred embodiment of a releasably engaging means when the device is in a contracted state and the outlet member 104 and inlet member 102 are proximal to each other. Preferably, the engagements means takes that from of a bayonet type fitting 158 comprised of a lug 160 and radially traversing recess 162 to receive the lug. Most preferably the three sets of lugs 160 and corresponding recesses 162 are arranged at 120° positions around a circumference of the device as shown in the figures.

[0110] FIG. 20 shows a perspective view of a preferred embodiment when the conduit 132 and support 116 are in the contracted state, with the mouth piece extended 122, showing the preferred arrangement of the outflow vents 184. The mouth piece 122 further comprises at least one outflow vent 184 directing any expired air into the surrounding atmosphere. It will be appreciated that the outflow vent 184 may be situated at any suitable location on the device, and any suitable number of vents may be used. Preferably the outflow vent 184 traverses from the cavity in between the mouth piece and one way valve to an exterior of the device. Most preferably the device comprises four outflow vents 184 radially dispersed around the mouth piece at 90° intervals.

[0111] Shown in FIG. 21 is a further set of embodiments of the disclosure where the inhaler in collapsed state 200 is adapted to receive an MDI canister and actuator 196 comprising an MDI canister 106, an actuator comprising a saddle for actuating the MDI canister and mouthpiece. In some embodiments the adaptation is by way of having a complementary shaped recess the recess comprising an aperture and having a shape complementary a mouthpiece of the MDI (not shown). Thus the mouthpiece of the MDI is received in the recess in fractional engagement where the MDI is readily removable whilst also capable of forming an at least partial seal when in use. In further embodiments the recess is shaped such that the MDI release of the medicament relative to the conduit substantially parallel to an axis of to the conduit. In this set of embodiments the saddle for actuating the MDI canister is associated with the MDI.

[0112] Shown in FIG. 22 is a further set of embodiments where the collapsible inhaler in the collapsed state 100 inhaler is adapted to receive an MDI canister and actuator 196 comprising an MDI canister 106, an actuator comprising a saddle for actuating the MDI canister 106 and mouthpiece. In this set of embodiments the interior of the inlet member is shaped such that the MDI is received within the tube shaped appendage. The MDI can be held in place by frictional engagement, the inner surface 199 of the tube may be provided with rubber or other suitably resilient material to aid in said engagement. Alternatively a frictionally engaging o-ring can be used. The arrow 197 indicates the direction that the MDI canister and actuator 196 is received in the inlet member, namely form a direction facing the chamber 130. In some embodiments the MDI canister and actuator 196 is inserted along the course of arrow 197 into the inhaler in an at least partially disassembled state, before use.

System for Respiratory Drug Delivery

[0113] The present disclosure relates to a collapsible inhaler for use with an MDI dispenser, and further to systems and methods of respiratory drug delivery. The device in combination with an MDI dispenser provides in a set of embodiments a system for respiratory delivery of a medicament, the system comprising an inhaler as previously described and an dispense, wherein the dispenser contains a medicament composition comprising a pharmaceutically active agent.

[0114] An MDI dispenser can comprise a MDI canister 106 or an MDI canister and actuator 196. The canister 106 containing medicament, a metering valve which releases a metered dose of medicament upon actuation, and a needle 126 which allows the medicament to exit the canister, often as an aerosol. Actuation is achieved by depression of the canister whilst the needle is held in a suitable means, such as the saddle arrangement 128 as shown previously, or where the saddle forms part of an MDI actuator, which results in the canister sliding over the needle 126 and opening of the calibrated valve to release the metered dose of medicament. Often the canister is pressurized such that the medicament is ejected under pressure through the needle value and dispersed as an aerosol which has the advantage of having a high surface area which encourages adsorption in to the patient. The chamber 132 provided by the conduit 132 and support 116 in the expanded state provides a cavity volume 144 within which the aerosol of medicament expands into. The patient then inhales the volume of expanded medicament. The volume 144 allows for the initially concentrated medicament aerosol to expand after ejection from the MDI canister 106 or MDI canister and actuator 196. The patient may then apply negative thoracic pressure and inhale the medicament to act upon or be absorbed by the pulmonary system. The use of a chamber 132 encourages a patient to inhale in a more consistent, deep and regular manner.

[0115] The system results in a more efficacious, consistent and less wasteful way of delivering pharmaceutically active agents through the respiratory system. In the expanded state, the chamber further slows the ejected medicament resulting in decreased deposition of medication in the oropharynx whose effect is both more reliable pulmonary delivery as well as decreased risk of side effects, such as hoarse voice. The system also negates the requirement for coordination of the MDI canister 106 MDI or canister and actuator 196 actuation with inhalation, which especially useful in young or unwell patients. In the expanded state, the chamber 130 further slows the ejected medicament resulting in decreased deposition of medication in the oropharynx whose effect is both more reliable pulmonary delivery as well as decreased risk of side effects, such as hoarse voice.

[0116] In some embodiments, the system further comprises the lockout 116 mechanism, as previously discussed, operation of the MDI dispenser is inhibited when the support is in the contracted state and operation of the MDI dispenser not inhibited when the support is in the expanded state.

[0117] In a further set of embodiments the system is adapted for pediatric use. Such adaptation may take the form of a cavity volume 144 adapted for pediatric lung capacity, in a preferred embodiment the volume is about 200 mL. In further embodiments the mouth piece 122 is adapted to fit a child's mouth size. In yet further embodiments the support 116, preferably a spring 142 has a tension not unduly high to be used by a child. Furthermore the adjustable support and conduit is user friendly which enables children of most ages to extend and collapse the device. In some embodiments, the outlet member further comprises a grip which may be formed of an over-molded rubber or silicone grip. The grip may be incorporated into or mounted on the outlet member. This aids in the user gripping the outer during the twisting motion of the bayonet locking engagement which may be especially useful for young and/or unwell patients.

[0118] In further embodiments of the disclosure the system comprises an MDI dispenser contains a composition comprising a pharmaceutically active agent selected from the list comprising, short-acting beta-adrenergic agonists, corticosteroids, tocolytics, long-acting beta-adrenergic agonist leukotriene inhibitors, mast cell stabilizers, phosphodiesterase 4 (PDE4) inhibitors, inhaled magnesium sulphate or mixtures thereof. Most preferably the system comprises and MDI dispenser comprising a pharmaceutically active agent for delivering respiratory drugs for the prophylaxis and/or treatment of asthma and related disorders characterized by symptoms such as reversible airflow obstruction, and/or bronchospasm. Such disorders may further include chronic obstructive pulmonary disease (COPD) and transient bronchospasm relating from allergens as might be experienced during thunderstorm asthma events.

[0119] In some embodiments the system is adapted to prevent adherence of the pharmaceutically active agent. Such adaptations include, the interior of the conduit 132 being smooth, featureless or continuous inner surface forming part of the chamber 130 which prevents physical adherence of the pharmaceutically active agent in discontinuities in the pliable conduit 132. The surface may also have a polish, gloss or be coated by an anti-static or non-stick material preventing adherence of the pharmaceutically active agent. Most preferably all surfaces exposed to the medicament containing the pharmaceutically active agent are adapted as discussed to prevent adherence, including the support 116, outlet member 104, inlet member 102, duck billed valve 124 and the mouth piece 122.

[0120] In yet further embodiments the medicament is comprised of the pharmaceutically active agent, various excipients, propellants and mixtures thereof.

[0121] A pharmaceutically active agent is to be understood as meaning the ingredient in a medicament that is biologically active. The active ingredient may have many active constituents whether defined or otherwise and may be a pharmaceutically acceptable salt or other acceptable formulation.

[0122] An excipient is to be understood as pharmaceutically inactive substance that serves to aid in the drug delivery, enchase shelf life, aid in solubility, facilitate flowability, reduce viscosity or otherwise enhance the properties of pharmaceutically active agent.

[0123] Common excipients include a pH regulator, a chelating agent, a tonicity adjusting agent, a vehicle, a solvent, a sweetener, a buffering agent, a preservative, or mixtures thereof.

[0124] A propellant is to be understood as compressible substance which is not substantially toxic and preferably does not cause undue environmental harm. In preferred embodiments the propellant is a fluoroalkane. Common fluoroalkanes include 1,1,1,2-tetrafluoroethane. In the compositions to be delivered with an MDI dispenser the propellant is preferably a hydrofluorocarbon selected from the group of HFA 134a, HFA CF.sub.3CHFCF.sub.3, also known as HFA 227, HFC 227 or 1,1,1,2,3,3,3-heptafluoropropane.

[0125] The following medicaments are provided by way of example of medicaments that may be administered by the system as described. These are exemplary in nature and not meant as a limitation to what may be contained in the MDI dispenser.

[0126] In one embodiment the system comprises an MDI dispenser containing a short acting bronchodilator. Short acting bronchodilators act upon the lungs to open air ways to improve breathing. Examples of a short acting bronchodilator may be selected from the list comprising albuterol sold under the trade name Vospire ER, levalbuterol sold under the trade name Xopenex, ipratropium sold under the trade name Atrovent, albuterol/ipratropium sold under the trade name Combivent, or mixtures thereof. The MDI disperser may further comprise theophylline.

[0127] In another embodiment the system comprises an MDI dispenser containing a long acting bronchodilators. Long acting bronchodilators also act upon the lungs to open air ways to improve breathing, but generally operate for a longer period of time. Examples of long acting bronchodilators may be selected from the list comprising aclidinium sold under the trade name Tudorza, arformoterol sold under the trade name Tudorza, arformoterol sold under the trade name Brovana, formoterol sold under the trade name Foradil and Perforomist, glycopyrrolate sold under the trade name Seebri and Neohaler, indacaterol sold under the trade name Arcapta, olodaterol sold under the trade name Striverdi and Respimat, salmeterol sold under the trade name Serevent, tiotropium sold under the trade name Spiriva, umeclidinium sold under the trade name Incruse Ellipta and Brovana, or mixtures thereof.

[0128] In another embodiment the system comprises an MDI dispenser containing a Corticosteroid. Corticosteroids reduce inflammation in the lungs and airways to improve breathing. Examples of Corticosteroids, often used for the treatment of COPD and/or asthma may be selected from the list comprising Fluticasone sold under the trade name Flovent, Budesonide sold under the trade name Pulmicort, and Prednisolone.

[0129] In another embodiment the system comprises an MDI dispenser containing a combination of drugs. Examples of common combinations may be selected from the list comprising glycopyrrolate and formoterol sold under the trade name Bevespi and Aerosphere, glycopyrrolate and indacaterol sold under the trade name Utibron amd Neohaler), tiotropium and olodaterol sold under the trade name Stiolto and Respimat, umeclidinium and vilanterol sold under the trade name Anoro and Ellipta, budesonide and formoterol sold under the trade name Symbicort, fluticasone amd salmeterol sold under the trade name Advair, fluticasone and vilanterol sold under the trade name Breo and Ellipta.

[0130] In another embodiment the system comprises an MDI dispenser containing Leukotriene receptor antagonists, which may be selected from the list comprising montelukast and zafirlukast. The MDI may also comprise a mast cell stabilizer such as cromolyn sodium. In further embodiments the MDI dispenser can comprise phosphodiesterase 4 (PDE4) inhibitors such as Cilomilast, Ibudilast, Roflumilast or mixtures thereof

Method of Respiratory Drug Delivery

[0131] According to a further aspect of the disclosure there is provided a method of respiratory administration of a medicament to a subject in need thereof the medicament comprises a composition comprising a pharmaceutically active agent. The method comprising providing the inhaler of as described, inserting an MDI dispenser into the inlet member 102; operating the MDI dispenser to dispense a metered dose of the medicament through the inlet 112 of the inlet member 102 into the chamber 130, wherein the medicament is dispersed within the cavity volume 144 of the chamber 130; and inhaling the medicament through the outlet 144 out the outlet member 104. The medicament can be dispersed, often by action of propellant, and mix with ambient air of the volume 144 of the chamber 130 to from a more homogenized aerosol, before inhalation. Furthermore, inhalation by negative thoracic pressure aids in mixing of the medicament. In some embodiments the inhaler further comprises vents 110 which allow passage of the air, preferably one-way into the device further aiding in mixing of the medicament.

[0132] The use of a chamber 132 encourages a patient to inhale in a more consistent, deep and regular manner. The method resulting in a more efficacious, consistent and less wasteful way of delivering pharmaceutically active agents through the respiratory system. Operation of the MDI dispenser is by depression and leads to actuation of a valve within the needle 126 by engagement with the saddle 128. The MDI canister 106 slides over the needle 128 until opening of the value contained therein leading to dispensation of a metered dose of medicament. Generally the composition comprises a propellant which propels the metered dose of medicament from within the canister.

[0133] In some embodiments the protrusion 174 abuts the saddle 128 during depression leading to dispensation of the medicament thought the inlet 112 into the chamber 130 of the inhaler and to mix with ambient air within the cavity volume 144. In the expanded state, the chamber 130 further slows the ejected medicament resulting in decreased deposition of medication in the oropharynx whose effect is both more reliable pulmonary delivery as well as decreased risk of side effects, such as hoarse voice. The method further negates the requirement for coordination of the MDI dispenser actuation with inhalation, which especially useful in young or unwell patients. In the expanded state, the chamber 130 further slows the ejected medicament resulting in decreased deposition of medication in the oropharynx whose effect is both more reliable pulmonary delivery as well as decreased risk of side effects, such as hoarse voice.

[0134] In a further set of embodiments, operating of the MDI dispenser 106 in the method is inhibited when the support 116 and conduit 132 is in the contracted state and operation of the MDI dispenser 106 not inhibited when the support 116 and conduit 132 is in the expanded state. In some embodiments the method further comprises a step of operating the inhaler such that the lockout mechanism 116 does not prevent actuation of the MDI dispenser 106. The step comprises operating the inhaler such that conduct 132 and support 116 are in the extended state allowing for operation of the MDI dispenser 106, and the elongate member 120 does not engage the MDI dispenser 106 allowing for operation thereof in the expanded state. Even more preferably operating the inhaler is such that the releasably engaging apparatus, preferably the bayonet fitting comprising lugs 160 and recesses 162, is released allowing for extending of the support 116 and conduit 132 into the extended state, disengaging the elongate member 120 with the MDI 106 allowing operation thereof.

[0135] In a further set of embodiments the method is adapted for pediatric use. Such adaptation may take the form of a chamber volume 144 adapted for pediatric lung capacity, in a preferred embodiment the volume is about 200 mL. In further embodiments the mouth piece 122 is adapted to fit a child's mouth size. In yet further embodiments the support 116, preferably a spring 142 has a tension not unduly high to be used by a child.

[0136] In yet further embodiments the medicament is comprised of the pharmaceutically active agent, various excipients, propellants and mixtures thereof.

[0137] A “pharmaceutically active agent” is to be understood as meaning the ingredient in a medicament that is biologically active. The active ingredient may have many active constituents whether defined or otherwise and may be a pharmaceutically acceptable salt or other acceptable formulation.

[0138] An excipient is to be understood as pharmaceutically inactive substance that serves to aid in the drug delivery, enchase shelf life, aid in solubility, facilitate flowability, reduce viscosity or otherwise enhance the properties of pharmaceutically active agent.

[0139] Common excipients include a pH regulator, a chelating agent, a tonicity adjusting agent, a vehicle, a solvent a sweetener, a buffering agent, a preservative, or mixtures thereof.

[0140] A propellant is to be understood as compressible substance which is not substantially toxic and preferably does not cause undue environmental harm. In preferred embodiments the propellant is a fluoroalkane. Common fluoroalkanes include 1,1,1,2-tetrafluoroethane. In the compositions to be delivered with an MDI dispenser the propellant is preferably a hydrofluorocarbon selected from the group of HFA 134a, HFA CF.sub.3CHFCF.sub.3, also known as HFA 227, HFC 227 or 1,1,1,2,3,3,3-heptafluoropropane.

[0141] In further embodiments of the disclosure the method comprises using an MDI comprises a pharmaceutically active agent selected from the list comprising, short-acting beta-adrenergic agonists, corticosteroids, tocolytics, long-acting beta-adrenergic agonist leukotriene inhibitors, mast cell stabilizers, phosphodiesterase 4 (PDE4) inhibitors, inhaled magnesium sulphate or mixtures thereof. Most preferably the method is used for delivering respiratory drugs for the prophylaxis and/or treatment of asthma and related disorders characterized by symptoms such as reversible airflow obstruction, and/or bronchospasm. Such disorders may further include chronic obstructive pulmonary disease (COPD) and transient bronchospasm relating from allergens as might be experienced during thunderstorm asthma events.

[0142] The following pharmaceutically active agents are provided by way of example of medicaments that may be administered by the method as described. These are exemplary in nature and not meant as a limitation to what may be contained in the MDI dispenser.

[0143] In one embodiment the method uses an MDI dispenser containing a short acting bronchodilator. Short acting bronchodilators act upon the lungs to open air ways to improve breathing. Examples of a short acting bronchodilator may be selected from the list comprising albuterol sold under the trade name Vospire ER, levalbuterol sold under the trade name Xopenex, ipratropium sold under the trade name Atrovent, albuterol/ipratropium sold under the trade name Combivent, or mixtures thereof. The MDI disperser may further comprise theophylline.

[0144] In another embodiment the method uses an MDI dispenser containing a long acting bronchodilators. Long acting bronchodilators also act upon the lungs to open air ways to improve breathing, but generally operate for a longer period of time. Examples of long acting bronchodilators may be selected from the list comprising aclidinium sold under the trade name Tudorza, arformoterol sold under the trade name Tudorza, arformoterol sold under the trade name Brovana, formoterol sold under the trade name Foradil and Perforomist, glycopyrrolate sold under the trade name Seebri and Neohaler, indacaterol sold under the trade name Arcapta, olodaterol sold under the trade name Striverdi and Respimat, salmeterol sold under the trade name Serevent, tiotropium sold under the trade name Spiriva, umeclidinium sold under the trade name Incruse, Ellipta and Brovana, or mixtures thereof.

[0145] In another embodiment the method uses an MDI dispenser containing a Corticosteroid. Corticosteroids reduce inflammation in the lungs and airways to improve breathing. Examples of Corticosteroids, often used for the treatment of COPD and/or asthma may be selected from the list comprising Fluticasone sold under the trade name Flovent, Budesonide sold under the trade name Pulmicort, and Prednisolone.

[0146] In another embodiment the method uses an MDI dispenser containing a combination of pharmaceutically active agents. Examples of common combinations may be selected from the list comprising glycopyrrolate and formoterol sold under the trade name Bevespi and Aerosphere, glycopyrrolate and indacaterol sold under the trade name Utibron amd Neohaler), tiotropium and olodaterol sold under the trade name Stiolto and Respimat, umeclidinium and vilanterol sold under the trade name Anoro and Ellipta), budesonide and formoterol sold under the trade name Symbicort, fluticasone amd salmeterol sold under the trade name Advair, fluticasone and vilanterol sold under the trade name Breo and Ellipta.

[0147] In another embodiment the system comprises an MDI dispenser containing Leukotriene receptor antagonists, which may be selected from the list comprising montelukast and zafirlukast. The MDI may also comprise a mast cell stabilizer such as cromolyn sodium. In further embodiments the MDI may comprise phosphodiesterase 4 (PDE4) inhibitors such as Cilomilast, Ibudilast, Roflumilast or mixtures thereof.

[0148] In a further set of embodiments there is provided a method of treating or prophylaxis of respiratory diseases to a subject in need thereof comprising providing the inhaler as previously described, inserting an MDI dispenser into the inlet member 102; operating the MDI dispenser to dispense a metered dose of the medicament through the inlet 112 of the inlet member 102 into the chamber 130, wherein the medicament is dispersed within the cavity volume 144 of the chamber 130; and inhaling the medicament through the outlet 144 out the outlet member 104.

[0149] Preferably the respiratory disease is selected from asthma, transient bronchospasm relating from allergens as might be experienced during thunderstorm asthma events and/or COPD. Even more preferably the pharmaceutically active agent. Short acting bronchodilators act upon the lungs to open air ways to improve breathing. In further embodiments of the disclosure the method comprises using an MDI comprises a pharmaceutically active agent selected from the list comprising, short-acting beta-adrenergic agonists, corticosteroids, tocolytics, long-acting beta-adrenergic agonist leukotriene inhibitors, mast cell stabilizers, phosphodiesterase 4 (PDE4) inhibitors, inhaled magnesium sulphate or mixtures thereof. Most preferably the system is used for delivering respiratory drugs for the prophylaxis and/or treatment of asthma and related disorders characterized by symptoms such as reversible airflow obstruction, and/or bronchospasm. Such disorders may further include chronic obstructive pulmonary disease (COPD).

[0150] Examples of a short acting bronchodilator may be selected from the list comprising albuterol sold under the trade name Vospire ER, levalbuterol sold under the trade name Xopenex, ipratropium sold under the trade name Atrovent, albuterol/ipratropium sold under the trade name Combivent, or mixtures thereof. The MDI disperser may further comprise theophylline.

[0151] In another embodiment the method uses an MDI dispenser containing a long acting bronchodilators. Long acting bronchodilators also act upon the lungs to open air ways to improve breathing, but generally operate for a longer period of time. Examples of long acting bronchodilators may be selected from the list comprising aclidinium sold under the trade name Tudorza, arformoterol sold under the trade name Tudorza, arformoterol sold under the trade name Brovana, formoterol sold under the trade name Foradil and Perforomist, glycopyrrolate sold under the trade name Seebri and Neohaler, indacaterol sold under the trade name Arcapta, olodaterol sold under the trade name Striverdi and Respimat, salmeterol sold under the trade name Serevent, tiotropium sold under the trade name Spiriva, umeclidinium sold under the trade name Incruse Ellipta and Brovana, or mixtures thereof.

[0152] In another embodiment the method uses an MDI dispenser containing a Corticosteroid. Corticosteroids reduce inflammation in the lungs and airways to improve breathing. Examples of Corticosteroids, often used for the treatment of COPD and/or asthma may be selected from the list comprising Fluticasone sold under the trade name Flovent, Budesonide sold under the trade name Pulmicort, and Prednisolone.

[0153] In another embodiment the method uses an MDI dispenser containing a combination of drugs. Examples of common combinations may be selected from the list comprising glycopyrrolate and formoterol sold under the trade name Bevespi and Aerosphere, glycopyrrolate and indacaterol sold under the trade name Utibron amd Neohaler), tiotropium and olodaterol sold under the trade name Stiolto and Respimat, umeclidinium and vilanterol sold under the trade name Anoro and Ellipta), budesonide and formoterol sold under the trade name Symbicort, fluticasone amd salmeterol sold under the trade name Advair, fluticasone and vilanterol sold under the trade name Breo and Ellipta.

[0154] In another embodiment the method uses an MDI dispenser containing Leukotriene receptor antagonists, which may be selected from the list comprising montelukast and zafirlukast. The MDI dispenser may also comprise a mast cell stabilizer such as cromolyn sodium. Further embodiments the MDI dispenser may comprise phosphodiesterase 4 (PDE4) inhibitors such as Cilomilast, Ibudilast, Roflumilast or mixtures thereof.

[0155] The skilled artisan will appreciate that the device, system and methods as previously described provides a convenient means of delivering respiratory drugs. When expanded the patient has increased reliability of dosage delivered into their pulmonary system, consistent, extended and deeper inhalation and overall reliability of respiratory drug delivery efficacy. In the expanded state, the chamber further slows the ejected medicament resulting in decreased deposition of medication in the oropharynx whose effect is both more reliable pulmonary delivery as well as decreased risk of side effects, such as hoarse voice. As discussed, the support conveniently supports the pliable conduit and the outlet member in the expanded state conveniently allowing the patient to hold and actuate the device using the inlet member. The pliability of the supported conduit enables collapsing of the device to decrease in volume providing the contracted state. Preferably the support is such that in the expanded state the pliable conduit is held taut and such that the weight of the outlet member is supported without substantial deformation of the chamber. The conduit, outlet member and inlet member define a chamber, having a cavity volume wherein the medicament mixes. The pliable conduit may be formed of any deformable material, preferably a durable plastic. Most preferably the combination of support and taut conduit allows inhalation of the medicament without substantial collapse of the camber.

[0156] In a further set of preferred embodiments, the inhaler, system and method further comprise a lockout mechanism for inhibiting operation of the MDI dispenser when the support and conduit are in the contracted state. The mechanism does not inhibit operation of the MDI dispenser when the support is in the expanded state. The MDI dispenser operates by having a body containing the medicament and a needle valve for dispensing the medicament there through, the valve opening upon depression of the MDI dispenser through engagement with a saddle. The lockout mechanism prevents depression of the MDI dispenser when the support and conduit is in the contracted state by engaging with the MDI dispenser and preventing actuation.

[0157] The lockout mechanism provides the advantage of inhibiting actuation of MDI dispenser whilst the device is in the contracted state, therefore coercing the patient to use the device in the expanded state and obtain the advantages provided by the expanded state as discussed. Furthermore, the lockout mechanism prevents unintended actuation of the MDI dispenser during storage, transport and manipulation reducing wastage of medicament and wear to the MDI dispenser.