Medicament unit dose cartridge and delivery device

Abstract

There is described a dry powder medicament delivery device comprising: a medicament container containing a unit dose of dry powder medicament; a medicament dispensing assembly; and optionally an air source.

Claims

1. A dry powder medicament delivery device comprising: a medicament container containing a unit dose of dry powder medicament; a medicament dispensing assembly; and optionally an air source; wherein said medicament container comprises i) an elongate member provided with airways; ii) an inset cavity which acts as a medicament reservoir and iii) a slidable outer closure sleeve, wherein a sliding action of the outer closure sleeve reveals some or the entire cavity and aligns the cavity with the airways; the container provides a non-linear pathway for the flow of the powdered medicament; and the medicament powder is caused to substantially flow via the pathway which comprises at least two right angled turns as the medicament powder is expelled from the delivery device.

2. A dry powder medicament delivery device according to claim 1 wherein the device includes an air source.

3. A dry powder medicament delivery device according to claim 2 wherein the air source is a delivery pump.

4. A dry powder medicament delivery device according to claim 1 wherein the medicament dispensing assembly generally comprises a body and a nozzle.

5. A dry powder medicament delivery device according to claim 1 wherein the medicament dispensing assembly comprises an intranasal delivery device.

6. A dry powder medicament delivery device according to claim 3 wherein the delivery pump is a syringe.

7. A dry powder medicament delivery device according to claim 3 wherein the air source or delivery pump is a bellows.

8. A dry powder medicament delivery device according to claim 3 wherein the air source or delivery pump is a squeezable bulb.

9. A dry powder medicament delivery device according to claim 3 wherein the delivery pump comprises an air source and is provided with a bursting diaphragm or dispensing valve.

10. A dry powder medicament delivery device according to claim 1 wherein the device is adapted to facilitate application of the medicament in dry powder form via an air flow to a body orifice.

11. A dry powder medicament delivery device according to claim 1 wherein the device is an inhaler.

12. A dry powder medicament delivery device according to claim 11 wherein the delivery device is a nasal dry powder inhaler.

13. A dry powder medicament delivery device according to claim 1 wherein the dry powder medicament delivery device is for the delivery of a therapeutically effective amount of glucagon to a diabetic experiencing a hypoglycaemic reaction.

14. A dry powder medicament delivery device according to claim 1 wherein the device is suitable for the delivery of one or more dry powder vaccines.

15. A method of delivering a medicament to a patient which comprises the use of a dry powder medicament delivery device comprising: a medicament container containing a unit dose of dry powder medicament; a medicament dispensing assembly; and optionally an air source; wherein said medicament container comprises i) an elongate member provided with airways; ii) an inset cavity which acts as a medicament reservoir and iii) a slidable outer closure sleeve, wherein a sliding action of the outer closure sleeve reveals some or the entire cavity and aligns the cavity with the airways; the container provides a non-linear pathway for the flow of the powdered medicament and the medicament powder is caused to substantially flow via the pathway which comprises at least two right angled turns as the medicament powder is expelled from the delivery device.

16. A method of treatment of a patient with a disorder or prevention of a disorder which comprises the administration to the patient of a suitable medicament using a medicament delivery device according to claim 15.

Description

(1) The invention will now be described by way of example only and with reference to the accompanying drawings in which

(2) FIG. 1a is a perspective view of the medicament delivery device of the invention;

(3) FIG. 1b is a cross-sectional view of the medicament delivery device;

(4) FIG. 1c is a cross-sectional view of the medicament delivery device with dry powder medicament present;

(5) FIG. 2a is a perspective view of the medicament delivery device in the primed position;

(6) FIG. 2b is a cross-sectional view of the medicament delivery device in the primed position with dry powder medicament present;

(7) FIG. 2c is a cross-sectional view of the medicament delivery device being actuated;

(8) FIG. 3 is a cross-sectional view of the medicament delivery device employing a bellows fitted with a dispensing valve;

(9) FIG. 4a is a perspective drawing of a valve of the invention in the closed position;

(10) FIG. 4b is a cross-sectional view of a valve of the invention in the closed position;

(11) FIG. 5a is a perspective drawing of a valve of the invention in the open position;

(12) FIG. 5b is a cross-sectional view of a valve of the invention in the open position;

(13) FIGS. 6a and 6b are perspective views of a valve of the invention illustrating the pimples on the valve;

(14) FIG. 7a is a cross-sectional view of the unit dose medicament container in the open position;

(15) FIG. 7b is a cross-sectional view of the unit dose medicament container in the closed position;

(16) FIG. 7c is a side view of the unit dose medicament container in the closed position;

(17) FIGS. 8a to 8d are schematic representations of the unit dose medicament container being filled;

(18) FIGS. 9a and 9b are schematic cross-sectional representations of the unit dose medicament container being filled;

(19) FIGS. 10a and 10b are schematic representations of the unit dose medicament container being filled by an alternative filling method;

(20) FIG. 11a is a cross-sectional view of the medicament delivery device for use in infusion, the device being in the closed position; and

(21) FIG. 11b is a cross-sectional view of the medicament delivery device for use in infusion, the device being in the open position.

(22) Referring to FIGS. 1a to 1c, 2a to 2c and 7a to 7c, a dry powder medicament delivery device 1 comprises a medicament container 2 containing a unit dose of dry powder medicament 12, a medicament dispensing assembly 3 and optionally a syringe 4. The dispensing assembly 3 comprises a body 5, a nozzle 6 and airways 7 and 8. The medicament container 2 comprises a member 9, cavity 10 and sleeve 11.

(23) To administer a dry powder medicament vaccine user (patient or medical person), connects a syringe 4, first extending the syringe 4 to its open (required capacity) position, to the dispensing assembly 3. The nozzle 5 is then depressed towards the syringe 4 and in doing so pushing the member 9, through the sleeve 11, to align the cavity 10, with the airways 7 and 8. The nozzle 6 is inserted into the patient's nostril (not shown) and the syringe 4 depressed, forcing air through airway 8 and cavity 10, entraining the dry powder medicament 12 and through airway 7 into the patient's nasal cavity (not shown).

(24) The device in its preferred embodiment, is a single use device, the device may therefore be a disposable device which is discarded after use.

(25) Referring to FIGS. 7a-c, the unit dose drug container 2, or cartridge, comprises a member 9 in which a cavity 10 is inset; a sleeve 11 is positioned on member 9. Member 9 is produced in a suitable polymer and the sleeve 11 is produced in an alternative suitable polymer, in a method known as two shot moulding, this process of moulding allows the combined component (member 9 & sleeve 11) to be produced in a single machine cycle with no subsequent assembly, producing clear economic savings.

(26) Referring to FIG. 3 body 5 is modified to incorporate feature 5a to house dispensing valve 32 retained by collar 33 and also retaining bellows 31, when the bellows 31 is depressed sufficiently to create the requisite pressure valve 32 opens releasing air at high velocity into airway 8.

(27) With reference to FIGS. 4a and 4b, a diaphragm valve (101) comprises a circular peripheral flange (102) surrounding a concave valve member (103). The flange is connected to an annular portion (104). The concave valve member (103) comprises a flexible material and is provided with a slit (105) or a pair of slits in its body. The version illustrated shows a pair of slits in the form of a cross, although it will be appreciated that a variety of slit arrangements may be suitable for the invention to perform satisfactorily. The concave valve member (103) is provided with a dispensing surface (106) and a non-dispensing surface (107). Generally the dispensing surface (106) is the upper surface and the non-dispensing surface (107) is the lower surface.

(28) Referring to FIGS. 5a and 5b, when the valve (101) is actuated pressure is applied either directly or indirectly to the non-dispensing surface (107) of the valve member (103). This causes the concave valve member (103) to flex and take up a concave form. The slit (105) opens to create an aperture (108).

(29) Referring to FIGS. 6a and 6b, the valve member of the invention is provided with a plurality of circumferential spaced apart pimples (112) on the inside surface (113) of the wall (104) of the valve member (103). When the valve is urged to an open position, the pimples (112) react against distortion of the side wall and therefore urge the valve back to a closed position. Thus a pressure differential is essential to reopen the valve member of the invention.

(30) Referring to FIGS. 7a to 7d, 8a and 8b, the medicament container 2 (member 9, cavity 10 and sleeve 11) is loaded into a barrel 13 of a filling device or mechanism 14. In FIG. 7a the upper surface of member 9 has a radius to correspond with the radius of barrel 13, the barrel 13 is rotated to align the cavity 10 in member 9 (FIG. 7b) with hopper 15, medicament powder 12 contained in hopper 15 fills cavity 10. In FIG. 5c barrel 13 is further rotated, the surface 16 of barrel 13 closes off hopper 15, the surface 16 of the barrel housing 17 closes off cavity 17, retaining the powder.

(31) Member 9 is then pushed through sleeve 1 so that sleeve 11 sits covering cavity 10 (note, shown as schematic from position b and c in FIG. 7). The barrel 13 is further rotated to facilitate the removal of the filled sub-assembly 3.

(32) It will be appreciated that the foregoing description is limited to describing the progress of one sub-assembly 3 through the filling mechanism, in practice the barrel 13 would facilitate a number of sub-assemblies 3 at a time in a continuous process.

(33) Referring to FIGS. 10a and 10b, in another embodiment of a filling device and method, the sub-assembly 3 is loaded into a disc 18. The upper surface of member 9 is flat (not shown) the disc 18 is rotated to align the cavity 10 in member 9 with hopper 19, the medicament powder 12 contained in hopper 19 fills cavity 10. Disc 18 is further rotated and the surface of disc 18 closes off the cavity 10, retaining the medicament powder 12. Member 9 is then pushed through sleeve 11 so that sleeve 11 sits covering cavity 10. The disc 18 is further rotated to facilitate the removal of the filled sub-assembly 4.

(34) The above two descriptions of filling devices and methods are by way of example only, it will be appreciated that those skilled in the art will identify variations to these basic descriptions, for example by adding means of automation.

(35) Referring to FIGS. 11a and 11b, the medicament device 20, for use in infusion, is assembled from four parts, a main body assembly 21, a drug (dry powder) carrier 22, a drug cavity cover sleeve 23 and a seal component 24.

(36) These four parts are desirably assembled as two sub assemblies:

(37) (a) the main body 21 and the seal 24; and

(38) (b) the drug carrier 22 and cover sleeve 23.

(39) The main body assembly 21 is a dispensing assembly comprising a body 25, a nozzle 26 and fluid/powder channels 27 and 28. The nozzle 26 is provided with lockable ends 29 and 30. In the embodiment shown, end 29 comprises a standard male luer lock and end 30 comprises a standard female luer lock.