APPARATUS FOR AGITATION OF MEDICAMENT FORMULATION

1 . A storage and dispensing apparatus for a pressurised metered dose inhaler, the apparatus comprising:

a canister containing a mixture of a propellant and a therapeutic agent;

an electronically actuated valve;

a controller configured to control the valve;

wherein the controller is further configured to:

actuate the valve to agitate the mixture within the canister; and

actuate the valve to release a dose of the agitated mixture from the canister;

wherein actuating the valve to agitate and actuating the valve to release a dose are discrete.

2 . An apparatus according to claim 1 , wherein the controller is further configured to move the valve in a reciprocal motion to actuate the valve to agitate the mixture within the canister.

3 . An apparatus according to claim 2 , wherein the controller is further configured to move the valve in a further reciprocal motion to actuate the valve to release a dose of the agitated mixture from the canister after the valve has been moved in a reciprocal motion to actuate the valve to agitate the mixture within the canister.

4 . An apparatus according to claim 2 , wherein the controller is further configured to move the valve in an oscillatory motion to actuate the valve to agitate the mixture within the canister.

5 . An apparatus according to claim 1 , wherein the valve comprises a moveable valve member, and wherein actuating the valve to agitate the mixture and actuating the valve to release a dose are separated by a dwell period in which the valve member is stationary.

6 . An apparatus according to claim 1 , wherein a flow restriction is provided between the valve and the canister, such that actuation of the valve to agitate the mixture causes a fluid jet to be created from the restriction into the canister to agitate the contents.

7 . (canceled)

8 . An apparatus according to claim 1 , wherein:

the valve comprises a moveable valve member;

wherein the valve member is moveable by a first distance to a condition in which fluid exits the canister to the valve when the valve is actuated to release a dose; and

wherein the valve member moves by a second distance less than the first distance such that no fluid exits the canister to the valve when the valve is actuated to agitate the mixture.

9 . An apparatus according to claim 1 , wherein the valve is a shuttle valve comprising a valve body and an axially moveable valve member.

10 . (canceled)

11 . An apparatus according to claim 1 , wherein the valve is a metering valve configured to release a predetermined volume of the mixture during actuating the valve to release a dose.

12 . An apparatus according to claim 11 , wherein the metering valve comprises:

a metering chamber inlet in fluid communication with the canister;

a metering chamber outlet for release of a dose of mixture; and

a valve member whose position is controlled by the controller to move between:

a rest position;

an agitation position in which the metering chamber is sealed from the inlet;

a filling position in which the metering chamber is in fluid communication with the inlet but sealed from the outlet; and

an emptying position in which the metering chamber is in fluid communication with the outlet but sealed from the inlet.

13 . An apparatus according to claim 12 , wherein:

the rest position and the emptying position are a first distance apart;

the rest position and the agitation position are a second distance apart, the second distance being greater than the first distance; and

the rest position and the filling position are a third distance apart, the third distance being greater than the second distance.

14 . (canceled)

15 . An apparatus according to claim 1 , wherein the mixture is a suspension of the therapeutic agent in the propellant.

16 . An apparatus according to claim 1 , wherein the controller is configured to only actuate the valve to release a dose within a predetermined time window after the valve has been actuated to agitate the mixture.

17 . An apparatus according to claim 1 , wherein the valve is resiliently biased to a closed condition by the pressure of the mixture within the container.

18 . An apparatus according to claim 1 , wherein the viscosity of the contents of the canister is between 1×10 −1 and 5×10 −4 Pa·s.

19 . An apparatus according to claim 1 , wherein the density ratio of the propellant to the therapeutic agent is between 0.4 and 1.3

20 . A method of actuating a storage and dispensing apparatus for a pressurised metered dose inhaler, the apparatus comprising:

a canister containing a mixture of a propellant and a therapeutic agent; and

a valve;

wherein the method comprises:

actuating the valve to agitate the mixture within the canister; and

actuating the valve to release a dose of the agitated mixture from the canister;

wherein actuating the valve to agitate and actuating the valve to release a dose are discrete.

21 . The method of actuating according to claim 20 , wherein the apparatus comprises an electronic controller, and wherein actuating the valve to agitate and actuating the valve to release the dose are carried out by the controller.

22 . The method of actuating according to claim 20 , wherein the apparatus is according to claim 1 .

23 . A method of delivery of a medicament to a human or animal comprising:

providing a pressurised metered dose inhaler having:

a storage and dispensing apparatus comprising:

a canister containing a mixture of a propellant and a therapeutic agent; and

a valve; and

a delivery portion for delivering the medicament to a human or animal;

wherein the method comprises:

actuating the valve to agitate the mixture within the canister; and

actuating the valve to release a dose of the agitated mixture from the delivery portion;

wherein actuating the valve to agitate and actuating the valve to release a dose are discrete.