Active Agent Delivery Devices and Methods of Using the same
Provided are active agent delivery devices configured to deliver an active agent formulation into or through a mucosal layer in a subject. The active agent delivery devices include a power reservoir configured to eject the active agent formulation at a pressure sufficient to deliver the active agent formulation into or through a mucosal layer in a subject. Methods of using the subject active agent delivery devices are also provided.
1 . An active agent delivery device comprising:
an active agent reservoir at an active agent reservoir end of the device configured to contain an active agent formulation;
a power reservoir at a power reservoir end of the device configured to eject the active agent formulation at a pressure sufficient to deliver the active agent formulation into or through a mucosal layer in a subject; and
a moveable separator separating the power reservoir from the active agent reservoir.
2 . The active agent delivery device of claim 1 , wherein the pressure generated by the device is 30 kPa or more.
3 . The active agent delivery device of claim 1 , wherein the active agent formulation is ejected from the device in 10 msec or less.
4 . The active agent delivery device of claim 1 , wherein the active agent formulation is ejected from the device at a velocity of 1 m/s or more.
5 . The active agent delivery device of claim 1 , wherein the device comprises a nozzle separating the active agent reservoir from the exterior of the device.
6 . The active agent delivery device of any of claims 1 to 5 , wherein the power reservoir contains a gas generating material.
7 . The active agent delivery device of claim 6 , wherein the gas generating material produces a gas upon contact with an aqueous medium.
8 . The active agent delivery device of claim 7 , wherein the gas is a product of a chemical reaction.
9 . The active agent delivery device of claim 6 , wherein the gas generating material is a volatile liquid.
10 . The active agent delivery device of claim 9 , wherein the volatile liquid has a vaporization temperature ranging from 37.5° C. to 45° C.
11 . The active agent delivery device of any of claim 1 , wherein the gas generating material is present in the moveable separator.
12 . The active agent delivery device of any of claims 9 to 11 , wherein the device comprises a heat reservoir in heat transfer relationship with the power reservoir, wherein the heat reservoir comprises a heat generating material that produces heat upon contact with an aqueous medium.
13 . The active agent deliver device of any of the preceding claims, wherein the device comprises a valve separating the power reservoir from the exterior of the device.
14 . The active agent delivery device of claim 13 , wherein the valve comprises a pH responsive material.
15 . The active agent delivery device of claim 14 , wherein the pH responsive material comprises a polymer.
16 . The active agent delivery device of claim 1 , wherein the device further comprises an aqueous medium reservoir configured to contact at least a portion of the power reservoir end of the device and activate the power reservoir.
17 . The active agent delivery device of claim 16 , wherein the power reservoir contains a gas generating material and the aqueous medium reservoir contains an aqueous medium.
18 . The active agent delivery device of any of the preceding claims, wherein the active agent comprises a macromolecule.
19 . The active agent delivery device of claim 18 , wherein the macromolecule comprises a protein.
20 . The active agent delivery device of any of the preceding claims, wherein the active agent formulation comprises a liquid.
21 . The active agent delivery device of any of the preceding claims, wherein the device comprises a tubular member having a planar surface at the active agent reservoir end and a hemispherical structure at the power reservoir end.
22 . The active agent delivery device of any of the preceding claims, wherein the device is configured to promote contact of the active agent reservoir end with a mucosal surface in a subject.
23 . A method of delivering an active agent to a subject, wherein the method comprises administering an active agent delivery device of any of claims 1 to 22 to a subject.
24 . The method of claim 23 , wherein the method is a method of treating the subject for a disease condition.
25 . A kit comprising:
an active agent delivery device of any of claims 1 to 22 ; and
a packaging containing the active agent delivery device.
26 . The kit of claim 25 , wherein the packaging contains two or more active agent delivery devices of any of claims 1 to 22 .
27 . The kit of claim 25 , further comprising a mucosal treatment agent.