Active Agent Delivery Devices and Methods of Using the Same

• US 20170246438A1
• Filed: 09/29/2015
• Published: 08/31/2017
• Est. Priority Date: 09/30/2014
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Aran, Kiana, Paredes, Jacobo, Murthy, Niren, Liepmann, Dorian, Lee, Kunwoo
• Granted Patent: US 10,729,895 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 2039/542 oral/gastrointestinal
• CPC Class Codes: A61K 39/0005 Vertebrate antigens from snakes A61K39/38
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

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.

Claims

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.