Ingestible Event Markers Comprising an Ingestible Component

• US 20120059257A1
• Filed: 05/10/2010
• Published: 03/08/2012
• Est. Priority Date: 05/12/2009
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Duck, Robert, Savage, George, Johnson, Patricia, Zdeblick, Mark, Robertson, Timothy, Costelo, Benedict, Au-yeung, Kityee, Hafesi, Hooman
• Granted Patent: US 9,149,423 B2
• Time in Patent Office: Days
• US Class Current: 600/431
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• CPC Class Codes: A61K 49/00 Preparations for testing in vivo
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• 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

Ingestible event markers comprising an identifier and an ingestible component are provided. The ingestible component may vary, where ingestible components of interest include osmotic ingestible components, liquid capsules, tablets, multi-layered ingestible component and multi-compartment ingestible components. In some instances, the identifier is mechanically stably associated with the ingestible component. Also provided are systems that include the ingestible event markers, as well as methods of using the ingestible event markers.

Claims

1. A device comprising:

an ingestible event marker to communicate a current signature; and

an ingestible component physically associated with the ingestible event marker.

2. The device of claim 1, wherein the ingestible component comprises an osmotic ingestible component.

3. The device of claim 2, wherein the osmotic ingestible component comprises a semipermeable layer and an osmotic member.

4. The device of claim 2, wherein the osmotic ingestible component is a tablet.

5. The device of claim 2, wherein the osmotic ingestible component is an osmotic capsule comprising:

an outer semi-permeable layer forming a passageway; and

an osmotic member physically associated with the outer semi-permeable layer.

6. The device of claim 3, wherein the osmotic member is physically associated with the ingestible event marker.

7. The device of claim 6, wherein the ingestible event marker is configured as a barrier that separates the osmotic member from an active agent composition present in the osmotic capsule.

8. The device of claim 5, wherein at least one ingestible event marker is stably associated with an outer location of the osmotic capsule.

9. The device of claim 8, wherein the osmotic capsule is configured such that each of the at least one ingestible event marker is activated when the respective ingestible event marker is approximately level with the osmotic member.

10. The device of claim 1, wherein the ingestible component comprises:

a liquid capsule comprising;

a shell; and

a liquid medium present in the shell.

11. The device of claim 10, wherein the ingestible event marker is in physical communication with the liquid medium.

12. The device of claim 11, further comprising a coating physically associated with the ingestible event marker to protect the ingestible event marker from the liquid medium.

13. The device of claim 12, wherein the coating comprises a pH sensitive coating.

14. The device of claim 1, wherein the ingestible component further comprises a vesicle and wherein the ingestible event marker is physically present in the vesicle.

15. The device of claim 10, further comprising an encasing liquid to encase the ingestible event marker, wherein the encasing liquid is immiscible with the liquid medium.

16. The device of claim 10, wherein the shell comprises a sealed compartment to house the ingestible event marker.

17. The device of claim 10, wherein the ingestible event marker is integrated with the shell.

18. A system comprising:

a device comprising;

an ingestible event marker to communicate a current signature; and

an ingestible component physically associated with the ingestible event marker; and

a receiver to detect the communicated current signature.

19. The system of claim 18, wherein the ingestible component comprises an osmotic ingestible component.

20. The system of claim 18, wherein the ingestible component comprises:

a liquid capsule comprising;

a shell; and

a liquid medium present in the shell.