CONTROLLED ACTIVATION INGESTIBLE IDENTIFIER

• US 20100239616A1
• Filed: 10/25/2007
• Published: 09/23/2010
• Est. Priority Date: 10/25/2006
• Status: Active Grant

• Current Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Hafezi, Hooman, Robertson, Timothy, Colliou, Olivier
• Granted Patent: US 8,945,005 B2
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61J 3/007 Marking tablets or the like apparatus for printing on tablets or the like B41F17/36
• CPC Class Codes: A61K 49/00 Preparations for testing in vivo
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: H01M 10/0436 Small-sized flat cells or batteries for portable equipment
• CPC Class Codes: Y02E 60/10 Energy storage using batteries
• CPC Class Codes: Y02P 70/50 Manufacturing or production processes characterised by the final manufactured product

Abstract

Controlled activation identifiers for use in ingestible compositions, such as pharma-informatics enabled compositions, are provided. The identifiers include a controlled activation element that provides for activation of the identifier in response to the presence of a predetermined stimulus at a target site of interest. The invention finds use in a variety of different applications, including but not limited to, monitoring of therapeutic regimen compliance, tracking the history of pharmaceutical agents, etc.

Claims

1. A pharmaceutical composition comprising:

(a) a pharmaceutical active agent;

(b) a controlled activation identifier that emits a signal upon contact with a target site; and

(c) a pharmaceutically acceptable carrier.

2-19. -19. (canceled)

20. A controlled activation ingestible identifier that emits a signal upon contact with target site fluid present at a target site.

21. The controlled activation ingestible identifier according to claim 20, wherein said identifier comprises:

(a) a solid support;

(b) first and second materials with dissimilar electrochemical activities present on a surface of said solid support.

22. The controlled activation ingestible identifier according to claim 21, wherein said identifier further comprises a dried conductive medium precursor.

23. The identifier according to claim 22, wherein said identifier further comprises a protective barrier that retains said dried conductive medium precursor.

24. The controlled activation ingestible identifier according to claim 21, wherein said identifier further comprises a protective barrier.

25. The controlled activation ingestible identifier according to claim 24, wherein said protective barrier is a semipermeable membrane.

26. The controlled activation ingestible identifier according to claim 24, wherein said protective barrier is a solid barrier comprising a flow path.

27. The controlled activation ingestible identifier according to claim 25, wherein said flow path is a capillary flow path.

28. The controlled activation ingestible identifier according to claim 27, wherein said capillary flow path comprises at least one surface that has been surface energy modified to enhance hydrophilic fluid flow through said capillary flow path.

29. The controlled activation ingestible identifier according to claim 21, wherein said identifier is protected by a barrier that disrupts upon contact with a fluid having sufficient conductivity to activate said identifier in a predetermined manner.

30. The controlled activation ingestible identifier according to claim 21, wherein said identifier is protected by a polymeric coating that dissolves upon contact with a fluid in a time-delayed manner.

31. The controlled activation ingestible identifier according to claim 21, wherein said identifier further comprises a signal producing system that emits a signal when said dried conductive medium precursor is combined with water to produce a conductive medium that conductively couples said first and second materials.

32. A system comprising:

(a) a controlled activation ingestible identifier that emits a signal upon contact with target site fluid present at a target site; and

(b) a receiver for detecting a signal produced by said identifier.

33. The system according to claim 32, wherein said receiver is an in vivo receiver.

34. The system according claim 32, wherein said receiver is an ex vivo receiver.

35. A method comprising:

administering to a subject a controlled activation ingestible identifier that emits a signal upon contact with target site fluid present at a target site.

36-46. -46. (canceled)

47. A battery smaller than 10 mm³ comprising two materials with dissimilar electrochemical activities and a dried conductive medium precursor, wherein said battery is activated upon contact with a physiological fluid.

48. The battery according to claim 47, wherein said battery is smaller than about 1 mm³.

49. The battery according to claim 47, wherein said two materials are electrode layers positioned on opposing sides of a semiconductor support.

50. The battery according to claim 47, wherein said two materials are electrode layers on separate semiconductor supports and are in opposing relationship.

51. The battery according to claim 50, wherein said battery is present in an identifier that further includes a signal generation element.