Integrated Ingestible Event Marker System with Pharmaceutical Product

• US 20150112243A1
• Filed: 05/27/2014
• Published: 04/23/2015
• Est. Priority Date: 10/25/2006
• Status: Abandoned Application

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Hafezi, Hooman, Duck, Robert, Robertson, Timothy, Costello, Benedict
• Application Number:
  US14/287,851
• Publication Number:
  US 20150112243A1
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• 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: A61B 5/6871 Stomach
• CPC Class Codes: A61B 5/6873 Intestine
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 3/007 Marking tablets or the like apparatus for printing on tablets or the like B41F17/36
• CPC Class Codes: A61J 3/06 into the form of pills, lozenges or dragees
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/2886 having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209
• CPC Class Codes: A61K 9/4825 Proteins, e.g. gelatin gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• 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
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: B30B 11/34 for coating articles, e.g. tablets
• CPC Class Codes: B32B 2250/02 : 2 layers
• CPC Class Codes: B32B 38/0004 : Cutting, tearing or severing, e.g. bursting; Cutter details cutting in general B26D; laminating combined with punching or perforating B32B38/04; removing all or part of the layers B32B38/10; cutting in combination with laying up and registration B32B38/185 takes precedence
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 156/1066 : Cutting to shape joining edge surfaces only

Abstract

A system and method are provided for securing an ingestible electronic device to a pharmaceutical product without damaging the ingestible electronic device. The product includes the ingestible electronic device being placed on the product in accordance with one aspect of the present invention. In accordance with another aspect of the present invention, the ingestible electronic device is placed inside the product. Various embodiments are disclosed in accordance with the present invention for protecting and/or coating of the electronic marker as well as securing the ingestible electronic device onto the product.

Claims

1-14. -14. (canceled)

15. A method for producing a pharmaceutical product with a current control device, the method comprising:

securing the current control device to a medication to produce a tagged medication; and

placing a layer on the current control device of the tagged medication to form the pharmaceutical product.

16. The method of claim 15, further comprising the step of cutting the protective layer to be the same size as the current control device.

17. The method of claim 15, further comprising the step of cutting the protective layer to be oversized relative to the current control device so that the protective layer is configured to be secured to a surface of the medication to seal the current control device from the surrounding environment.

18. The method of claim 15, wherein the step of securing comprises using a plurality of adhesive dots as the adhesive portion and positioning the plurality of adhesive dots on a bottom of the current control device.

19. The method of claim 15, wherein the step of securing includes using an adhesive sheet as an adhesive portion and making the adhesive sheet the same size as the current control device.

26. The method of claim 15, wherein the current control device is secured to the pill using an adhesive portion.

27. The method of claim 15, further comprising forming the current control device to a shape of the pill.

28. The method of claim 15, further comprising forming and securing the protective layer to the shape of the pill using a process, wherein the process comprises at least one of applying heat to the protective layer, applying pressure to the protective layer, or a combination thereof.

29. The method of claim 15, wherein the layer is a protective layer, wherein securing the current control device to the pill comprises securing the current control device to a top surface of the pill, and wherein placing the layer on the current control device comprises placing the protective layer over the current control device on the top surface of the pill.

30. The method of claim 29, wherein the protective layer is placed over the current control device such that is covers the current control device entirely and covers at least a portion of the top surface of the pill.

31. The method of claim 15, wherein the medication comprises a pill, a capsule, or a tablet.

32. The method of claim 31, wherein the medication comprises a capsule, and wherein securing the current control device to the medication comprises securing the current control device to an end of the capsule.

33. The method of claim 31, wherein the medication comprises a capsule, and wherein securing the current control device to the medication comprises securing the current control device to an inside surface of the capsule such that the current control device at least partially surrounds the inside surface of the capsule.

20. A method for producing an identifiable pharmaceutical tablet that contains a device, the method comprising:

loading a first portion of raw powder into a cavity defined by a press wheel, wherein the first portion of the raw powder is a drug;

compressing the first portion of the raw powder to form a first tablet portion;

inserting the device into the cavity containing the first tablet portion;

loading a second portion of raw powder into the cavity that forms a second tablet portion; and

pressing the content of the cavity to form the sealing of the first tablet portion to the second tablet portion and thereby forming the identifiable pharmaceutical tablet.

34. The method of claim 20, further comprising applying a coating to the identifiable pharmaceutical tablet.

21. A pharmaceutical product comprising:

a pill; and

a current control device including comprises a top and a bottom; and

wherein the current control device is secured to the pill using a securing portion located on the bottom of the device for securing the device to the pill; and

wherein a protective layer is positioned on top of the current control device for protecting the current control device from the environment.

22. The product of claim 21, wherein the protective layer is configured to be the same size as the current control device.

23. The product of claim 21, wherein the protective layer is configured to be oversized relative to the current control device, and wherein the protective layer is secured to a surface of the pill and is configured to seal the device from the environment.

24. The product of claim 21, wherein the securing portion comprises a plurality of adhesive dots and wherein the plurality of dots is positioned on the bottom of the current control device.

25. The product of claim 21, wherein the securing portion comprises an adhesive sheet and wherein the adhesive sheet is the same size as the current control device.