Miniature Ingestible Device

• US 20130030366A1
• Filed: 04/07/2011
• Published: 01/31/2013
• Est. Priority Date: 04/07/2010
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Robertson, Timothy, Hafezi, Hooman, Schmidt, Raymond
• Granted Patent: US 9,597,487 B2
• Time in Patent Office: Days
• US Class Current: 604/131
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• 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
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

The present invention discloses multiple approaches to preventing the capsule walls and other material from interfering with the performance of an electronic device once the device is activated by surrounding fluid. In accordance with the teachings of the present invention, a miniature ingestible device (MID) may be created using excipients and films. The MID, in accordance with various aspects of the present invention, will have a coating or laminating surrounding an electronic device and separating and isolating the device from the pharmaceutical product or drug within the capsule once the capsule is ingested as well as from the capsule itself as the capsule walls begin to collapse during the disintegration process.

Claims

1. Apparatus comprising having a first portion and a second portion and configured to generate power upon contact of the first portion and the second portion with a fluid:

a control unit electrically coupled between the first portion and the second portion of the partial power source and configured to be activated by receiving power from the partial power source and to encode information in a current flow between the first portion and the second portion through the fluid;

a material disposed on and isolating the first portion and the second portion of the partial power source from a surrounding environment and formulated to disintegrate upon contact with the fluid to expose the first portion and the second portion of the partial power source to the fluid.

2. The apparatus of claim 1, wherein the material comprises an excipient material that is a disintegrant and comprises at least one of povidone, crospovidone, croscarmellose sodium, sodium starch glycolate, startch, and microcrystalline cellulose cellulose.

3. The apparatus of claim 1, wherein the material is secured to the partial power source using pressure.

4. The apparatus of claim 1, wherein the material is secured to the partial power source using an adhesive material.

5. The apparatus of claim 1, wherein the material is secured to the partial power source using thermal application.

6. The apparatus of claim 1, wherein the material surrounds the partial power source and is secured to itself to define a cavity between the material and the partial power source.

7. The apparatus of claim 1, wherein the material is a soluble film material that comprises at least one of polyethylene oxide and hydroxypropyl cellulose.

21. The apparatus of claim 1, further comprising a pharmaceutical product and a capsule, the capsule including:

a wall, wherein the wall defines a cavity for holding the pharmaceutical product and wherein the wall loses its shape and disintegrates upon contact with a fluid and wherein a device is located within the cavity of the capsule and wherein the cavity disintegrates upon contact with the fluid to provide physical separation between the device and the disintegrating wall of the capsule.

8. Apparatus comprising:

an ingestible unit configured to be disposed in a capsule suitable for ingestions; and

;

a material disposed on at least part of the ingestible unit and formulated and configured to inhibit interaction of the ingestible device and the capsule during disintegration of the capsule.

9. The apparatus of claim 8, wherein the ingestible unit comprises an ingestible event marker.

10. The apparatus of claim 9, wherein the material comprises a super-disintegrant and comprises at least one of povidone, crospovidone, croscarmellose sodium, sodium starch glycolate, startch, and microcrystalline cellulose cellulose.

11. The apparatus of claim 10, wherein the super-disintegrant is physically coupled to the ingestible unit using pressure.

12. The apparatus of claim 10, wherein the super-disintegrant is physically coupled to the ingestible unit using an adhesive material.

13. The apparatus of claim 8, wherein the material includes a soluble film material that comprises at least one of polyethylene oxide and hydroxypropyl.

14. The apparatus of claim 13, wherein the soluble film material is physically coupled to the ingestible unit using thermal application.

15. Apparatus comprising:

an ingestible tablet configured for association with a pharmaceutical agent including;

an ingestible device configured to be activated upon contact with a fluid; and

;

a tablet material in contact with at least part of the ingestible device; and

a material surrounding at least a portion of the ingestible tablet, and formulated and configured to inhibit interaction of the ingestible device and the pharmaceutical agent during disintegration of the pharmaceutical agent.

16. The apparatus of claim 15, wherein the material is a soluble film material that includes at least one of polyethylene oxide and hydroxypropyl cellulose.

17. The apparatus of claim 15, wherein the material is a non-soluble film material that defines an opening at either end of the ingestible tablet such that when the tablet material comes in contact with the fluid and expands the film material controls the direction of expansion.

18. The apparatus of claim 15, wherein the material delays contact between the fluid and the ingestible device to delay activation.

22. The apparatus of claim 15, wherein the apparatus further comprising a capsule defining a cavity wherein the ingestible tablet is located within the cavity of the capsule.

19. A method comprising:

disposing between a first layer of material and a second layer of the material a device configured to be contained within a pharmaceutical product and to be activated by a liquid following dissolution of the pharmaceutical product in the liquid, the device having a first portion and a second portion, the disposing including disposing the device with the first portion in contact with the first layer and the second portion in contact with the second layer; and

securing the first layer of the material to one of the device and the second layer of the material, and securing the second layer of material to one of the device and the first layer of material.

20. The method of claim 19, further comprising the step of physically associating the device with the pharmaceutical product, wherein physically associating the device with the pharmaceutical product comprises incorporating the device in a gelatin capsule