Miniature ingestible device
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.
1. A manufacturing process comprising:
loading a first portion of a tablet material into a press, the tablet material formulated to disintegrate upon contact with a fluid;
loading an ingestible event marker into the press adjacent to the first portion of the tablet material, the ingestible event marker comprising:
a partial power source having a first portion and a second portion and configured to generate power upon contact of the first portion and the second portion with the fluid; and
a control unit electrically coupled between the first portion and the second portion of the partial power source, wherein the control unit is configured to be activated by receiving the 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;
loading a second portion of the tablet material into the press on a side positioned opposite of the ingestible event marker from the first portion of the tablet material, such that the ingestible event marker resides in the press between the first portion and the second portion of the tablet material;
applying pressure in the press to the first and the second portions of the tablet material, such that the first portion and the second portion of the tablet material completely encapsulates the ingestible event marker and the first portion and the second portion of the partial power source are exposed after the first portion and the second portion of the tablet material disintegrates upon contact with the fluid; and
covering at least partially the first portion and the second portion of the tablet material with a non-soluble film material to form an ingestible device, wherein the film material is formulated and configured to inhibit interaction between the tablet material and a pharmaceutical product during disintegration of the pharmaceutical product; and
wherein the film material covers at least partially the first portion and the second portion of the tablet material such that when the first portion and the second portion of the tablet material come in contact with the fluid, the film material controls the direction of expansion of the tablet material as the tablet material expands.
2. The process of claim 1 , further comprising enveloping the ingestible device with a capsule, wherein the first portion and the second portion of the tablet material further isolate the first portion and the second portion of the partial power source and the control unit from the capsule.
3. The process of claim 2 , wherein the capsule comprises a wall defining a cavity for containing the ingestible device, the wall configured to lose its shape and disintegrate upon contact with the fluid.
4. The process of claim 3 , further comprising filling the cavity with the pharmaceutical product.
5. The process of claim 1 , wherein the tablet material comprises an excipient material that is a disintegrant and comprises at least one of; povidone, crospovidone, croscarmellose sodium, sodium starch glycolate, starch, or microcrystalline cellulose.
6. The process of claim 1 , wherein the tablet material is a soluble film material that comprises at least one of polyethylene oxide or hydroxypropyl cellulose.