iPILL - INTELLIGENT PILL TECHNOLOGY

Digestive tract disorders such as Crohn's disease, colitis and colon cancer are becoming increasingly common, particularly in the western world. Crohn's disease and colitis can be treated with drugs, notably steroids, but many of these drugs have adverse and unpleasant side effects for patients when administered systemically as whole-body doses. However, by delivering the required drugs directly to the site of disease, dose levels may be lowered and many of these side effects could be reduced.

It is this need for accurate delivery of drugs to specific sites in the intestinal tract that drove the development of Philips Research's intelligent pill, "iPill," for electronically-controlled drug delivery. In addition to the potential benefits of this new technology for improving patient therapy, the iPill promises to be a valuable research tool for the development of any new drug that is delivered via the intestinal tract.

Capsules containing ultra-miniature cameras are already in use as diagnostic tools, but lack the ability to deliver drugs. The challenge for scientists at Philips Research was to find a way of navigating a drug-loaded pill capsule to the site of disease and then releasing a metered amount of drug into the intestinal tract at that location.

NAVIGATING THE INTESTINAL TRACT

What Philips Research has developed is a pill that can be swallowed with food or water in the normal way and is then carried along by the normal movement of food through the intestinal tract. Knowing where the iPill is in the intestinal tract relies on the fact that the intestinal tract's pH value (a measure of acidity) rises sharply upon exiting the stomach and becomes progressively alkaline from the upper intestine onwards. In addition, there is typically a noticeable drop in pH between the small intestine and the colon. Armed with pH information, which is measured by the iPill itself, and data about typical transit times through the intestinal tract, the iPill's location in the intestinal tract can be determined with good accuracy. Where greater accuracy is required, external medical imaging equipment could be introduced. Locations where the drug needs to be released could also be determined by medical imaging.

PROGRAMMABLE DRUG

In the form of an 11mm x 26mm capsule, the iPill incorporates a microprocessor, battery, pH sensor, temperature sensor, RF wireless transceiver, fluid pump and drug reservoir. It communicates via its wireless transceiver to a control unit outside the body.

Localized drug delivery is performed by the iPill's internal pump under the control of the microprocessor, allowing accurate control of the drug delivery profile. Examples of possible delivery profiles include a burst, progressive release, or a multi-location dosing.

Pre-planning can be used to determine the target location for drug delivery and hence to define a control program for the microprocessor. This program is loaded into the iPill before it is swallowed, where it controls execution of the drug delivery profile in response to pH measurements taken as the iPill moves through the intestinal tract. Further data from the iPill, such as its temperature measurements, are reported wirelessly to an external control unit, which records data and may also transmit additional control signals back to the iPill.

CURRENT STATUS

Philips Research has constructed a prototype iPill capsule and system.

The design of iPill is suitable for serial manufacturing. The iPill contains all the components described above and miniaturization was made possible by advanced electronic and mechanical integration. System functionality has been verified by invitro testing. Successful programming, measurement, and reporting functions were shown. Drug delivery was verified with model drugs using dissolution apparatus test equipment. The accuracy of the amount of drug dispensed versus time was measured and found to be better than 0.8%.

Philips Research Technology
Andover, MA
research.philips.com