Friday, July 30, 2010

Pill Signals That it has Been Swallowed

Can help ensure patient compliance

Pill Signals That it has Been Swallowed

Seeking a way to confirm that patients have taken their medication,University of Florida engineering researchers have added a tiny microchip and digestible antenna to a standard pill capsule. The prototype is intended to pave the way for mass-produced pills that, when ingested, automatically alert doctors,loved ones, or scientists working with patients in clinical drug trials.

“It is away to monitor whether your patient is taking their medication in a timely manner,” Rizwan Bashirullah, PhD, an assistant professor in electrical and computer engineering at the university, said in a statement.

Such a pill is needed because many patients either mismanage, forget, or refuse to take their medication. This causes or exacerbates medical problems, spurs hospitalizations or expensive medical procedures, and undercuts clinical trials of new drugs.

The American Heart Association (AHA) calls patients’ failure to follow prescription regimens the biggest problem in treating illness. Studies have found, for example, that patients with chronic diseases normally take only about half their prescribed medications. According to the AHA, 10% of hospital admissions result from patients not following their prescription guidelines. Other studies have found that taking medication improperly results in 218,000 deaths annually.

Compliance a Problem

Medication compliance is a big problem for clinical trials,Dr. Bashirullah said,because failure to take the experimental drugs skews study results or makes them useless. As a result, researchers often require visual confirmation of participants taking pills, an extremely expensive proposition for trials in which hundreds or thousands of people are participating.

“The idea is to use technology to do this in a more seamless, much less expensive way,” Dr. Bashirullah said. Doctoral student Hong Yu, Chris Batich, PhD, of the University of Florida’s materials science and engineering department, and Neil Euliano of Gainesville-based Convergent Engineering designed and tested the pill with Dr.Bashirullah.

The system has two parts. One is the pill, a standard white capsule coated with a label embossed with silvery lines. The lines comprise the antenna, which is printed using ink made of non-toxic, conductive silver nano particles. The pill also contains a tiny microchip about the size of a period.

When a patient takes the pill, it communicates with the second main element of the system, a small electronic device carried or worn by the patient. For now, it is a stand-alone device, but in the future it could be built into a watch or cell phone. The device then signals a cell phone or laptop that the pill has been ingested, and this informs doctors or family members.

No Batteries Needed

Dr. Bashirullah said the pill needs no battery because the device sends the pill power via imperceptible bursts of extremely low-voltage electricity. The bursts energize the microchip to send signals relayed by the antenna. Eventually the patient’s stomach acid breaks down the antenna, and the microchip is passed through the gastrointestinal tract,but not before the pill confirms its own ingestion. “The vision of this project has always been that you have an antenna that is biocompatible and that essentially dissolves a little while after entering the body,” Dr. Bashirullah said.

The team has successfully tested the pill system in artificial human models as well as cadavers. Researchers have also simulated stomach acids breaking down the antenna to learn what traces it leaves behind. Dr. Bashirullah said those tests had determined that the amount of silver retained in the body is minimal, less than the amount people often receive from common tap water.

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