Researchers at the University of Florida are conducting trials on a device that can identify whether a patient has taken a prescribed medication on a regular basis, according to a press release from the university. The Self-Monitoring And Reporting Therapeutics (SMART™) monitor used in the HIV/AIDS trial is from Gainesville, FL-based Xhale, Inc, which says that its technology “enables the creation of a breath-detectable version of any pharmaceutical drug.” The system seems to be based on the detection of 2-butanol “taggant,” that can be incorporated into a gel capsule.
The University of Florida explains:
“The machine sits in your home and when it’s time for you to take your medication, it makes a beeping noise. If you don’t hit a button after about five minutes, it’s going to beep louder and louder until you come,” Melker said. [Dr. Richard Melker, professor of anesthesiology at the UF College of Medicine and chief technology officer for Xhale –ed.] “If you don’t come after a certain amount of time, the machine can call the clinical trial coordinator and indicate that subject or patient didn’t take the medication as prescribed.”
The device, which is slightly smaller than a shoebox, records the results of each breath test, allowing patients to bring a memory card or USB key to the clinic once a month and receive a printout of their results. Eventually, the researchers hope to reduce the size of their detection device to fit inside a cell phone. But for now, they’re satisfied that the technology works.
“The doctor can see how often you took it and exactly what time. If it made the patient really sick or dizzy and they didn’t take it, they can find out why,” Melker said. “It’s not just a question of did I or didn’t I take it, but when you took it or why you didn’t take it.”
The researchers developed the adherence monitor by incorporating minute amounts of an alcohol into a gel capsule. The additive, called 2-butanol, is one of many GRAS — Generally Recognized as Safe — compounds approved by the Food and Drug Administration for use in foods.
“We wanted (patients) to swallow a chemical and have it transform into something else that’s easy to monitor,” said Matthew Booth, an assistant professor of anesthesiology at the UF College of Medicine and an investigator in the study. “When it hits the stomach lining and liver, an enzyme converts the alcohol to a gas that can be measured in the breath.”