How SMART™ Works
A SMART drug incorporates a taggant (marker) that makes the drug breath-detectible via a small electronic Xhale monitor. Capsules containing the Xhale taggants are available under license from Xhale through established capsule manufacturers, or the taggants can be incorporated into coatings. The presence of the taggants does not change the way the active pharmaceutical ingredient (API) is manufactured by the drug company, and has no impact on the PK/PD of the API.
Xhale's SMART breath monitor serves as an electronic medication reminder for the patient, reminding them to take the medication. The patient ingests the drug, pushes a button on the monitor, and a few minutes later the monitor reminds the patient to blow into the breath collection tube of the monitor. The monitor then detects the metabolite of the marker on the patient's breath, proving definitively that the medication was actually ingested. The time and date of the dose is recorded and transmitted for use by the healthcare provider, organization or trial center involved.
The current generation SMART system includes a monitor designed for use on a countertop in the home, with a portable set of collection tubes the patient can carry in a pocket or purse. Versions in development include small pocket-sized monitors that operate without the countertop base unit.
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