Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation.

Area of Science:

• Pharmaceutical Sciences
• Biotechnology
• Clinical Pharmacology

Background:

• Accurate medication adherence monitoring is crucial for effective personalized drug therapy.
• Existing methods for tracking oral medication intake lack precision.
• A US Food and Drug Administration (FDA)-cleared system utilizes an edible ingestion sensor (IS) and wearable patch to record medication ingestion events.

Purpose of the Study:

• To develop and validate a Good Manufacturing Practice (GMP) protocol for co-encapsulating (CoE) oral medications with an IS.
• To assess the bioequivalence and in vitro dissolution profiles of CoE-IS medications compared to their native formulations.
• To establish a method for generating "digitized-medications" for remote dosing history capture.

Main Methods:

• Developed a GMP protocol for co-encapsulating oral medications with an IS within certified capsules.
• Conducted a randomized bioequivalence study comparing CoE-IS-Rifamate to native Rifamate in 12 patients with active Mycobacterium tuberculosis.
• Performed in vitro dissolution testing of CoE-IS medications across various biopharmaceutical classes according to USP and FDA guidelines.

Main Results:

• The randomized study demonstrated bioequivalence between CoE-IS-Rifamate and native Rifamate in patients with active Mycobacterium tuberculosis.
• In vitro dissolution testing confirmed that CoE-IS medications met USP specifications and were equivalent to their native formulations.
• The CoE process successfully integrated the IS without compromising the quality of the original oral medications.

Conclusions:

• Co-encapsulation (CoE) is a viable method to combine oral medications with ingestion sensors (IS) without altering drug quality.
• This technology generates "digitized" medications capable of remote dosing history capture, enhancing medication adherence monitoring.
• CoE facilitates personalized drug therapy through high-resolution, accurate measurement of medication adherence.