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

High-resolution measurement of medication adherence is essential to personalized drug therapy . An FDA-cleared device, using an edible ingestion sensor (IS), external wearable patch and paired mobile device, can detect and record ingestion events. Oral medications must be combined with an IS to generate precise ‘digitized-medication' ingestion records. We developed a GMP-protocol to repackage oral medications with the IS within certified Capsugel® capsules, termed co-encapsulation (CoE). A randomized bioequivalence study of CoE-IS-Rifamate (Isoniazid/Rifampin 150/300mg) versus native-Rifamate was conducted in 12 patients with active Mycobacterium Tuberculosis (MTB) and demonstrated bioequivalence using the population method ratio test (95% CI). Subsequently, CoE-IS-medications across all bio-pharmaceutical classes underwent in-vitro dissolution testing utilizing USP and FDA guidelines. CoE-IS-medications tested met USP dissolution specifications and were equivalent to their native formulations. Co-encapsulation combines oral medications with the IS without altering the quality of the native formulation, generating ‘digitize' medications for remote capture of dosing histories. This article is protected by copyright. All rights reserved.