Welcome to CDC stacks | Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co‐encapsulation - 52966 | CDC Public Access
Stacks Logo
Advanced Search
Select up to three search categories and corresponding keywords using the fields to the right. Refer to the Help section for more detailed instructions.
Clear All Simple Search
Advanced Search
Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co‐encapsulation
  • Published Date:
    Sep 19 2017
  • Source:
    Clin Pharmacol Ther. 103(3):502-510.
Filetype[PDF-638.29 KB]

  • Pubmed ID:
  • Pubmed Central ID:
  • Description:
    High-resolution measurement of medication adherence is essential to personalized drug therapy. A US Food and Drug Administration (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 Good Manufacturing Practice 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 150/300 mg) vs. native-Rifamate was conducted in 12 patients with active Mycobacterium tuberculosis and demonstrated bioequivalence using the population method ratio test (95% confidence interval). Subsequently, CoE-IS-medications across all biopharmaceutical 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. CoE combines oral medications with the IS without altering the quality of the native formulation, generating "digitized" medications for remote capture of dosing histories.

  • Document Type:
  • Collection(s):
  • Main Document Checksum:
No Related Documents.
You May Also Like: