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

Abstract

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.

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  • Authors+Show Affiliations

    ,

    University of California, San Diego School of Medicine, Division of Infectious Diseases, San Diego, California, USA.

    ,

    University of Florida, College of Pharmacy and Emerging Pathogens Institute, Gainesville, Florida, USA.

    ,

    Research and Analytic Services, Sharp Clinical Services, Pennsylvania, USA.

    ,

    University of California, San Diego School of Medicine, Division of Infectious Diseases, San Diego, California, USA. Gilead Sciences, Gilead Sciences, Inc., Foster City, California, USA.

    ,

    University of California, San Diego Department of Medicine, Research Pharmacy, San Diego, California, USA.

    ,

    San Diego County Health and Human Services Agency, San Diego, California, USA. Centers for Disease Control, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, Georgia, USA.

    ,

    Proteus Digital Health, Inc., Redwood City, California, USA.

    ,

    University of California, San Diego School of Medicine, Division of Infectious Diseases, San Diego, California, USA.

    Stanford University, Stanford, California, USA.

    Source

    MeSH

    Antihypertensive Agents
    Antitubercular Agents
    Capsules
    Cross-Over Studies
    Drug Combinations
    Drug Therapy
    Electronics
    Glipizide
    Humans
    Hypoglycemic Agents
    Hypolipidemic Agents
    Medication Adherence
    Mobile Applications
    Precision Medicine
    Solubility
    Telemedicine
    Therapeutic Equivalency

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    28597911

    Citation

    Browne, S H., et al. "Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation." Clinical Pharmacology and Therapeutics, vol. 103, no. 3, 2018, pp. 502-510.
    Browne SH, Peloquin C, Santillo F, et al. Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation. Clin Pharmacol Ther. 2018;103(3):502-510.
    Browne, S. H., Peloquin, C., Santillo, F., Haubrich, R., Muttera, L., Moser, K., ... Blaschke, T. F. (2018). Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation. Clinical Pharmacology and Therapeutics, 103(3), pp. 502-510. doi:10.1002/cpt.760.
    Browne SH, et al. Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation. Clin Pharmacol Ther. 2018;103(3):502-510. PubMed PMID: 28597911.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation. AU - Browne,S H, AU - Peloquin,C, AU - Santillo,F, AU - Haubrich,R, AU - Muttera,L, AU - Moser,K, AU - Savage,G M, AU - Benson,C A, AU - Blaschke,T F, Y1 - 2017/09/19/ PY - 2016/12/19/received PY - 2017/05/08/revised PY - 2017/05/29/accepted PY - 2017/6/10/pubmed PY - 2019/4/13/medline PY - 2017/6/10/entrez SP - 502 EP - 510 JF - Clinical pharmacology and therapeutics JO - Clin. Pharmacol. Ther. VL - 103 IS - 3 N2 - 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. SN - 1532-6535 UR - https://www.unboundmedicine.com/medline/citation/28597911/Digitizing_Medicines_for_Remote_Capture_of_Oral_Medication_Adherence_Using_Co-encapsulation L2 - https://doi.org/10.1002/cpt.760 DB - PRIME DP - Unbound Medicine ER -