Details:

Alternative Title:
Clin Pharmacol Ther
Personal Author:
Browne, SH ; Peloquin, C ; Santillo, F ; Haubrich, R ; Muttera, L ; ... More +
Browne, SH ; Peloquin, C ; Santillo, F ; Haubrich, R ; Muttera, L ; Moser, K ; Savage, GM ; Benson, CA ; Blaschke, TF Less -
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.
Subject:
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Articles
Research

Source:
Clin Pharmacol Ther. 103(3):502-510.
Pubmed ID:
28597911
Pubmed Central ID:
PMC5836848
Document Type:
Journal Article
Funding:
R01 MH110057/MH/NIMH NIH HHS/United States ; R43 AI100479/AI/NIAID NIH HHS/United States
R01 MH110057/MH/NIMH NIH HHS/United States ; R43 AI100479/AI/NIAID NIH HHS/United States Less -
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:5d84e6cce6b3c9121489a693004c16c6100b7e3384f8ab8d9b656afba126c67e
File Type:

Supporting Files

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