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Medication adherence monitoring device

a technology of medication adherence and monitoring device, which is applied in the field of medication adherence monitoring system, can solve the problems of system insufficiency, methodological difficulty in assessing long-term adherent behavior with respect to medication regimen, and variability of non-adherence rate found, so as to facilitate rapid release of aem, facilitate stable storage of aem composition, and reliable filling of softgel capsules

Inactive Publication Date: 2017-03-16
UNIV OF FLORIDA RES FOUNDATION INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent describes a system for monitoring medication adherence using a marker substance called an AEM (Adherence Enabling Marker) that is contained in a medication. The AEM is in a chemical form or within a barrier that prevents its loss and comes into contact with the medication before being taken or administered by a subject. The system includes a medication containing the AEM and a barrier to protect the AEM from loss. The AEM can be chemically stable or in a softgel capsule within which it can be stored and later taken by the subject. The system also includes a device called a SMART® that accurately measures the AEM in the exhaled breath of the subject and provides medication reminder functions. The SMART® device uses sensors such as mGC-MOS, SAW, IR, and IMS to detect the AEM. The system helps to promote better adherence to medication and improve treatment outcomes.

Problems solved by technology

As recently as 2012, it has been acknowledged in the literature (see, for example, Oberguggenberger et al., BMC Cancer, 2012, 12:474, “Adherence evaluation of endocrine treatment in breast cancer: methodological aspects”), that the assessment of long-term adherent behavior with respect to medication regimens “is methodologically challenging.
This variability of non-adherence rates found in the literature has been suggested to be attributed to heterogeneous study designs as well as inconsistencies in methodological approaches.
In addition, the Ayer system is not scalable for a large scale clinical trial, thousands of implantation surgeries would be required to implant the drug delivery device.
Notwithstanding the significant and incremental developments that have occurred in this field, some of which are discussed above, none of the known systems, devices and methods fully meet the need in the art for an integrated system capable of providing both acute and chronic medication adherence monitoring options.

Method used

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Examples

Experimental program
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example 1

Hardware Specifications and Performance—Type I Device

[0597]General Overview:

[0598]The SMART® mGC is capable of detecting aldehydes, ketones, esters, ethers, and miscellaneous volatile organic compounds with, e.g., boiling points between 20° C. (68° F.) and 98° C. (208° F.)

[0599]FIG. 9 shows a typical output chromatogram detecting key constituents in the breath, including acetone and isoprene, with clear separation of 2-butanone, derived from ingestion of 2-butanol.

[0600]In one specific embodiment of the present invention, the SMART® device has the following specifications. These specifications are provided to ensure a complete and enabling written description of this invention, but those skilled in the art will appreciate that these specifications should not be interpreted as limiting on the invention.[0601]Operating Principle: Isothermal gas chromatography using ambient air carrier gas and solid-state detector[0602]Enclosure Size: 4.1″×8.9″×2.1″ (3.6″ max)[0603]Weight: 2.5 lbs. (1....

example 2

SMART® mGC Chromatographic Separation of Acetone, Isoprene and Ethanol—Type I Device

[0646]As shown in FIG. 9, a very clean separation of ethanol, acetone and isoprene is achieved when these compounds are simultaneously adsorbed to the sample concentrator followed by thermal desorption, separation via the mGC, and detection by the MOS sensor.

example 3

Clinical (In Vivo, Human) and Potential Interferenent (In Vitro, Benchtop and Clinical) Studies to Optimize and Validate the SMART® System and Composition According to this Invention

[0647]To support development and facilitate regulatory filings, a number of complementary in vitro (benchtop: Interference Studies 1 through 4) and clinical (human: Clinical Studies 1 through 4) studies have been carried out to characterize the SMART® Adherence System. In terms of human exposure, the system has been safely used to date in 33 human studies (oral, sublingual, and microbicide administration routes), encompassing 1,318 experiments in 328 subjects and 8,524 breath analyses. Of particular note, three recent prospective, blinded, randomized, cross over clinical validation studies (127 subjects with 472 experiments and 2,464 breath analyses) using the SMART® Adherence System designed for oral medications were executed that focused on identifying an optimal adherence-enabling marker (AEM) formula...

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Abstract

A Self Monitoring And Reporting Therapeutics, SMART® composition, method, apparatus and system are provided which flexibly provide options, by combining different embodiments of the device with different embodiments of the composition, the ability to conduct definitive medication adherence monitoring over the short term (Acute Medication Adherence Monitoring, immediately up to an hour or so after taking a medication), intermediate term (Intermediate Medication Adherence Monitoring, IMAM, an hour or so to a day or so after taking a medication), and longer term (Chronic Medication Adherence Monitoring, CMAM, a day to several days after taking a medication).

Description

1.0 FIELD OF THE INVENTION[0001]An improved Medication Adherence Monitoring System (MAMS) referred to as SMART®, an acronym for Self Monitoring and Reporting Therapeutics, is provided comprising an optimized device, medication composition, and method of making and using the system and its components.2.0 BACKGROUND OF THE INVENTION[0002]As recently as 2012, it has been acknowledged in the literature (see, for example, Oberguggenberger et al., BMC Cancer, 2012, 12:474, “Adherence evaluation of endocrine treatment in breast cancer: methodological aspects”), that the assessment of long-term adherent behavior with respect to medication regimens “is methodologically challenging. Studies have yielded inconclusive results indicating adherence rates between 20% and 100% across different phases of antineoplastic treatment. This variability of non-adherence rates found in the literature has been suggested to be attributed to heterogeneous study designs as well as inconsistencies in methodologi...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G01N33/497A61B5/097A61B5/00G01N30/74A61B5/083
CPCG01N33/497G01N30/74A61B5/0836A61B5/4833A61B2010/0087G01N2033/4975G01N2030/025G01N2030/743A61B5/097A61B5/082A61B5/087A61B5/4848G01N33/4975
Inventor DENNIS, DONNBOOTH, MATTHEWWASDO, SCOTTBATICH, CHRISWHOLTJEN, HANKCRUMB, DOUGLASTANNER, MARKBAUMGARTNER, SUSANKAUL, POONAM
Owner UNIV OF FLORIDA RES FOUNDATION INC
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