Medication adherence monitoring device

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...

AI Technical Summary

Benefits of technology

[0049]The system according to this invention includes a medication comprising an API and an AEM, wherein the AEM is contained in a chemical form or within a barrier adequate to contain loss of the AEM and / or to prevent the AEM from contacting the API prior to being taken or administered by a subject. In a preferred embodiment, the chemical form or barrier facilitates rapid release of the AEM and / or API in a subject to permit medication adherence monitoring by measurement of an EBM in the exhaled breath of a subject within a specified time period, either immediately or a short period (up to about an hour), or a longer period, (from about one hour up to and including several days) after a medication is ingested by, taken by, is administered to or applied onto the subject. In a medication for use according to the method or in the system according to this invention, the barrier in a preferred embodiment comprises a softgel capsule shell which is optionally coated by a barrier, surface coating, or materials which prevent loss of the AEM from the capsule. Alternatively, or in addition, the AEM is provided in a chemical form that is stable until exposed to the biological environment of the subject, whereupon it quickly forms the AEM in situ and is then expired in the exhaled breath as the EBM. In a further preferred embodiment of such a medication, the AEM comprises either or both (a) a non-ordinary isotope; (b) butanol, isopropanol, or both, either or both of which may include a non-ordinary isotope, or other selected secondary alcohols, or other AEMs. In a further embodiment, the medication includes a surface coating comprising an i-AEM. Given the sensitivity of a D2O detector described herein, a low quantity (e.g., 1-10 mg) of a deuterated AEM placed on the surface (partial surface or total surface) of SODFs (solid tablets, capsules) is adequate to permit medication adherence monitoring. Surface coating and containment, for example, in a blister pack or equivalent preserves the AEM or i-AEM on the surface of the SODF. Likewise, in some embodiments, the AEM is incorporated into the surface coating of the SODF so that it does not require storage in a blister pack, but rather can be stored in a standard pill bottle.

[0053](c) at least one bulking agent or other functional excipient to permit reliable filling of softgel capsules and stable storage of the AEM composition within a softgel capsule.

[0058](b) a SMART® device, which accurately measures the EDIMs and optionally provides medication reminder functions, and orchestrates critical adherence information flow between the relevant stakeholders; wherein the SMART® drug comprises an Adherence Enabling Marker (AEM) composition comprising: (i) at least one secondary alcohol which when ingested or otherwise taken or administered to a subject produces an Exhaled Drug Ingestion Marker (EDIM) detectable in the exhaled breath of the subject; (ii) an adequate quantity of flavorant such that greater than 90% of recipients of the AEM composition report little or no adverse taste following ingestion of the AEM composition; and (iii) an adequate quantity of bulking agent to permit reliable filling of soft-gel capsules and stable storage of the AEM composition within a soft-gel capsule. Preferably, the SMART® device accurately measures the EDIMs, optionally provides medication reminder functions, and orchestrates critical adherence information flow between the relevant stakeholders. This is achieved at least in part by selecting a sensor from the group consisting of miniaturized Gas Chromatography linked to any or a combination of a Metal Oxide Sensor (mGC-MOS), a surface acoustic wave (SAW) sensor, an infrared (IR) sensor, and an ion mobility spectroscopy (IMS) sensor.

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.

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