Ingestible Event Marker for Medication Adherence Tracking
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Clinical studies face challenges in accurately tracking patient adherence to medication regimens, leading to unreliable data on drug treatment efficacy and safety due to non-adherence, which can result in costly consequences and incorrect FDA approval decisions.
Innovation Solution
A pharmaceutical dosage delivery system comprising a carrier component and a cap with an ingestible event marker that encodes information through current flow, allowing for precise monitoring of medication administration time and adherence, using conducting fluid to activate the marker and produce a unique current signature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional medication administration is used without tracking mechanisms, then device complexity is reduced, but measurement precision of medication adherence is insufficient
Solution Approach 1:
The event marker device is nested within the dosage form itself, with the marker contained inside the capsule or tablet. This integration allows the tracking functionality to be embedded directly in the medication, eliminating the need for separate external tracking devices while maintaining measurement precision through the marker's activation upon ingestion.
Solution Approach 2:
The patent replaces complex mechanical tracking systems with an electrical/conductivity-based event marker. The marker uses conductivity changes in the gastrointestinal tract to generate and transmit signals, substituting mechanical complexity with simpler electrical principles that achieve the same adherence tracking function with reduced overall system complexity.
2Reliability
If an ingestible event marker with conductivity control is added to the dosage form, then reliability of adherence tracking is improved, but device complexity increases
Solution Approach 1:
The event marker device performs multiple functions within a single integrated component: it detects ingestion through conductivity changes, generates identification signals, and transmits data about the medication administration event. This multi-functionality improves reliability by ensuring all tracking capabilities are embedded in one reliable unit while avoiding the complexity of multiple separate components.
Solution Approach 2:
The event marker is designed to activate and function automatically upon ingestion, using the body's natural conductivity environment to power and operate the device. The marker self-activates when exposed to gastrointestinal fluids, eliminating the need for external activation mechanisms or complex power management systems, thereby improving reliability through autonomous operation while reducing overall system complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables reliable tracking of medication adherence, providing accurate data on drug efficacy and safety, improving clinical trial outcomes and reducing hospitalization and nursing home admissions by ensuring consistent regimen compliance.
Implementation Method 1
the device produces an identifiable current signature for communicating information... using conducting fluid to activate the marker and produce a unique current signature
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A~4
AI summary
Pharmaceutical delivery systems for delivering dosages according to the present invention include a carrier component (50) and a cap (20) configured to seal an internal volume of the carrier component, wherein the cap includes a device (40) that produces a unique current signature. Dosages prepared to be delivered according to embodiments of the invention find use in a variety of different applications, including clinical trials.