Gastric Residence System Architecture for Controlled Drug Release
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Solution Overview
Problem
Current gastric residence systems face challenges in achieving precise control over drug release, mechanical stability, and residence time in the stomach while avoiding premature passage into the small intestine, which can lead to intestinal obstruction.
Innovation Solution
The development of gastric residence systems with a customized architecture using an elastomer component and multiple carrier polymer-agent components, featuring elongate members with specific linker regions and reinforcing materials, allows for controlled drug release and extended stomach residence without causing obstruction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If the system remains in the stomach for extended periods to enable sustained drug release, then the therapeutic effectiveness is improved, but the risk of premature passage into the small intestine increases which can cause intestinal obstruction
Solution Approach 1:
The gastric residence system is divided into multiple segments including an elastomer component and multiple carrier polymer-agent components. Each segment serves a specific function: the elastomer provides mechanical stability and shape, while the carrier polymer components control drug release. This segmentation allows the system to maintain structural integrity during extended gastric residence while ensuring controlled breakdown into smaller, non-obstructive segments after the residence period, thereby preventing intestinal obstruction.
Solution Approach 2:
The system utilizes parameter changes in the form of pH-responsive and time-dependent linkers that control the structural integrity of the system. These linkers maintain the system's mechanical stability during the desired residence period in the stomach (acidic environment) and then undergo controlled degradation when pH changes or after a specific time period, causing the system to break down into smaller segments that can safely pass into the small intestine without causing obstruction.
2Manufacturing precision
If the system is designed with sophisticated material architecture to control drug release profile, then the drug delivery precision is improved, but the device complexity increases
Solution Approach 1:
The system employs local quality by incorporating different materials with specific properties at different locations within the structure. The elastomer component provides mechanical stability, while the carrier polymer components contain the therapeutic agent. The linkers connecting these components have specific pH-responsive or time-dependent properties. This localized functional differentiation enables precise control over drug release kinetics and system stability without requiring complex overall architecture, as each local region performs its specific function efficiently.
3Duration of action of moving object
If the system uses multiple carrier polymer-agent components with linker regions to control drug release, then the sustained release performance is improved, but the manufacturing complexity increases
Solution Approach 1:
The system merges multiple functions into integrated components. The carrier polymer components simultaneously serve as drug carriers, structural elements, and controlled-release mechanisms. The linkers connecting these components combine mechanical bonding functions with pH-responsive or time-dependent degradation capabilities. This merging of functions reduces the number of separate manufacturing steps compared to assembling multiple discrete components, as the multi-functional components can be manufactured as integrated units while still providing sustained drug release over the desired period.
Data Source
AI summary
The invention provides gastric residence systems with specifically tailored architectures and methods for making such systems. The components of the gastric residence systems can be manufactured by three-dimensional printing or by co-extrusion. The ability to construct precise architectures for the systems provides excellent control over drug release, in vivo stability, and residence time of the systems.