Self-Righting Capsule Density Distribution for GI Tract Anchoring
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Solution Overview
Problem
Current pharmaceutical delivery systems face challenges in effectively targeting and stabilizing biologic drugs like insulin in the GI tract, where they are degraded by enzymes, and require refrigeration or dilution, leading to instability and increased bulk, while oral administration methods struggle with random diffusion and low bioavailability.
Innovation Solution
Self-righting articles with distinct density portions and tissue-interfacing components, capable of anchoring and releasing active pharmaceutical agents directly into the GI tract tissue, utilizing a spring-actuated mechanism for precise delivery and high API loading, allowing for targeted drug delivery and enhanced bioavailability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If liquid formulation is used for injection, then delivery of API is achieved, but API becomes unstable and requires refrigeration
Solution Approach 1:
The patent changes the physical state of the API from liquid to solid formulation. The solid formulation allows the API to remain stable at room temperature without requiring refrigeration, while still enabling effective delivery through the self-righting mechanism that penetrates tissue and releases the solid API directly at the target location.
Solution Approach 2:
The patent extracts the API from the liquid formulation and incorporates it into a solid formulation within the self-righting article. This extraction eliminates the need for refrigeration and dilution while maintaining API stability and delivery effectiveness.
2Quantity of substance
If liquid formulation is used for injection, then delivery of API is achieved, but bulk of the dose increases due to required dilution
Solution Approach 1:
The patent changes the formulation from liquid to solid, eliminating the need for dilution. The solid formulation allows the API to be delivered in a concentrated form directly at the target tissue, significantly reducing the volume and bulk of the dose while maintaining effective delivery.
3Ease of operation
If oral administration is used, then ease of administration is improved, but random diffusion and low bioavailability occur
Solution Approach 1:
The patent employs a self-righting mechanism that automatically orients the article vertically and penetrates the tissue wall without requiring external intervention. The spring-loaded structure self-actuates upon contact with the tissue, delivering the API directly into the tissue with high reliability while maintaining the simplicity of oral administration.
Solution Approach 2:
The patent replaces the passive diffusion mechanism of oral administration with an active mechanical penetration system. The self-righting article uses a spring-loaded needle that mechanically penetrates the tissue wall, replacing the slow and unreliable diffusion process with direct, controlled delivery into the tissue.
4Measurement precision
If self-righting mechanism is added to ensure tissue contact, then delivery precision is improved, but device complexity increases
Solution Approach 1:
The patent divides the self-righting mechanism into distinct functional segments: a density-based orientation portion that ensures vertical alignment, a spring-loaded actuation portion that provides penetration force, and a tissue-contacting tip portion that delivers the API. This segmentation allows each component to perform its specific function efficiently while keeping the overall design relatively simple.
Solution Approach 2:
The patent uses changes in density distribution within the article to create the self-righting effect. By positioning heavier materials at specific locations, the article automatically orients itself vertically without requiring complex mechanical sensors or actuators, thereby achieving delivery precision with minimal 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
The self-righting articles efficiently anchor and deliver pharmaceutical agents to the GI tract tissue, maintaining orientation and stability, enhancing bioavailability and reducing the need for refrigeration or dilution, while minimizing bulk and degradation issues.
Implementation Method 1
a first portion, a second portion adjacent the first portion having a different average density than the first portion
Implementation Method 2
a spring at least partially encapsulated within the outer shell, a support material associated with the spring such that the support material maintains at least a portion of the spring under at least 5% compressive strain
Implementation Method 3
at least one anchoring mechanism associated with the self-righting article configured to anchor at a location internal to a subject
Data Source
AI summary
Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In some embodiments, the self-righting article may comprise a tissue interfacing component and/or a pharmaceutical agent (e.g., for delivery of the active pharmaceutical agent to a location internal of the subject). In some cases, upon contact of the tissue with the tissue engaging surface of the article, the self-righting article may be configured to release one or more tissue interfacing components. In some cases, the tissue interfacing component is associated with a self-actuating component. For example, the self-righting article may comprise a self-actuating component configured, upon exposure to a fluid, to release the tissue interfacing component from the self-righting article. In some cases, the tissue interfacing component may comprise and/or be associated with the pharmaceutical agent (e.g., for delivery to a location internal to a subject).