Self-Righting Liquid Injection Capsules for GI Mucosa Delivery
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Solution Overview
Problem
Existing pharmaceutical delivery systems face challenges in ensuring juxtaposition between articles and the GI mucosa, particularly for biologic drugs like insulin, which degrade in the GI tract, and require improved methods for targeted delivery and interaction.
Innovation Solution
Self-righting articles with differential density portions and self-actuating components, such as springs, enable targeted anchoring and release of active pharmaceutical ingredients directly into tissues, utilizing monostatic shapes and actuation mechanisms for precise delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional injection methods are used for biologic drugs, then drugs can be delivered directly into the body, but the drugs will be degraded by enzymes in the GI tract before reaching the bloodstream
Solution Approach 1:
The device performs self-righting automatically upon oral administration without requiring external intervention. The asymmetric density distribution causes the device to spontaneously orient itself with the tissue-engaging surface facing the GI mucosa, enabling autonomous positioning and eliminating the need for complex external positioning systems
Solution Approach 2:
The invention replaces traditional needle-based mechanical injection systems with a pressure-driven liquid ejection mechanism. The spring-loaded plunger system propels liquid pharmaceutical compositions through a nozzle directly into the GI mucosa, substituting complex mechanical needle insertion with a simpler pressure-driven injection system that reduces tissue trauma and improves reliability
2Ease of operation
If pills or articles are released into the GI tract for drug delivery, then administration is simple, but the drugs cannot reach the tissue wall effectively and are lost via convection and diffusion
Solution Approach 1:
The device employs asymmetric density distribution with a first portion having a different average density than a second portion, creating a monostatic shape that ensures the tissue-engaging surface automatically orients toward the GI mucosa. This asymmetric design provides precise directional control for drug delivery while maintaining simple oral administration
Solution Approach 2:
The invention changes the physical state and delivery parameters by transitioning from passive pill dissolution to active pressure-driven liquid injection. The liquid pharmaceutical composition is propelled at controlled velocity through a nozzle directly into the tissue, achieving precise delivery while maintaining administration simplicity
3Reliability
If mucoadhesives or texturing are used to improve GI mucosa interaction, then drug delivery to the mucosa is enhanced, but the system complexity increases
Solution Approach 1:
The invention extracts and eliminates the need for complex mucoadhesive coatings and surface texturing systems by implementing a self-righting mechanism with asymmetric density distribution. The device achieves reliable mucosa interaction through gravitational self-positioning and directed liquid injection, removing unnecessary complexity while maintaining effective mucosa engagement
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 achieve localized delivery of pharmaceuticals with high bioavailability, avoiding degradation and enabling mechanical and electrical interactions with tissues, reducing the need for external forces and enhancing drug absorption.
Implementation Method 1
a spring at least partially encapsulated within the outer shell... the self-actuating component, upon exposure to a fluid, to release the tissue interfacing component from the self-righting article
Implementation Method 2
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 under ambient conditions... the support material is configured for at least partial degradation in a biological fluid
Implementation Method 3
a first portion, a second portion adjacent the first portion having a different average density than the first portion... configured and arranged to be encapsulated in a 000 capsule, or smaller
Implementation Method 4
a first portion, a second portion adjacent the first portion having a different average density than the first portion, and a hollow portion
Implementation Method 5
a chamber disposed within the outer shell, the chamber comprising a liquid active pharmaceutical ingredient... configured for transfer of liquid from the chamber to a portion of tissue of the lumen wall
Data Source
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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) such as a liquid pharmaceutical agent. 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.