Swallowable Capsule Actuator for Intestinal Wall Drug Delivery
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Solution Overview
Problem
Conventional drug delivery methods, such as oral administration, intravenous, and implantable pumps, face limitations like gastric irritation, drug degradation, and poor absorption, especially for drugs requiring targeted delivery to the small intestine, necessitating an improved method for delivering therapeutic agents like PTH or its analogues effectively.
Innovation Solution
A swallowable drug delivery device comprising a capsule with an actuator and tissue penetrating members that deploy therapeutic agents into the intestinal wall, utilizing pH-sensitive coatings and biodegradable materials to ensure targeted and efficient delivery, allowing for faster absorption and controlled release of drugs previously inaccessible via oral routes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral administration is used, then ease of operation is improved, but drug degradation in the stomach and poor absorption occur
Solution Approach 1:
The device segments the drug delivery process into distinct phases: the capsule travels through the GI tract, the actuator deploys tissue-penetrating members at the target location, and the drug is delivered directly into the intestinal wall. This segmentation allows the drug to bypass stomach degradation and achieve reliable absorption at the intended site.
Solution Approach 2:
The device introduces an intermediary mechanism (the actuator with tissue-penetrating members) between the oral administration route and the absorption site. This intermediary delivers the drug directly into the intestinal wall, bypassing the harmful gastric environment while maintaining the ease of oral administration.
2Speed
If intravenous delivery is used, then drug absorption speed is improved, but pain and risk of infection from needle stick occur
Solution Approach 1:
The invention replaces the invasive mechanical needle puncture of IV delivery with a minimally invasive oral capsule that uses an internal actuator to deploy tissue-penetrating members. This substitution achieves rapid absorption similar to IV delivery while eliminating the pain and infection risk associated with needle sticks.
3Duration of action of moving object
If implantable drug delivery pumps are used, then controlled release is improved, but device complexity and requirement for semi-permanent implantation occur
Solution Approach 1:
The device employs a disposable, single-use capsule that is swallowed and delivers the drug in one action. The capsule and its actuator are designed for single-use, eliminating the need for complex implantation procedures and semi-permanent devices, while still providing controlled release to the intestinal wall.
4Productivity
If targeted delivery to small intestine is implemented, then drug absorption efficiency is improved, but device complexity increases
Solution Approach 1:
The capsule is designed as a universal platform that combines multiple functions: it protects the drug during transit, targets the small intestine through pH-sensitive coatings, deploys tissue-penetrating members via an integrated actuator, and delivers the drug directly into the intestinal wall. This multi-functionality achieves targeted delivery without requiring separate complex systems for each function.
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 device enables rapid and efficient delivery of therapeutic agents directly into the intestinal wall, reducing absorption time and increasing maximum concentration in the bloodstream, offering a more effective and less invasive alternative to conventional methods, with potential for long-term release and reduced side effects.
Implementation Method 1
The actuator is configured to respond to a pH or other condition in the small intestine
Implementation Method 2
utilizing pH-sensitive coatings and biodegradable materials to ensure targeted and efficient delivery
Data Source
AI summary
Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.