Swallowable Capsule Intestinal Wall 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, making it necessary to develop an improved method for delivering drugs, especially for therapeutic agents like natalizumab, which require targeted and efficient delivery to the small intestine.
Innovation Solution
A swallowable drug delivery device that includes a capsule with a pH-sensitive coating and an actuator mechanism, allowing for the controlled release of therapeutic agents into the intestinal wall using tissue penetrating members, which degrade to release the drug directly into the bloodstream, facilitating faster absorption and customizable release profiles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral administration is used, then ease of operation is improved, but drug absorption and bioavailability deteriorate due to gastric degradation and poor intestinal absorption
Solution Approach 1:
The patent extracts the drug delivery location from the conventional gastrointestinal lumen approach and moves it to the intestinal wall tissue itself. The capsule device penetrates the intestinal wall to deposit therapeutic agents directly into the tissue, bypassing the limitations of oral absorption through the GI tract while maintaining ease of oral administration.
Solution Approach 2:
The patent introduces a swallowable capsule device as an intermediary between oral administration and direct tissue delivery. The capsule contains penetration members that act as intermediaries to transport the therapeutic agent from the capsule through the intestinal wall into the tissue, enabling direct delivery while maintaining the simplicity of oral dosing.
2Quantity of substance
If intravenous delivery is used, then drug absorption is improved, but device complexity and patient burden worsen due to needle sticks and sterile requirements
Solution Approach 1:
The patent employs a self-service delivery system where the swallowable capsule autonomously navigates to the intestine, penetrates the wall, and delivers the therapeutic agent without external intervention. The capsule contains self-contained penetration members that automatically deploy upon contact with intestinal tissue, eliminating the need for needles, sterile techniques, or medical professional involvement during administration.
3Duration of action of moving object
If implantable pumps are used, then duration of action is improved, but device complexity and patient burden worsen due to semi-permanent implantation requirements
Solution Approach 1:
The patent employs a disposable swallowable capsule that performs its delivery function and is then excreted naturally. The capsule contains biodegradable penetration members that deliver the therapeutic agent and then decompose in the tissue, eliminating the need for permanent implants or removal procedures while providing sustained drug release over the required therapeutic period.
4Ease of operation
If conventional oral delivery is used, then ease of operation is improved, but treatment efficacy deteriorates due to slow and erratic absorption
Solution Approach 1:
The patent extracts the drug delivery location from the conventional gastrointestinal lumen approach and moves it to the intestinal wall tissue itself. The capsule device penetrates the intestinal wall to deposit therapeutic agents directly into the tissue, bypassing the limitations of oral absorption through the GI tract while maintaining ease of oral dosing.
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
This approach enables faster and more efficient drug absorption, potentially achieving 80% to 100 times greater maximum concentration in the bloodstream compared to conventional oral forms and allowing for long-term release with selectable half-lives, improving treatment efficacy and reducing side effects.
Implementation Method 1
The capsule has a pH-sensitive coating that degrades in response to pH changes in the intestinal tract
Implementation Method 2
The preparation is contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration to deliver the therapeutic agent into the intestinal wall
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.