Swallowable Capsule with pH-Responsive Actuator for Intestinal Wall Delivery
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Solution Overview
Problem
Many drugs are limited in their application due to poor oral toleration, degradation in the stomach, and poor absorption in the gastrointestinal tract, leading to the need for alternative delivery methods that often come with drawbacks such as pain, infection risk, and the requirement for semi-permanent implantation of devices.
Innovation Solution
A swallowable drug delivery device that contains a therapeutic agent preparation, which is designed to be delivered directly into the intestinal wall using a capsule with an actuator that responds to pH conditions, expanding to penetrate the intestinal wall and release the drug, allowing for targeted and efficient delivery of drugs that were previously only viable through intravenous or parenteral administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral delivery of drugs is used, then ease of administration is improved, but drug absorption and stability are worsened due to degradation in stomach and poor intestinal absorption
Solution Approach 1:
The patent introduces an intermediary delivery system (capsule with expandable members) that mediates between oral administration and direct intestinal wall delivery. The capsule acts as a carrier that protects the drug during gastric passage and enables targeted delivery to the intestinal wall, resolving the contradiction between ease of oral administration and reliable drug delivery.
Solution Approach 2:
The patent changes the physical parameters of the delivery system by using pH-responsive materials that change state in response to intestinal pH conditions. The expandable members transition from a compressed state during gastric passage to an expanded state in the intestine, enabling targeted drug delivery while maintaining ease of oral administration.
2Reliability
If intravenous or parenteral delivery is used, then drug absorption is improved, but pain and infection risk are worsened due to needle sticks and sterile requirements
Solution Approach 1:
The patent replaces the mechanical needle injection system with a swallowable capsule system that uses pH-responsive expansion mechanisms. This substitution eliminates the need for needle sticks and sterile injection techniques while achieving reliable drug delivery directly to the intestinal wall, thereby resolving the contradiction between effective absorption and avoidance of pain/infection risks.
3Duration of action of moving object
If implantable drug delivery pumps are used, then sustained drug delivery is improved, but device complexity and surgical requirements are worsened
Solution Approach 1:
The patent employs a disposable swallowable capsule that delivers the drug and then is excreted naturally. This approach provides sustained drug delivery through controlled release mechanisms while avoiding the complexity of implantable pumps and surgical procedures. The capsule is designed for single-use, eliminating the need for complex implantation and retrieval procedures.
4Ease of operation
If conventional oral delivery is used, then ease of administration is improved, but side effects are worsened due to poor toleration and gastric irritation
Solution Approach 1:
The patent extracts the harmful interaction between the drug and the gastric environment by delivering the drug directly to the intestinal wall, bypassing the stomach. This extraction of the drug from the harmful gastric environment eliminates gastric irritation and poor toleration while maintaining ease of administration through oral delivery.
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 method enables faster absorption of therapeutic agents into the bloodstream, potentially achieving maximum concentration 80% to 100% faster than traditional non-vascular injection and reducing side effects by titrating doses and using biodegradable materials for controlled release, facilitating the delivery of large molecule peptides and proteins that would otherwise require injection.
Implementation Method 1
a capsule with an actuator that responds to pH conditions, expanding to penetrate the intestinal wall
Implementation Method 2
This method enables faster absorption of therapeutic agents into the bloodstream
Data Source
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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.