Swallowable Capsule Penetrates Intestinal Wall for 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, making it necessary to develop an improved method for delivering drugs, especially those requiring parenteral administration, like etanercept for autoimmune diseases.
Innovation Solution
A swallowable drug delivery device that contains a therapeutic agent preparation in a capsule, equipped with an actuator and tissue penetrating members, which expands and penetrates the intestinal wall to release the drug, utilizing pH-sensitive coatings and biodegradable materials for controlled delivery and degradation.
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 effectiveness deteriorate due to gastric irritation and degradation
Solution Approach 1:
The patent uses the intestinal wall as an intermediary medium to deliver drugs into the bloodstream. Instead of direct oral absorption through the gastrointestinal tract, the swallowable device penetrates the intestinal wall to inject the drug directly into blood vessels, bypassing gastric degradation and improving absorption effectiveness while maintaining oral administration convenience
Solution Approach 2:
The patent replaces the natural mechanical absorption process through the gastrointestinal tract with a controlled injection mechanism. The swallowable device uses mechanical penetration through the intestinal wall to deliver the drug directly into the bloodstream, substituting the inefficient oral absorption mechanism with a more effective injection approach
2Reliability
If parenteral injection is used, then drug absorption effectiveness is improved, but ease of operation deteriorates due to needle stick and sterile requirements
Solution Approach 1:
The swallowable device is self-contained and automatically performs the injection function after being swallowed. The device uses its own embedded needle mechanism to penetrate the intestinal wall and deliver the drug without requiring external medical personnel or sterile technique, making parenteral-level delivery as easy as taking an oral medication
Solution Approach 2:
The swallowable device is designed as a single-use disposable unit that is swallowed, performs its injection function, and is then excreted. This eliminates the need for sterile technique and repeated needle sticks, as each device is pre-packaged, used once, and discarded, making parenteral injection as convenient as oral medication
3Duration of action of moving object
If implantable pumps are used, then drug delivery control is improved, but device complexity and ease of operation deteriorate due to semi-permanent implantation requirements
Solution Approach 1:
The swallowable device replaces complex semi-permanent implantable pumps with simple single-use disposable units. Each device is swallowed, performs its drug delivery function over the required duration, and is then naturally excreted, eliminating the need for surgical implantation and complex device retrieval procedures
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 and more efficient drug absorption into the bloodstream, potentially achieving 80% to 100% of the maximum concentration time compared to non-vascular injections and reducing side effects by titrating doses and using controlled release mechanisms.
Implementation Method 1
The capsule is configured to degrade in response to a pH in the intestinal tract so as to trigger a release and expansion of the preparation
Implementation Method 2
The preparation itself may comprise a biodegradable material and/or at least one pharmaceutical excipient configured to degrade within 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.