Swallowable Capsule Submucosal Delivery for Poor Absorption
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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 GnRH or its analogues, which are poorly absorbed in the GI tract.
Innovation Solution
A swallowable drug delivery device that contains a therapeutically effective dose of a therapeutic agent, configured to be delivered into the intestinal wall using a capsule with an actuator that expands or uses pH-sensitive coatings to release the drug, allowing for targeted and controlled delivery directly into the intestinal tissue, potentially enhancing absorption and reducing side effects.
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 relocates it to the submucosal tissue layer of the intestine. This is achieved through a swallowable capsule that deploys needles to inject the drug directly into the submucosal space, bypassing the degradation issues in the gastric lumen and achieving reliable absorption without intravenous administration.
Solution Approach 2:
The patent introduces a swallowable capsule system as an intermediary between oral administration and intravenous injection. This capsule contains the drug, protection mechanisms against gastric degradation, and a deployment mechanism that delivers the drug into the submucosal tissue, serving as a mediator that combines the ease of oral swallowing with the reliability of direct tissue delivery.
2Reliability
If intravenous or intramuscular injection is used, then drug absorption reliability is improved, but device complexity and risk of infection increase due to needle sticks and sterile technique requirements
Solution Approach 1:
The swallowable capsule performs self-service by containing all necessary components for delivery within the gastrointestinal tract. The capsule automatically deploys its needles and administers the drug into the submucosal tissue without requiring external sterile technique or medical professional intervention, thereby maintaining reliability while reducing complexity and infection risk.
Solution Approach 2:
The patent replaces the conventional external injection mechanical system with an internal self-deploying mechanical system housed within the swallowable capsule. The capsule uses internal mechanisms (such as pH-triggered deployment or mechanical expansion) to automatically deploy needles and inject the drug, eliminating the need for external syringes and sterile injection procedures.
3Productivity
If implantable drug delivery pumps are used, then drug delivery control is improved, but device complexity and patient burden increase due to semi-permanent implantation requirements
Solution Approach 1:
The swallowable capsule functions as a disposable, single-use device that is swallowed, delivers the drug, and is then excreted. This eliminates the need for semi-permanent implantation while maintaining controlled drug delivery through its self-contained deployment mechanism. The capsule achieves its delivery function and is discarded, avoiding long-term implantation complexity.
Solution Approach 2:
The capsule is prepared in advance with all necessary components for controlled drug delivery, including the drug reservoir, needle deployment mechanism, and activation system. This preliminary configuration allows the capsule to perform controlled delivery upon swallowing without requiring complex implantation procedures or post-implantation adjustments.
4Ease of operation
If conventional oral delivery is used, then ease of operation is improved, but side effects increase due to gastric irritation and bleeding
Solution Approach 1:
The patent extracts the drug delivery site from the gastric environment and relocates it to the submucosal tissue of the intestine. By deploying needles to inject the drug directly into the submucosal space, the system avoids contact with gastric acids and digestive enzymes that cause irritation and bleeding, thereby eliminating these harmful effects while maintaining ease of oral administration.
Solution Approach 2:
The swallowable capsule acts as an intermediary that protects the drug from gastric degradation and prevents direct contact between the drug and irritating gastric environment. The capsule delivers the drug through the intestinal wall into the submucosal tissue, serving as a protective mediator that avoids gastric irritation while enabling effective drug 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 approach enables faster and more efficient drug absorption into the bloodstream, potentially achieving higher maximum concentrations and longer-lasting effects compared to conventional oral or parenteral administration, while minimizing side effects and improving pharmacokinetics.
Implementation Method 1
The capsule includes an actuator configured to respond to a pH change in the intestinal tract
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.