Swallowable Capsule Intestinal Wall Delivery for Antibiotics
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Solution Overview
Problem
Conventional drug delivery methods, such as oral administration, are limited due to gastric irritation, drug degradation in the stomach, and poor absorption, while alternative methods like intravenous and implantable pumps have drawbacks like pain, infection risk, and semi-permanent device implantation. There is a need for an improved method to deliver therapeutic agents, including anti-interleukin antibodies, which are poorly absorbed and degraded in the GI tract.
Innovation Solution
A swallowable drug delivery device that targets the small intestine, using a capsule with a tissue-penetrating member and actuating mechanism to deliver therapeutically effective doses of interleukin neutralizing proteins, such as anti-interleukin antibodies, directly into the intestinal wall, minimizing adverse effects and improving absorption and bioavailability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral administration is used, then ease of operation is improved, but drug degradation and poor absorption occur
Solution Approach 1:
The patent uses the intestinal wall as an intermediary medium to deliver antibodies systemically. Instead of attempting direct absorption into bloodstream from the GI lumen, the device delivers antibodies through the intestinal wall into the mesenteric vasculature, using the intestinal wall as a mediator to bypass the problematic GI environment while maintaining oral administration advantages.
Solution Approach 2:
The patent changes the delivery parameter from luminal administration to transmural delivery. By delivering the antibody through the intestinal wall rather than into the lumen, the drug bypasses degradation enzymes and poor absorption conditions in the GI tract, achieving reliable systemic delivery while maintaining oral route advantages.
2Reliability
If intravenous delivery is used, then drug absorption reliability is improved, but ease of operation deteriorates due to needle sticks and sterile requirements
Solution Approach 1:
The patent replaces the mechanical needle injection system with a swallowable capsule system. The capsule uses mechanical expansion in the intestinal lumen to drive needle penetration through the intestinal wall, substituting the manual injection mechanism with an automated, patient-friendly oral delivery system that achieves equivalent reliable delivery.
Solution Approach 2:
The patent uses the intestinal wall and mesenteric vasculature as intermediaries to achieve reliable antibody delivery without direct venous access. This intermediary approach provides the reliability of intravenous delivery while avoiding needle sticks and sterile technique requirements by utilizing the natural GI tract as the delivery pathway.
3Reliability
If implantable pumps are used, then drug delivery reliability is improved, but device complexity and ease of operation worsen due to semi-permanent implantation
Solution Approach 1:
The patent employs a disposable, single-use swallowable capsule instead of a permanent implantable pump. The capsule is designed for one-time use, swallowed by the patient, delivers the antibody, and is then excreted. This disposable approach provides reliable delivery for the treatment course needed while avoiding the complexity and risks of semi-permanent implantation and long-term device maintenance.
Data Source
AI summary
Embodiments of the invention provide swallowable devices, preparations and methods for delivering therapeutic agents within the GI tract such as neutralizing proteins (NP) particularly antibodies which neutralize interleukins. Many embodiments provide a swallowable device e.g., a capsule for delivering various agents into the intestinal wall (IW). Embodiments also provide agent preparations that are configured to be contained within the capsule, advanced from the capsule into the IW and degrade to release the agent 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 IW. Embodiments of the invention are particularly useful for the delivery of interleukin NP's (INP) for treatment of inflammatory conditions where such INP's are poorly absorbed, tolerated and/or degraded within the GI tract.