Swallowable Capsule for Intestinal Wall Delivery of Anti-Interleukin Antibodies
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Solution Overview
Problem
Current drug delivery methods, such as oral administration, are limited due to poor absorption, degradation, and toleration issues in the gastrointestinal tract, while parenteral routes face challenges like pain, infection risk, and the need for invasive devices, necessitating an improved method for delivering therapeutic agents like anti-interleukin antibodies.
Innovation Solution
A swallowable drug delivery device that targets the small intestine, using a capsule with a tissue-penetrating mechanism and pH-sensitive coatings to release therapeutic agents directly into the intestinal wall, allowing for controlled and efficient delivery of anti-interleukin antibodies, reducing immune response and adverse effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional administration methods (IV, SC, IM injections) are used to deliver biologics, then the biologic can reach systemic circulation, but the patient must visit a healthcare facility and receive parenteral administration
Solution Approach 1:
The patent employs an absorption enhancer as an intermediary substance that temporarily modifies the intestinal epithelium to allow biologic passage. The enhancer mediates between the biologic (which cannot cross intact epithelium) and the systemic circulation, enabling oral delivery without requiring parenteral administration facilities.
Solution Approach 2:
The invention changes the physical-chemical parameters of the intestinal epithelium temporarily through the absorption enhancer. The enhancer modifies epithelial permeability parameters to allow biologic passage, then returns to normal state afterward, enabling controlled translocation of the biologic across the intestinal barrier.
2Reliability
If the intestinal epithelium remains intact, then it provides a protective barrier, but biologics cannot cross into systemic circulation
Solution Approach 1:
The absorption enhancer provides beforehand cushioning by preparing the epithelial barrier for controlled opening. It temporarily modifies the epithelium in a controlled manner before biologic arrival, allowing passage while maintaining overall barrier integrity, then restores the barrier afterward to prevent harmful substances from entering.
Solution Approach 2:
The invention converts the normally harmful impermeability of the intestinal epithelium into a beneficial feature. By temporarily and controllably modifying epithelial permeability with the absorption enhancer, the intact epithelium becomes a controlled gateway that can selectively allow biologic passage while maintaining protective functions.
3Quantity of substance
If absorption enhancers are used to increase epithelial permeability, then biologic delivery is improved, but there is a risk of uncontrolled opening of the epithelium allowing harmful substances to enter
Solution Approach 1:
The absorption enhancer operates through periodic action by temporarily modifying epithelial permeability only during the brief period when the biologic is present in the intestinal lumen. The enhancer is applied, allows controlled passage, then is removed or degraded, returning the epithelium to its normal impermeable state, thus preventing uncontrolled entry of harmful substances.
Solution Approach 2:
The invention applies local quality by having the absorption enhancer act locally at specific sites in the intestinal epithelium where the biologic is present. The permeability modification is localized rather than global, allowing biologic passage at targeted locations while maintaining barrier integrity in other regions, thus reducing the risk of uncontrolled harmful substance entry.
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 higher therapeutic ratios, reduced adverse reactions, and more consistent plasma concentrations, improving the treatment of autoimmune diseases by delivering therapeutic agents directly into the intestinal wall, avoiding initial degradation and immune response sites.
Implementation Method 1
contacting the biologic with an absorption enhancer that increases permeability of an epithelium
Implementation Method 2
anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract
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.