Swallowable Capsule with pH-Triggered Tissue Penetration

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Solution Overview

Problem

Many drugs are not orally deliverable due to poor absorption, chemical degradation, or gastric irritation, and conventional delivery methods like intravenous and implantable pumps have drawbacks such as pain, infection risk, and semi-permanent implantation.

Innovation Solution

A swallowable drug delivery device comprising a capsule with tissue penetrating members, a delivery member, and an actuating mechanism that allows for the delivery of drugs directly into the intestinal wall, using biodegradable materials and pH-sensitive release elements to ensure controlled drug release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If drugs are administered orally, then convenience is improved, but absorption efficiency deteriorates due to poor oral toleration and chemical degradation

Engineering Contradiction:
Improveconvenience of administrationVSAvoidabsorption efficiency
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The device segments the drug delivery process into distinct phases: oral ingestion of the capsule, transit through the GI tract, activation in the small intestine, and localized delivery into the intestinal wall. This segmentation allows the drug to bypass stomach degradation while ensuring targeted delivery in the small intestine where absorption is optimal

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The capsule acts as an intermediary vehicle that protects the drug during oral transit and facilitates controlled delivery. The pH-sensitive release element serves as a mediator that detects intestinal conditions and triggers drug release, bridging the gap between oral administration and effective intestinal delivery

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If intravenous delivery is used, then absorption reliability is improved, but patient comfort deteriorates due to pain and infection risk from needle sticks

Engineering Contradiction:
Improveabsorption reliabilityVSAvoidpain and infection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention replaces the mechanical needle puncture system with a swallowable capsule that uses pH-sensitive chemical activation. Instead of forceful mechanical injection, the drug is delivered through a biodegradable matrix that dissolves in response to intestinal pH, eliminating needle-related pain and infection risks while maintaining reliable drug delivery

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Extent of automation

If implantable pumps are used, then drug delivery control is improved, but device complexity and implantation requirements worsen

Engineering Contradiction:
Improvedrug delivery controlVSAvoidimplantation requirements
Core Design Contradiction:
Extent of automationVSDevice complexity

Solution Approach 1:

The capsule is designed to be self-activating through pH-sensitive release elements that automatically detect intestinal conditions and trigger drug release. The biodegradable matrix self-dissolves in the intestinal environment, eliminating the need for external power sources, complex control systems, or surgical implantation while maintaining automated drug delivery control

Inventive Principle:
Principle #25Self-service

4Speed

If drugs are released in the stomach, then delivery speed is improved, but drug stability deteriorates due to chemical degradation

Engineering Contradiction:
Improvedelivery speedVSAvoiddrug stability
Core Design Contradiction:
SpeedVSStability of the object's composition

Solution Approach 1:

The device employs local quality by designing the capsule to remain stable in the acidic stomach environment while being specifically activated in the small intestine. The pH-sensitive release elements and biodegradable matrix are engineered to resist degradation in stomach conditions but dissolve rapidly in the higher pH environment of the small intestine, achieving both stability and rapid delivery at the target location

Inventive Principle:
Principle #3Local quality

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

Enables rapid and controlled delivery of drugs into the bloodstream, overcoming absorption issues and reducing side effects, allowing for simultaneous administration of multiple drugs with improved pharmacokinetics.

Implementation Method 1

a release element comprising a material configured to degrade upon exposure to a selected pH in the intestine

Methodology Applied
Scientific EffectpH-sensitive degradation: Hydrolysis

Implementation Method 2

a tissue penetrating member... configured to be advanced into the wall of the small intestine

Methodology Applied
Scientific EffectMechanical penetration: Mechanical Force

Data Source

PatentEP4056173B1Swallowable drug delivery device
Publication Date: 2025.06.25 RANI THERAPEUTICS LLC
  • EP4056173B1 patent drawingFigure 1a
  • EP4056173B1 patent drawingFigure 1b
  • EP4056173B1 patent drawingFigure 1c

AI summary

An embodiment of the invention provides a swallowable device for delivering drugs and other therapeutic agents within the GI tract, the swallowable device comprising: a capsule (10) sized to pass through the gastrointestinal tract; a tissue penetrating member (40) positioned in the capsule, configured to contain a drug (100), and having a tissue penetrating end for penetrating a wall (IW) of the gastrointestinal tract; a delivery member (50) for delivering the drug from the tissue penetrating member into tissue; an actuating mechanism (80, 90, 94) coupled to at least one of the tissue penetrating member or the delivery member, the actuating mechanism configured to advance the tissue penetrating member into the wall and advance the delivery member to deliver the drug; and a release (70) element operatively coupled to the actuating mechanism, the release element configured to degrade such that the actuating mechanism is actuated to release the tissue penetrating member to penetrate the wall and advance the delivery member to deliver the drug into the wall.