Swallowable Capsule with pH-Responsive Actuator for Intestinal Wall Delivery

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Solution Overview

Problem

Many drugs are limited in their application due to poor oral toleration, degradation in the stomach, and poor absorption in the gastrointestinal tract, leading to the need for alternative delivery methods that often come with drawbacks such as pain, infection risk, and the requirement for semi-permanent implantation of devices.

Innovation Solution

A swallowable drug delivery device that contains a therapeutic agent preparation, which is designed to be delivered directly into the intestinal wall using a capsule with an actuator that responds to pH conditions, expanding to penetrate the intestinal wall and release the drug, allowing for targeted and efficient delivery of drugs that were previously only viable through intravenous or parenteral administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If oral delivery of drugs is used, then ease of administration is improved, but drug absorption and stability are worsened due to degradation in stomach and poor intestinal absorption

Engineering Contradiction:
Improveease of administrationVSAvoiddrug absorption and stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent introduces an intermediary delivery system (capsule with expandable members) that mediates between oral administration and direct intestinal wall delivery. The capsule acts as a carrier that protects the drug during gastric passage and enables targeted delivery to the intestinal wall, resolving the contradiction between ease of oral administration and reliable drug delivery.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the physical parameters of the delivery system by using pH-responsive materials that change state in response to intestinal pH conditions. The expandable members transition from a compressed state during gastric passage to an expanded state in the intestine, enabling targeted drug delivery while maintaining ease of oral administration.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If intravenous or parenteral delivery is used, then drug absorption is improved, but pain and infection risk are worsened due to needle sticks and sterile requirements

Engineering Contradiction:
Improvedrug absorptionVSAvoidpain and infection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical needle injection system with a swallowable capsule system that uses pH-responsive expansion mechanisms. This substitution eliminates the need for needle sticks and sterile injection techniques while achieving reliable drug delivery directly to the intestinal wall, thereby resolving the contradiction between effective absorption and avoidance of pain/infection risks.

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

3Duration of action of moving object

If implantable drug delivery pumps are used, then sustained drug delivery is improved, but device complexity and surgical requirements are worsened

Engineering Contradiction:
Improvesustained drug deliveryVSAvoiddevice complexity and surgical requirements
Core Design Contradiction:
Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The patent employs a disposable swallowable capsule that delivers the drug and then is excreted naturally. This approach provides sustained drug delivery through controlled release mechanisms while avoiding the complexity of implantable pumps and surgical procedures. The capsule is designed for single-use, eliminating the need for complex implantation and retrieval procedures.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Ease of operation

If conventional oral delivery is used, then ease of administration is improved, but side effects are worsened due to poor toleration and gastric irritation

Engineering Contradiction:
Improveease of administrationVSAvoidside effects and gastric irritation
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The patent extracts the harmful interaction between the drug and the gastric environment by delivering the drug directly to the intestinal wall, bypassing the stomach. This extraction of the drug from the harmful gastric environment eliminates gastric irritation and poor toleration while maintaining ease of administration through oral delivery.

Inventive Principle:
Principle #2Taking out (Extraction)

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 absorption of therapeutic agents into the bloodstream, potentially achieving maximum concentration 80% to 100% faster than traditional non-vascular injection and reducing side effects by titrating doses and using biodegradable materials for controlled release, facilitating the delivery of large molecule peptides and proteins that would otherwise require injection.

Implementation Method 1

a capsule with an actuator that responds to pH conditions, expanding to penetrate the intestinal wall

Methodology Applied
Scientific EffectpH-responsive expansion:

Implementation Method 2

This method enables faster absorption of therapeutic agents into the bloodstream

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentEP2726091B1Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
Publication Date: 2020.01.22 RANI THERAPEUTICS LLC
  • EP2726091B1 patent drawingFigure 1a
  • EP2726091B1 patent drawingFigure 1b
  • EP2726091B1 patent drawingFigure 1c

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.