Swallowable Capsule Intestinal Wall Penetration for Drug Delivery

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Solution Overview

Problem

Many drugs are limited in their application due to poor oral toleration, gastric irritation, 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 device implantation requirements.

Innovation Solution

A swallowable drug delivery device capable of delivering therapeutic agents directly into the intestinal wall, utilizing a capsule with an actuator and tissue penetrating members that expand and penetrate the intestinal wall to release the drug, triggered by pH changes in the small intestine, allowing for targeted and efficient drug delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If drugs are administered orally, then ease of administration is improved, but drug degradation in the stomach and poor absorption occur

Engineering Contradiction:

Improveease of administrationVSAvoiddrug absorption reliability

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The drug delivery system is segmented into multiple functional components: a swallowable capsule for oral administration, an expandable balloon for deployment, tissue-penetrating members for delivery, and a drug reservoir for controlled release. This segmentation allows each component to perform its specific function optimally while maintaining overall system reliability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The intestinal wall serves as an intermediary medium between the orally administered drug and the bloodstream. The drug is delivered into the intestinal wall where it can be absorbed into the circulation, bypassing the harmful gastric environment while maintaining ease of oral administration.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If intravenous or intramuscular delivery is used, then drug absorption reliability is improved, but pain and infection risk increase

Engineering Contradiction:

Improvedrug absorption reliabilityVSAvoidpain and infection risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The swallowable capsule performs self-service by automatically navigating through the GI tract, deploying at the target location, and delivering the drug without requiring external intervention. This eliminates the need for needle sticks and sterile techniques while maintaining reliable drug absorption.

Inventive Principle:

Principle #25Self-service

3Reliability

If implantable drug delivery pumps are used, then drug absorption reliability is improved, but device complexity and implantation requirements increase

Engineering Contradiction:

Improvedrug absorption reliabilityVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The swallowable capsule is designed as a disposable, single-use device that is orally administered and automatically disposed of after drug delivery. This eliminates the need for complex implantable pumps while achieving reliable drug absorption through the natural GI tract pathway.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Speed

If drugs are delivered into the intestinal wall, then drug absorption speed is improved, but device complexity increases

Engineering Contradiction:

Improvedrug absorption speedVSAvoiddevice complexity

Core Design Contradiction:

SpeedVSDevice complexity

Solution Approach 1:

The tissue-penetrating members are pre-loaded into the capsule and the drug is pre-positioned in the reservoir. Upon deployment, the pre-positioned components work together to rapidly deliver the drug into the intestinal wall, achieving fast absorption without requiring complex real-time control mechanisms.

Inventive Principle:

Principle #10Preliminary action

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 and increased bioavailability of drugs, reducing side effects and improving pharmacokinetics by delivering drugs directly into the intestinal wall, potentially achieving maximum concentration in the bloodstream up to 100 times faster than conventional oral forms and allowing for long-term release with customizable half-life.

Implementation Method 1

triggered by pH changes in the small intestine

Methodology Applied

Scientific EffectpH change detection:

Data Source

PatentUS9205127B2Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Publication Date: 2015.12.08 RANI THERAPEUTICS LLC

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.