Swallowable Capsule for Intestinal Drug Delivery via pH Actuation

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Solution Overview

Problem

Many drugs are limited in their application due to poor oral toleration, degradation in the stomach, and erratic absorption, leading to the need for alternative delivery methods that often come with drawbacks such as pain, infection risk, and device implantation complications.

Innovation Solution

A swallowable drug delivery device that contains a therapeutically effective dose of a therapeutic agent, configured to be delivered directly into the intestinal wall using a capsule with an actuator that responds to intestinal pH, expanding balloons, or tissue penetrating members to facilitate targeted and efficient drug delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional oral drug delivery is used, then ease of administration is improved, but drug absorption reliability deteriorates due to degradation in the stomach and erratic absorption

Engineering Contradiction:

Improveease of administrationVSAvoiddrug absorption reliability

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent extracts the drug delivery site from the stomach environment by using a capsule that travels through the GI tract to deliver the drug at a specific location in the small intestine, avoiding degradation in the stomach while maintaining oral administration ease

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The capsule undergoes preliminary actions of traveling through the GI tract and being positioned at the target site before drug release, ensuring the drug is delivered to the optimal location for absorption while avoiding harmful environments

Inventive Principle:

Principle #10Preliminary action

2Reliability

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

Engineering Contradiction:

Improvedrug absorption reliabilityVSAvoidpatient comfort

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The capsule acts as an intermediary device that enables reliable drug delivery through the GI tract without requiring needle sticks, eliminating pain and infection risk while achieving controlled drug release at the target site

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical needle injection system with a swallowable capsule system that uses physiological processes (GI tract movement, pH changes) to achieve drug delivery, eliminating the harmful mechanical penetration of skin

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Extent of automation

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

Engineering Contradiction:

Improvedrug delivery controlVSAvoiddevice complexity

Core Design Contradiction:

Extent of automationVSDevice complexity

Solution Approach 1:

The capsule is self-service in that it automatically navigates the GI tract, positions itself at the target site, and releases the drug in response to local physiological conditions (pH, enzymes) without requiring external control systems or implantation procedures

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The capsule uses changes in physiological parameters (pH, presence of specific enzymes) along the GI tract as triggers for drug release, enabling automated control without complex electronic systems or implantation

Inventive Principle:

Principle #35Parameter changes

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 allows for faster and more efficient absorption of drugs into the bloodstream, reducing side effects and improving pharmacokinetics, enabling the delivery of drugs previously only suitable for parenteral administration, such as pramlintide for diabetes treatment.

Implementation Method 1

configured to be delivered directly into the intestinal wall using a capsule with an actuator that responds to intestinal pH

Methodology Applied

Scientific EffectpH response:

Data Source

PatentUS10314891B2Method for delivering pramlintide into a lumen of the intestinal tract using a swallowable drug delivery device

Publication Date: 2019.06.11 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.