3D-Printed Core-Shell Dosage Form for pH-Triggered Colon Release

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Solution Overview

Problem

Existing oral dosage forms struggle to effectively target the colon due to degradation in the stomach's acidic environment and fail to provide localized drug delivery to specific sections of the large intestine, leading to reduced efficacy and off-target effects.

Innovation Solution

A 3D-printed oral dosage form with a core-shell configuration using enteric polymers that resist stomach acid and disintegrate at intestinal pH, allowing controlled release of active ingredients like budesonide to specific colon segments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional oral dosage forms are used, then the drug can be administered orally, but the dosage form degrades in the stomach's acidic environment and fails to target the colon

Engineering Contradiction:

Improvedosage form stabilityVSAvoidstomach acid degradation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The dosage form is segmented into multiple functional layers: an enteric coating layer that resists stomach acid, a matrix layer containing the drug, and a porous outer layer. This segmentation allows each layer to perform its specific function - the enteric coating protects the drug from gastric acid while the matrix layer provides controlled release in the colon

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The dosage form uses composite materials combining enteric polymers (resistant to stomach acid), matrix formers (for controlled release), and porous materials. This composite structure enables simultaneous acid resistance and targeted colon delivery, resolving the contradiction between stability in stomach acid and colon targeting capability

Inventive Principle:

Principle #40Composite materials

2Adaptability or versatility

If conventional oral dosage forms are used, then the drug can be delivered systemically, but localized delivery to specific colon segments is not achieved

Engineering Contradiction:

Improvelocalized delivery capabilityVSAvoiddrug delivery efficacy

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The dosage form incorporates local quality variations through its multi-layer structure with different pore sizes, material compositions, and release rates in different regions. This allows tailored drug release profiles for specific colon segments, enabling localized delivery while maintaining overall delivery reliability

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The dosage form uses dynamic release mechanisms where the matrix layer progressively releases drug molecules over time as the enteric coating dissolves in the colon. This dynamic release pattern ensures reliable drug delivery while adapting to the specific requirements of different colon segments

Inventive Principle:

Principle #15Dynamics

3Loss of time

If the dosage form releases drug in the stomach or small intestine, then the drug is released early, but the drug reaches the colon with reduced efficacy

Engineering Contradiction:

Improvedrug release timingVSAvoidtherapeutic efficacy

Core Design Contradiction:

Loss of timeVSReliability

Solution Approach 1:

The enteric coating layer performs preliminary protection by resisting stomach acid and preventing premature drug release in the stomach and small intestine. This preliminary anti-action ensures the drug reaches the colon intact, maintaining therapeutic efficacy by preventing early release

Inventive Principle:

Principle #9Preliminary anti-action

Solution Approach 2:

The dosage form exploits parameter changes in the gastrointestinal tract, specifically the pH transition from acidic stomach environment to neutral/basic colon environment. The enteric coating is designed to remain stable at low pH but dissolve at higher pH, ensuring timed release only when the dosage form reaches the colon

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

Achieves targeted and tunable drug delivery to the colon, enhancing localized efficacy and reducing off-target exposure by using a 3D printing process that maintains API stability and predictability.

Implementation Method 1

A 3D-printed oral dosage form with a core-shell configuration using enteric polymers that resist stomach acid and disintegrate at intestinal pH

Methodology Applied

Scientific EffectpH-dependent disintegration:

Data Source

PatentUS20250312281A1System for controllable release in 3d-printed colon targeting (corr3ct) oral dosage form

Publication Date: 2025.10.09 CRAFT HEALTH PTE LTD

AI summary

An oral dosage form for controllable release and method of forming are described. The oral dosage form includes a core layer including an active ingredient and a plurality of outer shell layers surrounding the core layer, the plurality of outer shell layers configured to disintegrate at a pH above a threshold. The method of forming the oral dosage form includes forming a core formulation paste including an active ingredient and forming an outer shell formulation paste configured to disintegrate at a pH above a threshold. The method further includes forming a wet tablet by sequentially depositing the outer shell formulation paste and the core formulation paste. The wet tablet is subsequently dried and cooled to produce the oral dosage form.