Solid Dosage Form Extrusion with Temporary Plasticiser

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Solution Overview

Problem

Existing 3D printing technologies for solid dosage forms face challenges with thermal degradation of thermally sensitive components, limited solubility of drugs in ink solutions, and restricted applicability due to the use of elevated temperatures, which limits the range of materials that can be used and the dosage forms that can be produced.

Innovation Solution

The use of a temporary plasticiser in an extrudable composition that can be vaporised at temperatures below 150°C, allowing extrusion at lower temperatures and subsequent removal or partial removal of the plasticiser to minimize thermal degradation, enabling the production of a wider range of solid dosage forms, including those with thermally sensitive ingredients.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If elevated temperatures are used in 3D printing solid dosage forms, then the extrusion process can be performed, but thermally sensitive components undergo thermal degradation

Engineering Contradiction:

Improveextrusion process feasibilityVSAvoidthermal degradation of thermally sensitive components

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

A temporary plasticizer is introduced as an intermediary substance that enables extrusion at lower temperatures. The plasticizer acts as a mediator between the thermally sensitive components and the extrusion process, allowing the composition to be extruded without subjecting the thermally sensitive components to high temperatures that would cause degradation.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention changes the temperature parameter of the extrusion process by using a temporary plasticizer that lowers the extrusion temperature. This parameter change allows the process to proceed at temperatures below 150°C, preventing thermal degradation of thermally sensitive components while still enabling successful extrusion.

Inventive Principle:

Principle #35Parameter changes

2Productivity

If conventional 3D printing technologies are used, then solid dosage forms can be produced, but the range of materials and dosage forms is limited

Engineering Contradiction:

Improveproduction capabilityVSAvoidrange of materials and dosage forms

Core Design Contradiction:

ProductivityVSAdaptability or versatility

Solution Approach 1:

The invention creates a universal extrusion system that can handle a wide range of materials including thermally sensitive components, various drug formulations, and different dosage form requirements. The temporary plasticizer enables the same extrusion process to be applied to diverse material compositions without requiring process adjustments or specialized equipment for each material type.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

By changing the temperature parameter through the use of a temporary plasticizer, the system becomes adaptable to process thermally sensitive materials that would otherwise be incompatible with conventional high-temperature extrusion. This parameter change expands the range of usable materials and enables customized dosage forms with specific release profiles.

Inventive Principle:

Principle #35Parameter changes

3Temperature

If temporary plasticizer is added to extrudable composition, then extrusion temperature can be reduced, but an additional removal step is required

Engineering Contradiction:

Improveextrusion temperatureVSAvoidprocess steps

Core Design Contradiction:

TemperatureVSDevice complexity

Solution Approach 1:

The temporary plasticizer is extracted or removed from the extruded solid dosage form after the extrusion process is complete. This removal step is necessary to eliminate the temporary plasticizer from the final product while preserving the benefits of low-temperature extrusion during the manufacturing process.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The temporary plasticizer functions as a disposable, temporary aid that is introduced for the specific purpose of enabling low-temperature extrusion and is then removed from the final product. It serves its purpose during the manufacturing process and is discarded or degraded, leaving the desired final solid dosage form without the plasticizer.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 approach allows for the production of solid dosage forms with reduced thermal degradation, broader material applicability, and customized dosage options, including immediate and extended release properties, while maintaining the integrity of thermally sensitive components.

Implementation Method 1

the temporary plasticiser being a vaporisable substance (or combination of vaporisable substances) capable of being vaporised at a temperature at or below 150° C.

Methodology Applied

Scientific EffectVaporisation: Evaporation

Data Source

PatentUS20250275927A1Solid dosage form production

Publication Date: 2025.09.04 UNIVERSITY OF LANCASHIRE

AI summary

The present invention provides methods of preparing solid dosage form, particularly pharmaceutical dosage forms, using extrusion and 3D-printing, as well as the solid dosage form itself, the compositions used to make said items, uses of the solid dosage forms, and containers used in their preparation.