Flowable Composite Tablet Manufacturing via Thermal Phase Transition

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Solution Overview

Problem

Current methods for manufacturing solid pharmaceutical administration forms, such as tablets, are limited by their inability to accommodate personalized medicine needs, are labor-intensive, and require complex and costly processes, especially for poorly water-soluble drugs, which restricts the complexity and stability of dosage forms.

Innovation Solution

A method involving the use of a flowable composite material comprising a binder agent and active pharmaceutical ingredients, which is liquefied and intermittently discharged to form solid administration forms, eliminating the need for prefabricated filaments and allowing for immediate preparation before use, enabling customizable and cost-effective production of personalized tablets.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional tablet manufacturing processes (milling, sieving, mixing, granulation, compression) are used, then tablets can be produced with proven long-term stability, but the processes are labor-intensive, complex, and unsuited for personalized medicine

Engineering Contradiction:
Improvelong-term stabilityVSAvoidprocess complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent utilizes phase transition of the binder agent from solid to liquid state through heating, enabling the formation of solid administration forms without conventional compression processes. The binder agent melts at elevated temperature to become flowable, then solidifies upon cooling to form stable tablets, eliminating multiple complex process steps while maintaining reliability

Inventive Principle:
Principle #36Phase transitions

Solution Approach 2:

The patent replaces mechanical compression processes with a thermal processing system. Instead of using tablet presses and mechanical force to compact powders, the invention uses heating to melt the binder agent, allowing material to be shaped in a flowable state, then cools to solidify the structure, substituting mechanical compression with thermal phase change

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

2Productivity

If centralized manufacturing plants produce tablets in large quantities, then economies of scale are achieved, but individual configuration and customization for single patients are not possible

Engineering Contradiction:
Improvemanufacturing efficiencyVSAvoidpersonalization capability
Core Design Contradiction:
ProductivityVSAdaptability or versatility

Solution Approach 1:

The patent segments the manufacturing process into two distinct levels: centralized production of the flowable composite material containing active pharmaceutical ingredients and binder agent, and decentralized point-of-care fabrication of individualized tablets. This segmentation allows bulk preparation of materials while enabling customization at the final product stage

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent performs preliminary action by pre-preparing and storing the flowable composite material in advance at centralized facilities. The composite material, containing active pharmaceutical ingredients mixed with binder agent, is manufactured ahead of time and stored ready for use, enabling rapid point-of-care tablet fabrication without requiring complex processing at the point of use

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If prefabricated filaments are used in 3D printing, then additive manufacturing can be performed, but the filament preparation is time-consuming and reduces manufacturing speed

Engineering Contradiction:
Improve3D printing capabilityVSAvoidmanufacturing speed
Core Design Contradiction:
Ease of manufactureVSProductivity

Solution Approach 1:

The patent extracts and eliminates the filament prefabrication step from the 3D printing process. Instead of requiring pre-made filaments to be loaded into the extrusion system, the invention feeds raw powder mixture directly into the extruder, where it is processed and extruded as a flowable material that forms tablets, removing the time-consuming filament preparation stage

Inventive Principle:
Principle #2Taking out (Extraction)

4Ease of manufacture

If conventional compression processes are used for tablets, then standardized dosage forms are produced, but complexity in dosage form design (multiple release profiles, geometries) is restricted

Engineering Contradiction:
ImprovestandardizationVSAvoiddosage form complexity
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The patent introduces dynamics into the tablet fabrication process through adjustable printing parameters, layer-by-layer construction, and variable extrusion rates. These dynamic controls enable customization of tablet geometry, density distribution, and internal structure, allowing multiple release profiles and complex geometries that cannot be achieved with static compression processes

Inventive Principle:
Principle #15Dynamics

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 enables the rapid, cost-effective, and flexible manufacturing of personalized tablets with improved bioavailability and stability, suitable for point-of-care applications and complex dosage forms, including those with poorly soluble active ingredients.

Implementation Method 1

a flowable composite material comprising the at least one active pharmaceutical ingredient is added together and sets to generate the solid administration form, whereby the flowable composite material is liquefied and delivered to a discharge unit

Methodology Applied
Scientific EffectMelting: Melting

Implementation Method 2

small portions of the liquefied composite material are intermittently discharged through an outlet of the discharge unit into a setting unit where the setting of small portions occurs

Methodology Applied
Scientific EffectSolidification: Freezing

Data Source

PatentUS20220105041A1Method for manufacturing a solid administration form and solid administration
Publication Date: 2022.04.07 MERCK PATENT GMBH
  • US20220105041A1 patent drawing
  • US20220105041A1 patent drawing
  • US20220105041A1 patent drawing

AI summary

For manufacturing a solid administration form comprising at least one active pharmaceutical ingredient, a flowable but setting composite material comprising the at least one active pharmaceutical ingredient is added together and set to generate the solid administration form. The flowable composite material is liquefied and delivered to a discharge unit. Small portions of liquefied composite material are intermittently discharged through an outlet into a setting unit. The flowable composite material comprises a polymer and at least one active pharmaceutical ingredient dispersed or dissolved within the polymer. The small portions are droplets and the solid administration form is generated by adding droplets that stick together before or during the setting of the liquefied composite material. An average diameter of the droplets can be less than 350 μm. There can be a void space between at least some small portions, resulting in a porous structure of the solid administration form.