Cryo-Milled PVA Powder for Continuous Melt Extrusion Dosing

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Solution Overview

Problem

The challenge in pharmaceutical formulations is the difficulty in uniformly dosing polyvinyl alcohol (PVA) with other ingredients into an extruder due to its chemical and physical properties, leading to material blockages and interruptions in the production process.

Innovation Solution

The development of a PVA grade, specifically PVA 4-88, which is cryo-milled to a particle size range of 45 to 1400 µm, preferably 50 to 300 µm, with a distribution of d10 = 20±10 µm, d20 = 30±10 µm, d50 = 70±10 µm, d90 = 200±30 µm, d99 = 300±30 µm, ensuring improved flowability and allowing continuous dosing without additives.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If polyvinyl alcohol is used as carrier material for extrusion, then the formulation can be produced by melt extrusion, but the material blocks the feeder and dosing is interrupted due to poor flowability

Engineering Contradiction:
Improvemelt extrusion capabilityVSAvoidflowability
Core Design Contradiction:
Ease of manufactureVSEase of operation

Solution Approach 1:

The patent changes the physical parameters of PVA by controlling particle size (45-1400 µm) and morphology through specific drying processes, transforming it from poor flowability to excellent flowability while maintaining melt extrusion capability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent utilizes phase transition during drying (spray drying, freeze drying, or spray freeze drying) to create particles with specific physical properties that enable both good flowability and melt extrusion, transitioning from liquid solution to solid particles with controlled morphology

Inventive Principle:
Principle #36Phase transitions

2Ease of operation

If PVA particles are made smaller to improve flowability, then dosing becomes easier, but particle size distribution becomes harder to control

Engineering Contradiction:
Improvedosing uniformityVSAvoidparticle size control
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent defines specific particle size ranges (45-1400 µm) and distributions (d10, d20, d50, d90, d99 values) achieved through controlled drying parameters, balancing flowability with manufacturability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates particles with specific local properties through spray drying techniques, where the drying process creates a porous or hollow structure that improves flowability while maintaining controlled size distribution

Inventive Principle:
Principle #3Local quality

3Ease of operation

If additives are added to improve PVA processing, then flowability improves, but the formulation becomes more complex

Engineering Contradiction:
ImproveflowabilityVSAvoidformulation complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent makes PVA self-sufficient by creating particles with inherent flow-improving properties through drying process control, eliminating the need for external additives like glidants or flow agents

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent uses phase transition during drying to create particles with porous or hollow structures that inherently improve flowability without requiring additional chemical additives

Inventive Principle:
Principle #36Phase transitions

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 PVA grade enables uninterrupted feeding and dosing during processing, facilitating the formation of homogeneous mixtures with active ingredients, enhancing the extrusion process by ensuring uniformity and stability.

Implementation Method 1

which is cryo-milled and which has particle sizes in the range of 45 to 1400 µm

Methodology Applied
Scientific EffectCryo-milling:

Data Source

PatentEP3454906B1Particle size and distribution of polymer for melt extrusion application
Publication Date: 2025.07.23 MERCK PATENT GMBH
  • EP3454906B1 patent drawingFigure 1
  • EP3454906B1 patent drawingFigure 2
  • EP3454906B1 patent drawingFigure 2

AI summary

The present invention relates to an improved powdered polyvinyl alcohol (PVA), which can be used for pharmaceutical products, and that due to its improved properties can be better dosed during formulation processes. Furthermore, this invention refers to pharmaceutical formulations comprising polyvinyl alcohol as carrier matrix and their use.