Opened Starch Biodegradable Material for Pharmaceutical Shaped Articles

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Solution Overview

Problem

Existing biodegradable materials based on starch for pharmaceutical and implantation applications often have poor mechanical properties, high cytotoxicity, and inadequate biodegradability, with additives like plasticizers and lubricants causing adverse effects, and processing factors like pressure, temperature, and residence time not being adequately considered.

Innovation Solution

A biodegradable material comprising 50-100% opened starch, characterized by a higher water content and specific processing conditions, including extrusion with water as a plasticizer at moderate temperatures and pressures, resulting in a granulate with enhanced tensile strength and rapid enzymatic degradation, suitable for injection moulding into shaped articles with improved mechanical and biodegradability properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If starch is subjected to high temperature and pressure processing to improve mechanical properties, then tensile strength increases, but biodegradability decreases

Engineering Contradiction:
Improvetensile strengthVSAvoidbiodegradability
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent applies parameter changes by optimizing processing conditions (temperature, pressure, residence time) to achieve the right balance between mechanical strength and biodegradability. Specifically, it uses moderate temperatures (100-200°C) and pressures (0-15 MPa) with controlled residence times to create a starch structure that is both strong and rapidly degradable, resolving the contradiction between strength and biodegradability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces dynamics by creating a starch structure with controlled crystallinity and molecular arrangement that allows rapid enzymatic degradation while maintaining mechanical integrity during use. The starch is processed to create a dynamic structure that can transition from a strong, stable state during implantation to a rapidly degrading state in the biological environment

Inventive Principle:
Principle #15Dynamics

2Ease of manufacture

If additives like plasticizers and lubricants are used to improve processing, then ease of manufacture increases, but cytotoxicity increases

Engineering Contradiction:
Improveprocessing easeVSAvoidcytotoxicity
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent applies the taking out principle by removing harmful additives (plasticizers, lubricants, and other additives) from the starch composition while maintaining processability through optimized processing conditions. The invention achieves ease of manufacture without cytotoxic additives by using pure starch processed under controlled conditions, thereby eliminating the harmful effects while preserving manufacturing feasibility

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses the disposable principle by relying on the starch material itself to provide all necessary functional properties without requiring persistent additives. The starch is processed to be inherently biodegradable and non-cytotoxic, allowing the material to be disposed of or degraded naturally in the body without leaving harmful residues from additives

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If starch is destructurised to improve biodegradability, then degradation rate increases, but mechanical properties deteriorate

Engineering Contradiction:
ImprovebiodegradabilityVSAvoidmechanical properties
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent applies partial action by performing controlled destructurization to the extent necessary for rapid biodegradability while preserving enough structural integrity for mechanical strength. The processing is optimized to achieve partial destructurization rather than complete degradation, creating a starch structure that is sufficiently exposed to enzymes for rapid degradation while maintaining enough molecular arrangement to provide tensile strength and mechanical properties

Inventive Principle:
Principle #16Partial or excessive action

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

The biodegradable material exhibits excellent tensile strength, rapid degradation, and reduced cytotoxicity, making it suitable for pharmaceutical, neutraceutical, and implantation applications, with shaped articles demonstrating increased susceptibility to enzymatic action and improved in vivo degradability.

Implementation Method 1

extrusion with water as a plasticizer at moderate temperatures and pressures

Methodology Applied
Scientific EffectPlasticization:

Implementation Method 2

rapid enzymatic degradation

Methodology Applied
Scientific EffectEnzymatic hydrolysis: Enzyme

Implementation Method 3

breaking of α-1,4-glycosidic bonds

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Data Source

PatentEP2115008B1Biodegradable material based on opened starch
Publication Date: 2019.09.18 DE STAAT DER NEDERLANDEN VERT DOOR DE MINIST VAN VWS
  • EP2115008B1 patent drawingFigure 1
  • EP2115008B1 patent drawing

AI summary

The present application relates to a biodegradable material comprising opened starch or a mixture of opened starch and destructurised starch. The biodegradable material comprises about 50 to about 100 wt.% of opened starch or of a mixture of opened starch and destructurised starch, based on the total weight of the biodegradable material, said biodegradable material having a bulk density of 1.0 to 1.5 kg/dm. The biodegradable material is used for manufacturing biodegradable shaped articles, wherein said biodegradable shaped articles are suitable for delivery of a biologically or pharmaceutically active component in or to a vertebrate, e.g. a mammal.