Soft Capsule Shell Composition Plasticizer System

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Solution Overview

Problem

Soft capsule shells that use glycerin as a plasticizer face issues with softening and adhesion under high temperature and humidity, and sorbitan, which prevents crystallization, is not approved by regulatory bodies, while existing formulations with sorbitol and maltitol struggle with transparency and gloss.

Innovation Solution

A soft capsule shell composition comprising a base of starch and carrageenan with sorbitol, maltitol, and glycerin as plasticizers, blended in specific proportions, which enhances flexibility, prevents adhesion, and maintains transparency and gloss, even when glycerin is used.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If glycerin is used as a plasticizer in the soft capsule shell, then plasticity and flexibility are improved, but the shell softens and becomes adhesive under high temperature and humidity conditions

Engineering Contradiction:
Improveplasticity and flexibilityVSAvoidsoftening and adhesion under high temperature and humidity
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent uses a composite plasticizer system combining glycerin (30-60 parts), sorbitol (1-15 parts), and maltitol (1-30 parts) per 100 parts of starch-carrageenan base. This composite approach allows glycerin to provide plasticity and flexibility while sorbitol and maltitol counterbalance the softening and adhesion issues under high temperature and humidity conditions.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent optimizes the proportions of each plasticizer component within specific ranges: glycerin at 30-60 parts, sorbitol at 1-15 parts, and maltitol at 1-30 parts per 100 parts of base material. These parameter adjustments ensure the shell maintains adequate plasticity while preventing excessive softening and adhesion.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If sorbitan is added to prevent sorbitol crystallization and maintain transparency, then appearance is improved, but regulatory approval is not obtained since sorbitan is not in the approved additives list

Engineering Contradiction:
Improvetransparency and prevention of crystal precipitationVSAvoidregulatory compliance
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent removes sorbitan from the formulation while maintaining the transparency and crystal prevention functions through an alternative approach. By using a specific combination of sorbitol and maltitol in controlled proportions within the plasticizer system, the patent achieves the desired optical properties without relying on the unapproved sorbitan additive.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent adjusts the proportions of sorbitol (1-15 parts) and maltitol (1-30 parts) within the plasticizer system to prevent sorbitol crystallization and maintain transparency. This parameter optimization achieves the optical stability function previously provided by sorbitan, but using only approved additives.

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If the soft capsule shell contains glycerin to enhance plasticity, then flexibility is improved, but the capsule adheres to itself and storage containers during storage

Engineering Contradiction:
ImproveplasticityVSAvoidadhesion to self and storage container
Core Design Contradiction:
Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The patent employs a composite plasticizer formulation combining glycerin (30-60 parts) with sorbitol (1-15 parts) and maltitol (1-30 parts). This composite system maintains the plasticity-enhancing properties of glycerin while the sorbitol and maltitol components reduce the adhesion tendency, preventing the capsule from sticking to itself and storage containers.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent optimizes the glycerin content within 30-60 parts per 100 parts of base material and balances it with specific amounts of sorbitol and maltitol. This parameter control ensures adequate plasticity is achieved while minimizing the harmful adhesion effect during storage.

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

The formulation achieves excellent plasticity, flexibility, and transparency, preventing cracking and adhesion, while maintaining softness and impact resistance, even with capsule fills that harden over time, and has a high commercial value.

Implementation Method 1

Glycerin is hygroscopic and has thus a moisture-retaining effect

Methodology Applied
Scientific EffectHygroscopic effect: Absorption (physical)

Implementation Method 2

The sorbitan has effects of preventing sorbitol from crystallizing and keeping the soft capsule shell transparent

Methodology Applied
Scientific EffectCrystallization prevention: Crystallisation

Implementation Method 3

the soft capsule shell containing glycerin softens under conditions of high temperature and high humidity

Methodology Applied
Scientific EffectThermal stability: Thermal Expansion

Data Source

PatentEP3332774B1Composition for soft capsule shell
Publication Date: 2021.09.29 FUJI CAPSULE
  • EP3332774B1 patent drawing
  • EP3332774B1 patent drawing
  • EP3332774B1 patent drawing

AI summary

When preparing a soft capsule shell by forming a film from a composition for a soft capsule shell comprising a base containing either gelatin or a mixture of starch and carrageenan as a main component and a plasticizer containing sorbitol, maltitol and glycerin as main components, it is possible to provide a soft capsule in which the soft capsule shell thereof does not easily soften and the surface of the soft capsule shell is resistant to adherence and which has excellent gloss and transparency even if the plasticizer contains glycerin.