Gastro-resistant Soft Capsule Shell via Gellan Gum and Starch

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Solution Overview

Problem

Gelatin-based soft shell capsules are costly, prone to cross-linking, and not gastro-resistant, posing challenges for vegetarian and halal compliance, and requiring additional costly coating steps, while alternatives have failed to replicate textural and functional properties effectively.

Innovation Solution

Development of gastro-resistant soft shell capsules using a blend of high acyl gellan gum, low acyl gellan gum, and starch with a plasticizer, which provides resistance under simulated gastric conditions without the need for enteric coatings, achieved through a specific manufacturing process involving controlled ribbon thickness and drying.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If gelatine is used for capsule shell, then good sealing and elasticity are achieved, but the capsules are not gastro-resistant and require additional coating steps

Engineering Contradiction:

Improvecapsule sealing strengthVSAvoidmanufacturing complexity

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent changes the material composition parameters by replacing gelatine with a specific formulation of gellan gum (combining high acyl and low acyl types) and starch, adjusted to achieve both sealing strength and gastro-resistance without additional coatings

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite capsule shell material combining gellan gum and starch in specific proportions, where gellan gum provides sealing and elasticity while starch contributes to gastro-resistance, eliminating the need for separate coating steps

Inventive Principle:

Principle #40Composite materials

2Reliability

If gelatine is used for capsule shell, then good solubility in aqueous media is achieved, but the capsules lack gastro-resistance

Engineering Contradiction:

Improvecapsule disintegrationVSAvoidgastric acid resistance

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent modifies the chemical composition parameters by incorporating starch and specific gellan gum types, changing the material's interaction with gastric acid to achieve resistance while maintaining controlled disintegration in intestinal fluid

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses a biodegradable natural polymer system (gellan gum and starch) that is cost-effective and environmentally friendly, replacing expensive gelatine while achieving the required functional performance

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Adaptability or versatility

If alternative materials replace gelatine, then vegetarian and halal compliance is achieved, but textural and functional properties are compromised

Engineering Contradiction:

Improvedietary complianceVSAvoidcapsule textural properties

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent optimizes the composition parameters of gellan gum (acyl content ratios) and starch to match the textural and functional properties of gelatine, achieving both dietary compliance and performance equivalence

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent develops a composite system combining gellan gum and starch that replicates the desirable properties of gelatine (sealing, elasticity, solubility) while maintaining vegetarian and halal compliance

Inventive Principle:

Principle #40Composite materials

4Object-affected harmful factors

If enteric coating is applied to gelatine capsules, then gastro-resistance is achieved, but manufacturing cost increases

Engineering Contradiction:

Improvegastric acid resistanceVSAvoidmanufacturing cost

Core Design Contradiction:

Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The patent extracts and eliminates the need for enteric coating by incorporating gastro-resistant properties directly into the capsule shell formulation through the use of starch and gellan gum, simplifying the manufacturing process and reducing costs

Inventive Principle:

Principle #2Taking out (Extraction)

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 capsules demonstrate gastro-resistance for at least 60 minutes in simulated gastric fluid and disintegrate within 60 minutes in intestinal fluid, offering a cost-effective, compliant, and functional alternative to traditional gelatin-based capsules.

Implementation Method 1

a) high acyl gellan gum having more than 40 % acetyl and more than 45 % glyceryl residual substituents per repeat unit, b) low acyl gellan having less than 25 % acetyl and less than 15 % glyceryl residual substituents per repeat unit

Methodology Applied

Scientific EffectGelation: Gel

Implementation Method 2

c) at least one starch, d) at least one plasticizer

Methodology Applied

Scientific EffectPlasticization: Plasticity

Data Source

PatentEP3010493B1Gastro-resistant soft shell capsule and process for its manufacture

Publication Date: 2019.08.07 SWISS CAPS RECHTE & LIZENZEN

Figure 1~2

AI summary

The invention relates to gastro-resistant soft shell capsules having a capsule shell comprising high acyl gellan gum, at least one starch and at least one plasticizer, wherein the capsules fulfil pharmacopoeial disintegration tests characterizing the capsules as gastro-resistant dosage forms. The invention further relates to a method for manufacturing such gastro-resistant soft shell capsules.