High Amylose Starch Tablet Coating via Dip Process

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Solution Overview

Problem

Existing pharmaceutical dosage forms, such as caplets and gelcaps, face limitations including decreased dissolution rate over time due to gelatin cross-linking and potential microbial contamination, while lacking the aesthetic appeal of gelatin-coated forms.

Innovation Solution

A method of coating tablets using a liquid containing at least 50% amylose content starch, such as pea starch, with optional gums and plasticizers, to create a high-gloss, crack-resistant coating that is free from gelatin and its associated issues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Illumination intensity

If gelatin is used as a coating material to achieve elegant and shiny appearance, then aesthetic appeal is improved, but dissolution rate decreases over time due to cross-linking and microbial contamination risk increases

Engineering Contradiction:

Improveaesthetic appealVSAvoiddissolution rate

Core Design Contradiction:

Illumination intensityVSReliability

Solution Approach 1:

The patent changes the chemical composition parameters of the coating material from gelatin to starch-based polymers with specific properties (amylose content, molecular weight, substitution degree) to maintain aesthetic appearance while improving dissolution reliability and eliminating cross-linking issues

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces gelatin with starch-based materials that are more stable, resistant to microbial contamination, and maintain their functional properties over extended storage periods without degrading or cross-linking

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Illumination intensity

If gelatin is used as a coating material to achieve elegant and shiny appearance, then aesthetic appeal is improved, but microbial contamination risk increases

Engineering Contradiction:

Improveaesthetic appealVSAvoidmicrobial contamination

Core Design Contradiction:

Illumination intensityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces gelatin with starch-based materials that are inherently more resistant to microbial contamination and do not require the same level of sterile handling and storage conditions, eliminating the harmful effect of microbial contamination

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent uses composite starch-based materials with specific chemical modifications (acetate, propionate, stearate substitutions) that provide both aesthetic properties and enhanced resistance to microbial contamination

Inventive Principle:

Principle #40Composite materials

3Ease of manufacture

If spray coating is used to apply polymer coating to improve aesthetics and swallowability, then ease of manufacture is improved, but surface gloss and elegance are reduced

Engineering Contradiction:

Improveease of manufactureVSAvoidsurface gloss

Core Design Contradiction:

Ease of manufactureVSIllumination intensity

Solution Approach 1:

The patent replaces the spray coating mechanical system with a dip coating process that allows the coating solution to uniformly envelop the tablet core, producing a smoother and more glossy surface while remaining commercially feasible

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Illumination intensity

If dip coating with gelatin is used to achieve elegant and shiny appearance, then aesthetic appeal is improved, but dissolution rate decreases over time due to cross-linking

Engineering Contradiction:

Improveaesthetic appealVSAvoiddissolution rate

Core Design Contradiction:

Illumination intensityVSDuration of action of moving object

Solution Approach 1:

The patent changes the chemical composition parameters from gelatin to starch-based polymers with controlled molecular weight, amylose content, and substitution degree to prevent cross-linking while maintaining aesthetic appearance and ensuring consistent dissolution over time

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses starch-based materials that remain stable and do not cross-link during extended storage, maintaining their dissolution properties throughout the product shelf life without degradation

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 coating provides a high-gloss, crack-resistant, and stable dosage form with improved dissolution properties and reduced microbial risk, comparable to gelatin coatings but without their drawbacks.

Implementation Method 1

a method of making a coated tablet by dipping a core comprising an active agent into a coating liquid and drying said dipped core to form a outer-coating on the core

Methodology Applied

Scientific EffectDip coating: Deposition (physical)

Implementation Method 2

drying said dipped core to form a outer-coating on the core

Methodology Applied

Scientific EffectEvaporation: Evaporation

Data Source

PatentUS8722089B2Dip coated compositions containing a starch having a high amylose content

Publication Date: 2014.05.13 KENVUE BRANDS LLC

AI summary

The present invention features a method of making a coated tablet by dipping a core comprising an active agent into a coating liquid and drying said dipped core to form a outer-coating on the core, wherein the coating liquid contains at least one a starch having an amylose content of at least about 50 percent by weight of said starch.