Natural Binder Composition for Tablet Hardness and Consistency

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Solution Overview

Problem

Current natural binder systems for solid oral dosage forms are inadequate, as they fail to provide reliable tablet hardness, friability, and dissolution profiles, often resulting in adverse processing characteristics like reduced flowability and batch-to-batch variation, and there is a lack of commercially available natural binder systems comprised entirely or almost entirely of certified organic components.

Innovation Solution

A natural binder composition comprising a blend of guar gum, xanthan gum, gum arabic, pullulan, honey powder, agave powder, isolated pea protein, and natural plant fibers, which improves flowability and compressibility, and can be used in direct compression or granulation techniques, forming a pre-mix that enhances tablet hardness and batch consistency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If natural binder compositions are used in solid dosage forms, then clean label and natural ingredients are achieved, but tablet hardness and processing reliability deteriorate

Engineering Contradiction:
Improveclean labelVSAvoidtablet hardness
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The patent combines multiple natural binder components (guar gum, xanthan gum, gum arabic, pullulan, starch, and natural plant fibers) into a composite binder composition. This merging of multiple natural substances creates synergistic effects that achieve both clean label requirements and sufficient tablet hardness, resolving the contradiction between natural ingredients and mechanical strength.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention uses composite material principles by formulating a multi-component natural binder system where each ingredient contributes specific properties. The combination of different gums, starches, and plant fibers creates a composite binder with enhanced binding capability while maintaining natural status, thus achieving both clean label and adequate tablet hardness.

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If natural binder compositions are used, then clean label is achieved, but flowability and compressibility deteriorate

Engineering Contradiction:
Improveclean labelVSAvoidflowability
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent optimizes the proportions of each binder component within specific ranges (e.g., guar gum 10-40%, xanthan gum 5-20%, gum arabic 10-30%) to achieve the right balance between clean label and processing characteristics. By carefully controlling the parameters of composition and ratios, the binder composition achieves both natural status and adequate flowability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention incorporates natural plant fibers (1-10%) as a specific functional component that improves flowability and compressibility locally within the binder system. This targeted addition of fibers addresses the specific processing issue without compromising the overall natural character of the binder composition.

Inventive Principle:
Principle #3Local quality

3Object-affected harmful factors

If natural binder compositions are used, then clean label and natural ingredients are achieved, but batch-to-batch consistency deteriorates

Engineering Contradiction:
Improveclean labelVSAvoidbatch-to-batch consistency
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The multi-component binder composition is designed to provide multiple functions simultaneously: binding, flow enhancement, compressibility improvement, and batch consistency stabilization. Each component serves multiple purposes, and their combined effect creates a robust system that maintains consistent performance across batches while remaining entirely natural.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The binder composition is pre-formulated with optimized ratios of all components before use in tablet manufacturing. This preliminary preparation ensures that the exact composition is achieved consistently across batches, eliminating variability that would occur with individual natural ingredients and ensuring reliable batch-to-batch performance.

Inventive Principle:
Principle #10Preliminary 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 natural binder composition significantly improves tablet hardness and batch-to-batch consistency, offering a clean label option and serving as an effective substitute for conventional dry binders, with even a 3% content outperforming hydroxypropyl cellulose in tablet hardness.

Implementation Method 1

providing cohesiveness on the ingredients of solid dosage forms to form granules or tablets

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentEP3634491B1Natural and organic binder compositions for oral solid dosage forms
Publication Date: 2023.04.05 BIOGRUND
  • EP3634491B1 patent drawingFigure 1
  • EP3634491B1 patent drawingFigure 2

AI summary

The present invention relates to a binder composition of different natural/organic binders to ensure efficient tablet manufacturing and batch to batch consistency with avoiding the risk of having capping or lamination problems during the manufacturing process. The composition comprises a blend of components selected from a blend of components selected from : a. of about 5% to about 65% by weight guar gum, xanthan gum or a combination thereof; b. of about 5% to about 65% by weight gum arabic; of about 5% to about 65% by weight pullulan, honey powder, agave powder, or isolated pea protein or any combination of the foregoing; and d. about 1% to about 15% by weight natural plant fibers, all weight percentages being based on the dry weight of the binder composition.